Reducing Tobacco Use A Report of the Surgeon General DEPARTMENTOFHEALTHANDHUMANSERVICES U.S. Public Health Service CDC CENTERS FOR DISEASE CONTROL AND PREVENTION Suggested Citation U.S. Department of Health and Human Services. Reducing Tobacco Use: A Report of the Surgeon General. Atlanta, Georgia: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2000. For sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, DC. 20402, S/N 017-001-00544-4. Use of trade names is for identification only and does not constitute endorsement by the U.S. Department of Health and Human Services. Message From Donna E. Shalala Secretary of Health and Human Services This nation is faced with many challenges in its efforts to improve the health status of all people living in the United States. One of the biggest challenges is to remedy the fact that approximately one-fourth of our adults continue to smoke and that tobacco use rates among our youth have increased since the early 1990s. Tobacco use, particularly cigarette smoking, remains the leading cause of prevent- able illness and death in this country Our overall success in improving the health status of the U.S. population thus depends greatly on achieving dramatic reduc- tions in the rate of tobacco use among both adults and young people. Reducing tobacco use is a key component of Healthy People 2020, the national action plan for improving the health of all Americans for the first decade of the 21st century. No fewer than 21 specific national health objectives related to to- bacco are listed, including a goal to more than halve the current rates of tobacco use among young people and adults. Attaining all of the Healthy People 2010 to- bacco use objectives will require significant commitment and progress in numer- ous areas. This Surgeon General's report provides a major resource in our national ef- forts to achieve the Healthy People 2020 tobacco use objectives. The research find- ings reviewed indicate that many strategies and approaches have been shown to be effective in preventing tobacco use among young people and in helping to- bacco users end their addiction. The challenge to public health professionals, health care systems, and other partners in our national prevention effort is to implement these proven approaches. Through the Secretary's Initiative to Prevent Tobacco Use Among Teens and Preteens, the Department works with federal and nonfederal efforts to reduce young people's demand for tobacco products. This Surgeon General's report highlights additional strategies and approaches that this initiative can expand upon. Only by a coordinated national effort will the tobacco use rates among our young people be reduced. Each day that we delay in developing a comprehensive national re- sponse to this problem, 3,000 additional teens and preteens become regular smok- ers. That statistic poses an urgent public health challenge and-given that we have at hand numerous strategies proven to be effective-a moral imperative. Foreword For more than three decades, the Surgeon General of the U.S. Public Health Service has released reports focused on tobacco use and the health of the Ameri- can people. The tone and content of these reports have changed over the years. Early on, there was a need for critical review of the epidemiologic and biologic aspects of tobacco use. Today, the deleterious effects are well documented, and the reports have begun to investigate the social, economic, and cultural conse- quences of these effects and what can be done to address them. The present report assesses past and current efforts to reduce the use of tobacco in this country and thereby ameliorate its disastrous health effects. Tobacco use is an extraordinary phenomenon. Although substantial progress has been made since the initial report of the Surgeon General's Ad Hoc Committee in 1964, approximately a quarter of the U.S. adult population smokes, and the percentage of high school youth who smoke has steadily increased throughout the 1990s. Results from community-based interventions and statewide programs show that a comprehensive approach to tobacco control is needed to curtail the epidemic. This report summarizes several effective approaches to reducing tobacco use and presents the considerable evidence-as well as the attendant controversies- supporting their application. Multifaceted school-based education programs that are performed in conjunction with community-based campaigns have met with substantial success. The management of nicotine addiction in persons who al- ready smoke has the benefit of clinical tools, that is, systems for weaning persons from nicotine, the efficacy of which is clearly demonstrated. Product regulation, enforcement of clean indoor air standards, and protecting young people from the supposed attractiveness of cigarettes all promise substantial impact. By analyzing the economics of tobacco and by examining models that assess the effect of eco- nomic policies, we find that various approaches can mitigate the adverse outcomes associated with tobacco use-and can do so without the dire economic conse- quences claimed by those who profit from tobacco use. But if the evidence is clear that tobacco use is harmful and if the tools are available to reduce its use, why has the reduction in prevalence been less than would be expected ? The answer is very complex. As described in Chapter 1 of this report, numerous forces influence a person's decision to smoke, or if that per- son is a smoker, the forces that drive continued use. The most important force for smoking is the totality of industry activity, including advertising, promotion, organizational activity, support for ancillary issues, and political action, which maintains marketability and profitability of the product. Efforts to reduce tobacco use face a more than $5 billion annual budget that the tobacco industry dedicates to advertising and promotion aimed at sustaining or increasing tobacco use. None- theless, there is cause for optimism based on considerable public support for ef- forts to prevent children from becoming addicted to tobacco. If the recent pattern of increases in youth tobacco use can be reversed, we can make progress toward tobacco-free generations in the future. Jeffrey I? Koplan, M.D., M.P.H. Director Centers for Disease Control and Prevention and Administrator Agency for Toxic Substances and Disease Registry ii Preface from the Surgeon General, U.S. Department of Health and Human Services Almost 50 years ago, evidence began to accumulate that cigarette smoking poses an enormous threat to human health. More than 30 years ago, an initial report from the Surgeon General's office made an unqualified announcement of tobacco's harm. Beginning in 1969, the series of Surgeon General's reports began meticulous documentation of the biologic, epidemiologic, behavioral, pharmaco- logic, and cultural aspects of tobacco use. The present report, an examination of the methods and tools available to reduce tobacco use, is being issued at a time of considerable foment. The past several years have witnessed major initiatives in the legislative, regulatory, and legal arenas, with a complex set of results still not entirely resolved. This report shows that a variety of efforts aimed at reducing tobacco use, particularly by children, would have a heightened impact in the absence of countervailing pressures to smoke. Besides providing extensive background and detail on historical, social, economic, clinical, educational, and regulatory efforts to reduce tobacco use, the report indicates some clear avenues for future research and implementation. It is of special concern to derive a greater understanding of cultural differences in response to tobacco control measures. Since racial and eth- nic groups are differentially affected by tobacco, elimination of disparities among these groups is a major priority. Perhaps the most pressing need for future research is to evaluate multifocal, multichannel programs that bring a variety of modalities together. For example, as Chapter 3 demonstrates, school-based education programs are more effective when coupled with community-based initiatives that involve mass media and other techniques. As pointed out in Chapter 4, a combination of behavioral and phar- macologic methods improves the success rate when managing nicotine addiction. Synergy among economic, regulatory, and social approaches has not been fully explored, but may offer some of the most fruitful efforts for the future. Chapter 7 provides the preliminary data on new statewide, comprehensive tobacco control programs, which offer great promise as new models for tobacco control and com- bine multiple intervention modalities. Although all aspects-social, economic, educational, and regulatory-have not been combined into a fully comprehensive effort, it is exciting to contemplate the potential impact of such an undertaking to eventually ensure that children are protected from the social and cultural influ- ences that lead to tobacco addiction, that all smokers are encouraged to quit as soon as possible, and that nonsmokers are protected from environmental tobacco smoke. David Satcher, M.D., Ph.D. Surgeon General and Assistant Secretary for Health Reducing Tobacco Use Acknowledgments This report was prepared by the U.S. Department of Health and Human Services under the general direc- tion of the Centers for Disease Control and Preven- tion, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health. Jeffrey l? Koplan, M.D., M.P.H., Director, Centers for Disease Control and Prevention, Atlanta, Georgia. James S. Marks, M.D., M.P.H., Director, National Cen- ter for Chronic Disease Prevention and Health Promo- tion, Centers for Disease Control and Prevention, Atlanta, Georgia. Michael I'. Eriksen, Sc.D., Director, Office on Smoking and Health, National Center for Chronic Disease Pre- vention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia. The editors of the report were Richard B. Rothenberg, M.D., M.P.H., Senior Scientific Editor, Professor, Department of Family and Preven- tive Medicine, Emory University School of Medicine, Atlanta, Georgia. Terry F. Pechacek, Ph.D., Associate Scientific Editor, Associate Director for Science, Office on Smoking and Health, National Center for Chronic Disease Preven- tion and Health Promotion, Centers for Disease Con- trol and Prevention, Atlanta, Georgia. Frank J. Chaloupka, IV, Ph.D., Consulting Scientific Editor, Professor, Department of Economics, Univer- sity of Illinois, Chicago, Illinois. Michael C. Fiore, M.D., M.P.H., Consulting Editor, Pro- fessor, Department of Medicine, and Director, Center for Tobacco Research and Intervention, University of Wisconsin Medical School, Madison, Wisconsin. Gayle Lloyd, M.A., Managing Editor, Office on Smok- ing and Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia. Frederick L. Hull, Ph.D., Technical Editor, Technical Information and Editorial Services Branch, National Center for Chronic Disease Prevention and Health Pro- motion, Centers for Disease Control and Prevention, Atlanta, Georgia. Contributing authors were Timothy B. Baker, Ph.D., Professor of Psychology, Associate Director, Center for Tobacco Research and Intervention, University of Wisconsin Medical School, Madison, Wisconsin. Michele Bloch, M.D., Ph.D., Health Policy Consultant, Rockville, Maryland. Ross C. Brownson, Ph.D., Professor and Chair, Depart- ment of Community Health, School of Public Health, Saint Louis University, St. Louis, Missouri. Frank J. Chaloupka, IV, Ph.D., Professor, Department of Economics, University of Illinois, Chicago, Illinois. Patricia Davidson, J.D., Staff Attorney, Tobacco Control Resource Center, Boston, Massachusetts. Richard A. Daynard, J.D., Ph.D., Chair, Tobacco Prod- ucts Liability Project, and Professor, Northeastern University School of Law, Boston, Massachusetts. Clifford E. Douglas, J.D., President, Tobacco Control Law and Policy Consulting, Ann Arbor, Michigan. Brian S. Flynn, Sc.D., Professor and Director, Office of Health Promotion Research, College of Medicine, Uni- versity of Vermont, Burlington, Vermont. Jean L. Forster, Ph.D., M.P.H., Associate Professor, Division of Epidemiology, School of Public Health, University of Minnesota, Minneapolis, Minnesota. Marc Galanter, J.D., John and Rylla Bosshard Profes- sor of Law, University of Wisconsin Law School, Madi- son, Wisconsin. u Surgeon General's Report Lawrence 0. Gostin, J.D., Professor of Law, Georgetown University Law Center, and Co-Director, Georgetown/ Johns Hopkins Program on Law and Public Health, Washington, D.C. Mark Gottlieb, J.D., Staff Attorney, Tobacco Control Resource Center, Boston, Massachusetts. Douglas E. Jorenby, Ph.D., Assistant Professor, Center for Tobacco Research and Intervention, University of Wisconsin Medical School, Madison, Wisconsin. Graham Kelder, J.D., Managing Attorney, Tobacco Control Resource Center, Boston, Massachusetts. Robert Kline, J.D., Staff Attorney, Tobacco Control Resource Center, Boston, Massachusetts. Jeff McKenna, M.S., Chief, Health Communications Branch, Office on Smoking and Health, National Cen- ter for Chronic Disease Prevention and Health Promo- tion, Centers for Disease Control and Prevention, Atlanta, Georgia. Thomas M. Piasecki, MS., Research Associate, Center for Tobacco Research and Intervention, University of Wisconsin Medical School, Madison, Wisconsin. Raymond Porfiri, J.D., Staff Attorney, Tobacco Control Resource Center, Boston, Massachusetts. Michael Schudson, Ph.D., Professor, Department of Communication, University of California, San Diego, La Jolla, California. Donald Sharp, M.D., Medical Officer, Office on Smok- ing and Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia. John Slade, M.D., Professor, New Jersey School of Public Health, University of Medicine and Dentistry of New Jersey, New Brunswick, New Jersey. David T. Sweanor, LL.B., Senior Legal Counsel, Non- Smokers' Rights Association, Ottawa, Ontario, Canada. Edward L. Sweda, Jr., J.D., Senior Attorney, Tobacco Control Resource Center, Boston, Massachusetts. Gerald J. Thain, J.D., Consumer Law Professor, University of Wisconsin Law School, Madison, Wisconsin. David W. Wetter, Ph.D., Assistant Professor, M.D. Anderson Cancer Center, University of Texas, Hous- ton, Texas. John K. Worden, Ph.D., Research Professor, Office of Health Promotion Research, College of Medicine, University of Vermont, Burlington, Vermont. Reviewers were David G. Altman, Ph.D., Professor, Department of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, North Carolina. Dileep G. Bal, M.D., Chief, Cancer Control Branch, California Department of Health Services, Sacramento, California. Scott D. Ballin, J.D., Vice President and Legislative Counsel, Office of Public Affairs, American Heart Association, Washington, D.C. Glen Bennett, M.P.H., Coordinator, Advanced Tech- nologies Applications in Health Education Programs, Office of Prevention, Education, and Control, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland. Neil Bracht, M.A., M.P.H., Professor Emeritus, School of Social Work and School of Public Health, Univer- sity of Minnesota, Minneapolis, Minnesota. Allan M. Brandt, Ph.D., Professor Emeritus, Depart- ment of Social Medicine, Harvard Medical School, Boston, Massachusetts. Jesse W. Brown, Jr., M. Div., President, National Asso- ciation of African Americans for Positive Imagery, Philadelphia, Pennsylvania. John C. Burnham, Ph.D., Professor of History and Pro- fessor of Psychiatry, Ohio State University, Columbus, Ohio. David M. Burns, M.D., Professor of Medicine, Depart- ment of Medicine, University of California, San Diego, California. Joseph A. Califano, Jr., President and Chairman, The National Center on Addiction and Substance Abuse, Columbia University, New York, New York. Julia Carol, Co-Director, Americans for Nonsmokers' Rights, Berkeley, California. vi Nelba Chavez, Ph.D., Administrator, Substance Abuse and Mental Health Services Administration, Rockville, Maryland. Moon S. Chen, Jr., Ph.D., M.P.H., Professor and Chair, Division of Health Behavior and Health Promotion, School of Public Health, Ohio State University, and Editor-in-Chief, Asian American and Pacific Islander Journal of Health, Columbus, Ohio. Gregory Connolly, D.M.D., M.P.H., Director, Massa- chusetts Tobacco Control Program, Massachusetts Department of Public Health, Boston, Massachusetts. Stephen B. Corbin, D.D.S., M.P.H., Chief of Staff, Of- fice of the Surgeon General, and Chief Dental Officer, Public Health Service, Rockville, Maryland. Linda S. Crossett, R.D.H., Health Intervention Scien- tist, Division of Adolescent and School Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia. K. Michael Cummings, Ph.D., M.P.H., Senior Research Scientist and Chair, Department of Cancer Control and Epidemiology, Roswell Park Cancer Institute, Buffalo, New York. Lisa Daily, Associate Director for Planning, Evaluation, and Legislation, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia. Ronald M. Davis, M.D., Director, Center for Health Promotion and Disease Prevention, Henry Ford Health System, Detroit, Michigan. Joseph R. DiFranza, M.D., Professor of Family and Community Medicine, University of Massachusetts, Worcester, Massachusetts. Fran Du Melle, Deputy Managing Director, American Lung Association, Washington, D.C. John I? Elder, Ph.D., M.P.H., Professor and Head, Division of Health Promotion, Graduate School of Public Health, San Diego State University, San Diego, California. Ellen Feighery, R.N., M.S., Research Associate, Stanford Center for Research in Disease Prevention, School of Medicine, Stanford University, Palo Alto, California. Reducing Tobacco Use Burke Fishburn, M.P.P., Health Policy Analyst, Office on Smoking and Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia. Julie Fishman, M.P.H., Lead Health Policy Analyst, Office on Smoking and Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia. Brian R. Flay, D. Phil., Director, Health Research and Policy Centers, University of Illinois, Chicago, Illinois. Adele L. Franks, M.D., Associate Director for Science, Division of Nutrition and Physical Activity, National Center for Chronic Disease Prevention and Health Pro- motion, Centers for Disease Control and Prevention, Atlanta, Georgia. John A. Gardiner, Ph.D., LL.B., Director of the Office of Social Science Research, University of Illinois, Chi- cago, Illinois. Gary A. Giovino, Ph.D., MS., Senior Research Scien- tist, Department of Cancer Prevention, Epidemiology, and Biostatistics, Roswell Park Cancer Institute, Buf- falo, New York. Stanton Glantz, Ph.D., Professor of Medicine, Division of Cardiology, University of California, San Francisco, California. Mark M. Hager, J.D., Ph.D., Professor, Washington College of Law, American University, Washington, D.C. William Hansen, Ph.D., President, Tanglewood Re- search, Clemmons, North Carolina. James A. Harrell, Commissioner, Administration on Children, Youth and Families, Administration for Chil- dren and Families, Washington, D.C. Jeffrey E. Harris, M.D., Ph.D., Professor, Department of Economics, Massachusetts Institute of Technology, and primary care physician, Massachusetts General Hospital, Boston, Massachusetts. Sandra W. Headen, Ph.D., Assistant Professor, Depart- ment of Health Behavior and Health Education, School of Public Health, University of North Carolina, Chapel Hill, North Carolina. vii Slqeorl Gerleral `s Report Jack E. Henningfield, Ph.D., Associate Professor of Behavioral Biology, Department of Psychiatry and Behavioral Sciences, The Johns Hopkins University School of Medicine, Baltimore, Maryland, and Vice President, Research and Health Policy, Pinney Associ- ates, Bethesda, Maryland. Thomas l? Houston, M.D., Director of Preventive Medi- cine and Environmental Health, American Medical Association, Chicago, Illinois. Teh-wei Hu, Ph.D., Professor, School of Public Health, University of California, Berkeley, California. John R. Hughes, M.D., Professor, Departments of Psy- chiatry, Psychology, and Family Practice, University of Vermont, Burlington, Vermont. Corinne Husten, M.D., M.P.H., Chief, Epidemiology Branch, Office on Smoking and Health, National Cen- ter for Chronic Disease Prevention and Health Promo- tion, Centers for Disease Control and Prevention, Atlanta, Georgia. Jonathan B. Imber, Ph.D., Professor, Department of Sociology, Wellesley College, Wellesley, Massachusetts. Murray J. Kaiserman, Ph.D., M.B.A., Coordinator, Research and Surveillance, Office of Tobacco Control, Health Protection Branch, Health Canada, Ottawa, Ontario, Canada. Laura K. Kann, Ph.D., Chief, Surveillance Research Section, Division of Adolescent and School Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia. Nancy J. Kaufman, R.N., M.S., Vice President, The Robert Wood Johnson Foundation, Princeton, New Jersey. Beverly Kingsley, Ph.D., M.P.H., Epidemiologist, Of- fice on Smoking and Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia. Norman A. Krasnegor, Ph.D., Chief, Human Learning and Behavior Branch, Center for Research for Moth- ers and Children, National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland. Rick Kropp, Executive Director, Tobacco Prevention and Policy Resources Center, Stop Tobacco Access for Minors Project and Stop Tobacco Advertising Aimed at Minors Project, Santa Rosa, California. Harry Lando, Ph.D., Professor, Division of Epidemi- ology, School of Public Health, University of Minne- sota, Minneapolis, Minnesota. Murray Laugesen, F.F.P.H.M., F.R.C.S., Public Health Physician, Health New Zealand, Auckland, New Zealand. Edward Lichtenstein, Ph.D., Research Scientist, Oregon Research Institute, Eugene, Oregon. Douglas S. Lloyd, M.D., M.P.H., Director, Center for Public Health Practice, Health Resources and Services Administration, Rockville, Maryland. Alan D. Lopez, Ph.D., Epidemiologist, Programme on Substance Abuse, World Health Organization, Geneva, Switzerland. Barbara S. Lynch, Ph.D., Consultant, Rockville, Maryland. Willard Manning, Ph.D., Professor, Department of Health Studies, Graduate School of Public Policy Stud- ies, University of Chicago, Chicago, Illinois. Paul Marantz, M.D., M.P.H., Associate Professor and Head, Division of Preventive Medicine, Department of Epidemiology and Social Medicine, Albert Einstein College of Medicine, Bronx, New York. Kristen L. McCall, MXA., Health Communications Specialist, Office on Smoking and Health, National Center for Chronic Disease Prevention and Health Pro- motion, Centers for Disease Control and Prevention, Atlanta, Georgia. Sharon Natanblut, Deputy Director, Office of Tobacco Programs, Food and Drug Administration, Rockville, Maryland. Constance A. Nathanson, Ph.D., Professor, Department of Population and Family Sciences, School of Hygiene and Public Health, The Johns Hopkins University, Bal- timore, Maryland. Thomas E. Novotny, M.D., M.P.H., Centers for Disease Control and Prevention Liaison, Office of Global Health, World Bank, Washington, D.C. .., Ulll Reducing Tobacco Use Judith K. Ockene, Ph.D., Professor of Medicine, Depart- ment of Medicine, and Director, Division of Preventive and Behavioral Medicine, University of Massachusetts Medical School, Worcester, Massachusetts. C. Tracy Orleans, Ph.D., Senior Program Officer, The Robert Wood Johnson Foundation, Princeton, New Jersey. Guy S. Parcel, Ph.D., Professor and Director, Center for Health Promotion Research and Development, Uni- versity of Texas Health Science Center, Houston, Texas. Cheryl L. Perry, Ph.D., Professor, Division of Epide- miology, School of Public Health, University of Min- nesota, Minneapolis, Minnesota. Michael Pertschuk, J.D., Co-Director, Advocacy Insti- tute, Washington, D.C. Richard Pollay, Ph.D., Professor of Marketing and Curator, History of Advertising Archives, Faculty of Commerce, University of British Columbia, Vancouver, British Columbia, Canada. Robert L. Rabin, Ph.D., J.D., A. Calder Mackay Profes- sor of Law, Stanford University, Stanford, California. Lars M. Ramstrom, Ph.D., Director, Institute for Tobacco Studies, Stockholm, Sweden. Nancy A. Rigotti, M.D., Director, Tobacco Research and Treatment Center, Massachusetts General Hospital, and Assistant Professor of Medicine, Harvard Medi- cal School, Boston, Massachusetts. Diane Rowley, M.D., M.P.H., Associate Director for Sci- ence, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia. Jonathan M. Samet, M.D., Professor and Chairman, Department of Epidemiology, School of Hygiene and Public Health, The Johns Hopkins University, Balti- more, Maryland. Joseph Sanders, Professor, University of Houston Law Center, Houston, Texas. Thomas C. Schelling, Ph.D., Professor, School of Pub- lic Affairs, University of Maryland, College Park, Maryland. Steven A. Schroeder, M.D., President, The Robert Wood Johnson Foundation, Princeton, New Jersey. Gary Schwartz, Professor, School of Law, University of California, Los Angeles, California. Heather Selin, M.A., Health Policy Analyst, Office on Smoking and Health, National Center for Chronic Dis- ease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia. Donald R. Shopland, Coordinator, Smoking and Tobacco Control Program, National Cancer Institute, National Institutes of Health, Rockville, Maryland. Jesse L. Steinfeld, M.D., Surgeon General, U.S. Public Health Service, 1969-1973, San Diego, California. Charyn D. Sutton, President, The Onyx Group, Bala Cynwyd, Pennsylvania. Scott L. Tomar, D.M.D., Dr.l?H., Epidemiologist, Divi- sion of Oral Health, National Center for Chronic Dis- ease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia. Kenneth E. Warner, Ph.D., Richard D. Remington Col- legiate Professor of Public Health, Department of Health Management and Policy, School of Public Health, University of Michigan, Ann Arbor, Michigan. Judith Wilkenfeld, J.D., Senior Advisor for Tobacco Policy, Food and Drug Administration, Rockville, Maryland. Ernst L. Wynder, M.D., President, American Health Foundation, New York, New York. Mitchell R. Zeller, J.D., Director, Office of Tobacco Pro- grams, Food and Drug Administration, Rockville, Maryland. Other contributors were Milonne Ambroise, Program Assistant, Department of Family and Preventive Medicine, Emory University School of Medicine, Atlanta, Georgia. Ruth Atchison, Proofreader, Cygnus Corporation, Rockville, Maryland. Mary Bedford, Proofreader, Cygnus Corporation, Rockville, Maryland. Surgeon General's Report Maureen Berg, Desktop Publishing Specialist, Market Experts, Silver Spring, Maryland. Brenda Mazzocchi, M.L.S., Technical Information Specialist, Technical Information and Editorial Services Branch, National Center for Chronic Disease Preven- Elizabeth A. Cooper, Program Assistant, University of tion and Health Promotion, Centers for Disease Con- Wisconsin Law School, Madison, Wisconsin. trol and Prevention, Atlanta, Georgia. Judith A. Corr, Research Assistant, Office of Health Promotion Research, College of Medicine, University of Vermont, Burlington, Vermont. James H. Davis, Research Assistant, Institute for Legal Studies, University of Wisconsin Law School, Madison, Wisconsin. Susan R. Derrick, Program Analyst, Office on Smok- ing and Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia. Ellen C. Dreyer, R.N., M.S., Project Director, Cygnus Corporation, Rockville, Maryland. Jeffrey L. Fellows, Ph.D., Health Economist, Office on Smoking and Health, National Center for Chronic Dis- ease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia. Sue Frank, Technical Specialist, Tobacco Control Resource Center, Boston, Massachusetts. Maritta Perry Grau, M.A., Copy Editor, The Write Touch: Editorial Services, Frederick, Maryland. Lucy G. Gritzmacher, MS., Librarian, Cygnus Corpo- ration, Rockville, Maryland. Laura Hermer, J.D., Staff Attorney, Tobacco Control Resource Center, Boston, Massachusetts. Elizabeth Hess, Editor, Cygnus Corporation; Rockville, Maryland. Janis B. Hubbard, MS., Indexer, Fredericksburg, Virginia. Paulette Clark McGee, Proofreader, Editus, Kearneys- ville, West Virginia. Linda A. McLaughlin, Word Processing Specialist, Cygnus Corporation, Rockville, Maryland. Robert H. Miller, Ph.D., Director, Tobacco and Peanut Analysis Division, Agricultural Stabilization and Con- servation Service, U.S. Department of Agriculture, Washington, D.C. Michael D. Morneault, J.D., Morgan, Lewis, and Bockius Law Firm, Pittsburgh, Pennsylvania. Paulette Murphy, M.L.I.S., Technical Information Specialist, Office on Smoking and Health, National Center for Chronic Disease Prevention and Health Pro- motion, Centers for Disease Control and Prevention, Atlanta, Georgia. Leslie A. Norman; Public Affairs Specialist, Office on Smoking and Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia. Ward C. Nyholm, Desktop Publishing Specialist, Cygnus Corporation, Rockville, Maryland. Lisa Rogers, Administrative Program Manager, Cen- ter for Tobacco Research and Intervention, University of Wisconsin Medical School, Madison, Wisconsin. Ann E. Schensky, Education and Outreach Program Manager, Center for Tobacco Research and Interven- tion, University of Wisconsin Medical School, Madi- son, Wisconsin. Peggy E. Williams, M.S., Proofreader, Marietta, Georgia. Patricia L. Mallin, Director of Electronic Advocacy, Advocacy Institute, Washington, D.C. William T. Marx, M.L.I.S., Technical Information Specialist, Office on Smoking and Health, National Center for Chronic Disease Prevention and Health Pro- motion, Centers for Disease Control and Prevention, Atlanta, Georgia. Trevor A. Woollery, Ph.D., Health Economist, Office on Smoking and Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta; Georgia. Reducing Tobacco Use Chapter 1. Issues in Reducing Tobacco Use, Summary, and Conclusions 3 Introduction 5 Summary and Implications 2.2 Chapter Conclusions 22 References 25 Chapter 2. A Historical Review of Efforts to Reduce Smoking in the United States 27 Introduction 29 Early Events 29 The Rise of the Cigarette 30 Medical Warnings 38 Turning Point: The Surgeon General's Report 40 The Diverse Momentum of the Movement to Reduce Smoking 43 From Antismoking to Nonsmokers' Rights 46 The Impact of the Movement to Reduce Smoking 48 Conclusions 52 References 52 Chapter 3. Effective Educational Strategies to Prevent Tobacco Use Among Young People 59 Introduction 62 Recent Research on Educational Strategies for Smoking Prevention 64 Diffusing Programs to Prevent Tobacco Use 80 Conclusions 8.5 References 86 Chapter 4. Management of Nicotine Addiction 95 Introduction 97 Methods for Managing Nicotine Addiction 100 Contemporary Issues in Research on Tobacco Addiction 228 Conclusions 234 References 235 Chapter 5. Regulatory Efforts 157 Introduction 259 Advertising and Promotion 262 Product Regulation 178 Clean Indoor Air Regulation 2 93 Minors` Access to Tobacco 207 Litigation Approaches 223 Conclusions 260 References 262 :urgeon GetTeral's Report Chapter 6. Economic Approaches 293 Introduction 295 Supply of Tobacco and Tobacco Products 295 Effect of Price on Demand for Tobacco Products 322 Taxation of Tobacco Products 337 Conclusions 359 References 360 Chapter 7. Comprehensive Programs 371 Introduction 373 Conceptual Frameworks 373 Description of Comprehensive Programs 374 Community Intervention Trials 376 Statewide Interventions 382 Components of Community Programs 403 Summary 416 Conclusions 42 7 References 418 Chapter 8. A Vision for the Future -Reducing Tobacco Use in the New Millennium 431 Introduction 433 Continuing to Build the Scientific Base 433 The Changing Tobacco Industry 434 The Need for a Comprehensive Approach 435 Identifying and Eliminating Disparities 436 Improving the Dissemination of State-of-the-Art Interventions 436 Tobacco Use in Developing Nations 437 Tobacco Control in the New Millennium 438 References 439 Abbreviations 441 List of Tables and Figures 443 Index 445 Chapter 1 Issues in Reducing Tobacco Use, Summary, and Conclusions Introduction 5 Development of the Report 5 Major Conclusions 6 Issues in Reducing Tobacco Use 6 Eliminating Disparities Related to Tobacco Use and Its Effects 12 Summary and Implications 22 Historical Review (Chapter 2) 12 Educational Strategies (Chapter 3) 12 Management of Nicotine Addiction (Chapter 4) 23 Regulatory Efforts (Chapter 5) 14 Advertising and Promotion 14 Product Regulation 15 Clean Indoor Air Regulation 16 Minors' Access to Tobacco 16 Litigation Approaches 17 Overview and Implications 28 Economic Approaches (Chapter 6) 18 Comprehensive Programs (Chapter 7) 20 A Vision for the Future-Reducing Tobacco Use in the New Millennium (Chapter 8) 2 Chapter Conclusions 22 Chapter 2. Historical Review 22 Chapter 3. Educational Strategies 22 Chapter 4. Management of Nicotine Addiction 22 Chapter 5. Regulatory Efforts 22 Advertising and Promotion 22 Product Regulation 23 Clean Indoor Air Regulation 23 Minors' Access to Tobacco 23 Litigation Approaches 23 Chapter 6. Economic Approaches 24 Chapter 7. Comprehensive Programs 24 References 25 Reducing Tobacco Use Introduction What works? It would be a boon if the answer were as easy to state as the question. Programs to reduce the use of tobacco have a long history in the United States and in other countries, and the accumulated experience has provided considerable empirical understanding of the prospects and pitfalls of such efforts. Rigorous answers to formal evaluation questions are difficult to obtain, however, in part because of the wide variety of influ- ences that are brought to bear on the use of tobacco. Researchers have little control over many of these influences and are only beginning to learn how to measure some of them. Nonetheless, a substantial body of literature exists on attempts to reduce the use of tobacco. This report provides an overview of the major modalities that have been studied and used intensively, and it at- tempts, where possible, to differentiate their techniques and outcomes. The report also attempts a more diffi- cult task: to provide some qualitative observations about how these efforts interact. The report is thus a prologue to the development of a coherent, long-term policy that would permit these modalities to be used as effectively as possible. Development of the Report This report of the Surgeon General was prepared by the Office on Smoking and Health, National Cen- ter for Chronic Disease Prevention and Health Promo- tion, Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Ser- vices, to report current information on the health ef- fects of cigarette smoking and smokeless tobacco use. Previous reports have dealt with some of the issues included in this report, but a composite assessment of efforts to reduce tobacco use is a new topic for this series. However, the current report must acknowledge the considerable contributions of three prior mono- graphs: Growing Up Tobacco Free, a report of the Insti- tute of Medicine (Lynch and Bonnie 1994), Healthy People 2000: National Health Promotion and Disease Pre- vention Objectives, and Healthy People 2010, an ongoing work of the Office of Health Promotion and Disease Prevention (U.S. Department of Health and Human Services [USDHHS] 1991,200O). The current report is the result of the work of 16 experts in the field of reducing tobacco use who contributed initial drafts in major chapter areas. The chapters were reviewed separately by some 60 re- searchers and public health workers whose expertise was specific to particular subject areas. After revision, a preliminary draft volume was reviewed by an addi- tional 40 experts, including representatives of the in- stitutes and agencies within the Department of Health and Human Services that have special interests in re- ducing tobacco use. Several concerns guided preparation of the re- port. First, it was clear that the primary countervailing influence against reducing tobacco use is the effort of the tobacco industry to promote the use of tobacco products. Although this report was not conceived as a documentation of such industry efforts, repeated reference to them is necessary to underscore the diffi- culties both in achieving desired outcomes and in evaluating the effectiveness of efforts to reduce the use of the industry's products. Second, the report has at- tempted to present the wide variety of techniques and methods used for tobacco control, but the disparate methods make comparisons difficult. The result is more a menu than a cookbook-a set of activities, as outlined in Chapter 7, whose combination depends on specific circumstances and the context in which they are undertaken. Third, a result of this methodological diversity is that rigorous evaluation of the ways in which tobacco reduction efforts interact remains part of the unfinished research agenda. Although interac- tion of interventive efforts is noted several places in the report (see, for example, the discussion of the in- teraction of school education with community-based programs in Chapter 31, such demonstration of syn- ergy has been elusive. Finally, during the report's preparation, a cascade of legal and legislative events substantially changed the landscape where the diverse efforts to reduce to- bacco use take place. Several legal rulings, still under adjudication, and the Master Settlement Agreement between states and the tobacco industry to recover costs of government programs have altered prospects for reducing tobacco use through large-scale social maneuvers. Many of these issues are still unresolved, and they are likely to influence activities in the com- ing years. issues in Reducing Tobacco Use 5 Major Conclusions 1. Efforts to prevent the onset or continuance of to- bacco use face the pervasive, countervailing in- fluence of tobacco promotion by the tobacco industry, a promotion that takes place despite overwhelming evidence of adverse health effects from tobacco use. 2. The available approaches to reducing tobacco use-educational, clinical, regulatory, economic, and comprehensive-differ substantially in their techniques and in the metric by which success can be measured. A hierarchy of effectiveness is difficult to construct. 3. Approaches with the largest span of impact (eco- nomic, regulatory, and comprehensive) are likely to have the greatest long-term, population im- pact. Those with a smaller span of impact (edu- cational and clinical) are of greater importance in helping individuals resist or abandon the use of tobacco. 4. Each of the modalities reviewed provides evi- dence of effectiveness: . Educational strategies, conducted in conjunc- tion with community- and media-based activities, can postpone or prevent smoking onset in 20 to 40 percent of adolescents. o Pharmacologic treatment of nicotine addic- tion, combined with behavioral support, will enable 20 to 25 percent of users to remain ab- stinent at one year posttreatment. Even less intense measures, such as physicians advising their patients to quit smoking, can produce cessation proportions of 5 to 10 percent. o Regulation of advertising and promotion, par- ticularly that directed at young people, is very likely to reduce both prevalence and uptake of smoking. o Clean air regulations and restriction of minors' access to tobacco products contribute to a changing social norm with regard to smoking and may influence prevalence directly. o An optimal level of excise taxation on tobacco products will reduce the prevalence of smok- ing, the consumption of tobacco, and the long- term health consequences of tobacco use. 6 Chapter 1 The impact of these various efforts, as measured with a variety of techniques, is likely to be un- derestimated because of the synergistic effect of these modalities. The potential for combined effects underscores the need for comprehensive approaches. State tobacco control programs, funded by excise taxes on tobacco products and settlements with the tobacco industry, have produced early, en- couraging evidence of the efficacy of the com- prehensive approach to reducing tobacco use. Issues in Reducing Tobacco Use Two themes have permeated the history of to- bacco use in the United States. First, and most obvi- ously, tobacco is an extraordinary economic fuel, and its powerful economic impact comes into direct con- flict with its vast social costs. Second, antitobacco ac- tivity has a continuous history characterized by waxing and waning and by a changing mix of motivations and strategies. These two themes are inextricably linked, and their interaction provides a backdrop for current efforts to reduce tobacco use. Such efforts take place in a complicated context. Chronic diseases have largely replaced infectious pro- cesses as the leading causes of death during the 20th century (Rothenberg and Koplan 1990). But this re- placement has occurred during a period of remark- able gains in life expectancy. Mortality is now less than half of what it was in 1900. The single most important risk associated with the leading chronic diseases is cigarette smoking; the evidence for that statement fills volumes of Surgeon General's reports on smoking and health, and these volumes are merely summaries of a massive literature. Since the first of these reports in 1964, the prevalence of smoking has declined by nearly half, and it is clear that the declining use of tobacco has contributed to the observed decline in mortality. But paradoxically, as life expectancy increases, an in- creasing proportion of deaths are caused by the chronic diseases associated with smoking-primarily cancer, cardiovascular disease, and emphysema. This inter- play raises key questions. First, does the current smoking prevalence of about 25 percent represent a remarkable public health success, or is it evidence of continuing failure? The answer is yes to both questions. Health advocates can be both pleased with overall trends and loathe to de- clare success for a job unfinished, because goals and standards change with evolving efforts to reduce to- bacco use. If the worldwide public health response to smallpox can be used as an analogy, the control pro- gram reached a point at which a single case was deemed unacceptable. Second, why has the decline in smoking preva- lence been slow? In the face of voluminous evidence about adverse health effects, prevalence has declined sluggishly (an average of about 0.5 percent per year since the mid-1960s). Currently, the decline exhibits epidemiologic signs of pausing in its downward tra- jectory, and it has even reversed in some population subgroups. There is no single, facile explanation for the persisting practice of tobacco use. If rationality were the only force at work, tobacco use would have been abandoned long ago. But as is shown in Figure 1.1, the forces that can be brought to bear on current or potential smokers are more complex and subtle than the mere awareness that smoking is harmful to one's health. A young person on the threshold of deciding to smoke may be subject to various influences, including the existence or nonexistence of targeted health educa- tion programs that discourage smoking, as well as of restrictions on access to cigarettes and a variety of regu- lations that determine the content and packaging of the product. Widespread and local norms, affecting this young person in the form of peer pressure, perceived smoking prevalence, and the commercial presentation of tobacco products, can affect the decision either way. The cost of cigarettes is likely to have significant influ- ence on a young person, and other economic policies- largely unseen by the potential smoker-can affect the outcome. Personal psychosocial factors undoubtedly Figure 1.1. Influences on the decision to use tobacco Antitobacco Protobacco Health education Economic policy Minors' access Product regulation Reducing Tobacco Use play a role and are likely to interact with these other influences. Arrayed among and against such factors are the variety of conduits-also largely unseen by the current or potential smoker-through which the influences of the tobacco industry are manifested: use of advertising and promotion to alter perceived social norms, alteration or prevention of legislation that would inhibit smoking, legal mechanisms to influence regulation, political mechanisms to influence economic policy, and countereducation that can serve to encour- age the uptake of smoking. Whatever the precise interplay of these influences, the net result has been a slower decline than would be warranted by awareness of the well-publicized public health threat that smoking poses. The forces that have tried to accelerate the decline may be thought of col- lectively as "interventions," although the term, in a more narrow sense, is often reserved for circumscribed, planned, and measurable activities. Many of the ma- neuvers described in this report do not meet the nar- rower definition, but all share the common characteristic of being directed toward a reduction in tobacco use. With a broader definition in mind, Ramstrom (1995) has classified tobacco interventions by the point they affect on the spectrum of tobacco use. These classifications, depicted in Figure 1.2, are creating a nonsmoking norm, reducing stimuli to smoke, strengthening motivation to quit, and reduc- ing impediments to quitting. Although the conceptu- alization is useful, a line could legitimately be drawn from each box to any other box in Figure 1.2, as these activities are all intimately tied to each other in both Clean indoor air regulation Social advocacy Personal litigation Advertising restrictions Promotional restrictions __----------- A current ! smoker :- I I------------a _____-------- Widespread social norms A former Local community norms t+ smoker / :- Behavioral treatment I ____ -- ------ 2 Pharmacologic treatment I I Psychosocial factors Peer pressure Industry influence Perceived social norms Advertising Promotion Legislation Regulation Economic policy Education Surgeon General's Report process and outcome. To borrow from the language of statistics, the main effects of these efforts may be much less important than their interactions, both with each other and with the counterinfluences of the to- bacco industry. The result is a considerable challenge for evalua- tion. Suppose the young person in Figure 1.1 "decides" not to smoke, or the current smoker quits. Attribution of cause to this outcome in individual cases is highly unlikely. The totality of such decisions-which leads to a decline in prevalence-poses similar problems of attribution. Although the epidemiologic methods ex- ist, data are rarely available to make attributive judg- Figure 1.2. Overview of relationships among interventions men&. The challenge of evaluating these separate ef- forts and strategies results from their disparate na- ture and the type of metric that may be appropriate to their evaluation (Table 1 .l). Management of nicotine addiction (Chapter 4), for example, is usually studied by using standard epidemiologic study design-often a prospective comparison of a study group and a control group- and the effect is measured by some form of the rela- tive or attributable risk statistic. Educational strategies (Chapter 3), like other behavioral studies, may use similar statistics but usually invoke a different set of confounding factors to be considered; sorting out Reduce morbidity and mortality Protect nonsmokers' health and rights Manage nicotine Manage nicotine Create a smoke-free Create a smoke-free addiction addiction environment environment Prevent smoking Prevent smoking uptake uptake Chapter Health education 3,4 Economic policy 6 Smoke-free policy 5 Comprehensive 7 programs Chapter Pharmacologic Rx 4 Behavioral Rx 4 Knowledge Rx 4 Attitude Rx 4 Chapter Health education 3 Economic policy 6 Product regulation 5 Smoke-free policy 5 Comprehensive 7 programs Personal litigation 5 Chapter Advertising restrictions 5 Promotion restrictions 5 Sales restrictions 4 Comprehensive 7 programs Source: Adapted from RamstrGm 1995. 8 Chapter 1 Reducing Tobacco Use Table 1.1. Characteristics of interventions Type of intervention Targets Tools Study approaches Outcome measurements Educational Clinical Regulatory Economic Social/Com- prehensive Children and adoles- cents, usually in school Administrative groups (e.g., members of health maintenance organizations) General population Health care providers Persons who smoke, usually in a health care setting General population of smokers in a commercial or quasi- commercial setting Product manufacture Product sale Vendors and buyers Public venues Public transportation Worksites Health care sites Taxes Tariffs and trade Price supports Legislators Media Communication networks Case-by-case strategy State/local programs School curricula Interactive training Targeted services Mass media Pharmacologic Epidemiologic and methods behavioral: Behavioral modification Reinforcing environment o Usually a comparison of "treatment" and "no treatment" groups o Control of confounding by behavioral and demographic variables Local ordinance State regulation Federal regulation Federal law Nongovernment action (e.g., joint commission accreditation of hospital organization) Local ordinance State regulation Federal regulation Federal law International agreements Media advocacy Direct advocacy Community interventions Countermarketing Regulation Policy formation Epidemiologic and behavioral: o Usually a comparison of "treatment" and "no treatment" groups o Control of confounding by behavioral and social variables Observational Knowledge/attitude/ practice studies Surveillance Case study Econometric analysis Trend analysis Multivariate models Relative risk Attributable risk Effect size (absolute or relative) Relative risk Attributable risk Effect size (absolute or relative) Linear trend Cross-sectional comparison of proportions Case analysis results Linear trend Parameter estimates (e.g., elasticities) Observational Case study General epidemiologic methods Trend analysis Knowledge/attitude/ practice studies Linear trends Case study analysis Cross-sectional comparisons Issues in Reducing Tobacco Use 9 Surgem Gelreral's Report the relative influence of such factors often requires complex multivariate procedures. Regulatory efforts (Chapter 5) are frequently evaluated after the effect (with a pre- and post-type of study design) or are evaluated according to ecological correlations with changes in epidemiologic trends. Economic measures (Chapter 6) depend for their evaluation on economet- ric information-that is, on administrative data sets and survey results that are subjected to correlation and trend analysis. Finally, comprehensive program strat- egies are often evaluated using surveillance data sys- tems, trend analyses, and case studies. In each instance, some form of evaluation is pos- sible, but the ability to connect the intervention to the outcome differs greatly among these efforts, as does the ability to estimate impact. Theoretically, it might be possible to associate each effort with some pre- sumed number of persons who start smoking or some number who quit, but to do so would usually require numerous assertions and assumptions. For example, to estimate the number of persons who would benefit, through prevention or cessation of smoking, from an educational strategy, assumptions would be needed about its generalizability to the U.S. population, the variability of its impact, the use-effectiveness to which it is put, the proportion of the population reached, and the permanence of its effect. It is even more difficult to create a set of assumptions for the impact of a regu- lation that is promulgated in an environment of de- clining prevalence and whose existence may depend on the prior emergence of the very changes it wishes to create. For example, a ban on smoking during airline flights, a measure intended not only to protect nonsmokers from environmental tobacco smoke (ETS) but also to promote a norm of nonsmoking, was pos- sible only in an era when the dangers of ETS were widely known and when the danger and discomfort experienced by nonsmokers had begun to outweigh the inconvenience, discomfort, and even social ostra- cism experienced by smokers being subjected to such restrictions. It is virtually impossible to link a social strategy to a direct effect on prevalence, however suc- cessful by other criteria. (Many would argue, quite justly, that the impact measure of reducing prevalence by reducing uptake and increasing cessation is not the only outcome of interest. Unfortunately, proximal process measures are even more variable among the dif- ferent strategies, and the ultimate outcome measures- morbidity and mortality-are too distal to easily consider.) Without a common metric, the various types of efforts to reduce tobacco use are difficult to compare quantitatively, although several attempts have been made (USDHHS 1998a; U.S. Department of the Treasury, Office of Economic Policy, unpublished report, 1998). Per- haps a more qualitative approach could be used. One approach, illustrated in Table 1.2, would be to consider the potential span of impact (the proportion of the population, or population sectors) that the particular effort can exercise in the context of a qualitative esti- mate of its potential impact. Several examples of each type of effort are presented, and a qualitative assess- ment is made based on the data provided in the re- port. The assessments in Table 1.2 are by no means meant to be definitive but are meant to provide a framework for approaching the difficult issue of rela- tive effectiveness. Although some observers would urge a more quantitative approach (e.g., using only randomized controlled trials as a measure of effective- ness), a number of effective modalities would likely be falsely discredited. For example, advocacy activity played a critical role in the formulation of the Food and Drug Administration's (FDA's) policy regarding regulation of tobacco products (see "Product Regula- tion" in Chapter 5), yet linking that policy, or anteced- ent advocacy work, directly to changing prevalence would be difficult. In a qualitative assessment of relative impact, the examples provide a basis for a hierarchy of activities, but that hierarchy requires still another framework: consideration of the entity conducting the activity (in- dividual, nongovernment citizens group, nongovern- ment agency, or government agency) and the organizational level at which the activity is conducted (local, state, national, or international). Thus, no single set of rules is available for invoking these efforts to reduce tobacco use, and relative efficacy depends on the context in which an effort takes place. For example, local efforts to reduce tobacco use might include regu- latory ordinances (with potentially large impact on many people), education programs in schools (smaller impact on fewer people), and promotion of treatment for nicotine addiction (targeting a still smaller group). Specific local circumstances would dictate the specific activities. The federal government would more likely act to put in place economic measures and a variety of regulatory efforts (both types of interventions having very large span and size of impact), depending on the specific political context. In summary, then, these efforts to reduce tobacco use line up side by side and not in relative order. Their use is predicated on the particular context in which they are to operate. Because they all face the same counterinfluence of the industry's tobacco promotion (the right-hand side of Figure l.l), a reasonable case can be made that the large-scale strategies (economic 10 Chapter 1 Reducing Tobncco Use Table 1.2. Examples of a qualitative assessment of intervention impact Type of intervention Specific modality Span of impact Size of impact Educational School curriculum Large Moderate Mass media Large Small Clinical Pharmacologic Small Moderate Behavioral (alone) Small Very small Regulatory Product manufacture Very large Very large Product sale Large Large Public venues Large Moderate Worksites Large Small Economic Taxation Very large Very large Tariffs and trade Very large Very large Comprehensive programs Statewide programs Large Large Case-by-case strategy Unpredictable Unpredictable Note: Examples use a five-point ordinal scale (very small, small, moderate, large, very large), with the additional use of "unpredictable." (See text for the context for such assessment.) and regulatory) have the greatest direct impact on that barrier. But the context necessary for those large-scale efforts to work depends on public attitudes and social norms that must be influenced by other means. In the 199Os, it became increasingly apparent that a public health success in reducing tobacco use requires activity on all fronts. A comprehensive approach-one that optimizes synergy from a mix of strategies-has emerged as the guiding principle for future efforts to reduce tobacco use. Such an approach makes moot the issue of a hierarchy of interventions, since a compre- hensive approach presupposes an interdependence of the available strategies. A coordinated, cohesive in- frastructure makes intuitive sense, since it permits a modular approach to the interventions themselves, but has been challenged on analytic grounds. In such a framework, attribution of success to particular pro- gram elements is difficult, and there is no experimen- tal evidence (nor is there likely to be) that an approach that is comprehensive is superior to one that is not. Nonetheless, the 20th century's difficult experience with tobacco control (as described in Chapter 2) and the previous decade's success in changing social norms and generating assets (as discussed in Chapter 7) lend empirical credibility to the comprehensive approach. Eliminating Disparities Related to Tobacco Use and Its Effects The elimination of health disparities related to tobacco use poses a great challenge to this nation. This was not a main focus of the current report, because two other recent, important publications have emphasized the issue. The 1998 Surgeon General's report Tobacco Use Among U.S. Racial/Ethnic Minority Groups (USDHHS 1998b) was the first to address the diverse tobacco con- trol needs of the four major U.S. racial/ethnic minor- ity groups-African Americans, American Indians and Alaska Natives, Asian Americans and Pacific Island- ers, and Hispanics. Hedthy People 2020 (USDHHS 2000) presents two overarching goals: increase qual- ity and years of healthy life and eliminate health dis- parities among different segments of the U.S. population. Evidence reviewed in these two publica- tions highlights the significant disparities that exist in the United States. These publications also discuss the critical need for a greater focus on this issue, both in research and in public health action. Issues ill Reducirlg Tobm-o Use 2 1 Summary and Implications In fact, each of the approaches described in this report shows evidence of effectiveness. In some in- stances, the synergism that might be expected through interaction among these various efforts has been docu- mented. The remainder of this chapter describes the major findings and implications for each type of activ- ity and presents the conclusions of the other chapters. Historical Review (Chapter 2) The forces that have shaped the movement to reduce tobacco use over the past 100 years are com- plex and intertwined. In the early years (1880-1920), antitobacco activity-some of it quite successful-was motivated by moral and hygienic principles. After important medical and epidemiologic observations of the midcentury linked smoking to lung cancer and other diseases, and after the subsequent appearance of the 1964 report of the advisory committee to the Surgeon General on smoking and health (USDHEW 1964), the movement to reduce tobacco use was fu- eled by knowledge of the health risks that tobacco use poses and by reaction against the continued promo- tion of tobacco in the face of such known risks. De- spite overwhelming evidence of adverse health consequences of smoking, the stubborn norm of smok- ing in the United States has receded slowly, in part because of such continued promotion that works syn- ergistically with tobacco addiction. Although strate- gies have varied, health advocates have focused in recent years on the prevention of harm to nonsmokers and on the concept of smoking as a pediatric disease, with the consequent need for protecting young per- sons from forces influencing them to smoke. Educational Strategies (Chapter 3) The design of educational programs for tobacco use prevention and the methods used to evaluate them have become increasingly refined over the past two decades. Early studies tended to be confined to the school context, to have short duration, and to be of low intensity. Studies tended to focus on a single mo- dality and to ignore the larger context in which pre- vention takes place. The reported size, scope, and duration of program effects have become larger in re- cent reports. In particular, several large programs have attempted a multifaceted approach that incorporates 22 Chapfu 1 other than school-based modalities. Improvements in evaluation designs have increased confidence in the validity of these reports. The pattern of consistency across this group of large studies also provides assur- ance that these effects can be achieved in a variety of circumstances when programs include the critical multiple elements that have been defined by this re- search literature. To summarize the major findings, school-based social influences programs have significant and sub- stantial short-term impacts on smoking behavior. Those programs with more frequent educational con- tacts during the critical years for smoking adoption are more likely to be effective, as are programs that address a broad range of educational needs. These effects have been demonstrated in a range of imple- mentation models and student populations. The smok- ing prevention effects of strong school programs can be extended through the end of high school or longer when combined with relatively intensive efforts di- rected through other powerful channels, such as strat- egies that vigorously engage the influences of parents, the mass media, and other community resources. These conclusions have been codified in national guidelines for school programs to prevent tobacco use. Thus, an extensive body of research findings document the most effective educational programs for preventing tobacco use. This research has produced a wide array of curricula, protocols, and recommenda- tions that have been codified into national guidelines for schools. Implementing guidelines could postpone or prevent smoking onset in 20 to 40 percent of U.S. adolescents. Unfortunately, existing data suggest that evidence-based curricula and national guidelines have not been widely adopted. By one set of criteria, less than 5 percent of schools nationwide are implement- ing the major components of CDC's Guidelines for School Health Programs to Preveuf Tobacco Use and Ad- dicfioir (CDC 1994). Almost two-thirds of schools (62.8 percent) had smoke-free building policies in 1994, but significantly fewer (36.5 percent) reported such poli- cies that included the entire school environment. Schools, however, should not bear the sole respon- sibility for implementing educational strategies to prevent tobacco use. Research findings, as noted, indi- cate that school-based programs are more effective when combined with mass media programs and with community-based efforts involving parents and other community resources. In addition, CDC's school health Reducing Tobacco Use guidelines and numerous Healthy People 2020 objectives recognize the critical role of implementing tobacco-free policies involving faculty, staff, and students and relat- ing to all school facilities, property, vehicles, and events. Although significant progress is still required, the cur- rent evaluation base provides clear direction for the amalgamation of school-based programs with other modalities for reducing tobacco use. Management of Nicotine Addiction (Chapter 4) The management of nicotine addiction is a com- plex field that continues to broaden its understanding of the determinants of smoking cessation. Current lit- erature suggests that several modalities are effective in helping smokers quit. Although the overall effect of such intervention is modest if measured by each attempt to quit, the process of overcoming addiction is a cyclic one, and many who wish to quit are eventu- ally able to do so. The available approaches to man- agement of addiction differ in their results. Self-help manuals and minimal clinical interventions. Although self-help manuals have had only modest and inconsistent success at helping smokers quit, manuals can be easily distributed to the vast population of smokers who try to quit on their own each year. Adjuvant be- havioral interventions, particularly proactive telephone counseling, may significantly increase the effect of self- help materials. Process measures are not routinely in- corporated into self-help investigations, but the available process data suggest that persons who not only have a self-help manual but also perform the exercises recom- mended in the manual are more likely to quit smoking than are persons who try to quit smoking without them. Substantial evidence suggests that minimal clini- cal interventions (e.g., a health care provider's repeated advice to quit) foster smoking cessation and that the more multifactorial or intensive interventions produce the best outcomes. These findings highlight the impor- tance of cessation assistance from clinicians, who have access to more than 70 percent of smokers each year. Moreover, minimal clinical interventions have been found to be effective in increasing smokers' motivation to quit and are cost-effective (see "Cost-Effectiveness" in Chapter 4). However, research has not fully clarified the specific elements of minimal interventions that are most important to clinical success nor the specific changes they produce in smokers that lead to abstinence. Intensive clinical interventions. Intensive pro- grams-more formally systematic services to help people quit smoking-serve an important function in the nation's efforts to reduce smoking, despite the re- sources the programs demand and the relatively small population of smokers who use them. Such programs may be particularly useful in treating those smokers who find it most difficult to quit. Because intensive smoking cessation programs differ in structure and content, evaluation is often hampered by variation in methodology and by a lack of research addressing spe- cific treatment techniques. Because few studies have chosen to isolate single treatments, assessment of the effectiveness of specific approaches is difficult. None- theless, skills training, rapid smoking, and both intra- treatment and extra-treatment social support have all been associated with successful smoking cessation. When such treatments are shown to be effective, they are usually part of a multifactorial intervention. Little clear evidence has implicated particular psychologi- cal, behavioral, or cognitive mechanisms as the agents of change. The specific impact of intensive interven- tions may be masked by the efficacy of several multi- component programs, some of which have achieved cessation proportions of 30 to 50 percent. Thus, in their positive effect on smoking cessation and long-term abstinence rates, intensive interventions seem little different from other forms of counseling or psycho- therapy. With intensive interventions, as with coun- seling, it is difficult to attribute the efficacy to specific characteristics of the interventions or to specific change mechanisms. Pharmacologic infemenfions. Abundant evidence confirms that nicotine gum and the nicotine patch are effective aids to smoking cessation. The efficacy of nicotine gum may depend on the amount of behav- ioral counseling with which it is paired. The 4-mg dose (rather than the 2-mg dose) may be the better phar- macologic treatment for heavy smokers or for those highly dependent on nicotine. The nicotine patch ap- pears to exert an effect independent of behavioral sup- port, but absolute abstinence rates increase as more counseling is added to patch therapy. Nicotine inhal- ers and nicotine nasal spray are effective aids for smok- ing cessation, although their mechanisms of action are not entirely clear. All nicotine replacement therapies produce side effects, but these are rarely so severe that patients must discontinue use. Nicotine nasal spray appears to have greater potential for inappropriate use than other nicotine replacement therapies. Nicotine replacement therapies, especially the gum and the patch, have been shown to delay but not prevent weight gain following smoking cessation. All nico- tine replacement therapies are thought to work in part by reducing withdrawal severity. The available evi- dence suggests that they do ameliorate some elements issues in Reducing Tobacco Use 13 Surgeon Gerzeral's Report of withdrawal, but the relationship between withdrawal suppression and clinical outcome is inconsistent. Bupropion is the first nonnicotine pharmaco- therapy for smoking cessation to be studied in large- scale clinical trials. Results suggest that it is an effective aid to smoking cessation. In addition, bupropion has been demonstrated to be safe when used in conjunc- tion with nicotine replacement therapy. In the only direct comparison with a nicotine replacement prod- uct, bupropion achieved quit rates about double those achieved with the nicotine patch. Bupropion appears to delay but not prevent postcessation weight gain, and available literature contains inconsistent evidence about bupropion-mediated withdrawal relief. Bupropion does not appear to work by reducing postcessation symptoms of depression, but its mecha- nism of action in smoking cessation remains unknown. Evidence suggests that clonidine is also capable of improving smoking cessation rates. Clonidine is hypothesized to work by alleviating withdrawal symp- toms. Although clonidine may reduce the craving for cigarettes after cessation, it does not consistently ame- liorate other withdrawal symptoms, and its effect on weight gain is unknown. Unpleasant side effects are common with clonidine use. Antidepressants and anxiolytics are potentially useful agents for smoking cessation. At present, only nortriptylene appears to have consistent empirical evidence of smoking cessation efficacy. However, tri- cyclic antidepressants produce a number of side ef- fects, including sedation and various anticholinergic effects, such as dry mouth. In summary, research on methods to treat nico- tine addiction has documented the efficacy of a wide array of strategies. The broad implementation of these effective treatment methods could produce a more rapid and probably larger short-term impact on tobacco-related health statistics than any other com- ponent of a comprehensive tobacco control effort. It has been estimated that smoking cessation is more cost- effective than other commonly provided clinical pre- ventive services, including Pap tests, mammography, colon cancer screening, treatment of mild to moderate hypertension, and treatment of high levels of serum cholesterol. Contemporaneously with the appearance of this report, research advances in managing nicotine ad- diction have been summarized in evidence-based clinical practice guidelines by the Centers for Disease Control and Prevention (CDC). That document con- firms that less intensive interventions, such as brief physician advice to quit smoking, could produce ces- sation rates of 5 to 10 percent per year. More intensive interventions, combining behavioral counseling and pharmacologic treatment of nicotine addiction, can produce 20 to 25 percent quit rates at one year. Thus, the universal provision of even less intensive interven- tions to smokers at all clinical encounters could each year help millions of U.S. smokers quit (Fiore et al. 2000). Progress has been made in recent years in dissemi- nating clinical practice guidelines on smoking cessation. Healthy People 2010 Objective 27-8 calls for universal insurance coverage of evidence-based treatment for nicotine dependency by both public and private pay- ers. Similarly, CDC's Best Practices for Comprehensive Tobacco Control Programs advises states that tobacco- use treatment initiatives should include o Establishing population-based counseling and treatment programs, such as cessation help lines. o Making the system changes recommended by the CDC-sponsored cessation guidelines. o Covering treatment for tobacco use under both public and private insurance. o Eliminating cost barriers to treatment for under- served populations, particularly the uninsured (CDC 1999, p. 24). Regulatory Efforts (Chapter 5) Advertising and Promotion Attempts to regulate advertising and promotion of tobacco products were initiated in the United States almost immediately after the appearance of the 1964 report to the Surgeon General on the health conse- quences of smoking. Underlying these attempts is the hypothesis that advertising and promotion recruit new smokers and retain current ones, thereby perpetuat- ing a great risk to public health. The tobacco industry asserts that the purpose of marketing is to maintain brand loyalty. Considerable evidence has accumulated showing that advertising and promotion are perhaps the main motivators for adopting and maintaining to- bacco use. Attempts to regulate tobacco marketing continue to take place in a markedly adversarial and litigious atmosphere. The initial regulatory action, promulgated in 1965, provided for a general health warning on cigarette pack- ages but effectively preempted any further federal, state, or local requirements for health messages. In 1969, a successful court action invoked the Fairness Doctrine Reducing Tobacco Use (not previously applied to advertising) to require broadcast media to air antitobacco advertising to counter the paid tobacco advertising then running on television and radio. Indirect evidence suggests that such counteradvertising had considerable impact on the public's perception of smoking. Not surprisingly, the tobacco industry supported new legislation (adopted in 1971) prohibiting the advertising of to- bacco products on broadcast media, because such leg- islation also removed the no-cost broadcasting of antitobacco advertising. Adecade later, a Federal Trade Commission (FTC) staff report asserted that the domi- nant themes of remaining (nonbroadcast) cigarette advertising associated smoking with "youthful vigor, good health, good looks and personal, social and pro- fessional acceptance and success" (Myers et al. 1981, p. 2-13). A nonpublic version of the report detailed some of the alleged marketing strategy employed by the industry; the industry denied the allegation that the source material for the report represented indus- try policy. Nonetheless, some of these concerns led to the enactment of the Comprehensive Smoking Educa- tion Act of 1984 (Public Law 98-474), which required a set of four rotating warnings on cigarette packages. The law did not, however, adopt other FTC recommen- dations that product packages should bear informa- tion about associated risks of addiction and miscarriage, as well as information on toxic compo- nents of cigarettes. In fact, many FTC-recommended requirements for packaging information that have been enacted in other industrialized nations have not been enacted in the United States. The role of advertising is perhaps best epitomized by R.J. Reynolds Tobacco Company's Camel brand campaign (initiated in 1988) using the cartoon charac- ter "Joe Camel." Considerable research has demon- strated the appeal of this character to young people and the influence that the advertising campaign has had on minors' understanding of tobacco use and on their decision to smoke. In 1997, the FTC brought a complaint asserting that by inducing minors to smoke, R.J. Reynolds' advertising practices violated the Fed- eral Trade Commission Act Public Law 96-252). The tobacco company subsequently agreed to cease using the Joe Camel campaign. Although the FTC's act grants no private right of enforcement, a private law- suit in California resulted in a settlement whereby the tobacco company agreed to cease its Joe Camel cam- paign; notably, the Supreme Court of California re- jected R.J. Reynolds' argument that the Comprehensive Smoking Education Act of 1984 preempted the suit's attempt to further regulate tobacco advertising. Product Regulation Current tobacco product regulation requires that cigarette advertising disclose levels of "tar" (an all- purpose term for particulate-phase constituents of to- bacco smoke, many of which are carcinogenic or otherwise toxic) and nicotine (the psychoactive drug in tobacco products that causes addiction) in the smoke of manufactured cigarettes and that warning labels appear on packages and on some (but not all) adver- tising for manufactured cigarettes and smokeless to- bacco. The current federal laws preempt, in part, states and localities from imposing other labeling regulations on cigarettes and smokeless tobacco. Federal law (the Comprehensive Smokeless Tobacco Health Education Act of 1986 and the Comprehensive Smoking Educa- tion Act of 1984) requires cigarette and smokeless to- bacco product manufacturers to submit a list of additives to the Secretary of Health and Human Ser- vices; attorneys for the manufacturers released such lists in 1994 to the general public. Smokeless tobacco manufacturers are required to report the total nicotine content of their products, but these data may not be released to the public. Tobacco products are explic- itly protected from regulation in various federal con- sumer safety laws. No federal public health laws or regulations apply to cigars, pipe tobaccos, or fine-cut cigarette tobaccos (for "roll-your-own" cigarettes). Although much effort has been devoted to con- sidering the need for regulating nicotine delivery, tar content, and the use of additives, until recently no regu- lation had directly broached the issue of whether to- bacco should be subject to federal regulation as an addictive product. Responding in part to several pe- titions filed by the Coalition on Smoking OR Health in 1988 and 1992, the FDA began serious consideration of the need for product regulation. Motivated by the notion that the cigarette is a nicotine delivery system, by allegations of product manipulation of nicotine lev- els, and by the concept that smoking is a pediatric dis- ease and that young people are especially susceptible to cigarette advertising and promotion, in August 1995 the FDA issued in the Federal Register (1) a proposed rule of regulations restricting the sale and distribution of cigarettes and smokeless tobacco products to pro- tect children and adolescents and (2) an analysis of the FDA's jurisdiction over cigarettes and smokeless to- bacco. The final regulations published by the FDA on August 28, 1996, differed only slightly from the pro- posed regulation. The announcement prompted immediate legal action on the part of the tobacco in- dustry, advertising interests, and the convenience store industry, which challenged the FDA's jurisdiction over Issues irz Reducitlg Tobacco Use 15 Surgeon Grrleral's Report tobacco products. In April 1997, a federal district court upheld the FDA's jurisdiction over tobacco products, but held that it lacked authority under the statutory provision relied on to regulate tobacco product advertising. Although many of the FDA's regulations on to- bacco sales and distribution were incorporated, to some extent, in the June 20,1997, proposed settlement of lawsuits between 41 state attorneys general and the tobacco industry, the settlement presupposed congres- sional legislation that would uphold the FDA's as- serted jurisdiction. After considerable congressional negotiation, no such legislation emerged. In August 1998, a three-judge panel of the United States Court of Appeals for the Fourth Circuit held that the FDAlacked jurisdiction to regulate tobacco products. In Novem- ber 1998, the full Court of Appeals rejected the government's request for rehearing by the entire court. On March 21, 2000, in a 5 to 4 decision, the United States Supreme Court affirmed the decision of the United States Court of Appeals for the Fourth Circuit and held that the FDA lacks jurisdiction under the Fed- eral Food, Drug, and Cosmetic Act to regulate tobacco products as customarily marketed. As a result of this decision, the FDA's August 1996 assertion of ju- risdiction over cigarettes and smokeless tobacco and regulations restricting the sale and distribution of ciga- rettes and smokeless tobacco to protect children and adolescents (principally codified at 21 Code of Fed- eral Regulations Part 897) are invalid. Clean Indoor Air Regulation Unlike the regulation of tobacco products per se and of their advertising and promotion, regulation of exposure to ETS has encountered less resistance. This course is probably the result of (1) long-standing grassroots efforts to diminish exposure to ambient to- bacco smoke and (2) consistent epidemiologic evidence of adverse health effects of ETS. Since 197l, a series of rules, regulations, and laws have created smoke-free environments in an increasing number of settings: government offices, public places, eating establish- ments, worksites, military establishments, and domes- tic airline flights. As of December 31, 1999, smoking was restricted in public places in 45 states and the Dis- trict of Columbia. Currently, some 820 local ordi- nances, encompassing a variety of enforcement mechanisms, are in place. The effectiveness of clean indoor air restrictions is under intensive study. Most studies have concluded that even among smokers, support for smoking restric- tions and smoke-free environments is high. Research has also verified that the institution of smoke-free workplaces effectively reduces nonsmokers' exposure to ETS. Although most studies indicate that smoke- free environments have not reduced smoking preva- lence, such environments have been shown to decrease daily tobacco consumption and to increase smoking cessation among smokers. Minors' Access to Tobacco There is widespread approval for restricting the access of minors to tobacco products. Recent research, however, has demonstrated that a substantial propor- tion of teenagers who smoke purchase their own tobacco, and the proportion varies with age, social class, amount smoked, and factors related to local availability. In addition, research has shown that most minors can easily purchase tobacco from a variety of retail outlets. It has been suggested that a reduction in commercial availability may result in a reduced prevalence of tobacco use among minors. Several approaches have been taken to limiting minors' access to tobacco. All states prohibit sale or distribution of tobacco to minors. More than two-thirds of states regulate the means of sale through restrictions on minors' use of vending machines, but many of these restrictions are weak, and only two states have total bans on vending machines. Restrictions on vending machines are a subclass of the larger category of regu- lation of self-service cigarette sales; in general, such regulation requires that cigarettes be obtained from a salesperson and not be directly accessible to custom- ers Such policies can reduce shoplifting as well, an important source of cigarettes for some`minors. Regulations directed at the seller include the specification of a minimum age for sale (18, in all but two states and Puerto Rico), a minimum age for the seller, and the prominent in-store announcement of such policy. Providing merchant education and train- ing is an important component of comprehensive mi- .. nors' access-programs. Penalties for sales to minors vary considerably; in general, civil penalties have been found to be more effective than criminal ones, Requir- ing licensure of tobacco retailers has been found to provide a funding source for compliance checks and to serve as an incentive to obey the law when revoca- tion of the license is a provision of the law. Applying penalties to business owners, instead of to clerks only, is considered essential to preventing sales to minors. Tobacco retail outlets and the tobacco industry have vigorously opposed this policy. An increasing num- ber of states and local jurisdictions are imposing sanc- tions against minors who purchase, possess, or use 26 Chapter 1 Reducing Tobacco Use tobacco products. Sanctions against both buyers and sellers are enforced by a variety of agencies and mecha- nisms. Because regulations in general may be more effective if generated and enforced at the local level, considerable energy is devoted to the issue of oppos- ing or repealing preemption of local authority by states. Public health analyses have resulted in strong recom- mendations that state laws not preempt local action to curb minors' access to tobacco. Litigation Approaches Private litigation shifts enforcement of public health remedies from the enterprise or the government to the private individual-typically, victims or their surrogates. In the tort system, the coalescence of in- stances in which injurers are forced to compensate the injured can create a force that generates preventive effects. Although relatively inefficient as a system for compensating specific classes of injuries, the tort sys- tem is justified by its generation of preventive actions and by its flexibility. Tobacco represents an atypical pattern of litigation and product modification, because private law remedies have not yet succeeded in insti- tutionalizing recovery for tobacco injuries or have not yet generated significant preventive effects. In the case of tobacco, regulation has been the predominant control, and such regulation has been distinctive in re- lying primarily on notification requirements rather than safety requirements. Private litigation against tobacco has occurred in several distinct waves. The first wave was launched in 1954 and typically used one or both of two legal theories: negligence and implied warranty. Courts proved unreceptive to both these arguments, and this approach had receded by the mid-1970s. In many of these and subsequent cases, legal devices and exhaus- tion of plaintiff resources figured prominently in the defendants' strategy. A second wave began in 1983 and ended in 1992. In these cases, the legal theory shifted from warranty to strict liability. The tobacco industry based its defense on smokers' awareness of risks and so-called freedom of choice. For example, plaintiffs argued that the addictive nature of nicotine limited free choice; defense counsel rebutted by point- ing to the large number of former smokers who suc- cessfully quit. Taking freedom-of-choice defense even further, counsel argued that the claimant's lifestyle was overly risky by choice or was in some way immoral. The case that symbolized the second-wave litigation was that filed by Rose Cipollone, a dying smoker, in 1983. The Supreme Court accepted the tobacco industry's defense that federal law requiring warning labels on product packages had preempted claims under state law that imposed liability for failure to warn. The Supreme Court left open several other ap- proaches, but the likelihood of recovery seemed small, and counsel for the Cipollone estate withdrew. In the third wave, begun soon after the Cipollone decision and still ongoing, diverse legal arguments have been invoked. This third wave of litigation dif- fers from its predecessors by enlarging the field of plaintiffs, focusing on a range of legal issues, using the class action device, and making greater attempts to use private law for public policy purposes. These new claims have been based on theories of intentional misrepresentation, concealment, and failure to dis- close, and such arguments have been joined to a new emphasis on addiction. For example, in one case that ended as a mistrial, plaintiffs were barred from pre- senting evidence that the tobacco companies may have manipulated nicotine levels. The class action device has figured prominently in these new cases, which have included claims of smokers as well as claims of those who asserted that they have been injured by ETS. Arguably the most notable series of third-wave claims brought against tobacco companies is the proposed 1997 settlement of suits brought by 41 state attorneys general attempting to recover the states' Medicaid ex- penditures for treating tobacco-related illnesses. In the absence of congressional legislation needed to give that settlement the force of law, four states made indepen- dent settlements with the tobacco industry. Notably, each state obtained a concession guaranteeing that it would benefit from any more favorable agreement that another state might later obtain from the tobacco in- dustry. Subsequently, a multistate Master Settlement Agreement was negotiated in November 1998 cover- ing the remaining 46 states, the District of Columbia, and five commonwealths and territories. Another notable recent development is the filing of large claims by other third-party payers, such as large health care plans. Perhaps in partial response, the level of litiga- tion initiated by the tobacco industry itself has in- creased in recent years and has included a number of well-publicized cases, including a threatened suit against the media to prevent airing of a program that accused a tobacco company of manipulating nicotine levels. The company was successful in making the network withdraw the program, even though similar information was later made public in other contexts. Although the industry continues aggressive legal pur- suit of its interests on a number of fronts, litigation against the industry has had undoubted impact on Issues in Reducing Tobacco Use 17 tobacco regulation and is likely to continue to play a key role in efforts to reduce tobacco use. Overview and Implications Tobacco products are far less regulated in the United States than they are in many other developed countries. This level of regulation applies to the manu- factured tobacco product; to the advertising, promo- tion, and sales of these products; and to the protection of nonsmokers from the involuntary exposure to ETS from the use of these products. As with all other con- sumer products, adult users of tobacco should be fully informed of the products' ingredients and additives and of any known toxicity when used as intended. Additionally, as with other consumer products, the manufactured tobacco product should be no more harmful than necessary given available technology. The sale, distribution, and promotion of tobacco prod- ucts need to be sufficiently regulated to protect un- derage youth from influences to take up smoking. Finally, involuntary exposure to ETS remains a com- mon public health hazard that is entirely preventable by appropriate regulatory policies. Such are the basic, reasonable regulatory issues related to tobacco products. Yet these issues remain unresolved as the new millennium begins. When con- sumers purchase a tobacco product, they receive little information regarding the ingredients, additives, or chemical composition in the product. Although public knowledge about the potential toxicity of most of these constituents is negligible, findings in this report con- clude that the warning labels on cigarette packages in this country are weaker and less conspicuous than in other countries. Further, the popularity of "low tar and nicotine" brands of cigarettes has shown that consum- ers may be misled by another, carefully crafted kind of information-that is, by the implied promise of reduced toxicity underlying the marketing of these products. Current regulation of the advertising and pro- motion of tobacco products in this country is consid- erably less restrictive than in several other countries, notably Canada and New Zealand. The review of cur- rent case law in this report supports the contention that greater restrictions of tobacco product advertis- ing and promotion could be legally justified. In fact, the report concludes that regulation of the sale and promotion of tobacco products is needed to protect young people from smoking initiation. ETS contains more than 4,000 chemicals; of these, at least 43 are known carcinogens (Environmen- tal Protection Agency 1992). Exposure to ETS has serious health effects (USDHHS 2000b). Despite this documented risk, research has demonstrated that more than 88 percent of nonsmokers in this country aged 4 years and older had detectable levels of se- rum cotinine, a marker for exposure to ETS (Pirkle et al. 1996). The research reviewed in this report indi- cates that smoking bans are the most effective method for reducing ETS exposure. Four Heulthy People 2020 objectives address this issue and seek optimal pro- tection of nonsmokers through policies, regulations, and laws requiring smoke-free environments in all schools, worksites, and public places. Despite the widespread support among the gen- eral public, policymakers, and the tobacco industry for restricting the access of minors to tobacco products, a high proportion of underage youth smokers across this country continue to be able to purchase their own tobacco. National efforts by the Substance Abuse and Mental Health Services Administration to increase the enforcement of state laws to comply with the Synar Amendment and by the FDA to implement the access restrictions defined in their 1996 rule have reduced the percentage of retailers in many states who sell to mi- nors. Unfortunately, nine states failed to attain their Synar Amendment targets in 1999. Additionally, the March 2000 Supreme Court ruling that the FDA lacks jurisdiction to regulate tobacco products has suspended all enforcement of the agency's 1996 regulations. Although several states have increased emphasis on this issue as part of their state-funded program efforts, the loss of the FDA's program removes a major infrastructure in support of these state efforts. The current regulatory environment poses considerable challenges for the interweaving of regulation into a comprehensive, multicomponent approach to tobacco use control and prevention. Economic Approaches (Chapter 6) The argument for using economic policy for re- ducing tobacco use requires considerable technical and analytic understanding of economic theory and data. Because experiments and controlled trials-in the usual sense-are not available to the economist, judg- ment and forecasting depend on the results of com- plex analysis of administrative and survey data. Such analyses have led to a number of conclusions regard- ing the importance of the tobacco industry in the U.S. economy and regarding the role of policies that might affect the supply of tobacco, affect the demand for to- bacco, and use different forms of taxation as a pos- sible mechanism for reducing tobacco use. Reducing Tobacco Use Sup@y. The tobacco support program has success- fully limited the supply of tobacco and raised the price of tobacco and tobacco products. However, the princi- pal beneficiaries of this program are not only the farmers whose income is supported but also the own- ers of the tobacco allotments. If policies were initiated to ameliorate some short-run effects, the tobacco sup- port program could be removed without imposing substantial losses for many tobacco farmers. Elimi- nating the tobacco support program would lead to a small reduction in the prices of cigarettes and other tobacco products, which would lead to slight increases in the use of these products. However, because the support program has created a strong political con- stituency that has successfully impeded stronger leg- islation to reduce tobacco use, removing the support program could make it easier to enact stronger policies that would more than offset the impact that the result- ing small reductions in price would have on demand. Throughout the 1980s and 199Os, competition within the tobacco industry appeared to have de- creased as a result of the favorable deregulatory busi- ness climate and an apparent increase in collusive behavior. This reduction in competition, coupled with the addictive nature of cigarette smoking, has magni- fied the impact that higher cigarette taxes and stronger smoking reduction policies would have on demand. The recent expansion of U.S. trade in tobacco and tobacco products through multinational agreements, together with the U.S. threat of retaliatory trade sanc- tions were other countries to impede this expansion, is nearly certain to have increased the use of tobacco products worldwide. Such an increase would result in a consequent global rise in morbidity and mortality related to cigarette smoking and other tobacco use. These international trade policy efforts conflict with current domestic policies (and the support of compa- rable international efforts) that aim to reduce the use of tobacco products because of their harmful effects on health. Industry importance. Although employment in the tobacco industry is substantial, the industry greatly overstates the importance of tobacco to the U.S. economy. Indeed, most regions would likely benefit- for example, through redistribution of spending and changes in types of job-from the elimination of rev- enues derived from tobacco products. Moreover, as the economies of tobacco-growing regions have be- come more diversified, the economic importance of tobacco in these areas has fallen. Higher tobacco taxes and stronger prevention policies could be joined to other efforts to further ease the transition from tobacco in major tobacco-producing regions. Finally, trading lives for jobs is an ill-considered strategy, particularly with the availability of stronger policies for reducing tobacco use. Demand. Increases in the price of cigarettes will lead to reductions in both smoking prevalence and ciga- rette consumption among smokers; relatively large re- ductions are likely to occur among adolescents and young adults. Limited research indicates that increases in smokeless tobacco prices will similarly reduce the use of these products. More research is needed to clarify the impact of cigarette and other tobacco prices on the use of these products in specific sociodemographic groups, particularly adolescents and young adults. Additional research also is needed to address the po- tential substitution among cigarettes and other tobacco products as their relative prices change. T~xntion. After the effects of inflation are ac- counted for, federal and average state excise taxes on cigarettes are well below their past levels. Similarly, average cigarette excise taxes in the United States are well below those imposed in most other industrialized countries. Moreover, U.S. taxes on smokeless tobacco products are well below cigarette taxes. Studies of the economic costs of smoking report a wide range of es- timates for the optimal tax on cigarettes. However, when recent estimates of the costs of ETS (including the long-term costs of fetal and perinatal exposure to ETS) are considered, and when the premature death of smokers is not considered an economic benefit, a tax that would generate sufficient revenues to cover the external costs of smoking is almost certainly well above current cigarette taxes. The health benefits of higher cigarette taxes are substantial. By reducing smoking, particularly among youth and young adults, past tax increases have significantly reduced smoking- related morbidity and mortality. Further increases in taxes, indexed to account for the effects of inflation, would lead to substantial long-run improvements in health. The revenue potential of higher cigarette and other tobacco taxes-obviously not in itself a goal-is considerable; significant increases in these taxes would lead to sizable increases in revenues for many years. However, because of the greater price responsiveness of adolescents and young adults and the addictive nature of tobacco use, the long-run increase in revenues is likely to be less than the short-run gain. Neverthe- less, current federal and most state tobacco taxes are well below their long-run revenue-maximizing levels. In short, the research reviewed in this report sup- ports the position that raising tobacco prices is good public health policy. Further, raising tobacco excise taxes is widely regarded as one of the most effective Issues in Reducing Tobacco Use 19 tobacco prevention and control strategies. Research indicates that increasing the price of tobacco products would decrease the prevalence of tobacco use, particu- larly among minors and young adults. As noted, how- ever, this report finds that both the average price of cigarettes and the average cigarette excise tax in this country are well below those in most other industrial- ized countries and that the taxes on smokeless tobacco products are well below those on cigarettes. Making optimal use of economic strategies in a comprehen- sive program poses special problems because of the complexity of government and private controls over tobacco economics and the need for a concerted, mul- tilevel, political approach. Comprehensive Programs (Chapter 7) Community-based interventions were originally developed as research projects that tested the efficacy of a communitywide approach to risk reduction. A number of national and international efforts to con- trol cardiovascular disease (in the United States, nota- bly the Minnesota, Stanford, and Pawtucket studies) used controlled designs. The results from these and other studies were largely disappointing, particularly regarding prevention and control of tobacco use. Other large-scale research efforts, such as the Community In- tervention Trial (COMMIT) for Smoking Cessation, also failed to meet their primary goals for smoking re- duction and cessation. Similarly, the results to date from numerous worksite-based cessation projects sug- gest either no impact or a small net effect (summarized in Chapter 4). As these studies were under way in the 1970s and 198Os, health promotion-an organized approach to changing social, economic, and regulatory environ- ments-emerged as a more effective mechanism for population behavior change than traditional health education. Although the aforementioned community- based research projects used a health promotion per- spective, they lacked the reach and penetration required for effective social change. In any event, the results made clear the distinction between a specific program (even one using multiple modalities) and a comprehen- sive multimessage, multichannel approach that used some or all of the modalities described in Chapters 3 through 6. The legal and economic events of the 199Os- most notably large excise tax increases and the settle- ments with the tobacco industry for reimbursement of Medicaid costs incurred by caring for smokers-have provided those states with the resources necessary to mount such a comprehensive approach. The early results are encouraging, as exemplified by results from California, Massachusetts, Oregon, and Florida. The well-funded, coherent, and organized approach to to- bacco prevention and control provides a credible coun- terweight to the advertising and promotional efforts of the tobacco industry and fosters a powerful nonsmok- ing norm. On a broader scale, other social initiatives can also serve some of these same purposes through means that are not directly related to changing population behav- ior. For example, direct advocacy-the presentation of information to decision makers to encourage their support for nonsmoking policies-has been pursued vigorously by health advocates since the organization of grassroots movements for nonsmokers' rights in the early 1970s. Much of the clean air legislation now in place may be attributed in part to such direct advo- cacy. An interesting observation that supports the logic behind comprehensive programs is that initial short- comings in direct advocacy activity may have been related to a failure of coordination among grassroots groups and professional organizations. In recent years, in part as the result of electronic networking and me- diating by the Advocacy Institute, a more unified ap- proach to reducing tobacco use has been achieved among the participating organizations. Media advocacy-the use of mass media to ad- vance public policy initiatives-has also been effective in placing smoking issues in the public eye and main- taining a continued impetus for reducing tobacco use. Case analysis cf several instances of such activity- advocacy opposing the promotion of the "X" cigarette, the marketing of "Dakota" cigarettes, the Philip Morris-sponsored Bill of Rights tour, and the attempted marketing of "Uptown" cigarettes-highlights several successes but also indicates that such activities do not always achieve their immediate aims. Nonetheless, considerable experience has been gained in seizing such opportunities. Countermarketing activities can promote smok- ing cessation and decrease the likelihood of initiation. Countermarketing campaigns also can have a power- ful influence on public support for tobacco control ac- tivities and provide an educational climate that can enhance the efficacy of school- and community-based efforts. For youth, the CDC has estimated that the average l&year-old has been exposed to more than $20 billion in imagery advertising and promotions since age 6, creating a "friendly familiarity" for tobacco products. The recent increase in movie depictions of tobacco use further enhances the image of tobacco use as glamorous, socially acceptable, and normal. In light 20 Cllnpter 1 Reducing Tobacco Use of the ubiquitous and sustained protobacco messages, countermarketing campaigns need to be of comparable intensity and duration to alter the general social and environmental atmosphere supporting tobacco use. In sum, the comprehensive approach that has been developed-within the statewide tobacco control programs has produced results that led the Institute of Medicine (2000) to conclude that "multifaceted state tobacco control programs are effective in reducing to- bacco use" (p. 4). Although these initial results are encouraging, they need to be considered from the per- spective of the less favorable results from the commu- nity trials. Nevertheless, although our knowledge about the mechanisms by which these new compre- hensive tobacco control efforts function is imperfect, the results are sufficiently favorable to support the con- tinued application of this model. But, accountability and program evaluation must be emphasized in these new statewide tobacco control programs to improve our understanding of how the various components of the comprehensive programs work. Perhaps the most important aspect of comprehen- sive programs has been the emergence of statewide to- bacco control efforts as a laboratory for their development and evaluation. The number of states with such pro- grams grew slowly in the early and mid-1990s, but in recent years there has been a surge in funding for such efforts fueled by the state settlements with the tobacco industry. Although the data on the impact of these pro- grams on per capita consumption, adult prevalence, and youth prevalence are generally favorable, the uni- fo:m data systems needed to conduct more controlled evaluations of these efforts are still emerging. The chal- lenge for the new millennium will be to ensure that these ever increasing comprehensive statewide tobacco con- trol programs are as efficient and effective as possible. The review of statewide tobacco control programs indicates that reducing the broad cultural acceptability of tobacco use necessitates changing many facets of the social environment. In addition, this report stresses- as does the Best Practices (CDC 1999) document-that these individual components must work together to produce the synergistic effects of a comprehensive program. However, both of these findings highlight the complexity involved in evaluating these types of programs. Within the current statewide tobacco control pro- grams, each of these various modalities discussed in this report is represented with varying degrees of in- tensity. As noted above, some of the recommendations for actions within these modalities could most effec- tively be done at the national rather than the state level. Thus, the overall efficacy of these emerging statewide programs will depend in some ways on public health advances at the national level. Again, this synergy between the statewide and national efforts adds greater complexity to the evaluation issue. Finally, this report concludes that the span of impact of these educational, clinical, regulatory, eco- nomic, and social approaches indicates the importance of their sustained and long-term implementation. Pro- gram evaluation and research efforts are needed to improve our understanding of how these various ele- ments work. Although knowledge about the efficacy of comprehensive programs is imperfect, evidence points to early optimism for their continuance. With the expansion of tobacco control surveillance and evaluation systems and increases in the number and diversity of statewide tobacco control programs, criti- cal questions can be answered about how to make these efforts more efficient and effective. A Vision for the Future-Reducing Tobacco Use in the New Millennium (Chapter 8) Chapter 8 outlines broad strategies and courses of action for tobacco control in the future. Six future challenges are outlined: continuing to build the scien- tific base, responding to the changing tobacco indus- try, using a comprehensive approach in reducing tobacco use, eliminating health disparities, improving dissemination of state-of-the-art interventions, and influencing tobacco use in developing nations. Surgeorl Gerwal's Rr,vorf Chapter Conclusions Following are the specific conclusions for each chapter of the report. Note that Chapters 1 and 8 have no conclusions. Chapter 2. Historical Review 1. 2. 3. In the years preceding the development of the modern cigarette, and for some time thereafter, antismoking activity was largely motivated by moralistic and hygienic concerns. Health con- cerns played a lesser role. In contrast, in the second half of the 20th cen- tury, the impetus for reducing tobacco use was largely medical and social. The resulting plat- form has been a more secure one for efforts to reduce smoking. Despite the growing scientific evidence for ad- verse health effects, smoking norms and habits have yielded slowly and incompletely. The rea- sons are complex but attributable in part to the industry's continuing stimulus to consumption. Chapter 3. Educational Strategies Educational strategies, conducted in conjunction with community- and media-based activities, can postpone or prevent smoking onset in 20 to 40 percent of adolescents. Although most U.S. schools have tobacco use pre- vention policies and programs in place, current practice is not optimal. More consistent implementation of effective edu- cational strategies to prevent tobacco use will re- quire continuing efforts to build strong, multiyear prevention units into school health education cur- ricula and expanded efforts to make use of the influence of parents, the mass media, and other community resources. Chapter 4. Management of Nicotine Addiction 1. 2. 3. 4. 5. Tobacco dependence is best viewed as a chronic disease with remission and relapse. Even though both minimal and intensive interventions in- crease smoking cessation, most people who quit smoking with the aid of such interventions will eventually relapse and may require repeated at- tempts before achieving long-term abstinence. Moreover, there is little understanding of how such treatments produce their therapeutic effects. There is mixed evidence that self-help manuals are an efficacious aid to smoking cessation. Be- cause these materials can be widely distributed, such strategies may have a significant public health impact and warrant further investigation. Programs using advice and counseling-whether minimal or more intensive-have helped a sub- stantial proportion of people quit smoking. The success of counseling and advice increases with the intensity of the program and may be im- proved by increasing the frequency and duration of contact. The evidence is strong and consistent that phar- macologic treatments for smoking cessation (nicotine replacement therapies and bupropion, in particular) can help people quit smoking. Clonidine and nortriptylene may have some util- ity as second-line treatments for smoking cessa- tion, although they have not been approved by the FDA for this indication. Chapter 5. Regulatory Efforts Advertising and Promotion 1. Since 1964, numerous attempts to regulate ad- vertising and promotion of tobacco products have had only modest success in restricting such activity. 22 Chnptu 1 Current regulation in the United States is con- siderably less restrictive than that in several other countries, notably Canada and New Zealand. Current case law supports the contention that ad- vertising does not receive the protections of free speech under the First Amendment to the Con- stitution that noncommercial speech does. Product Regulation 1. 2. 3. 4. 5. Warning labels on cigarette packages in the United States are weaker and less conspicuous than those of other countries. Smokers receive very little information regard- ing chemical constituents when they purchase a tobacco product. Without information about toxic constituents in tobacco smoke, the use of terms such as "light" and "ultra light" on pack- aging and in advertising may be misleading to smokers. Because cigarettes with low tar and nicotine con- tents are not substantially less hazardous than higher-yield brands, consumers may be misled by the implied promise of reduced toxicity un- derlying the marketing of such brands. Additives to tobacco products are of uncertain safety when used in tobacco. Knowledge about the impact of additives is negligible and will remain so as long as brand-specific information on the identity and quantity of additives is unavailable. Regulation of tobacco product sale and promo- tion is required to protect young people from in- fluences to take up smoking. Clean Indoor Air Regulation 1. Although population-based data show declining ETS exposure in the workplace over time, ETS exposure remains a common public health haz- ard that is entirely preventable. Reducing Tobacco Use 3. Beyond eliminating ETS exposure among non- smokers, smoking bans have additional benefits, including reduced smoking intensity and poten- tial cost savings to employers. Optimal protec- tion of nonsmokers and smokers requires a smoke-free environment. Minors' Access to Tobacco 1. 2. Measures that have had some success in reduc- ing minors' access include restricting distribu- tion, regulating the mechanisms of sale, enforcing minimum age laws, having civil rather than criminal penalties, and providing merchant edu- cation and training. Requiring licensure of to- bacco retailers provides both a funding source for enforcement and an incentive to obey the law when revocation of the license is a provision of the law. The effect of reducing minors' access to tobacco products on smoking prevalence requires further evaluation. Litigation Approaches 1. Two historic waves of tobacco litigation were ini- tiated by private citizens, were based largely on theories of negligence and implied warranty, and were unsuccessful. 2. A third wave has brought in new types of claim- ants, making statutory as well as common-law claims and using more efficient judicial proce- dures. Although several cases have been settled for substantial money and have yielded public health provisions, many other cases remain unresolved. 3. Private law initiative is a diffuse, uncentralized activity, and the sum of such efforts is unlikely to produce optimal results for a larger policy to reduce tobacco use. On the other hand, the liti- gation actions of individuals are likely to be a valuable component in some larger context of strategies to make tobacco use less prevalent. 2. Most state and local laws for clean indoor air re- duce but do not eliminate nonsmokers' exposure to ETS; smoking bans are the most effective method for reducing ETS exposure. Issurs irz Reduci?rg Tobacco Use 23 Surxeotl General's Report Chapter 6. Economic Approaches The price of tobacco has an important influence on the demand for tobacco products, particularly among young people. Substantial increases in the excise taxes on ciga- rettes would have considerable impact on the prevalence of smoking and, in the long term, re- duce the adverse health effects caused by tobacco. Policies that influence the supply of tobacco, par- ticularly those that regulate international com- merce, can have important effects on tobacco use. Although employment in the tobacco sector is substantial, the importance of tobacco to the U.S. economy has been overstated. Judicious policies can be joined to higher tobacco taxes and stron- ger prevention policies to ease economic diver- sification in tobacco-producing areas. Chapter 7. Comprehensive Programs The large-scale interventions conducted in com- munity trials have not demonstrated a conclu- sive impact on preventing and reducing tobacco use. Statewide programs have emerged as the new laboratory for developing and evaluating com- prehensive plans to reduce tobacco use. Initial results from the statewide tobacco control programs are favorable, especially regarding declines in per capita consumption of tobacco products. Results of statewide tobacco control programs suggest that youth behaviors regarding tobacco use are more difficult to change than adult ones, but initial results of these programs are gener- ally favorable. 24 Chapter 2 Reducirrg Tobacco Use References Centers for Disease Control and Prevention. Besf Prac- tices for Comprehensive Tobacco Collfrol Proxra1Tzs- August 1999. Atlanta: Centers for Disease Control and Prevention, National Center for Chronic Disease Pre- vention and Health Promotion, Office on Smoking and Health, 1999. Fiore M, Bailey W, Bennett G, Bennett H, Cohen S, Dorfman SF, Fox B, Goldstein M, Gritz E, Hasselblad V, Heishman S, Heyman R, Husten C, Jaen CR, Jorenby D, Kamerow D, Kottke T, Lando H, Mecklenburg R, Melvin C, Morgan G, Mullen I'D, Murray E, Nett L, Orleans CT, Robinson L, Stitzer M, Tommasello A, Villejo L, Wewers ME, Baker T. Trdy Tob~~cco Use ord Deyelzdence. Clinical Practice Guideline. Rockville (MD): US Department of Health and Human Services, Public Health Service, 2000. Lynch BS, Bonnie RJ, editors. Growillg Up Tobacco Free. Preventing Nicotilze Addiction irz Children alld Youths. Washington: National Academy Press, 1994. Myers ML, Iscoe C, Jennings C, Lenox W, Minsky E, Sacks A. Staff Report on the Cigarette Adzlerfisilzg lnves- figafion. Washington: Federal Trade Commission, 1981. Ramstrijm LM. Consequences of tobacco dependence- a conceptual reappraisal of tobacco control policies. Paper presented at the 37th International Congress on Alcohol and Drug Dependence; Aug 22,1995; San Diego (CA). Rothenberg RB, Koplan Jl'. Chronic disease in the 1990s. Amual Reuiew of Public Health 1990;11:267-96. US Department of Health and Human Services. Healthy People 2000: Nafiollal Health Promotion and Disease Pre- zle,ztiorl Objectizjes. Washington: US Department of Health and Human Services, Public Health Service, 1991. DHHS Publication No. (PHS) 91-50212. US Department of Health and Human Services. Guide to Community Preventme Services [brochure]. Atlanta: US Department of Health and Human Services, Cen- ters for Disease Control and Prevention, 1998a. US Department of Health and Human Services. Tobacco Use A\?IOIZ~ U.S. Racial/Ethnic Minority Groups- AfricaI? Americans, American lndiam and Alaska Natives, Asiarl Americnns and Pacific Islanders, and Hispanics: A Report of the Surgeon General. Atlanta: US Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 1998b. US Department of Health and Human Services. Healthy Peoyle 2010 (Conference edition, in two volumes). Washington: US Department of Health and Human Services, 2000. US Department of Health, Education, and Welfare. Smoking and Health: Report of the Advisory Committee to the Surgeorz General of the Public Health Service. Wash- ington: US Department of Health, Education, and Welfare, Public Health Service, 1964. PHS Publication No. 1103. issues ~JI Rrduci,lg Tobacco Use 25 Chapter 2 A Historical Review of Efforts to Reduce Smoking in the United States Introduction 29 Early Events 29 The Rise of the Cigarette 30 Popularity and Protest 30 The Attraction of Cigarettes 31 Women and Cigarettes 36 Winds of Change 37 Medical Warnings 38 Public Dissemination 38 Toward a Medical Consensus 39 Turning Point: The Surgeon General's Report 40 A Stubborn Norm 40 Economic and Social Impedance 41 Delayed Effects and Delayed Actions 47 From Disease Treatment to Risk Management 42 The Diverse Momentum of the Movement to Reduce Smoking 43 Support From Business 43 The Attack on Advertising 45 Toward a National Policy to Reduce Smoking 4.5 From Antismoking to Nonsmokers' Rights 46 Regulations, Legislation, and Lobbying for Nonsmokers 46 ETS: From Annoyance to Carcinogen 47 The Impact of the Movement to Reduce Smoking 48 Conclusions 51 References 52 Reducillg Tobacco Use Introduction Like many other social phenomena, the use of tobacco has created a tapestry of themes, motivations, and social forces, woven together with a complexity that has begun to capture the interest of social histori- ans (Brandt 1990; Burnham 1993; Klein 1993; Tate 1999). Tobacco has economic, social, and political reverberations and is intimately tied to collective im- ages and attitudes. Nonetheless, some simplification is possible: the history of tobacco use can be thought of as the conflict between tobacco as an agent of eco- nomic gain and tobacco as an agent of human harm. An exhaustive history would not be content with such a simple contrast, but it serves the purpose of this chap- ter. The chief barrier to reducing tobacco use-the path of most resistance-is a powerful industry whose efforts to promote tobacco have continued to shape public opinion and social norms. Against this back- ground, the chapter considers the underlying forces Early Events that have motivated the movement to reduce smok- ing. Many recent events that are of critical historical importance for nonsmoking are considered in other segments of the report (e.g., social advocacy actions [Chapter 71; taxation-based initiatives in states [Chap- ter 71; Food and Drug Administration regulations re- garding minors as the target of tobacco advertising {Chapter 51; and proposed national legislation, settle- ment and attempted settlement of various lawsuits against the tobacco companies, and criminal proceed- ings against tobacco companies [Chapter 51). As noted in Chapter 1, some of the most dynamic changes in the history of smoking control efforts are currently taking place, and we are not sufficiently distanced from these events to evaluate them fully. This chapter will con- sider, rather, the changing thematic content-religious, hygienic, medical, and social-of the movement to reduce smoking that has presaged the current events. In North America, the history of tobacco use pre- cedes written records. After American Indians intro- duced tobacco to the European colonists, tobacco was transported from the colonies to Europe, where it quickly became a widely used consumer item. Just as quickly, however, the use of tobacco became contro- versial. Critics of the day attacked tobacco use as morally irresponsible, extravagant, and a habit of people of base condition (Best 1979). In England, King James I published an antitobacco tract in 1604 that, among other things, offered an early critique of sec- ondhand smoke: the royal author expressed his con- cerns that a husband who smoked might "reduce thereby his delicate, wholesome, and cleane complex- ioned wife to that extremitie, that either shee must also corrupt her sweete breath therewith, or else resolve to live in a perpetual1 stinking torment" (quoted in Apperson 1916, p. 206). In many countries of north- ern Europe, tobacco use was criminalized (Best 1979). Part of the objection in England and elsewhere was that trading gold to Spain for tobacco-the best tobacco came from Spain's colonies--was dangerous to the state economy. But with the English colonization of Virginia and the growing need in England, and else- where in Europe, for more state revenue, governments turned their policies around, despite continued moral objections to tobacco use. King James I himself set aside his previous objections and sought ways for the crown to profit from the tobacco trade (Morgan 1975; Best 1979). Of all the novel consumer goods the New World made available to the Old World, "tobacco enjoyed the most rapid diffusion" (Shammas 1990, p. 801 among people of different income levels, who bought it on a fairly regular basis. Closer to the source, mass consumption was even more pronounced: in the American colonies during the 18th century, yearly con- sumption averaged between 2 and 5 pounds per capita (Shammas 1990). When used medicinally, tobacco was favorably regarded; but in its widespread use for plea- sure, "it was considered harmful and faintly immoral" (Morgan 1975, p. 91; see also Stewart 1967). Sw~eorz Gerzrral's Rqmrt Although that reputation for immorality never one historian reports, "helped to buy American inde- entirely vanished, by 1776, tobacco was not only a val- pendence" (Morgan 1975, p. 6). Thomas Jefferson ued consumer good but also the economic foundation thought well enough of tobacco to propose that its of the colonies' independence movement. "King leaves be carved into the pillars in one of the Capitol Tobacco Diplomacy" was a central element in gaining rotundas in Washington (U.S. House of Representa- French support for the struggling colonies; tobacco, tives 1969). The Rise of the Cigarette Before the 20th century, tobacco was used pre- dominantly for chewing, pipe smoking, inhaling (as snuff), and cigar smoking. The cigarette was an inno- vation that appeared sometime early in the 19th cen- tury. The term "cigarette" first made its appearance in English in the 1840s (Apperson 1916). For reasons including cost and ease of use (discussed later in this chapter), the product quickly caught on among tobacco users. In the United States, cigarette smoking increased enough during the Civil War for cigarettes to become subject to federal tax in 1864 (Tennant 1950). But it was not until its manufacture was mechanized that the cigarette became a major tobacco product. James Albert Bonsack patented a cigarette roll- ing machine in 1881 that, by the late 188Os, produced cigarettes at 40 times the rate of a skilled hand worker (Tennant 1950; Chandler 1977). The mechanization of cigarette manufacture, like that of a number of other products in the late 19th century (such as prepared cereals, photographic film, matches, flour, and canned food products such as soup), precipitated a marketing revolution. Industries that developed "continuous process" production (Chandler 1977, p. 249) could increase unit production without increasing produc- tion costs-the main production problem of the day. The cigarette industry, like these others, could now pro- duce almost unlimited quantities of product at mini- mal cost per additional unit. When James Buchanan Duke installed two Bonsack machines in 1884 and arranged the next year an advantageous leasing ar- rangement with Bonsack, his cigarette output soared. Within a decade, his unit cost of producing cigarettes dropped to one-sixth of what it had been (Chandler 1977). In 1890, following a series of price wars made feasible by these cost savings, Duke merged with several competitors to form The American Tobacco Company. With the production problem solved and competition reduced, the focus of business thinking shifted to marketing. At a time when national adver- tising of many products was in its infancy, The Ameri- can Tobacco Company was innovative and expansive in its promotional efforts (U.S. Department of Health and Human Services [USDHHSI 1994). Popularity and Protest The growing popularity of cigarette smoking coincided with the years of populist health reform in the 19th century. Antitobaccoism was a standard fea- ture of various writings on personal health, which held that any "stimulant" was unhealthy (Nissenbaum 1980). Some of these health beliefs were tied to a reli- gious orientation. Ellen Gould Harmon White, the prophetess who founded the Seventh-day Adventists, spoke out strongly against tobacco. In 1848, her first vision concerning healthful living taught her the reli- gious duty of abstaining from tobacco, tea, and coffee. She attacked these products for the money squandered on them and for their dangers to health. White may have picked up these views from Captain Joseph Bates, a Millerite (follower of William Miller, whose millenarian group believed that the Second Coming of Christ would occur in 1843). Not until 1855, how- ever, did tobacco abstention become a larger theme among the Adventists. In that year, the group's Reuirzu a& Herald printed two lead articles attacking "the filthy, health-destroying, God-dishonoring practice of using tobacco" (quoted in Numbers 1976, p. 40). This protest was an integral part of the complex antitobacco crusading at the time. In addition to the religious motif, there was the considerable influence of the hygiene movement, which branded "tobacco- ism" a disease, tobacco a poison (Burnham 1989, p. 6), and dubbed cigarettes "coffin nails" (Tate 1999, p. 24). 30 Chapter 2 Reducing Tobacco Use Spearheaded by the American Anti-Tobacco Society, which was founded in 1849, antitobacco critics found tobacco a cause of ailments ranging from insanity to cancer. During this time, cigarettes were often con- sidered narcotics because they seemed to have addict- ing qualities (Tate 1999). This litany of physiological ills ascribed to tobacco use did not prove to have the social power of the announcement, a century later, that numerous medical studies had found a direct link be- tween smoking and specific diseases that, as was un- derstood only in that later century, often took decades to manifest themselves. Between 1857 and 1872, George Trask published the Anti-Tobacco Jozmal in Fitchburg, Massachusetts, attacking the filth (especially of chew- ing tobacco), the dangers to health, and the costliness of tobacco (Tennant 1971). Early 19th century popular health movements tended to ally themselves with "nature" and "natural" remedies in opposition to pro- fessional medicine; by the late 19th century, health movements were more likely to take medical profes- sionals as their spokesmen (Burnham 1987). One such professional was Dr. John Harvey Kellogg, Seventh-day Adventist and director of the famous Adventist-founded Battle Creek (Michigan) Sanitarium, whose main concern was improving diet. Kellogg argued that tobacco was a principal cause of heart disease and other illnesses and that it adversely affected both judgment and morals (Schwarz 1970). Along with Ellen Gould Harmon White and her hus- band, a Millerite preacher, Kellogg organized the American Health and Temperance Association in 1878, which opposed the use of alcohol, tea, coffee, and tobacco. Later, Kellogg served as president of the Michigan Anti-Cigarette Society and, after World War I, as a member of the Committee of Fifty to Study the Tobacco Problem. Other organizational efforts directed specifically at cigarettes began in the last two decades of the 19th century. These efforts were generally directed at sav- ing boys and young men from the dangers of cigarette smoking. In New York City, the president of the board of education, a smoker himself, set up the Consolidated Anti-Cigarette League and won the pledges of 25,000 schoolboys not to smoke until they turned 21 (Troyer and Markle 1983). The first to call for cigarette prohibition was the National Woman's Christian Temperance Union (WCTU) (Tate 1999). Led by Frances Willard, a friend of Harvey Kellogg, who was further inspired by her brother's death from smoking-related illnesses, the WCTU as early as 1875 made plans to instruct mem- bers of its youth affiliate, the Juvenile Work, about the dangers of tobacco, as well as the hazards of alcohol. In 1883, the WCTU established the Department for Overthrow of Tobacco Habit, which was renamed the Department of Narcotics in 1885 (Lander 1885; Tate 1999). The campaign against tobacco became a perma- nent part of the WCTU. Reports from their annual meetings documented the accomplishments of state and local chapters in combating smoking. In 1884, the superintendent of the Department for Overthrow of Tobacco Habit acknowledged the difficulty of the task before her: "With a spittoon in the pulpit and the vis- ible trail of the vice in countless churches, with its entrenchments bearing the seal of respectability, its for- tifications so long impregnable will yield slowly and unwillingly to the mightiest opposing forces" (WCTU 1884, p. v). She noted that tobacco was a habit costing people "more than the support of all [their] ministers of the gospel" or than the price of educating their chil- dren; that it caused disease, "especially the loss of sight, paralysis, prostration, and scores of ailments hitherto credited to other sources"; and that it "lower[ed] the standard of morality" (WCTU 1884, p. v). The WCTU was one group that pressed with some success for legislation to prohibit the sale of tobacco to minors.' By 1890, such laws had been passed in 23 states. Connecticut and New York enacted pen- alties for both the underaged smoker and the merchant who sold to the minor (WCTU 1890). In New York, the strengthened law arose out of WCTU lobbying. "We found so many evasions of the law as it stood," the WCTU reported at its annual meeting in 1890, "that we decided our only way to save the boys was to amend the law, so as to punish the boy who was found using tobacco in any public place, street or resort" (WCTU 1890, p. 185). The Department of Narcotics organized a letter-writing campaign that mobilized women, educators, and ministers (p. 185). By 1897, the Department of Narcotics report could proudly claim, "everything points to the death of the little cof- fin nail, if our women will only continue faithful" (WCTLJ 1897, p. 343). `The laws prohibiting sales to minors began in New Jersey and Washington as early as 1883, Nebraska in 1885, and Maryland in 1886. By 1940, all states except Texas had laws of this sort on the books (Gottsegen 1940). By 1964, Texas had joined the list, but Louisiana and Wisconsin had repealed their laws as unenforceable (LJSDHHS 1989). The legality of the laws was confirmed by the United States Supreme Court (Austi~~ zl. Ennessre, 179 US. 343,21 S. Ct. 132 [19001), and a Federal Court of Appeals ruled in 1937 to uphold the authority of local jurisdictions to ban vending machine sales of cigarettes in the effort to protect minors (USDHHS 1989). Historical Reuiezu 31 Surgeor Gcrwrd `s` Report Announcements of tobacco's death were prema- ture, but cigarette sales declined in the last years of the 19th century. Most likely, the decline was precipi- tated by the "Plug War," in which The American Tobacco Company bought several plug tobacco pro- ducers and sharply cut prices, attracting cigarette us- ers back to other tobacco products. Moreover, as the country came out of the depression of the 189Os, cigar smokers who had shifted to the cheaper cigarettes moved back to their preferred smoke (Sobel1978). But the campaign against the cigarette certainly had a leg- islative impact. Cigarettes were prohibited for both adults and minors by law-if only temporarily-in North Dakota in 1895, Iowa in 1896, Tennessee in 1897, and Oklahoma in 1901. Eleven states had some gen- eral anticigarette legislation by 1901, and almost all state legislatures had considered curbs on cigarette sales (Outlook 1901). In 1899, Lucy Page Gaston, a WCTU activist, set up the Chicago Anti-Cigarette League (changed to the National Anti-Cigarette League in 1901 and to the Anti- Cigarette League of America in 1911). The league focused on the dangers of cigarettes to boys. Gaston sponsored frequent rallies, at which a chorus of young nonsmoking men provided the music (Duis 1983; Tate 1999). One of the innovations of Gaston's crusade was the establishment of a smoking cessation clinic in Chi- cago (Troyer and Markle 1983). Gaston, whose long career against tobacco would culminate with her bid for the Republican presidential nomination in 1920 on an antitobacco platform (New York Times 1920), worked tirelessly lobbying for antitobacco legislation. Such legislation continued to pass, particularly in midwestern and some western states-Indiana, Nebraska, and Wisconsin in 1905; Arkansas in 1907; and Kansas, Minnesota, South Dakota, and Washing- ton in 1909. But evasion of the laws was apparently easy. Cigarette "makings" (e.g., cigarette papers and cigarette tobacco) were sold even if cigarettes were not, and some retailers sold matches for a higher-than- usual price and gave away cigarettes with them (Warfield 1930; Sobell978). Other retailers and smok- ers evaded the law through a product wrapped in a tobacco leaf rather than paper (New York Times 1905). The WCTU was not alone in its efforts. Several businesses and prominent individuals were outspo- ken in the crusade against tobacco use, some going so far as to support Gaston's proposed (and defeated) 20th amendment to the Constitution that would have outlawed the manufacture and shipment of tobacco products (Junod 1997). Henry Ford attacked the habit of cigarette smoking and enlisted Thomas Edison to investigate its dangers (Brandt 1990). According to Harper's Weekly (1910), many railroads and other firms would not hire smokers. Sears, Roebuck and Com- pany and Montgomery Ward Holding Corporation refused to employ smokers (Porter 1947-48). The Non- Smokers' Protective League of America was estab- lished in 1911 with a distinguished board of directors, including Harvey W. Wiley, chief chemist of the U.S. Department of Agriculture and father of the (1906) Pure Food and Drug Act; James Roscoe Day, chancel- lor of Syracuse University; and David Starr Jordan, president of Stanford University (New York Times 1911). Dr. Charles G. Pease, a physician and dentist, was the leader of this group. "Almost single-handed," according to a New York Times report (1928, p. 71, Pease won a 1909 prohibition against smoking in the sub- ways. In 1917, he opposed sending tobacco to Ameri- can soldiers in Europe. But the New York Times reported in 1928 that "little has been heard from Dr. Pease since" (p. 7). Indeed, the anticigarette movement by then was waning. Cigarette prohibition was repealed in Indiana in 1909; Washington in 1911; Minnesota in 1913; Okla- homa and Wisconsin in 1915; South Dakota in 1917; Nebraska in 1919; Arkansas, Idaho, Iowa, and Tennes- see in 1921; Utah in 1923; North Dakota in 1925; and Kansas in 1927 (Gottsegen 1940). Legislatures in other states-including Lucy Page Gaston's home state of Illinois-considered but did not enact anticigarette bills (Duis 1983). Even the WCTU, at the time judged "the most powerful and the most formidable organization which is actively opposing the use of tobacco" (Brown 1920, p. 4471, in 1919 voted against supporting tobacco prohibition. The organization pledged to keep to an educational rather than a legislative campaign (New York Times 1919). A major weapon against the tobacco prohibition movement was the American soldier. Cigarettes had been popular among the armed forces since the Civil War. By 1918, during World War I, cigarettes were part of the army's daily ration (Dillow 1981); soldiers used cigarettes for relief during the extremes of tedium and tension characteristic of the profession. General John Joseph Pershing himself is supposed to have said, "You ask me what we need to win this war. I answer tobacco, as much as bullets" (quoted in Sobel 1978, p. 84). "The soldiers, we are told, must have their tobacco," a newspaper editorialized in 1915: "The ciga- rette is the handiest form in which this can be sent" (Lymr [Mass.] Ewr7iq News 1915, p. 4). Even the Young Men's Christian Association altered its antitobacco stance and, along with the International Red Cross and other charitable and patriotic organizations, sent ciga- rettes off to the soldiers in the field (Schudson 1984). Reducing Tobacco Use This outspoken, soldier-directed sentiment in favor of the cigarette was thus a large-scale factor in the reversal of anticigarette laws. A representative ques- tion that fueled the repeal effort in Kansas in 1927 was, "If cigaret[te]s were good enough for us while we were fighting in France, why aren't they good enough for us in our own homes?" (Literary Digest 1927, p. 12; see also Smith 1973). Weakened but not vanquished by these legisla- tive setbacks, the war on tobacco persevered. In 1921, the Loyal Temperance Legion reported holding anti- cigarette essay contests, distributing antitobacco blot- ters in schools, and stubbing out 125,000 cigars and cigarettes (WCTU 1921). The Department of Narcot- ics held up its own end; in 1929, for instance, it held poster contests, cooperated in antitobacco work with other civic organizations, sponsored 214 debates on tobacco, and ran essay contests producing more than 50,000 essays against tobacco use (WCTU 1929). Reli- gious denominations, including the Presbyterians, Methodists, and Baptists, also took a stand against tobacco (Troyer and Markle 1983). The antitobacco position was especially strong among the Mormons (Latter-day Saints). A motto of the Mormon youth or- ganization in 1920, "We stand for the non-use and non- sale of tobacco" (quoted in Smith 1973, p. 3601, seems to have presaged the current low prevalence of tobacco use in Utah. Such dedicated opponents did not prevent the popularity of the cigarette-an inexpensive, easy-to- use form of tobacco product-from increasing in the 1920s (Figure 2.1; the demographic and epidemiologic Figure 2.1. Adult per capita cigarette consumption and major smoking and health events, United States, 1900-1999 1964 Surgeon General's report 1 r Broadcast ad ban Coalescence of u.3. entry into WWII modern advocacy movement First modern Fairness Doctrine messages on broadcast media Great Depression 1940 1950 1960 1970 1980 1990 Year Note: The 1999 data are preliminary. Sources: Adapted from Warner 1985; U.S. Department of Health and Human Services 1989; Creek et al. 1994; U.S. Department of Agriculture 2000. Historical Rezkw 33 Surgeon Getzcrtll's Report details of cigarette consumption have been docu- mented in detail in prior reports [USDHHS 1989,1994] and will not be repeated here). Men in substantial numbers either switched from other tobacco forms or took up smoking, and women in smaller but visible numbers began taking up tobacco use-in the form of cigarette smoking-for the first time, even as the fre- quently women-led antitobacco efforts continued. By the 193Os, cigarettes accounted for more than one-half of all tobacco consumption (Schudson 1984). In response to these trends, the WCTU cam- paigned for strict enforcement of laws forbidding the sale of tobacco to minors, attacked advertising that claimed or suggested health benefits, and criticized smoking among women. In 1927, the Department of Narcotics reported that chapters across the country had sponsored thousands of antismoking events and strat- egies. For example, the Portland, Oregon, chapter suc- cessfully protested a leading department store's use of a female mannequin holding a cigarette. Members stubbed out 219,560 cigarettes and 39,713 cigars. The WCTU also lobbied for laws prohibiting smoking in places where food was displayed for sale and reported that 21 states had enacted such laws (Schudson 1993). As the cigarette's popularity increased, so did concerns about its health consequences. Serious rt'- search of the day sought to link tobacco with a variety of conditions (Burnham 1989), but uncovered little new ground (Tate 1999), while sobering results were often lost amid a welter of overblown charges. For example, the common observation at the time that cigarette smokers seemed more dependent on their habits than other tobacco users, now explained by increased blood nicotine levels (`rate 1999), led one writer in 1912 to warn that users would naturally progress from tobacco to alcohol to morphine (Sinclair 1962). Similar unsub- stantiated charges have often made better headlines than the results of serious scientific studies over the years. In 1930, one doctor claimed that 60 percent of all babies born to mothers who smoked died before reaching the age of two (Sinclair 1962). Smoking was said to depress intelligence and academic achievement (Troyer and Markle 1983). One historian writing in 1931 recalled a widely distributed antismoking poster that wordlessly voiced these concerns by showing a woman who had a cigarette in her mouth and was holding a baby; the poster bore "no words-the mere presentment, it was hoped, would have a deterrent effect" (Corti 1931, p. 266). That image of mother and child projected an anti- smoking message that, typical of its time, contained both a moral and a medical objection to smoking. His- torian Allan M. Brandt has observed that antitobacco crusaders early in the century "saw no tension in see- ing the cigarette as ungodly and unhealthy; they equated moral dangers and health risks" (Brandt 1990, p. 159). A 1925 WCTU pamphlet held that because the brain's higher functions develop last, youthful smok- ers would have "impaired morals, weak will, lack of religious and spiritual development, and a shocking incapacity for unselfishness and consideration of the rights of others" (p. 9). One of the moral dangers that remained a theme in anticigarette propaganda was the danger smoking posed to thrift, as cigarettes were a needless expense, especially among the poor (Brown 1920). Although anticigarette crusaders had medical objections to smoking, they did not have any medical consensus behind them. Medical opinion was gener- ally noncommittal. Most physicians counseled that tobacco in moderation was not harmful (Hygeia 1928; Tobey 1930; Johnson 1932). Media reports even located medical research that suggested that smoking had health benefits. During World War I, army surgeons praised cigarettes for providing the wounded relax- ation and relief from pain (Nez(~ York Times 1918); a Paris physician claimed that tobacco use might prevent the development of microbial infections (Nezc, York Times 1923); and a famous mountain climber said that smok- ing helped breathing at high altitudes (NL>ZO York Times 1922). Without a strong medical component, the objec- tion against tobacco use was scarcely distinguished from any number of other protest targets of the reform movement early in the century. Lacking as strong an opponent as, for example, the alcohol temperance movement, tobacco use continued unabated. In the instance of cigarettes, use proliferated. The Attraction of Cigarettes Throughout its boom period, from the 1920s un- til the mid-1960s, cigarette smoking was generally regarded as a consumer activity rather than as a medi- cal problem. In its commercial essence, the cigarette is simply a "package," as a Philip Morris Companies Inc. memorandum has suggested, for a "product" (Cipollone u. Liggett Group, Inc., 505 U.S. 504, 112 S. Ct. 2608 [1992], cited in Lynch and Bonnie 1994, p. 60). In fact, the cigarette is by far the most commercially suc- cessful package for the product-tobacco, itself a delivery device for nicotine-yet devised. Such think- ing fits well with the notion that consumption is an act of imagination-that is, that one buys not the prod- uct but rather the attributes for which the product is merely the vehicle (Fox and Lears 1983). 34 Clraptrr 2 Reducing Tobacco Use Each vehicle for nicotine delivery has different social propensities. The unique qualities of the cigarette as a tobacco form were critical in its role as the agent through which tobacco use was made both available and acceptable to all social classes. Put simply, ciga- rettes not only made tobacco cheaper (through auto- mated production) but also easier to use. This utility stemmed from several distinctive features that sepa- rated cigarettes from other modes of tobacco use and fueled the spread of the smoking habit. The first distinctive feature of the cigarette is its mildness. This attribute, along with its inexpensive unit cost, made the cigarette especially appealing to boys. Before the cigarette became popular, adolescent males were likely to first try smoking by using cigars, a practice that required a degree of skill to draw in but not inhale the strong smoke. The unpleasant side effects resulting from failing this tobacco rite of pas- sage were largely avoided when new smokers tried cigarettes, which used a milder form of tobacco that was meant to be inhaled. Many of the legislative ef- forts during the 1890s and after were directed not at tobacco use generally but at cigarettes exclusively be- cause they were so accessible to boys and young men and because they were inhaled (Ol~tlook 1901). A 1907 Wisconsin court decision used this issue of adolescent accessibility to justify a regulatory distinction between cigarettes and other forms of tobacco. The cigarette, the decision stated, was able ". . . to remove the pro- tection which nature placed in the way of acquiring habits of use of the more vigorous tobacco commonly used in cigars. Before the day of the cigarette, mas- tery of the tobacco habit was obstructed by agonies of nausea usually sufficient to postpone it to a period of at least reasonable maturity" (State u. Goodrich, 113 N.W. 388, p. 390 [Wis. 19071). Mildness was especially characteristic of ciga- rettes smoked after the 187Os, when cigarette tobacco was made milder by being flue-cured rather than fire- cured. Moreover, the stronger Turkish tobaccos that were popular in the early 20th century became unavail- able with the interruption of trade during World War I; thus, blended American tobaccos came into wider use, making the cigarette an even milder product than be- fore (Tennant 1950). The inhalability of the milder tobaccos used in cigarettes is the source of a second important distinc- tion between cigarettes and other forms of tobacco. Because the smoke of pipes, cigars, and dark tobacco is relatively alkaline, its nicotine dose is absorbed through the linings of the mouth and nose. Flue-cured "blond" or light-colored tobacco, from which Ameri- can cigarettes are normally blended, produces slightly acidic tobacco smoke; the nicotine dose thus must be inhaled to be absorbed. Drawn into the lungs through cigarette smoking, nicotine is absorbed into the sys- temic circulation more quickly than in other forms of smoking-hence the greater potential for nicotine addiction (Lynch and Bonnie 1994). A third distinctive feature of the cigarette is its relative convenience and disposability. This mild and quickly consumed tobacco product seemed to contem- poraries "peculiarly adaptable to the temperament of the American people in an age when things are done hurriedly and yet with greater efficiency than at any previous time" (Young 1916, p. 119). The New York Tinles editorialized in 1925 that the cigarette was "short, snappy, easily attempted, easily completed or just as easily discarded before completion-the cigarette is the symbol of a machine age in which the ultimate cogs and wheels and levers are human nerves" (New York Tir~rs 1925, p. 24). Facility of use was further aug- mented by the introduction of the safety match just before World War I (Burnham 1989). In short, cigarettes had a "natural adaptability" to the rhythms of urban life (Tennant 1950, p. 142). Cigarettes fit more easily than other forms of tobacco into brief moments of relaxation, they were more readily used while working, and they were more eas- ily managed without the use of one's hands. Ciga- rettes helped combat the tedium of industrial work. Particularly before workplace smoking restrictions were widespread, cigarettes could, in the words of one commentator, "not only help pace out a day-on the production line, in the typing pool, behind a lunch counter or waiting on a welfare line-but they could give you a steady flow of small rewards to keep on trucking" (Blair 1979, p. 33). Cigarettes organized and controlled the passage of time; a cigarette, writes Ri- chard Klein, is "a clock" (Klein 1993, p. 24). After World War I, cigarettes, which were less costly to use than cigars or pipe tobacco, became part of a more general "throwaway ethic" reflected in other consumer developments of the day (Busch 1983). The disposable razor blade came into widespread use dur- ing and after World War I (Schudson 1984); in 1927, U.S. wristwatch production surpassed pocket watch production, as the more conveniently consulted wrist- watch had won favor among soldiers (Busch 1983). Changing attitudes about hygiene also stimu- lated this predilection for convenience and disposa- bility. Between 1909 and 193645 states banned the common drinking cup used in public facilities such as railroads; the railroads became the first principal customers for the paper cup and paper cup dispens- ers (Busch 1983). Disposable sanitary napkins and Historical Reuieul 35 Kleenex tissues also became mass-market items for the first time in the 1920s (Busch 1983). From a strictly hygienic perspective, the cigarette appeared to give a cleaner smoke than the cigar. A Lucky Strike adver- tisement directly contrasted the neatness of cigarettes to the messiness of cigars, which require more oral manipulation: "Spit Is an Ugly Word, but It's Worse on the End of Your Cigar" (Tennant 1950, p. 286). This advertisement also played on an earlier scandal in which cigar makers were purported to have used spit to seal the cigar's leaf wrapper (John C. Burnham, tele- phone conversation with Richard B. Rothenberg, May 25, 1995). For a generation working in offices and riding to work in subways, streetcars, and automobiles, milder smoke was less irritating to others. Both the strong fumes of cigar and pipe smokers and the unsightly by-products of snuff and chewing tobacco users were generally more objectionable than the smoke and ashes of cigarette smokers. Historian Cassandra Tate has concluded that one of the lessons of the first antismoking campaign is that "any success- ful social reform movement carries within it the seeds of a backlash" while "incessant warnings can fade into the ozone of the commonplace" (Tate 1999, p. 155). An important part of the cigarette's convenience was its readiness of use. Some smokers still rolled their own cigarettes in the 1920s and 193Os, but these con- sumers were a small segment of the market (Tennant 1950). By far, most smokers during these key decades of rising cigarette popularity used cigarettes prerolled by the manufacturer. (Cigars were also prerolled, but by hand rather than by machine, and thus at consider- able expense to the buyer.) The cigarette's ready-made convenience was immediately apparent when com- pared with, for example, the care required to load a pipe so that it burned neither too quickly (thereby over- heating the bowl) nor too slowly (thereby requiring frequent relighting). The cigarette was far more easily lit and drawn than other smoked tobacco products. One final distinctive feature of the cigarette is its cultural connotation as a minor moral transgres- sion. Smoking cigarettes is-and has always been- considered slightly illicit. A practice that "looked so strange, felt so pleasant, accomplished so little, and cost so much [although less than cigar or pipe smok- ing] could not be unopposed" (Tennant 1950, p. 115). The pleasure it offers is culturally mediated-that is, part of the pleasure of smoking is the guilt connected with it. None of the marketing efforts of the tobacco giants ever fully legitimized the image of smoking- and there is some suspicion that they never meant to (Burnham 1993). As one sympathetic cultural observer has put it, part of the seductive quality of the cigarette is "beauty [that] has never been understood or repre- sented as unequivocally positive; the smoking of ciga- rettes, from its inception in the nineteenth century, has always been associated with distaste, transgression, and death" (Klein 1993, p. xi). A modern parallel is the recent cachet of smoking as a sexual fetish, with images available on the Internet (Hwang 1996, p. 5). Culturally, in fact, interviews have shown that ciga- rettes became a generational marker for the transform- ing generation that had come of age during World War I, as well as for the reform-minded generation of the Viet- nam War era (Tate 1999). Women and Cigarettes Several features of the cigarette helped make it a particularly suitable product for, and symbol of, the liberation of women, who came to smoking in grow- ing numbers beginning in the 1920s. Just as the ciga- rette "fairly leaped" into its rightful position as "the smoke of manly men" with the aid of stories and pic- tures from the World War I front ([New York] Tobacco Leaf 1914, p. 6, quoted in Young 1916, p. 228), so for young women after the war smoking was "perhaps the one most potent symbol" of the new sense of free- dom and equality (Fass 1977, p. 292). For the growing number of women who attended college in the 192Os, smoking was "a welcome form of notoriety" (p. 293). Objections to women's smoking betrayed a traditional double standard, for such opposition arose from the twin cultural perceptions that cigarettes were not moral and were not feminine. Smoking "implied a promis- cuous equality between men and women and was an indication that women could enjoy the same vul- gar habits and ultimately also the same vices as men" (p. 294). But while they were tokens of equality with men, cigarettes were also amorphic, making men ap- pear more manly and women more womanly (Tate 1999). Aware of (and perhaps sharing) these objections, cigarette manufacturers were initially cautious about targeting this potential new market. As late as 1924, the editor of a tobacco trade journal wrote that "all responsible tobacco opinion [found the idea of women smoking so] novel.. . that it would not be in good taste for tobacco men as parties in interest to stir a particle toward or against a condition with whose beginnings they had nothing to do and whose end, if any, no one can foresee" (Wessell924, p. 6). Even advertisements with women in mind did not dare picture them actu- ally smoking. 36 Chnpter 2 Reducing Tobacco Use This initial caution was dictated by canny atten- tion to the political environment. Cigarette manufac- turers feared a backlash in legislation or public opinion if they too aggressively sought female consumers (Tennant 1950). In light of anticigarette leg- islation arising during the 192Os, and particularly in light of the ongoing experiment in alcohol prohibition, this anxiety was reasonable. The cigarette industry's caution was short-lived. As the 1920s advanced, appeals to women through tobacco marketing were increasingly direct. In 1926, the Chesterfield brand ran a then-controversial advertisement wherein a woman urged a male com- panion to "Blow Some My Way" (Ernster 1985, p. 336). In 1927, Lucky Strike advertisements showed a famous female opera star recommending Luckies as soothing to the throat and a famous actress assuring readers that Luckies did not irritate the throat (Schudson 1984). And in 1928, Luckies were advertised with the diet- conscious slogan, "Reach for a Lucky Instead of a Sweet" (Ernster 1985, p. 336). Winds of Change The industry's direct appeal to the new market of female smokers likely reflected less boldness than it did a recognition of a prevailing wind of cultural change, of which the women's movement was only a single component. In the 192Os, on the heels of the 19th Amendment, women's growing assertion of their equality with men was part of a larger shift in Ameri- car. culture, the move to a more modern culture from the somewhat puritanical milieu that supported the populist reform movement. In the language of one observer, the change was from a culture of middle-class respectability to one of "lower-order parochialism" sponsored and encouraged by industries that catered to the minor vices (Burnham 1993, p. 16). The 1920s saw the triumph of "a new behavioral ethic" (Brandt 1990, p. 157), one of consumerism and self-indulgence rather than the self-denial that had been, for example, the traditional lot of women. Through the marketing of cigarettes, the tobacco companies strategically ex- ploited this development among the less puritanical and self-recriminating members of both sexes. Even at the time, opinion was divided on whether the massive marketing efforts of the cigarette giants motivated the change toward a society of smokers or only took advantage of a cultural and behavioral shift already under way. In 1940, by which time the cigarette had clearly triumphed over other forms of tobacco, one study of the tobacco industry concluded, "how much of increased cigarette consumption is due to advertising and how much to fashion is impossible to determine. The latter influence is still imponder- able" (Gottsegen 1940, p. 204). Fashion and advertising were not the only two factors. Three other matters were potentially impor- tant: (1) the physical product itself was not a constant, (2) the price was variable, and (3) society changed in ways that influenced consumption. For example, before the explosion of cigarette marketing in 1914 (Burnham 1989), men smoked more than women, the rich smoked more than the poor, and urban dwellers smoked more than rural inhabitants. (For a more com- prehensive account of the demographic dynamics, see USDHHS 1989.) With growth in the movement for women's equality, a rising per capita income in real dollars, and the long-term trend toward urbanization, there would likely have been an increase in cigarette sales even if tobacco companies had not marketed the product aggressively. Regardless of what directed the impetus, per capita consumption of all forms of tobacco was remark- ably steady from 1913 to 1945 (Figure 2.11, rising when real income per capita rose, falling when real income fell (Tennant 1950). The spectacular growth in ciga- rette consumption reflected not only the introduction into the tobacco market of new consumer groups (such as women) but also, as was previously noted, a major shift among existing male smokers from other forms of tobacco use to the cigarette. Annual per capita con- sumption of tobacco hovered at 7 pounds from 1915 through the late 193Os, except for a transient decline in the early 1930s that was coincident with a drop in per capita income in the early years of the Great De- pression (Tennant 1950). It is possible, however, that actual consumption of tobacco per unit of weight in- creased because of less work in both the manufactur- ing and the use of the increasingly popular cigarette. World War II, like World War I, served to increase and promote cigarette smoking, to which numerous war novels, movies, and other public images testify (Klein 1993). A 1943 treatise observed that the cigarette achieved a heroic standing from its association with soldiers during World War II (Gehman 1943). In short, between about 1920 and 1950, "cigarettes became an acceptable and noncontroversial part of U.S. life" (Troyer and Markle 1983, p. 124). Historical Review 37 Surgeorl Grrwal's Report Medical Warnings Medical opinion at first took little heed of the growing popularity of cigarettes. Physicians tended to take an ambivalent or qualified position on the ciga- rette phenomenon. For instance, although Dr. James J. Walsh wrote in 1937, "We physicians of the older generation who have seen the smoking of cigarettes grow from what seemed scarcely more than a toy into what is now one of the most significant of social insti- tutions are under an obligation to the rising genera- tion to warn them of the serious dangers associated with the abuse of cigarettes in our day" (Walsh 1937, p. 665), even Walsh admitted to smoking an occasional cigarette himself. He further attested that many doc- tors he knew smoked 20 or 30 cigarettes a day and yet were "as healthy as the proverbial trout" (p. 665). He held that "not the cigarette smoke so much as the ex- cess of it" (p. 665) brought about serious conditions like Buerger's disease. The Puritan temperament that had fueled anticiga- rette activity early in the century was on the defensive. Antipathy to Puritan moralism was strong enough to weaken faith in any research tainted by it. For example, Alton Ochsner's suggestions in the 1930s and 1940s of a connection between cigarette smoking and lung can- cer were discounted by his colleagues because he was known to be "an anti-smoking enthusiast" (Burnham 1989, p. 18). During these crucial times when cigarette smoking became widespread, "physicians tended to absorb the common sense of the general population" (p. 11). By the 193Os, common sense, in some measure influenced by the advertising claims of the era, held that smoking in moderation was not a health hazard (Burnham 1993). In 1938, Raymond Pearl published one of the first significant epidemiologic studies that indicated smok- ing to be "statistically associated with an impairment of life duration" (Pearl 1938, p. 217, quoted in Breslow 1982, p. 134; see also Brandt 1990). But only in the late 1940s and early 1950s did definitive evidence begin to accumulate from various sources and studies show- ing the association between cigarette smoking and overall mortality. First retrospective and then large- scale prospective studies confirmed that smoking was associated with higher death rates; excess mortality was especially pronounced for coronary artery disease and lung cancer. In the late 1940s and early 195Os, research linked lung cancer to smoking. The initial report by Wynder and Graham (1950) just preceded an article by Doll and Hill (1950). Subsequent articles by Doll and Hill (19521, Levin (19531, and others confirmed the asso- ciation. Levin's contribution was of particular inter- est, because he derived the formula for attributable risk in a footnote to the article-an overt demonstration of the link between the smoking etiology and the emerg- ing methodology of epidemiologic analysis. Public Dissemination The findings from these and other studies of the era were publicized in a 1952 Christian Herald article. In December 1952, that article was reprinted in the widely circulated magazine Reader`s Digest as "Can- cer by the Carton" (Norr 1952). Popular concerns aroused by this publicity apparently led to an almost immediate decline in cigarette consumption (Tennant 1971). The decline was temporary but severe enough to lead the tobacco companies to step up their market promotion of the relatively new filter-tip cigarette. Originally intended to attract new smokers by offer- ing a milder smoking experience, the filtered cigarette assumed a marketing prominence that was seen as a tacit acknowledgment that there might be a health risk in smoking (Fortune 1953). Whether for smoking com- fort or for supposed health advantage, the market share of filter brands increased from less than 1 per- cent in 1952 to 73 percent in 1968 (Tennant 1971). The nonprofit consumer advocacy organization Consumers Union paid attention to smoking through- out the 1950s. Early mentions in the organization's monthly magazine Comurner Reports, like so much commentary elsewhere, warned only against excessive smoking. In 1953, Consumer Reports found the evidence connecting smoking to lung cancer "suggestive" and recommended that until further research results were available, "those who can" should reduce smoking to a "moderate" level, which was defined as not more than one pack a day (p. 74). In the same issue, how- ever, the magazine reminded readers that smoking had health benefits; specifically, smoking reduced "the inner nervous tensions and strains resulting from man's exposure to the stresses and responsibilities imposed by society" (p. 74). Smoking, the magazine further observed, relieved such pressure in a way less harmful than alcohol or overeating (Consumer Reports 1953). 38 Chapter 2 Reducing Tobacco Use In 1954, medical advisers for Consumers Union spoke more strongly about the research link between smoking and lung cancer, but the organization remained vague in its advice to smokers (Consumer Xeports 1954). In the absence of further scientific sup- port, this tentativeness was not surprising. It was hard to imagine that a habit so widespread, so apparently normal, so integrated into American culture, and so ennobled by its wartime use could turn out to be fun- damentally destructive. In 1954, the American Can- cer Society's (ACS) Tobacco and Cancer Committee adopted a resolution recognizing an association be- tween cigarette smoking and lung cancer (Breslow 19821, but the board of directors did not consider the possibility of a causal association. Efforts of the phy- sician members of the board were blocked by lay mem- bers in meetings that were themselves "filled with smoke" (Breslow 1977, p. 849). By 1958, Consumers Union agreed that the medi- cal research provided nearly definitive evidence on the risk of lung cancer posed by smoking. The organi- zation further argued that smokers should not try to allay their concerns by switching to filter cigarettes, as no evidence indicated that filters reduced the risk of cancer. Smokers were thus advised "to cut out or cut down" on cigarettes (Consunler Reports 1958, p. 636). Toward a Medical Consensus With growing sentiment, in and beyond the medical community, that there were serious risks to tobacco use, government agencies became more con- cerned about tobacco advertising that stated or implied health benefits to the cigarette. Several times during the 195Os, the Federal Trade Commission (FTC) issued orders against cigarette advertising that made health claims. Congress also took an interest in tobacco advertising; in 1957, Representative John A. Blatnik (D-MN) held hearings on deceptive filter-tip cigarette advertising (Neuberger 1963). The Surgeon General first brought the Public Health Service into the scene by establishing a scientific study group in 1956 to ap- praise the effects of smoking on health. The study group determined that there was a causal relationship between excessive smoking of cigarettes and lung cancer. Surgeon General Leroy E. Burney issued a statement in 1957 that "the weight of the evidence is increasingly pointing in one direction: that excessive smoking is one of the causative factors in lung can- cer" (Burney 1958, p. 44). In an article he subsequently published in the Journal of the American Medical Asso- ciation, Burney reiterated this view and went even further: "The weight of evidence at present implicates smoking as the principal etiological factor in the increased incidence of lung cancer" (Burney 1959, p. 18351. Much of the medical profession, however, remained ambivalent on the issue. In an editorial sev- eral weeks after Burney's article, the journal itself ar- gued against taking the Surgeon General too seriously: "Neither the proponents nor the opponents of the smoking theory [that cigarette smoking causes cancer] have sufficient evidence to warrant the assumption of an all-or-none authoritative position" (Talbott 1959, p. 2104). In June 1961, the presidents of the ACS, the American Public Health Association, the American Heart Association (AHA), and the National Tubercu- losis Association (later the American Lung Association [ALA]) urged President John F. Kennedy to establish a commission to study the health consequences of smoking (U.S. Department of Health, Education, and Welfare [USDHEW] 1964). Early in 1962, representa- tives of these organizations met with Surgeon General Luther L. Terry, who then proposed establishing an advisory committee to assess available knowledge and make recommendations concerning smoking and health. In April, Terry provided the Secretary of Health, Education, and Welfare a fuller proposal ask- ing to reevaluate the Public Health Service's position on smoking. Among the factors prompting his call for action, Terry cited new studies on the adverse conse- quences of smoking, the 1962 Royal College of Physi- cians report (which had been summarized that year in Reader's Digest [Miller 1962]), and other evidence of a shift in medical opinion against smoking as well as similar views among the national voluntary organiza- tions. Terry also pointed to efforts to reduce tobacco use in Britain, Denmark, and Italy; to Senator Maurine (Brown) Neuberger's (D-OR) proposal that Congress create a commission on smoking; and to a request from the FTC for guidance on the labeling and advertising of tobacco products. In the summer, Terry announced the appoint- ment of a committee to review all of the data on the medical effects of smoking. The committee was es- tablished after consultation with representatives of relevant government agencies, the voluntary health or- ganizations, the American Medical Association (AMA), the American College of Chest Physicians, and the Tobacco Institute. Each organization was empowered to veto any names proposed for the committee; people who had taken public positions on the questions at issue were eliminated from consideration. Historical Review 39 Surgeon Ger7eral's Report While the committee reviewed the data, actions were being urged or taken in response to the evidence that had emerged. Leroy Collins, former governor of Florida and president of the National Association of Broadcasters, urged broadcasters in 1962 to "make corrective moves" on their own to limit or regulate tobacco advertising to which children might be ex- posed. "We cannot ignore the mounting evidence that tobacco provides a serious hazard to health," he as- serted (Nezo York Ti777es 1962, p. 71). Also in 1962-a busy year for efforts to reduce smoking-Air Force Surgeon General Major General Oliver K. Niess ordered an end to the distribution of free cigarettes in Air Force hospitals and flight lunches (Neuberger 1963). Smoking education was a growing phenom- enon in public schools, where materials were provided by the ACS and other voluntary organizations. Church groups (particularly the Seventh-day Adventists) and temperance organizations continued their campaign against smoking. And although the AMA remained silent on the issue, at least eight state medical societies had adopted resolutions on smoking and health. Turning Point: The Surgeon General's Report Social movements may be precipitated or strengthened by events that "dramatize a glaring con- tradiction between a highly resonant cultural value [such as health] and conventional social practices [such as smoking]" (McAdam 1994, p. 40). Rarely in social history, however, can a single such event be identified as a key source of social change. The publication of the 1964 Surgeon General's report on smoking and health might qualify as such a rarity. The Surgeon General's report consolidated and legitimized I5 years of growing evidence of the dangers of smoking to health (USDHEW 19641. Its publication "marked the beginning of a revolution in attitudes and behaviors relating to cigarettes" (Brandt 1990, p. 156). "Begin- ning" should be stressed, because abandonment of cigarettes was not precipitous. Smoking prevalence did begin a persistent but hardly precipitate decline in 1965 of 0.5 percent per year (USDHHS 1989). Cigarette sales kept increasing and would not peak until the late 1970s. Although per capita cigarette con- sumption reached its highest level in 1963, the year before the report's publication, it did not begin a steady year-to-year decline until 1973 (USDHHS 1994). Thus, the Surgeon General's report was certainly a pivotal event, but it did not change smoking pat- terns overnight. Why this was so-why people did not, upon learning of the report's findings, immedi- ately cease either beginning or continuing to smoke- is a complex phenomenon, even if one disregards the major role of nicotine addiction. On the one hand, a change in behavioral norms can be precipitated by a change in what people generally believe. On the other hand, people do not always act in their own best interests, even in response to clearly stated facts (Schudson 1984; USDHHS 19891. The outcome in a conflict between cultural mores (in this instance, be- liefs instilled through the social, behavioral, and physi- ological habit of smoking; reinforced by marketing) and scientific fact (as represented in the widely publi- cized findings of the Surgeon General's report) often depends on how the -latter is diffused-that is, on whether new information can become so broadly and effectively. transmitted and received that it .becomes accepted knowledge that then supplants habit. As one sociologist has observed, "The diffusion of new knowl- edge is a major cause of collective searches for new norms in the modern world" (Davis 1975, p. 53). A Stubborn Norm In the case represented by the Surgeon General's report, the diffusion of new knowledge was impeded by the entrenched norm of smoking, a widespread practice fueled by the persistent and pervasive mar- keting of cigarettes (see "Advertising and Promotion" in Chapter 5). During the decade preceding the report, many social norms were established or strengthened through the dominant new. mass medium, television. Whatever effect television adver- tising had on cigarette sales, the constant presence of cigarettes both in advertisements and in the real and imaginary lives of the medium's "stars" was a strong force in reinforcing smoking as a norm. Furthermore, TV-related marketing coincided with, and helped bring to the public's attention, the availability of the filter- tipped cigarette-thereby not only reinforcing the 40 Chapter 2 Reducing Tobacco Use smoking norm but also helping screen the imputed health hazards of smoking (USDHHS 1994). The smoking norm could be found in the most unlikely settings and thus gave rise to considerable cognitive dissonance. The first significant government response to the report was the FTC's 1964 ruling that warning labels be required on cigarette packs and that tobacco advertising be strictly regulated (see "Attempts to Regulate Tobacco Advertising and Packaging" in Chapter 5). The resulting legislation that was passed, however (the Federal Cigarette Labeling and Adver- tising Act of 1965 [Public Law 89-9211, undermined much of the original proposal's strength by requiring a more weakly worded warning label than the FTC had proposed (USDHHS 1994). Furthermore, the act not only preempted the FTC's ruling but also prohibited the FTC or any other federal, state, or city authority from further restricting cigarette advertising until after the expiration of the law on June 30,1969. In 1969, former Surgeon General Terry would refer to the 1965 act as a "hoax on the American people" (U.S. House of Representatives 1969, p. 267, citing Dr. Terry). This dissonance between legislative intent and legislative action was detectable, in more than one sense, in the smoke-filled congressional hearings at the time. In 1967, for example, when Dr. Paul Kotin, director of the Division of Environmental Health Sci- ences, National Institutes of Health, came to testify about the health hazards of cigarette smoking, Sena- tor Norris Cotton (R-NH) asked, "Is it going to preju- dice anybody if I smoke my pipe?" Dr. Kotin replied, "I trust it won't prejudice anybody any more than my smoking my pipe will" (U.S. Senate 1968, p. 14). Dr. Kotin's smoking was a topic of conversation again in congressional hearings in 1969. Dr. Kotin along with Surgeon General William H. Stewart, Dr. Kenneth Milo Endicott (director of the National Cancer Institute), and Dr. Daniel Horn (director of the National Clearing- house on Smoking and Health) came together to tes- tify in favor of stronger health warnings on cigarette packages and legislation requiring similar warnings in all cigarette advertising. At one point, Representa- tive Dan H. Kuykendall (R-TN) asked Surgeon General Stewart, "Isn't [Dr. Kotin] one of the most knowledgeable men in this field?" When the Surgeon General replied affirmatively, Kuykendall returned, "Why doesn't he quit smoking?" Kuykendall then directly asked Kotin whether he was sure that smok- ing a pipe did not cause lip cancer; Kotin responded, "A risk I am willing to take, sir" (U.S. House of Repre- sentatives 1969, p. 167). The next day, Representative Tim Lee Carter (R-KY) observed that, in fact, all four of the men in the delegation, including the Surgeon General, were smokers (U.S. House of Representatives 1969). Actions undermine words, and scenes such as these were symbolic of a strong wish not to believe in the health consequences of smoking. Given that the nation's chief health policymakers did not, or were not able to, apply to their own behaviors the very evidence they had gathered, the strength with which the smok- ing norm persisted among the general population is more easily comprehended. Economic and Social Impedance General economic conditions also supported the continuation of smoking. The 1960s and early 1970s was a time of general prosperity. Real cigarette prices rose in the 1960s but declined in the 1970s (USDHHS 1994). The affordability of cigarettes increased from 1965 to 1980 and served as an economic counterweight to the growing awareness of tobacco's ill effects (Lynch and Bonnie 1994) (see also "Effect of Price on Demand for Tobacco Products" and "Taxation of Tobacco Prod- ucts" in Chapter 6). Another compelling social condition may have further limited the initial impact of the Surgeon General's report. From the early 1960s to 1973, Ameri- can military personnel were engaged in Vietnam. During this period, 8.7 million Americans served in the military, including 2.7 million in Vietnam (Moss 1990). Whether the Vietnam War encouraged smok- ing has not been a topic of speculation, probably because of that war's more publicized role in suppos- edly encouraging the use of marijuana and other drugs (Klein 1993). But the norm of smoking would only have been strengthened by the mobilization of a large military force bringing several million young men and women into a setting where smoking was tradition- ally held to offer relief from both stress and boredom, and where it was part of a lingering cultural image of the heroic soldier. Moreover, the prevalence of ciga- rette smoking was and has remained higher in the military than in the population at large (in 1992,35 vs. 26 percent) (Lynch and Bonnie 1994). Delayed Effects and Delayed Actions A significant biologic explanation for the delayed effect of the 1964 report can be found in the delayed progression of smoking-related diseases, which generally take substantial time to fully manifest themselves in chronic illness and death. The cigarette's tremendous growth in popularity during the decades preceding the Surgeon General's report would thus Historical Rezlieup 41 Srrrgeo77 Gcrreral's Report have only begun to show its vast health consequences. In 1965, an estimated 180,000 persons died from smoking-related diseases (USDHHS 1989); over the next two decades, that yearly estimate increased to 337,000, even though smoking prevalence had been steadily declining since the early 1970s (USDHHS 1989). First-time or long-time smokers in the mid-1960s to mid-1970s thus had far less opportunity than the next generation to personally witness the tragic but convincing demonstration of the health consequences of smoking. It might be hypothesized that this som- ber proof of the Surgeon General's report at last evoked a meaningful response among the surviving relatives and friends of the deceased. From Disease Treatment to Risk Management Another possible reason for the delayed response to the Surgeon General's report was its less-than- traditional medical perspective. The report's medical researchers were reporting not the kind of traditional clinical data that physicians were used to encounter- ing in their literature but rather data from epidemio- logic studies that indicated the risks of smoking. Eventually, such data would be persuasive enough to mark a perceptual shift to "a new kind of numeracy among medical researchers and clinicians alike" (Burnham 1989, p. 19). But in 1964, most physicians were not prepared to understand-much less be per- suaded by-the epidemiologic data represented in the report, nor to incorporate a public health model into their medical practice. Accordingly, the medical profession did not quickly jump on the smoking reduction bandwagon that began rolling with the Surgeon General's report. The American Medical Association Alliance House of Delegates, in fact, refused to endorse the report when it appeared in 1964 (Burnham 1989). Medical person- nel increasingly warned people against smoking, but this precept did not carry over into practice. In 1964, smoking remained as acceptable in medical settings as it was elsewhere. Moreover, although 95 percent of physicians in that year saw smoking as hazardous, 25 percent continued to smoke (Burnham 1989); even by the mid-1970s, nearly one in five physicians was a smoker (Nelson et al. 1994). The AMA was criticized by other health organizations for not taking a more aggressive stance to reduce tobacco use. As late as 1982, for example, the association was faulted for help- ing prepare for Newszueek a 16-page "personal health care" supplement, in which the only advice provided on smoking was that a smoker should discuss the risks with a personal physician and should refrain from smoking in bed (Iglehart 1984). Soon thereafter, the AMA had become an active advocate (see "Toward a National Policy to Reduce Smoking," later in this chap- ter). By 1990-1991, only 3.3 percent of physicians smoked, although smoking rates among nurses were significantly higher (Nelson et al. 1994). Some social critics of the time tacitly welcomed what they saw as a rare reluctance by the establish- ment to embrace a social movement. Sociologists and other outside observers of American medicine had noted a previous tendency of the establishment to "medicalize" social problems, such as tobacco use and alcohol abuse. From this perspective, medicine was viewed askance as an "institution of social control," as a "new repository of truth, the place where abso- lute and often final judgments are made by suppos- edly morally neutral and objective experts" (Zola 1972, p. 487). Implicit in this criticism was the fear that the medical establishment was using its considerable clout-its professional domination of the world of facts-to translate all social ills into clinical terms that could be treated in a clinical setting. One such critic, medical sociologist Eliot Freidson, wrote that the phy- sician who calls alcoholism a disease "is as much a moral entrepreneur as a fundamentalist who claims it is a sin" (Freidson 1974, p. 253). But the medical establishment's initial hesitancy to join the movement to reduce smoking likely had little to do with scruples about overstepping its pur- view. There is no dispute that cancer is a disease and little dispute that the medical profession is the expert social authority for defining and treating it. The "moral entrepreneurship" of the Surgeon General's 1964 re- port was not to declare cancer a medical problem but rather to declare smoking a health risk-hence the cen- tral position of epidemiologic data in the report. Thus, while organized medicine followed slowly and sometimes reluctantly in the wake, and while so- cial skeptics worried about the Orwellian implications, a battery of public health officials, politicians, and con- sumer advocates, armed with the findings of the Sur- geon General's report, moved against the persisting social and medical problem of smoking. Ultimately, the broad cultural current that distrusted medical moral entrepreneurship embraced these efforts. The "de- medicalizing" movement, which sought to make health care both a personal matter and a political matter rather than one wholly under the guardianship of physicians (Starr 1982), supported a practice of medicine that took a preventive stance instead of an exclusively therapeu- tic one. Preventive action-to prevent smoking, and 42 Chapter 2 thereby to prevent unnecessary illness and death from called for in the epidemiologically based recommen- smoking-related illnesses-was precisely the solution dations of the 1964 Surgeon General's report. The Diverse Momentum of the Movement to Reduce Smoking Another reason for the languid pace of change in smoking prevalence after 1964 is that it took time to assemble an active dissemination and lobbying force around the Surgeon General's report. In the present period, so many different groups are active in anti- smoking activity, and so many different strategies are operating, that sorting them becomes difficult. Since 1964, the campaign to reduce smoking refers to "the entirety of changes in the social environment spawned by scientific and social interest in the hazards of smok- ing" (Warner 1989, p. 144); this movement covers not only specific activities but also "the changing social norms that have accompanied them" (p. 144). The span of activities involves persons, private organizations, and government agencies, all with different motiva- tions: those ideologically committed to a movement to reduce smoking, those who operate profit-making businesses, those seeking public office, and those in public office who mandate laws and regulations. Important actors have included national health orga- nizations, medical researchers, organized medicine, government regulatory agencies and health depart- ments, school officials, voluntary organizations in health, lobbying groups for reducing smoking, private firms dealing with the health or insurance needs of employees, smoking cessation clinics, and individual medical practitioners. The industry-funded Tobacco Institute began distributing smoking education materials in 1984 KJSDHHS 19941, although with a different agenda. For example, the institute's "It's the Law" program pur- ports to discourage minors from purchasing cigarettes (Tobacco Institute 19901, but the program focuses on the legal responsibilities of the purchaser rather than the vendor, characterizes smoking as an "adult behav- ior" (which may make it more attractive to adoles- cents), does not address the dangers of smoking, and, in one assessment, was ineffective in preventing ille- gal sales (DiFranza et al. 1996). The work of the Tobacco Institute highlights what may be the foremost obstacle to changing the social norm of smoking: the multifaceted actions of the industry in preventing prevention. In an analysis of tobacco industry tactics, the Advocacy Institute (1995) has defined nine areas of activity: intimidation, alli- ances, front groups, campaign funding, lobbying, legislative action, buying expertise, philanthropy, and advertising and public relations (see the text box). In its discussion of well over 100 instances in these areas, documented largely from media reports, the Advocacy Institute does not accuse the tobacco industry of ille- gal activity but rather of a far-ranging and systematic effort to ensure the continued use of tobacco. Taken together, and backed by the enormous resources of the industry, these efforts have considerable impact in pro- moting tobacco use and retarding efforts to reduce or prevent it. Because of the considerable litigation now directed at the industry, however (see Chapter 51, the public is more aware of these efforts and may prove more resistant than previously to this powerful com- mercial s:lbterfuge. Support From Business The supportive role of businesses in the move- ment to reduce smoking probably did not arise from a spontaneous realization that preventive measures could improve employee health. Already shoulder- ing new costs from complying with health-related (but non-tobacco-related) new federal legislation, such as the Occupational Safety and Health Act of 1970 (Pub- lic Law 91-596) and the Toxic Substances Control Act (1976) (Public Law 94-4691, many companies in the 1970s sought ways to control the rapidly rising costs of health care (Iglehart 1982). Supporting or enacting policies to curb a proven health risk (such as smok- ing) that had expensive consequences simply made good business sense. A special case is insurance. Beginning with State Mutual Life Assurance Company of America in 1964, life insurance companies began offering discounted policies for nonsmokers (Cowell 1985). By 1987, approximately 80 percent of life insurance companies offered discounts to nonsmokers (Schauffler 1993). Framework of Tobacco Industry Tactics T he Advocacy Institute has developed an overview of tobacco industry strategy, with extensive docu- mentation taken from current media reporting. The documentation provides examples of each of the strategies listed below. I. Intimidation A. Legal (harassing suits, subpoenas, in- junctions, outspending plaintiffs) B. Economic (withdrawal of advertising, withdrawal of business operations) C. Political (retribution directed at elected and other officials) D. Personal (harassing researchers, advo- cates, and reporters) II. Alliances A. Strong allies (subsidiaries, trade asso- ciations, advertising industry, tobacco farmers) B. Weak allies (labor unions, lawyers' asso- ciations, doctors' associations) III. Front Groups A. Political groups (Michigan Citizens for Fair Taxes, Californians for Statewide Smoking Restrictions) B. Scientific groups (Council for Tobacco Research U.S.A. Inc., Healthy Buildings International) C. Smokers' rights groups (National Smok- ers Alliance) IV. Campaign Funding A. Candidate funding B. Continued contributions after election C. Direct funding of interest groups and caucuses D. Political party funding E. Funding state ballot initiatives, or fund- ing opposition to initiatives V. Lobbying A. Support of lobbyists at state and national levels B. Seeking alliances with other lobbying groups on specific issues C. Gifts and contributions to specific causes D. Generating grassroots activity Source: Advocacy Institute 1995 VI. Legislative Action A. Preemption B. Weakening or diluting legislation, or making it unenforceable C. Adding unrelated clauses to, or chang- ing, the contents of legislative bills D. Shifting debate (stressing personal free- dom rather than health; promoting smok- ers' rights) VII. Buying Expertise A. Enlisting outside experts (economists, epidemiologists, medical researchers, statisticians, legal counsel) B. Creating the Council for Tobacco Re- search U.S.A. Inc. VIII. Philanthropy A. Buying innocence by association (finan- cial support to wide range of organiza- tions) B. Funding (women's groups, racial and eth- nic minority groups, homeless shelters, acquired immunodeficiency syndrome [AIDS] groups, arts groups, educational initiatives, community-based nonprofit organizations, sporting events) IX. Advertising and Public Relations A. Issue framing (choice, civil rights, per- sonal freedom) B. Advertising to promote corporate char- acter C. Disinformation (health effects, economic importance of tobacco) 44 Chapter 2 Health insurance rates, in contrast, have not typically distinguished between smokers and nonsmokers. Acceptable actuarial data on additional medical ex- penses incurred by smokers did not exist until the early 1980s; at present, discounts for nonsmokers or sur- charges for smokers have not been widely adopted by health insurance companies (Schauffler 1993). None- theless, both the health insurance and the life insur- ance industries have become active in smoking-related public policy. In 1977, the trade associations of the two industries formed the Center for Corporate Pub- lic Involvement to take up public policy issues that affected them. By 1980, the organization was urging its members to adopt workplace nonsmoking policies, and by 1984, it had become an active lobbyist support- ing legislation to reduce tobacco use (Schauffler 1993). The Attack on Advertising In the 1970s and 198Os, the movement to reduce smoking was in part the work of grassroots activity, in part the work of professional consumer advocates, and in part the work of the public health bureaucracy. In 1966, a complaint filed with the Federal Communica- tions Commission (FCC) by John F. Banzhaf III called for the application of the Fairness Doctrine to man- date repIy time to cigarette advertising on television and radio broadcasts (see also "Attempts to Regulate Tobacco Advertising and Packaging" in Chapter 5). The FCC agreed with Banzhaf's complaint and on June 2,1967, ordered broadcasters to provide "significant" air time for antismoking messages. Banzhaf, antici- pating and forestalling an almost certain appeal from the tobacco industry, appealed his own victory (Whiteside 1971). Under the guise of seeking equal rather than significant broadcast time, Banzhaf succeeded in having his original ruling upheld and in having its application specified: television and radio stations were required to run one counter- advertisement, free of charge, for every three cigarette commercials. This policy lasted until 1971, when a ban on cigarette broadcast advertising went into effect. The campaign to ban or regulate cigarette adver- tising has been one of the most visible and emotion- ally compelling of all the subthemes in the campaign to reduce smoking. (Highlighted in this section, this theme is discussed in greater detail in "Attempts to Regulate Tobacco Advertising and Packaging" in Chapter 5.) All along, opponents have apparently "re- sented most of all the ubiquity and presumed power of cigarette advertising" (Patterson 1987, p. 224). These critics have argued that advertising is a powerful force blinding Americans to the health consequences of smoking, but the tobacco industry has maintained a vigorous defense of its right to advertise (Patterson 1987). In 1969, congressional hearings considered ban- ning cigarette advertising on television and radio; strengthening health warnings on packages; extend- ing the warnings to all cigarette advertising; and ending the preemptive ban on FTC, state, and local regulatory activity. This time, the tobacco industry did not benefit, as they had during hearings in previous years, from the hesitancy of those conducting the hear- ings. Since 1964, public concern about the health haz- .ards of smoking had been growing, and although the tobacco industry had powerful supporters in the U.S. House of Representatives, in the Senate, Warren Grant Magnuson (D-WA) and Frank E. Moss (D-UT) were canny and committed antagonists. Recognizing it would have to make some concessions, the industry agreed to a television and radio advertising ban. This concession may not have been unwilling. There is some indication that since the Fairness Doc- trine was invoked in 1966, the resulting counter- advertisements were hurting cigarette sales more than the cigarette commercials were helping (Hamilton 1972). With the.passage in 1969 of the Public HeaIth Cigarette Smoking Act (Public Law 91-222), which con- tained the ban on cigarette advertising on television and radio, the counteradvertisements vanished.. The tobacco industry shifted its advertising to print and, perhaps even more notable, shifted its marketing bud- get from advertising toward promotion. The latter move exposed vast audiences to cigarette brands through techniques such as sponsoring sports events and, later, merchandising brand-touting items such as T-shirts and caps. Nonetheless, the elimination of ciga- rette advertising from the nation's most powerful medium was at the very least a stunning symbolic defeat for the tobacco industry. At the same time, the presence of cigarettes was gradually fading in televi- sion programming; by 1982, fictional television char- acters smoked nine times fewer cigarettes than they had before 1964 (Signorielli 1993). Toward a National Policy to Reduce Smoking Victories through federal administrative agencies or through direct assault on Congress were rare. The first chairman of the new (1973) Consumer Product Safety Commission claimed authority to set standards for cigarettes or even to ban them, but Congress in 1976 passed legislation to deny the commission that authority (Walsh and Gordon 1986). In 1972, the Civil Aeronautics Board required a nonsmoking section on commercial air flights, in part because of some volun- tary action already taken; in 1983, responding to a Court of Appeals ruling that nonsmokers were inad- equately protected, the board banned smoking alto- gether on flight segments up to two hours-but almost at once Congress passed legislation to reverse this move (Walsh and Gordon 1986). In the executive branch, several voices spoke out against smoking. During his tenure as Surgeon Gen- eral and thereafter, Dr. Jesse L. Steinfeld was an active participant in the national and international movement to reduce smoking (Steinfeld et al. 1976). Joseph A. Califano, President Jimmy Carter's Secretary of Health, Education, and Welfare, declared in 1978 that smoking was "Public Health Enemy Number One." When Califano was designated Secretary, he had no notion that reducing smoking should be a significant effort of the Secretary's department, but experts he From Antismoking to Nonsmokers' Rights consulted invariably urged that his public health efforts include a major campaign on that topic (Califano 1981). Over the years, the main voluntary organizations increased their aggressive posture against smoking. In 1982, the ACS, the ALA, and the AHA established the jointly sponsored Coalition on Smoking OR Health as a Washington-based lobbying organization. The coa- lition represented some 5 million volunteers across the country, at least some of whom were physicians and other civic leaders who could influence particular leg- islators (Pertschuk 1986). In 1985, the AMA called for a complete ban on tobacco advertising and promotion (Troyer 1989). Also that year, a rotating series of four more specific, more severe, and larger print warning labels replaced the traditional warning that "The Sur- geon General has determined that cigarette smoking is dangerous to your health" (Waxman 1985; see "Attempts to Regulate Tobacco Advertising and Pack- aging" in Chapter 5 for discussion of this regulatory process). The rhetoric of the smoking controversy in the 1950s and 1960s focused on the scientific evidence link- ing smoking and disease. In the wake of the 1964 Sur- geon General's report and subsequent research and reports, the battle over the credibility of the scientific evidence was essentially over. In what has been called "a remarkable demonstration of creative lobbying" (Jacobson et al. 1992, p. 391, the tobacco industry sought to shift the debate from the medical conse- quences of smoking to the legal implications of impeding the personal freedom of smokers to smoke and of tobacco companies to advertise their wares under the protection of the First Amendment. The tactic appeared to work. By the late 197Os, the effort to reduce smoking was foundering "on a traditional American libertarian ethic: `It's my body and I'll do with it as I please"' (Brandt 1990, p. 167). Serious dis- cussion on the ethics of legislation to reduce smoking emerged (Goodin 1989). To bring a public health per- spective back into the center of the debate, a countershift to nonsmokers' rights seemed strategi- cally sound (Jacobson et al. 1992). During the 198Os, this strategy acquired a conceptual foundation that was framed in a persuasive vocabulary when the terms (and the concerns they aroused) "passive smok- ing, " "ambient smoke, " "secondhand smoke," and most commonly, "environmental tobacco smoke" (ETS) increasingly appeared in research reports and public debate. Regulations, Legislation, and Lobbying for Nonsmokers Evidence mounted in the 1970s and 1980s that smoking was not only an annoyance but also a health hazard to nonsmokers. The 1972 Surgeon General's report on smoking and health became the first of the series to include a review of the effects of ETS. A year earlier, Surgeon General Steinfeld had called for a na- tional "Bill of Rights for the Non-Smoker." The call was answered when the National Interagency Coun- cil on Smoking and Health developed a Non-Smoker's Bill of Rights and promoted the nonsmokers' rights theme among its 34 member agencies (Schmidt 1975). At the same time, the first successful efforts were made to segregate smokers and nonsmokers in public places. In 1971, United Air Lines became the first 46 Chnpfer 2 Redlicing Tobacco Use major carrier to institute separated "smoking" and "nonsmoking" sections on its airplanes. Analogous to private citizens who were active in the antismoking movement early on, some private businesses took the initiative to introduce worksite regulations for reducing smoking. Typically, the pri- vate firms would begin with a mild antismoking policy that was made stricter over time. A life insurance com- pany in Connecticut, for instance, in 1976 restricted smoking in parts of the employee cafeteria. In 1983, smoking was prohibited throughout the cafeteria and was also banned from all conference rooms. In 1986, all smoking at the workplace was prohibited except in designated restrooms and lounges. Moreover, the com- pany instituted an educational campaign about smok- ing hazards and provided subsidies for employees who attended smoking cessation clinics (Petersen et al. 1988). Other firms have also turned to carrots as well as sticks, paying employees bonuses if they stop smok- ing for a given length of time (Fielding 1984). States began advancing legislation against ET'S in the early 1970s. In 1973, Arizona passed the first statewide ban on smoking in public places. This im- portant step for nonsmokers' rights, which was initi- ated by a private citizen, Betty Carnes, was defeated in a vote in 1972 but passed on its second try and a year later was further strengthened (Schmidt 1975). Two years later, Minnesota passed the first statewide act to keep indoor air smoke free; the legislation re- quired no-smoking areas in all buildings open to the public unless a posted sign explicitly permitted smok- ing. By 1975, legislation had passed in 10 states to regu- late smoking in public places (Schmidt 1975); more than 30 states and hundreds of local jurisdictions had done so by 1985 (Koop 1985). By 1990, smoking was restricted to some extent in public places or worksites in 44 states, and hundreds of cities and towns had passed their own, often more rigorous ordinances (Rigotti and Pashos 1991). In cities with populations of 25,000 or more, local smoking restrictions reached more than two-thirds of citizens in various public and private settings, and one-half of these restrictions could be judged comprehensive. The courts supported these public and private efforts to protect nonsmokers' rights. In 1976, a Supe- rior Court of New Jersey ruled that an office worker with an allergy to tobacco smoke had the right to a smoke-free office. New Jersey was also the site of a comprehensive ruling in 1978 that restricted smoking in restaurants and other public places; this was the first such regulation to be enacted by administrative rule (through the State of New Jersey Department of Health) rather than by new legislation, though the rule was never actually implemented (Regina Carlson, memorandum to John Slade, September 30,1996). At the federal level, government acted not only legislatively to regulate public behavior in the states but also administratively to regulate domains the government itself directly controlled. For instance, ciga- rettes were removed from military C rations and K ra- tions in 1975, and smoking was restricted in all federal government buildings in 1979. Smoking was banned in the White House in 1993 (Stephanopoulos 1993). Behind many of these reforms in industry and government were the unified efforts of private citizens. How these grassroot activists could band together to form powerful lobbying groups for nonsmokers' rights was shown in the transformation of a segment of the Group Against Smokers' Pollution (GASP), Inc., a na- tional organization founded in 1971. In 1976, local California chapters of GASP banded together and tried but failed to effect statewide ordinances to protect nonsmokers. In 1981, the chapters became Californians for Nonsmokers' Rights and began focusing on local legislative activity. Five years later, the group became a national organization that took its successful local- level approach to sites throughout the country. By 1986, more than 75 ordinances had been enacted in California alone; nationwide, more than 400 had been enacted by 1990 (Samuels and Glantz 1991). In 1985, Los Angeles banned smoking in most public places and in businesses employing four or more persons if nonsmokers requested it (Fritschler 1989). California has now banned smoking in practically all public places (Tobacco Education and Research Oversight Committee 1995). By the 198Os, the movement to reduce smoking proceeded along many avenues and through a wide set of loosely coordinated organizations. This lack of systematic action has concerned activists in the move- ment, who bemoan duplication of effort, lack of com- munication, organizational rivalries, and the lack of a federal effort and policy. At the same time, the move- ment has clearly benefited from its multiple locations; the movement is represented by active legislative ef- forts in hundreds of small communities as well as by a strong presence in Washington, DC, and in state capi- tals (see also "Direct Advocacy" in Chapter 7 for a dis- cussion of the influences of these advocacy activities). ETS: From Annoyance to Carcinogen The powerful call for nonsmokers' rights added considerable momentum to the campaign to reduce smoking. The Surgeon General's report in 1979 reviewed further research on ETS. Considerable pub- lic interest was aroused by a Japanese study, published early in 1981, that found a high incidence of lung can- cer among nonsmoking women married to smoking men (Hirayama 1981; Nezc~smerk 1981). While local- level smoking restrictions began to gather force, often proving more comprehensive than statewide legisla- tion, the evidence on passive smoking accumulated. On releasing his 1982 report on smoking and health, Surgeon General C. Everett Koop observed that ETS might be a serious public health problem (Troyer 1989); two years later, he spoke of solid evidence on this point (quoted in Molotsky 1984, p. 1). The growing urgency of a public health focus on ETS set the stage for two authoritative messages that ETS posed a definite danger to all. In 1986, the National Research Council report Elrvirorzmer7tal To- bacco Smoke: Menslrrirrg &!~os~~i'es arm' hxessirlg Health Effects found that ETS exposure increased the risk for lung cancer by 30 percent in nonsmokers and had del- eterious effects on the respiratory health of children (National Research Council 1986). The same year, the Surgeon General released Tile Health Cor~sequcnces of Inoo~z~~~fauJ/ Smoki~J~, which concluded that "involun- tary smoking is a cause of disease, including lung can- cer, in healthy nonsmokers" (USDHHS 1986, p. 13). That report also found that children of smoking par- ents have an increased incidence of respiratory infec- tions and that separating smokers and nonsmokers within the same air space "may reduce, but does not eliminate" exposure of nonsmokers to tobacco smoke (p. 13). Critics charged that the evidence on passive smoking was weak, but the evidence and the authori- tative conclusions of the Surgeon General and the National Academy of Sciences added support for stronger acts to limit or prohibit smoking indoors. In 1987, Congress banned smoking on domestic air trips shorter than two hours; in 1990, the ban was effectively extended to all domestic commercial air travel. Two further developments raised public (and public policy) awareness of ETS to a level that posi- tioned it in the front ranks of the campaign to reduce smoking. In 1991, the National Institute for Occupa- tional Safety and Health, Centers for Disease Control, issued the report Environmental Tobacco Smoke in the Workplace, which concluded that ETS can cause lung cancer and other health problems (National Institute for Occupational Safety and Health 1991). More important, in December 1992, the Environmental Pro- tection Agency (EPA) classified ETS as a "Class A" carcinogen, the most dangerous class of carcinogens. The agency's final report, Respirntor!y Health Effects of hsivc Smoking: LJfJlg Cancer nrld Otkr Disorders, con- cluded that ETS is a human lung carcinogen respon- sible for some 3,000 deaths annually from lung cancer among nonsmokers (EPA 1992). The Impact of the Movement to Reduce Smoking The campaign against tobacco promotion is, in a sense, a public health hybrid. It is in part a public health movement, like those oriented to ensure that food and drugs are pure and that water supplies and air quality are clean-movements that look to improve upon the collective provision of healthful environ- ments. But because the campaign to reduce smoking necessarily seeks to alter personal behavior, it is per- ceived or cast by some as a moral reform movement. "We are in the midst of one of those periodic moments of repression," writes one observer, "when the culture, descended from Puritans, imposes its hysterical visions and enforces its guilty constraints on society, legislat- ing moral judgments under the guise of public health, all the while enlarging the power of surveillance and the reach of censorship to achieve a general restriction of freedom" (Klein 1993, p. 3). Such critics worry about possible erosions of civil liberties and express irrita- tion with the puritanical cast of the movement to re- duce smoking (Berger 1986; Hitchens 1994; Leonard 1994; Laqueur 1995). One recent historian refers to health reform movements of this and the past century as "hygienic ideologies, " because the movements have sometimes reached levels of "devotion, asceticism, and zeal" that virtually mark them as "hygienic religion" (Whorton 1982, p. 4). In sum, the arguments have pit- ted this moralism against the freedom to choose (Sullum 1996). In doing so, issues of addiction and corporate responsibility are sidestepped (Hilts and Collins 1995). Reducing Tobacco Use It would be hard to deny that moral zealotry has entered into the contemporary movement to reduce smoking. But it would be equally hard to argue that zealotry is the dominant element in the movement. The contemporary campaign to reduce smoking, like some elements of the early 20th-century efforts, has been fueled by medical research and, more recently, by revelations about the additional but secret medical research carried on by tobacco companies themselves on nicotine and other addictive substances (Kluger 1996). But leadership has been both medical and non- medical and has been oriented to conventional public policy mechanisms rather than to moral reformation. Where the broad contemporary health movement has "an ambivalent orientation toward science and technol- ogy" and "draws upon Americans' significant and growing distrust of physicians" (Goldstein 1992, pp. 30-l), the movement to reduce smoking firmly em- braces establishment medical research. Its sometimes inventive and ingenious strategies notwithstanding, the movement has typically avoided ideological ends and has instead worked toward concrete, public policy ob- jectives. In this respect, it is self-consciously political, adopting a style found now in many health movements (e.g., AIDS, breast cancer, and even advocates of spe- cific health care reforms). Whether or :lc)t the movement to reduce smok- ing has avoided the finger-pointing associated with many ideological movements is debatable. On the one hand, the movement has tended to demonize the to- bacco companies rather than the smokers who use their products. This distinction may arise partly because, some cultural icons aside, smoking has rarely been perceived as a feature of personal behavior that is cen- tral to someone's identity. Placing the burden else- where than on the smoker has been amply reinforced by the research-steered perceptual transition of smok- ing as "habit" to smoking as "addiction." As codified by the 1988 Surgeon General's report (USDHHS 1988) and reiterated more recently (Lynch and Bonnie 19941, smoking is now medically viewed as nicotine addic- tion, and as the title for Chapter 4 states, smoking ces- sation is now the management of such addiction. This transition has had considerable impact on overall strat- egy for reducing smoking, especially in litigation ap- proaches (see "Litigation Approaches" in Chapter 5). On the other hand, as regulations against smok- ing become more widespread, the tendency to stigma- tize smokers may increase (Troyer 1989). Moreover, some critics ha;e complained of an ideology that smacks of political conservatism, in that the focus for the problem is turned away from the product source (the manufacturer) and to the user-victim (the smoker); this blame-the-victim perspective also characterizes sociopolitical movements that divert public attention to personal behaviors and away from larger, corporate sources of environmental health risks, such as indus- trial pollution and workplace hazards (Crawford 1979). In at least one sense-that of social values- efforts to reduce smoking have been moralistic. The contemporary reform movement can fairly be charac- terized as middle-class-that is, its values are those connected with traditional values such as deferred gratification, self-control, and personal responsibility (Goldstein 1992). Nonsmokers may feel morally su- perior to smokers, and former smokers may pride themselves on their personal accomplishment and self- denial. As one cultural observer has pointed out, former smokers especially may be "tediously zealous about the addiction they have left behind" (Styron 1987, p. 284). The net result, whatever the role of moral issues, is the main emphasis the movement places on chang- ing the social conditions that enable, and the cultural conditions that legitimatize or romanticize, smoking. In this sense, the movement to reduce smoking is an old-fashioned populist movement that seeks to defend the "public interest" against the moneyed corpora- tions, the purveyors of death and disease. It is now less an "anti-smoking" political movement and more a campaign against tobacco promotion. A reflection of this broadly populist attitude has been the movement's lack of any real links to partisan politics. Senators Wallace F. Bennett (R-UT) and Rich- ard L. Neuberger (D-OR) were among the first to seek curbs on the tobacco industry (Fritschler 1989). In the early 198Os, Republican Senators Robert W. Packwood (R-OR) and Orrin G. Hatch (R-UT) introduced legisla- tion to require more explicit warning labels on ciga- rette packages (Troyer 1989). House Democrats have been both key defenders and key critics of the tobacco industry. In the White House, Democratic President Lyndon 8. Johnson remained silent on the preemptive Federal Cigarette Labeling and Advertising Act of 1965, but White House pressure helped support the Tobacco Institute's efforts to pass the bill (Pertschuk 1986); the President signed the act into law privately in his office, without guests or comment (Fritschler 1989). Similarly, Democratic President Jimmy Carter refused to take a position on tobacco (Fritschler 19891, but he regarded USDHEW Secretary Joseph Califano's crusade against tobacco as "an enormous political liability" (Califano 1985, p. 360). The absence of po- litical affiliation for the antitobacco movement may be altered, however, by recent changes in the party com- position of elected officials from tobacco-producing states. The efficacy of efforts to reduce smoking, inde- pendent of other social changes beginning early in the 20th century, is hard to determine. Students of 19th- century temperance, for example, have concluded that although the temperance efforts likely accelerated the antebellum decline in alcohol consumption, the decline may have been more deeply tied to independent changes in styles of liquor consumption (Aaron and Musto 1981). The antismoking movement of the early 20th century, despite temporary gains, had little long- term effect on stopping the rapid growth of smoking; though noteworthy, the emergence of antismoking legislation in some midwestern and western `states was brief and showed little convincing evidence of enforcement. But neither the temperance movement of the 19th century nor the antismoking movement early in the 20th century commanded the significant allies and the range of weapons of the contemporary effort to reduce smoking. The critical factor has been definitive medi- cal research linking smoking to cancer, heart disease, chronic obstructive pulmonary disease, and adverse outcomes of pregnancy (USDHHS 1989). Beginning in 1964, the imprimatur of the Surgeon General of the United States provided a symbolic centerpiece that has given inestimable momentum to the campaign. The all-but-unanimous and compelling character of the epidemiologic research in that first report and its suc- cessors is the chief factor that leads to the-conclusion, "As a target of opportunity for public health action, smoking stands alone" (Walsh and Gordon 1986, p. 127). Measuring the overall impact of the rich and multifaceted effort to reduce smoking is difficult, in part because current prevalence should not be judged against an arbitrary historical benchmark (for instance, against prevalence at the time of the 1964 Surgeon General's report) but against an estimate of what prevalence would have been in the absence of such efforts. The events of the past decades that coincided with these efforts are clear: cigarette consumption rose steadily from the 1930s until 1963, fluctuated, then fell from 1973 tq the present. But such broad-brush observations provide little insight into cause and ef- fect, especially given the multiplier effect of certain social actions, the differential changes in demographic and social subgroups, and the influence of forces ex- traneous to smoking (Warner 1989). It is problematic, for example, to try to assess the relative impact of, on the one hand, government edu- cational actions and government regulatory actions and, on the other hand, changing social norms-two factors that are clearly interrelated. The impact of gov- ernment curbs on smoking in public places (see "Clean Indoor Air Regulation" in Chapter 5) may actually be bound up with "voluntary adjustments to new infor- mation" (Zimring 1993, p. 97). Similarly, doubts have been raised as to the influence of curbs on tobacco advertising (Schudson 1993; see "Advertising and Pro- motion" in Chapter 51, because such restrictions have occurred in conjunction with a growing stigmatization of smoking. Once nonsmoking is established as a norm, the minority status of smokers makes them "more vulnerable to negative social evaluations. . As smokers, the group most interested in defending the moral position of the cigarette smoker, become both less numerous and less influential, smoking behavior and the people who engage in it become more vulner- able to social reinterpretation" (Zimring 1993, p. 106). Such a reinforcing chain of events may permit curbs on advertising, rather than the reverse. It is equally difficult to gauge or predict the in- fluence of government restrictions. On the one hand, a regulation may be an educative force-for example, by reminding people to take their Surgeon General seriously. In some instances (such as indoor prohibi- tions and access restrictions), government actions in- terpose a physical barrier. On the other hand, legal or otherwise formal barriers could have an unintended effect on individual predisposition, as the abiding aura of antisocial behavior can be at least as great a stimu- lus for some as it is a deterrent for others. Finally, the psychological and social pathways by which economic actions of government affect smoking are complex. Sorting through this complexity is critical to understanding appropriate policy and action for re- ducing smoking. The ensuing chapters assess the available evidence to judge the efficacy of educational efforts (Chapter 3), the management of nicotine addiction (Chapter 4), regulatory efforts (Chapter 51, economic approaches (Chapter 61, and comprehensive programs (Chapter 7). This brief history of the anti- smoking movement provides a backdrop to such as- sessment and may furnish some perspective on future directions. 50 Clq't'r 2 Reducing Tobacco Use Conclusions 1. In the years preceding the development of the 3. Despite the growing scientific evidence for ad- modern cigarette, and for some time thereafter, verse health effects, smoking norms and habits antismoking activity was largely motivated by have yielded slowly and incompletely. 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Historical Review 57 Chapter 3 Effective Educational Strategies to Prevent Tobacco Use Among Young People Introduction 61 Trends in Tobacco Use Among Young People 61 Reasons Young People Smoke 62 Educational Models for Smoking Prevention 63 Recent Research on Educational Strategies for Smoking Prevention 64 Shorter-Term Follow-Up of School-Based Programs 65 Project Towards No Tobacco Use 65 Know Your Body 65 Project SHOUT 68 Longer-Term Follow-Up of School-Based Programs 69 Life Skills Training Program 69 Minnesota Smoking Prevention Program 70 Waterloo Smoking Projects 70 Project ALERT 71 Summary of Recent School-Based Research Studies 72 Research on Multifaceted Programs 73 Minnesota Heart Health Program: Class of 1989 Study 74 Midwestern Prevention Project 75 University of Vermont School and Mass Media Project 76 Observations on Research on Multifaceted Educational Programs 77 Diffusing Programs to Prevent Tobacco Use 80 National Guidelines 80 School Health Policies and Programs Study 80 A State-Based Assessment 82 Basic Curriculum 82 Supplemental Programs 82 Programs Including Families 83 Community Programs 83 Combined Activities 83 Monitoring Program Objectives 83 Interpreting the Diffusion Process 83 Conclusions 85 References 86 Reducing Tobacco Use Introduction Trends in Tobacco Use Among Young People Smoking prevalence among youth underwent a sustained and substantial decline for about a decade from the mid-1970s to the mid-1980s. The Monitoring the Future study, funded by the National Institute on Drug Abuse, has assessed the substance use behaviors of large representative samples of high school seniors annually since 1975 (Giovino et al. 1994; Johnston et al. 1994). The data from this multiyear study have shown that daily cigarette smoking reached a peak of about 29 percent among high school seniors in 1977. Daily smok- ing then declined steadily until 1986, falling below 19 percent, but has shown little change since. Detailed analyses of trends in smoking by adolescents in 1974- 1991, based on Monitoring the Future data and two other national health behavior survey series, also have shown consistent evidence that smoking prevalence among adolescents has generally been stable since about 1985 (Nelson et al. 1995). In 1997, daily cigarette smok- ing in the month before the survey was reported by 24.6 percent of high school seniors, the highest level since 1979, when 25.4 percent reported daily smoking. Long- term trends show that daily smoking among seniors was at a 25-year high of 28.8 percent in 1976 and 1977, declined to 21.3 percent in 1980, varied in the range of 18-21 percent from 1980 to 1991, and decreased to 17.2 percent in 1992. After that, seniors' daily cigarette use increased steadily to reach 24.6 percent in 1997, then decreased to 22.4 percent in 1998 and remained statisti- cally unchanged at 23.1 percent in 1999 (Johnston et al. 1999). A recent report with more current prevalence estimates and trend data from 1991 through 1997 shows that current cigarette use increased overall and for white, black (the racial/ethnic terms "black" and "Af- rican American" are both used in this report, according to the usage in the study cited), and Hispanic high school students (Centers for Disease Control and Pre- vention [CDC] 1998). Even so, the prevalence of smok- ing among African American high school seniors was lower than that for Asian Americans/Pacific Islanders and for American Indians/Alaska Natives (US Depart- ment of Health and Human Services [USDHHSI 1998). Although the decade-long decline in smoking prevalence among young people stalled in the mid- 198Os, it has persisted among all major adult popula- tion groups in the United States (Giovino et al. 1994). Changes in prevalence among young people thus do not seem to be closely linked to changes among adults (Reid et al. 1992) and may be more heavily influenced by other social forces. Downward trends in smoking by adults may, for instance, be partly the result of the continued accumulation of scientific knowledge about the long-term health consequences of smoking and of secondary exposure to cigarette smoke (USDHHS 1989; Environmental Protection Agency 1992). That no such downward trend was observed among most groups of adolescents in the past decade may reflect other factors: prices of tobacco products decreased (see Chapter 6); during the 198Os, public education efforts to prevent tobacco use among young people dimin- ished; and youth-oriented marketing by cigarette manufacturers intensified (Nelson et al. 1995). More- over, because of the highly addictive nature of ciga- rette smoking, the recent increases in prevalence of smoking among young people could carry over into their adulthood and eventually arrest or reverse the long-term declines that have persisted for decades (CDC 1994a; Giovino et al. 1994). In a similar vein, a major portion of tobacco con- sumption at the beginning of the 20th century was in the form of spitting tobacco. The emergence of machine-made cigarettes as the dominant form of to- bacco use in the 1930s (see Chapter 2) was accompa- nied by a 38.4-percent decline in total smokeless tobacco production from 150.2 million to 92.5 million pounds between 1944 and 1968. In the early 197Os, however, the market for smokeless tobacco reemerged. Between 1970 and 1981, the production of fine-cut tobacco, used in the manu- facture of moist snuff, increased threefold from 4.8 million to 15.2 million pounds (USDHHS 1986). Sales of moist snuff have increased every year since the Fed- eral Trade Commission (FTC) began monitoring it, from 36.1 million pounds in 1986 to 55.3 million pounds in 1997 (FTC 1999). Loose leaf chewing to- bacco has seen a slight decline in sales over this pe- riod, from 65.7 million pounds in 1986 to 51.8 million pounds in 1997. The growth in the sales of moist snuff has been attributed to a smokeless tobacco advertising and marketing campaign that encourages young non- users to experiment with low nicotine starter products with the intent of graduating new users to higher nico- tine brands as dependence progresses (Connolly 1995). Surgeon General's Report The basis and success of this "graduation" strategy is supported by laboratory and epidemiologic data as well as tobacco industry documents. Smokeless tobacco manufacturers appear to be able to manipu- late the nicotine-dosing characteristics of their prod- ucts and have developed moist snuff products with a wide range of bioavailable nicotine (Henningfield et al. 1995; Djordjevic et al. 1995; Food and Drug Administration 1996; Tomar and Henningfield 1997). A national longitudinal study found that young males were twice as likely to switch from a brand with low or medium nicotine delivery to a high nicotine deliv- ery product than to switch in the opposite direction (Tomar et al. 1995). Advertising and promotional expenditures have increased for nearly every year between 1986 and 1997, from $76.7 million to $150.4 million (FTC 1999). In 1997, $103.6 million was spent for advertising and promotion of moist snuff. Smokeless tobacco use is primarily a male behav- ior. Use of snuff and chewing tobacco by young males increased sharply through the 1970s and early 1980s. Data from the National Health Interview Survey indi- cate that the prevalence of smokeless tobacco use among males aged 18-24 years increased from 2.2 per- cent in 1970 to 8.9 percent in 1987 and declined slightly to 8.4 percent in 1991 (Giovino et al. 19941. Based on CDC's Youth Risk Behavior Survey, the prevalence of past-month smokeless tobacco use remained at about 20 percent among high school males during most of the 1990s (CDC 1992; Kann et al. 1995). Recent data indicate that smokeless tobacco use may be starting to decline among high school males (CDC 1998). More vigorous steps are clearly required to pre- vent young people from beginning to use tobacco products. This chapter considers the effect of educa- tional programs in such prevention. Throughout the discussion, the term "education" is used to encompass the range of activities that impart knowledge, alter per- ceptions, and modify behavior. Reasons Young People Smoke The public health importance of smoking among young people has generated a substantial amount of research on why they take up the habit. The results of these efforts have provided several consistent insights that have been reviewed in detail and summarized in recent reports (Lynch and Bonnie 1994; USDHHS 1994). Development of tobacco addiction is a staged process that requires several years to progress from ini- tiation to acquisition of an established habit (Leventhal and Clear-y 1980; McCarthy 1985; see also Flay 1993). The initial stages are consistently associated with a well-defined group of risk factors. Early adolescence (aged 11-15 years, or bth-10th grades) is the period when people are most likely to try smoking for the first time. Especially at risk are adolescents whose parents or guardians smoke or have lower levels of income and education (USDHHS 1994). Young people's perceptions of smoking behav- iors in proximal and wider social environments are among the most powerful psychosocial forces influ- encing whether they begin to smoke (USDHHS 19941. Cigarette smoking among friends, peers, siblings, and others from the young person's immediate environ- ment is consistently associated with smoking initia- tion. The influence of friends and peers seems to be especially powerful in the early stages of developing a smoking habit. Perceptions of the larger social envi- ronment also seem to have considerable influence on smoking decisions. Adolescents tend to overestimate the prevalence of smoking among people their own age and among adults. Such perceptions-and in gen- eral, susceptibility to becoming a smoker-are likely to be strongly influenced by the effects of advertising (Evans et al. 1995). Young people who perceive high levels of smoking among their peers and who report that peers are more likely to approve of cigarette smok- ing are more likely to become smokers themselves. These external influences are likely supported or opposed by internal, personal factors. The personal factors most often associated with smoking initiation include the young person's belief that cigarette smok- ing is linked with positive functions, such as having a positive social image and bonding with a peer group. Among young women, smoking may be viewed as a means of weight control (French et al. 1994). Adop- tion of such perceptions may reflect, in part, the influ- ence of a larger social environment in which smoking is presented through local and mass media as an adventurous and glamorous adult behavior. Thus, smoking provides some young people a perceived tran- sition from childhood to adulthood (USDHHS 1994). These findings, summarized in the 1994 Surgeon General's report Preventing Tobacco Use Among Young People, strongly suggest that tobacco use is socially learned by children and adolescents and that it tends to have socially relevant meanings for them (USDHHS 1994). Smoking prevention programs should thus address the most salient psychosocial dimensions that can influence a young person to not begin smok- ing. These dimensions include enabling the young to cope with direct social pressure to smoke from their friends and peers and correcting or preventing misperceptions about the social effects and short-term 62 Chapter 3 Reducing Tobacco Use health consequences of smoking, about peers' and adults' attitudes toward smoking, and about smoking prevalence. Educational Models for Smoking Prevention During the past two decades, several different theoretical orientations and program objectives have emerged for educational approaches to smoking pre- vention. Several changes have influenced these events: research and evaluation results that highlighted the ineffectiveness of the models used in earlier programs, the accumulation of consistent research characterizing the process of smoking initiation, advances in theo- ries of human behavior, and promising results obtained from initial tests of newer educational models. Another important change is the expansion from relatively simple strategies and educational techniques to more complex plans that use multiple educational channels. Complex sociobehavioral problems are thus being addressed with more intensive educational strategies. The earliest group (mostly from the 1960s and 1970s) of evaluated programs designed to prevent ado- lescents from beginning to smoke was based on an information deficit model (USDHHS 1994). This approach assumed that adolescents, as rational crea- tures, would refrain from cigarette smoking if they were supplied with adequate information demonstrat- ing that this habit causes serious harm to the body. The educational techniques associated with these pro- grams included lectures, demonstrations, films, post- ers, and books intended to raise levels of awareness and comprehension of health effects. Many programs based solely on this objective did increase knowledge among children and adolescents, as intended, but the programs were consistently found to be ineffective in dissuading young people from smoking (Goodstadt 1978; Thompson 1978; Kinder et al. 1980; Schaps et al. 1980,198l). Although this approach alone was clearly inadequate, information about the health and social consequences of smoking was retained as an impor- tant component of later developments in smoking prevention education. The limitations of this approach led to efforts in the 1970s to identify a more complex set of personal factors related to cigarette smoking by young people. Once these factors were identified, educational pro- grams could be developed to try to modify them. Stud- ies conducted during these years often observed that the use of cigarettes was associated with negative or antisocial patterns of adolescent behavior WSDHHS 1994). Educators interpreted these patterns as reflect- ing reduced levels of perceived self-worth and poor attitudes toward family, school, and community; these factors were hypothesized to be the root causes of smoking initiation. Various educational strategies to address these broad educational targets included programs focused on clarifying values, building self- esteem, and developing general skills for decision mak- ing, communication, and assertiveness. Such efforts to prevent smoking initiation by helping young people develop stronger intrapersonal resources and general social competence have been collectively referred to as the affective education model. Evaluations of these programs, however, dem- onstrated that they were not much more effective in reducing cigarette smoking among young people than programs based on the information deficit model (Schaps et al. 1981; Durell and Bukoski 1984; Hansen 1992). The affective education strategy did mark the beginning of promising trends in designing education programs to prevent smoking: many programs began more directly incorporating results from research about factors found to influence smoking initiation and began including more powerful theoretical models of behavior change. By the mid-1970s, results of analytic and theo- retical research began to highlight a complex set of psychosocial factors associated with smoking initiation. Numerous studies had consistently found that smoking experimentation by the young was as- sociated with peer smoking, smoking by others in the immediate social environment, and other social and psychological factors WSDHHS 1994). Although the resulting psychosocial intervention programs were developed through several different conceptual per- spectives, they tended to share a core set of compo- nents that compose what is generally called the social influences model (USDHHS 1991). This model focuses on the development of social skills to resist social influences that encourage smoking. The initial efforts to design programs based on these findings used a public health model: the prob- lem was conceptualized as a social contagion in which the habit spread through a population by passing from one person to another. This concept directed program efforts toward strengthening the resistance of non- smoking adolescents to the behavior of their smoking peers. For example, Evans and colleagues (1978) at the University of Houston used methods derived from communications and social learning theories to try "inoculating" young people against peer influences to smoke cigarettes; the study group of adolescents was Effa-tiuc Edrrcatior~al Strategies 63 shown videotaped models of credible peers who suc- formats, used different delivery methods, and been cessfully resisted such influences (McGuire 1964). offered to diverse student populations. This approach was developed further in small- scale studies that added other objectives and used other educational technologies (Botvin et al. 1980; McAlister et al. 1980; Perry et al. 1980). The appeal of the overall conceptual approach and the generally positive results of this initial group of studies stimu- lated a sustained evolution of the approach through several stages of development; the result was a gener- ally recognized social influences model for school- based programs to prevent smoking (Flay 1985). The main goal of this approach was to equip younger adolescents with specific skills and other resources that would help them resist direct and indi- rect social influences to try smoking cigarettes. The specific objectives usually included having the young person learn the short-term negative social and health consequences of smoking and the advantages of re- maining a nonsmoker; learn that a relatively small proportion of young people and adults are regular smokers; recognize the social influences in the imme- diate environment and from the wider community and culture that promote smoking; and develop specific skills for managing direct social pressures from friends and peers, as well as indirect pressures from adult modeling, the mass media, and tobacco industry mar- keting. Although representing a significant departure from previous approaches, this model retained the provision of information on the negative short- term consequences of smoking (from the information deficit model) and continued to emphasize the devel- opment of social competencies (from the affective education model). By the mid-1980s, detailed analyses of research results indicated that social influences programs were consistently more effective than programs based on the information deficit or affective education models in preventing cigarette smoking (Tobler 1986, 1992; Rundall and Bruvold 1988; Hansen 1992; Bruvold 1993). Some reviewers, however, wondered whether this evidence was strong enough to justify developing public policies that would make these school-based programs a large-scale, key component of policies to prevent tobacco use (Flay 1985; Cleary et al. 1988; Kozlowski et al. 1989). Social influences strategies have typically been applied through school-based programs for students in sixth through eighth grades (primarily during early adolescence). These programs have taken various Concern focused on the quality of the effects achieved, the quality of the evaluation research that provided the evidence, and the generalizability of the programs. The programs' effects reported up to the mid-1980s were not consistently achieved, were of short duration, and tended to be small. For example, Drug Abuse Resistance Education (D.A.R.E.), a drug resistance program that included but was not pri- marily focused on tobacco use, has been in wide use since the mid-1980s. A recent meta-analysis of pub- lished and unpublished results concluded that the program's effect on tobacco use was small at best (Ennett et al. 1994). Limitations in evaluation methods-such as outcome measurement, attrition ef- fects, consistency between assignment and analysis units, and completeness of reported effects on total populations-precluded drawing clear conclusions about program effectiveness. These reviewers also were concerned that the programs might be too com- plex to be carried out in most schools by most class- room teachers. Since 1990, many of these questions have been addressed by research on these educational strategies (Graham et al. 1991). Recent Research on Educational Strategies for Smoking Prevention Most early research programs on smoking pre- vention were located exclusively in school settings. Schools provide direct access to target populations and have a mission consistent with smoking prevention education. Schools, however, have some inherent limitations that reduce their usefulness as exclusive channels for such education; the obvious one is that school programs cannot reach individuals who leave school. This section reviews shorter-term and longer- term studies of the effects of school-based smoking pre- vention programs (Table 3.1). The section also reviews studies of prevention programs that have tried to 64 Chapter 3 Reducing Tobacco Use enhance such programs by combining them with edu- cational activities directed toward young people through parents, community programs, and the mass media or by combining them with programs that tar- geted multiple substances. Shorter-Term Follow-Up of School-Based Programs The group of studies summarized in this subsec- tion evaluated programs that were based, with few exceptions, exclusively on educational experiences provided in school classrooms. These studies gener- ally have addressed methodological problems com- monly found in earlier evaluations of smoking prevention efforts. Improvements include use of bio- chemical measures to enhance the accuracy of self- reported smoking behavior, attention to validity issues related to attrition, and improved consistency between units of assignment to treatment and units of analysis. Most of this initial group of studies also improved on earlier reports by using more diverse study popu- lations to test these programs and by following participants into the first year of high school to assess smoking prevention effects at an intermediate stage of adolescent development. The studies described and analyzed in this subsection thus represent the cur- rent state of the art in the evaluation of school-based smoking prevention. Project Towards No Tobacco Use Project Towards No Tobacco Use (Project TNT) was designed to assess the relative effectiveness of three main components of most smoking prevention pro- grams based on the social influences model (Sussman et al. 1993b, 1995). The investigators developed sepa- rate classroom curricula to address each of these com- ponents (Sussman 1991; Sussman et al. 1993a). The first curriculum provided social skills to help students more easily refuse direct offers of cigarettes from peers; the second provided methods to counteract the impact of indirect pressures to smoke cigarettes, such as smoking (real or perceived) by peers or adults, tobacco industry advertising, and exaggerated notions of the actual prevalence of smoking among peers and adults; and the third improved knowledge of the short-term and long-term negative effects of smoking. A fourth cur- riculum addressed all three of these areas and was similar to the social influences model used with many other school-based smoking prevention programs. Each curriculum included 10 lessons designed for seventh-grade students. The curricula were delivered on 10 consecutive school days by trained health educa- tors employed by the project. A control group received the standard curriculum. The study included seventh graders from 48 junior high schools in 27 southern California school districts. Students from 8 schools were assigned to receive one each of the four curricula; students from the remaining 16 schools were assigned to receive the standard education program provided by their schools. These populations were relatively diverse: about 40 percent were from minority ethnic groups. Student reports of smoking behavior were measured immedi- ately after the curricula were completed in the seventh grade (n = 6,716) and one year later in the eighth grade (n = 7,052). Analyses of these data indicated that the curricu- lum that combined all three main objectives drawn from the social influences model achieved the lowest increase in weekly smoking prevalence (defined as smoking one or more cigarettes per week); this increase was 64 percent lower than the increase in the control group. The curricula that focused on indirect pressures to smoke cigarettes and on negative consequences of smoking also were significantly more effective than the control condition. The curriculum that focused on refusal skills did not yield results significantly differ- ent from the comparison condition. Changes in psychosocial mediators of program effects were con- sistent with these results (Sussman et al. 1993a). Simi- lar effects were obtained for smokeless tobacco use. A two-year follow-up survey, completed when the participating students were in ninth grade, showed that the combined curriculum continued to have a sig- nificant impact on weekly smoking rates after these students entered high school (Dent et al. 19951. Know Your Body The Know Your Body (KYB) program, a school- based effort to reduce risk factors for chronic disease among young people, addressed cigarette smoking status, dietary behaviors, and physical fitness through curricula for fourth- through ninth-grade students (Walter 1989; Walter and Wynder 1989). Program components included parent education and periodic student health examinations. Designed to meet the rapidly changing educational needs of young people in this age group, the six-year curriculum progressed from a focus on knowledge and beliefs to a focus on decision-making skills (Walter and Wynder 1989). In the fourth and fifth grades, the curriculum's compo- nent on smoking prevention concentrated on students' Effective Educatiorlal Strategies 65 Surgeon General's Report Table 3.1. School-based and multifaceted educational strategies Proiect name Educational methods School-based educational strategies with shorter-term follow-up Project TNT (Towards No Tobacco Use) 2 years; 10 class sessions delivered by project staff in grade 7 Know Your Body 6 years; multiple risk factor curriculum delivered weekly by classroom teachers in grades 4-9, plus parent education SHOUT (Students Helping Others Understand Tobacco) 3 years; 18 class sessions in grades 7-8 delivered by project staff, plus telephone and mail contact in grade 9 School-based educational strategies with longer-term follow-up Life Skills Training Program 3 years; 30 class sessions delivered by teachers in grades 7-9 Minnesota Smoking Prevention Program 1 year; 5 class sessions in grade 7 delivered by teachers and peers Waterloo Smoking Projects 3 years; 11 class sessions delivered by project staff in grades 6-8 Project ALERT 2 years; 11 class sessions delivered by teachers and peers in grades 7-8 Multifaceted educational strategies Class of 1989 Study (Minnesota Heart Health Program) 5 years; 17 class sessions delivered by teachers and peers in grades 7-9, plus related school courses and activities and very intensive community education directed toward adults Midwestern Prevention Project 3 years; 15 class sessions delivered by teachers and peers in grades 6-7 or 7-8, plus parent education and participation in school curriculum, informational media, and community organization University of Vermont School and Mass Media Project 4 years; 15 class sessions in grades 5-8 or 6-9 or 7-10 delivered by teachers, plus 540 television and 350 radio spot broadcasts each year 66 Chapter 3 Reducing Tobacco Use Comment 5 conditions tested in 48 schools (n = 6,716) 64% less weekly smoking for full Very large short-term effect intervention group by end of achieved by moderately intensive grade 8 and 55% by end of grade 9 school program 2 conditions in 15 schools (n = 911) 73% less smoking by end of grade 9 2 conditions in 22 schools (n = 3,655) 33% less monthly smoking by end of grade 9 3 conditions tested in 56 schools (n = 5,954) 4 conditions tested in 18 schools (n = 7,030) 2 conditions tested in 22 schools (n = 654) 3 conditions tested in 30 schools (n = 0,527) 18% less weekly smoking observed at grade 12 Program effects at grades 8 and 9 but not at grade 12 Program effects at grades 8 and 9 but not at grade 12 Program effects less at grades 8 and not at grade 12 2 conditions tested in 13 schools (n = 2,401) 39% less weekly smoking by end of grade 12 2 conditions tested in 42 schools (n = 5,065) 32% less monthly smoking after 1 year; 19% less monthly smoking by end of grades 9-10 2 conditions tested in 50 schools (n = 5,458) 40% less weekly smoking by end of grades 8-10; 31% less weekly smoking at end of grades lo-12 Very large short-term effect achieved by very intensive school program with parent education Large short-term effect achieved by intensive school program supplemented with other contacts Large sustained effects achieved by very intensive school program No long-term effects of less-intensive school program No long-term effects of moder- ately intensive school program No long-term effects of moder- ately intensive school program Large sustained effects achieved by intensive school programs supported by intensive commu- nity programs Large short-term effects achieved by intensive school program sup- ported by parent education, mass media, and community programs Large sustained effects achieved by intensive school program combined with intensive mass media intervention *Results are reported relative to a comparison group. Effectizfe Edtrcatiollal Strategies 67 Surcpeolr Gtv7cr~l's Report health beliefs about smoking. Social influences, both direct and indirect, on decisions about smoking were addressed in the sixth through eighth grades. Psycho- logical influences, such as stress and self-image, were addressed in the ninth grade. The classroom program was delivered by the stu- dents' usual classroom teachers, who had been trained by project staff. The overall curriculum required about two hours per week throughout the school year. If the curriculum gave equal attention to each of the three targeted behavioral areas, the smoking component would include about 24 hours of class time per year over six years. The parent education component of the program included participation in students' homework from the curriculum, attendance at school meetings about the program, receipt of program news- letters, and self-assessment of risk factors for chronic disease. The program was initially tested with students attending the fourth grade in 15 elementary schools from suburban communities near New York City (Walter et al. 1989). Students in eight schools received the KYB educational program, and students in the remaining schools received only measurement acti- vities from the study. The follow-up survey in the ninth grade included 593 students (65 percent) from the origi- nal study cohort. Analyses of these data showed that students who had received the program were significantly less likely than students not receiving the program to smoke ciga- rettes (verified through salivary cotinine measures). Smoking prevalence in the ninth grade was 73 percent lower among students who had received the program. This smoking prevention effect was stronger among boys than among girls. Favorable changes in health knowledge, dietary behavior, blood cholesterol, and obesity were also observed (Walter et al. 1988; Walter and Wynder 1989). Project SHOUT The Students Helping Others Understand Tobacco (SHOUT) project was designed to assess the effectiveness of a prevention program delivered to sev- enth through ninth graders by trained college under- graduates through classroom activities and telephone and mail support (Elder et al. 1993b). The program began with 10 class sessions distributed throughout the seventh-grade school year. Components focused on pressures to smoke, refusal skills, negative social and health consequences of smoking, decision mak- ing, and commitment to nonsmoking. In the eighth grade, eight classroom sessions reviewed refusal skills and engaged students in community action projects, such as encouraging others to quit, writing letters about tobacco issues to mass media organizations and tobacco firms, and debating issues about tobacco use. Throughout the ninth grade, when students had transferred into secondary school, the college under- graduates trained by the program staff made four sup- portive telephone calls to each participant; 69 percent of participants were reached at least once (Elder et al. 1994a). Also during the ninth grade, five newsletters were mailed to students and two to their parents. This program was initially tested in 22 southern California schools. Students from 12 schools received the SHOUT program, and students from the remain- ing schools did not. About 45 percent of the students were from minority ethnic groups. The effectiveness of the program was assessed through classroom and mail surveys conducted at the end of each of the three years. The ninth-grade survey included 2,668 mem- bers (73 percent) of the original study cohort. By the end of the ninth grade, the prevalence of monthly smoking (defined as smoking one or more cigarettes per month) was about 33 percent lower among students who had received the program than among those who had not. The relative difference in the two groups' reported smoking increased each year and was statistically significant at the end of the ninth grade. The results at the end of the ninth grade were particularly encouraging, because program contact (via telephone calls and newsletters) was less costly. It was not possible to assess whether program effects had accumulated during the seventh and eighth grades. Results for ethnic subgroups were consistent with these overall results but were not always statistically signifi- cant. Similar effects for ninth graders were obtained for weekly cigarette smoking and for smokeless to- bacco use. Assessments of cigarette refusal skills among students receiving and not receiving the pro- gram indicated that the program had positive effects on this mediator of smoking initiation at the end of the seventh grade but not subsequently (Elder et al. 1993a, 1994b). As was found with Project TNT, the results of the SHOUT program did not in general sup- port a strong link between refusal skills and smoking behavior. In an extension of this program, newslet- ters and supportive telephone calls were offered again in 11th grade to a subset of the original intervention group. Results of an additional follow-up survey suggested positive effects of providing continued smoking avoidance support to students throughout the secondary school years (Eckhardt et al. 1997). 68 Chnpter- 3 Reducing Tobacco Use Longer-Term Follow-Up of School-Based Programs The preceding group of studies did not address whether the observed prevention effects were perma- nent or whether they simply represented delays in smoking initiation from middle school to later high school years. Because few people begin smoking after high school, programs that prevent young people from smoking throughout the high school years are likely to prevent young people from ever becoming regular smokers. Several studies of school-based programs to pre- vent smoking have followed participating students into the later years of high school to assess the dura- bility of effects several years after the programs were implemented. Life Skills Training Program The Life Skills Training (LST) Program \vas designed to help adolescents develop a wide spectrum of personal and social skills, including those related to preventing cigarette smoking and the use of alco- hol and other drugs (Botvin et al. 1990a). The core program consists of 12 curriculum units designed to be taught in 15 class periods to seventh graders. The problem-specific components of the LST Program are similar to those included in smoking prevention pro- grams focused more directly on the social influences model. These components include offering practice in assertively resisting peer pressure to smoke and providing information about the negative short-term social consequences of cigarette use, the decreasing social acceptability of use, and the actual prevalence of use among adolescents and adults. Other program components address the development of generic per- sonal and social competencies, such as communica- tion skills and ways to develop personal relationships. One of the notable strengths of this program is the relatively large number of separate trials reported by the investigators. The largest trial was conducted among students attending 56 suburban and rural schools in three geographic regions of New York (Botvin et al, 1990a). Students in 34 schools received the smoking prevention program, and students from the remaining schools did not. The smoking preven- tion program included the full IS-session LST Program in the seventh grade, followed by a lo-session booster program in the eighth grade and a 5-session booster ii1 the ninth grade. These programs \vere delivered by the students' usual classroom teachers, who had been trained either through group workshops followed by monitoring, feedback, and reinforcement of imple- mentation procedures or through use of a training videotape. This study thus tested whether program effectiveness could be maintained while using low-cost methods for disseminating the program to large num- bers of schools, teachers, and students. Analyses of reports from the 4,466 students sur- veyed at the end of the ninth grade (75 percent of the original cohort) showed that the prevalence of ciga- rette smoking was significantly lower among students who had received the LST Program than among those who had not. The relative difference in the smoking scores was about 10 percent. Results were similar for both teacher training conditions. The analyses indi- cated that most of the knowledge, attitude, and skill lrariables that were targeted as mediators of effects showed significant changes consistent with program objectives. Program recipients also had significantly louver levels of marijuana use and alcohol intoxication. In a long-term follow-up of the LST Program, data lvere collected from school, telephone, and mailed surveys administered six years after the initial 56 pub- lic schools had been randomized to treatment and control conditions (Botvin et al. 1995). The 3,597 pre- dominantly white, 12th-grade students sampled repre- sented 60.4 percent of the initial 7th-grade sample. Among all students included in the 12th-grade follow-up, weekly cigarette smoking was reported by about 22 percent of those receiving the intervention and by 27 percent of those in the comparison condition, rep- resenting an l&percent relative reduction in smoking prevalence. For the subset of students receiving a rea- sonably complete version of the program, the relative reduction in smoking prevalence was 26 percent. The study is unique in demonstrating effects of a preven- tion program that lasted through high school. The generalizability of these results to other populations and school settings is an important area for exploration. Similar support for the effectiveness of the LST Program has been obtained from shorter-term studies of variations in implementation procedures and study populations. These studies have provided evidence for the effectiveness of booster sessions after the initial program delivery (Botvin et al. 1983) and have compared the use of peers and teachers as pro- gram facilitators (Botvin et al. 1990b). Other studies have replicated the short-term effectiveness of the pro- gram with African American and Hispanic adolescents (Botvin et al. 1989a,b, 1992). Components of the pro- gram also appear to have had positive effects when implemented outside the context of a research project (Bru\-old 1990). These multiple tests of one approach to school-based smoking prevention provide a Surgeon Gerzeral's Report well-rounded picture of the potential effectiveness of various approaches. The results also demonstrate that relatively intensive programs that address the core objectives of the social influences model in the context of a larger curriculum can reduce smoking prevalence in diverse target populations and school settings when the curriculum maintains a reasonable level of integ- rity to the program design. Minnesota Smoking Prevention Program Two replications of a smoking prevention pro- gram based on the social influences model were com- bined into a single study of long-term effects, the Minnesota Smoking Prevention Program (Arkin et al. 1981; Murray et al. 1984). The core program contained units that identified social pressures to smoke, offered practice in skills to resist direct social pressures, pro- vided information about actual levels of smoking among peers and adults, and provided information about the negative short-term social and physiologi- cal consequences of smoking. These objectives were addressed in five class periods delivered throughout the seventh grade; no additional educational compo- nents were offered in later grades. Both replications of the program compared the relative effectiveness of same-age peer leaders and adult leaders. The. two studies included 7,030 seventh-grade students participating in baseline surveys in 18 sub- urban Minnesota schools. In the first study, students received a social influences program led by adults or by peers or received an adult-led program of simi- lar length on the long-term health consequences of smoking. In the second study, conducted a year later, seventh-grade students from the same 18 schools received the adult-led or peer-led social influences pro- gram, the adult-led health consequences program, or no specific smoking prevention program. Results from the first study indicated that among students who were nonsmokers at the start of seventh grade, those who received the peer-led smoking pre- vention program were significantly less likely than those who received the adult-led programs to have tried smoking by the end of the eighth grade; similar results were seen for students who at the start had al- ready tried smoking (Murray et al. 1984). Results from the second study indicated that at the end of the eighth grade, students who were initially nonsmokers and who received any of the test programs were signifi- cantly less likely than similar students from the schools receiving no program to have tried smoking (Murray et al. 1987). In the first study, differences among treat- ment groups had diminished by the ninth grade and were not statistically significant. In the second study, students who had initially tried smoking and who received the peer-led programs had a significantly lower smoking prevalence than students receiving the adult-led health consequences program (Murray et al. 1987). Modest effects of a peer-led program were detected in an llth-grade follow-up conducted for the second study (Murray et al. 1988). The investigators surveyed members of the origi- nal study cohorts when the first study participants were one year beyond high school and the second study participants were in the 12th grade (Murray et al. 1989). Those still attending school in their original districts participated in a classroom survey, and oth- ers were interviewed by telephone; participation ex- ceeded 90 percent in both studies. Responses indicated that the programs had no lasting differential effects on smoking behavior. Waterloo Smoking Projects The Waterloo Smoking Projects (WSP) in Canada tested a social influences program designed to follow students from the sixth through eighth grades. The program included three main components common to social influences curricula (Best et al. 1984). The first component provided information on negative consequences of smoking, on smoking prevalences in the general population, and on social influences to smoke. The second component provided practice in skills to resist direct social pressures to smoke. The third component focused on decision making and public commitment to not smoke. These topics were delivered in six sessions during the first three months of the sixth grade. Information about social influences was reviewed in two booster sessions later in the sixth grade. Two additional booster sessions in the seventh grade and one in the eighth grade featured student presentations and discussions about smoking pres- sures and decisions. All sessions were presented by graduate students who were members of the project staff. The evaluation design for this study provided methodologically stronger evidence for potential longer-term effects than previous follow-up studies of school-based programs. The WSP was tested with stu- dents from 22 schools in two school districts in south- western Ontario (Flay et al. 1985). Students from half the schools received the program, and students from the other half did not. The schools were located in urban, suburban, and rural areas. The study sample included 654 students tested at the sixth-grade baseline classroom survey. 70 Chapter 3 Reduchg Tobacco Use At the end of the seventh grade, 18 months after the baseline survey, results were reported for the 498 students (76 percent) who had been present for all cross-sectional analyses at each time point. The analy- ses showed reduced experimentation with smoking in the entire target population receiving the program and reduced consumption among students who were regular smokers before involvement in the program (Flay et al. 1985). Longitudinal analyses showed significantly less smoking among program recipients who had already tried smoking before starting the program. Psychosocial mediators, such as knowledge and perceived control, showed changes throughout the target population that were consistent with program objectives (Flay et al. 1983). Results at the end of the eighth grade were re- ported for the 439 students (67 percent) who had par- ticipated in all six school surveys administered through that time (Best et al. 1984). These analyses indicated that the program significantly reduced the amount of experimental smoking among the subgroup that at the baseline survey had reported never smoking. Effects that had been detected at the end of the seventh grade among students with more smoking experience were still apparent but no longer statistically significant. The project surveyed original cohort members at the 12th grade by classroom survey, mailed question- naire, and telephone interview. This effort yielded long-term follow-up data for 560 members (86 percent) of the original study cohort (Flay et al. 1989). There were no program effects at the 12th grade for any smoking level in the overall study sample or for any subgroups defined by initial level of risk. Project ALERT The Adolescent Learning Experiences in Resis- tance Training (ALERT) school program was based on a social influences model that included many features common to this type of program (Ellickson et al. 1993a). The overall goal was to provide young people with the motivation and skills needed to avoid substance use, including alcohol and marijuana as well as cigarettes. The motivational component focused on reducing barriers to resisting social pressures, such as normative beliefs that most young people and adults smoke, that this behavior is widely acceptable and approved, and that smoking has positive physical and social consequences. The skill component focused on practicing skills to resist direct social pressures to smoke. Eight sessions covering these objectives were delivered one week apart during the seventh grade; three booster sessions reviewed the main points dur- ing the eighth grade. This program was tested with students from 30 schools in eight school districts located in urban, sub- urban, and rural communities of California and Oregon (Ellickson and Bell 1990). In the initial school survey, about 33 percent of these students were from minority ethnic groups. Students in 20 schools received the ALERT curriculum, and students in the other 10 schools did not. In 10 of the program schools, the curriculum was delivered by classroom teachers alone; in the other 10 program schools, teachers were assisted by older peer leaders recruited from nearby high schools. The initial assessment of this program was re- ported for follow-up school surveys completed 15 months after the baseline survey. After substantial follow-up effort, about 60 percent of the baseline co- hort of 6,527 students were included in these reports (Ellickson and Bell 1990). Among students in the treat- ment group who had experimented with smoking be- fore the program, smoking was reduced by about 20 percent. Among students who had never smoked, however, the program did not achieve a statistically significant reduction. Psychosocial risk factors tar- geted by the program, including beliefs about the con- sequences of use and perceived norms for cigarette smoking, showed changes consistent with program objectives (Ellickson et al. 1993a). These findings were generally consistent across school districts in various geographic regions with differing ethnic and socioeco- nomic profiles; the results were not affected by whether an older peer assisted in delivering the program. An additional follow-up of these students was reported at the ninth grade, two years after the baseline survey (Bell et al. 1993). These analyses included about 75 percent of the baseline sample. Earlier effects on psychosocial risk factors persisted, but program effects on cigarette smoking and other substance use behav- iors had disappeared at this time (one year after the end of the program). A final follow-up survey was completed in the 12th grade, five years after the baseline survey and four years after completion of the program; 57 percent of the baseline sample were included in these analy- ses (Ellickson et al. 199313). By the end of high school, the program had no detectable effect on cigarette smok- ing or other substance use behaviors; most program effects on cognitive risk factors had also disappeared by this time. Similar to the other longer-term follow- up studies, these outcomes indicated that program effects eroded rapidly when the program ended and that no effects on smoking behavior or related beliefs were detectable at a later time. E@fiz'e Educofiorlal Sfrafegies 72 Summary of Recent School-Based Research Studies These reports reflect a high level of consistency in approaches taken to prevent smoking initiation and in the results obtained. All studies used some form of multiple-session school curriculum that was based on the social influences model and was delivered through classroom activities beginning in the sixth or seventh grade; all included a similar set of core curriculum components; and all reported achieving significant differences in smoking behaviors for one year or more after the program was initiated. For most programs, significant differences were reported through the ninth grade (the first year of high school and more than two years after program initiation). Some specific features of these results strengthen the case for the effectiveness of school-based social influences curricula. The magnitude and scope of the effects achieved across studies were generally more impressive than those reported by earlier studies. The size of the reduction in smoking achieved at the eighth and ninth grades and the duration of these effects were larger than those of the short-term follow-up studies. Most of these studies also reported substantial effects on theory-based psychosocial mediators of cigarette smoking that were targeted for change by the pro- grams, such as relevant knowledge, attitudes, skills, and perceived norms. These results thus indicated important and persistent effects (at least for several years) across a wide range of outcomes anticipated by the theoretical approach. As discussed later in this section, however, the effects did not persist in the longer term. Programs that were successful in achieving pre- vention effects through the ninth grade tended to in- clude a larger number of educational contacts with students over a longer time period than most earlier programs. For example, Project ALERT included 11 class sessions over two years; SHOUT included 18 class sessions, four telephone contacts, and five newsletters over three years; the LST Program included 30 class sessions over three grades; and the KYB program in- cluded an even larger number of class sessions over six school years. These relatively intensive programs successfully deterred young people from smoking cigarettes and using other substances during the peri- ods that these curricula were provided. Comparable programs with smaller numbers of contacts over a more limited time have reported achieving a less sus- tained effect on smoking initiation (Biglan et al. 1987; Ary et al. 1990). These observations suggest a dose- response relationship between how much the students are exposed to the social influences program and how effective the program is in preventing students from smoking. These results suggest that larger numbers of educational contacts over a longer period of time may yield larger and more enduring smoking preven- tion effects. This conclusion is strongly supported by the long-term reductions in cigarette smoking preva- lence achieved by the relatively intensive LST Program. The results were also obtained within a wide range of curriculum formats. Some of the recent so- cial influences programs have tried to reduce the prevalence of several substance use behaviors often linked in the behavioral development of young people. These programs have included efforts within the same curriculum to prevent the use of smokeless tobacco, marijuana, and alcohol, as well as cigarettes. Includ- ing several substances in the program objectives, as might often be the case in ordinary school programs to prevent substance abuse, does not appear to have reduced the potential effectiveness of these programs in reducing cigarette smoking. In several cases, the positive effects on smoking behavior were also ob- served for other substance use behaviors. Similarly, social influences programs have been successful in diminishing smoking behavior when they have been incorporated in a larger health education program that successfully addressed other health behaviors, such as diet and physical activity. The success of programs under this broad diversity of curriculum formats in- creases confidence in the theoretical relevance and generalizability of this approach. These studies also tested the social influences model under various implementation conditions. Successful programs were reported from a diverse group of geographic areas and with urban, suburban, and rural populations. A much wider mix of ethnic student populations has been involved in these than in earlier studies. Some studies reviewed here have reported favorable program effects for African Ameri- can and Hispanic adolescents; similar programs have demonstrated positive effects for American Indian adolescents (Schinke et al. 1988, 1994; Moncher and Schinke 1994). Successful programs also used various personnel to deliver the programs. These included programs delivered by students' usual classroom teachers with or without intensive training, programs delivered with and without the assistance of peer lead- ers, programs delivered by college undergraduate or graduate students, and programs delivered by profes- sional staff members of the research team. These diverse characteristics of successful programs further support the generalizability of the social influences model. 72 Chapter 3 Reducing Tobacco Use The more recent studies can be interpreted with much greater confidence than was possible with the pioneering studies reviewed a decade ago because of improvements in study design, measurement, and data analysis methods. Internal validity has been im- ITroved by including larger numbers of schools and students in study samples to enable investigators to account for school-level effects on smoking behavior (Murray and Hannan 1990). This approach also has improved external validity by providing for tests of programs with more diverse populations and placing program activities farther from the direct control of the chief investigators. In general, these reports have thus provided stronger demonstrations than were pre- viously available of the benefits of social influences programs over other school health education programs for preventing smoking. The reports also provide greater assurances that the results obtained could be achieved in many types of classrooms if this curricu- lum approach was implemented with a reasonable level of fidelity. The primary limitation of this promising record of success is its generally short-lived nature. Three of the studies that followed participants through the 12th grade consistently found that effects had faded over the high school years. The fourth, the LST Program, demonstrated a statistically significant impact through the 12th grade (Botvin et al. 1995). Thus, although the majority of programs based on the social influences model did not permanently protect young people from pressures or desire to begin smoking, the evidence shows that all of these programs successfully delayed this initiation for several years and that the most in- tensive of these programs reduced smoking prevalence through the end of high school. These results demon- strate that larger-scale implementation of intensive in- terventions based on this model can achieve long-term reductions in cigarette smoking among young people. Further suggestions for overcoming this duration limitation may be drawn from these recent school- based studies. The studies provide evidence not only for the importance of overall program intensity, or the amount of exposure to the program (discussed earlier), but also for the effectiveness of programs that target a relatively broad array of educational modalities for smoking prevention. The LST Program addresses a spectrum of developmental concerns in addition to using a core unit on resistance to social influences that promote smoking; this curriculum has been shown to be effective with a wide range of populations. The KYB program achieved smoking prevention effects with a curriculum that was embedded in a larger program to change health behaviors. The SHOUT program included classroom-based community action and advocacy components in addition to conventional units based directly on the social influences model. Such broader approaches within school settings thus seem to be effective in addressing the diversity of smoking prevention needs among adolescents. This perspective receives additional support from a series of studies that have tried to identify more pre- cisely the strengths of the social influences model by testing main components separately. The design of the Project TNT program evaluation provided a direct comparison between the effects of four curricula focused on skills training for resisting peer pressures, on social norms about the prevalence and acceptabil- ity of smoking, on knowledge of the negative conse- quences of smoking, or on a combination of the three elements. Contrary to theory-based expectations, the social skills curriculum did not perform as well as the social norms or negative consequences curriculum; the combined curriculum had the best results (Sussman et al. 1993b). A similar study found that a curriculum based on correcting erroneous normative perceptions was more effective than a curriculum on training in resistance skills; the results also suggested that a com- bined curriculum addressing a variety of educational needs about social influences on smoking was more effective than curricula focused on individual compo- nents of the model (Hansen and Graham 1991). These studies thus indicate that attempts to reduce the scope of smoking prevention programs to skills training alone are likely to be ineffective. Al- though school programs are well suited to provide skills training through direct modeling and practice, as well as to convey knowledge about the conse- quences of smoking, they may not be as well equipped to influence young people's perceptions of the preva- lence and acceptability of cigarette smoking among their wider peer group and adult society. As is discussed in the next section, more complex and intensive programs combining interventions within and outside of schools may be needed to overcome the powerful prosmoking cultural images fostered by the larger social environment. Research on Multifaceted Programs Another group of recent studies has expanded the traditional school-based scope of educational methods to prevent smoking. To counteract the multiple sources of social influences that promote smoking initiation, these projects enlist the positive influences of parents, community organizations, Effectiw Educational Strategies 73 Surgeotz General's Report and the mass media in addition to offering strong school programs based on the social influences model. Relatively few examples of this new direction for smoking prevention efforts have been reported. Edu- cational objectives for these programs have generally been developed directly from programs that have school-based components only, but specific strategies reflect various approaches, as might be expected when new techniques are being developed. Results provide good evidence that these multifaceted educational programs can achieve substantial smoking prevention effects that persist throughout the high school years more consistently than programs based only in schools. Minnesota Heart Health Program: Class of 1989 Study The Class of 1989 Study of the Minnesota Heart Health Program (MHHP) tested the efficacy of a school- based smoking prevention program conducted in the context of a wide range of associated school and community programs designed to improve health behaviors. These programs focused collectively on the overall goal of reducing the risk of cardiovascular dis- ease among the adults of the targeted communities (Perry et al. 1992). Smoking prevention programs were provided in the seventh through ninth grades. The main compo- nent of this multifaceted effort was based on the Min- nesota Smoking Prevention Program (discussed in the previous section), which was one of the early success- ful designs for a social influences program (Perry and Jessor 1985). The Class of 1989 Study used a seven- session program delivered in weekly sessions during the seventh grade by peer leaders assisted by teachers (Perry et al. 1986). This program was followed by a two-session unit in the eighth grade that addressed smoking and exercise and by an eight-session unit in the ninth grade to prevent smoking and drug abuse. Similar curriculum units on eating and exercise behav- iors were added to the school curriculum after the smoking prevention unit in the seventh grade (Perry et al. 1988). These classroom components were supported in school by the development of health councils through which students participated in other projects related to the overall community program theme of cardio- vascular risk reduction. Altogether, the students in the Class of 1989 Study participated in five years of educational programs that were provided through their schools and were focused on smoking and other health behaviors. The school-based educational components were complemented and supported over the entire program period by community education and organization activities intended to reduce three cardiovascular risk factors-cigarette smoking, high levels of serum cho- lesterol, and elevated blood pressure-in adults of the targeted communities (Mittelmark et al. 1986; Perry et al. 1992; Luepker et al. 1994). The activities included individual risk factor screening and education, which was received by more than 60 percent of all adults; direct education sessions that were conducted in vari- ous community settings, which engaged more than 30 percent of all adults; food labeling education in gro- cery stores and restaurants; intensive mass media edu- cation; continued education of health professionals; and community organization to engage citizens, health professionals, and community leaders in developing and carrying out annual community education plans. Although the MHHP did not demonstrate a significant impact on adults (Luepker et al. 1994), a set curriculum and face-to-face training were found to increase the participation of teachers (Perry et al. 1990a). The effect of these interventions on the smoking behavior of the targeted students was assessed through an evaluation design in which students from one com- munity received these direct and indirect interventions and students from a matching community did not (Perry et al. 1992). At baseline, the target population consisted of all sixth graders attending the 13 elemen- tary schools in these two communities. Longitudinal analyses at each annual follow-up considered students who had been present since the baseline surveys. The 12th-grade survey included 45 percent of the original cohort of 2,401 students. Cross-sectional analyses in- cluded all students participating in each survey. Cohort analyses comparing weekly smoking prevalence and amount of smoking showed that students in the two communities did not differ sig- nificantly at the sixth-grade survey, which was admin- istered before exposure to any substantial amount of program activities. Significant differences appeared at the seventh-grade survey, which was administered af- ter completion of the core components of the smoking prevention program. Weekly smoking prevalence was about 40 percent lower in the treatment community co- hort. Similar effects were found in the cross-sectional analyses. These significant differences were maintained through the 12th-grade survey, three years after the end of direct smoking prevention education and one year after the end of general community education. This study was one of the first demonstrations in the United States that the effects of educational programs to prevent smoking could be maintained 74 Chapter 3 Reducing Tobacco Use through late adolescence-and thus, theoretically, through life. Longer-term community programs sup- porting these school-based components appeared to play a key role in maintaining positive effects. Midwestern Prevention Project The Midwestern Prevention Project (MN'), a three-year school-based program for preventing substance use, was supported by several community interventions explicitly designed for this purpose (Pentz et al. 1989a). The school program consisted of 10 classroom sessions in the sixth or seventh grade, (depending on the year of transition into middle school) and is the same as that reported by Hansen and Graham (1991). These sessions emphasized the negative consequences of cigarette, alcohol, and mari- juana use; corrected misperceptions on actual levels of use among peers and adults; discussed direct and indirect pressures to use substances; practiced skills to resist pressures for substance use; and obtained public commitments to avoid substance use. These activities were presented by classroom teachers with the assistance of peer leaders. Ten homework sessions that involved parents' participation accompanied the school program. These sessions. emphasized clarify- ing family rules on substance use, practicing tech- niques for avoiding substance use, and learning ways to counteract media and community influences to use substances. The mass media component of this pro- gram occurred throughout all three years of program effcrt and was equally available to program and con- trol group students. Media messages focused on news coverage of program activities through newspaper articles, brief television news segments, and radio and television talk show interviews with project staff. During the second year of the program (occur- ring in either the seventh or the eighth grade) for the target cohort, a five-session classroom booster program was combined with homework designed to keep par- ents actively engaged in prevention efforts (Pentz et al. 1989b). School administrators, parents, and stu- dents also planned and presented a parent education evening featuring communication skills and school policies on substance use (Rohrbach et al. 1995). Dur- ing the third year of the program, community leaders received training in organizing task forces to prevent substance use. This program component, like the media component, was equally capable of influencing students in the program or the control group (Johnson et al. 1990). The overall program was tested in 42 schools from eight communities in the Kansas City metropoli- tan area. About 21 percent of the students from these sixth- and seventh-grade target groups were from mi- nority ethnic groups. Students from the target grades in these schools were assigned to the school and par- ent cotiponents (24 schools) or to a delayed-treatment control condition (18 schools).. All students and par- ents were exposed to the mass media components and were potentially exposed to the effects of the com- munity organization component beginnirig with the third program year. Effects were evaluated by using a one-third sample of the large sixth- and seventh-grade target group. This study sample was obtained through baseline surveys of all targeted students in 16 schools and through a one-fourth sample from the remaining schools (total n = 5,065). Follow-up surveys combined sequential cross- sectional surveys, including all students present at a survey point, and longitudinal surveys of a subset of baseline cohort members. The. one-year follow-up sample- included 5,008 members of the target popula- tion, who.were then in the seventh and eighth grades. Monthly cigarette use was about 32 percent lower among students who had received the combined school, parent, and mass media programs than among students who had received the mass media informa- tion only. Similar effects were observed among the subset of students tracked longitudinally (Dwyer et al. 1989). Additional classroom .surveys were completed with 3,875 students two years after baseline, when the students were in the eighth and ninth grades (Pentz et al. 1989b). Significant program effects on monthly and weekly smoking prevalence were maintained from the one-year follow-up, although the magnitude of the dif- ferences between program and control students was smaller. Similar results were obtained from the panel of students measured longitudinally (Pentz et al. 1989~). The longitudinal panel from the original sample was followed up into the 9th and 10th grades (Johnson et al. 1990). The baseline sample included 1,607 sixth- and seventh-grade students, of whom 1,105 (69 per- cent) provided complete data at both baseline and the three-year follow-up. Analyses indicated a significant treatment effect for monthly cigarette smoking. Stu- dents receiving the entire program reported about 19 percent less monthly smoking than students who received only the mass media and community organi- zation components. Effcctiue Educational Strategies 75 University of Vermont School and Mass Media Project The University of Vermont School and Mass Media Project (VSMM) evaluated the effects of supple- menting a school-based smoking prevention curricu- lum with intensive mass media campaigns carefully targeted to the needs of adolescents. Both the school and the mass media programs shared a set of objec- tives consistent with the social influences model. These common objectives stated that adolescents exposed to the programs would perceive fewer advantages of smoking, perceive more disadvantages of smoking, acquire social skills to resist peer pressures to smoke, and perceive that most people their age do not smoke (Worden et al. 1988). Other objectives concerned with smoking cessation and awareness of tobacco industry marketing to young people were introduced as the tar- get group matured. The school program included grade-specific lesson plans and teaching materials, and classroom teachers received annual training. Curriculum con- tent covered key elements of the social influences model, such as short-term social and health conse- quences, awareness of social pressures to smoke, skills for coping with peer pressures and other social pres- sures, and decision-making skills related to smoking behavior (Flynn et al. 1995). The three-grade study cohort received this program for four years, in either the 5th-8th grades, 6th-9th grades, or 7th-10th grades. The program required four class sessions for the units in the 5th-8th grades and three class sessions for the units in the 9th and 10th grades. The mass media campaigns used the common objectives and data from high-risk young people in six predefined age and sex groups. High-risk students were defined as those who had previous smoking experience or who knew at least two people in their immediate social environment who smoked, such as parents, siblings, or friends. High-risk girls and boys from three age groups participated in diagnostic re- search activities on two occasions during the study to provide information needed to tailor the mass media campaign to their needs (Worden et al. 1988). These data were used to develop pilot mass media spots, which were assessed by small samples of high-risk students. Mass media advertisements that clearly ad- dressed the common educational objectives and were attractive to their intended target groups were pro- duced for broadcast as 30- and 60-second television and radio spots. Spots targeted to the six specific target groups were broadcast on programs that school survey data had indicated were popular among these groups; 36 television and 17 radio spots were pro- duced. An average of 190 television broadcasts, 350 cable television broadcasts, and 350 radio broadcasts of these spots was purchased per year for four years in each target community. The evaluation design included four geographi- cally separate but demographically matched metro- politan areas from three states (Flynn et al. 1992). Students in two communities received the mass me- dia and school programs for four years. Students in the other two communities received only the school programs during these four years. The initial cohort included all students from the fourth through sixth grades from 50 elementary and middle schools; more than 99 percent of these students (n = 5,458) partici- pated in the first school survey. Interventions and annual follow-up surveys were conducted for the next four years, beginning at the 5th-7th grades in the 1985- 1986 school year and ending at the Bth-10th grades. A classroom and telephone follow-up survey attempted to reach all original cohort members during the IOth- 12th grades. Results after four years of the program concen- trated on the 47 percent of the original cohort who were fully exposed to the program components (n = 2,540). These analyses indicated that significant hypothesized differences in mediators of program effects occurred in the media-school communities beginning at the end of the second program year and that the amount and prevalence of cigarette smoking were significantly reduced at the beginning of the third program year (Flynn et al. 1992; Worden et al. 1996). By the end of the four-year program period, alternative measures of smoking prevalence and intensity indicated that stu- dents in the media-school communities reported 34-41 percent less smoking than students in the school- only communities. Two years later, when the study cohort was in the IOth-12th grades, differences between smoking prevalences in the two groups con- tinued to be statistically significant and of similar mag- nitude (Flynn et al. 1994). Among students who were at high risk for smoking in grades 4-6, further analy- ses showed that these interventions produced signifi- cant differences in weekly smoking prevalence at grades lo-12 (Flynn et al. 1997). Cost-effectiveness analyses indicated that the cost per student smoker averted as a result of these interventions was about $754 in 1996 dollars, and the cost per life year gained was about $696 (Seeker-Walker et al. 1997). These findings show that carefully targeted mass media campaigns can add to school programs a sub- stantial and enduring effect on smoking prevention when the program efforts are sufficiently intensive 76 Chapter 3 and the educational objectives for these two channels are closely coordinated. These interventions did not include a substantial program component directed to- ward parents or other adults in the community. The results provide powerful evidence of the influence of mass media messages on health behavior decisions made by young people. Observations on Research on Multifaceted Educational Programs These studies are notable because they all repre- sent efforts to extend the impact of school programs by enlisting the influence, preferably throughout ado- lescence, of other polrerful forces in the lives of young people and because their effects more consistently ex- ceed those achieved by programs in\rolving only the school (Table 3.1). This notion has added importance in view of the competition for curricular time ~\.ithin schools. The studies that M'ere able to follo\v up studv participants into the later high school years ha\re prd- vided the best evidence thus far that program effects can be extended when educational or other prel~en- tion strategies include multiple components and take place over longer terms. Because fen- people begin smoking after high school, these results suggest that long-term multifaceted programs can prevent signifi- cant proportions of young people from smoking not only during their junior and senior high school years but also for the rest of their lives. The interventions used in these three studies were based on a common core of approaches. The main shared theme was that a strong school program was necessary to achieve substantial effects. The school component of the MHHP included 17 class sessions explicitly directed toward smoking prevention objec- tives over three school years; the MPP school program included 15 class sessions over two school years, as well as other school-based student activities; and the VSMM included 14-16 class sessions over four school years. The intensity of these school programs was simi- lar to the intensity of successful school-only programs and approached that recommended by experts (Glynn 1989; CDC 1994b). A related theme was use of the so- cial influences model in designing programs. The re- search groups that developed the MHHP and the MIT included investigators who were key contribu- tors to the development of this model for school-based programs. The design of the VSMM program compo- nents also closely followed this model. The third shared theme for these studies was their focus on entire communities. The MHHP was pro- vided to, and evaluated in, all schools in a single moderate-sized community and \vas supported by communitywide mass media and organizational pro- grams. Some components of the MPP M'ere provided to students, parents, and community members in an entire large metropolitan area. The VSMM was pro- vided to adolescents in two entire moderate-size metropolitan areas, and the same large groups were the focus of targeted media campaigns. The educa- tional messages of the school-only programs, in con- trast, generally did not reach beyond the walls of the selected school. Directing messages to entire commu- nities of adults and adolescents may have increased the capacity of multifaceted studies to influence ado- lescents' normative perceptions of the prevalence and acceptability of cigarette smoking. The importance of the school component was emphasized by results of a study conducted Lvithin the context of the Stanford Fi\.e-City Project. This study shared M'ith the MHHP the goal of reducing car- diovascular risk factors in entire adult populations and shared many features of the programs for adults (Farquhar et al. 1990). The adolescent smoking feature of this study assessed whether reductions in cigarette smoking among adults (Fortmann et al. 1993) M'ere reflected among adolescents. A seven-session smoking prevention program was provided to ado- lescents in 7th and 8th grades during the fourth pro- gram year (Telch et al. 1982; Winkleby et al. 1993), and a four-session cessation unit was provided to half of the IOth-grade classes (Killen et al. 1988). The effect of this combination of programs was assessed through cross-sectional population surveys conducted over a lo-year period. No statistically significant differences in smoking prevalence were detected among partici- pants aged 12-15,16-19, or 20-24 years. The duration of the community programs in the MHHP was one year less than that of the Stanford study. The school programs in the MHHP, however, were much more intensive and of longer duration. Although differences in evaluation methods preclude direct com- parisons, results suggested that the MHHP's substan- tial impact on the smoking behavior of adolescents in the Class of 1989 Study depended on the presence of a strong school-based program that was enhanced by the supportive community environment in which it was conducted. The Stanford study's lack of effects on ado- lescents suggested that intensive, communitywide pro- grams to reduce health risks among adults would not be sufficient to change adolescent smoking unless these programs were combined with more intensive school programs. These contrasting results affirm that a strong school program is important to the succe~ of educa- tional strategies for prevention. The MHHP community activities were not spe- cifically designed as smoking prevention programs; they were directed toward adults and addressed sev- eral cardiovascular risk factors in addition to smok- ing These efforts to reduce adolescent smoking may have resulted because young people were directly exposed to community program messages and appeals intended for adults, school programs had heightened intensity from being conducted in communities focused on developing healthy behaviors, or parents stimulated by the community programs gave greater attention to adolescent health behaviors. The inten- sity, pervasiveness, and duration of the community program may also have affected the general norms of the community on health behavior, which in turn may have influenced young people to decide against start- ing to smoke. Similar results were obtained by another youth smoking prevention study conducted in the context of pervasive community cardiovascular risk reduction campaigns. The North Karelia Youth Project in Fin- land included a school program with three sessions in grade seven, five sessions in grade eight, and two ses- sions in grade nine (Vartiainen et al. 1998). Intensive community programs on cardiovascular risk reduction were conducted for adults, including community organization and mass communication campaigns for cigarette smoking cessation, during the years the school program was delivered. Significant differences in cigarette smoking prevalence between young people in the intervention and comparison areas were found at each follow-up survey through age 21. At age 28, significant differences in smoking prevalence were found among those who were nonsmokers at the baseline survey, in seventh grade. These results pro- vide strong support for the findings of the MHHP Class of 1989 Study and emphasize the potential impact on youth smoking of combining school and community programs. The community component of the MPP was ex- plicitly designed to complement the school program to prevent substance use. Program activities that oc- curred outside the classroom were more focused on parents' behaviors than is usually found in research studies on smoking prevention. These activities in- cluded 10 homework exercises in the first program year and a wide range of family norm-setting activities; similar exercises accompanied the second year of the school curriculum. Parents helped plan and present a parent education evening in participating schools in the second year and participated in community orga- nization activities in the third year. The only program components to directly reach or involve the wider community were the media mes- sages and community organization activities. The latter component was not introduced until the third program year and may not have had much effect on students' smoking behaviors. Because parents, then, were the principal focus of educational efforts outside the classroom, the MPP effects were likely achieved mainly through strong and consistent parental sup- port of the objectives of this school-based program. The media messages may also have influenced ado- lescents' perceptions of peer, family, and community smoking norms. Results of the MPP, the MHHP, and the North Karelia Youth Project thus offer the possible common interpretation that the programs' effects depended on strong school programs supported by community pro- grams that may have affected students in two ways: through substantially increased efforts by parents and through young people's perceiving that smoking is not normative. Although parental components similar to the MPP homework assignments have been included in some school-only smoking prevention programs, the full scope of parent-oriented efforts used by the MPP in support of the school curriculum has not been tested previously. Further exploration of combined school and parent programs may be a promising avenue for future educational research studies. Similarly, these results highlight the importance of program compo- nents designed to influence adolescents' normative perceptions. The VSMM shared with the MPP and the MHHP the general strategy of supplementing a relatively strong school-based smoking prevention program with other forms of intervention but differed in several respects. The combined school and mass media pro- gram in the VSMM was directed toward the target ado- lescents, and no adult participation was anticipated outside of the classroom. The project's resources thus were applied to influencing adolescents' smoking behaviors directly through changes in the students' beliefs, skills, and perceived norms. The VSMM also differed in focusing on use of the mass media as a sole supplement to the school pro- gram. This design provided a reasonably clear indi- cation that the magnitude and duration of a relatively strong school curriculum to prevent smoking could be significantly increased by a mass media component that concentrated exclusively on the target audience of adolescents. Three other large-scale tests of mass media ap- proaches to smoking prevention have been reported. One study conducted in North Carolina tested three 78 Clmpfrr 3 Reducing Tobacco Use mass media campaigns that were not combined with school-based programs (Bauman et al. 1988). The media campaigns included radio spots on the expected consequences of smoking, a similar radio campaign that featured a smoking prevention contest, and the radio and contest components with television spots added. The messages were broadcast during three four-week periods at levels intended to reach 75 percent of the target audience four times during each period. Each campaign was conducted in two metro- politan areas; four other communities served as control areas. Adolescents aged 12-14 years were in- terviewed through household surveys at baseline (n =.2,102); 78 percent of them were followed up 11,17 months later. Results indicated that the campaigns had effects on the recipients' knowledge of the conse- quences of smoking and other mediators but not on cigarette smoking behavior (Bauman et al. 1991). In the Television, School, and Family Smoking Prevention and Cessation Project (TVSFP), Flay and colleagues (1988, 1995) tested a mass media supple- ment to a school program. The study design was similar to that used in the MPP. The main study was conducted in a single metropolitan area. The mass media component was generally available to members of the community, and the school program was offered only to members of the main treatment group. The main research question thus addressed whether a school program combined with a mass media cam: paign had a stronger effect than the mass media campaign alone. The school curriculum included 10 classroom sessions delivered by trained health educa- tors during the seventh grade. The media component included segments that ran for two months in evening television news shows that were linked to the class- room sessions. Students in the main intervention con- ditions were asked to view these segments with their parents and to complete related homework activities together. Seventh-grade students from 47 schools par- ticipated in the study; they were surveyed during the seventh, eighth, and ninth grades. Program effects were observed in the follow-up surveys for mediating variables but not for smoking behavior. More promising results have been reported for a three-year mass media campaign on youth smoking in Norway (Hafstad et al. 1997). This campaign used the novel approach of creating messages intended to stimulate antismoking interactions among young people through use of provocative messages that pre- sented starkly negative images of adolescent smokers. Unlike other mass media approaches, these messages were presented as movie and newspaper advertise- ments and posters, as well as through broadcast media channels. Messages were broadcast or placed at a relatively high level of intensity over one three- week period each year for three years. Message themes were varied each year. The impact of these campaigns was evaluated over three years by comparing baseline and follow-up survey results among a cohort of 11,033 young people aged 14 and 15 years for one interven- tion county and one control county. Results showed that young people from the intervention county were less likely to start smoking and more likely to stop smoking at the follow-up survey. This study demon- strates the potential impact of relatively intensive, highly targeted mass media smoking prevention cam- paigns that are not combined with any other type of smoking prevention intervention. Results of these studies using mass media as a primary educational strategy suggested that better outcomes were associated with more intensive, multi- faceted program efforts on social influences. The TVSFP intervention included a substantial school curriculum for the seventh grade but did not include further sessions in later grades. The mass media campaign included a maximum of 10 exposures over a two-month period. The North Carolina study did not include a direct component for interpersonal edu- cation; the media component for this study did not directly address social influences on adolescent smok- ing and was delivered over a total period of three months. These program efforts contrast sharply with the three-year Norwegian media campaign and the 14- to 16-session school program combined with a mass media campaign delivered over four years in the VSMM. Because only relatively brief individual messages about cigarette smoking can be delivered to adoles- cents through the mass media, it is reasonable to hypothesize that behavioral effects can be achieved only when the media spots run frequently and over many months. Other evidence discussed here indi- cates that these types of media campaigns are most likely to be effective when combined with some form of coordinated interpersonal education, such as school- based smoking prevention programs. The VSMM results thus align with those of the MHHP and MPP in supporting the importance of school programs. The VSMM also directly targeted normative perceptions in its school and media components and demonstrated positive changes in these mediators of adolescents' smoking behaviors. Several guidelines for designing future educa- tional efforts to prevent smoking can be drawn from this review of three successful multifaceted programs. The central role of school programs in E~fectiw Educatiorzal Strategies 79 smoking pre\.ention education ~`as atfirmed by the results of all three studies. The MHHI' and the MPP results both suggested the potter of influencing ado- lescents' perceptions of cigarette smoking norms through community programs that enhance the effect of school programs; the MPP results demonstrated the effectiveness of parents' participation as a specific strat- egy for enhancing school prevention programs; and the VSMM demonstrated that long-term mass media campaigns targeted to adolescents' beliefs, skills, and Diffusing Programs to Prevent Tobacco Use perceived norms could enhance the effect of school programs. On a cautionary note, the theoretical and dem- onstrated ability of these programs to alter the smok- ing behavior of young people must be viewed in the larger context of their practicality. As noted earlier, the ability to disseminate such programs has been a matter of active public health engagement. The following section examines the current status of such dissemination. In the mid-1990s, several surveys were under- taken to assess the extent to which national guidelines for tobacco pre\:ention in schools (CDC 1994b) were being implemented. One of these, the School Health Policies and Programs Study (SHPPS), queried state and local education districts directlv about their ad- herence to guidelines (Collins et al..1995). A second survey used health department tobacco coordinators as the primary information source about tobacco pre- vention programs in schools (J.K. Worden and B.S. Flynn, Tobacco use pre\.ention education in the United States, 1994, unpublished data, September 1995). National Guidelines According to the CDC's "Guidelines for School Health Programs to Prevent Tobacco Use and Addic- tion" (CDC 1994b), all schools should, for developmen- tally appropriate ages, provide instruction about the short-term and long-term negati\,e physiological and social consequences of tobacco use, about social influences on tobacco use, about peer norms regard- ing tobacco use, and about refusal skills. Local school districts and schools are advised to "re\+ew these con- cepts in accordance with student needs and educa- tional policies to determine in which grades students should receive particular instruction" (CDC 1994b, p. 9). The guidelines recommend that students in kin- dergarten through the 12th grade receive curricula for pre\renting tobacco use. Because tobacco use often begins in the 6th-8th grades (USDHHS 1994), more intrnsi\re instructional programs should he provided in these grades, and students should rtxcei\,e annual pre\,cntion education thereafter through the 12th grade. The guidelines also recommend that programs include support from families, support from commu- nity organizations, tobacco-related policies, and adver- tising campaigns for preventing smoking, because school-based efforts appear to be enhanced by comple- mentary programs in the community. Finally, an on- going assessment should monitor whether an adequate tobacco education program is being maintained. School Health Policies and Programs Study The SHPPS survey, in a follow-up to a similar sur\`ey conducted by the American School Health As- sociation in 1989, examined state-, district-, school-, and classroom-level data (Collins et al. 1995). SHPPS ex- amined specific instruction provided in six critical ar- eas: intentional and unintentional injury, alcohol and other drug use, tobacco use, sexual behaviors, dietary patterns, and physical activity. The education agencies in all 50 states and the District of Columbia, a national sample of 413 school districts, a national sample of 607 middle/junior and senior high schools, and 1,040 randomly selected health education teachers were sur- veyed. State and district data were collected with self- administered questionnaires mailed to the person most knowledgeable about or responsible for each compo- nent of the school health program. School and class- room data were collected through on-site personal interviews with lead health education and classroom teachers. The multiple levels of data collection were necessitated by the embedded tradition of local control in determining educational requirements and content of instruction. The data from SHPPS are most clearly assessed bv their relationship to the CDC guidelines. Reducing Tobacco Use Guideline: All schools should develop and enforce a school policy on tobacco use. Policies should prohibit tobacco use by all students, stnff, and visitors during school-related activity. Almost two-thirds of schools had smoke-free building policies in place in 1994, though significantly fewer (37 percent) had prohibited the use of tobacco products by all persons on school property, in school vehicles, and at school-sponsored functions away from the school site. Most schools (83 percent) prohibited tobacco use by athletes and coaches during school- sponsored events, and most (89 percent) provided writ- ten copies of the policy to students, staff, and parents. Schools were significantly more likely to have used exclusively punitive consequences (58 percent) in response to the most recent violation of their school's tobacco use poiicy than exclusively remedial conse- quences (2 percent) or a combination of punitive and remedial consequences (30 percent); few (8 percent) invoked attendance at a tobacco use prevention pro- gram as remediation for violations. Only 30 percent of schools offered tobacco cessation services in or through the school. Guideline: All schools should provide tobacco prevention education in kindergarten through 12th grade. The instruc- tion should be especially intensive in middle and junior high school and reinforced i/r high school. In 1994, tobacco use prevention education was required in 37 states (72 percent) and in 83 percent of school districts. At the school level, 91 percent of middle/junior high schools and 82 percent of senior high schools included tobacco use prevention educa- tion in a required course. However, only 55 percent of middle/junior high school teachers and 47 percent of senior high school teachers of health education re- ported tobacco use prevention as a "major" topic in their courses. Of the middle/junior and senior high school teachers who included tobacco use prevention education as a major topic, only 21 percent spent six or more class periods on the topic. Guideline: Schools should provide instruction about the immediate and long-term consequences of tobacco use, about social norms regarding tobacco use and the reasons why adolescents say they smoke, and about social influences that promote tobacco use. Schools should provide behavioral skills for resisting social influences that promote tobacco use. Of the approximately 50 percent of teachers who taught tobacco use prevention as a major topic, 74 percent taught both short- and long-term effects of cigarette smoking. Fewer (61 percent) taught both short- and long-term effects associated with using smokeless tobacco. Although 61 percent of teachers addressed group attitudes (i.e., social norms) about tobacco use, only 42 percent taught about the actual amount of smoking and tobacco use among adoles- cents and adults. Less than half (48 percent) of this group of teachers provided instruction about "healthy alternatives" to tobacco use. Sixty-eight percent in- cluded instruction on social influences. Most teachers taught behavioral and social skills, though it is unclear if these skills were taught specifically within the context of tobacco use prevention education. For ex- ample, 89 percent of teachers taught decision-making skills, 87 percent taught skills for resisting social pres- sures, 81 percent taught communication skills, and 78 percent taught goal-setting skills. Guideline: lmproue curriculum implementation and overall program effectiveness. In 1994, 82 percent of states had offered in- service training on teaching tobacco use prevention during the past two years. However, only 24 percent of school districts had offered in-service training on tobacco use prevention. Consequently, it is not sur- prising that only 9 percent of teachers of health edu- cation received training on tobacco use prevention education during the same time period. Although state-level training is typically designed for district staff, district-level training is the most common source of training for teachers. Increased training opportu- nities for teachers are needed to improve the effective- ness of tobacco use prevention education. The 1994 SHE'S data were analyzed to examine the extent to which U.S. schools were implementing the CDC's "Guidelines for School Health Programs to Prevent Tobacco Use and Addiction" (Crossett et al. 1999). Although data do not exist in SHPPS that spe- cifically assess adherence to each of the six recom- mended program areas, three criteria were selected that reflect a "comprehensive" approach to tobacco use prevention (Crossett et al. 1999): (1) a tobacco-free policy consistent with CDC guidelines, (2) at least one teacher who taught tobacco as a major topic and cov- ered four essential content areas (short-term health effects, groups' attitudes toward tobacco, social influ- ences, and life/refusal skills), and (3) access to tobacco cessation services for students. Only 4 percent of middle schools, junior high schools, and high schools nationwide met all three criteria. Twenty-six percent met two of the three criteria, and 41 percent met one of the three. More than one-fourth of schools (29 per- cent) met none of the three criteria. This analysis is Effective Educational Sfrategies 81 limited, because not all of the CDC guideline recom- mendations could be measured directly by SHPPS. Nevertheless, these findings indicated that very few schools were fully implementing the CDC recommen- dations in 1994. Schools are faced with many competing demands for instruction and classroom content. Currently, most of this nation's schools are providing students with some basic tobacco use prevention education. How- ever, the recent increases in tobacco use prevalence among youth and the overwhelming documentation of the health consequences of tobacco addiction em- phasize the need for improvement in what schools are doing to reduce tobacco use and nicotine addiction among their students, faculty, and staff. A State-Based Assessment To estimate current program activity in smoking prevention education across the United States, tobacco control coordinators in all 50 states and the District of Columbia were asked to participate in a survey (Worden and Flynn, unpublished data; unless other- wise noted, cited data in this section are derived from this survey). The position of tobacco control coordina- tor was established to oversee tobacco control and edu- cation efforts in each state health department, through either the American Stop Smoking Intervention Study (ASSIST) program of the National Cancer Institute (NCI) (Shopland 1993) or the Initiatives to Mobilize for the Prevention and Control of Tobacco Use (IMPACT) program of the CDC (USDHHS 1995). The survey was conducted between December 1994 and March 1995. The tobacco control coordinators were asked to describe any educational programs to prevent tobacco use-including school, community, and mass media activities-that were being imple- mented in their state during 1994 and to send writ- ten descriptions or examples of materials used in these programs. This survey differed from SHPPS in its primary reliance on health department rather than education department personnel and in the absence of a multilevel sampling approach. The state-based survey, on the other hand, focused more on the types of materials used. Basic Curriculum The state-based survey determined that school systems were generally left to create their own tobacco use prevention programs or to decide which of several available commercial programs would be imple- mented. Examples such as Here's Looking At You, 2000 or the LST Program (Bosworth and Sailes 1993; Glynn 1994) were mentioned by a few of the states. A number of states had implemented some school-based educational programs on tobacco use that wer,= supple- mental to statewide school curricula. Among the supplementary programs, the most popular was Teens As Teachers (American Nonsmokers' Rights Founda- tion 1994). Reported in 10 states, this program trains older high school youth to discuss with younger students the physiological and social consequences of tobacco use. The older youth also may convey the accurate norm that most young people do not use to- bacco. Six states reported using the Tar Wars program, in which medical professionals discuss the conse- quences of tobacco use with junior high school students (Tar Wars 1995). Save a Sweet Heart, a program that emphasizes social influences on tobacco use for junior high school and high school youth (American Heart Association 19891, was reported in three states. Spo- radic use was reported for several other programs, in- cluding Growing Healthy"; Teenage Health Teaching Modules, a version of D.A.R.E. that includes tobacco use prevention; the Minnesota Smoking Prevention Program; and a curriculum developed at the Univer- sity of Vermont (Bosworth and Sailes 1993; Gerstain and Green 1993; Glynn 1994). In several states, either a vol- untary health agency or a community or school group originated its own supplement to a school program. Supplemental Programs During 1994, two states-Massachusetts and Cali- fornia (see Chapter 7)-were particularly active in developing and implementing supplemental programs (i.e., in addition to statewide curricula1 using mass media in smoking prevention. Although smoking prevention was one of several aims of the generic me- dia campaigns funded through tobacco tax revenues in each state, the topic was clearly emphasized in a set of media spots specifically targeting youth in 1994 in each state. The Massachusetts campaign was compre- hensive; seven messages addressed various topics suggested in the CDC guidelines (Massachusetts De- partment of Public Health 1994). The 1994 California campaign used seven television spots and six radio spots to describe the physiological consequences of smoking. Using humorous vignettes, the campaign identified toxic substances in cigarette smoke, such as arsenic, formaldehyde, ammonia, methane, and dichlorodiphenyltrichloroethane (DDT). On a smaller scale, supplemental efforts with comprehensive coverage also occurred in West Virginia and in Denver, Colorado. In West Virginia, through a Reducing Tobacco Use contest sponsored by the American Cancer Society, four winning scripts for radio spots on smokeless to- bacco use and on environmental tobacco smoke were selected from more than 300 entries from students in kindergarten through the 12th grade. The spots were broadcast on 22 stations and included several topics, although the only one related to the CDC guidelines concerned the physiological consequences of tobacco use. In Denver, a three-month billboard campaign promoted the theme "Smoking Doesn't Add Up," which suggested the financial consequences of tobacco use (Colorado ASSIST Alliance 1994). Programs Including Families Only two states reported large-scale supplemental programs that included families: New Jersey in its community grants programs and Oregon in a program entitled Parenting for a Positive Future. Three other states reported using the Unpuffables program, which requires parents' participation and includes the topics of social influences and refusal skills (Perry et al. 1990b). It should be noted, however, that this estimate of parental involvement is likely to be low, since districts and schools, which vary considerably in the degree to which they involve parents in school activi- ties, were not queried directly. Community Programs In general, virtually no states reported community organization programs dedicated to supplementing educational programs to prevent tobacco use. Several programs-including the Kids Against Tobacco program, which involved 5,000 young people in northwestern Louisiana-combined tobacco education and advocacy, but the main emphasis was on inspiring young people to advocate against tobacco use. Combined Activities At the time of the Worden and Flynn survey, only Pennsylvania reported combining a mandated school curriculum with supplemental school, community, and mass media programs in an educational strategy to prevent tobacco use. The statewide Youth Against To- bacco program was sponsored by the state's health and education departments along with the American Can- cer Society and the Pennsylvania Medical Society. These sponsors asked community organizations throughout the state to participate in the program, which ran from 1992 through 1995. More than 175,000 young people in 47 counties participated with local Boy Scouts and Girl Scouts, Boys' &Girls' Clubs, health organizations, Students Against Driving Drunk, D.A.R.E., and other groups. Community events in- cluded the 1994 Farm Show, in which 8,444 young people pledged not to smoke. The 1994 mass media program included a rap radio message aired by 223 stations in January and 280 stations in June. Declar- ing it "not cool" to smoke, the message described the social consequences of smoking (Pennsylvania Depart- ment of Health 1992). Monitoring Program Objectives Only Vermont reported having a system in place to annually assess school program activity. Act 51 stipulates that schools in Vermont annually report the number of schools implementing a curriculum. In 1994, 219 schools reported using the Here's Looking At You, 2000 program, 25 used the LST Program, and 19 used other programs (Glynn 1994). Arkansas, In- diana, Missouri, Pennsylvania, and Rhode Island were able to report the estimated number of students re- ceiving specific programs run by voluntary agencies or local school districts. For example, Indiana reported that 15 percent of its students received the Growing Healthy program. Interpreting the Diffusion Process Because of the methodological differences, the results of SHPPS cannot be compared directly with those of the state-based survey conducted by Worden and Flynn. In particular, it is likely that the latter underestimated the type and amount of tobacco use prevention activity that may have been occurring on the local level. The two surveys concurred, however, in their overall assessment: considerable progress has been made, but comprehensive school health educa- tion can be improved in some areas, including tobacco use prevention. SHPPS, which focused on multiple activity levels, concluded that few schools met all the major criteria provided in the CDC guidelines (CDC 1994a; Crossett et al. 19991. As a result of its focus, the state-based survey concluded that optimal use had not yet been made of the available research on multichan- nel methods for maximizing the impact of school health education programs for tobacco use prevention. Thus, the review of reported program activity in 1994 indicated that we are far from attaining an ideal, national level of educational programs to prevent to- bacco use. By one set of criteria, only 4 percent of the middle, junior, and high schools in this nation were Effective Educatioml Str-ategics 83 meeting three criteria of a comprehensive tobacco use prevention program in 1994 (Crossett et al. 1999). Sev- eral reasons have been offered for this shortcoming at the time. One reason is that the year 1994 fell between two periods that may have been more active. The first period was the late 1980s and early 199Os, when the states of Minnesota and California were implement- ing large-scale campaigns to reduce tobacco use that were financed by tax revenues from cigarette sales. For a brief time, Michigan also developed mass media spots for preventing smoking among adolescents. Resources for these efforts apparently shrank (Begay et al. 19931, and the campaigns faded by 1994. A sec- ond period, which follows the 1994 activities reported here, arguably began with the 1994 publication of the Surgeon General's report Preventing Tobacco Use Among Young People (USDHHS 1994). That report seems to have stimulated development of a new set of guide- lines. In addition, by this time all states had received support to coordinate their education and policy efforts to reduce tobacco use. This support came through the ASSIST program, which began such activities as early as 1991, and through the IMPACT program, which supplemented ASSIST coverage. Therefore, 1994 may represent an interregnum in the enthusiasm for tobacco prevention education. This view is supported by the events of the late 1990s. The major legal and legislative activities (see Chapter 5) were instrumental in mobilizing several states to intensify multichannel efforts at tobacco prevention (described in detail in Chapter 7). A second reason is that there has been little evidence that the community-based approaches to prevent tobacco use that have been shown to be effec- tive in controlled research studies have been adapted effectively to statewide use. Two states, California and Minnesota, have attempted some evaluation of community-based programs to prevent smoking on a statewide scale. In both cases, marketing research tech- niques similar to those described as diagnostic and formative research in the VSMM (Worden et al. 1988, 1996) were applied in developing mass media cam- paigns. Several creative messages for preventing smoking were developed in each state, but the num- ber of messages dedicated to young people was limited; exposure also was limited, because paid ad- vertising slots were allocated to target groups of adults as well as youths (Kizer et al. 1990; Minnesota Depart- ment of Health 1991). Although awareness of each of these campaigns appeared to be high among adolescents, there was no reduction in smoking behavior (Murray et al. 1994; Pierce et al. 1994; Popham et al. 1994). Part of the difficulty may have been the absence of a sufficiently strong school-based program having similar educa- tional objectives. It is also possible that, with funds divided to reach many targeted groups, the media could not be concentrated sufficiently on smoking pre- vention among youth to have a measurable effect. A third reason is that programs implemented on a day-by-day basis over the years often lack the essen- tial ingredients for success that were evident when they were created and evaluated by researchers. To be ef- fective, programs should be taught as designed (Rohrbach et al. 1993). For many curricula, teachers require training-if not to encourage adoption of the program, then at least to ensure that the curriculum is correctly and completely delivered (Perry et al. 1990a; Smith et al. 1993). Many teachers are resistant to train- ing (Brink et al. 19911, and teachers who smoke may be particularly uncomfortable with a curriculum that discourages smoking. Such resistance may not affect the quality of a brief, single-pronged program format, such as the Smoke Free Class of 2000, but may jeopar- dize the integrity of more long-term and comprehen- sive curricula. It also has been found that a school system's decision to use a curriculum is simply not enough to ensure successful implementation; teach- ers should be brought in at the earliest stages of adop- tion (Rohrbach et al. 1993). Teachers and school administrators with prior experience in tobacco use prevention education should be involved in orienting and inspiring other teachers, who will then be more likely to deliver the curriculum faithfully and effec- tively (Smith et al. 1993). Successful implementation also depends on the size of the school organization; smaller organizations are more likely to adopt new programs quickly, whereas larger organizations are more likely to maintain a program once it is adopted (McCormick et al. 1995). A fourth reason is that there appears to be a short- age of linking agents, who have been found to be essential for maintaining educational programs to pre- vent tobacco use (Dijkstra et al. 1993) and have been recommended in several diffusion studies (Brink et al. 1991; Goodman et al. 1992; Rohrbach et al. 1993). Link- ing agents are persons or groups that have a strong incentive for maintaining a program and promoting its continuation by consistently and faithfully coordi- nating all of the necessary resources for implementa- tion. Potential candidates for local linking agents are school health teachers, principals, volunteers, and health professionals; each could ensure that school curricula include a strong component for preventing tobacco use, much as local voluntary agencies have supported the Smoke Free Class of 2000 effort (Brink 84 Chapter 3 Reduchg Tobacco Use et al. 1991). These individuals, working through a coalition, could also coordinate community program efforts involving families, community organizations, and mass media. On a state level, the natural linking agents would be the tobacco control coordinators, who could work through coalitions or other state agencies to accom- plish several long-term, comprehensive aims: (1) es- tablish legislation mandating school-based tobacco use prevention with guidelines specifying effective cur- ricula; (2) establish a curriculum training program, through the state education department, that would involve school administrators and teachers in the on- going implementation of school-based curricula to prevent tobacco use; (3) establish a monitoring and support system to determine the penetration and qual- ity of programs throughout the school system and improve instruction with ongoing teacher training; (4) work with parents' groups and volunteer organi- zations to support the school program; and (5) work Jvith interested citizens to place media messages that support each of the content areas recommended by the CDC guidelines. On a national level, linking agents could be agen- cies, such as the NC1 or the CDC, that could support local and state efforts to reduce tobacco use with funding and continued coordination, such as by regu- larly convening state coordinators to share program ideas. These national linking agents might focus their diffusion efforts on using the mass media, because youth in different markets respond equally well to media-based messages for preventing tobacco use (Flynn et al. 1992). Considerable opportunity exists Conclusions for enhanced diffusion of programs that have demon- strated effectiveness (Parcel et al. 1989a,b, 1995; O'Hara et al. 1991; Brink et al. 1995; Parcel 1995; McCormick and Tompkins 1998; Siegel and Biener 2000). As an example of such diffusions, the CDC's Division of Adolescent and School Health initiated the Research to Classroom project. Through this project, CDC iden- tified programs with credible evidence of effectiveness in reducing health risk behaviors among young people. So far, CDC has identified curricula for sexuality and tobacco use prevention. The CDC staff review elec- tronic databases, literature reviews, meta-analyses, and reports to identify evaluation studies that meet the criteria for consideration in the Research to Classroom project. Two external panels, one of evaluation experts and the other of program experts, review the curricula and their evaluations. If both panels recommend adop- tion of the curriculum, based on attainment of identi- fied criteria, CDC designates the curriculum as a Program that Works. The Research to Classroom project identified Project Tozmrds No Tobacco Use and Lift Skills T~~irii~zg as appropriate tobacco use preven- tion curricula. Research to Classroom also provides information and training on these curricula for inter- ested educators from state and local education agencies, departments of health, and national nongov- ernmental organizations. The CDC identifies and disseminates information on Programs that Work to help inform local and state choices. The choice to adopt a curriculum ultimately rests with local deci- sion makers and must address community standards and needs. Educational strategies, conducted in conjunction with community- and media-based activities, can postpone or prevent smoking onset in 20 to 40 percent of adolescents. Although most U.S. schools have tobacco use pre- vention policies and programs in place, current practice is not optimal. 3. 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Health Education Quarterly 1996;23(4):453-68. 94 Chapter 3 Chapter 4 Management of Nicotine Addiction Introduction 97 Methods for Managing Nicotine Addiction 100 Self-Help Manuals 100 Efficacy ZOO Relevant Process Measures 201 Summary 102 Minimal Clinical Interventions 102 Efficacy 204 Relevant Process Measures 105 Summary 105 Intensive Clinical Interventions 105 Problem Solving/Skills Training 106 Rapid Smoking 207 Other Aversive-Smoking Strategies 108 Cue Exposure 108 Nicotine Fading 2 09 Motivational Rewards 110 Social Support 12 0 Weight Control 211 Hypnosis 112 Acupuncture 222 Summary of Intensive Clinical Interventions 122 Pharmacologic Interventions 113 Nicotine Polacrilex 123 Transdermal Nicotine 116 Nicotine Nasal Spray 118 Nicotine Inhaler 220 Bupropion 2 2 1 Clonidine 222 Nortriptylene 223 Other Antidepressants and Anxiolytics 124 Summary of Pharmacologic Interventions 124 Large-Scale Public Health Programs 125 Media-Based Programs 125 Worksite Programs 226 Community Programs 227 Statewide Programs 128 Summary of Large-Scale Public Health Programs 128 Contemporary Issues in Research on Tobacco Addiction 128 Epidemiologic Concerns and Clinical Issues 2 28 Nicotine Dependence 229 Stages of Change 229 Negative Affect 130 Conclusions 1 .i4 References 1.3.7 Reducing Tobacco Use Introduction Preventing tobacco addiction among young people and promoting abstinence among current smokers are the final common denominators for pub- lic health strategies to reduce smoking prevalence. Al- though prevention efforts are increasingly regarded as the most promising long-term approach for reducing tobacco use (Lynch and Bonnie 1994; U.S. Department of Health and Human Services [USDHHS] 19941, about 1.2 million youths become regular smokers each year in the United States-adding to the millions of adult smokers who are candidates for addiction manage- ment (Leventhal et al. 1991; Centers for Disease Con- trol and Prevention [CDCI 1998; see "Trends in Tobacco Use Among Young People" in Chapter 3). Effective treatments do exist for smoking cessation, and they are available for both the clinical and the public health context (Fiore et al. 1996). These treatments compose an important modality in the effort to eradicate tobacco use. Many of the adverse health effects of tobacco use are reversible by cessation WSDHHS 19891-a fact im- portant to the millions of adults who already smoke, as well as to the large numbers of young people who continue to take up smoking. Since the 1964 release of the first Surgeon General's report on the health consequences of smok- ing, the prevalence of cigarette smoking among adults in the United States has decreased by 41 percent, fall- ing from 42.2 percent in 1965 to 24.7 percent in 1997 (Giovino et al. 1994; CDC 1999a). Although these data represent significant progress in the public health cam- paign against tobacco use, the steady decline of 0.5 percentage points per year observed from 1965 to 1985 has lessened in recent years. In 1997, approximately 48 million adult Americans smoked; the prevalence was higher among men (27.6 percent) than among women (22.1 percent) and among American Indians and Alaska Natives (34.1 percent) than among blacks (26.7 percent), whites (25.3 percent), Hispanics (20.4 percent), or Asian Americans and Pacific Islanders (16.9 percent) (Table 4.1). Smoking prevalence was also lower among college graduates (11.6 percent) than among high school dropouts (35.4 percent) and higher among those below the poverty level (33.3 percent) than above it (24.6 percent) (CDC 1999a). Since smok- ing prevalence did not decline at a more rapid rate than that observed in the past few years, the Healthy People 2000 goal of an adult smoking prevalence of 15 percent or less by the year 2000 (USDHHS 1991) was not met. Unless smoking prevalence declines at a more rapid rate than that observed in the past, we will not achieve the Healthy People 2020 goal of an adult smok- ing prevalence of 12 percent or less by the year 2010 (USDHHS 2000). Considered over the time frame of the last 30 years, however, smoking cessation has increased dra- matically. Self-reported data from 1997 suggest that almost 50 percent (44 million) of people who have ever smoked have successfully quit smoking (Thomas and Larsen 1993). In 1991, the earliest year for which so- cioeconomic data are available, the prevalence of smoking cessation was greater among male, white, older, more educated, and wealthier persons (Table 4.2) (Giovino et al. 1994). An encouraging finding from the 1993 National Health Interview Survey was that most (70 percent) current adult smokers were inter- ested in quitting. Such interest was higher among women, African Americans, and younger persons (Thomas and Larsen 1993). Cessation represents a desired end result to what is usually a lengthy, demanding, and often frustrating undertaking. Data on cessation should be interpreted in light of the fact that for every successful attempt to quit using tobacco, many more attempts fail. Although millions of Americans say they want to quit smoking, studies suggest that only about 6 percent of persons who try to quit smoking at any given time are suc- cessful for more than one month (CDC 1993a). Re- search into tobacco cessation seeks tools that will translate the desire to quit into prolonged abstinence from tobacco. Such treatments hold a greater poten- tial for immediate public health returns than do pre- vention methods, and cessation treatments may also be cost-effective (see "Cost-Effectiveness" later in this chapter). In the course of this chapter, the terms "smoking cessation" and "management of tobacco addiction" are used interchangeably. Though the former is the more familiar, the latter better conveys a more rigorous and systematized approach to a complex addiction behav- ior. Value judgments on the impact of a particular modality should be interpreted within a qualitative system for judging costs and benefits. A small impact may be viewed favorably if achieved with minimal intervention. More intense intervention may have a larger impact, but may not be justified by the resources it requires. Malzagemerzt of Nicotirle Addiction 97 Table 4.1. Percentage of adults aged 218 years who were current cigarette smokers,+ by sex, raceiethnicity, -. education, age, and poverty status-United States, National Health Interview Survey, 1997 Men Women Total (n = 15,361) (n = 20,455) (n = 35,816) Characteristic % (95% c1+1 % (95% CIl % (95% CR Race/EthnicityS White, non-Hispanic Black, non-Hispanic Hispanic American Indian/Alaska Natives Asian American/Pacific Islander 27.4 (k 1.0) 23.3 (+ 0.8) 25.3 (+ 0.7) 32.1 (+ 2.4) 22.4 (+ 1.7) 26.7 (k 1.4) 26.2 (k 2.1) 14.3 (k 1.4) 20.4 (+ 1.4) 37.9 (k 13.7) 31.3 (+ 8.8) 34.1 (? 7.7) 21.6 (+ 4.4) 12.4 (k 3.5) 16.9 (k 2.7) Education (yearslA 18 9-11 12 13-15 216 29.9 (* 3.0) 15.1 (k 2.2) 22.5 (k 1.9) 41.3 (k 3.1) 30.5 (k 2.4) 35.4 (k 2.0) 31.8 (k 1.7) 25.7 (+ 1.3) 28.4 (+ 1.0) 27.4 (+ 1.7) 23.1 (+ 1.4) 25.1 (+ 1.1) 13.0 (+ 1.2) 10.1 (* 1.0) 11.6 (? 0.8) Age (years) 18-24 25-44 45-64 265 31.7 (k 2.8) 25.7 (+ 2.4) 28.7 (k 1.9) 31.2 (+ 1.3) 26.1 (k 1.1) 28.6 (210.8) 27.6 (k 1.5) 21.5 (k 1.3) 24.4 (k 1.0) 12.8 (i 1.4) 11.5 (k 1.1) 12.0 (& 0.9) Poverty statusq At or above Below Unknown 27.3 (k 1.0) 21.8 (? 0.8) 24.6 (+ 0.7) 38.7 (k 2.8) 29.8 (+ 1.9) 33.3 (k 1.7) 23.4 (+ 2.0) 18.2 (k 1.5) 20.5 (+ 1.2) Total 27.6 (+ 0.9) 22.1 (k 0.7) 24.7 (+ 0.6) *Persons who reported having smoked at least 100 cigarettes during their lifetime and who reported currently smoking every day or some days. Excludes 300 respondents with unknown smoking status. +95% confidence interval. SExcludes 74 respondents of unknown, multiple, and other racial/ethnic categories. SWide variances on estimates reflect the small sample sizes. *Persons aged 2 25 years. Excludes 305 respondents with unknown years of education. _I'ublished 1996 poverty thresholds from the Bureau of the Census are used in these calculations. Source: Centers for Disease Control and Prevention 1999a. 98 Chnpter 4 Reducing Tobacco Use Table 4.2. Percentage of adults* who abstained from smoking cigarettes in the previous year, by sex, race/ethnic@, age, education, and poverty status- United States, National Health Interview Survey, 1991+ Characteristic Sex Male Female RaceiEthnicity White" BlackA Hispanic American Indian/ Alaska Native Asian American/ Pacific Islander Age (years) 18-24 25-44 45-64 265 Education (years) <12 12 13-15 216 Poverty status** At or above Below Unknown Total 42.1 (40.9-43.3) 13.8 (12.5-15.1) 5.7 (5.2-6.3) Abstinence for Maintenance 21 day among abstainers 42.6 (40.8-44.4) 13.8 (12.0-15.6) 5.8 (5.0-6.6) 41.5 (40.0-43.0) 13.7 (12.0-15.4) 5.6 (4.9-6.3) 40.3 (39.0-41.6) 48.7 (45.2-52.2) 52.1 (46.4-57.8) 53.3 (39.7-67.0) 45.0 (33.7-56.3) NAT NAY 56.7 (52.9-60.5) 14.0 (9.9-18.1) 7.9 (5.6-10.3) 43.4 (41.8-45.0) 12.7 (11.0-14.4) 5.4 (4.7-6.1) 36.1 (33.9-38.3) 14.1 (11.4-16.8) 5.0 (4.0-6.0) 35.7 (32.2-39.2) 19.4 (14.6-24.2) 6.8 (5.1-8.5) 36.5 (34.1-38.9) 12.9 (10.2-15.6) 4.7 (3.7-5.7) 42.5 (40.8-44.2) 12.8 (10.9-14.7) 5.3 (4.5-6.1) 46.9 (44.2-49.6) 14.3 (11.4-17.2) 6.6 (5.2-8.0) 45.9 (42.5-49.3) 18.8 (14.9-22.7) 8.5 (7.0-10.0) 42.7 (41.4-44.0) 14.8 (13.4-16.3) 6.2 (5.6-6.8) 42.9 (39.5-46.3) 7.5 (4.7-10.3) 3.2 (2.0-4.4) 35.2 (31.2-39.2) 12.6 (8.3-16.9) 4.4 (2.9-6.0) 14.0 7.9 16.3 (12.6-15.4) (5.1-10.7) (10.3-22.2) NA" Maintenancet among all persons who were daily smokers 1 year earlier* 5.6 3.8 8.5 (5.0-6.2) (2.4-5.2) (5.2-11.8) NAY `Persons aged 218 years who reported having smoked at least 100 cigarettes in their lifetime and smoked cigarettes daily 1 year earlier and who provided information of their current smoking status. %ample size = 9,703; race/ethnicity variable excludes 34 respondents of other, unknown, or multiple race; education variable excludes 24 respondents of unknown education level. *Abstinence from smoking cigarettes for at least 1 month at the time of the survey. Excludes 92 respondents who were abstinent from cigarettes for <1 month or for whom duration of abstinence was unknown. SConfidence interval. AExcludes persons of Hispanic origin. %ample sizes too small to derive reliable estimate. **Poverty statistics are based on definitions developed by the Social Security Administration, which includes a set of income thresholds that vary by family size and composition. Source: National Center for Health Statistics, public use data tape, 1991. Mmnpmerzf of Nicofim Addicfion 99 Surgeon General's Report Methods for Managing Nicotine Addiction Historically, the great majority of smokers (more than 90 percent) who successfully quit smoking did so "on their own"-that is, without the assistance of formal cessation programs (USDHHS 1989; Fiore et al. 1990). With the advent of new treatments, including pharmaceuticals, more smokers (20 percent) are using some form of assistance when trying to quit (Zhu et al. 2000). The success rate among this large group of unassisted quitters is half that observed for those who use some form of assistance. Although more than 1 million smokers quit each year, 75-80 percent relapse within six months (Carmody 1992). Those who quit may relapse at any time (even after a period of years), and a substantial portion of quitters go through cycles of quitting and relapse (Cohen et al. 1989a). Given this complex context in which the natural history of smoking occurs (an important leitmotif in the man- agement of tobacco addiction), it is difficult to assign a single number to the proportion who quit on their own. Nonetheless, in the current environment of declining prevalence, the end result of this cyclic pro- cess, and of all the interventional efforts brought to bear on it, is that each year about 3-5 percent of smok- ers quit for a year, for longer, or for good. The success of smoking cessation methods should be evaluated in terms of both process and out- come measures. Process measures are designed to as- sess those variables that are affected by treatments and that influence outcomes. Ideally, process measures should target the specific change mechanisms that treatments are intended to influence. For instance, if a treatment is intended to provide smokers with coping skills, process measures might assess a patient's abil- ity to anticipate and generate appropriate responses to stresses. If a treatment is intended to promote ces- sation by reducing withdrawal symptoms, then a with- drawal symptom scale might be used as a process measure. Clinically significant outconze measures in- clude attempts at quitting and abstinence success. Withdrawal symptom severity and concomitants of cessation attempts, such as weight gain, may be viewed as outcomes as well. Some of the efficacy evaluations reported here incorporate the results of published meta-analyses. Meta-analysis is a statistical technique that assesses the impact of a variable (or, in this context, a treatment) across a set of related investigations (Dickersin and Berlin 1992). Meta-analyses may present a more objective assessment of accumulated research findings than do traditional narrative reviews (e.g., Cooper and Rosenthal 1980) and can be useful for identifying study or treatment characteristics that are associated with differences in study outcomes (Dickersin and Berlin 1992). Meta-analyses of smoking cessation treatments have used different techniques for estimating the size of treatment effects. The precise methods used to cal- culate and pool these estimates vary (for detailed de- scriptions, see Fleiss 1981 and Cooper and Hedges 1994). In both meta-analyses and individual studies, the most frequently encountered measures are the odds ratio (an estimate of the relative risk for the outcome in control versus treatment groups) and some form of effect size (difference in effect between treatment and control groups). Self-Help Manuals Because of the size of the population who try quitting on their own, the broad dissemination of ma- terials that can help them in their efforts-without re- quiring them to participate in a formal cessation program-may be a potent strategy at the national level for decreasing the prevalence of smoking (Glynn et al. 1990a; Curry 1993). A wide array of self-help strategies has been developed for smoking cessation (Curry 1993). This section discusses the efficacy of written manuals, the most extensively investigated self-help materials (Curry 1993). The discussion is lim- ited to studies of such manuals distributed to relatively small populations of smokers. Self-help materials de- livered to large populations are discussed later in the chapter in association with nonprint messages and pro- grams (self-help or supervised) included in mass me- dia and community-based efforts. Efficacy In a review of the research literature on self-help manuals, the median long-term prevalence of cessation associated with manual-based interventions was about 5 percent (Curry 1993). This proportion is lower than those of face-to-face cessation programs (Schwartz 1987; Lichtenstein and Glasgow 1992; Lando 1993). Further- more, recent evidence suggests that self-help manuals, when used by themselves, may produce negligible 100 Chnpfer 4 Redllcing Tobacco Use increases in long-term cessation (Gritz et al. 1992; Petersen et al. 1992; Gomel et al. 1993; Fiore et al. 2000). Because self-help manuals can be distributed, at low cost, to very large numbers of smokers, even rela- tively small cessation success could translate into large numbers of successful quitters. Since 30-40 percent of smokers each year make a serious effort to quit, self- help aids could have a vast influence on public health (Hatziandreu et al. 1990; CDC 1993b, 199913). The avail- able evidence suggests that self-help manuals work better for smokers who are less dependent on nico- tine, more motivated, and more confident of quitting (Curry 19931, but the relationship between motivation and success is complex. Less addicted smokers may be less likely to seek formal treatment (Fiore et al. 1990; Zhu et al. 2000) and are therefore an apt audience for self-help manuals. More addicted smokers are more likely to seek formal self-help programs (Wagner et al. 1990) but may be less successful in quitting (Schoen- bath et al. 1992). Thus, in view of both their uncertain effectiveness and their potential to be cost-effective, it is important to determine whether self-help manuals have a consistent, albeit small, benefit. Although many self-help manuals have been de- veloped, there is little evidence that they differ in their effectiveness (Cummings et al. 1988; Glynn et al. 1990a; Curry 1993). Accordingly, an Expert Advisory Panel convened by the National Cancer Institute (NCI) has recommended that public health professionals try to increase the availability of existing manuals rather than refine them or develop new ones (Glynn et al. 1990a). The committee also concluded that if new materials are deemed necessary, they should, at a minimum, contain the following components: (1) information about the social and health effects of smoking; (2) specific strategies and exercises for quitting; and (3) specific strat- egies and exercises to avoid relapse and, in the event of relapse, to try quitting again (Glynn et al. 1990a). Manuals tailored to special populations of smok- ers, such as pregnant women, older adults, African Americans, and Hispanics, have been developed and tested (Windsor et al. 1985; Glynn et al. 1990b; Davis et al. 1992; USDHHS 1998). Although manuals tar- geted to specific populations have not had consistently greater success than generic manuals at helping mem- bers of relevant populations quit (Curry 1993; Rimer et al. 1994), such manuals have the potential to reach smokers missed by traditional materials (Curry 1993). It appears that combining multiple types of self-help materials (manuals, videotapes, etc.) does not improve long-term cessation rates. A meta-analysis of 21 studies using multiple types of self-help without person-to-person contact found no significant difference between multiple types of self-help and no self-help at all (Fiore et al. 2000). Reading level has been increasingly recognized as an important attribute of self-help manuals. Since the early 197Os, trends in smoking prevalence have been different for those with differing levels of educa- tional attainment (Pierce et al. 1989). Smoking preva- lence has dropped sharply among persons with a college education (10.1 percentage points between 1974 and 1985) but has declined only marginally among high school dropouts (2.1 percentage points during the same period). Concerns about literacy have led to the recommendation that self-help materials for smoking cessation be written at no more than a seventh-grade reading level (Glynn et al. 1990a), although this level may be too high in some situations. Adjuncts to self-help manuals, such as telephone counseling (Orleans et al. 1991; Curry et al. 1992; Lando et al. 19921, hot lines (Ossip-Klein et al. 1991), and per- sonalized feedback (Curry et al. 1991; Prochaska et al. 19931, have also been evaluated. These adjunctive in- terlrentions have met with varying success (Curry 1993). For example, self-help treatments that include nicotine gum as well as smoking cessation manuals have not had greater long-term efficacy than the manuals alone (Harackiewicz et al. 1988; Killen et al. 1990b). Computer-generated personalized feedback (Curry et al. 1991) and telephone outreach, however, have im- proved cessation success (Orleans et al. 1991; Lando et al. 1992; Prochaska et al. 1993; Strecher et al. 1994). At present, research suggests that such adjuvants materi- ally improve the effectiveness of self-help manuals. Adjunctive interventions that require financial and personnel resources, however, may undercut the potential population impact of self-help interventions. The addition of other components to self-help manu- als may also mark the point at which the self-help modality merges with more formal assistance, which, as mentioned earlier, have not appealed to as large a population of smokers motivated to quit. But at least one such treatment, proactive telephone counseling (as opposed to reactive approaches, such as help lines smokers must call), appears to be effective when used as an adjuvant (Fisher et al. 1993). Relevant Process Measures Most studies of self-help manuals lack process measures, and the specific measures used across stud- ies vary considerably (Curry 1993). Two distinct pro- cess measures, manual reading and manual use, have been assessed in some studies of self-help manuals for smoking cessation. Reading measures simply ask Swymz Gerzrral'~ Report smokers whether they read most or all of the manual. Use measures assess the extent to which smokers performed the specific exercises recommended in the manual. In theory, persons who actually read a manual or practice manual-recommended exercises should be more successful than those who merely possess a manual. Curry (1993) concluded that although read- ing has sometimes been related to program success, use has been more consistently related to improved outcomes. Further work is needed to determine with some certainty whether the information conveyed by the manuals, rather than nonspecific motivational ef- fects, is responsible for their efficacy. Summary Although self-help manuals have had only mod- est and inconsistent success at helping smokers quit, manuals can be easily distributed to the vast popula- tion of smokers who try to quit on their own each year. Adjuvant behavioral interventions, particularly pro- active telephone counseling, may increase the effect of self-help materials. Process measures are not rou- tinely incorporated into self-help investigations, but the available process data suggest that persons who not only have a self-help manual but also perform the exercises recommended in the manual are more likely to quit smoking. Minimal Clinical Interventions Minimal clinical interventions are those that can be delivered briefly to smokers by health care profes- sionals during the course of a regular health care en- counter. These strategies may be as simple as advising smokers to quit, or they may be as complex as using computers to tailor the intervention to the individual smokers. Minimal clinical interventions could have a great influence at a national level on smoking cessa- tion, but they have been underused. Findings from a 1985 (Ockene et al. 1987), a 1991 (CDC 1993b), and a 1992 national survey (Tomar et al. 1996) suggest that nearly 70 percent of American smokers (nearly 36 mil- lion) make at least one outpatient health care visit each year; however, only 40-52 percent of the smokers in the surveys reported that during the preceding year they had been advised by a health care professional to quit smoking. In a separate study, 48.8 percent of 2,710 current smokers had been advised by their physician to stop smoking or to smoke less (Frank et al. 1991). More than 50 percent of adult smokers in the United States saw a dentist in 1992, but fewer than 25 percent of those who saw a dentist in the preceding year re- ported that the dentist had advised them to quit smok- ing (Tomar et al. 1996). Among adult users of smokeless tobacco, 18 percent reported that they had ever been advised by a dentist and 15 percent had ever been advised by a physician to quit (Tomar et al. 1996). Many clinicians may believe that they are not equipped to help smokers quit (Wells et al. 1984; Glynn 1988) or that a physician can help a smoker quit (Ockene et al. 1988a). Training programs for clinicians have been developed to address this problem (Ockene et al. 198813; Cummings et al. 1989a,b; Duncan et al. 1991; Manley et al. 1991; Strecher et al. 1991); however, data suggest that simply training clinicians may not be effective (Dietrich et al. 1992; Carney et al. 1995; Klein et al. 1995). However, implementing reminder systems in the clinic has been shown to triple clinician intervention with smokers (Fiore et al. 1996, 2000). Some evidence suggests that the delivery of these mini- mal clinical interventions is becoming more common (Gilpin et al. 1992). Surveys suggest that smokers who are white, fe- male, older, better educated, or ill, or who smoke more cigarettes per day are more likely than others to re- ceive clinical advice to quit (Ockene et al. 1987; Frank et al. 1991; Gilpin et al. 1992; CDC 1993b). At present, clinicians apparently do not ensure that all of their patients who smoke receive cessation advice and as- sistance, in part because of structural and policy is- sues (such as reimbursement) related to medical care delivery. Nonetheless, such efforts might be more com- mon if clinicians were trained to view smoking as a chronic disease, marked by periods of remission and relapse, rather than as an acute disorder (Fiore and Baker 1995). Researchers have shown that institutional changes can increase the systematic delivery of minimal clinical interventions for smoking cessation. For example, brief physician training, availability of nicotine gum, and patient chart stickers documenting smoking status can increase the amount of time physicians spend in cessa- tion counseling and increase successful cessation by a factor of 2 to 6 (Cohen et al. 1989b; Ockene et al. 1991). One proposed change is to expand patient vital signs to include an assessment of tobacco use (Fiore 1991). This simple institutional change has been shown to increase markedly the proportion of patients who re- port that their health care providers asked and coun- seled them about smoking cessation (Fiore et al. 1995; Robinson et al. 1995). Finally, institutional changes are critical for prompting more clinicians to play a role in smoking cessation. Currently, clinicians are only sporadically 102 Chnyter 4 Reducing Tobacco Use reimbursed for clinical and pharmacologic treatments to help patients quit smoking (Group Health Associa- tion of America, Inc. 1993; Schauffler and Parkinson 1993). Appropriate reimbursement may be essential to ensuring greater clinical attention to tobacco addic- tion (Schauffler and Parkinson 1993; Fiore and Baker 1995; Kaplan et al. 1995). The Public Health Service-sponsored Clinical Practice Guideline Trenting Tobncco Use and Dependence has recommended that health care professionals use the "five A's" to help their patients quit smoking: (1) nsk about smoking, (2) ndvise all smokers to quit, (3) address willingness to make a quit attempt, (4) assist patients who want to quit, and (5) arrange follow-up visits (Manley et al. 1991; Glynn and Manley 1993; Orleans et al. 1993; Houston et al. 1994; Fiore et al. 2000). These recommendations, based on a comprehensive review of the empirical literature, constitute a proscriptive algorithm for clinical inter- ventions (see the text box). Additional follow-up visits, at increasing inter- vals, with patients who continue not to smoke have been associated with greater long-term abstinence (Kottke et al. 1988; Wilson et al. 1988; Orleans et al. 1991). Patients who have relapsed should be helped to quit again at follow-up visits and subsequent visits. The Five A's T o help their patients quit smoking, clinicians can use the "five As" approach: (1) rusk patients about smoking, (2) odsjise all smokers to quit, (3) ns- scss willingness to make a quit attempt, (4) nssist those who want to quit, and (5) arrnnge follow-up visits with those trying to quit (Glynn and Manley 1993). These brief clinician interventions, which are described in this text box, can be completed within two to three minutes at each visit and have been associated with a cessation prevalence of 5 percent (Glynn 1988) to 8 percent (Kottke et al. 1988). All patients seen in a primary care setting should be routinely asked about their smoking sta- tus. One means of institutionalizing the identifica- tion of smokers is to expand the vital signs to include smoking status (Fiore 1991). Another means is to use stickers or other markers to clearly identify charts and prompt clinicians to help their patients who smoke quit (Cohen et al. 1989b; Ockene et al. 1991). All patients who smoke should be advised to quit. This advice should be clearly stated and per- sonalized. After giving this advice, clinicians should assess whether smokers desire to quit at the present time. Clinicians should provide motivational ma- terials and messages to those not willing to quit. These patients should be asked about smoking and advised to quit at all subsequent visits. Clinicians should assist patients who want to quit. The clinician should work together with the patient to set a date to quit (preferably within two weeks of the clinic visit) and should provide the patient with practical advice about how to quit and self-help materials. Clinicians should determine whether the pa- tient is likely to require adjunctive help and whether the patient is a candidate for pharmacotherapy. Pharmacotherapy should be considered for all pa- tients motivated to make a quit attempt, except in the presence of specific contraindications (Fiore et al. 2000). The choice may take into account previ- ous patient experience, preferences, and other fac- tors (see "Pharmacologic Interventions," later in this chapter). Clinicians should also present other treat- ment options to their patients who want to quit. In particular, patients should be made aware of com- munity cessation resources (such as those offered by the American Cancer Society and the American Lung Association) and of intensive clinical inter- ventions (see "Intensive Clinical Interventions," later in this chapter) available in the community. The primary care clinician, however, should con- tinue to monitor and assist those patients who elect to undergo intensive treatments. Clinicians should arrange for a follow-up visit to discuss smoking cessation within two weeks of the chosen date to quit. Researchers have docu- mented that scheduling follow-up visits or making follow-up telephone calls improves cessation suc- cess (Kottke et al. 1988; Wilson et al. 1988; Ockene et al. 1991, 1992; Orleans et al. 1991). Follow-up visits should be arranged whether the patient has been referred to another clinic or treated by the pri- mary care clinician. Mamgcnw~~t of Nicotine Addiction 203 Surgeon Gerleral's Rrport Modifications in treatment, including a discussion of more intensive efforts, should be considered for relaps- ing patients at each iteration. An area of current active research in minimal in- terventions is the use of computer-tailored messages for individual smokers who want to quit. Computer software that approximates deductive or inductive human reasoning has been proposed as an efficient and cost-effective mechanism for this modality (Velicer et al. 1993). In a large trial of one such system, interac- tive computer reports plus individualized manuals produced higher current abstinence (20 percent) and prolonged abstinence (11 percent) than did standard manuals, individualized manuals alone, or personal- ized counselor calls (Prochaska et al. 1993). Similarly, analyses of two separate controlled trials found that computer-tailored letters generated significantly greater cessation proportions in groups receiving them than in control groups (Strecher et al. 1994). Although these mechanisms have not been extensively evaluated, they are a promising avenue for further investigation. Efficacy Kottke and colleagues (1988) performed a meta- analysis of 39 smoking cessation trials conducted in medical practice settings. Most of these trials involved relatively minimal interventions, but some more in- tensive treatments were included. Participants had a mean of 4.8 (standard deviation = +4.4) contacts with these clinic-based programs. The major conclusion of this analysis was that success increased with the num- ber of intervention modalities employed, the number of health care professionals involved in the effort, and the number of follow-up assessments. Duration of follow-up (as opposed to number of follow-ups) was not predictive of success. Using diverse techniques may be a key characteristic of successful clinic-based smoking cessation programs (Fiore et al. 2000). A suc- cessful program might be one in which face-to-face counseling or advice is given; dates for quitting are set; pamphlets are distributed; reminders by telephone are made; smokers are advised and counseled on quit- ting by physicians, nurses, and other health profes- sionals; and multiple clinic visits or telephone calls are made after the smoker's quitting day. In the meta- analysis by Kottke and colleagues (1988), cessation assistance delivered by nonphysicians tended to be slightly more effective than that performed by physi- cians, but a more recent meta-analysis (Fiore et al. 2000) found no difference in effectiveness between physi- cians and nonphysicians. Both individual and group counseling was effective (Fiore et al. 2000). The meta-analysis by Kottke and colleagues (1988) also suggested, however, that complex interventions are not necessary for clinic-based success. Compared with smokers who received no assistance, smokers who received help consisting of advice only or brief coun- seling had a 13.1-percentage point increase in cessation 6 months after treatment and a 3.8-percentage point in- crease after 12 months. Comparable estimates for smokers whose only treatment was to receive written self-help materials from health care professionals were 1.6 percent at 6 months and 2.0 percent at 12 months. The impact of brief intervention is illustrated in one study by Russell and colleagues (1979), who found that providing advice in a primary care setting produced a biochemically confirmed increase in abstinence of 3.3 percentage points; when smokers were told they would be followed up and when self-help materials were distributed in conjunction with the advice, the resulting one-year increase in abstinence was 5.1 percentage points. Trials postdating the meta-analysis of Kottke and colleagues (1988) have also indicated that brief clini- cal interventions have a small but reliable impact on smoking cessation success (Cummings et al. 1989a; Risser and Belcher 1990; Taylor et al. 1990; Ockene et al. 1991, 1994; Weissfeld and Holloway 1991; Hollis et al. 1993; Strecher et al. 1994). A meta-analysis of seven studies found that physician advice to quit increases cessation by 30 percent (Fiore et al. 2000). The consis- tency of these findings over a considerable time span and in multiple settings lends credence to the useful- ness of minimal interventions. Smokeless tobacco use may be particularly ame- nable to minimal clinical interventions, especially in dental office settings. Oral lesions caused by smoke- less tobacco are quite common among users of these products (Ernster et al. 1990; Tomar et al. 1997) and provide the opportunity for the dentist to point out the direct adverse health effects of smokeless tobacco. Several trials have examined the efficacy of minimal clinical interventions in smokeless tobacco cessation. In a randomized trial conducted in a dental health maintenance office clinic to test a minimal clini- cal intervention, Stevens and colleagues (1995) re- ported significantly higher smokeless tobacco quit rates in the intervention group than in the usual-care group at both 3 months (32.2 vs. 21.3 percent) and 12 months (33.5 vs. 24.5 percent). In a randomized clini- cal trial conducted in private dental offices, Severson and colleagues (1998) also found that a minimal inter- vention significantly increased smokeless tobacco quit rates in the intervention group compared with rates in the usual-care group at 3 months (17.8 vs. 8.8 IO4 Chapter 4 Reducing Tobacco Use percent) and 12 months (10.2 vs. 3.3 percent). A mini- mal intervention trial for smokeless tobacco use among college athletes, which included dental examinations to demonstrate oral lesions, 15-20 minutes of counsel- ing by dental hygienists, and follow-up telephone calls, found that three-month biochemically assayed quit rates were 24 percent in the intervention group and 16 percent in the control group (Masouredis et al. 1997). Relevant Process Measures Although minimal clinical interventions provide smokers with some practical advice about quitting, their primary purpose is to increase smokers' motivation to quit. Specific process measures-such as measures of this motivation-are seldom incorporated into minimal clinical interventions. The nonspecific measures some investigators use do not associate clinical success with changes (such as greater awareness of disease risk or enhanced belief in one's ability to quit). Nonetheless, the available evidence suggests that minimal clinical interventions can enhance smokers' desire and inten- tion to quit (Russell et al. 1979), decrease the number of cigarettes smoked per day (Folsom and Grimm 19871, and increase the number of attempts to quit smoking (Folsom and Grimm 1987; Cummings et al. 1989b; Strecher et al. 1991). In addition, patients have reported that physicians trained to perform more intensive in- terventions are more helpful than physicians without such training (Ockene et al. 1991). Summary Substantial evidence suggests that minimal clini- cal interventions (e.g., a health care provider's repeated advice to quit) foster smoking cessation and that the more multifactorial or intensive interventions produce the best outcomes. These findings highlight the im- portance of cessation assistance by clinicians, who have a unique access to more than 70 percent of smokers each year. Moreover, minimal clinical interventions have been found to be effective in increasing smokers' motivation to quit and are cost-effective (see "Cost- Effectiveness," later in this chapter). However, re- search has not clarified fully the specific elements of minimal interventions that are most important to clini- cal success nor the specific types of changes they pro- duce in smokers that lead to abstinence. Intensive Clinical Interventions Intensive clinical interventions (sometimes called "formal" or "organized" cessation treatments) are multisession counseling programs involving extensive contact between a health care provider and a smoker. The value of intensive interventions has been ques- tioned because they are more expensive and reach fewer smokers than self-help and minimal clinical in- terventions do (Chapman 1985). However, more in- tensive interventions continue to attract interest because they are more successful at helping people quit smoking (Schwartz 1987). Despite their comparatively high cost, they are cost-effective (Elixhauser 1990), and they may be especially well-suited for treating the most addicted smokers (Lichtenstein and Glasgow 1992; Orleans 1993). Intensive clinical interventions may be charac- terized by structure and content. Structural variables include providers' credentials and training; individual, telephone, or group format; session length; total num- ber of sessions; and duration of follow-up. Relatively little research into intensive treatments has been de- signed to assess the effects of different structural vari- ables (Lichtenstein and Glasgow 1992). Increased patient contact results in better outcomes (Land0 1981; Decker and Evans 1989; Lichtenstein and Glasgow 1992; Fiore et al. 2000). In a meta-analysis of research on the nicotine patch (Fiore et al. 1994~1, researchers found that the following counseling features were as- sociated with significant increases in six-month absti- nence rates: counseling being a main reason for clinician-patient contact, at least weekly clinician- patient meetings during the first 4 weeks of treatment, and more than six clinician-patient meetings in the first 12 weeks of treatment. A more recent meta-analysis that was not restricted to nicotine patch studies (Fiore et al. 2000) found that quitting success increased with increasing contact time (up to 90 minutes of total con- tact) and that there was a dose-response relationship between number of sessions and treatment efficacy (Fiore et al. 2000). Thirty to 90 minutes of total coun- seling and four or more sessions were two to three times more effective in producing long-term smoking cessation than no contact controls. This research sup- ports the notion that in general, as the intensity of clinician-patient counseling increases, so does the long- term effectiveness of treatment. Because so little information is available on how structural variables affect intensive treatment outcomes, this section concentrates on a review of con- tent variables. Content refers to the specific informa- tion, materials, and techniques to which smokers are Marlagement of Nicotine Addiction 105 exposed during the course of treatment. The various contents of intensive smoking cessation interventions are not easy to evaluate, partly because the method- ological quality of clinical trials tends to differ across content areas. For example, trials of relatively unor- thodox treatments, such as acupuncture and hypnosis, tend to use shorter follow-up periods than assessments of efforts involving pharmacologic and behavioral treat- ments (Schwartz 1987; Ter Riet et al. 1990); inflated effi- cacy estimates may thus result for unorthodox treatments. These methodological concerns are handled here by limiting the review primarily to studies report- ing outcomes with at least five months of follow-up. Another problem in evaluating the content of intensive interventions is that the evolution of treat- ments over the past 40 years prevents a cumulative assessment of specific intensive interventions. More- over, changing research interests and methodologies make it difficult to integrate findings from over the entire period. For instance, pharmacotherapies have changed greatly during this period and are now in- corporated routinely into intensive treatments. In ad- dition, treatment response may be affected by changes in the nature of the smoking population; for instance, compared with 40 years ago, a higher proportion of today's smokers are women. Methodological and sta- tistical changes have also altered the nature of the stud- ies themselves: sample sizes are larger to increase statistical power, and biochemical confirmation of ab- stinence is now routine, as is the application of the "intent to treat" principle in analyses. Because of these refinements, early cessation research is now often ne- glected, perhaps because it is difficult to integrate with newer work. On the other hand, some apparently ef- fective methods, such as rapid smoking, have often not been evaluated by newer methods. The older lit- erature on such strategies is included selectively in this review. A related problem, complicating the interpreta- tion of relatively recent research, arises from what Lichtenstein and Glasgow (1992) have referred to as a shift from a "clinical" to a "public health" (p. 518) ori- entation among smoking cessation researchers. This shift has resulted in a dearth of theory-driven research into intensive interventions. In fact, one observer has suggested that the long-term research trajectory favors modifying established models over applying innova- tion in the basic approach to treatment (Shiffman 1993b). Recent emphasis on public health has also produced a research climate that favors the evaluation of treatment packages and minimal interventions over treatment components (Lichtenstein and Glasgow 1992). One reason for this shift is the high cost and large sample sizes required to evaluate individual com- ponents. Thus clinical trials rarely allow assessment of a given treatment's independent contribution. Smoking cessation trials now tend to combine specific treatment components into multicomponent interven- tions. Moreover, within the same study, not only may groups receive different treatment packages but the packages may differ in their structural components. Finally, the question of selection bias remains a challenge to interpreting the literature on intensive interventions. Investigators typically recruit highly motivated volunteers to serve as subjects, because the efficacy of intensive interventions can be tested only if the patients under study actually receive the entire treatment. Efficacy estimates derived from this atypi- cal population may not be appropriate for making pre- dictions about the larger population of smokers. The principal types of intensive interventions must be evaluated in the context of these limitations stemming from the nature of the available evidence. Problem Solving/Skills Training Various strategies try to impart to smokers the knowledge and skills necessary to cope with cessation- that is, both to attain and to maintain abstinence when confronted with withdrawal symptoms or the temp- tation to smoke (Marlatt and Gordon 1985; Curry and McBride 1994). This approach (hereafter referred to as problem solving/skills training) springs from the observation that most relapse efforts seem to be asso- ciated with a finite number of factors, such as alcohol use, negative affect (e.g., depression), and the presence of others smoking (Shiffman 1982; Baer and Lichten- stein 1988; Brandon et al. 1990). Problem solving/skills training tries to help people who have recently quit smoking anticipate these "high-risk" situations and learn to cope with them when they arise. Such inter- ventions also train participants to cope with with- drawal symptoms, replace positive reinforcements they had linked to smoking, and meet other challenges that might be encountered during or after an attempt to quit smoking. General problem solving/skills training targets challenges that occur early in the quitting process (e.g., withdrawal discomfort). Because newly abstinent smokers often return to regular smoking (Curry and McBride 1994), one specialized type of intervention teaches skills to help the former smoker maintain ab- stinence (Marlatt and Gordon 1985). These interven- tions also train former smokers to prevent any relapse from becoming a long-term return to smoking. Former smokers are encouraged to view relapses as a normal 106 Chapter 4 Reduciq Tobacco USC part of the quitting process rather than as an indica- tion of failure (Curry et al. 1988). Another type of problem solving/skills training focuses on coping with the immediate negative affects of quitting smoking. The growing body of research on dysphoria (feeling unhappy or unwell) after smok- ing cessation (Glassman et al. 1988; Covey et al. 1990; Brandon 1994; Hall et al. 1994) suggests that strategies that help smokers who have just quit resist negative moods may be particularly successful (Shiffman 199313). However, a recent meta-analysis (Fiore et al. 2000) did not find that interventions that targeted nega- tive affect improved cessation rates. These interven- tions were used with the general population as well as smokers with a history of depression. It is possible that the results might be more positive if the studies were restricted to high-risk populations. Efficacy Because nearly every state-of-the-art smoking cessation program contains elements of problem solv- ing/skills training (Curry and McBride 1994), the tech- nique is difficult to assess as an individual treatment. Some investigators have failed to uncover evidence that this technique increases cessation success relative to comparison groups (Curry et al. 1988; Emmons et al. 1988; Omenn et al. 1988; Minneker-Hiigel et al. 1992; Zelman et al. 1992). Other studies have found benefi- cial effects, but these benefits have often been modest and have come only through protracted treatment (Hall et al. 1984b; Davis and Glaros 1986; Goldstein et al. 1989; Stevens and Hollis 1989). Even in studies that report success in long-term abstinence through skills train- ing, the overall relapse curves for treatment subjects have paralleled those for comparison groups (Glasgow and Lichtenstein 1987; Goldstein et al. 1989; Stevens and Hollis 1989; Mermelstein et al. 1992; Minneker- Hiigel et al. 1992; Gruder et al. 1993). A recent meta- analysis (Fiore et al. 2000) of 104 studies, however, reported that problem solving/skills training increased quitting success by 50 percent. Some evidence sug- gests that problem solving/skills training may be par- ticularly useful for female smokers (Curry et al. 1988), those who smoke fewer cigarettes (Hall et al. 1984b), those who smoke to cope with emotional stress (O'Connor and Stravynski 1982), and those who are less prone to negative affect (Zelman et al. 1992). Although multicomponent skills-training programs have sometimes included information about managing the dysphoria associated with smoking ces- sation (Tiffany et al. 1986; Kristeller et al. 1993), relevant behavioral interventions have only recently begun (Hall et al. 1994). Initial results suggest that such strategies are promising, but these findings re- quire replication and extension. In sum, the evidence on problem solving/skills training suggests a beneficial impact (Fiore et al. 2000). Such training can offer practical strategies about quit- ting and inculcate desired coping skills. Releuallt Process Measures Skills training rests heavily on two assumptions: (1) coping skills will help former smokers remain ab- stinent in the face of temptation, and (2) smokers can be taught these skills. Some cross-sectional research (Shiffman 1984) and skills-training intervention trials (Hall et al. 1984b; Davis and Glaros 1986; Zelman et al. 1992) have suggested that coping strategies help avert relapse. The available evidence also indicates that patients given skills training acquire coping skills (Hall et al. 1984b; Davis and Glaros 1986; Zelman et al. 1992), and there is evidence that the level of skill acquisition predicts long-term abstinence (Zelman et al. 1992). Although the results of one trial suggest that coping skills are not retained for very long (Davis and Glaros 1986), consistent self-monitoring of smoking during treatment is associated with longer-term maintenance (Kamarck and Lichtenstein 1988); this finding suggests the importance of behavioral characteristics that fos- ter maintenance. One of the goals of skills training is to encourage relapsed former smokers to renew their efforts to quit smoking. Curry and colleagues (1988) found evidence that smokers who had received skills training were more likely to try quitting again if they relapsed. Rapid Smoking Rapid-smoking strategies typically require that smokers inhale deeply from a cigarette about every six seconds until they become nauseated. In theory, this aversive conditioning transforms the subject's perception of smoking from a pleasurable activity into an unpleasant one, thereby making it easier for smok- ers to give up cigarettes. Medical complications produced by rapid smok- ing can include elevations in heart rate, blood pres- sure, and carboxyhemoglobin blood levels as well as electrocardiogram abnormalities (Horan et al. 1977). Because of these potential problems, candidates for rapid smoking should be selected carefully (Lichtenstein and Glasgow 1977). Older persons and persons with cardiovascular or pulmonary conditions are generally excluded from rapid-smoking strategies, Surgeorl Grrwr~l's Report but some evidence suggests that rapid smoking can be conducted with these persons if appropriate pre- cautions are taken (Hall et al. 1984a). Efficacy The 1988 Surgeon General's report on smoking and health (USDHHS 1988) reviewed the literature on rapid smoking and reached two conclusions: (1) al- though its effectiveness is variable when used alone, rapid smoking yields moderately high long-term ab- stinence success (40 percent of subjects were abstinent 6-12 months after treatment) when incorporated in multicomponent behavioral interventions, and (2) aux- iliary treatment factors, such as patient expectations, patient-therapist rapport, and admonitions not to smoke between sessions, can influence how success- ful rapid-smoking strategies are. Few rapid-smoking trials have appeared since the 1988 report. The mid-1980s advent of pharmacologic treat- ments for smoking cessation greatly reduced research interest in rapid smoking. Pharmacologic aids, such as nicotine gum, appear as efficacious as rapid smoking (Zelman et al. 1992) and are probably more acceptable to smokers and program administrators. Nonetheless, the doubling of long-term success associated with rapid smoking (Fiore et al. 2000) suggests that it may remain an option for smokers who are unable to quit through other methods and for whom such aversive condition- ing is acceptable. Relevant Process Measures Rapid smoking is intended to produce aversive conditioned responses to stimuli associated with smok- ing (USDHHS 1988). The technique reliably produces tachycardiac responses to cigarettes, and the magnitude of these responses is directly related to treatment out- come (Tiffany et al. 1986; Zelman et al. 1992). More eas- ily observable variables, such as the number of cigarettes smoked during a rapid-smoking session or the degree of nausea reported by patients, have not been shown to be consistently related to outcome (USDHHS 1988). Other Aversive-Smoking Strategies Three other techniques intended to produce aver- sion to cigarettes have been investigated: satiation therapy, rapid puffing, and focused smoking. Con- cern over the safety of rapid smoking (Horan et al. 1977) was partly responsible for investigation of these alternative aversion techniques. Some evidence sug- gests that they are less unpleasant and less risky than rapid smoking (Glasgow et al. 1981; Tiffany et al. 1986). Satiation therapy requires that patients smoke many more cigarettes per day than they normally do, usu- ally about twice as many (Best et al. 1978). Rapid puff- ing is similar to rapid smoking, but patients are instructed not to inhale cigarette smoke (Tiffany et al. 1986). Focused smoking requires patients to smoke for an extended period of time at a normal rate while concentrating on the negative sensations smoking pro- duces (Lowe et al. 1980). Efficacy Satiation therapy alone produces relatively little cessation success (15 percent at one year) (Land0 19821, but the technique may be more effective when incor- porated into multicomponent programs (USDHHS 1988). Focused smoking and rapid puffing produce long-term abstinence rates that are equivalent to, or slightly lower than, those produced by rapid smoking (USDHHS 1988; Fi;rp et al. 2000). Because these tech- niques do not appear to result in significant tachycar- disc responses (USDHHS 1988), their efficacy is probably accounted for by mechanisms other than aversive conditioning. Cue Exposure Cue exposure therapy is based on the premise that smokers become conditioned to certain cues or contextual signals correlated with smoking behavior. When persons who have recently quit smoking are exposed to these cues, they are motivated to begin smoking again (Rohsenow et al. 1990-91; Brandon et al. 1995). In cue exposure therapy, persons trying to quit smoking are repeatedly exposed to these signals in a therapeutic context in which smoking is prohib- ited; the resulting reduced association between smok- ing and previous cues is hypothesized to reduce some of the temptation for relapse that former smokers will face in the natural environment. Because cue exposure therapy has produced promising results with other addictive disorders (Monti et al. 19931, several researchers have suggested that such strategies be developed for smoking cessation (Hodgson 1989; Heather and Bradley 1990). These strategies may be particularly important for women, whose responsiveness to nicotine replacement therapy appears to be less than that of men (Perkins 1996). Women may be less controlled by nicotine and more influenced by nonnicotine factors (sensory stimuli, en- vironmental factors) (Perkins et al. 1999) and may there- fore respond better than men to behavioral approaches. 108 Chyter 4 Efficacy Studies conducted to date that have evaluated cue exposure have failed to find significant differences in outcome between cue exposure and comparison interventions (Lowe et al. 1980; Raw and Russell 1980; Gtitestam and Melin 1983; Corty and McFall 1984). However, clinical research on cue exposure for smok- ing cessation is sparse, and interpretation of most ex- isting trials is hampered by methodological flaws (Brandon et al. 1995). Relevant Process Measures Environmental associations with cigarette smok- ing can be strong enough to provoke the desire to smoke (Herman 1974; Rickard-Figueroa and Zeichner 1985; Tiffany and Hakenewerth 1991). These provoked responses may affect treatment outcome (Niaura et al. 1989). However, because cue reactivity has not been assessed in existing clinical trials of cue exposure therapy, it is impossible to determine whether such interventions extinguish motivational responses to smoking-related cues. Nicotine Fading Nicotine fading is based on the assumption that withdrawal symptoms will be lessened through a gradual reduction of nicotine intake (Foxx and Brown 1979; McGovern and Lando 1991). Nicotine fading can be accomplished either by progressively switching to brands of cigarettes yielding less nicotine or by using a series of graduated filters (McGovern and Lando 1991). Once the lowest nicotine level is reached, ces- sation is attempted. Nicotine fading should be distin- guished from cigarette fading, in which the number of cigarettes smoked per day is gradually reduced. Cigarette fading has generally not been shown to be an effective smoking cessation technique; participants generally reach a level beyond which they find it diffi- cult to reduce cigarette consumption (Land0 1993; Fiore et al. 2000). Efficacy Foxx and Brown (1979) reported that 4 of 10 sub- jects who tried nicotine fading had quit smoking at 18 months, but subsequent investigations have found more modest long-term results (usually around 20 percent) (Beaver et al. 1981; Lando and McGovern 1985; Burling et al. 1989). Some evidence suggests that nico- tine fading can increase abstinence success indepen- dently within a larger smoking cessation program (Burling et al. 1989). In a community setting where participants were allowed to select their treatment, about 25-30 percent of those who chose multicompo- nent interventions containing nicotine fading achieved long-term abstinence (Land0 et al. 1990; Lando 1993). Brand switching and graduated filters have produced equivalent outcomes (McGovern and Lando 1991). Cinciripini and colleagues (1995) found that 44 per- cent of persons using a combined nicotine fading and skills-training package were abstinent from nicotine at one year, a proportion significantly higher than that produced by matched conditions. Relevant Process Measures Nicotine fading is presumed to exert its effects by gradually weaning smokers from nicotine, thereby reducing withdra>val symptoms. Reductions in nico- tine intake and Mithdrawal indexes are thus the pro- cess measures of primary importance to nicotine fading. One early study suggests that nicotine fading reduces the severity of withdrawal symptoms (West et al. 1984a,b). The process measure of reduced nicotine intake is problematic, because smokers' nicotine consump- tion seldom matches a given brand's machine-rated nicotine yields (McMorrow and Foxx 1983). Smokers are able to compensate for reduced nicotine yield by adjusting how they smoke-by inhaling more strongly, holding smoke in longer before exhaling, inhaling more frequently, or smoking the cigarette closer to its high-yield butt (Benowitz et al. 1983; Kozlowski et al. 1988). Smokers can also compensate for nicotine fad- ing by blocking the air inlet holes on the filters that are used to decrease nicotine intake (McGovern and Lando 1991). The best available evidence indicates that although nicotine consumption is indeed reduced by nicotine fading, the extent of these reductions is smaller than would be expected (i.e., based on machine rat- ings); apparently, some compensatory smoking occurs (Land0 1993). For example, one study (McGovern and Lando 1991) compared two nicotine fading regimens, brand switching and graduated filter use, each of which was designed to reduce nicotine intake by 80 percent by the final stage. Each regimen significantly reduced nicotine consumption but by far less than 80 percent: brand switching reduced intake by 42.5 per- cent and graduated filters by 55.2 percent. Lando and McGovern (1985) suggested that nico- tine fading increases smokers' self-efficacy by provid- ing them with a series of concrete steps that are mastered before cessation. Self-efficacv does increase during the fading process (McGo\.ern al;d Lando 1991), although no more than with comparison treatments (Burling et al. 1989). Moreover, increased self-efficacy has not been shown to predict treatment outcome for nicotine fading (McGovern and Lando 1991). Motivational Rewards Strategies that use motivational rewards are rooted in operant conditioning theory. These efforts are designed to provide reasons for remaining absti- nent to smokers who have just quit-reasons more tan- gible and immediate than the important but delayed outcomes that typically motivate cessation attempts (e.g., improvements in health). In a typical motiva- tional rewards intervention, the provider collects a deposit from each participant at the outset of treatment and refunds a portion of this sum at each follow-up assessment at which the participant demonstrates ab- stinence (Paxton 1983). Other variations of this tech- nique have used nonmonetary rewards (Land0 1982), punished smokers for every cigarette smoked (Murray and Hobbs 19811, instructed participants to reward themselves for abstinence (Tiffany et al. 19861, and rewarded participants who had reduced their carbon monoxide levels (Stitzer and Bigelow 1985). Curry and colleagues (1991) used a theoretical framework that tested intrinsic motivation (personalized feedback) against extrinsic motivation (financial incentive). Ab- stinence at 3 and 12 months was two times higher in the intrinsically motivated groups. Efficacy When used alone, inotivational rewards foster relatively high abstinence success in the short term, but these gains do not appear to be durable (Antonuccio et al. 1992). Participants often return to smoking after the term of the contract expires (Paxton 1980,1981). At- tempts to prolong .abstinence by varying factors such as duration and frequency of reward have generally been unsuccessful (Paxton 1981, 1983). Multicompo-. nent treatments using motivational rewards have some- times fared better than comparison treatments, but these comparisons are generally confounded by other factors (Jason et al. 1990; Lando~et al. 1990) and may lead to type II errors. A meta-analysis of 62 studies comparing components of behavioral controls found that motiva- tional rewards (contingency contracting) did not sig- nificantly alter long-term cessation rates (Fiore et al. 2000). In the final results of the Minnesota Heart Health Program, the failure of community education methods (which included motivational rewards for smoking cessation) to produce results that exceeded secular trends is an important demonstration of the difficulties in evaluating such modalities (Land0 et al. 1995). Relevant Process Measures The process measures most relevant to this strat- egy are presumably motivational; making rewards contingent on abstinence should increase a smoker's resolution to remain abstinent. However, motivational measures have been neglected in research on this intervention. Many programs require participants to administer their own rewards or punishments. Evalu- ations of these strategies should routinely assess how well participants take on this responsibility; to date, evaluations have not made this assessment. Social Support Social support intervention> try to ease the smok- .ing cessation process by enlisting the support of sig- nificant persons in smokers' lives (extratreatment social support) and by providing support from clini- cians (intratreatment social support). Both strategies may range from intense' and pervasive to relatively minimal and limited. Intensive extratreatment social support may train participants to elicit aid and sup- port of family and friends, whereas training clinicians to communicate caring, concern, and encouragement increases intratreatment social support. Increasing the cohesiGeness of smoking cessation groups can enhance both forms of social support (Hajek et al. 1985; Lando and McGovern 1991). At the basic level, the simple use of a group rather than an individual format can be viewed as a social support intervention. Efficacy Strategies that add social support to fiharmaco- logic treatment appear to significantly increase long- term quit rates compared to treatments without social support, although some intensive interventions have reported mixed results (Glasgow et al. 1986; McIntyre- Kingsolver et al. 1986). A recent meta-analysis of 19 studies (Fiore et al. 2000) reported that interventions to increase social support in the smoker's environment increase long-term cessation by 50 percent. A meta- analysis of 50 studies (Fiore et al. 2000) reported that within-treatment social support increased cessation by 30 percent. -The importance of intratreatment social support may well be reflected in the finding that indi- vidual and group counseling are both much more ef- fective than no contact interventions (Kottke et al. 1988; Fiore et al. 1996). Rcducirlg Tobmro Usr Relevant Process Measures Studies of intensive social support interventions have regularly included measures of smokers' per- ceived support. These investigations have found that the amount of support a smoker perceives is directly related to outcome (Malott et al. 1984; Glasgow et al. 1986; McIntyre-Kingsolver et al. 1986; Gruder et al. 19931, but the trials have typically failed to find evi- dence that the support itself has increased this per- ception (Malott et al. 1984; Glasgow et al. 1986). In one study that found social support intervention to be effective, the strategy was itself associated with an in- crease in received support (Gruder et al. 1993). More- over, this increase in support was statistically related to the differential outcome. Because support measures have rarely been incorporated into the evaluation of group treatments for smoking cessation, little is known about whether group formats enhance perceived sup- port and about what influence such support has on treatment outcome (Hajek et al. 1985). Weight Control Most people who quit smoking gain weight (Klesges et al. 1989), and this effect may be greater for women than for men (Williamson et al. 1991; Fant 1996). This effect has been hypothesized to result from nicotine's ability to modify various mechanisms in the central nervous system that regulate body weight (Schwid et al. 1992; Perkins 1993). Apprehension about weight gain may serve as a barrier to cessation at- tempts, especially among young women (Gritz et al. 1989). Cessation strategies that address this barrier have only recently begun to be assessed. Efficacy Two important trials have examined the contri- bution of a weight control component to a multicom- ponent smoking cessation program. One study (Hall et al. 1992) compared a specialized weight control pro- gram with both a nonspecific weight control program and a standard program. Patients in the specialized group learned behavioral self-management, reduced their caloric intake under the direction of a dietitian, and received an individualized activity plan from an exercise counselor. Patients in the nonspecific group attended several group sessions devoted to discuss- ing weight-related issues. Results showed that par- ticipants in both of these weight control programs were less likely to be abstinent after one year (21 percent success for both groups combined) than participants treated with the standard protocol (35 percent success). Another study (Pirie et al. 1992) examined the ef- fects of adding nicotine gum, weight control counsel- ing, both, or neither to a standardized smoking cessation program in a sample of women who had indicated that they were concerned about postcessation weight gain. After 12 months, the group that added nicotine gum to the standard program had much greater success (44.4 percent had quit smoking) than the groups that added weight control counseling to the standard package (27.8 percent success for the group that added weight con- trol only and 27.6 percent success for the group that added both weight control and nicotine gum). How- ever, the standard package alone was the least success- ful program (19.4 percent had quit smoking) and was viewed by participants as less appealing than the weight control component (Pirie et al. 1992). A meta-analysis of six studies (Fiore et al. 2000) that looked at the effect of dieting and physical activ- ity on smoking cessation did not find that these inter- ventions increased cessation success. A recent single study (Marcus et al. 1999) found that vigorous physi- cal activity increased quit rates. Relevant Process Measures Weight gain has not been a consistent predictor of smoking relapse (Gritz et al. 1989), and it has pre- dicted abstinence as well (Hall et al. 1986; Gritz et al. 7989; Hughes et al. 1991b). Nonetheless, actual con- trol of weight is an important process measure for weight control interventions-the primary purpose of which is relapse prevention-because they explicitly assume that preventing weight gain will boost absti- nence rates (Hall et al. 1992; Pirie et al. 1992). Neither published trial of weight control interventions found differences in weight gain among abstinent subjects across treatment conditions (Hall et al. 1992; Pirie et al. 1992). One of the studies (Hall et al. 1992) found evidence for lower caloric intake in specialized weight control interventions, especially among women, but failed to find differences in activity levels across treat- ment conditions. In sum, despite the intuitive appeal of weight control interventions to promote smoking cessation, there is mixed evidence relating such inter- ventions to cessation success (Fiore et al. 2000). Hall and colleagues (1992) suggested that such interventions may interfere with cessation. However, Marcus and colleagues (1999) found that a vigorous exercise inter- vention increased quit rates while contributing to weight management. Pharmacotherapies, including bupropion sustained release (SR) and nicotine gum, may help to delay weight gain after cessation (Emont and Cummings 1987; Doherty et al. 1996; Jorenby et al. 1999). Hypnosis Efficacy Some smokers try hypnosis therapy to help them quit (Schlvartz 1987). Strategies for hypnosis interven- tions include direct hypnotic suggestions to quit, sug- gestions intended to produce aversion to smoking, and training in self-hypnosis to reinforce formal treatment (Simon and Salzberg 1982). Efficacy The methodological shortcomings of hypnosis research make it difficult to estimate the value of this therapy for smoking cessation (Schwartz 1987). Re- viewers have noted that, in general, hypnosis is not very effective when used alone, but it may be useful as part of a multicomponent intervention in which subjects see a therapist many times (Holroyd 1980; Schwartz 1987). In methodologically sound studies, hypnosis often fails to outperform comparison tech- niques, such as self-help strategies (Rabkin et al. 1984; Lambe et al. 1986). Hypnosis techniques may work best for the relatively small proportion of people highly susceptible to hypnosis (Barabasz et al. 1986; USDHHS 1988). Since the late 198Os, there have been only two trials of hypnosis in smoking cessation, with incon- clusi\-e results. Johnson and Karkut (1994) conducted an uncontrolled clinical trial of hypnosis plus aversion treatment and reported about 90 percent abstinence at three months. A similar uncontrolled study of 226 smokers reported a 23-percent abstinence at two years (Spiegel et al. 1993). A recent review of hypnosis by the Cochrane group (Abbot et al. 2000) found insuffi- cient evidence to support hypnosis as a treatment for smoking cessation. Releoar; t Process Measures Appropriate process measures for studies of hypnosis are those that assess the various means of hyp- notic induction and the motivational changes that are presumed to accrue from them. Because measures have rarely been collected, little is known about the mecha- nisms of hypnotic treatments for smoking cessation (Holroyd 1980; Schwartz 1987; USDHHS 1988). Acupuncture The typical acupuncture treatment for smoking cessation involves the insertion of needles or staples into the outer ear, but a number of other techniques ha1.e been investigated (Schwartz 1988). The most commonly cited rationale for using acupuncture is that it relie\,cs the discomfort of nicotine withdrawal. The available evidence suggests that acupunc- ture is no more effective in smoking cessation than placebo treatments (Schwartz 1987). For example, Schwartz (1988) reviewed eight studies in which acu- puncture at a theoretically appropriate site was con- trasted with acupuncture at a placebo site. Only one of these studies found greater success among partici- pants undergoing the procedure with theoretically appropriate sites (MacHovec and Man 1978). A recent meta-analysis of five studies (Fiore et al. 2000) found that acupuncture was no more effective than placebo. Relevant Process Measures Acupuncture is commonly presumed to exert its effects by easing tobacco withdrawal. At present there is no evidence that acupuncture is capable of relieving withdrawal symptoms associated with smoking cessa- tion (Clavel et al. 1987; Schwartz 1987; USDHHS 1988). Summary of Intensive Clinical Interventions Intensive programs serve an important function in the nation's efforts to reduce smoking, despite the resources the programs demand and the relatively small population of smokers who use them. Such pro- grams may be particularly useful in treating smokers who find it most difficult to quit. Because intensive smoking cessation programs differ in structure and content, evaluation is often ham- pered by variation in methodology and by a lack of research addressing specific treatment techniques. Because few studies have chosen to isolate single treat- ments, assessment of the effectiveness of specific ap- proaches is difficult. Nonetheless, skills training, rapid smoking, and both intratreatment and extratreatment social support have been associated with successful smoking cessation. When such treatments are shown to be effective, they are usually part of a multifactorial intervention. Little clear evidence has implicated par- ticular psychological, behavioral, or cognitive mecha- nisms as the agents of change. The specific impact of intensive interventions may be masked by the efficacy of several multicomponent programs, some of which have achieved cessation proportions of 30-50 percent (Land0 1993). Thus, in their positive effect on smoking cessa- tion and long-term abstinence rates (Kottke et al. 1988; Fiore et al. 1994a), intensive interventions seem little different from other forms of counseling or psy- chotherapy. With intensive interventions, as with counseling, it is difficult to attribute the efficacy to Reducing Tobacco Use specific characteristics of the interventions or to spe- cific change mechanisms (Luborsky et al. 1975; Elkin et al. 1989). Pharmacologic Interventions At first look, nicotine replacement therapy ap- pears to be the treatment of a disease with its cause. The rationale, however, is well established. Observa- tions on the beneficial effects of nicotine replacement in abstinent smokers were first made in 1967 (Lucchesi et al. 19671, and the process has its medical precedent in the use of methadone for opiate dependence. Nico- tine use, in the form of 10 or more cigarettes a day, provides continuous neuroexposure (Benowitz 1993). The resulting tolerance and physical dependence pro- duce classic withdrawal symptoms (USDHHS 1988). As Benowitz (1993) has summarized, "Nicotine re- placement therapy serves primarily to break the daily addiction cycle by relieving withdrawal symptoms, thereby facilitating behavioural modification that is necessary for permanent smoking cessation" (p. 158). However, as will be discussed later in this chapter, re- cent data suggest that nicotine replacement may be effective without behavioral support or counseling. A number of candidate delivery systems have now been extensively evaluated with clear and consistent results. In addition, nonnicotine pharmacotherapies for treat- ment of tobacco use are now available. Nicotine Polacrilex Nicotine polacrilex (nicotine gum) was approved by the Food and Drug Administration (FDA) for use as an aid to smoking cessation in a 2-mg dose in 1984 and in a 4-mg dose in 1994. The nicotine in the gum is bound to an ion-exchange resin. Chewing the gum liberates the nicotine, which is absorbed through the buccal mucosa. Currently, both doses of nicotine polacrilex are approved for use as over-the-counter preparations by adults. The package insert instructs patients to use the gum as needed with the constraint that they not exceed a daily dose of 20 pieces of 4-mg gum or 30 pieces of 2-mg gum. Efiicacy With more than 50 studies on its efficacy, nico- tine gum is the most extensively investigated pharma- cologic treatment for smoking cessation. This body of research has been summarized by several major meta-analyses (Lam et al. 1987; Cepeda-Benito 1993; Silagy et al. 1994; Tang et al. 1994). The most recent meta-analysis (Fiore et al. 2000) is summarized in Table 4.3. All meta-analyses found the gum to be effective in helping smokers quit. Lam and colleagues (1987) performed a meta- analysis of nine randomized, controlled trials of the 2-mg nicotine gum. These authors performed sepa- rate analyses on the trials conducted in specialized smoking cessation clinics and on those conducted in general medical settings. In the specialized clinics, ces- sation success was greater with nicotine gum than with placebo gum. In general medical practice settings, however, nicotine gum was no more successful than placebo gum; both types of gum were more successful than usual care. The authors suggested that partici- pants at the specialized cessation clinics had greater success because such participants may have been more motivated to quit and may have received more inten- sive adjuvant behavioral support than those at the generalized settings. The authors also speculated that patients who seek treatment in specialized clinics may be more physically dependent on nicotine and thus more likely to benefit from nicotine replacement than the average patient seen in a general medical clinic. Cepeda-Benito (1993) performed a meta-analysis of 33 trials of the 2-mg gum. As in the review by Lam and colleagues (19871, the trials were categorized ac- cording to whether the adjuvant behavioral support was intensive or brief and according to whether the control group used placebo gum or no gum. Pooled estimates of efficacy were derived for short-term (O-8 weeks after treatment) and long-term (12 2 2 months) outcome measures within each category. Effect sizes were not systematically related to the type of control treatment used but were related to the intensity of be- havioral support provided. When used in intensive interventions, the gum was associated with greater abstinence success than the control treatments at both long-term and short-term follow-up. When used in brief behavioral interventions, however, the gum out- performed the control interventions only at short-term follow-up. The author concluded that nicotine gum is an effective aid to smoking cessation but questioned its long-term value in the absence of adjuvant psycho- social support. In the context of a larger review of available nico- tine replacement therapies, Tang and colleagues (1994) performed a meta-analysis of 28 randomized, controlled trials of the 2-mg gum and 6 randomized, controlled trials of the 4-mg gum. The authors found that among participants recruited through advertise- ments to attend specialized cessation clinics, the 2-mg gum was associated with an ll-percent increase in success over control treatments. However, among Mmmger?rtwt of Nicotirw Addiction 2 13 smokers who were directly invited to participate in a general smoking cessation trial conducted by a non- specialist physician, the 2-mg gum increased absti- nence success by only 3 percentage points over control conditions. Consistent with the analysis by Lam and colleagues (1987), the authors suggested that these findings reflect (1) the greater motivation of the smok- ers who referred themselves (i.e., responded to adver- tisements instead of being directly invited), (2) the greater degree of nicotine dependence in the self- referred group, and (3) the more extensive encourage- ment and more detailed instructions provided by therapists in the specialized settings in which the self- referred smokers were treated. Six of the 28 trials of the 2-mg gum (Fagerstrcm 1982,1984; Jarvik and Schneider 1984; Areechon and Punnotock 1988; Hughes et al. 1989b; Jensen et al. 1990) reported abstinence success as a function of nicotine dependence as assessed by the Fagerstrijm Tolerance Questionnaire (described later in this chap- ter). The authors aggregated these data and found that the 2-mg gum improved cessation success by 16 percentage points among smokers scoring high (indicating considerable nicotine dependence) on the Table 4.3. Meta-analyses of efficacy (estimated odds ratio and abstinence rates) for seven pharmacotherapies used in tobacco dependence treatment Pharmacotherapy Number of study groups Bupropion SR' (n = 2i) Placebo Bupropion SR Nicotine gum, 2 mg (n = 13) Placebo Nicotine gum Nicotine inhaler (n = 4) Placebo Nicotine inhaler Nicotine nasal spray (n = 3) Placebo Nicotine spray Transdermal nicotine (the nicotine patch) (n = 27) Placebo Transdermal nicotine Clonidine (n = 5) Placebo Clonidine Nortriptyline (n = 2) Placebo Nortriptyline 2 4 16 18 4 4 3 3 28 32 6 8 3 3 Estimated Estimated odds ratio abstinence rate (95% CI') (95% CI) 1.0 2.1 (1.5, 3.0) 1.0 1.5 (1.3,1.8) 1.0 2.5 (1.7, 3.6) 1.0 2.7 (1.8,4.1) 17.3 30.5 (23.2,37.8) 17.1 23.7 (20.6, 26.7) 10.5 22.8 (16.4,29.2) 13.9 30.5 (21.8,39.2) 1.0 1.9 (1.7,2.2) 1.0 2.1 (1.4, 3.2) 1.0 3.2 (1.8, 5.7) 10.0 17.7 (16.0, 19.5) 13.9 25.6 (17.7,33.6) 11.7 30.1 (18.1,41.6) *Confidence interval. `SR = sustained release. iNumber of studies. Source: Fiore et al. 2000. 2 24 Chayter 4 ReducilTg Tobacco Use questionnaire but produced only a 2-percentage point increase among smokers whose scores indicated low levels of nicotine dependence. When data from the 4-mg gum trials (Puska et al. 1979; Kornitzer et al. 1987; Tonnesen et al. 1988a,b; Blondal 1989; Hughes et al. 1990a) were aggregated, the influence of nicotine dependence paralleled that seen in trials using the lower dose. Among smokers highly dependent on nicotine, those who used the 4-mg gum had a 21-percent greater success at cessa- tion than those using the 2-mg gum. In contrast, among smokers low in nicotine dependence, those who used the 4-mg gum had an l&percent lower success than those using the 2-mg gum. Highly dependent participants using the 4-mg gum had a 35-percent greater success than those using the placebo gum, but this comparative improvement was only 5 percent greater among less dependent participants. Tang and colleagues (19941 concluded that nico- tine gum is an effective aid to smoking cessation and suggested that its efficacy is a direct function of the dependence of the smoker. On the basis of their re- view of other nicotine replacement therapies (includ- ing the nicotine patch), the authors concluded that the 4-mg gum is the most effective form of nicotine re- placement for highly dependent smokers. Silagy and colleagues (1994) examined 42 nico- tine gum trials in their meta-analysis of nicotine re- placement interventions. To compute effect sizes for each analysis, the authors combined data from the longest follow-up assessments (mainly 12 months) from available trials, regardless of gum dose or type of control treatment. Across all 42 trials, 42 percent of participants using nicotine gum quit smoking, whereas only 18 percent of participants in the control groups, who used either placebo gum or no gum, succeeded in quitting. The pooled odds ratio (OR) for the gum- to-control comparison across all trials was 1.61 (95 percent confidence interval [CI], 1.46-1.78). Differ- ences between gum and control conditions did not vary according to the intensity of adjuvant behavioral support. Fiore and colleagues (1990) conducted a meta- analysis of 13 randomized controlled trials of 2-mg nicotine gum therapy with at least five months of fol- low-up (Table 4.3). Nicotine gum treatment was asso- ciated with a 50-percent increase in quit rates (23.7 percent quit rate vs. 17.1 percent) in the control group. There were too few studies done in the over-the- counter setting to allow meta-analysis of the over-the- counter effect of nicotine gum. Taken together, these meta-analyses suggest that nicotine chewing gum is an effective aid to smoking cessation. This conclusion continues to be borne out as evidence continues to accumulate. In an ongoing project, Silagy and colleagues (1999) have been regu- larly searching medical databases for new nicotine re- placement trials, recalculating effect sizes as new data sources are identified, and frequently publishing the updated meta-analyses. In the most recent edition of this meta-analysis, the pooled gum-to-control OR was estimated at 1.63. That in most settings nicotine- containing gum is associated with greater cessation success than placebo gum suggests that the gum's ef- ficacy is due to its pharmacologic properties. Some evidence indicates that the efficacy of the 2-mg gum depends on the presence of intensive adjuvant behav- ioral support. The meta-analysis by Silagy and col- leagues (1994) suggests that nicotine gum may be beneficial even without intensive adjuvant therapy. In this analysis, however, because 2-mg and 4-mg gum studies are combined, definitive conclusions about the efficacy of either dose alone in the absence of behav- ioral support cannot be drawn. This finding under- scores the importance of selecting those smokers for whom nicotine gum is likely to be beneficial. The avail- able evidence suggests that traditional measures of nicotine dependence may be a useful basis for select- ing gum candidates. Both doses of the gum appear to be of greater value to smokers who are more depen- dent on nicotine. The 4-mg gum may be particularly effective for the most dependent smokers. RelevaA Process Measures Nicotine gum is presumed to exert its effects by replacing a portion of the nicotine that smokers usu- ally obtain through smoking; in therapy, the gum ame- liorates aversive tobacco withdrawal (Benowitz 1991; Hughes 1993). Some evidence suggests that nicotine gum reliably reduces some withdrawal symptoms. Patients receiving the 2-mg nicotine gum have consistently reported having less total withdrawal dis- comfort than patients treated with placebo gum (Jarvis et al. 1982; Hughes et al. 1984,1989a, 1991b; Gross and Stitzer 1989; Hatsukami et al. 1991). However, studies have found that withdrawal severity is not consistently related to smoking relapse (West 1992; Hughes 19931, and the withdrawal suppression produced by nicotine gum appears to be somewhat independent of its effi- cacy. Moreover, the suppression reported seems to accrue through the lessening of a relatively small sub- set of withdrawal symptoms (Hughes et al. 1990b). The 2-mg gum consistently alleviates symptoms such as Sqeo)~ Grtreral's Report anxiety and irritability but does not appear to reliably ameliorate craving, hunger, sleep disturbance, or dif- ficulty concentrating (West et al. 1984a,b; Gross and Stitzer 1989; Hughes et al. 1989a, 1990a; Hatsukami et al. 1991). One trial (Hughes et al. 1990a) has found that the 4-mg gum was no more effective than the 2-mg gum either in suppressing total withdrawal se- verity or in relieving any of the individual symptoms of withdrawal. Future research must explore whether these counterintuitive findings are a result of poor measurement of withdrawal severity or whether other mechanisms explain how nicotine gum produces clini- cal success (Hughes 1993). Effect on Postcessation Change in Body Weight Evidence suggests that the 2-mg gum is capable of delaying, but not preventing, postcessation weight gain. Early in the cessation process, smokers given the 2-mg gum tend to gain less weight than smokers treated with placebo gum (Gross et al. 1989). During this period, weight gain among the 2-mg gum users is inversely related to the amount of gum used (Emont and Cummings 1987; Fagerstrom 1987; Killen et al. 1990a; Nides et al. 1994). However, differences in weight gain between smokers using the 2-mg gum, using placebo gum, and using no gum (Gross et al. 1989; Nides et al. 1994) disappear when follow-up is conducted after gum therapy has ended. Relatively little is known about the weight- related effects of the 4-mg gum. Early trials did not show it to diminish weight gain any more than either the 2-mg gum (Kornitzer et al. 1987; Tonnesen et al. 1988a) or the placebo gum (Puska et al. 1979; Tonnesen et al. 1988a). These trials, however, tended to use dif- ferent weight measures and more distal end points than the typical trial with 2-mg gum, and one trial used a mixed-dose regimen (Tonnesen et al. 1988a). A more recent study, however, reported that nicotine gum sup- pressed weight gain with greater suppression occur- ring with the 4-mg dose (Doherty et al. 1996). Analysis of salivary cotinine showed that smokers who replaced a greater percentage of their baseline cotinine levels gained less weight. Side Effects and Likelihood of Inappropriate Use Common side effects reported by the 2-mg gum users include mouth soreness, hiccups, indigestion, jaw ache, and unpleasant taste (American Medical As- sociation [AMA] 1993; Tang et al. 1994). Most of these symptoms are relatively mild and transient, and many can be resolved by correcting the user`s chew- ing technique. Symptoms observed less frequently (in less than 2 percent of patients) include irritability, lightheadedness, headache, excessive salivation, and anorexia (AMA 1993). Moreover, absorption of nico- tine from the gum is highly dependent on the pH of the mouth (Henningfield et al. 1990). Because nico- tine is inactivated by an acidic environment, patients are urged to refrain from eating or drinking anything but water for 30 minutes before using the gum. Ap- proximately lo-25 percent of successful abstainers con- tinue to use the gum for one year or longer (Hajek et al. 1988; Hughes 1988; Hughes et al. 1991a). Although discontinuance of use should be encouraged, contin- ued use confers a substantial reduced health risk com- pared to a return to smoking. The 4-mg gum appears to have similar side effects, but it may produce slightly more dyspepsia and hiccuping than does the 2-mg gum (Tonnesen et al. 1988a,b). Transdermal Nicotine In 1991, the FDA approved the use of transdermal nicotine patches as an aid to smoking cessation. Nico- tine patches contain a reservoir of nicotine that diffuses through the skin and into the wearer's bloodstream at a constant rate. Patients are usually instructed to apply one patch each day. Specific dosing regimen may vary. All currently marketed brands are designed to deliver approximately 0.9 mg per hour of nicotine over the weaning period. Most are intended for 24-hour wear and deliver 21-22 mg of nicotine; one is intended for waking hours wear (16 hours per day) and deliv- ers 15 mg of nicotine. Full-strength patches typically produce serum nicotine levels similar to trough levels of serum nicotine in moderate to heavy smokers (Mulligan et al. 19901. On July 3, 1996, the FDA ap- proved the transdermal nicotine patch for over-the- counter sales at a dose of 15 mg for use as part of a comprehensive behavioral program of smoking ces- sation, although the FDA's proscription does not pro- vide a clear statement of the constituents of such a program. Since that time, all varieties of nicotine patches have become available over the counter, some as "house brands." Efficacy Several meta-analyses of the efficacy of the nico- tine patch have been published (PO 1993; Fiore et al. 1994~; Gourlay 1994; Silagy et al. 1994; Tang et al. 1994; Fiore et al. 2000). Each meta-analysis has concluded that the patch is an effective aid to smoking cessation. PO (1993) combined data from 11 nicotine patch trials and found that persons using the nicotine patch had greater cessation success than persons using a 12 6 Chapter 4 Reducing Tobacco Use placebo patch. This finding held for both short-term follow-up (3-10 weeks; combined OR = 3.10 J95 per- cent CI, 2.65-3.621) and long-term follow-up (6-12 months; combined OR = 2.26 [95 percent CI, 1.80- 2.861). Gourlay (19941 pooled the results of six trials and found that the nicotine patch produced greater cessation success than a placebo patch at all follow-up assessments (2-3 months, 6 months, and 12 months; all pooled ORs were between 2.2 and 2.4 I95 percent CI, 1.6-3.41). Tang and colleagues (1994) conducted a meta-analysis of six patch trials. Overall, at long-term (12-month) follow-up, persons using nicotine patches had a 9-percent (6-13 percent) greater success at ces- sation than did persons using placebo patches. Nico- tine patches were found to be more effectivre among self-referred subjects than among invited subjects and slightly more effective among smokers \vho were more dependent on nicotine. Silagy and colleagues (199-l) combined data from nine patch trials and found that at long-term (12-month) follow-up, nicotine patches were associated with a combined OR of 2.07 (95 per- cent CI, 1.64-2.62) when compared with control con- ditions (placebo patches or no patch). Secondary analyses indicated that the patch's relative efficacy was not affected by the intensity of adjuvant support. Fiore and colleagues (1994~) examined 17 nicotine patch tri- als and found a combined OR of 2.6 (95 percent CI, 2.2-3.0) at the end of the treatment and 3.0 (95 percent CI, 2.4-3.7) at 72-month follow-up. More intensive ad- juvant support was found to produce higher absti- nence rates at six months (26.5 vs. 19.5 percent for low-intensity interventions) but did not increase the relative advantage of nicotine patches over placebo patches. The 16- and 24-hour patches were found to be equally effective. Neither weaning nor extending treatment beyond eight weeks was found to improve outcome. A recent meta-analysis (Fiore et al. 2000) of 27 studies reported that transdermal nicotine increased long-term cessation by 90 percent (Table 4.3). A meta- analysis of three studies reported that over-the-counter nicotine patch use increased successful long-term cessation by 80 percent (Fiore et al. 2000). These meta-analyses strongly indicate that the nicotine patch is an effective aid to smoking cessation. This conclusion is buttressed by the findings of a con- tinuing, regularly updated review of the existing re- search literature on transdermal nicotine (Silagy et al. 1999). In the most recent release of this evolving meta- analysis, Silagy and colleagues (1999) found a pooled patch-to-control OR of 1.84 (95 percent CI, 1.60-2.10). The data continue to suggest that 16- and 24-hour patches are equivalent in efficacy, that there is no ad vantage associated with weaning or tapering of patch dose, and that the relative efficacy of the patch is fairly independent of the intensity of adjuvant therapy. Nico- tine patches have been consistently found to outper- form placebo patches regardless of dosing regimen and in a variety of investigational settings. For example, a study of "real-world" use of the patch-based on a follow-back of older persons who had filled patch prescriptions-produced a self-reported cessation pro- portion of 29 percent at six months (Orleans et al. 1994). The patch is more effective than placebo treatment when paired with only brief support, and it is associ- ated with the higher long-term success when paired with more intensive counseling or behavioral interven- tions (Fiore et al. 1994b). Though the nicotine patch does increase success rates when used with minimal formal counseling, many nicotine patch clinical trials invrolve frequent follow-up assessments. Such contacts might boost success rates obtained with the patch. In support of this possibility, Jorenby and colleagues (1995b) found that the combination of nicotine patch treatment plus frequent assessments produced follow- up outcomes equivalent to the nicotine patch plus in- tensive behavioral therapy. Further assessment of this issue is important, as frequent follow-up contact does not usually accompany nicotine patch use outside of clinical trials (Cummings et al. 1994; Swartz et al. 1995). A meta-analysis of three studies of over-the-counter nicotine patches, however, indicated that patch therapy was superior to placebo (Fiore et al. 2000). Effects on Discomfort of Nicotine Withdrawal Some evidence suggests that the nicotine patch reduces overall measures of nicotine withdrawal dis- comfort (Daughton et al. 1991; Transdermal Nicotine Study Group 1991; Jorenby et al. 19961, but this find- ing has not been consistent (Abelin et al. 1989; Tannesen et al. 1991; Merz et al. 1993). Use of the nico- tine patch has been repeatedly found to reduce the craving for cigarettes (Abelin et al. 1989; Rose et al. 1990; Tonnesen et al. 1991; Transdermal Nicotine Study Group 1991; Merz et al. 1993; Sachs et al. 1993; Westman et al. 1993; Fiore et al. 1994b; Levin et al. 1994; Jorenby et al. 1996), but other symptoms of nicotine withdrawal are affected less reliably (Palmer et al. 1992). In a study designed to clarify the impact the patch has on with- drawal symptoms, the patch reliably reduced craving, anxiety, and irritability but did not alleviate depressed mood, restlessness, or sleep disruption (Jorenby et al. 1996). The authors noted that with or without the patch, most withdrawal symptoms disappeared within three to four weeks. Effect on Postcessation Change in Body Weight Nicotine patches can attenuate postcessation weight gain while they are in use (Abelin et al. 1989; Sachs et al. 1993; Jorenby et al. 1995a; Dale et al. 19981, but this short-term effect has not always been observed (Rose et al. 1990; Tonnesen et al. 1991; Transdermal Nicotine Study Group 1991; Fiore et al. 1994b). More- over, studies that follow up effects after treatment has ended have not found that persons who used the nico- tine patch gained less weight than those who used a placebo patch (Tonnesen et al. 1991). Side Effects and Likelihood of Inappropriate Use Most side effects of nicotine patch use are rela- tively mild; less than 5 percent of patients need to dis- continue patch therapy because of side effects (Hughes and Glaser 1993). Minor skin irritation at the patch site is reported by 30-50 percent of patch users and can be relieved by moving the patch to another site. Insomnia is reported by l-23 percent of patch users (AMA 1993). Comparatively rare side effects include headache, dizziness, fatigue, gastrointestinal distress, sweating, limb pain, and palpitations (Palmer et al. 1992). Studies have found little evidence that people will inappropriately use transdermal nicotine systems (Palmer et al. 1992; Hughes 1993; Jorenby et al. 1995b). The risks associated with using the nicotine patch during pregnancy are largely unknown. Nicotine it- self poses risks to the fetus, including neurotoxicity (Slotkin 1998), and pregnant women should first be encouraged to quit without pharmacotherapy. Because exposure to nicotine through maternal use of the patch probably poses less danger to the fetus than does con- tinued maternal smoking (Hackman et al. 19991, how- ever, nicotine replacement therapy may be indicated for pregnant women who are unable to quit smoking (Benowitz 1991; Lewis and Fiore 1994). However, if a decision is made to use nicotine replacement therapy during pregnancy, the physician should consider moni- toring blood nicotine levels, using doses at the low end of the effective range, and choosing intermittent de- livery systems (such as nicotine gum) (Fiore et al. 2000). The issue is under active investigation. Continued smoking while using the patch may be a significant problem. In an observational study of self-reported patch use, almost one-half the respon- dents stated that they smoked while using the patch; 20 percent of the respondents did so every day (Or- leans et al. 1994). A small number of adverse cardio- vascular events were reported in patients who continued to smoke while using the patch. When these events received much attention from the popular press, several analyses, including one by an FDA advisory committee, have documented no association between nicotine replacement therapy and cardiovascular events even in patients who continue to smoke inter- mittently (Working Group for the Study of Transdermal Nicotine in Patients with Coronary Ar- tery Disease 1994; Joseph et al. 1996; Benowitz and Gourlay 1997; Mahmarian et al. 1997). Caution should be used, however, for patients with acute cardiovas- cular disease (immediately post-myocardial infarction or in the presence of serious arrhythmias or serious or accelerating angina pectoris). Relevant Process Measures Like nicotine gum, the nicotine patch is intended to reduce tobacco withdrawal symptoms Palmer et al. 1992; Glover 1993b; Hughes and Glaser 1993). Al- though the nicotine patch appears to reduce with- drawal severity, particularly craving for cigarettes, withdrawal suppression may or may not be respon- sible for the patch's efficacy (Hughes 1993). For ex- ample, one trial failed to reveal reliable differences in withdrawal severity between persons using nicotine patches and those using placebo patches (Merz et al. 1993); the trial nevertheless found that participants who used the nicotine patch were nearly twice as likely to quit smoking. Another trial employing two doses of transdermal nicotine found that the higher-dose patch produced significantly greater cessation success than the lower-dose patch, even though both doses provided about the same amount of relief from with- drawal symptoms (Transdermal Nicotine Study Group 1991; Hughes 1993). Clearly, other potential mecha- nisms of the patch's action, as well as the action of nico- tine replacement therapy in general, need to be explored. Nicotine Nasal Spray Nicotine nasal spray was approved for prescrip- tion use in the United States in March 1996. The spray consists of a pocket-sized bottle and pump assembly, which is fitted to a nozzle designed for insertion into the nose. Each metered spray delivers 0.5 mg of nico- tine to the nasal mucosa. The recommended dose is 1 mg, or one 0.5-mg spray per nostril, as needed (Sutherland et al. 1992). Efficacy A number of clinical trials have assessed the effi- cacy of the nicotine nasal spray as an aid to smoking cessation. Sutherland and colleagues (1992) found that Reducing Tobacco Use 26 percent of participants given nicotine nasal spray were abstinent after one year, compared with only 10 percent of participants given placebo. Hjalmarson and colleagues (1994) found similar results in a placebo- controlled trial; at one-year follow-up, abstinence rates were 27 percent and 15 percent, respectively, for par- ticipants given active spray or placebo. Schneider and colleagues (1995) again replicated this effect, finding continuous abstinence rates of 18 percent and 8 per- cent among participants given active or placebo spray. Another study (Blondal et al. 1997) did not find a sig- nificant difference in abstinence rates between active spray and placebo groups at one year (25 vs. ;17 per- cent); active spray was associated with higher absti- nence rates at six months and earlier in this trial. Recently, Blondal and colleagues (1999) provided all participants in a second trial with active nicotine patches, then studied the incremental efficacy of add- ing nasal spray therapy to the patch regimen in a double-blind, placebo-controlled fashion. Results showed that participants given the active spray were more likely to be abstinent -after one year than partici- pants given placebo (27 vs. 11 percent). Participants given active spray had a higher rate of abstinence than participants given placebo a full six years after the start of treatment 06 vs. 9 percent), but this effect was only marginally significant. Taken together, the results of these studies suggest that nicotine nasal spray is an aid to smoking cessation. A meta-analysis by Silagy and colleagues (1999) reported a pooled spray-to-control OR of 2.27, and a recent meta-analysis (Fiore et al. 2000) reported an OR of 2.7 (30.5 percent long-term abstinence rate) (Table 4.3). Effect on Discomfort of Nicotine Withdrawal Evidence regarding the nicotine nasal spray's effects on nicotine withdrawal discomfort is sparse. The results of two studies suggest that the spray may be useful for coping with craving, but may not be ef- fective in alleviating other withdrawal symptoms. One study (Sutherland et al. 1992) found that, compared with participants using placebo spray, participants treated with nicotine spray reported having less total withdrawal discomfort during the 48 hours immedi- ately after smoking cessation and reported less crav- ing for cigarettes during this period. After 48 hours, however, the two groups reported equivalent levels of withdrawal discomfort and craving. When craving did arise, the nicotine spray was consistently rated more effective than the placebo spray. The other study (Hjalmarson et al. 1994) found that during the first 48 hours of smoking cessation, users of nicotine spray reported somewhat less severe withdrawal discomfort than placebo users, but this effect was not statistically significant. The severity of craving was found to be similar across both groups, but the nicotine spray was more helpful in quelling craving than the placebo spray was. Other clinical tri- als have not reported comparisons between active and .placebo spray groups with regard to withdrawal mea- sures (e.g., Schneider et al. 1995; Blondal et al. 1999). Effect on Postcessation Change in Body Weight The limited evidence available suggests that the nicotine nasal spray may be capable of delaying, but not preventing, postcessation weight gain. In one of the trials (Sutherland et al. 19921, participants were allowed to use the spray they were assigned for as long as one year.. Weight effects in that study differed as a function of duration of spray use: abstinent subjects who had continued to use the nicotine spray for the entire year of the study had gained significantly less weight than subjects still using the placebo spray. However, change in body weight was equivalent for abstinent patients who had stopped using either type of spray during the year. Another study (Hjalmarson et al. 1994) failed to find any statistically significant differences in weight gain between participants using nicotine spray and those using placebo spray. The authors observed, how- ever, that participants still using nicotine spray at the 12-month follow-up tended to gain less weight than both participants continuing to use a placebo spray and participants who had stopped using the nicotine spray before that time. Side Effects and Likelihood of Inappropriate Use Unpleasant side effects are common with the nasal spray. Between 75 and 100 percent of nasal spray users reported experiencing irritant effects, such as runny nose, sneezing, throat irritation, nasal irritation, watering eyes, and coughing (Sutherland et al. 1992; Hjalmarson et al. 1994; Schneider et al. 1995). Some authors have reported that these sensory irritation ef- fects are actually viewed as desirable by many smok- ers and have suggested that they may help bridge the gap between cigarette smoking and nicotine replace- ment (Glover 1993a; Schneider 1993). Less common side effects, present in 15-25 percent of users, include nausea, sweating, headache, dizziness, and cold hands and feet. Because the spray rapidly delivers nicotine to the user, the potential for inappropriate use (e.g., using more often or at a higher dose than recommended) is high. The results of both clinical trials lend some cre- dence to these speculations. Sutherland and colleagues (1992) found that 43 percent of abstinent study par- ticipants who had been given the nicotine spray chose to continue using it for the entire year of the study; moreover, mean plasma nicotine concentrations in- creased over the follow-up period among participants who continued to use the spray. Participants in the trial conducted by Hjalmarson and colleagues (1994) were explicitly encouraged to begin weaning them- selves from the spray (whether nicotine or placebo) after three months. Nonetheless, 30 percent of absti- nent participants who had been given the nicotine spray continued to use it after one year. Schneider and colleagues (1995) required that participants in their trial use the spray daily for six weeks, then allowed participants to use spray for up to six months postcessation as needed. Thirty-two percent of par- ticipants given active spray continued using it daily for six months, compared with 13 percent of partici- pants given placebo. The authors also reported that some continuous abstainers assigned to active spray reported being concerned that they were dependent upon the spray at six months postcessation. However, a substantial proportion of these individuals remained abstinent many months after drug weaning. Tonnesen et al. 19931. Each inhaler contains enough nicotine for approximately 300 puffs. Smokers are in- strutted to use between 6 and 16 inhalers per day. Efficacy A handful of published trials have examined the efficacy of the nicotine inhaler as an aid to smoking ces- sation. Tonnesen and colleagues (1993) found that 17 percent of participants randomized to active inhalers had quit smoking at six months, compared with 8 per- cent of participants given placebo. Corresponding rates at one year were 15 vs. 5 percent. Schneider and col- leagues (1996) found active-placebo abstinence rates of 17 vs. 9 percent and 13 vs. 8 percent at six months and one year, respectively. These differences were not sig- nificant in the Schneider trial, although active inhalers were superior to placebo at all follow-ups through three months postcessation. Hjalmarson and colleagues (1997) found continuous abstinence rates of 35 percent and 28 percent for active inhaler users at 6 and 12 months, compared with 19 percent and 18 percent, respectively, among placebo users. Active-placebo comparisons were statistically significant at all follow- ups in this trial. The most recent edition of a regularly updated meta-analysis of nicotine replacement prod- ucts (Silagy et al. 1999) found an inhaler-to-control pooled OR of 2.08, and another recent meta-analysis of four studies (Fiore et al. 2000) reported a pooled OR of 2.5 (Table 4.3). Relevant Process Measures Nicotine nasal spray, like other nicotine replace- ment products, is intended to aid smoking cessation by relieving withdrawal symptoms. Although the spray has been found effective in promoting cessation, its circumscribed impact on total withdrawal severity suggests that withdrawal relief is not itself responsible for the spray's usefulness. The spray's documented ability to alleviate craving may be what makes it an effective smoking cessation treatment. More research is needed to advance definitive conclusions about the Taken together, the results suggest that the nico- tine inhaler is an effective aid to smoking cessation. However, the findings of Schneider and colleagues (1996) suggest that the inhaler may be most useful for producing initial abstinence and that additional inter- ventions may be needed to prevent relapse among users of the inhaler. Effects ou Discomfort of Nicotine Withdrawal spray's mechanism of action. Nicotine Inhaler Limited information is available regarding the effects of the nicotine inhaler on nicotine withdrawal symptoms. Two studies (Schneider et al. 1996; In May 1997, the FDA approved the nicotine in- haler for prescription use. The inhaler consists of a plastic tube, about the size of a cigarette, that contains a plug impregnated with nicotine. Menthol is added to the plug to reduce throat irritation. Smokers are instructed to puff on the inhaler as they would on a cigarette. An average puff delivers approximately 13 ,ug of nicotine (about 1/80th the amount of nicotine contained in an average cigarette puff), which is ab- sorbed primarily by the buccal route (Glover 1993a; Hjalmarson et al. 1997) showed that active inhaler use was associated with decreased craving during the first several days of the quit attempt but not thereafter. Hjalmarson and colleagues (1997) assessed a wide ar- ray of withdrawal symptoms across the cessation at- tempt, but did not find any effects of active inhalers on these other than the fleeting effects on craving. However, this may have been influenced by a floor effect, as mean withdrawal scores were very low in both groups across all assessments. 220 Chapter 4 Reducing Tobacco Use Side Effects and Likelihood of Inappropria te Use The most common side effects associated with inhaler use are throat irritation and coughing. These are reported by between 20 to 50 percent of active in- haler users and are less common among placebo inhaler users (Tonnesen et al. 1993; Schneider et al. 1996; Hjalmarson et al. 1997). Other less common side effects include nausea, bad taste in the mouth, dizzi- ness, gastrointestinal disturbances, and oral burning or smarting. Few (O-9 percent) active inhaler users have withdrawn from clinical trials or stopped using the inhaler because of side effects. The potential for inappropriate use appears to be fairly low, with between 2 to 16 percent of active inhaler users continuing to use the device at six months postcessation in clinical trials allowing unrestricted inhaler use (Tonnesen et al. 1993; Schneider et al. 1996; Hjalmarson et al. 1997). Effect on Postcessation Change in Body Weight Two placebo-controlled inhaler trials have exam- ined postcessation weight gain (Tonnesen et al. 1993; Hjalmarson et al. 1997). Neither study found evidence that active inhaler use prevented or reduced weight gain among successful quitters. Relevant Process Measures The nicotine inhaler is thought to act by reliev- ing withdrawal symptoms (Glover 1993a; Leischow 1994), but little published evidence to date supports this contention. It is often suggested that the inhaler may be effective because it more closely resembles smoking than other pharmacotherapies do, replacing some of the orosensory and behavioral aspects of smoking (Glover 1993a; Tonnesen et al. 1993; Leischow 1994; Schneider et al. 1996; Hjalmarson et al. 1997). Schneider and colleagues (1996) asked partici- pants to rate their assigned inhalers relative to their usual brand of cigarettes in terms of sensory effects, preference, and satisfaction. Results showed that par- ticipants given the active inhaler rated their devices more highly than did participants given placebo. How- ever, the absolute magnitude of the ratings revealed that the inhalers did not compare very favorably to cigarettes in either group. The mechanism of action of the nicotine inhaler would seem to require further scrutiny. Bupropion Bupropion is an atypical antidepressant that is believed to work by blocking neurotransmitter reuptake in noradrenergic and dopaminergic sites in the central nervous system (Ascher et al. 1995). Anec- dotal reports of spontaneous smoking cessation in patients prescribed bupropion for depression, coupled with a growing appreciation of the importance of nega- tive affect and clinical depression in smoking mainte- nance (Hall et al. 1994; Piasecki et al. 1997) have recently stimulated clinical investigations of a sustained-release bupropion preparation as an aid to smoking cessation. These investigations led to the approval of a smoking cessation indication for bupropion by the FDA in 1997. The typical dosing regi- men for smoking cessation consists of 150 mg sustained-release bupropion per day for three days, followed by 150 mg twice a day thereafter. Therapy is initiated one to two weeks before the target quit date and is generally continued for three months. Two large-scale clinical trials of bupropion's ef- ficacy as a smoking cessation aid have been published to date. Hurt and colleagues (1997) compared three doses of bupropion (100 mg, 150 mg, and 300 mg) with placebo. Abstinence rates in the 150-mg and 300-mg groups were significantly higher than those of the pla- cebo group at 12 months. All active treatment groups were found to have higher abstinence rates than the placebo group at earlier end points. Jorenby and col- leagues (1999) studied active and placebo patches and active and placebo bupropion in a 2 x 2 factorial de- sign. Abstinence rates after one year showed no dif- ference between patch-only and placebo groups (16 percent and 15 percent, respectively). Both placebo and patch treatments were associated with higher ab- stinence rates when given with bupropion. Thirty percent of the bupropion-only group (150 mg twice a day) were abstinent at 12 months, whereas 36 percent of participants given active patches and bupropion were counted as abstinent. A recent meta-analysis (Fiore et al. 2000) of two studies reported a pooled OR of 2.1 and an estimated abstinence rate of 30.5 percent (Table 4.3). Thus, the available evidence suggests that bupropion is an ef- fective aid to smoking cessation, and that it may im- prove quit rates over those observed with conventional nicotine replacement therapies, although further stud- ies will be needed to demonstrate such efficacy. Effect on Discomfort of Nicotine Withdrawal The evidence concerning bupropion's ability to suppress withdrawal symptoms is somewhat mixed. Hurt and colleagues (1997) found that their groups using 150 mg and 300 mg reported withdrawal Mnnngcment of Nicotirrr Addictior~ 121 symptoms that were equivalent to those reported by placebo participants. Individuals assigned to the IOO-mg group, however, reported withdrawal that was significantly worse than that among either the placebo group or the other bupropion groups. The authors sug- gested that this effect may have arisen because the lOO-mg dose produced side effects similar to with- drawal symptoms but was not strong enough to re- duce true withdrawal symptoms. Jorenby and colleagues (1999) found that all three groups receiv- ing active treatments compared with the placebo group reported reduced withdrawal. The group given both active patches and active bupropion reported the most consistent withdrawal relief. Further research is needed to characterize the reliability and magnitude of bupropion effects on withdrawal symptoms. Relevant Process Measures Although nicotine replacement therapies are strongly predicated on the assumption that nicotine will relieve withdrawal symptoms, withdrawal relief represents only one of several rationales for using bupropion as a smoking cessation aid. One hypoth- esis is that bupropion may selectively reduce depres- sive symptoms after cessation. However, both trials mentioned previously excluded individuals with cur- rent major depression. Both clinical trials (Hurt et al. 1997; Jorenby et al. 1999) also included multiple as- sessments of postcessation depressive symptomatol- ogy, and neither found any differences among treatment groups on these measures. These findings suggest that bupropion does not work through its an- tidepressant effects per se in relatively healthy clinical trial participants. Bupropion moderates dopaminergic activity in the central nervous system, and dopaminergic circuits are known to play a role in drug reinforcement (Nutt 1997). This raises the possibility that bupropion may exert its effects by replacing positive reinforcement associated with smoking (Hurt et al. 1997). To date, there is no evidence directly bearing on this hypothesis, and it is clear that this process is not easily studied in clinical trials. Laboratory-based pharmacokinetic and neuroimaging studies should be performed to explore this hypothesis. Effects of Postcessation Change in Body Weight Hurt and colleagues (1997) found evidence for a dose-response effect among continuous abstainers, suggesting that participants given the highest doses gained less weight after quitting. Moreover, the dis- parities between treatment groups in terms of weight gain increased across time while medication was dis- pensed. At six-month follow-up, 17 weeks after par- ticipants went off the assigned medication, no differences in weight gain were observed. These com- parisons were limited to a small subsample of continu- ous abstainers. In the Jorenby and colleagues (1999) trial, members of all active treatment groups tended to gain less weight than did placebo participants over the first seven weeks of cessation. Weight gain suppression was greatest for the combined patch- bupropion group. However, none of the groups dif- fered in weight gain after seven weeks after quitting. Together, the results of these trials suggest that bupropion treatment may delay, but not prevent, postcessation weight gain. Side Effects In both clinical trials, two side effects were re- ported more commonly among participants given bupropion than among those given placebo. Dry mouth was reported by 10 to 15 percent of bupropion users, and insomnia was reported by about 30 to 40 percent of bupropion users. Bupropion may increase the risk of seizure and is thus contraindicated for in- dividuals who are seizure prone, such as individuals with a history of alcoholism or alcohol abuse, eating disorder, seizure disorder, or using MAO inhibitors. No seizures were reported in either clinical trial, but participants with risk factors for seizure were excluded from each before enrollment. Clonidine Clonidine is a centrally acting cc,-adrenergic agonist that dampens sympathetic nervous system activity. Clonidine is most commonly used in the man- agement of hypertension; it has not been approved by the FDA as an aid to smoking cessation. Clonidine is available for prescription in oral and transdermal forms; both of these preparations have been investi- gated in smoking cessation trials. Smokers using clonidine as an aid to smoking cessation are generally started on the drug several days before quitting and are maintained on a fixed daily dose for several weeks. Efficacy Covey and Glassman (1991) conducted a meta- analysis of nine early trials of clonidine for smoking cessation. They found that persons given clonidine were more successful at quitting than those given a pla- cebo (OR = 2.36). Five of the nine trials assessed out- come after the therapy was discontinued; only one 122 Chnpter 4 Rrducing Tobacco Use (Glassman et al. 1988) showed a significant overall ad- vantage for clonidine. Clonidine trials using adjunc- tive behavioral therapy were associated with greater relative success (OR = 4.2) than were trials in which treatment essentially consisted of dispensing the drug (OR = 1.7). Trials using transdermal clonidine produced somewhat greater relative success (OR = 3.2) than did trials using oral clonidine (OR = 2.2). The two trials that analyzed efficacy according to sex found clonidine to be much more effective, relative to placebo, among women (OR = 11.0) than among men (OR = 0.9). There is no obvious explanation for this finding. Since the Covey and Glassman (1991) meta- analysis, several large-scale clonidine trials have ap- peared (Prochazka et al. 1992; Glassman et al. 1993; Hilleman et al. 1993; Niaura et al. 1996). These studies indicated a therapeutic effect for clonidine, with some evidence suggesting that clonidine was more effective among women (Glassman et al. 1993; Hilleman et al. 1993) and among those most dependent on nicotine (Glassman et al. 1993). A recent meta-analysis (Fiore et al. 2000) of five clinical trials reported a pooled OR for long-term effectiveness of 2.1 (25.6 percent abstinence rate) (Table 4.3). In these studies, the clonidine dose ranged from 0.1 mg to 0.75 mg per day and was delivered either orally or transdermally. Because of the side effects, the lack of a specific dosing regimen, the prob- lems with abrupt discontinuation of the drug, and the lack of FDA approval, clonidine has been recom- mended as a second-line agent for smoking cessation (Fiore et al. 2000). Effect on Discomfort of Nicotine Withdrawal An early report (Glassman et al. 1984) that clonidine could reduce tobacco withdrawal symptoms, especially craving, spurred the initial investigations of clonidine's usefulness in smoking cessation. Since that report, evidence for this effect has been mixed. Clonidine- and placebo-treated patients have had equivalent levels of withdrawal severity (Wei and Young 1988; Franks et al. 1989; Gourlay et al. 1994). Studies have fairly consistently found that clonidine diminishes the specific symptom of craving (Glassman et al. 1984; Ornish et al. 1988; Prochazka et al. 1992; Gourlay et al. 1994), and some studies have found some effects on withdrawal symptoms, such as anxiety and irritability (Ornish et al. 1988; Prochazka et al. 1992). Side Effects Unpleasant side effects are commonly associated with clonidine use (Gourlay et al. 19941, and as many as 25 percent of patients may discontinue clonidine therapy because of them (Covey and Glassman 1991). The most frequently observed symptoms are dry mouth, fatigue, and dizziness. Local skin irritation is common with transdermal clonidine therapy. The in- cidence of side effects appears to be dose dependent (Gourlay et al. 1994). Care must also be taken to dis- continue clonidine gradually to prevent rebound hy- pertension. No published clinical trials have assessed the effect of clonidine on postcessation weight gain. Relevant Process Measures Clonidine is presumed to exert its effects by ame- liorating withdrawal discomfort (Glassman et al. 1984; Franks et al. 1989). Although a few studies have found that clonidine reduces withdrawal discomfort, find- ings from a well-designed, large-scale multicenter trial (Prochazka et al. 1992) have suggested that this effect does not necessarily lead to greater abstinence. Nortriptyline Nortriptyline is a tricyclic antidepressant that blocks reuptake of norepinephrine and serotonin. As with clonidine, smoking cessation is not an FDA- approved indication for nortriptyline; its primary indication is for the treatment of depressive symptoms. It is a prescription medication and is available in ge- neric form. In smoking cessation studies conducted to date, treatment was initiated 2-4 weeks before the target quit date with gradual titration of dose. Efficacy Two studies have assessed the efficacy of nortrip- tyline for smoking cessation. Hall and colleagues (1998) conducted a 2 (nortriptyline vs. placebo) x 2 (his- tory vs. no history of major depression) x 2 (cognitive behavioral vs. health education therapy) trial that pro- duced a 24-percent sustained abstinence rate in nortrip- tyline users compared with 12 percent in the placebo group. There was no difference in cessation rates as a function of previous history of major depression. In a straight comparison of nortriptyline to placebo, Prochazka and colleagues (1998) found cessation rates at six months of 14 percent in participants given nortriptyline and 3 percent in participants given pla- cebo. A meta-analysis (Fiore et al. 2000) of these two studies reported a pooled OR of 3.2 and a 30.1-percent abstinence rate (Table 4.3). Both studies provide clear evidence of nortriptyline's therapeutic effect. Surgeon Gcrzeral's Report Effect on Discomfort of Nicotine Withdrawal The Hall and colleagues (1998) study assessed both nicotine withdrawal symptoms and negative af- fect in the first eight days following the target quit date. There were no significant differences between the drug therapy groups on nicotine withdrawal severity, sug- gesting that as with many of the other smoking cessa- tion pharmacotherapies, withdrawal relief may not be the primary mechanism of action. The negative affect measure, however, increased in the first three days in the placebo group and declined in the nortriptyline group. This suggests that a negative affect assessment may be more sensitive to some of nortriptyline's thera- peutic effects than a conventional nicotine withdrawal symptom scale. Side Effects Tricyclic antidepressants are known to produce a number of side effects, including sedation and vari- ous anticholinergic effects. In the smoking cessation studies, commonly reported side effects included dry mouth (64-74 percent), lightheadedness (49 percent), shaky hands (23 percent), and blurry vision (16 per- cent) (Hall et al. 1998; Prochazka et al. 1998). Other Antidepressants and Anxiolytics Investigators have begun to explore the poten- tial use of other antidepressants and anxiolytics as pharmacologic aids to smoking cessation, because population-based epidemiologic samples have found that depression and anxiety are associated with ciga- rette smoking (Breslau et al. 1991; Kendler et al. 1993). Research has also shown that smokers with a history of depression are more likely to experience depressive symptoms (Covey et al. 1990) and to relapse after quit- ting (Glassman et al. 1988; Anda et al. 1990) than are smokers without such a history. Some anxiolytics (Glassman et al. 1984; Hilleman et al. 1992) have been shownto ameliorate symptoms of tobacco withdrawal, and preliminary smoking cessation trials using anti- depressants (Edwards et al. 1989) and anxiolytics (Hilleman et al. 1994) have yielded encouraging re- sults. Among the drugs that have been studied or hypothesized to be useful for smoking cessation are buspirone hydrochloride, doxepin hydrochloride, and fluoxetine hydrochloride. Although promising, this avenue of research is not yet developed enough to permit the multipart discussion given to other phar- macologic agents in this chapter. Summary of Pharmacologic Interventions Abundant evidence confirms that both nicotine gum and the nicotine patch are effective aids to smok- ing cessation. The efficacy of nicotine gum may de- pend on the amount of behavioral counseling with which it is paired. The 4-mg dose may be the better pharmacologic treatment for heavy smokers or for those highly dependent on nicotine. The nicotine patch appears to exert an effect independent of behavioral support, but absolute abstinence rates increase as more counseling is added to patch therapy. Nicotine nasal spray and nicotine inhalers are effective aids for smok- ing cessation, although their mechanisms of action are not entirely clear. All nicotine replacement therapies produce side effects, but these are rarely severe enough that patients must discontinue use. Nicotine nasal spray appears to have greater potential for inappro- priate use than other nicotine replacement therapies. Nicotine replacement therapies, especially the gum and the patch, have been shown to delay but not pre- vent weight gain. All nicotine replacement therapies are thought to work in part by reducing withdrawal severity. The available evidence suggests that they do ameliorate some elements of withdrawal, but the relationship between withdrawal suppression and clinical outcome is inconsistent. Bupropion is the first nonnicotine pharma- cotherapy for smoking cessation to be studied in large- scale clinical trials. Results suggest that bupropion is an effective aid to smoking cessation. In addition, bupropion has been demonstrated to be safe when used jointly with nicotine replacement therapy. In the only direct comparison with a nicotine replacement product, bupropion achieved quit rates about double those achieved with the nicotine patch. Bupropion appears to delay but not prevent postcessation weight gain. The available literature contains inconsistent evidence regarding bupropion-mediated withdrawal relief. Bupropion does not appear to work by reduc- ing postcessation depressive symptomatology, but its mechanism of action in smoking cessation remains unknown. Further research is needed to characterize bupropion's central nervous system effects, particu- larly to assess whether the drug partially replaces smoking-related positive reinforcement. Evidence suggested that clonidine is capable of improving smoking cessation rates. Clonidine is hy- pothesized to work by alleviating withdrawal symp- toms. Although clonidine may reduce craving for cigarettes after cessation, it does not consistently ame- liorate other withdrawal symptoms, and its effects on weight gain are unknown. Unpleasant side effects are common with clonidine use. 124 Chapter 4 Antidepressants and anxiolytics are potentially useful agents for smoking cessation. At present, only nortriptyline appears to have consistent empirical evi- dence of smoking cessation efficacy. However, tricy- clic antidepressants produce a number of side effects, including sedation and various anticholinergic effects. Large-Scale Public Health Programs The shift in recent years from a clinical to a pub- lic health perspective in smoking cessation research has led to an increased emphasis on developing and evaluating cost-effective strategies that can be tvidely disseminated (Lichtenstein and Glasgow 1992). This emphasis is reflected in the proliferation of research on self-help manuals (see "Self-Help Manuals," ear- lier in this chapter and "Community Programs," later in this chapter) and on media- and community-based interventions (Flay 1987; Gruman and Lynn 1993). As is true for self-help strategies, media-, worksite-, and community-based programs have promise because they can potentially reach many smokers who may try to quit without formal, face-to- face assistance (Fiore et al. 1990). Moreover, some evi- dence suggests that less educated smokers profit from media campaigns at least as much as more highly edu- cated smokers do (Macaskill et al. 1992). (Other large- scale interventions-educational [Chapter 31 and social [Chapter 7]-are discussed separately.) Investigators have evaluated an array of such programs, but methodological variations across the individual trials have hampered comparisons among studies (Flay 1987; Schwartz 1992). Moreover, meth- odological challenges compromise how research on these programs may be interpreted. For instance, on- going coverage of smoking and its health consequences in the general media may alter the effect of research- based media information. Similarly, secular trends and events that could individually affect large populations of smokers (e.g., the introduction of a new nicotine replacement product) may alter the impact-and complicate the assessment-of media campaigns conducted around the time of such events. Such chal- lenges may account for the inconsistencies seen in this area of research. Media-Based Programs Media used to transmit smoking cessation mes- sages have included television (Brannon et al. 1989; Korhonen et al. 1992; Mudde and De Vries 1999), ra- dio (Farquhar et al. 1990; COMMIT Research Group 19911, the telephone (Ossip-Klein et al. 1991; Pierce et al. 1992), newspapers (Cummings et al. 1987), and the mail (Gritz et al. 1992; McFall et al. 1993). The intensity of media-based programs has var- ied greatly, and these variations may be related to pro- gram success. For example, one study (Gritz et al. 1992) evaluated a minimal mail-based intervention. The in- vestigators mailed self-help smoking materials to a sample of nonvolunteer women who smoked and who belonged to a health maintenance organization. The intervention had no impact; at no point during the 1% month follorv-up period were women ivho had re- ceived the materials more likely to quit smoking or report changes in their moti\.ation to quit than women who had not. In contrast, a more intense media cam- paign evaluated in another study (Orleans et al. 1991) yielded encouraging findings, albeit among treatment volunteers. The investigators tested the impact of add- ing telephone calls from a smoking cessation counse- lor to an intervention that mailed self-help manuals to the volunteers. After 16 months, abstinence from smoking was reported by 23.0 percent of the volun- teers who had received adjuvant telephone counsel- ing and by 15.2 percent of those recei\?ng the self-help materials alone. Mass media campaigns of intermediate intensity, such as televised programs (Flay et al. lY8Y), gener- ally produce modest increases in abstinence-increases that fall short of the moderate effect of telephone coun- seling found among volunteers (Orleans et al. 1991). The influence of intermediate-intensity interventions is difficult to determine precisely, because the results of individual trials may be affected by the peculiari- ties of the specific communities in which they are tested and (as previously discussed) by concurrent changes in secular attitudes toward smoking behavior. These problems are compounded by the designs of communitywide and mass media programs frequently failing to include matched control communities for com- parison. Although more intensive interventions appear to increase cessation over time (Flay 1987), the absence of well-controlled experimental media trials limit any conclusions about a dose-response relationship for media-based programs. The content of various media-based programs can be divided into three categories: (1) programs that present information about the negative health effects of smoking and exposure to secondhand smoke and attempt to motivate smokers to quit; (2) programs that promote the performance of simple cessation-related activities, such as calling a hot line, requesting self- help materials, or enrolling in a smoking cessation contest; and (3) programs that mimic intensive clini- cal interventions (Flav 1987). In general, informational or motivational campaigns can be effective in chang- ing smokers' attitudes, but the effect of such campaigns on behavior is not clear, in part because of the paucity of well-controlled trials that yield a consistent pattern of findings. Research suggests that other types of cam- paigns have greater potential than informational pro- grams to influence smoking behavior, especially if the campaign has multiple components and intense ex- posure (Flay 1987; CDC 1996,1999b; Pierce et al. 1998). Worksite Programs For many years, advocates for tobacco control have been enthusiastic about worksite-based programs, because worksites appear to furnish an ideal setting: a contained audience, an opportunity for smoker partici- pation, an environment in which to convey coherent and consistent messages, and an opportunity to tie in- dividual smoking cessation to overarching institutional policy. Much of the early work in this area provided some justification for the enthusiasm (USDHHS 1986; Glasgow 1987; Fielding and Piserchia 19891, but more recent data, described later in this section (Glasgow et al. 1995; Sorensen et al. 19961, give pause. The main components of smoking cessation efforts in the workplace are nonsmoking policies and specific assistance for cessation attempts (Gruman and Lynn 1993). The evolution of worksite smoking policies, in- timately tied to concerns about the health effects of en- vironmental tobacco smoke (ETS) (Eriksen 1986; USDHHS 1986), is described in some detail in Chapter 5. Although early assessment suggested that restric- tive policies had little effect on smoking outside of work (Glasgow 1987; Rigotti 1989; Tager 1989), most recent studies have demonstrated either reductions in daily consumption of cigarettes (Stillman et al. 1990; Borland et al. 1991; Jeffery et al. 1994) or increases in smoking cessation (Stave and Jackson 1991; Patten et al. 1995; Longo et al. 1996). As described in Chapter 5 (see "Clean Indoor Air Regulation"), there is persistent movement toward increasing restrictions in public workplaces. The strategies for smoking cessation within workplaces are largely those discussed earlier in this chapter: self-help, physician's advice, and formal treat- ment (Gruman and Lynn 1993). As of 1989, about one- half of worksites that sponsored cessation activities offered self-help materials (Fielding and Piserchia 1989). Although initial dropout rates were high, 20-26 percent of participants had quit smoking by 6-12 months after the worksite programs had begun (Orleans and Shipley 1982; Glasgow 1987). Such proportions compare favorably with those observed in general populations. Physician's advice to quit smoking was a component of only about 15 percent of the company programs, but in a number of studies, this modality seemed to exert an effect similar to that observed in general populations: 15-30 percent of par- ticipants had quit smoking at the one-year follow-up (Gruman and Lynn 1993). The programs offering for- mal treatment appeared to produce results at the worksite that were similar to those found for such pro- grams outside the workplace. A special feature of worksite cessation programs is the opportunity to provide incentives, such as com- petitions. Several studies have documented some ef- ficacy in this approach. For example, in one study, 33 percent of participating workers and 25 percent of all workers remained abstinent at work (Glasgow 1987). In a second study, the use of a competition was associ- ated with significantly greater success at quitting than was reported for persons not participating in the com- petition (Klesges et al. 1988). In a review of incentive programs, from 15 to 60 percent of participants quit smoking; the average was around 40 percent (Gruman and Lynn 1993). Some disadvantages of incentives are that (1) determining the award may be difficult, (2) employees may falsely claim cessation, and (3) non- smokers may feel slighted (Fiore et al. 1996). On a population basis, incentives have not been found to be effective. In these settings, incentives may be most attractive to smokers who were going to attempt quit- ting in any case (Chapman et al. 1993). In contrast, a trial of the Take Heart program, which involved 26 heterogeneous worksites, a low-cost intervention, random assignment, and use of worker and management steering committees, failed to pro- duce short-term improvements in smoking cessation that exceeded the secular trend (Glasgow et al. 1995). These results were particularly disheartening in view of the methodological strengths of the study and the diversity of the workplace settings. The authors offer a number of potential reasons for the lack of impact: the cessation activities may have been inappropriate; the behaviors may have been more resistant to change than previously assumed; workers may have had in- sufficient "ownership" of the project; secular trends may have been so strong that they canceled out a mod- est effect; the variability among worksites may have been too great; and, in general, worksite programs may not work. Similar negative findings were observed by Sorensen and colleagues (1996) in an even larger trial of 111 worksites randomized to sites receiving or not receiving the cessation program. The Working Well Trial involved more than 28,000 workers in 16 states and compared seven-day abstinence, six-month Reclucirlg Tobacco Usr abstinence, and changes in smoking prevalence for both types of \%rorksites. Changes occurred in the di- rection hypothesized, but they were small and non- significant; for example, the six-month abstinence rate was only 1.5 percent higher in the program group. Similarly, the program sites showed a nonsignificant trend toward greater adoption of smoking bans. The authors observed that the overall cessation proportions at both types of sites compared favorably with those in other worksite programs. The lack of difference may have resulted from the higher than expected cessation at control sites, which is a phenomenon reflecting a general increase in antismoking awareness. These studies postdate recent reviews of worksite cessation efforts. Several early reviews expressed op- timism about the value of worksite programs but did not provide a quantitative assessment (Hallett 1986; Bibeau et al. 1988). In a detailed meta-analysis of 20 worksite programs involving 34 comparisons, Fisher and colleagues (1990) found that the mean weighted effect size was significantly positive and that an aver- age of 13 percent of participants had quit smoking af- ter treatment. Although modest, these effects provide some quantitative basis for the enthusiasm for worksite programs. The addition of the two recent large projects (Glasgow et al. 1995; Sorensen et al. 1996) may well alter the meta-analytic balance. Although the worksite setting has aforemen- tioned features favorable to large-scale programs (in- cluding the importance of adding to a generalized reduction in exposure to ETS), the strategy cannot be recommended without qualification. Nonetheless, the role of such activities, perhaps enlightened by further targeted research, may be important in multicompo- nent efforts at smoking cessation. Community Programs Results from a number of long-term trials of communitywide programs have recently appeared. (See Chapter 7 for a more detailed discussion of these projects in the context of approaches used in the 1990s.) These trials typically incorporate mass media strate- gies into larger health education programs. Some, such as the Stanford Five-City Project (Farquhar et al. 1990), the Minnesota Heart Health Program (Perry et al. 1992; Luepker et al. 19941, and the Pawtucket Heart Health Program (Elder et al. 1986; Carleton et al. 19951, have been aimed at modifying smoking, as well as other risk factors for cardiovascular disease. Final reports suggest that these trials have met with little success in promoting smoking cessation. The Stanford Five-City Project (Farquhar et al. 1990; Fortmann et al. 1993) tested an intensive multi- media approach, including television, radio, newspa- per, and mass-distributed printed materials. All materials contained information about modifiable risk factors for cardiovascular disease. The average resi- dent of a community receiving the program was ex- posed to more than 500 educational episodes over the course of the five-vear program. By the end of this period, smoking pievalence-the only risk factor on which an impact could be demonstrated-had declined 13 percent more in the program communities than in the control ones. The Minnesota Heart Health Program failed to demonstrate an appreciable impact (Land0 et al. 1995). The Pawtucket Heart Health Program had little impact on smoking behavior; its first attempt at a smoking cessation program prompted only 11 smokers to quit (Elder et al. 1986, 1987). The final results con- firmed the lack of impact (Carleton et al. 1995). One ambitious community project-COMMIT (Community Intervention Trial for Smoking Cessation)-focused on smoking cessation and on policy strategies to reduce prevalence (COMMIT Re- search Group 1991; Gruman and Lynn 1993). In 1986, the NC1 began COMMIT, the largest randomized smoking intervention trial in the world. The design of COMMIT included 11 pairs of matched communities- 10 from across the United States and 1 in Canada. One community from each pair was randomly selected to be the site in which volunteers and local agencies car- ried out COMMIT's 58 mandated program activities. Designed to augment existing community-based efforts to reduce smoking, these activities occurred between 1988 and 1992. The primary end point for COMMIT was smok- ing cessation among heavy smokers. Main goals in- cluded increasing the priority of smoking as a public health issue, increasing the community's ability to in- fluence smoking behavior, strengthening the community's existing economic and policy factors designed to discourage smoking, and fortifying social norms and values that stressed nonsmoking (Gruman and Lynn 1993). Main strategies included training health care providers to routinely assess and manage nicotine dependence, working with community insti- tutions and private organizations to create smoke-free environments, increasing the availability and visibil- ity of smoking cessation services, and using the mass media and schools to educate communities about the dangers of tobacco use. Results of COMMIT indicate that even intensive community-based programs may not have a demon- strable impact on smoking behavior (COMMIT Kcwarch Group lWJa,b). Declines in smoking preva- lence \\.ere no greater in program communities than in control communities (COMMIT Research Group 1995b). Although the overall populations in the pro- gram communities became more aware of available resources for smoking cessation, the prevalence of smoking cessation among persons who smoked more than 25 cigarettes per day did not differ between pro- gram (18.0 percent) and control communities (18.7 percent). Persons who smoked fewer than 25 cigarettes per day \l.ere significantly more likely to quit in pro- gram communities than in control communities (30.6 L'S, 27.5 percent), and that result \vas attributable to success among light smokers with less than a college education (COMMIT Research Group 1995a). Statewide Programs Recent statewide initiatives have integrated to- bacco policy and smoking cessation programs. Al- though Minnesota \vas the first state to implement a statetride initiati\re to reduce tobacco use, California has provided what is perhaps the most ambitious ex- ample. Massachusetts has also conducted a similar stateivide effort based on a tax increase and incorpo- rating a mass media campaign, policy initiatives, and smoking cessation services. These initiatives and oth- ers are discussed in detail in Chapter 7. The state findings are promising. lf this success is replicated by other states that adopt a dedicated in- crease in cigarette excise taxes, or that are able to use resources from settlements tvith the tobacco industry, statewide and nationwide initiatives may play an important role in achieving the public health goal of reducing smoking prevalence among U.S. adults to less than 12 percent by the year 2010 WSDHHS 2000). Summary of Large-Scale Public Health Programs Community- and media-based programs have the potential to reach large numbers of smokers who are reluctant to seek formal treatment. Such programs could greatly influence smoking prevalence in the United States. The results from major randomized tri- als and community-based efforts are thus especially disappointing. Though these projects have set new standards for such research and have produced nu- merous ancillary results of interest, the overall con- clusions suggest that even large-scale, well-funded programs may have difficulty promoting changes in smoking behavior. Similarly, the results to date from numerous worksite cessation projects suggest either no impact or a small net effect. On the other hand, results of the California and Massachusetts initiatives (see Chapter 7) suggest that tobacco taxes may be an effective means of funding efforts to reduce tobacco use. The states that have devoted money obtained from Medicaid settlements with the tobacco industry have also had considerable success in implementing a comprehensive approach (Chapter 7). Their results suggest that the disappointing outcomes from research programs may be related to the reach and penetration of these programs and the isolated context in which they \vere conducted. Contemporary Issues in Research on Tobacco Addiction Epidemiologic Concerns and Clinical Issues Because smoking cessation research has focused more on improving standard paradigms than on in- novativ-e approaches (Shiffman 1993b), much of the current energy is directed to pursuing well-trod paths. But current directions have an internal logic, because no new paradigms loom large. Established approaches are perhaps unfairly criticized for lacking innovation. As the foregoing discussion demonstratecl, valid meth- ods for treating nicotine addiction are available, but they must be better understood and can be improved. Despite considerable research on smoking cessation during the past 40 years, the essential elements or com- bination of elements necessary for successful programs are difficult to extract. In a number of key areas, how- ever, careful research can sharpen interpretation of existing results and provide direction for future inves- tigation and perhaps even innovation. Reducing Tobacco Use Nicotine Dependence Dependence, a central construct in research on drug abuse, has been defined as "self-administration of a psychoactive drug in a manner that demonstrates that the drug controls or strongly influences behav- ior" (USDHHS 1988, p. 248). Evidence strongly sug- gests that most smokers are dependent on nicotine (USDHHS 1988). However, most researchers agree that individual smokers differ in the degree to which they are dependent (FagerstrGm 1978; McMorrow and Foxx 1983; Pomerleau et al. 1983; Shiffman 1989; Killen et al. 1992; Niaura et al. 1994). Some occasional smokers may not meet the criteria for physical dependence (Shiffman et al. 1991). These differences in degree of nicotine dependence have important implications for treatment and research. Flaws in the assessment of nicotine dependence have impeded progress toward understanding its role in smoking cessation. For example, nicotine depen- dence consists of both physical and behavioral com- ponents (USDHHS 1988). However, most smoking cessation researchers have used the term to refer to physical dependence exclusively. Although items in two widely used nicotine-dependence assessment in- struments (the Fagerstrijm Tolerance Questionnaire and its successor, the Fagerstr%n Test for Nicotine De- pendence) assess the extent to which nicotine controls behavior, the instruments are intended to measure physical dependence (Fagerstrbm 1983; FagerstrGm and Schneider 1989; Heatherton et al. 1991). Other in- vestigators have measured dependence by how much nicotine smokers typically self-administer (Hurt et al. 1994) or by the severity of withdrawal symptoms (Brigham et al. 1990-91); these two measures are typi- cally not highly correlated with each other, and nei- ther is highly correlated with the Fagerstriim questionnaires (Kenford et al. 1994). Furthermore, the scales themselves, especially the Fagerstram Tolerance Questionnaire, suffer from psychometric limitations (Lichtenstein and Mermelstein 1986; Pomerleau et al. 1989; Tate and Schmitz 1993). In sum, tobacco research is hampered by an inadequate conceptualization of nicotine dependence and an inadequate assessment of the nicotine dependence construct. Because widely used dependence instruments such as the Fagerstrijm questionnaire are thought to measure physical dependence, it has been hypothesized that they can help identify patients who would benefit from nicotine replacement therapies (Fagerstrgm and Schneider 1989) or from higher doses of these thera- pies. The evidence for this assertion is mixed, with support somewhat more consistent for ths nicotine gum than for the nicotine patch (Abelin et al. 1989; Fagerstram and Schneider 1989; Transdermal Nicotine Study Group 1991; Killen et al. 1992; Kenford et al. 1994; Niaura et al. 1994; Tang et al. 1994). To the ex- tent that current measures capture variation in depen- dence, they would be expected to predict outcome in trials not using nicotine replacement and in groups of subjects treated with placebo nicotine replacement. Although this hypothesized correlation between de- pendence measures and outcome has been found in several studies (FagerstrGm and Schneider 19891, the correlations have tended to be weak (Gritz et al. 1991; Kozlowski et al. 1994) and have usually been signifi- cant only at relatively short-term follow-up points (Hall and Killen 1985; Pinto et al. 1987; Gritz et al. 1991; Norregaard et al. 1993). Specialized assessments of nicotine dependence are not recommended in current treatment guidelines, and pharmacotherapy is recom- mended for all tobacco users interested in quitting. The one exception is that highly dependent smokers may derive more benefit from 4-mg (as compared with 2-mg) nicotine gum (Fiore et al. 2000). Other measures of nicotine dependence have been developed, but these have fared no better than the Fagerstriim questionnaire. For example, the Heaviness of Smoking Index, a derivative, offers no advantage in predicting cessation (Kozlowski et al. 1994). Older mea- sures of smoking motives, such as the Horn-Waingrow Reasons for Smoking Scale (Horn and Waingrow 1966) and McKennell's occasion for smoking scales (McKennell 19701, have good psychometric properties but questionable construct validity (Shiffman 1993a). Continued reconceptualization of nicotine de- pendence and improved consensus on mechanisms for measuring it are critical issues for future study. Stron- ger ties to generic issues of substance abuse-already begun but not discussed in detail here (see Orleans and Slade 1993)-can facilitate such research and im- prove recognition of behavioral mechanisms that are common to the use of all addictive substances. Stages of Change Smokers differ in their motivation to quit smok- ing, and these differences are thought to affect treat- ment prognosis. The transtheoretical model, advanced by Prochaska and DiClemente (1983), provides a theo- retical structure for assessing these differences and has greatly influenced smoking cessation research in re- cent years. Briefly, the model proposes that smokers go through a series of stages (not necessarily linearly) on the way to achieving prolonged abstinence from smoking: not thinking seriously about quitting in the next six months, thinking seriously about quitting in the next six months, planning to quit in the next month, actually trying to quit, and trying to remain abstinent. If relapse occurs, smokers return to an earlier stage in the model. It is hypothesized that smokers in the ini- tial stages are less ready to quit and thus less likely to profit from traditional treatments (see Orleans 1993 for a more detailed discussion). Some evidence supports the notion that smok- ers in earlier stages of change fare worse in smoking cessation than do smokers in later stages (DiClemente et al. 1991; Kristeller et al. 1992; Ockene et al. 1992; Rohren et al. 1994). The finding of interactions between treatment assignment and stage membership (Prochaska et al. 1993) has led to the recommendation that clinical protocols for smoking cessation be based on stage assessments (Abrams 1993; Orleans 1993; Velicer et al. 1993; Hughes 1994). Evidence is not available, however, that linking motivational stage to a stage-appropriate strategy leads to better outcomes than do nontailored interven- tions of equal intensity (see Prochaska et al. 1993; Fiore et al. 2000), perhaps because motivation to change is more a continuum than a set of discrete states (Lichtenstein et al. 1994). Nonetheless, the stages-of- change model has considerable theoretical and empiri- cal appeal as a typology that is easy to use in day-to-day decision making (Wiggins 1988). Further refinement and clarification of this model, coupled with continued assessment of its relationship to smok- ers' probability of quitting, is a potentially fruitful re- search area. Negative Affect A negative affective reaction to quitting tobacco use (Baker et al. 1987; Brandon 1994; Hall et al. 1994) may be an important predictor of relapse (Shiffman 1982; Brandon et al. 1990; Piasecki et al. 1997). As mentioned previously, depressed persons are less likely to quit smoking successfully than persons with- out a history of depression (Classman et al. 1988; Anda et al. 1990), and depressed persons suffer an increase in symptoms after quitting (Covey et al. 1990; Hall et al. 1991). These related findings have special impor- tance because the frequency of clinical depression among smokers may exceed that among nonsmokers (Frederick et al. 1988; Hall et al. 1991; Brandon 1994). The role of adverse psychological states-even mild conditions-in prolonging smoking and imped- ing cessation is an important avenue for further in- vestigation. For example, depressed or otherwise affectively disturbed persons may require special interventions to succeed in smoking cessation; at least two studies have identified behavioral treatments that have boosted success rates among such persons (Zelman et al. 1992; Hall et al. 1994). As noted, antide- pressants and anxiolytics have been proposed as smok- ing cessation aids and are undergoing clinical trials because of their ability to ameliorate negative affects. Sex-Specific Differences Some studies (Pomerleau et al. 1991; Kenford et al. 1993; Swan et al. 1993), but not all (Derby et al. 1994; Whitlock et al. 1997; Gritz et al. 1998), have suggested that women find it more difficult than men to quit smoking. The quit ratio (the proportion of persons who have quit smoking out of those who ever smoked) has increased at the same rate or at a faster rate among women than men in recent years (Fiore et al. 1989; Giovino et al. 1994; Husten et al. 1996). An extensive review of difference in nicotine effects between men and women (Perkins et al. 1999) cites complex differ- ences in psychological and biologic aspects in the main- tenance of nicotine self-administration. Women may differ from men in the response to withdrawal, possi- bly mediated by menstrual cycle phase (Perkins et al. 2000), as well as a variety of nonnicotine effects (Perkins et al. 1999). For example, although the same treatments benefit both women and men, some treatments (e.g., nicotine replacement therapies) may be less efficacious in women (Perkins 1996; Wetter et al. 1999; Fiore et al. 2000). Other reviews of this phenomenon (Fant et al. 1996; Christen and Christen 1998) confirm the need for further exploration of such differences. A further difference between men and women may be related to genetic factors, particularly differ- ences by sex in the metabolism of nicotine (Messina et al. 1997; Tyndale et al. 1999). These studies have fo- cused on differences in the roles of enzymes involved in the metabolism of nicotine to cotinine (enzymes CYP2A6 and CYP2D6). The considerable variability in nicotine metabolism appears to be due to variable expression of CYP2A6 (Messina et al. 1997) and may play a role, as yet undefined, in gender response to therapeutic modalities. Other researchers, using stud- ies of twins, have postulated that genetic factors may play a role in predicting which cigarette smokers progress to long-term addiction, an effect that may be stronger for men than for women (Heath et al. 1998). Withdrawal Symptoms The vast majority of smokers become physically dependent on nicotine, and these persons commonly 2 30 Chnpter 4 Reducing Tobacco Use display several withdrawal symptoms when deprived of the substance (Shiffman and Jarvik 1976; USDHHS 1988; Hughes et al. 1991b). Conventional wisdom holds that two persons who have different degrees of nico- tine dependence will have different degrees of with- drawal severity when they quit smoking (FagerstrBm 1978; Gritz et al. 1991; Hughes 1993). Withdrawal symptoms are presumed to give a conflicting (and of- ten canceling) motivation to people who have other- wise been motivated to quit (West 1984; Hughes et al. 1991b). The severity of the withdrawal is thus expected to be a strong predictor of eventual relapse (Gritz et al. 1991; West 1992; Hughes 1993). Some research sug- gests that the various discomforts of abstinence are valid indicators of eventual relapse (Baker et al. 1987; Anda et al. 1990; Hughes 1992; Zelman et al. 1992). Despite the intuitive appeal of this proposed associa- tion, other studies have found an inconsistent relation- ship between withdrawal severity and relapse (Hughes et al. 1984; Hughes and Hatsukami 1986; Stitzer and Gross 1988; West et al. 1989; Transdermal Nicotine Study Group 1991; Prochazka et al. 1992; West 1992; Hughes 1993). Interpretation of this literature remains complicated because researchers use different instru- ments to assess withdrawal, sometimes reporting total withdrawal discomfort and other times reporting re- sults on a symptom-by-symptom basis, and because they assess symptomatology at different time points. Improved assessment of withdrawal and consensual definitions, coupled with epidemiologic assessment, may better clarify the critical connection between the withdrawal syndrome and the likelihood of relapse. Recent studies demonstrate that there is considerable between-subject variability in the time course of smok- ing withdrawal and suggest that more consistent links between withdrawal and relapse may be found if this variability is systematically assessed (Piasecki et al. 1998). Weight Gain As noted earlier in the discussion of specific modalities, weight gain is a common concomitant of smoking cessation (Klesges et al. 1989). The average smoker gains 5-10 pounds after cessation, and a small percentage of smokers gain more than 25 pounds (Klesges et al. 1989; Williamson et al. 1991). The con- cern that smokers express about gaining weight may be great enough to prevent them from attempting to quit (Klesges et al. 1988; Gritz et al. 1989; French et al. 1992). Similarly, persons who quit smoking and who do subsequently gain weight may be more likely to relapse (Wack and Rodin 1982; Hall et al. 1986). Two prospective studies, however, found that concern about weight did not predict cessation success (French et al. 1995; Jeffery et al. 1997). Innovative strategies have failed to reduce weight gain or to improve absti- nence rates among persons concerned about gaining weight (Hall et al. 1992; Pirie et al. 1992). Because weight change is a complex metabolic phenomenon (about which there is a considerable epidemiologic and biologic literature, not reviewed here) that is subject to the interplay of behavioral and pharmacologic in- fluences, further research on the behavior and physi- ological mechanisms that produce postcessation weight gain may suggest new strategies for dealing with this problem and may provide insights into mechanisms of addiction. Early Relapse Three recent reports from four trials of the nico- tine patch have found that any smoking during the first two weeks of using either the nicotine or the pla- cebo patch is a strong predictor of relapse at long-term follow-up (Hurt et al. 1994; Kenford et al. 1994; Stapleton et al. 1995). For example, Kenford and col- leagues (1994) analyzed data from two patch trials. In both trials, large proportions (97.1 and 83.3 percent) of patients treated with the nicotine patch who smoked during the second week of treatment had relapsed by the six-month follow-up. Early relapse may predict longer-term failure-regardless of the cessation strat- egy, if any-because physiological and behavioral forces may present their most significant challenges to smokers during the first two weeks they try to quit. Strategies that could shepherd smokers through the first two weeks without a single cigarette might be expected to improve treatment outcome. According to another view, most lapses during the first two weeks of treatment merely identify those smokers who will find it difficult to quit no matter what the interven- tion. Even if given adjunctive interventions to help them pass this two-week period without smoking, these smokers would be expected to relapse soon af- ter these adjuncts were withdrawn. Research on treat- ments for persons who are strongly addicted and likely to relapse early (should they attempt cessation at all) is a great challenge for cessation research. Dose-Response More intense interventions yield better outcomes (Kottke et al. 1988; Lichtenstein and Glasgow 1992; Fiore et al. 1994c, 2000). Although this general rela- tionship has not been precisely explained, outcomes Management of Nicotine Addiction 131 Surgeon Gerzeral's Report may be influenced by a host of structural factors, in- cluding session length, session frequency, total num- ber of sessions, and number and types of treatment modalities (e.g., telephone contacts and individual vs. group formats). More specific issues must be clarified, such as determining what level of adjuvant behavioral sup- port is most cost-effective when used with pharmaco- therapy. However, a central question surrounding the use of intensive interventions is whether a greater pro- portion of smokers can be motivated to enroll in such treatment. Debate over whether program refinements can improve outcomes may be moot, from a public health perspective, if most smokers continue to shy away from-or cannot afford to spend the time or money needed for-intensive interventions (Fiore et al. 1990; Lichtenstein and Hollis 1992). A final area for dose-response research concerns the optimal dose for nicotine replacement. Two recent studies (Jorenby et al. 199513; Hughes et al. 19991 have found that dou- bling the normal patch dose does not improve cessa- tion outcomes. There may be some benefit, however, to combining different smoking cessation pharmaco- therapies (Blondal et al. 1999; Jorenby et al. 19991, in- cluding two different nicotine pharmacotherapies (Fiore et al. 2000). Treatment Components Defining the individual impact of treatment com- ponents will require controlled trials that systemati- cally manipulate individual treatment components against a background of constant treatment intensity. As Lichtenstein and Glasgow (1992) have noted, smok- ing cessation researchers have largely abandoned this line of research because most comparison studies (though not all; see Stevens and Hollis 1989) failed to find significant treatment effects. Nonetheless, until the combined effects of treatment components can be determined, empirical design of multicomponent treat- ments will be difficult. Individualized Treatment Investigators have become increasingly inter- ested in seeking interactions between treatment con- tent and smokers' characteristics. Identifying such interactions would allow individual smokers to be given specific interventions to maximize their chances of attaining long-term abstinence. Although subject- by-treatment interactions have been obtained (Zelman et al. 1992; Niaura et al. 1994), these relationships re- main too elusive to suggest an overall strategic theory. Research that incorporates unconfounded compari- sons of specific ingredients may suggest algorithms for matching patient and treatment. In view of the increasing presence of the computer in many people's lives, computer-assisted tailored treatments warrant further exploration. Some tailoring and individual- ization may be appropriate for older smokers whose other medical problems and pharmacologic treatment must be given special consideration (Rimer and Or- leans 1993). Currently, however, there is insufficient evidence to recommend individually tailored interven- tions (Fiore et al. 2000). An alternative to treatment matching is the strat- egy of offering smokers increasingly more intensive treatments as they continue to have trouble quitting (Abrams 1993; Orleans 19931, despite the risk that this strategy will reinforce failure. There is insufficient evidence, however, to recommend such a stepped-care approach (Fiore et al. 20001. Research must first re- veal hierarchies of treatment as well as determine when patients should be given more intensive interventions. Dissemination and the Role of the Clinician Because self-help and minimal clinical interven- tions are likely to continue to be the preferred method of cessation for most smokers, innovative strategies must be developed to improve efficacy and delivery (Cohen et al. 1989b; Orleans et al. 1991; Fiore et al. 19951. Some of the most effective of the minimal clini- cal interventions include the institutionalization of system changes as core components of health care (Glynn and Manley 1993; Fiore et al. 2000). For ex- ample, having a screening system in place to identify smokers triples clinician intervention (Fiore et al. 2000). Dissemination is intimately tied to the willing- ness of clinicians to advise their patients about smok- ing. An important area for ongoing research is the investigation of strategies that foster this behavioral role not only among physicians but also among a broad range of health care providers, including dentists, nurses, pharmacists, chiropractors, psychologists, phy- sician assistants, and pulmonary technicians. But it is unlikely that behavioral modification for clinicians would be sufficient to produce the required dissemi- nation. Reimbursement policies, financial incentives, and underlying institutional support are all critical for the effective management of tobacco addiction through clinical interventions (Kaplan et al. 1995; Rothenberg et al. 19981. 132 Chapter 4 Reducing Tobacco Use Cost-Effectiveness Ultimately, the test of clinical modalities for treat- ment of nicotine addiction will be their survival in the current environment of cost containment and managed care. Private insurers are unlikely to embrace such treat- ment unless "they are convinced that there is a market for such a product and that it is viable financially" (Schauffler and Parkinson 1993, p. 189). For public in- surers, demonstration of cost-effectiveness has become the de facto standard for adoption of new technology (G. Wilensky, cited in Schauffler and Parkinson 1993, reference 17), though some may insist on cost-savings, a strict standard of proof, for preventive practices. Smoking cessation has been called the "gold stan- dard" of cost-effective interventions (Eddy 1992). A number of studies (and several reviews [Elixhauser 1990; CDC 1992; Tsevat 19921) have addressed issues of cost-effectiveness in behavioral counseling. Cummings and colleagues (1989~) calculated that the cost-effectiveness of brief office counseling during a routine visit ranges from $705 to $988 per year of life saved for men and from $1,204 to $2,058 for women. The use of nicotine gum increases the cost-effectiveness fourfold. Oster and colleagues (1986) performed a similar study incorporating nicotine gum with brief office counseling. The costs per year of life saved ranged from $4,113 to $6,465 for men and from $6,880 to $9,473 for women. Both studies noted that these costs compare favorably with those derived for other widely accepted preventive practices. Altman and colleagues (1987) found that self-help materials cost $22-144 per person who quit, a cessation contest costs $129-239, and a cessation class costs $235-399. In the setting of acute myocardial infarction, Krumholtz and colleagues (1993) concluded that a nurse-managed smoking cessation program after myocardial infarction was cost-effective, particularly when compared with other modalities. (These studies are not necessarily reported in standardized dollarsand are then only roughly com- parable.) An analysis of the cost-effectiveness of imple- menting the 1996 Agency for Health Care Policy and Research-sponsored Clinical Practice Guideline Smok- ing Cessation reported that cost per quality-adjusted- life-year saved ranged from $1,108 to $4,542. This compares very favorably with $61,744 for annual mam- mography for women aged 40-49 years and $23,335 for hypertension screening in 40-year-old men (Crom- well et al. 1997). Because smoking during pregnancy is associated with lower birth weight, which in turn has been linked to various adverse outcomes of pregnancy, cessation of smoking in pregnancy has been the subject of a num- ber of economic analyses. Several of these have been performed in a managed care setting. Using patients in a study performed by the Maxicare Research and Educational Foundation, Ershoff and colleagues (1990) weighed the intervention's programmatic costs against the smoking-related increased costs of medical care in- curred by mothers who continue smoking and by their infants. The program consisted of an initial interview, smoking counseling by a health educator, and a series of self-help books mailed to participants. The nonsmok- ing message was reinforced at prenatal care visits. The investigators concluded that in a health maintenance organization of 100,000 members, the cost savings from the cessation program was $13,432, the net benefit was $9,202, and the benefit-to-cost ratio was 3.17:1. Windsor and colleagues (1988) compared three cessation protocols for women in public health mater- nity clinics: standard care, standard care combined with use of a cessation manual developed by the Ameri- can Lung Association, and standard care combined with the use of that manual and a pregnancy-specific manual. At the end of pregnancy, smoking cessation had been achieved by 2 percent, 6 percent, and 14 per- cent, respectively, of women in the three groups. The investigators calculated cost-effectiveness as the cost per patient divided by the percentage who quit. The respective values were $104.00, $118.83, and $50.93. In a second study (Windsor et al. 19931, the treatment group in a multicomponent intervention involving counseling and support had a cessation rate of 14.3 percent, and the control group had a rate of 8.5 per- cent. Under varying assumptions, the economic analy- sis found that benefit-to-cost ratios ranged from 6.72:1 to 17.18:1 and that estimated savings from statewide use of the program ranged from $247,296 to $699,240. Marks and colleagues (1990) estimated the ben- efits that would accrue from shifting low-birth-weight infants into the normal-birth-weight category, from averting deaths attributable to prematurity, and from avoiding the long-term costs associated with the care of premature infants. They concluded that the ratio of savings to costs would be as high as 6:l. If long-term costs were omitted, the ratio would still be $3.31 for each- $1 spent. Finally, in a somewhat different ap- proach to the problem, Shipp and colleagues (1992) tried to identify the break-even point for the cost of a smoking cessation program. Under general circum- stances, the break-even cost was $32 per pregnant woman, but this cost varied from $10 to $237, depend- ing on the probability of adverse outcomes in various populations. Management of Nicotine Addiction 133 Surgeon Gerzerd's Report As Schauffler and Parkinson (1993) point out, economic analyses of smoking cessation are often based on hypothetical populations, start with differ- ent assumptions about prevalence and intervention effectiveness, and differ in their estimation of out- comes. Although initial results are encouraging, con- siderable work is needed to codify the results and make them appealing to insurers and employers. In a re- cent survey, only 8.6 percent of large corporations in California had even considered using smoking status in their risk ratings, and only 2.2 percent had imple- mented such a rating. About 20 percent of companies offered plans that covered smoking cessation services (Schauffler and Parkinson 1993). Perhaps observations comparing long-term hospitalized care of smokers and nonsmokers will alter this policy. A recent study esti- mated that helping one smoker to quit reduces antici- pated medical costs associated with acute myocardial infarction and stroke by $893 over seven years (Lightwood and Glantz 1997). Wagner and colleagues (1995) point out that smokers have consistently Conclusions increasing rates of hospitalization over five to six years of follow-up. In contrast, smokers who quit have increased hospitalization during the year in which they quit (probably associated with the medi- cal reason-e.g., emphysema-for quitting in many cases); this rate declines thereafter. The authors note that the cost savings that accrue from reduced utili- zation would more than pay for effective cessation interventions within three to four years. The alteration of terminology-from "smoking cessation" to "treatment of nicotine dependence"- acknowledges the need to make cessation activity con- sonant both with modern medical practice and with the current climate for health care delivery. The cur- rent body of evidence suggests that efficacious and cost-effective therapeutic modalities are available and that such consonance can be achieved. Further inves- tigation not only of theoretical cost-effectiveness but also of actual use-effectiveness will have considerable impact on institutionalizing the treatment of nicotine addiction. Tobacco dependence is best viewed as a chronic disease with remission and relapse. Even though both minimal and intensive interventions in- crease smoking cessation, most people who quit smoking with the aid of such interventions will eventually relapse and may require repeated at- tempts before achieving long-term abstinence. Moreover, there is little understanding of how such treatments produce their therapeutic effects. There is mixed evidence that self-help manuals are an efficacious aid to smoking cessation. Be- cause these materials can be widely distributed, such strategies may have a significant public health impact and warrant further investigation. 3. Programs using advice and counseling-whether minimal or more intensive-have helped a sub- stantial proportion of people quit smoking. 4. The success of counseling and advice increases with the intensity of the program and may be im- proved by increasing the frequency and duration of contact. 5. The evidence is strong and consistent that phar- macologic treatments for smoking cessation (nicotine replacement therapies and bupropion, in particular) can help people quit smoking. Clonidine and nortriptylene may have some util- ity as second-line treatments for smoking cessa- tion, although they have not been approved by the FDA for this indication. 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Chapter 5 Regulatory Efforts Introduction 159 Food and Drug Administration (FDA) Regulations 259 Initial Attempts at Multistate Settlement and Federal Legislation 160 Public and Private Litigation 160 Advertising and Promotion 161 Introduction 161 Attempts to Regulate Tobacco Advertising and Packaging 2 63 Cigarette Warning Labels 2 63 Broadcast Advertising Ban 165 A Midcourse Assessment 166 Smokeless Tobacco Warning Labels 2 67 Regulation of Tobacco Packaging 168 Examples of Product Labeling in Other Countries 2 69 Tobacco Advertising, Commercial Speech, and the First Amendment 2 70 Constitutionality of Regulating Advertising 171 Constitutionality of Regulating Tobacco Advertising 172 A Critical Example: Joe Camel 2 77 Product Regulation 178 Introduction 178 The Constituents of Smoke From Manufactured Cigarettes 179 Regulation by Tar Levels 279 Implications of Nicotine Levels 2 80 Other Constituents in Cigarette Smoke 182 Additives to Tobacco Products 182 Cigarette Additives 182 Smokeless Tobacco Additives 183 The Low-Tar "Alternative" 184 Compensatory Smoking 184 Health Risks From Low-Tar Cigarettes 184 Nicotine Replacement Products 185 Product Regulations for Consumer Education 285 Tobacco Packaging and Informed Choice 286 Tobacco Use and Informed Consent 186 Further Regulatory Steps 287 Judicial Developments and the Status of FDA Regulations 289 The Court of Appeals Ruling on FDA Authority 290 The U.S. Supreme Court Ruling on FDA Authority 191 Legislative Developments 291 Master Settlement Agreement 193 Clean Indoor Air Regulation 193 Introduction 2 93 Health Consequences of Exposure to ETS 195 Other Consequences of ETS 196 Prevalence of Exposure to ETS 196 Legal Foundation for Regulation of Public Smoking 797 Status of Restrictions to Limit Smoking in Public Places 297 Government Restrictions 2 99 Private Sector Restrictions on Smoking in Workplaces 202 Effectiveness of Clean Indoor Air Restrictions 202 Population-Based Studies 202 Effects of Restrictions on Smoking Behavior 203 Case Studies of State and Local Smoking Restrictions 206 Minors' Access to Tobacco 207 Introduction 207 Efforts to Promote Adoption and Enforcement of Minors' Access Laws 209 Restrictions on Distribution of Samples 211 Regulation of Means of Sale 2 2 1 Regulation Directed at the Seller 214 Regulation Directed at the Buyer 216 Enforcement of Laws on Minimum Ages for Tobacco Sales 226 State Settlements 222 Preemption of Local Action by State Policy 223 Litigation Approaches 223 Introduction 223 Private Law as a Means of Risk Control 224 Tort as a Private Law Control 224 U.S. Reliance on Private Law Controls 224 Potential Public Health Benefits of Tobacco Litigation 224 The First Two Waves of Tobacco Litigation 225 The First Wave 225 The Second Wave 226 The Aftermath of the First Two Waves 227 The Third Wave of Tobacco Litigation 229 Common-Law Claims 230 Statutory Claims 231 Individual Third-Wave Cases 235 Aggregation Devices 235 Class Actions 235 Recovery Claims by Third-Party Health Care Payers 238 Small Claims Tribunals to Recover the Cost of Quitting 243 Other Cost Reduction Procedures 243 Claims of Nonsmokers 243 Enhancing Prohibitory Regulation by Private Litigation 250 The International Dimension of Tobacco Litigation 251 Counterthrust: Tobacco Industry Initiation of Litigation and Other Tactics 252 Anticipatory Effects 255 Criminal Proceedings 256 Nature, Extent, and Focus of the Criminal Investigation 257 Key Sources of Evidence 258 Initial Results of the Criminal Investigation 258 Prognosis for Future Actions Through the Criminal Justice Process 259 Comment 259 Conclusions 260 References 262 Reducing Tobacco Use Introduction Efforts to regulate the use of tobacco date back to its introduction to European colonists of North America (see Chapter 2). As noted, these early move- ments to restrict tobacco use were motivated less by health concerns than by complex political, economic, and social factors. With the appearance in the 1950s of substantial scientific evidence on specific health risks of smoking, and with subsequent dissemination of that information in the 196Os, general support for a gov- ernment regulatory response emerged. As noted in Chapter 1, such regulatory activities do not necessarily fit the traditional concept of "inter- vention," but their effect is to change the way people use tobacco. Because advertising and promotion are perhaps the chief social force for continued tobacco use, their regulation-or the failure to regulate them- can have substantial effects on smoking prevalence. The manner in which the product is manufactured, packaged, and distributed can similarly influence people's decision to smoke. Regulation of smoking in public places provides an opportunity to reduce the quantity of tobacco used, the prevalence of smoking, and the exposure of nonsmokers to environmental to- bacco smoke. The regulation of minors' access to ciga- rettes has considerable potential for postponing or preventing the uptake of smoking, thereby making a long-term impact on the smoking epidemic. Finally, personal litigation and the tort system can influence the policies and practices of the tobacco industry and can have an impact on social perceptions of smoking. Thus, if a broad definition of intervention can be entertained, each of these regulatory processes can be assessed for the nature of its influence on the use of tobacco. Unlike assessments of more traditional in- terventions (see Chapters 3 and 41, evaluation of regu- latory processes must invoke a different set of measurement tools that are less quantitative but not necessarily less compelling (see Chapter 1). Several key developments in the mid-to-late 1990s have propelled tobacco regulation in new direc- tions and into new forums. Three key events have catalyzed these changes. They are discussed briefly in the next sections and in greater detail later in this chapter in "Further Regulatory Steps" and "Litigation Approaches." Food and Drug Administration (FDA) Regulations First, on August 28, 1996, after receiving public comment on a proposed rule, the FDA issued final regulations restricting the sale, distribution, advertis- ing, and promotion of cigarettes and smokeless tobacco (Fcrlrral Rcgisfrr 1996). Several tobacco companies, re- tailers, and advertisers sued the FDA to block the implementation of the regulations, arguing that the agency lacked the jurisdiction or authority to regulate these products and that the proposed advertising re- strictions violated the First Amendment of the United States Constitution (Coyly Beahnl, Inc. u. Food and Drug Adrllirristratiorl, No. 2:95CVOO591 [N.C. Aug. 10, 19951, rikd irl 10.5 Tobacco Products Litiqatiot~ Reporter [TPLR] 3.379 [1995]). On April 25, 1997, the federal district court in Greensboro, North Carolina, ruled that the FDA had the authority to regulate cigarettes and smokeless to- bacco products, as drug delivery devices, under the Federal Food, Drug, and Cosmetic Act (Coylze Beahm, Ir~c. il. U.S. Food &T Drug AdnlirJistration, 966 F. Supp. 1374 [M.D.N.C. 19971). The court upheld all of the FDA's 1996 restrictions involving youth access to to- bacco products and regulating product labeling. How- ever, the court "stayed," or temporarily blocked, implementation of most of these provisions. The only FDA regulations that escaped this stay were the pro- hibition on sales of cigarettes and smokeless tobacco to minors and the requirement that retailers check photo identification of customers who appear to be under 27 years of age. These provisions went into ef- fect on February 28,1997. The age and identification provisions remained in force until the Supreme Court's March 21,2000, decision. Most notably, the court invalidated the FDA's restrictions on the advertising and promotion of ciga- rettes and smokeless tobacco. Both sides in the FDA case appealed the decision to the Fourth Circuit of the United States Court of Appeals in Richmond, Virginia. A three-member panel of the court overturned the lower court's decision and ruled that the FDA lacked the authority to regulate tobacco products. The full Fourth Circuit Court of Appeals declined to review this reversal. The government petitioned the United States Supreme Court for review, and the Supreme Court accepted the case in April 1999. Oral argument was held December 1999, and the Court, in a 5 to 4 decision, upheld the Fourth Circuit's decision on March 21,200O. The FDA continued to enforce the age and photo identification provisions while the case was appealed to the United States Supreme Court. On March 21,2000, the Supreme Court ruled that although premature deaths from tobacco use present "one of the most troubling health problems facing our nation to- day" (Food and Drug Administration v. Brown 6 Williamson, 529 U.S. [20001, 120 S. Ct. 1291), the FDAlacks the authority to issue and enforce its tobacco regulations. These developments, central to most of the regu- latory efforts covered in this chapter, are discussed in detail in the major section "Product Regulation," later in this chapter. Initial Attempts at Multistate Settlement and Federal Legislation Second, on June 20,1997, a group of 41 state at- torneys general presented a tobacco settlement pro- posal to the American public (Tobacco Products Litigation Reporter 1997a; see "Legislative Developments" and "Master Settlement Agreement," later in this chapter). In essence, the proposal was intended to settle all pend- ing lawsuits against the tobacco industry brought by states and other governmental entities as well as all pending class action lawsuits. Although the settlement did not include 9 of the 50 states, its scope was inher- ently national: to enact its stipulated regulations of the tobacco industry, the settlement presumed the pas- sage of congressional legislation that would necessar- ily affect the legal rights of all Americans. The settlement included provisions for IDAauthority, new warning labels, advertising restrictions, youth access prohibitions, rules to reduce public exposure to envi- ronmental tobacco smoke, and a provision designed to provide financial incentives for tobacco manufac- turers to reduce sales to underaged consumers. Despite its intuitive appeal-that the slow, and largely unsuccessful, course of change possible through individual lawsuits would be retired for a sweeping, national, unified policy that dealt with the tobacco problem-the settlement raised concerns from the start. Public health advocates recognized that given the settlement's national scope, it was taking on the role of being the chief public health policy tool for reducing tobacco use. These critics feared that the settlement (and moreover the legislation it presumed) would fail in this role. In particular, by limiting future lawsuits against the tobacco industry, the settlement might in the end benefit the industry more than the public. A number of bills filed in Congress in 1997 and 1998 intended to codify the terms of the proposed na- tional settlement. One of the bills, S. 1415 (National Tobacco Policy and Youth Smoking Reduction Act, 105th Cong., 2nd Sess., S. 1415, Congressional Record, 144:S5034-S5084), which ultimately departed from the settlement proposal in a number of areas, was debated on the Senate floor for several weeks. It was vehe- mently opposed by the tobacco industry and rejected by the Senate almost one year to the day after the at- torneys general announced the proposed national settlement. The regulatory implications of the national settlement proposal are discussed together with the FDA rules, primarily in the "Product Regulation" sec- tion of this chapter. Ultimately, this activity served as prologue to a Master Settlement Agreement that was negotiated in November 1998. On November 23, 1998, the agree- ment was reached between state attorneys general and major U.S. tobacco companies to settle pending and prospective lawsuits by states to recover Medicaid expenditures incurred as a result of tobacco use. Forty- six states signed the agreement, pending the required ratification in state courts (four states settled separate, individual lawsuits with the industry). The agreement requires tobacco companies to pay $246 billion to states over 25 years and to adhere to specified restrictions on tobacco advertising and promotion. Some provi- sions are also made for improved disclosure of tobacco industry documents released in litigation. A separate, parallel agreement with the United States Tobacco Com- pany was negotiated for smokeless tobacco products. Public and Private Litigation Third, throughout 1997 and 1998, while federal legislation was being filed and debated, the states of Mississippi, Florida, Texas, and Minnesota settled their lawsuits against the tobacco industry. Besides produc- ing sizable settlement funds for the individual states, these settlements (in all but Mississippi) feature provi- sions akin to public health regulations. For example, the Florida settlement (Florida u. American Tobacco Co., Civil Action No. 95-1466 AH, sets. II.A.l and II.A.2 [Fla., Palm Beach Cty. Aug. 25, 19971) was the first to incorporate a ban on outdoor advertising and to call for statewide restrictions on vending machines. The 160 Chapter 5 Reducing Tobacco Use Minnesota settlement (Minnesota u. Philip Morris Inc., No. Cl-94-8565 [Minn., Ramsey Cty. May 8,19981, cited in 13.2 TPLR 3.39 [19981), which followed a trial and the release of thousands of incriminating internal docu- ments from the tobacco industry, contains an even wider array of public health restrictions, including a ban on promotional items and a national prohibition on com- mercial placement of tobacco products in movies. Settlements of other private suits against the in- dustry in the late 1990s have also resulted in impor- tant regulatory measures. For example, in a class action lawsuit alleging that flight attendants were injured by exposure to environmental tobacco smoke (Brain 2'. PhilipMorris Inc., No. 91-49738 CA [221 [Fla., Dade Cty. Oct. 9, 19971, cited in 12.6 TPLR 3.397 [1997]), the to- bacco industry agreed to support legislation banning smoking on all airlines departing from or landing in the United States. In a California case, R.J. Reynolds Advertising and Promotion Tobacco Company agreed to accept advertising restric- tions and to fund counteradvertising programs for teens. The latter provision was based on a claim that the company was violating the California consumer protection law by using their Joe Camel advertising campaign to target minors (Mangini u. R.J. Reynolds Tobacco Co., No. 939359 [Calif. Sept. 8, 19971, cited in 12.5 TPLR 3.349 [1997]). As of September 1998, these nonnational litiga- tions against the tobacco industry had had a greater and more immediate impact on tobacco regulation than the delayed FDA rules, proposed national settle- ment, and defeated federal legislation. Regulation through litigation is a new tool for reducing tobacco use. Specific regulatory measures contained in these smaller-scope settlements are discussed in relevant sections of this chapter, Introduction Industries use various marketing tools and strat- egies to influence consumer preference, thereby in- creasing market share and attracting new consumers. The tobacco industry is among the most intense in its efforts; among U.S. manufacturers, only the automo- bile industry markets its products more heavily (Cen- ters for Disease Control [CDC] 1990a). It may be assumed that cigarette manufacturers, like other in- dustrial entities, direct their money and marketing ef- forts in ways that will reach consumers they believe are most likely to purchase their products. The ensu- ing discussion focuses on direct product marketing and excludes other promotional and public relations efforts that are not product specific. The potential influence of cigarette advertising and promotion on smoking prevalence has been a sub- ject of concern and debate for many years (U.S. De- partment of Health and Human Services [USDHHSI 1994).' Much of the concern has focused on whether consumers know about the adverse health effects of smoking and can make informed choices; whether children and adolescents are exposed to and are af- fected by tobacco advertising and promotion; and whether tobacco companies inappropriately target advertising and promotion to specific consumer groups. A contentious debate has persisted about whether marketing induces demand and what the appropriate role of government is in protecting the consumer. Although some of these issues are not fully settled, they provide the background for considering the reduction of smoking through regulating cigarette advertising, promotion, product availability, and prod- uct presentation. In May 1981, a Federal Trade Commission (FTC) staff report (see "A Midcourse Assessment," later in this chapter) concluded that consumer knowledge about the health effects of cigarette smoking was gen- erally inadequate (Myers et al. 1981). Since then, adult smoking prevalence has declined substantially (from 33.5 percent in 1980 [Giovino et al. 19941 to 24.7 per- cent in 1995 [CDC 1997a]), and the general population's knowledge about the adverse health effects of tobacco use has improved (in recent years, 80-90 percent of ' In the following discussion, advertising refers to company- funded advertisements that appear in paid media (e.g., broad- casts, magazines, newspapers, outdoor advertising, and transit advertising), whereas promotion includes all company-sponsored nonmedia activity (e.g., direct-mail promotion, allowances, coupons, premiums, point-of-purchase displays, and entertain- ment sponsorships). Regulatory Efforts 162 Surgeon Gerwd's Rrporf the general population has known that smoking is a health hazard [USDHHS 1989, 1998131). During the same period, revenue devoted to advertising and pro- motion by the tobacco companies has increased from $1.24 billion in 1980 to a high of $6.03 billion in 1993 (FTC 1999) and $5.10 billion in 1996 (FTC 1999). To- bacco companies spent $5.66 billion on advertising and promotion in 1997 (FTC 1999). The relationship among these three events is not straightforward, and consid- erable ancillary information is needed for proper in- terpretation. In particular, the effects that both knowledge and advertising and promotion have on smoking prevalence are complex. For example, the increase in smoking uptake among women beginning in 1967 was associated with the marketing of specific cigarette brands for women (Pierce et al. 1994a). Simi- larly, an increase in smoking initiation among adoles- cents during 1985-1989 has been ecologically associated with considerable increases in promotion expenditures, as exemplified by the Joe Camel cam- paign (see "A Critical Example: Joe Camel," later in this chapter) (CDC 199513). Regardless of how these associations are interpreted, the actions of the tobacco industry bespeak the industry's belief in corporate benefit from a major investment in advertising and promotion-an investment that may be interpreted as even exceeding an economically optimal level (see Chapter 6). The tobacco industry has argued that its main purpose in advertising is to maintain brand loyalty and to capture a greater market share of current smokers (USDHHS 1994). Intensive review of the available data, however, suggests a positive correlation between level of advertising and overall tobacco consumption- that is, as advertising funds increase, the amount of tobacco products purchased by consumers also in- creases (USDHHS 1989, 1994; Smee 1992; Pierce and Gilpin 1995; also see Chapter 6). Furthermore, several judicial opinions (reviewed in "Constitutionality of Regulating Tobacco Advertising," later in this chap- ter) have questioned whether the enormous invest- ment in advertising serves only brand loyalty It has also been argued that a significant part of the expand- ing budget for tobacco marketing is for promotion to specific market segments (Hollie 1985). Other observ- ers have suggested that marketing campaigns heavily target cultural and ethnic minorities through product development, packaging, pricing, and brand promo- tion (Warner et al. 1986; Ernster 1993). Underlying these observations is awareness of a basic commercial principle: to continue to be SUC- cessful, a product must not only retain consumers but also, over time, gain new consumers. Gaining new consumers is necessarily of particular concern to the tobacco industry. Advocates for reducing tobacco use have pointed out that if the tobacco industry is to main- tain current consumption or even slow the ongoing decline in smoking, the industry must aggressively seek replacement smokers for the estimated 3,500 Americans who quit smoking each day and for the additional 1,200 tobacco customers and former cus- tomers who die each day of smoking-related illnesses (CDC 1993b, 199713). The facts about uptake of tobacco use strongly suggest where the industry's replacement smokers will come from. Epidemiologic studies show that nearly all first use of tobacco occurs before high school gradu- ation (USDHHS 1994). Whether tobacco companies deliberately market their products to preadults is dif- ficult to ascertain. Nonetheless, indirect evidence of the importance of advertising and promotion to the tobacco industry is provided by surveys that suggest that most adolescents can recall certain tobacco adver- tisements, logos, or brand insignia; these surveys cor- relate such recall with smoking intent, initiation, or level of consumption (Alexander et al. 1983; Goldstein et al. 1987; Pierce et al. 1991; Evans et al. 1995). The American Medical Association (Utah Delega- tion 19891, together with a broad range of public health organizations, has called for stricter regulation of ciga- rette advertisements and even for a complete ban- resolutions that were reiterated in 1995 (American Medical Association House of Delegates 1995). Many public health and smoking prevention groups specifi- cally seek government regulation to address what they consider discriminatory practices of tobacco manufac- turers in targeting members of minority groups (Warner et al. 1986). These groups claim that adver- tisements overwhelm smoking prevention messages and increase the number of people who smoke each year beyond the number that would smoke if adver- tising and promotion affected only market share. In- dustry officials deny targeting and argue that because most of the population is now aware of the risks asso- ciated with tobacco products, citizens can make in- formed decisions for themselves. More important, the tobacco industry claims its First Amendment consti- tutional right to promote its products (Cotton 1990; Tollison and Wagner 1992; see the discussion in "Con- stitutionality of Regulating Tobacco Advertising," later in this chapter). Such arguments and counterarguments have been at the heart of a 30-year endeavor to regulate advertising and promotion in the tobacco industry. A review of this effort, with some specific examples from the United States and other countries, provides insight 262 Chapter 5 Reduhg Tobacco Use into the strengths and weaknesses of both sides of the argument and suggests several areas for policy development. Attempts to Regulate Tobacco Advertising and Packaging Regulatory efforts to restrict the advertising and promotion of cigarettes were among the earliest re- sponses to the 1964 landmark report of the Surgeon General's Advisory Committee, which set forth over- whelming scientific evidence on the health hazards of cigarette smoking. A week after the January 11,1964, release of the report, the FTC filed a Notice of Rule- Making Proceeding (January 17, 1964) that appeared in the January 22,1964, Federal Register. The notice set forth the agency`s tentative views of how the require- ments of the Federal Trade Commission Act (Public Law 96-252) would apply to the advertising and la- beling of cigarettes in light of the Advisory Committee's report (Federal Register 1964). In a perti- nent part, section 5 of the Federal Trade Commission Act states that "unfair or deceptive acts or practices [are] declared unlawful" and that the commission has the power to proceed against them as an administra- tive agency. In its notice of rulemaking, the FTC stated its concern with "two ways in which cigarette advertis- ing may be unlawfully misrepresenting or concealing the health hazards of smoking. First, the Commission has reason to believe that many current advertisements falsely state, or give the false impression, that ciga- rette smoking promotes health or physical well-being or is not a health hazard, or that smoking the adver- tised brand is less of a health hazard than smoking other brands of cigarettes" (Federal Register 1964, p. 530). The FTC also stated that much cigarette ad- vertising then current portrayed cigarette smoking as pleasurable, desirable, compatible with physical fit- ness, or indispensable to full personal development and social success-all without informing the con- sumer of the health hazards of cigarette smoking. The FTC posited that the dangers to health from cigarette smoking are so serious that knowledge and appreciation of them would be a material factor in in- fluencing a person's decision to smoke cigarettes or to smoke a particular brand. (This point is considered in detail in "Tobacco Packaging and Informed Choice," later in this chapter.) Affirmative disclosures of these health hazards might thus be necessary in cigarette advertising that could cloud or obscure public con- sciousness of these health hazards. After receiving written comments and materials from interested parties and after conducting hearings in March 1964 on the proposed rule (see the text box "Response From the Tobacco Industry-1964"), the FTC issued on June 22,1964, the "Statement of Basis and Purpose" regard- ing its proposed Trade Regulation Rule. (A Trade Regulation Rule is, in effect, an administrative statute with the force of law.) In this document, the commis- sion announced that it would require warnings on ciga- rette packages and in advertisements for cigarettes that cigarette smoking is dangerous to human health. Cigarette Warning Labels After participating in hearings before the U.S. House of Representatives Committee on Interstate and Foreign Commerce on cigarette labeling and FK rules, the commission postponed until 1965 the implemen- tation of any Trade Regulation Rule. In that year, the Federal Cigarette Labeling and Advertising Act of 1965 (Public Law 89-92) required that the warning "Cau- tion: Cigarette Smoking May Be Hazardous to Your Health" (Federal Cigarette Labeling and Advertising Act, sec. 4) be placed in small print on one of the side panels of each cigarette package. The act permitted no additional labeling requirement under any federal, state, or local law, thus effectively preempting any other health messages on cigarette packages. The act also suspended for three years the FTC's authority to require health warnings on cigarette advertising. This preemption was strongly opposed in the minority view of Representative John E. Moss (D-CA), who presented the argument as follows: I most strongly object to sections 6 and 7 of this bill. Section 6 would prevent the Federal Trade Commission, the Food and Drug Administration, and the U.S. Public Health Service in administer- ing their respective laws from imposing any addi- tional requirement with regard to the labeling of cigarettes involving a health warning. The bill would also preclude State and local health authori- ties from imposing such requirements. Section 7, the preemption provision of the bill, provides that no cautionary statement with respect to smoking and health other than specified in this legislation shall be required on any package; and that no such statement with respect to smoking and health shall be required in advertising for ciga- rettes packaged in conformity with the labeling provisions of this legislation. Rep/a tory Efforts 2 63 Surgeon Gellend's Report The Secretary of Health, Education, and Welfare has said that preventing any regulatory agency from imposing a label warning requirement other than that prescribed in the bill is "a position which we consider too inflexible." The National Interagency Council on Smoking and Health submitted a petition to the committee ask- ing us "not to approve any legislation which will prevent the Federal Trade Commission from car- rying out its reaffirmed intention of requiring health warnings in cigarette advertising" (Moss 1965, pp. 2365-6). Representative Moss concluded his minority report with a strong condemnation: In summary I am strongly opposed to those fea- tures of this legislation which would preclude the imposition of more stringent labeling requirements or the imposition of health warnings in advertise- ments which Federal, State, or local health authori- ties may deem necessary in the future in the proper exercise of their respective powers. We must face the facts as presented to us by the Surgeon Gen- eral, American Cancer Society, American Medical Association, American Heart Association, and the National Tuberculosis Association. We must first concern ourselves with public health and welfare, not legislate to the whims of a special interest (Moss 1965, p. 2367). In commenting on the 1965 labeling law, the Sec- retary of the Department of Health, Education, and Welfare outlined an alternative view of effective health warnings on cigarette packages (Celebrezze 1965). Secretary Anthony J. Celebrezze recommended that the warning appear in large type on the main faces of the package. He commented: The statute should require the warning to be prominent and conspicuous but should leave the precise location and size of the warning on the la- bel, and related matters, to regulation in the light of the expertise and experience of the regulatory agency. . . . [Ten]-point type, which is 2 points smaller than the type size used in typing this let- ter, is hardly calculated to invite the consumer's attention. . . . If the required warning is in effect negated or dis- claimed on the label or in accompanying literature by words, statements, designs, or other graphic material, the warning requirement shall be deemed I Response From the Tobacco Industry-1964 I n April 1964, in rapid response to the Surgeon General's report, the tobacco industry published a voluntary code for advertising and marketing prac- tices (Gray 1964). The stated purpose of the code was "to establish uniform standards for cigarette advertising and to provide means whereby compli- ance with this code can be ascertained promptly and fairly and on a consistent basis" (p. 141). The code was designed to restrict cigarette advertisements aimed at young people, to limit implied or direct health claims to those that could be medically and scientifically proved, and to curb the so-called viril- ity theme in cigarette advertisements. The code spe- cifically prohibited advertising that suggested that cigarette smoking was essential to "sexual attrac- tion," "success," sophistication, athletic abilities, physical stamina, and "social prominence" (p. 143)- images that the industry recognized as influencing smoking by young people. At hearings before the House Interstate and Foreign Commerce Committee on June 25, 1964, Bowman Gray, Chairman of the Board of R.J. Reynolds Tobacco Company, speaking on behalf of the industry, told Congress, "This advertising code represents a sincere effort by the industry to respond to criticism of the industry's advertising which has been voiced in some quarters. It is an earnest effort at industry self-regulation. I hope the industry will be given reasonable opportunity to implement this code" (Gray 1964, p. 141). The code was to be enforced by an indepen- dent administrator. All advertisements were to be precleared, and violations of the code were subject to a fine of $100,000. Enforcement provisions of the code were dropped shortly after passage of the Fed- eral Cigarette Labeling and Advertising Act in 1965. i 164 Chapter 5 Reducing Tobacco Use not to have been met. . . [Congress should con- sider giving the department] specific authority to prohibit or regulate the use of statements that while not clearly negating the warning and while literally true or at least not demonstrably false, may give the consumer the misleading impression that a given cigarette is safer than others (Celebrezze 1965, p. 2359). These recommendations predate by three decades simi- lar implementation of warnings in other countries (de- scribed in "Examples of Product Labeling in Other Countries," later in this chapter); such an approach, however, has not been taken in this country. The 1965 law also required that the FTC annu- ally transmit to Congress a report on the effectiveness of cigarette labeling, on current cigarette advertising and promotion practices, and on recommendations for legislation. In June 1967, in its first report to Congress, the FTC recommended that the package label be changed to "Warning: Cigarette Smoking Is Danger- ous to Health and May Cause Death from Cancer and Other Diseases" (FTC 1967, p. 30). Broadcast Advertising Ban In 1969 Congress passed the Public Health Ciga- rette Smoking Act (Public Law 91-2221, which prohib- ited cigarette advertising on all media subject to Federal Communications Commission (FCC) regula- tion, especially radio and television broadcasting, and required that each cigarette package contain the label "Warning: The Surgeon General Has Determined That Cigarette Smoking Is Dangerous to Your Health" (Pub- lic Health Cigarette Smoking Act, sec. 4). This new law also preempted any other health warning require- ments for cigarette packages. The prohibition on broadcast media advertising became effective on Janu- ary 2, 1971. The FTC issued complaints against the cigarette companies that eventually led to a consent decree requiring the companies to add the statutory label warning to their advertising in magazines, news- papers, and outdoor displays (Trade Regulation Reporter 1973). The prohibition on television and radio advertis- ing was challenged-not by the cigarette companies, but by a group of broadcasters-in Capital Broadcasting Co. u. Mitchell (333 E Supp. 582 [D.D.C. 19711). That case upheld the constitutionality of the congressional prohibition by a 2 to 1 vote. Despite this victory, a so- bering note was struck in the dissenting opinion of Judge J. Skelly Wright. Far from casting his vote against smoking prevention, Judge Wright was concerned that upholding the act, and thus upholding the prohibition on broadcast advertising, would actually aid the tobacco industry. His reasoning-which proved correct-was that the ban would put an end not only to tobacco ad- vertising but also to the cost-free counteradvertising that had been running in the electronic media since 1969, when the FCC's Fairness Doctrine was first held appli- cable to cigarette advertising. The Fairness Doctrine, which was put forth in 1949 (and ceased applying to tobacco in 1971 after ciga- rette advertising on radio and television ended), re- quired that whenever material covering "`a controversial issue of public importance' " (Banzhaf II. FCC, 405 E2d 1082, 1086 [D.C. Cir. 19681, cert. denied, 396 U.S. 842,90 S. Ct. 50 [19691) was aired, the broad- caster had an obligation to present, to some degree, both sides of the issue. Although the Fairness Doc- trine had not previously been interpreted to apply to advertising, in Banzhaf the Federal Circuit Court of Appeals ruled that the FCC had the authority, through the Fairness Doctrine, to require that radio and televi- sion stations carrying cigarette advertising devote (i.e., without charging advertising fees) a significant amount of broadcast time to presenting the case against smoking. (For more on the plaintiff, John F. Banzhaf, see "The Attack on Advertising" in Chapter 2.) In the court's ruling, Chief Judge David Bazelon observed that "if we are to adopt [the tobacco industry's] analy- sis [of Congress' intention in enacting the Federal Ciga- rette Labeling and Advertising Act], we must conclude that Congress legislated to curtail the potential flow of information lest the public learn too much about the hazards of smoking for the good of the tobacco industry and the economy. We are loathe to impute such a purpose to Congress absent a clear expression" (Bamhaf, p. 1089). However, three years later, in Capital Broadcasf- ing Co. ZI. Acting Afforney General (405 U.S. 1000 [1972], aff'd sub nom. Capital Broadcasting Co. u. Mitchell, 333 F. Supp. 582 [D.D.C. 197111, it was Judge Wright's view that the television and radio counteradvertising that had arisen from the Fairness Doctrine was so effective that the tobacco companies actually favored the chal- lenged ban. There is some support for this view. Per capita cigarette consumption in the United States, which had declined (with some fluctuation) generally since the 1964 report to the Surgeon General on the health effects of smoking, had leveled off and then in- creased after cigarette advertising was removed in 1971 from radio and television. Some analysts have asserted that these changes indicate that the cost-free counteradvertisements opposing cigarette use, which along with the commercials promoting cigarettes, Rcglilafory Efforts 265 Surgeof' Gerwal's Rrporf largely disappeared from the airwaves except for a relatively few public service announcements, were more effective in discouraging consumption than ciga- rette commercials were in encouraging consumption (Warner 1979). Moreover, the prohibition of cigarette advertising on broadcast stations has allowed the to- bacco companies to avoid the significant expense of advertising on national television and to devote their promotional dollars to other media. A Midcourse Assessment A decade after the broadcast ban, the FTC issued a staff report in May 1981 on cigarette advertising (Myers et al. 1981). This report asserted that "the domi- nant themes of cigarette advertising are that smoking is associated with youthful vigor, good health, good looks and personal, social and professional acceptance and success, and that it is compatible with a wide range of athletic and healthful activities" (p. 2-13). Although such advertising included the required general warn- ing about the health hazards of cigarette smoking and listed the cigarette's tar and nicotine contents (as de- termined by FTC testing methods), the advertisements otherwise made no mention of the adverse health con- sequences of smoking cigarettes. The overriding mes- sage of cigarette advertising was thus that smoking is a positive, desirable experience. Details from a nonpublic version of the FTC re- port revealed, for example, that a primary theme for the marketing of Salem cigarettes was the association of the cigarette with the lifestyle of young adult males who were (in the words of the company's campaign notes) "masculine, contemporary, confident, self- assured, daring/adventurous, mature" (Banzhaf 1982, p. 260). The report quoted from a Dora1 cigarette cam- paign that sought to project the image of "an indepen- dent, self-reliant, self-confident, take-charge kind of person" (p, 260) and a campaign that depicted a "Win- ston man" as "a man's man who is strong, vigorous, confident, experienced, mature" (p. 260). Taking an- other tack, the Eve cigarette campaign sought to por- tray the smoker as a "sophisticated, up-to-date, youthful and active woman who seems to have dis- tinct ideas about what she wants" (p. 261). The cam- paign for the Lark brand was designed to position it as a "youthful, contemporary brand that satisfies the lifestyles of the modern smoking public" (p. 260) and emphasizes "moments of post-tension and relaxation" (pp. 260-l ). The nonpublic version of the FTC report also detailed and quoted from the conclusion of a market- ing and research firm that had conducted focus group interviews to help Ted Bates and Company, Inc., de- velop a marketable image for Viceroy cigarettes. The report, summarizing the results of the research, as- serted that many smokers perceived the smoking habit as a dirty and dangerous one engaged in only by "very stupid people" (Banzhaf 1982, p. 262). The report con- cluded: "Thus, the smokers have to face the fact that they are illogical, irrational and stupid. People find it hard to go throughout life with such negative presen- tation and evaluation of self. The saviors are the ra- tionalization and repression that end up and result in a defense mechanism that, as many of the defense mechanisms we use, has its own logic, its own ratio- nale" (p. 262). This marketing analysis went on to state that because there "are not any real, absolute, positive quali- ties or attributes in a cigarette" (Banzhaf 1982, p. 262), the most effective advertising is designed to "reduce objections" (p. 262) to the product by presenting a pic- ture or situation ambiguous enough to provide smok- ers with a rationale for their behavior and a means of repressing their health concerns about smoking. The advertisement must thus project the image that ciga- rettes have clearly beneficial functions, such as improv- ing the smoker's self-image and self-acceptance or serving as a stimulant or tranquilizer that offers an ac- ceptable means of self-reward. Accordingly, the analy- sis recommended that advertisers should start from "the basic assumption that cigarette smoking is dangerous to your health" (p. 263) and then try to circumvent the problem rather than fight what would be a losing battle. A particularly notable element of the report was how to persuade young people to smoke: For the young smoker, the cigarette is not yet an integral part of life, of day-to-day life, in spite of the fact that [young smokers] try to project the image of a regular, run-of-the-mill smoker. For them, a cigarette, and the whole smoking process, is part of the illicit pleasure category. _ . In the young smoker's mind a cigarette falls into the same category with wine, beer, shaving, wearing a bra (or purposely not wearing one), declaration of independence and striving for self-identity. For the young starter, a cigarette is associated with in- troduction to sex life, with courtship, with smok- ing "pot" and keeping late studying hours (Banzhaf 1982, p. 263). The survey then recommended a strategy for attract- ing young people to start cigarette smoking: present the cigarette as one of a few initiations into the adult world and show the cigarette as part of the illicit pleasure category of products and activities. To the 166 Chapter 5 Reducing Tobacco Use degree possible under legal constraints, the strategy advised relating the pleasure of smoking cigarettes to the pleasures of adult or illicit activities, such as drink- ing alcohol, smoking marijuana, or having sex (Myers et al. 1981). Brown & Williamson Tobacco Corpora- tion stated that these proposals were never imple- mented and did not represent their policy. In sum, the marketing and research firm recom- mended that successful cigarette advertising must ei- ther consciously or unconsciously deal with smoking and health issues by repressing the health concerns of the consumers of the product and providing a ratio- nalization for consumption. The 1981 FTC report also concluded that the federally mandated health warn- ing had little impact on the public's level of knowl- edge and attitudes about smoking. The report further observed that the warning was outworn, abstract, dif- ficult to remember, and not perceived as personally relevant (Myers et al. 1981). These concerns contrib- uted to Congress' enactment of the Comprehensive Smoking Education Act of 1984 (Public Law 98-4741, which required four specific, rotating health warnings on all cigarette packages and advertisements (Com- prehensive Smoking Education Act, sec. 4): SURGEON GENERALS WARNING: Smoking Causes Lung Cancer, Heart Disease, Emphysema, and May Complicate Pregnancy. SURGEON GENERAL'S WARNING: Quitting Smoking Now Greatly Reduces Serious Risks to Your Health. SURGEON GENERALS WARNING: Smoking by Pregnant Women May Result in Fetal Injury, Pre- mature Birth, and Low Birth Weight. SURGEON GENERAL'S WARNING: Cigarette Smoke Contains Carbon Monoxide. The Comprehensive Smoking Education Act of 1984 thus amended the Federal Cigarette Labeling and Advertising Act and required warnings to be placed on advertisements as well as on cigarette packages. The act preempts state and federal attempts to place additional warnings on packages, but it preempts only state action with regard to advertising. The FTC re- tains such jurisdiction under section 5. From the first, the exact appearance of warning labels (wording, layout, and positioning on packages and advertisements) has represented compromises between the recommendations of the FTC and smok- ing prevention advocates and those of the tobacco industry. In 1969, for example, the FTC recommended a warning on cigarette packages that specifically men- tioned death, cancer, heart disease, chronic bronchitis, and emphysema. The resulting legislation required the legend to provide the general warning only that smoking is "dangerous" to one's health (Public Health Cigarette Smoking Act of 1969, sec. 4). Similarly, in its 1981 report on cigarette advertising, the FTC recom- mended that new warning labels use a "circle-and- arrow" format that would be more effective than the traditional rectangular format, but Congress did not take this approach in the Comprehensive Smoking Education Act of 1984. Also, the new labels did not incorporate the FTC's recommendations to contain specific references to addiction, miscarriage, and death and to disclose the brand's yields of tar, nicotine, and carbon monoxide. Smokeless Tobacco Warning Labels Requirements for warning labels on smokeless tobacco products lagged behind those on cigarettes by more than 20 years. By the mid-1980s, the strong evi- dence that smokeless tobacco causes oral cancer, nico- tine addiction, and other health problems and that its use was increasing among boys led Massachusetts to adopt legislation requiring warning labels on packages of snuff and caused 25 other states to consider similar legislation (USDHHS 1989). The Massachusetts law was preempted, before it could take effect, by the federal Comprehensive Smokeless Tobacco Health Education Act of 1986 (Pub- lic Law 99-252). This law not only required three ro- tating warning labels on smokeless tobacco packaging and in all advertising (except billboards) but also stipu- lated that the labels have the circle-and-arrow format that the FTC had recommended earlier for cigarette warnings. The three rotating labels read as follows (Comprehensive Smokeless Tobacco Health Education Act of 1986, sec. 3): WARNING: This product may cause mouth cancer. WARNING: This product may cause gum disease and tooth loss. WARNING: This product is not a safe alternative to cigarettes. Initially, the FTC excluded utilitarian items-such as hats, T-shirts, lighters, and jackets-bearing the name or logo of smokeless tobacco products. A consortium Regulatory Efforts 167 Surgeon General's Report of Public Citizen and several prominent health orga- nizations sued the FTC, arguing that this exclusion was contrary to the provisions of the act, which sought a comprehensive rather than a narrow use of health warnings (Public Citizen v. Federal Trade Commission, 869 E2d 1541 [D.C. Cir. 19891). The Court of Appeals for the District of Columbia ruled for the plaintiff, stating that the act was intended to cover utilitarian items, since those were among the smokeless tobacco industry's most effective means of promoting its prod- ucts to adolescents. The court elaborated its point, saying that adolescents were less likely than adults to read magazines and newspapers and thereby less likely to encounter the mandated warnings there. Adolescents were also likely to have passed the criti- cal moment of decision by the time they obtained the product itself and encountered its warning label. Ac- cordingly, in 1991, the FTC issued a final rule requir- ing health warnings to be displayed on utilitarian items and providing for the manner in which the warnings were displayed. All advertising of smokeless tobacco products is also banned on any medium of electronic communi- cation subject to the jurisdiction of the FTC. Under this act, federal agencies and state and local govern- ments are preempted from imposing additional health warnings on smokeless tobacco products and adver- tisements (except for billboards, which were excluded from this act). Furthermore, instead of stipulating where the labels must be positioned, the act required only "conspicuous and prominent" placement (Com- prehensive Smokeless Tobacco Health Education Act of 1986, sec. 3). Implementation was left to the FTC, which enacted enabling regulations on November 4, 1994. Regulation of Tobacco Packaging Package size of tobacco products has been an- other area of public health concern and action. Evi- dence that levels of tobacco consumption reflect the affordability of tobacco products (see Chapter 6) has raised concern about selling cigarettes in packs con- taining fewer than the usual 20 cigarettes. In many countries, cigarettes are sold in packages of 15,10, or 5 cigarettes. These smaller package formats have been dubbed "kiddie" packs in Canada by smoking preven- tion activists (Chretien 1994). Research has shown that young people account for many sales of smaller ciga- rette packages (Wilson et al. 1987; Nova Scotia Coun- cil on Smoking and Health 1991; IMPACT Research 1993), probably because of their low price and ease of concealment. These findings have led some jurisdictions to prohibit the marketing of packages containing fewer than 20 cigarettes. An Australian state legislature has also passed such a ban (the Western Australia Tobacco Control Act of 1990). In Canada, several provinces have banned small package sizes, and the revised fed- eral Tobacco Sales to Young Persons Act of 1993 na- tionally banned packages of fewer than 20 cigarettes. Another issue of concern regarding tobacco pack- aging is the use of potentially misleading descriptive words in the labeling of some tobacco products (Davis et al. 1990). A recent Gallup poll found that words such as "slim," " low tar," and "light" conveyed mes- sages viewed as healthful (Gallup Organization, Inc. 1993, pp. 23,251. Cohen (1992) reported that tobacco companies have long known that their customers equate the marketing term "low tar" (p. 85) with health benefits. Chapman and colleagues (1986) reported that smokers tend to systematically underestimate the ac- tual tar deliveries of their particular brands, and Gori (1990) found that one-half of smokers interviewed in the United States and Europe assume that the lower the tar rating, the lower the brand's propensity to cause disease. The Coalition on Smoking OR Health (1988) has further analyzed how promoting cigarette brands as having low tar and low nicotine content communi- cates a message to consumers that these brands have health benefits. The use of such descriptive words in cigarette brand names has been called into question because variations in the way cigarettes are actually smoked may mean that the actual yield of toxic constituents from cigarettes differs from the levels determined by currently accepted testing procedures (Henningfield et al. 1994; see "Compensatory Smoking," later in this chapter). For example, smokers of reduced-tar cigarettes may (deliberately or not) inhale harder to draw more smoke through the denser filter and deep into the lungs and may smoke the cigarette down closer to the filter, thereby inhaling greater concentra- tions of toxins. This concern led to the appointment of an ad hoc committee of the President's Cancer Panel of the National Cancer Institute (NC11 to evaluate the current FTC protocol for testing tar, nicotine, and car- bon monoxide. One of the conclusions of this panel was that "brand names and brand classifications such as `light' and `ultra light' represent health claims and should be regulated and accompanied, in fair balance, with an appropriate disclaimer" (NC1 1996, p. vii). This recommendation has not yet been carried out. A further aspect of tobacco packaging that is cur- rently receiving significant attention, although prima- rily outside the United States, is the possibility of 168 Chapter 5 Reducing Tobacco Use legislated plain (or "generic") packaging for tobacco products. This initiative is partly motivated by the belief that removing much of the brand image of to- bacco products would not only make the product less attractive but also weaken the connection with-and thus lessen the effect of-visual and verbal image- linked efforts to promote particular brands (Mahood 1995). There is evidence that young people find plain packaging less attractive (Beede and Lawson 1992; Centre for Health Promotion 1993) and that plain pack- aging makes health messages more noticeable (Centre for Behavioural Research in Cancer 1992). In Canada, the federal government has considered using plain packaging for tobacco products (Standing Committee on Health 1994; Health Canada 1995131, and the prov- ince of Ontario, in enacting the Tobacco Products Control Act in 1994, authorized the requirement for plain packaging on all cigarettes sold in Ontario. Such packaging reforms have not yet been enacted in any jurisdiction. Examples of Product Labeling in Other Countries In recent years, many countries have taken sig- nificant action on specifying packaging and warning labels for tobacco products. All countries of the Euro- pean Union must comply with a May 15,1992, direc- tive (Council Directive 92/41/EEC 1992 O.J. [L 1581) that requires stipulated health warnings on each of the main package panels. In Thailand, pursuant to its To- bacco Products Control Act, which was based on prin- ciples developed in Canadian regulations (discussed later in this section), prominent black-and-white health messages are required on the front of the package. South Africa and New Zealand require detailed health messages on the main package panels; the messages are based largely on Australian packaging. The messages appearing on Australian cigarette packages are based on the work of the Centre for Behavioural Research in Cancer (1992). These mes- sages were required as of January 1, 1995, and were incorporated into a broad effort "to inform smokers of the long-term health effects of tobacco use" (Lawrence 1994, p. 1). The Australian system uses six rotating messages covering 25 percent of the front of the ciga- rette packets. One side of the packet is entirely given to the labeling of dangerous constituents, and all the labels must be in black and white. Thirty-three percent of the rear main packet panel must be covered by the same health message given on the front of the pack and followed by an elaboration of that message (Chapman 1995). Of special interest are the package regulations currently in place in Canada. The Canadian health messages were established by regulatory power granted under the 1988 federal Tobacco Products Con- trol Act, which came into effect on January 1,1989. This legislation gives broad regulatory powers over tobacco product packaging. It also gives regulatory authority to require package inserts, although this power has not yet been acted on. By eventually delegating formula- tion of the precise warnings to administrative regula- tion, this legislation took the approach that had been recommended 25 years earlier by the U.S. Department of Health, Education, and Welfare (Celebrezze 1965; see also "Cigarette Warning Labels," earlier in this chap- ter). This law also makes clear that the various prov- inces of Canada can require additional messages and that the provision of federal messages does not pre- empt other messages. The first set of regulations fol- lowing this law required that four specific rotating health messages be placed on the two main panels of cigarette packages and be printed in a large typeface; this set of regulations stipulated that the messages must be "prominently displayed in contrasting colours" (De- partment of National Health and Welfare 1989, p. 64) and cover at least 20 percent of the panel face. When the mandated Canadian health messages started appearing on tobacco products in 1989, it was clear to many public health workers that the language of the regulations had left the tobacco companies too much room for interpretation and had resulted in less prominence and contrast than the regulations had in- tended. Minister of National Health and Welfare Henry Perrin Beatty commented, "It's very clear that, when you look at [the health warning on cigarette packs], it's not designed to stand out. If our experts [at the Department of National Defencel knew as much about camouflage as the tobacco company did, nobody'd ever find our fellows" (Spectator 1989). This situation gained more attention when it was revealed that a prominent tobacco lobbyist had apparently in- fluenced development of the regulations (Fraser 1989). Health advocates subsequently campaigned to attain more prominent messages through revising the regu- lations (Mahood 1995). New legislation was enacted on August 11, 1993 (Department of National Health and Welfare 19931, and all packaging for tobacco products destined for sale in Canada had to comply by September 11,1994. Among these precedent-setting regulations (Mahood 1995) were the following requirements: o The message must cover at least 25 percent of the top of each main panel. Regulafory Efforts 169 SurgeoH Gc~leral's Report The message must be framed by a stipulated bor- der (on many packs, this border yields a total mes- sage area that uses over 40 percent of the surface). Each of eight rotating messages must be presented one-half of the time in black on a white background with a black border. The other one-half of the time, the messages must be white on a black background surrounded by a white border. One entire side panel must be used to present in- formation on the toxic constituents. Every side panel of tobacco cartons must display a black-on-white message covering 25 percent of the panel area and stating "Cigarettes are addictive and cause lung cancer, emphysema, and heart disease" (Department of National Health and Welfare 1993, p. 3278). The message must bear no attributions. One ironic result of these requirements was that cigarettes manufactured in the United States for the Canadian market were produced, albeit only for ex- port, with health messages that conform with the rec- ommendations provided in 1965 by the U.S. Department of Health, Education, and Welfare. The Canadian regulations were reversed in 1995, when the Supreme Court of Canada held that the country's complete ban on overt tobacco advertise- ments (another key component of the 1993 regulations) and its requirement of unattributed health warnings on packages were in violation of the tobacco industry's freedom of expression and the Canadian Charter of Rights and Freedoms (RJR-MacDonald Inc. v. Attorney General of Canada, File Nos. 23460, 23490 [Can. Nov. 29-30, 1994, Sept. 21, 19951, cited in 10.6 TPLR 2.167 [1995]). These central elements of Canada's Tobacco Products Control Act fell because the Canadian gov- ernment did not meet its constitutional obligation of proving that the approach taken was the least drastic means of achieving a public health objective. These narrow evidentiary grounds on which the decision was made left room for the Canadian government to counter. The government offered a new proposal, called Tobacco Control: A Blueprint to Protect the Health of Canadians, that reinstated the advertising ban, im- posed restrictions on brand-name promotion and sponsorship, instituted controls over packaging and labeling, and increased product regulation and report- ing requirements. In creating a new legal framework, the Canadian government would make tobacco a de facto illegal product whose sale could be permitted but would be subject to specific conditions. This reversal of the burden of proof gives constitutional allowance to the advertising restrictions in Canada. Following the un- veiling of the Blueprint, the tobacco industry brought forward a voluntary proposal to restrict advertising. Subsequent resumption of advertising has been con- troversial, and the industry has been accused of breach- ing its own code (LeGresley 1996). Tobacco Advertising, Commercial Speech, and the First Amendment Regulation of tobacco advertising in the United States is legally problematic. Although protections afforded by the First Amendment to the U.S. Consti- tution may be modified for commercial speech, includ- ing advertising, such modification is an area of intensive legal debate. The two decades of lawsuits described in this section make it clear that a concerted and persistent government interest is essential if such restriction of free speech is to be upheld in courts. To satisfy legal scrutiny, the government's efforts must clearly show that any restrictions directly and materi- ally advance its asserted interest-protecting the health of the American people. The United States Supreme Court has defined commercial speech as "expression related solely to the economic interests of the speaker and its audience" (Cerrtral Hudson Gas 6 Electric v. Public Service Commis- siolz of New York, 447 U.S. 557 [19801). Commercial speech thus includes advertisements by cigarette manufacturers that invite consumers to buy their prod- uct. As the Supreme Court has observed, "For most of this Nation's history, purely commercial advertising was not considered to implicate the constitutional pro- tection of the First Amendment" (United States v. Edge Broadcasting Co., 113 S. Ct. 2696,2703 119931). Restric- tions on commercial speech were viewed as being simi- lar to economic regulation and were routinely upheld. A midcentury example key to later efforts to restrict tobacco advertising occurred when the Supreme Court, in Vulentine v. Ckrestensen (316 U.S. 52 [2d Cir. 19421, rev'd), held that the state could prohibit the street dis- tribution of handbills containing commercial adver- tising matter (see also Village of Sckaumburg v. Citizens for a Better Environment, 444 U.S. 620 [19801). Such pre- cedents enabled the courts to uphold the 1972 congres- sional ban on tobacco advertising on radio and television (Capital Brondcasting Co., 405 U.S. 1000). Subsequent legal scrutiny, however, has acted to re- verse this trend. 2 70 Chapter 5 Reducilzg Tobacco Use Constitutionality of Regulating Advertising In 1975, the United States Supreme Court held for the first time that commercial advertising in gen- eral was entitled to protection under the First Amend- ment. In Bigelozo v. Virginia (421 U.S. 809 [19751), the Court struck down a state statute banning commer- cial advertisements for abortion referral services. The Court found that "the relationship of speech to the marketplace of products or services does not make Icommercial advertising] valueless in the marketplace of ideas" (p. 826). However, the Court emphasized that it was defending not merely commercial speech, but speech that contained "material of clear `public interest' " (p. 822). The Court also defended commercial speech in a case involving advertising of the price of pharmaceu- ticals. In Virginia Stnte Board of Pharmcy ZJ. Virgilzia Citizens Consumer Council, Ix. (425 U.S. 748 1197611, the Court found that the constitutional protection af- forded to advertisements of the price of pharmaceuti- cals was shared by advertisers and recipients of the information. The Court noted the importance of in- formation to consumers: `As to the particular consumer's interest in the free flow of commercial in- formation, that interest may be as keen, if not keener by far, than his interest in the day's most urgent politi- cal debate" (p. 763). The Court pointed out that ad- vertising is disseminating information to the consumer about who is producing the product, for what reason, and at what price, even if it does not "editorialize on any subject, cultural, philosophical, or political" (p. 761). In that same ruling, however, the Supreme Court emphasized that commercial speech would not be af- forded the same level of protection as other forms of speech and therefore that the state can regulate adver- tising if such regulation is in conformity to a valid public interest. These interests include avoiding de- ceptive and misleading claims; preventing unlawful activities, such as the sale of alcoholic beverages to minors; and protecting public health. "The First Amendment . . . does not prohibit the State from in- suring that the stream of commercial information flow cleanly as well as freely" (Virginia State Board of Phar- macy, pp. 771-2). Most cases involving regulated advertising are assessed through a four-pronged test to determine whether the regulations violate the First Amendment. This test was set forth in Central Hudson (447 U.S. 557). First, the speech being suppressed must have forfeited its First Amendment protection by being unlawful or deceptive or fraudulent: "The First Amendment's concern for commercial speech is based on the infor- mational function of advertising. . . . Consequently, there can be no constitutional objection to the suppres- sion of commercial messages that do not accurately inform the public about lawful activity. The govern- ment may ban forms of communication more likely to deceive the public than to inform it" (p. 563). Second, the government must assert a substantial interest in regulating the speech. Third, regulating commercial speech must directly and materially benefit this gov- ernment interest. Fourth, the government must show that the means chosen to benefit its interest are no more extensive than necessary. (This four-pronged test is discussed more fully in "Constitutionality of Regulat- ing Tobacco Advertising," later in this chapter.) The level of deference the Supreme Court gives to legislatures in meeting these four requirements seems to vary. In some cases, the Court defers to the legislative judgment that the speech restriction will be effective (Posadas de Puerto Rico Associates u. Tourism Co777par7y of Puerto Rico, 478 US. 328 119861; Edge Broud- casting), while in other cases the Court demands more empirical support for the legislature's assumptions and conclusions (Rubirl zl. Coors Brewing Co., 514 U.S. 476, 115 S. Ct. 1585 [1995]; 44 Liquormart, Inc. ~7. Rhode ls- /and, 517 U.S. 484, 116 S. Ct. 1495 119961). In Poslzdas de Puerto Rico, the Supreme Court up- held a statute that prohibited advertising legal gam- bling casinos to residents. The Court found that even though nonfraudulent advertising that concerned a legal activity deserved First Amendment protection, the commonwealth's legislature could take steps to regulate it. The government has a substantial interest in protecting the health, safety, and welfare of its citi- zens, and this interest includes reducing the demand for gambling among residents through the regulation of advertising. The Court accepted the argument by the commonwealth that resident gambling would dis- rupt moral and cultural patterns, cause an increase in crime, foster prostitution, and develop corruption. In Board of Trustees of the State University of New York u. Fox (492 U.S. 469 [1989]) (also known as Fox III), the Court deferred to the legislature and refused to set aside a State University of New York statute that pro- hibited private commercial enterprises from operat- ing on campus. In Edge Broadcasting (113 S. Ct. 26961, the Court upheld a federal statute that prohibited the broadcast of lottery advertisements generally but per- mitted advertisements of state-run lotteries on stations licensed to a state that conducts lotteries. The Court held that "the State [has] `a strong interest in adopting and enforcing rules of conduct designed to protect the public' " (p. 2706). Citing Fox III with approval, the Regulfltory Efforts 171 Court said, "Within the bounds of the general protec- tion provided by the Constitution to commercial speech, we allow room for legislative judgments" (p. 2707). In contrast, in 44 Liquovnzavt, the Supreme Court looked closely at the logic of the Rhode Island gov- ernment in the ban it imposed on liquor price adver- tising. The Court considered that the Rhode Island restriction was a total prohibition and that there was too weak a connection between banning speech regard- ing prices and the state's assertion that this restriction would reduce liquor consumption. Furthermore, the Court was aware of the concern that the legislature had been captured by one group of economic competi- tors (small liquor stores that could not otherwise com- pete in price wars) and that the law was then drafted at the expense of the disfavored economic competitor (larger liquor chains). In the 44 Liquwnzart decision citing the dissent in Rhode Island Liquor Stores Associa- tion u. Evening Call Pub. Co. (497 A.2d 331 [R.I. 19851), it was "suggested that the advertising ban was moti- vated, at least in part, by an interest in protecting small retailers from price competition" (p. 491, FN4). In Coors Brezuitlg Co., the Supreme Court struck down a regulation restricting the printing of alcohol strength on beer labels. The Court found that the re- striction did little to advance the government interest in preventing "strength wars" between competing beer manufacturers, particularly when other types of alco- hol were required to list the alcohol potency on their labels. Finding that the speech restriction lacked a logi- cal foundation, the Court viewed the regulation skeptically. The pattern that emerges from these legal judg- ments is that where a law restricting commercial speech has a solid grounding in logic and empirical data, the Court will uphold it. If the regulatory system has a faulty connection between its goal and its method, the law will fail the third prong of the Central Hudsorr test and be struck down. In 44 Liquormart, Justice John Paul Stevens' plurality opinion required that the social science evidence supporting the legislative rationale di- rectly and materially tie the government's goal (reduc- ing liquor consumption) to its methodology (restricting liquor price advertising); the government failed to meet this legal requirement. Furthermore, the Court views harshly laws that impose a total ban on speech and thus paternalistically deprive consumers of information be- cause the government perceives that the ban is "for their own good." Constitutionality of Regulating Tobacco Advertising Government regulations of tobacco product ad- vertising can withstand legal scrutiny if they are care- fully crafted and are not overbroad (Edge Broadcasting, p. 2705 [citing Fox III, p. 4801). Courts have found state and local regulations of tobacco advertising to be pre- empted by the Federal Cigarette Labeling and Adver- tising Act when they conclude that the regulation is based on "smoking and health." If the regulation is not preempted, then it must pass the four-pronged test advanced in Central Hudson. Reasonable regulations on tobacco advertising are likely to be upheld. Preemption and the Federal Cigarette Labeling and Advertising Act The Federal Cigarette Labeling and Advertising Act preempts a "requirement or prohibition based on smoking and health . . . imposed under State law with respect to the advertising or promotion of any ciga- rettes the packages of which are labeled in conformity with the provisions of this chapter" (15 U.S.C. [United States Code] 1334[bJ). In Cipo[[one u. Liggeff Group Inc. (505 U.S. 504,112 S. Ct. 2608 [1992]), the Supreme Court interpreted that language narrowly, allowing Cipollone to sue the tobacco industry if the claim were not based on a failure to warn about smoking and health issues in product advertising or promotion. The claim would not be preempted if it were based on more generalized state interests, such as preventing inten- tional fraud or enforcing manufacturer warranties. In Marzgirzi ~1. R.]. Reynolds Tobecco Co. (22 Cal. App. 4th 628 [19931), the California Court of Appeals restated the Cipo/lorle holding by declaring that regulations are preempted only if they demand a "requirement or pro- hibition based on smoking and health. . . imposed under State law with respect to.. . advertising or pro- motion." If one of these elements is missing, the state law is not preempted. State and local governments can still regulate to- bacco advertising if they justify the law with a valid rationale not related to health. For example, Baltimore asserted that its ordinance restricting tobacco adver- tising on billboards was a reasonable and necessary measure for reducing illegal consumption of cigarettes by minors (Perm Advertising of Baltimore, Inc. z?. Mayor arrd Cify Council of Baltimore, 862 E Supp. 1402 [Md. 19941). The city claimed that the focus of the ordinance was not on protecting the health of young people; the language of the ordinance was instead exclusively re- lated to preventing youth from engaging in illegal transactions. (This assertion was made even though Baltimore does not criminalize youth purchase or 2 72 Chapter 5 Reducing Tobacco Use possession of tobacco products; Baltimore criminalizes the sale of tobacco to minors.) The district court ac- cepted this stated intent of the ordinance. Even when legislators who supported the ordinance made certain health-related comments, the court discounted these as not necessarily being representative of the motives of the city council as a whole. On appeal by the advertising company that was the plaintiff in the case, the Fourth Circuit Court of Appeals further held that the Baltimore ordinance was not preempted by the Federal Cigarette Labeling and Advertising Act because it did not relate to the con- tent of advertising, but rather to billboard location (Penn Advertising of Baltimore, Inc. u. Mayor artd City Council of Baltimore, 63 E3d 1318 ]4th Cir. 19951). The court interpreted the ordinance as a limited physical restriction in a limited media, for Baltimore allows such billboards in parts of the city zoned for commercial and industrial use. The court also observed that the Baltimore ordinance did not restrict tobacco industry advertising in other media, such as newspapers and magazines. State or local governments that cannot separate such ordinances from health-related issues, however, will have difficulty passing the preemption test. In Minnesota, for example, the court struck down a municipal statute that restricted tobacco advertising explicitly to protect health (Chiglo u. Cify of Prestott, 909 F. Supp. 675 [D. Minn. 19951). The Four-Pronged Test Is the Advertising Unlawful or Misleading? A central justification for affording constitutional protection to advertising is the consumer's interest in the free flow of information (Central Hudson). Public health and smoking prevention groups often question whether attractive images that portray smoking as a socially acceptable, sexual, and athletic activity have any informational use to the consumer (Lowenstein 1988). Despite the emotive, noninformative character of cigarette advertising, the tobacco industry might argue that restricting such advertising should fail the first prong of the Central Hudson test because the prod- uct being advertised is lawful for adults and its pro- motion is not directly deceptive or fraudulent. Certainly, advertisements that use images to con- nect health, vitality, and the good life with cigarette smoking distort the truth (Law 1992). Yet the United States Supreme Court's definition of "inherently mis- leading" refers to advertisements that promote fraud, represent overreaching, or create consumer confusion (Ohralik ZI. Ohio State Bar Assn., 436 U.S. 447,462 [19781). Proscriptions against misleading advertising have not traditionally extended to "puffery" or imagery alone (Zauderer u. Office of Disciplinary Counsel of the Supreme Court of Ohio, 471 U.S. 626 [1985]). For example, courts have held that advertisements for alcoholic beverages that project images of drinkers as successful and fun- loving and do not warn of the dangers of alcohol abuse are not legally "misleading" (Oklahoma Telecasters As- sociation u. Crisp, 699 E2d 490,500 [lOth Cir. 19831, reu'd OII other gromds sub nom; Capital Cities Cable, Inc. u. Crisp, 467 U.S. 691 [1984]1. By analogy, courts may not find that promotions are directly misleading simply because they project images of smokers as glamorous people and do not mention the associated dangers of smoking. A cigarette advertisement would be found to be misleading, however, if it included unsubstantiated health claims. Advertisements could not assert that cigarette smoking poses little or no risk to health or does not affect breathing. For example, the FTC chal- lenged as false and misleading a newspaper advertise- ment (or advertorial), paid for by R.J. Reynolds Tobacco Company, that claimed smoking is not as hazardous to health as the public has been led to believe. Al- though the tobacco company initially stated that the statement was not commercial speech because it did not invite the public to purchase a particular product, the parties entered into a consent decree under which R.J. Reynolds agreed to stop the advertisement and to avoid future misrepresentation of scientific studies (Bureau of National Affairs, Inc. 1990). Some proponents of restricting tobacco advertis- ing argue that courts in the future could find the vi- sual images projected in cigarette advertisements to be inherently deceptive or misleading. A legal opin- ion for the American Medical Association concluded, "Given what the cigarette advertising does portray, what it fails to say, and the vast public ignorance of the dangers and addictive quality of smoking, particu- larly among young persons, it is plain to us that this kind of advertising can be proscribed as deceptive or misleading" (Blasi and Monaghan 1986, p. 506). Analo- gously, the Supreme Court has construed the preemp- tive provisions of the cigarette labeling act to permit tort actions against cigarette manufacturers in the in- stance of fraudulent misrepresentation or conspiracy to misrepresent or conceal material facts (Cipollone). Furthermore, to the extent that recent documents from the tobacco industry show that the industry pur- posefully marketed to minors, the courts may find this to be a deceptive advertising practice that leads to an illegal act. There is no constitutional speech protec- tion for proposing illegal transactions, such as sales of cigarettes to minors. The tobacco company Liggett Group Inc. has admitted that the entire tobacco indus- try conspired to market cigarettes to children (.Settl~- m~zt Agreement Between Settling States a!ld Brooke Group LTD, Liggett 0 Myers, 1~. nnd Liggett Group, Inc., cited in 13.1 TPLR 3.11 [1998]), and documents obtained in litigation from the other tobacco companies and re- cently made Public confirm that tobacco companies have purposefully marketed to children as young as 14 years old (Coughlin et al. 1999). Regulation of some tobacco advertising may thus pass the first prong of the Central Hudson test (see the discussion of the Mangini case in "A Critical Example: Joe Camel," later in this chapter). Is the Government's Interest Substantial? Appellate courts have consistently found that states have a substantial interest in limiting tobacco advertisements (see, for example, Penn Advertising; Oklahoma Telecasters; and Dunagirz z,. City of Oxford, 718 E2d 738 [5th Cir. 19831, cert. denied, 467 U.S. 1259 [1984]). Because of the strong epidemiologic evidence associating smoking with lung cancer, heart disease, and other causes of morbidity and mortality (USDHHS 1989), no court would deny that the federal govern- ment has a compelling interest in reducing smoking. As evidence mounts concerning the health hazards of environmental exposure to cigarette smoke (Environ- mental Protection Agency [EPA] 1992; Leary 1993; Reynolds 1993; Bero et al. 1994; California EPA 19971, the federal government may also exercise its police powers to protect nonsmokers. The Federal Cigarette Labeling and Advertising Act preempts state and local governments from regu- lating cigarette advertising based on "smoking and health." Instead, as noted, many governments (such as those of Baltimore and New York City) are assert- ing an interest in preventing minors from being in- volved in illegal transactions. Additional nonhealth rationales include avoiding deceptive advertising and providing economic (as opposed to health-based) con- sumer protection. Does the Regulation Directly Benefit t/w Public Irrtercst? The third prong of the C~ntunl Hudson test requires that governmental regulation of commercial speech must advance the government interest. The Supreme Court has not yet given clear direction as to what level of evidence is required to show that such regulation directly advances the government interest, but the Court is beginning to demand some scientific or statistical evidence of efficacy. In Florida Bur v. Weizt For If, Inc. (515 U.S. 618,632 [1995]), the Court was satisfied with a general assertion by the state that common sense dictated that restricting attorneys from advertising by direct mail would reduce ethical violations by attorneys and have a positive effect on the public's opinion of at- torneys. Limited social science evidence was presented, yet the restriction was upheld. On the other hand, in 44 Liquormart, Justice Stevens' plurality opinion stated that one reason the Rhode Island statute was struck down was that the state had not produced evidence that its speech restriction would directly and materi- ally produce the results desired to advance the gov- ernment interest. Even if the courts require empirical support of efficacy, tobacco advertising restrictions can still sat- isfy the third prong of the Central Hudson test. There is extensive social science research regarding the ef- fect of tobacco advertising on the purchasing habits of teen smokers and on the positive imagery with which children regard and recognize tobacco advertising images. After R.J. Reynolds Tobacco Company intro- duced the Joe Camel advertising campaign in the late 198Os, the market share of Camel cigarettes among teenagers increased at least 20-fold; from the same point in time, the previous decline in overall teenage smoking prevalence was reversed (CDC 1994b). An association between a rise in young girls' smoking habits and the tobacco industry's decision to target marketing to adolescent girls has also been docu- mented (Pierce et al. 1994a). Some relevant legal judgments suggest that al- though the courts tend to require more than a commonsense assertion of the government's interest in restricting commercial speech, something less than empirical evidence may suffice. For example, although Justice Stevens in 44 Liqnormflrt demanded empirical evidence, he also recognized there is "some room for the exercise of legislative judgment" (p. 508). The Su- preme Court in Edenfield v. Forze (113 S. Ct. 1792 [1993]) suggested the need for a scientific validation of a con- nection between regulation and the achievement of a substantial state interest: the Court stated that the government "must demonstrate that the harms it re- cites are real and that its restriction will in fact allevi- ate them to a material degree" (p. 1800). In cases involving advertising restrictions for al- coholic beverages, the courts have consistently accepted-even in the absence of objective scientific studies-the reasonable legislative belief that such re- strictions would lower consumption. The Tenth Cir- cuit Court of Appeals found it not "constitutionally unreasonable for the State of Oklahoma to believe that advertising will not only increase sales of particular brands of alcoholic beverages but also of alcoholic beverages generally" (Oklalzonra Telecasters, p, 501). 2 74 Chapter 5 Reducipzg Tobacco Use Similarly, the Ohio Supreme Court found that the ad- vertising of drink prices would encourage and stimu- late consumption of alcoholic beverages (Qrieensgate lrwestment Co. v. Liquor Corrtrol Commission, 433 N.E.Zd 138,142,69Ohio St: 2d 361 [Ohio 19821). The adver- tising prohibition was thought to be closely connected to the state's interest in preventing consumption. Courts have found a direct relationship between advertising and consumption or abuse in other dan- gerous products and activities (see, for example, Will- innrs U. Spencer, 622 E2d 1200 (4th Cir. 19801; Capitnl Broadcasting). In Central Hudson, the Supreme Court found an immediate connection between advertising and the demand for electricity. The Court in Mkromedk, Inc. u. City of SRU Diego (453 U.S. 490 [1981]) similarly found a link between billboard advertisements and traf- fic safety. The Court stated that this link is established by the "accumulated, common-sense judgments of local lawmakers" (p. 509). Claims made on behalf of the tobacco and ad- vertising industries that tobacco advertising is de- signed not to increase consumption but only to develop brand loyalty and gain an increased market share (Boddewyn 1989) may be unpersuasive to the courts (Chetwynd et al. 1989; Joossens 7989). Although some of the studies showing that advertising increases to- bacco consumption have methodologies that are controversial-such as econometric (Lewit et al. 1981; Schneider et al. 1981; Seldon and Doroodian 19891, cross-cultural (Hamilton 1976; Reuijl19821, and adver- tising recognition (Goldstein et al. 1987; DiFranza et al. 1991; Fischer et al. 1991a)-the courts would likely accept the legislature's reasonable belief that what the studies show is true. For example, the Ninth Circuit, in a 1997 opinion after 44 Liquormart, maintained that "common sense suggests that advertising increases participation" (Valley Broadcasting Co. v. United Stntes, 107 E3d 1328, 1344 [9th Cir. 19971). This portion of Posadas de Puerto Rico has survived 44 Liquormnrf. In an analogous situation, alcohol industry argu- ments against the relationship between advertising and consumption were rejected by the Fifth Circuit Court of Appeals, which held that Mississippi's ban on intra- state liquor advertising directly promoted the state's interests in the health and safety of its citizens. The court said that it did not `I. . . believe that the liquor in- dustry spends a billion dollars a year on advertising solely to acquire an added market share at the expense of competitors. . . . we hold that sufficient reason exists to believe that advertising and consumption are linked to justify the ban, whether or not `concrete scientific evi- dence' exists to that effect" (Dunagin, p. 750). Because the tobacco industry spends six times as much as the liquor industry on advertising and promotion (FTC 19951, because smoking remains the leading cause of avoidable death in America (McGinnis and Foege 19931, and because about 50 million Americans still smoke, even small reductions in smoking behavior-whether consumption or uptake-resulting from reduced adver- tising could achieve significant health benefits. Cases trying to restrict alcohol advertising have also, however, set precedents that may. stand in the way of comparable cases involving tobacco advertis- ing. Most notably, in 44 Liquormnrt, Inc. zl. Rticine (829 F. Supp. 543 [R.I. 1993]), the Rhode Island District Court judge found that the state's specific statute banning liquor price advertising had had "no significant im- pact on levels of alcohol consumption" (p. 549). Jus- tice Stevens, in his plurality opinion, found that the statute could not survive without social science evi- dence because "speculation certainly does not suffice when the State takes aim at accurate commercial in- formation for paternalistic ends" (44 Liquormart, Inc. i'. Rhde lshzd, p. 5071. Yet the Fourth Circuit Court of Appeals, the high- est court to rule on tobacco advertising restrictions, has twice upheld Baltimore's limitation on tobacco advertising. The Fourth Circuit noted several differ- ences between the liquor price advertising prohibition in 44 Lir]uorninrt, Inc. U. Rhode Island and the limited re- strictions in the Baltimore ordinance. 44 Liquormart dealt with a total ban on speech directed to adults, whereas the Baltimore ordinance was a partial restriction of speech that targeted children as consumers of an adult product. The Fourth Circuit Court also held there was a close connection between the government's goal of preventing teen participation in illegal transactions and the limited speech restriction intended to support that goal (Penn Advertising, 63 E3d 1318; Penn Advertising of Baltimore, Inc. v. Mayor and City Council of Baltimore, 101 E3d 332 [4th Cir. 199611. By contrast, a notable reason for the Supreme Court's rejection of advertising restric- tions in 44 Liquormart was that the government had not proved a clear tie between its interest and the re- strictions supposedly supporting that interest. The Fourth Circuit reaffirmed its decision in Penn Advertisitzg after the Supreme Court had asked it to review the decision in light of 44 Liquormart. The Fourth Circuit specifically stated, "We have read the opinion in 44 Liquormart and have considered its im- pact on the judgment in this case. . . we conclude that 44 Liquormnrt does not require us to change our deci- sion" in this case (Penn Advertising of Baltimore, Inc. u. Mnyor aild City Co1411cil of Baltimore, 101 E3d 332 [4th Cir. 19961, cert. denied, 117 S. Ct. 1569 [1997]). Because a restriction like that upheld in Penn Advertising cannot constitutionally be a complete ban on all advertising of the product, some minors will be exposed to some level of adult tobacco advertising. This limit in scope does not constitute serious grounds for an appeal. A recent decision involving liquor regulation notes that the "Supreme Court has made it clear in the commercial speech context that underinclusiveness of regulation will not necessarily defeat a claim that a state interest has been materially advanced" (Bad Frog Brewery, Inc. v. New York State Li- quor Authority, 134 E3d 87, 99 [2d Cir. 199811. In sum, the regulation need not cure all ills but it does need to advance the state interest in a demonstrably significant, rather than a small or otherwise circumstantial, way. Is the Regulation of Advertising a Reasonable Fit? The Supreme Court has made it clear that this standard is not to be confused with the "least restric- tive means" test. In Edge Broadcastirzg (p. 27051, the Court said that the "requirement of narrow tailoring was met if `the . . regulation promotes a substantial government interest that would be achieved less ef- fectively absent the regulation,' provided that it did not burden substantially more speech than necessary to further the government's legitimate interests." The existence of less restrictive methods of achieving the government's goals does not automatically defeat the legislation as it would in political speech cases. In- stead the Court looks to see if the restriction does not sweep more broadly than necessary. In Florida Bar the Court stated, In Fox, we made clear that the "least restrictive means" test has no role in the commercial speech context. . "What our decisions require," instead, "is a `fit' between the legislature's ends and the means chosen to accomplish those ends, a fit that is not necessarily perfect, but reasonable; that rep- resents not necessarily the single best disposition but one whose scope is `in proportion to the inter- est served,' that employs not necessarily the least restrictive means but . . , a means narrowly tai- lored to achieve the desired objective" (citations omitted) (p. 632). In practical terms, the decision implies that re- strictions on tobacco advertising that target areas where children gather, such as schools and play- grounds, do not create a total ban, because the tobacco industry will still have many alternative channels to communicate with its adult customers. Adults can still receive information on price, quality, comparative product features, and any other information to help them make an informed decision on tobacco products. Even if the tobacco industry were limited to commu- nicating in tombstone format (black letters on a white background), the government would not have prohib- ited the flow of information. For a similar reason, 44 Liquormart, Inc. v. Rhode Island does not change this analysis. The rationale the Supreme Court used there in overturning Rhode Island's alcohol advertising restriction-that the statute was a paternalistic ban on the free flow of truth- ful information-does not apply in tobacco advertis- ing regulations like those upheld in Penn Advertising, because the tobacco industry would still have many avenues of communication open to it and could com- municate all aspects of information. Justice Stevens in 44 Liquormart also generally rejected a vice exception to commercial speech restric- tions. In Posadas de Puerto Rico, the Court was willing to allow the legislature broad deference to curb speech that promoted "vice" activities such as gambling. Jus- tice Stevens rejected this approach that allowed legis- latures to ban speech rather than the vice itself. He stated, however, that "a `vice' label that is unaccom- panied by a corresponding prohibition against the commercial behavior at issue fails to provide a prin- cipled justification for the regulation of commercial speech about that activity" (44 Liquormart, Inc. u. Rhode Island, p. 514). In the case of restricting tobacco adver- tising aimed at children, the restriction matches the prohibition. It is illegal to sell tobacco products to minors, and therefore the legislature has a principled reason to prevent commercial speech in the limited area where it has already prohibited the commercial activity. This is in accord with Justice Clarence Thomas' view that a jurisdiction "may not restrict ad- vertising regarding commercial transactions except to the extent that it outlaws or otherwise directly restricts the same transactions within its own borders" (p. 525). In 44 Liquormart, Justice Sandra Day O'Connor's concurrence set out the guideposts she would use to judge commercial speech restrictions. "The availabil- ity of less burdensome alternatives to reach the stated goal signals that the fit between the legislature's ends and the means chosen to accomplish those ends may be too imprecise to withstand First Amendment scru- tiny. If alternative channels permit communication of the restricted speech, the regulation is more likely to be considered reasonable" (44 Liquormart, Inc. u. Rhode Island, pp. 529-30 [internal citations omitted]). The ruling presupposes that other less restrictive alterna- tives, such as price increases and access restrictions, have been tried (if enacted) and have not completely solved the problem. It is reasonable for a legislature 176 Chapter 5 Rcduciug Tobacco Use to conclude that limited restrictions on commercial speech aimed at youth must be a component of an overall plan to limit youth involvement with tobacco products. At the same time, the tobacco industry will have alternative channels to communicate to adults all the information in which adults are interested, in- cluding price, tar and nicotine levels, and taste. In the context of alcohol advertisements, courts have asserted that "the state's concern is not that the public is un- aware of the dangers of alcohol. . . . The concern in- stead is that advertising will unduly promote alcohol consumption despite known dangers" (Drlnngirr, cert. denied, 467 U.S. 1259). The preceding review of relevant cases suggests that carefully designed, reasonable government restric- tion of cigarette advertising would likely meet the Supreme Court's four criteria for restricting commercial speech and would therefore be found constitutional. A Critical Example: Joe Camel Perhaps the most discussed tobacco promotion of the 1990s-and one that brings together many of the issues discussed in the preceding section-is the advertising campaign for Camel cigarettes that features a cartoon camel character called Old Joe (often referred to as Joe Camel). Assertions have been made that this campaign improperly targeted minors, seeking to at- tract them to cigarette smoking. These concerns were heightened in the wake of the 1994 Surgeon General's report on smoking and health, which focused on ado- lescents (USDHHS 1994). That report's major conclu- sions included the following: those who smoke usually begin by age 18; most adolescent smokers become ad- dicted to nicotine; tobacco addiction is associated with the later development of other drug addiction; tobacco use is related to psychosocial risk factors; and some cigarette advertising appears to be particularly effec- tive on adolescents. Critics argue that the cartoon character of Joe Camel, which has been used by R.J. Reynolds Tobacco Company in its advertising campaign for Camel ciga- rettes since 1988, has had substantial impact on smok- ing among underaged youth (DiFranza et al. 1991; Fischer et al. 1991a; Breo 1993; CDC 1994b). The char- acter appears in print advertising and on promotional products disseminated by the company, such as mugs, matchbooks, store exit signs, and soft drink can hold- ers. After a staff investigation, in 1994 the FTC de- clined, by a 3 to 2 vote, to issue a complaint charging that advertising using the Joe Camel character violated section 5 of the Federal Trade Commission Act by in- ducing minors to smoke. Subsequently, the FTC did bring a complaint against R.J. Reynolds on May 28, 1997, alleging that "the purpose of the Joe Camel cam- paign was to reposition the Camel brand to make it attractive to younger smokers. . . . The Joe Camel cam- paign induced many of these children and adolescents under the age of 18 to smoke Camel cigarettes or in- creased the risk that they would do so. . . . R.J. Reynolds' actions . . have caused or were likely to cause substantial and ongoing injury to the health and safety of children and adolescents under the age of 18 that is not offset by any countervailing benefits and is not reasonably avoidable by these consumers" (In re R.]. Rcyr7olds Tobacco Co., Docket No. 9285 [FTC, May 28, 19971, ritcd ill 12.3 TPLR 8.1, 8.2 [1997]). As late as the spring of 1998, Joe Camel memorabilia were still being offered for sale in R.J. Reynolds catalogs. The FTC ultimately dismissed its complaint as no longer necessary after the November 23, 1998, Master Settle- ment Agreement banned the use of all cartoon charac- ters, including Joe Camel, in the advertising, promotion, packaging, and labeling of any tobacco product. The Federal Trade Commission Act grants no private right of enforcement (Holloway u. Bristol-Myers COY~J., 485 E2d 986 [D.C. Cir. 19731). However, the California Unfair Competition Law authorizes actions for injunctive relief (a measure sought to prevent a given course of action) not only by specified state and local officers but also by persons acting for the inter- est of themselves or the general public. A private ac- tion was brought in California state court by Janet Mangini, who asserted that R.J. Reynolds' advertising practices in the Joe Camel campaign violated the Fed- eral Trade Commission Act and the California statu- tory law of unfair competition (Mangini u. R.]. Reynolds Tobacco Co., 7 Cal. 4th 1057,875 P.2d 73 [Cal. 19941, cert. denied, 1994 U.S. LEXIS 8361 [Nov. 28, 19941). Unfair competition is defined to include "any unlawful, un- fair or fraudulent business act or practice and unfair, deceptive, untrue or misleading advertising" (Califor- nia Business & Professions Code, sec. 17200). R.J. Reynolds, in contesting Mangini's action, asserted that federal law preempted any action in the state courts. The Federal Cigarette Labeling and Advertising Act, as amended by the Public Health Cigarette Smoking Act of 1969, provides that "no requirement or prohibition based on smoking and health shall be imposed under State law with respect to the advertising or promotion of any cigarettes the packages of which are labeled in conformity with the provision of this Act" (Public Health Cigarette Smoking Act of 1969, sec. 5[b]). The Sup-cvne C`L)LII.~ of C`alit~~rnia rejected the preemption argument and held that the cause of dc- tion against the nd\.ertisin~-that it improperI\ targeted minors--\vould stand. According to the tour;, the ad\,ertising had apparently been effecti1.e in tar- geting adolescents: Camel cl+ `t~3rettes rt'ere chosen b\ an estimated 0.5 percent of teenage smokers in lY& (the last full year of sales before the Joe Camel cam- paign) and by an estimated 25-33 percent in 1992 (as quoted in the decision; other sources cite a substan- tial, although smaller, increase (CDC 1991b]). In 1992, teenage smokers accounted for about $176 million of Camel sales, a vastly greater amount than the $6 mil- lion in sales for 1988 (Mi711,yyi11i, p. 1060). The portion of the MITJI@II~ lalvsuit regarding the Joe Camel ad\Ter- tising campaign \vas settled September 8, lYY7, tvhen R.J. Reynolds agreed to cease placing Joe Camel on California billboards, placing Joe Camel materials in magazines and ne\vspapers, and distributing proniu- tional materials through retail mechanisms (M1711::i/li il. R.]. Rel/rzo/& T&?ri-c~ Co., iitvil if? 12.5 TPLR 3.319 [1997]). it also agreed to pay the cities and counties that had joined the action as co-plaintiffs SY million for a counteradvertising campaign, presumable to dis- pel the lingering effects of the Joe Camel marketing. In another state, Washington, a pri\,ate action using that state's la\v failed to prohibit adiwtising using Joe Camel (Sfmrii.; ~1. X.1. Rct//mlds 72wc-~-o Ccl., Ko. CY4783C [W.D. Wa. Dec. 9, 194-I], citvll irk Y.6 TI'LR 2.171 [19Y3]). Nonetheless, the decision of the Supreme Court of California indicates that at least in some in- stances in some jurisdictions, private parties acting as representatilres of the general public can bring an Product Regulation action normally brought only under specific federal or state la\v against cigarette advertising. Thus, as tvith a number of other legal issues (see "Litigation Approaches," later in this chapter), the judicial response to aggressive pursuit of legal policy options is still unfolding. Although the process of le- galls regulating tobacco advertising and promotion has-been under \vay for decades, the extent of such regulation and its ultimate limits are not yet known. The most significant developments in this area revol\:ed around the release of-and subsequent reaction to-the FDA'sAugust 10,1995, preliminaryde- termination. The determination accompanied a pro- posed rule that sought to restrict the availability and marketing of tobacco products to children and adoles- cents. The FDA's final determination that it had au- thoritv to regulate cigarettes and smokeless tobacco products (released on August 28,1996) is discussed later in this chapter, where the analysis of product regula- tion focuses on "Further Regulatory Steps." Arguably the second most important develop- ment in this area was the June 20,1997, proposed agree- ment that \vould have settled lawsuits between 41 state attorneF.5 general and the tobacco industrv. Because the ad\wtising and promotion provisions of that agree- ment directlv presupposed legislation that would have upheld the FDA'S asserted jurisdiction to regulate to- bacco products, this key multistate agreement is, like the FDA announcemelit, discussed later in this chap- ter, \vhcre the analysis of product regu!ation focuses on "Legislati1.e De\.elopments" and "Master Settle- ment I\greenient." Introduction Cigarette smoke contains approximately 1,000 chemicals, including a number of carcinogens and other toxic chemicals, such as hydrogen cyanide and oxides of nitrogen (USDHHS 1989). Regulating tobacco prod- ucts requires appropriate assessment of these primary and secondary products of combustion and other sub- stances that mav be inhaled. Current tobacco product regulation requires that cigarette advertising disclose levels of "tar" (an all-purpose term for particulate- phase constituents of tobacco smoke, man\; of w,hich are carcinogenic or otherwise toxic) and nicotine (the psychoactiv-e drug in tobacco products that causes ac- diction [USDHHS 19881) in the smoke of manufactured cigarettes and that warning labels appear on packages and on some (but not all) advertising for manufactured cigarettes and smokeless tobacco;' the current federal la\vs preempt, in part, states and localities from impos- ing other labeling regulations on cigarettes and smoke- less tobacco (see the pre\.ious major section, "Ad\.ertising and Promotion"). Since the mid-198Os, federal la\\- has required makers of manufactured cigarettes and of smokeless tobacco products to submit lists of additi\,es to the tobaccos (but not to filters or papers) in their products to the Secretarv of Health and Human Services (Com- prehensive Smbking Education Act, Public Lalj. 98-371, sec. 5; Comprehensive Smokeless Tobacco Health Edu- cation Act of 1986, Public Laiv 99-252, sec. 4). Infor- mation about the quantitv ofadditi\.es used ancl their placement in specific brands is not required, and the Secretary is bound by lalz to safeguard the lists from public disclosure. In 1991, attornevs for six manufac- turers released to the public the.list of ingredients added to tobacco in 1993. Tobacco products are explicitly protected from regulation in \.arious federal consumer safetv 1`~~~s (L'SDHHS 198Y). Although regulation requirtis pub lit reporting of some constituents in cigarette smoke, cigarette manufacturers are not required to report to a go\-ernmental body (or to include on product labels for consumers) brand-specific information about the nicotine content or anv other propertv (e.g., nitro- samine le\.els, ammonia le\,el, pesticide resiclues, heavy metals [lead, cadmium, mercury, or chromium], pH, or sugar content) of the material that forms the tobacco rod of their products. At the \`erv least, know,l- edge of the upper bound of nicotine in the tobacco rod of cigarettes is important because actual smoking ma\; produce constituent levels that \.arv considerably from that in smoke deliverv yields reported to the FTC (USDHHS 1988; see also "Compensatory Smoking," later in this chapter). Those measurements were con- ducted by the Tobacco Institute Testing Laboratory. The Comprehensive Smokeless Tobacco Health Education Act of 1986 requires smokeless tobacco manufacturers to report the total nicotine content of their products to the Secretarv of Health and Human Services (Public Law 99-252, sec. 4), but the Secretary may not release the data to the public. A uniform pro- tocol implementing this provision M'as published in the March 23, 1999, Fedcrnl R~@~trr. No federal public health laws or regulations apply to cigars, pipe tobac- COS, or fine-cut cigarette tobaccos (for "roll-your-o\vn" cigarettes) in anv manner other than prohibiting the advertising of small cigars through electronic media (USDHHS 1989). The Constituents of Smoke From Manufactured Cigarettes Since 1967, the FTC has regularly published tables of tar and nicotine delivery of smoke from manu- factured cigarettes. Since 1980, the tables have also included a measurement for carbon monoxide deliverv. The data are based on results of a standard- ifed, machine-dri\ren test procedure (Pillsbury et al. 1969) that provides a basis of comparison among vari- ous brands of cigarettes. Manufacturers are not re- quired to print these values on the product package, but "ultra Io~v" cigarette brands often include tar and nicotine deliveries on the package, presumably to dif- ferentiate these brands (Davis et al. 1990). No brand ha\ing a tar yield above 11 mg prints this information on the package. Carbon monoxide deliveries are not listed either on packages or in advertising (USDHHS 1989). Regulation by Tar Levels The FTC's tables of tar le\,els have provided some jurisdictions \vith criteria for regulating tar content by le\,ying taxes on higher-tar cigarettes or, in the case of countries in the European Union, by altogether ban- ning high-tar cigarettes. The apparent assumption be- hind such action-that discouraging or banning consumption of higher-tar cigarettes will result in reduced morbidity and mortality from smoking- related diseases-has been questioned, as is discussed in the section "Compensatory Smoking," later in this chapter. Tar content has in several instances served as the basis for cigarette taxation, on the presumption that the taxing structure would provide a competitive ad- l'antage to low-tar brands-an advantage of interest, for supposed public health reasons, to the jurisdiction levying the tax. For several years beginning in 1971, New York City taxed cigarettes that had either tar yields over 17 rng or nicotine yields over 1.1 mg an additional 3 cents per pack and cigarettes that exceeded both thresholds, 4 cents (Lc~rrg Islnr~il K~bncco C~J., fr~c. ~1. Limfqt/, 74 Misc. 2d 445,343 N.Y.S.2d 759 [N.Y. 19731). Although the levy was upheld by the courts, the law seems to have been repealed because of allegations that unequal taxation across political boundaries was fos- tering smuggling (Ranzal 1973). There are no reports on the effects this tax may have had on consumption patterns. In 1978, the British government imposed a supplementary tax on cigarettes having a measured tar yield greater than 20 mg (Gray and Daube 1980 Figure 5.1. Sales-weighted nicotine and tar levels in smoke as percentage of 1982 levels 1 Average of all brands* YO( 1 , , , , ( ( , , , , , , , , 901 1982 1983 1986 lY88 19YO 1992 1991 1996 1982 1984 1986 1988 1990 1992 1994 1996 Year Year 1 Low-tar category (6-15 mg tar)* 90 1982 1981 1486 1988 1YYO 199' 19'34 1YYh \I'mr - Nicotine *By Federal Trade Commission method. 1 High-tar category (>I5 mg tar)* 1 Ultra-low-tar category (~6 mg tar)# YU/ , I , , 1 , , , , , , , , , , 1982 1984 19% 1988 1990 1992 1994 1996 Year - Tar Source: Kessler 1994b; Federal Trade Commission, unpublished data, 1998. [note misprint in this publication: on page 93, line 3, "more" should ha\,e been "less"; correction furnished by Michael Daube, Februarv 13, 19961). Within three months of the imposition of the tax, the market share of such brands fell from 15 to 3 percent (Michael M. Daube, letter to John Siade, February 24,1995). Asirni- lar tax was used in Sweden, but it IVas repealed to achieve uniformity Lvith tax policies of the European Union (Paul Nordgren, letter to Da\,id T. Sweanor, December 23,1994). Among countries in the European Union, a fixed ceiling on tar content has been used as a regu- latory method. The European Union has imposed a graduated decline in the upper limit of tar deliveries permitted for cigarettes sold in member countries. Be- ginning January 1, 1993, the ceiling was 15 mg tar delivery per cigarette; after December 31, 1997, the ceiling \vas 12 mg (Council Directive 90/239/EEC 1990 O.J. [L 1371). Implications of Nicotine Levels The FTC's tables on nicotine levels have revealed a recent change in the ratio of tar to nicotine in ciga- rettes. Kessler (1994b) has reported that for 1982-1991, the ratio of average sales-weighted nicotine yield to tar yield' in cigarette smoke has risen steadily for each of three major tar-yield categories and for the overall market (Figure 5.1). Gi\,en the addictive properties of nicotine and its contribution to cardio\,ascular disease (USDHHS lY88), this change may have important pub- lic health implications. Moreo\-er, "lots-yield" and "ultra lolz--yield" cigarettes in the same period had higher nicotine yield to tar ratios than did brands in the high tar-!lield categories. Consumers Ivho pay more heed to the "numbers" for tar le\rels than to the much smaller (but no less important) numbers for nicotine levels may be under the illusion that the): are reducing their health risks and increasing their chances of quitting by smoking "lo\\`-tar" cigarettes. (This illusion is further discussed in "The Lo\\.-Tar `AlternatixTe,' " later in this chapter.) A manufactured cigarette generally contains ii-10 mg of nicotine (USDHHS 19881, regardless of the machine-measured nicotine deli\,erv in the smoke. L`n- der usual smoking conditions, consumers absorb about lo-30 percent of the nicotine contained in the tobacco rod of the cigarette (USDHHS 1988; Beno'rvitz and Henningfield 1994). Some thought has recently been given to systematically lo\vering the nicotine content of tobacco products to le\rels that \vould not pose a threat of addiction (Benowitz and Henningfield 19%; Douglas 1994). Benowitz and Henningfield (199-l) ha1.e suggested that addiction is unlikely to be sustained below a nicotine dose of about 5 mg ier day. This dose is about one-fourth the dailv dose commonly ingested by tobacco users. To achie\e such a ceiling for ciga- rettes, the nicotine content of the tobacco rod Lvould have to be 0.5 mg or less, assuming that the smoker consumes about 30 cigarettes per day and receives 30 percent of the nicotine available. Ho\ve\,er, cigarettes with such low levels of nicotine may not be popular (Campbell 1994). The experience of Philip Morris Companies Inc. in trying to sell a low-nicotine-content cigarette, "Next," illustrates this point; the company judged the test-marketing of this cigarette a failure. Such failure provides indirect support for the impor- tance of nicotine addiction to the tobacco industrv. Mandating the reduction of nicotine for the purpose of weaning smokers from tobacco products \\-as contemplated as a strategy available to the FDA in legislation proposed to enable the multistate settle- ment agreement with the tobacco companies (see "Legislative De\,elopments" and "Master Settlement Agreement," later in this chapter). A similar strategy is used in some voluntary stop-smoking programs (e.g., Gahagan 1987). But this strategy cannot work unless accurate measures are available of the actual nicotine uptake that smokers and other tobacco users receive. In 1994, the NC1 convened an ad hoc expert com- mittee to determine the adequacy of the standard, smoking-machine-based, FTC protocol for determin- ing the tar and nicotine content of cigarettes. The com- mittee concluded that "the FTC test protocol was based on cursory observations of human smoking behavior. Actual human smoking behavior is characterized by \vide variations in smoking patterns, which result in [Tide \.ariations in tar and nicotine exposure. Smok- ers i\,ho slvitch to lolzer tar and nicotine cigarettes fre- quently change their smoking behavior, which may negate potential health benefits" (NC1 1996, p. vi). III 1496, Massachusetts enacted a law designed to obtain reports of brand-specific nicotine levels that more closelv approximate the uptake by actual smok- ers of the& brands. The statute instructs the state Department of Public Health to establish standards for nicotine yield ratings that "accurately predict nicotine intake for a\.erage consumers" (Mass. Gen. Laws ch. 93, sec. 3078). Each cigarette and smokeless tobacco manufacturer must then report, in a manner consis- tent \z,ith these standards, the nicotine yield rating of each brand of tobacco products it produces. These reports become public records. Other Constituents in Cigarette Smoke Tar and nicotine measurements have tradition- ally been used as surrogate measures for other toxic constituents in cigarette smoke, because changes in tar and nicotine levels presumably are predictive of changes in the levels of most other particulates. Stud- ies suggest otherwise. For example, tar level as mea- sured by smoking machines is not a good predictor of benzo[a]pyrene level (Kaiserman and Rickert 1992). In general, declared tar values are not predictive of tobacco-specific nitrosamine levels (Fischer et al. 1990, 1991b). Similarly, tar delivery is a poor predictor of the delivery of gas-phase constituents, such as carbon monoxide, hydrogen cyanide, and acrolein (Young et al. 1981). In Canada, the Department of National Health and Welfare (Health Canada) has undertaken a program to develop methods for collecting and analyzing toxic constituents, other than tar, nicotine, and carbon mon- oxide, in tobacco smoke. Methods have been devel- oped to measure the levels of benzo[a]pyrene, the tobacco-specific nitrosamines, h!-drogen cyanide, ben- zene, formaldeh\,de, I-amino-biphen~l, and hea\.v metals such as lectcl and cadmium (Health Canada lYY5a). The Department of National Health and Wel- fare intends to require manufacturers to use these test methods to provide quantita ti\,e reports on these chemi- cals in tobacco smoke or, in the case of heavv metals, in the tobacco itself (Health Canada lYY5a). Rickert (I 994) has described the presence of the potent bladder carcinogen I-amino-biphenvl in the sidestream smoke from all 10 brands of cigarettes tested in a study for Health Canada. Under occupa- tional safety regulations, the permissible level of ex- posure to 4-amino-biphenyl is zero. Applying these standards to cigarette smoke rvould require either that this material be absent from cigarette smoke entirely or that cigarette smoke not be permitted in spaces sub- ject to regulation. An important de\.elopment indicating a possible design flare in the manufacture of cigarettes has been the report that cellulose acetate fibers are shed from ciga- rette filters. Such fibers, coated ivith tar, have been ob- served in the lungs of smokers; this obscr\.ation suggests that these fibers may be long-li\.ed in human tissue and may be associated with disease (I'aulv et al. lYY5). Additives to Tobacco Products Hundreds of ingredients besides tobacco are used in the manufacture of tobacco products. Additives make cigarettes more acceptable to the COIISU~~~; thcv can make smoke seem milder (and easier to inhalei, prolong shelf life, prolong burning, and impro\.e taste. These additives may be a single chemical used as a humectant or a complex mix of chemicals used as a flavorant. Cigarette Additives The six major cigarette manufacturers reported a pooled list of 599 ingredients that \vere added to the tobacco of manufactured cigarettes as of 1991 (R.J. Reynolds Tobacco Company 19%). The list is anno- tated lvith references to Ivhich materials are approved for use as food additives by the FDA (under the cat- egor) "Generally Recognized as Safe") and are thought to be safe by the Fla\,or and Extract Manufacturers Association of the United States. HoFvever, that a material is regarded as safe \vhtn ingested in foods provides no assurance of its safety in a tobacco prod- uct, Mrhere it \viIl be combined bzith other substances, heated to high temperatures, and may be inhaled into the lungs. The American Health Foundation (1990) has pointed out the toxic potential of numerous cigarette tobacco additives under expected conditions of use. Heating and burning may lead to the formation of car- cinogens from some of the additives used. For in- stance, amino acids used as additives are known to form compounds of various elements, including genotoxic agents (known to damage DNA) and experi- mental carcinogens, during heating. Licorice root ex- tract contains glycyrrhizin, and both are used as additives in cigarettes; glycyrrhizin produces carcino- genic by-products when burned. The leukemia- producing agent benzene is a component of cigarette smoke that may be formed from the combustion of many cigarette additives. Because the Federal Food, Drug, and Cosmetic Act requires that a food additive "be safe under the conditions of its intended use" (sec. 321), tobacco additives in manufactured cigarettes may not fulfill the specifications of the law were the law applied to tobacco. The use of additives may reinforce cigarette smoking by strengthening the addictive effects of nico- tine. At least one major domestic cigarette maker uses some additives to boost the absorption of nicotine in cigarette smoke (Kessler 1994~). Ammonia compounds alter the pH of nicotine in tobacco, converting it from the protonated, bound form (various nicotine salts) to the unprotonated, freebase form. Freebase nicotine more readily enters the smoke stream and has been predicted to cross lung and oral cavity membranes more quickly than nicotine salts do (Henningfield et al. lYY5). The broader issue of enhancing the delivery of nicotine is discussed in the introductory section of "Further Regulatory Steps," later in this chapter. Sel,eral European countries regulate cigarette ad- diti\,es, but onlv to a modest extent. In France, the to- tal percentage df the cigarette that consists of additives is listed on the side of the package. Among representa- ti\re brands manufactured in the United States but sold in France (e.g., Camel, Kent, Marlboro, and Winston), the cigarette labels indicate that between 6.2 and 10.0 percent of each cigarette is composed of additives. The British government maintains a list of "permitted" or "nppro\red" additi\,es for smoking tobacco and ciga- rette paper (Le\vis and Davis 1994, p. 206). The list, ivhich had 474 ingredients in 1988, specifies the maxi- mum le\,el permitted for each specific additive (Lewis and Davis 19Y4). In Canada, the Tobacco Products Con- trol Act (sec. 10; Department of National Health and Welfare lY8Y) requires manufacturers to report a quar- terly list of ingredients used in their products. Cana- dian producers use far fewer additives-about 50 in all-than do American manufacturers. Massachusetts, Minnesota, and Texas ha\,e en- acted laws to require the disclosure of nontobacco in- t?redients in tobacco products (Mass. Gen. Lalvs ch. $4, sec. 307B; Minn. Larys ch. 227 [ 1997); Vernon's Texas Statutes and Codes Annotated ch. 161, sec. 161.252 [199i]). Health officials in the Canadian province of British Columbia ha\,e announced their intention of taking similar steps there. The Massachusetts la\v, applicable to cigarettes and smokeless tobacco, requires the manufacturer to report, in descending order bv 12-eight, measure, or nu- merical count, the identitv of each brand's added con- stituents other than tobacco, reconstituted tobacco sheet, or bvater. Ingredients that are recognized as safe \\Then burned and inhaled are exempted. The Depart- ment of Public Health is then instructed to disclose the reported information to the public to the extent that "there is a reasonable scientific basis for concluding that the availabilitv of such information could reduce risks to public health" (Mass. Gen. La\vs ch. Y-I, sec. 3078). The tobacco industry challenged the statute in court on both preemption and trade secret grounds. The Federal District Court ruled that nothing in fecl- era1 la\v preempted Massachusetts from taking this action, and the court of appeals affirmed (P/~i/i/l !l/lrll-- rig LITC. P. Hr7~s/~h7l;sy~~, 122 E3d 58 [lst Cir. 19971). Horn- ever, the same Federal District Court thereafter issued a preliminarv injunction that pre\.ented the state from enforcing th'e ingredient disclosure provision of the statute; the court ruled that doing so \vould expose the trade secrets of the manufacturers (Pl~i/i/~ Morris Irlc. :I. Hnrshha,~~~, Civil Action No. 96-113YY-GAO, Civil Action No. Yh-11619-GAO, 1997 U.S. Dist. LEXIS 21012 [D. Mass. Dec. 10, 1997]). That ruling is cur- rently under appeal. Texas has adopted a similar stat- ute requiring the tobacco industry to submit a list of ingredients and nicotine vield ratings to the Texas Department of Health by -December 199X (Vernon's Texas Statutes and Codes Annotated ch. 161, sets. 161.252, 161.254, 161.255). The Minnesota statute requires manufacturers of tobacco products to publiclv disclose, for each brand, ivhether the product contains detectable levels-in either its unburned or its burned states-of ammonia or ammonia compounds, arsenic, cadmium, formal- dehyde, or lead. The industrv filed suit in Federal Djs- tric;Court to enjoin the enfoicement of the statute but agreed to drop the suit as part of its Mav 1998 settle- ment of the state's Medicaid reimbursement la\vsuit (discussed in "Recoverv Claims by Third-Party Health Care Payers," later in this chapter) (Mirrrwsot~7 7'. Philip Morris Iuc., citcll ill 13.2 TPLR 3.3Y, 3.45 [1998]). Most recently, British Columbia health officials announced plans to require cigarette manufacturers to disclose to the government all ingredients, includ- ing additives used to treat the papers and filters. Manufacturers ~~rould also have to test and report on 44 poisons that the health officials claim are contained in cigarette smoke (Reuters 1998). Smokeless Tobacco Additives In 199-f, ten manufacturers of smokeless tobacco products released a list of additives used in their prod- ucts (Patton, Boggs & Blot2 1994). As with the addi- ti1.e list for cigarette tobacco, the smokeless tobacco list notes ~~hich of the 562 materials listed have been appro\.ed for use in foods by- the FDA and also notes ivhich arc regarded as safe bv the Federal Emergency Management Agency. As \vith cigarette tobacco, ap- plying these safety standards to nonfood substances is problematic; holz.ever, smokeless tobacco used in an unaltered (unburned) state lessens some of the con- cern o\`er the possible hazards of aclditives. The list of ndditit~es to smokeless tobacco in- cludes sodium carbonate and ammonium carbonate, \vhich are alkalinizing agents that increase the level of "free" (chemically uncombined) nicotine in moist snuff bv raising the pH le\rel (Slade 1995). A division of the S\yedish Tobacco Company has stated that so- dium carbonate is added to its moist snuff brands to alkalinize the tobacco and thus enhance nicotine absorption (Kronquist 1994). The pH of moist snuff products-lvhich is not reported to consumers- \-arks from acidic to alkaline, providing a wide range of free-nicotine levels in various products (Djordjevic et al. 1995; Henningfield et al. 1995). Products for per- sons entering the market (such as those that have easy- to-use unit dosages) are acidic (thus reducing absorption) and have \`ery low levels of free nicotine, Lvhercas products for more experienced users (such as the Copenhagen brand) are alkaline and have high levels of free nicotine. The epidemiology of moist snuff use among teenagers and young adults indicates that most no\Jices start with brands having low levels of free nicotine and then graduate to brands with higher levels (Tomar and Henningfield 1992; Tomar et al. 1995). These patterns are consistent with the industry's marketing strategies as reflected in their advertising and marketing activities and their internal documents (Connolly 1993). Sweeteners and flavorings, such as cherry juice concentrate, apple juice, chocolate liqueur, and honey, are used in various smokeless tobacco products, and dominant fla\,ors are often mentioned in the product name (e.g., the Skoal Cherry, Long Cut brand). As with manufactured cigarettes, these additivrcs increase pal- atabilitv and may intensifv use of smokeless tobacco, at least-among novices (Freedman 1994). The Low-Tar "Alternative" As the health hazards of smoking have been in- creasingly documented, the production of lower-tar cigarettes has increased. The FTC's tables on avrerage sales-weighted tar levels for cigarettes on the U.S. market from 1968 through 1987 reflect this shift toward lower-tar cigarette brands (USDHHS 1981,1989).' The public health implications of this shift merit closer inspection. Compensatory Smoking Considerations of product regulation must take into account the variability in toxic exposure attribut- able to specific smoking practices. The overall evi- dence suggests that many smokers compensate when smoking low-deliverv cigarettes by inhaling more tar and nicotine than are measured by smoking machines under standard conditions. Any potential health ben- efit implied by machine measurements of loller tar and nicotine yields may thus be mitigated bv such com- pensatory smoking. Studies have shovzn that as consumers sl\-itched to lower-yield cigarettes in Great Britain, they tended to smoke more cigarettes each day (Ferris 198-l), al-`- parently to compensate for the lovz,er nicotine yield per cigarette. Similar compensatory measures may have occurred in the United States. For example, smok- ers in Cancer Prevention Study I, conducted during the 1960s \zhen loM-er-yield brands were rare, smoked fewer cigarettes per day than smokers in Cancer I+- vention Studv II, which was conducted during the 198Os, by which time most smokers used louver-yield brands (Thun et al. 1997). Strong evidence suggests that smokers increase the number of cigarettes con sumed as nicotine availabilitv is reduced, and vice versa (USDHHS 1988; Kaufman et al. 1989; Palmer et al. 1989; Stellman and Garfinkel 1989; I%egri et al. 1993; Thun et al. 1997). In addition, loller nicotine delivery in the FTC test is associated Ivith smoking a greater number of cigarettes (USDHHS 1988). This compensatory effect has been confirmed in other stud- ies (Benowitz et al. 1983; Bridges et al. 1990; Hofer et al. 1991; Wood ward and Tunstall-Pedoe 1992; Coultas et al. 1993); only one published study found no such effect (Rosa et al. 1992). In an abstract, Byrd and col- leagues (1994) reported no compensatory effect, but their small study population may not have been rep- resentative of all smokers; for instance, the nicotine intake seen among the group that smoked the ultra lo\\,-delivery cigarettes was smaller than that observed bv others. Health Risks From Low-Tar Cigarettes Even when compensatory smoking is not ac- counted for and calculations are derived from machine-rated tar levels, the risk of lung cancer is only slightly lower from using low-tar cigarettes than from using high-tar cigarettes, and reduced tar level has little if any impact on the occurrence of other cigarette- caused lung disease or of heart disease (USDHHS 1981, 1989; Parish et al. 1995; Wannamethee et al. 1995). Giovino and colleagues (1996) have examined results from several national surveys of tobacco use for attitudes and behaviors related to the use of IoM,- tar cigarettes. In these surveys, current smokers of low- tar brands vvert found to be more likely than smokers of high-tar brands to acknowledge the health risks of smoking, to express concerns about these risks, to re- port that they had been advised by a physician to stop, and to report that they had experienced negative health consequences from smoking. These smokers were also more likely, hovvevrer, to believe that smoking a low- tar brand reduced those risks. For example, in the 1987 National Health Interview Survey, 44 percent of smok- ers reported that thev had switched to a low-tar cigarette to reduce their health risk, and 48 percent of lo\\,-tar brand users thought their brand was less haz- ardous than most other brands (Giovino et al. 1996). These attitudes were confirmed by a 1993 Gallup poll in lvhich 49 percent of respondents stated that they believed that the advertising message in terms such `1S "low tar, " "101~ nicotine," or "lower yield" was that the "brand [was] safer"; only 4 percent believed that the advertisements were "false/misleading" (Gallup Organization, Inc. 1993, p. 23). The analysis by Giovino and colleagues (1996) also suggested that many smokers of low-tar cigarettes may have used these brands instead of quitting. Low- tar &ers were more likely than high-tar users to have tried unsuccessfully to stop smoking. Similarly, a greater proportion of people who had successfully quit smoking had been high-tar cigarette users. This latter obser\ration has been confirmed in another survey: those M.ho had stopped smoking tended to have been higher-tar cigarette smokers (Cohen 1996). As was previously suggested (Kessler 1994b), the higher ra- tios of nicotine yield to tar yield in lower-tar cigarettes than in higher-tar cigarettes could impede efforts to quit among persons \vho smoke loiver-tar cigarettes. Assessment of consumer attitudes, as well as epidemiologic consideration of health risks from loafer-yield cigarettes, has raised concerns about the reporting of FTC test results (Henningfield et al. 1994). An ad hoc committee of the President's Cancer Panel, convened in December 1994 (Jenks 1995), concluded that consumers misunderstand the FTC test results and should be given a range of values for smoke deliver- ies (reflecting the M'av cigarettes are actuallv smoked) and that these \ralues;hould be included on iach pack- age and in all advertisements (NC1 19%). The com- mittee also concluded that terms such as "light" and "ultra light" are in fact health claims that mislead consumers. Nicotine Replacement Products The "safe cigarette," long sought, has not been found (Gori and Bock 1980; USDHHS 1981,1989; Slade 1989,1993), and the axiom that no tobacco product is safe wrhen used as intended remains true (USDHHS 1989). As long as tobacco products are sold, some people \vill be unable to stop using nicotine (Kozlowski 1987). ILove nicotine deli\-ery devices have been tried in test markets (R.J. Reynolds Tobacco Company 1988; Slade 1993; Hilts 1994), and several tobacco compa- nies have patents for various designs (David A. Kessler, letter to Scott D. Ballin, February 25, 1994; Slade 1994; Htvang 1995b). All designs share the ability to deliver nicotine for inhalation with a minimum of, or no, tar- thereby avoiding the smoking-associated increased risk of cancer (although not the nicotine-associated increased risk of cardiovascular disease) (USDHHS 1988). Nicotine replacement products have been devel- oped and marketed by pharmaceutical companies as adjuncts to help people stop smoking (Jarvik and Henningfield 1993). As was discussed in Chapter 4 (see "Pharmacologic Interventions"), concerns over possible intentional or unintentional misuse of these products have been weighed against the health ben- efits resulting from their effectiveness as a cessation aid. Nicotine gum and nicotine patches, previously approved by the FDA as prescription drugs for brief use (months), \vere approved in 1996 for over-the- counter use, concluding an intense examination of the issues of nicotine availability. Both a nicotine nasal spray and a nicotine inhaler were approved for pre- scription use. The Drug Abuse Advisory Committee (1994) of the FDA has expressed concern about the potential abuse liability of the spray and the inhaler, because the pharmacokinetics of their delivered dose of nicotine comes closer than the gum or patch to what occurs through using tobacco products. Benowitz and Pinney (1998) concluded that the benefits from over- the-counter availability of the gum and patch would outlzeigh the risks. In December 1996, the FDA's Drug Abuse Advisory Committee recommended approval of the nicotine inhaler for prescription use (FDA Drug Abuse Advisory Committee, draft minutes of Decem- ber 13, 1996, meeting). Nicotine maintenance is not an approved thera- peutic approach, but some observers have called for a coordinated clinical and public health program to ex- plore this option (Slade et al. 1992). A useful program not only must substantially reduce health risks and satisfy addicted individuals who cannot otherwise stop using tobacco products but also must include realistic safeguards to prevent the neM' onset of nicotine de- pendence among the young, to prevent relapse among those who have already stopped, and to further re- duce overall smoking prevalence. The elements of such a program would include research to (1) fully characterize the population that lvould benefit from nicotine maintgnance, (2) identify potential delivery devices for nicotine or an appropri- ate analogue, (3) explore fully the safety of these de- \rices as Mel1 as the safety of nicotine or the chosen analogue (including assessments of potential cardio- vascular, fetal, cognitive, and performance problems consequent to use of the drug, as well as other poten- tial health effects), and (4) design a drug distribution svstem that would be acceptable to intended users but &at would substantially limit access by novices to to- bacco use and by those who have already been suc- cessful at achieving abstinence from nicotine (Slade et al. 1992). Product Regulations for Consumer Education The previous discussion of product regulation centered on the contents of the tobacco product itself. Another critical focus for product regulation is pack- aging, a promising field for public information and education on smoking and health. Government ac- tions in this area have included product packaging to convey health messages (see "Attempts to Regulate Tobacco Ad\.ertising and Packaging," earlier in this chapter). The goal of this packaging strategy, as dis- cussed in the follo\ving section, is to help ensure that the purchase of tobacco products occurs only as a trans- action invol\?ng informed consumer choice. Also dis- cussed is a related, more complex goal for this strategy: to help ensure a situation of informed consumer con- sent rather than simply choice. Tobacco Packaging and Informed Choice The current required warning labels on U.S. to- bacco packages are but a single, narrow means by which package-based messages can promote informed choice among consumers. The vast amount of infor- mation available on the adverse health effects of to- bacco use constitutes a \vide range of messages that can be presented this way (USDHHS 1989). This in- formation can appear on packages in many ways, given the numerous variables such as size, wording, placement, colors, graphics, typefaces, and package inserts. The potential public education value of package- based health messages is inherent in their exception- ally large rate of exposure to consumer vierz. In the United States, about 478 billion cigarettes \vere con- sumed in 1997 (Tobacco Institute 1998). Each of these cigarettes will be removed from a package that could be vielved bv many cigarette users at exactly the time they are preparing to engage in the activity such mes- sages are intended to prevent. These messages can be seen not onlv immediatelv before use but also at the point of sale or at any time the package is in the pos- session of the user. The messages do not have to be directed only at tobacco users; any exposed package can be vielved by, and can provide information equally germane to, users and nonusers alike. An example of the potential inherent in package messages is provided from Canada. In legislation supplementing the Tobacco Products Control Act (sec. 9), the federal go\`ernment of Canada not only increased the number of rotating messages from four to eight but also made neiv stipulations regarding the messages' size, location, and color (Department of National Health and Welfare 1993; for details on these changes, see "Examples of Product Labeling in Other Countries," earlier in this chapter). These changes follo\ved stud- ies undertaken to determine the existing messages' leg- ibility, readability, believability, and ease of understanding. These studies had indicated that health M-arnings were read about 1 .-I times per daV (t\romen, 1.8 times; men, 1.2 times) and that cigarette packs ivere a primary source of tobacco-related health information for 55 percent of smokers, second only to television (59 percent) and well ahead of newspapers (17 percent) (Tandemar Research Inc. 1992; Kaiserman 1993). Tobacco Use and Informed Consent Although many discussions of tobacco use in- voke "free choice," the more rigorous legal concept is "informed consent." As applied to tobacco use, in- formed consent would obtain only when potential purchasers of tobacco products could make fully in- formed purchase decisions after carefully weighing the health risks of using those products. Thus, like pa- tients considering whether to undergo potentially harmful medical procedures, consumers considering whether to use tobacco would have to know which health problems are caused by the product's use, what increases in personal risk of these various problems occur through this use, what the prognosis is should any of these problems arise, and what effect ending or adjusting the use could have on these problems. Courts of law in this country and elsewhere have ar- ticulated the duty of product manufacturers to warn consumers about product hazards. A particularly clear statement of the principles involved in informed con- sent is found in an Ontario Court of Appeal decision concerning oral contraceptives: Once a duty to warn is recognized, it is manifest that the warning must be adequate. It should be communicated clearly and understandably in a manner calculated to inform the user of the na- ture of the risk and the extent of the danger; it should be in terms commensurate with the grav- itv of the potential hazard, and it should not be neutralized or negated by collateral efforts on the part of the manufacturer. The nature and extent of any given warning will depend on what is rea- sonable having regard to all the facts and circum- stances relevant to the product in question (Bucl~r i'. Orfho Plznrnlncclitical [Crrrzndnl Ltd., [ 19861 54 O.R.2d 101 [Ct. App.] [Can.]). Similarly, a U.S. court has described an adequate prod- uct Iyarning in the following way: In order for a warning to be adequate, it must pro- vide "a complete disclosure of the existence and extent of the risk involved" (!&~/i&s ~1. GaliTejto/l Ynchf B~sill, Itzc., 727 E2d 330 [5th Cir. 19841) citing Almrr Brofhcrs Fnrrm ~5 Feed Mill, 117~. v. Diamomi Laborntorics, 11x., 437 E2d 1295, p. 1303 [5th Cir. 19711). A warning must (1) be designed so it can reasonably be expected to catch the attention of the consumer; (2) be comprehensible and gi\re a fair indication of the specific risks in\.ol\,ed lvith the product; and (3) be of an intensity justified by the magnitude of the risk (I'o:~/iil~~, p. 338). At issue, then, is IVhether consumers ha1.e re- ceived adequate ivarning for informed consent to ap- ply to tobacco use. Although public kno\\,lcdge about the health effects of tobacco use has inipro~~ed o\-ei the past 15 vears (FTC 1983; L:SDHHS lL)XY), widence persists of iaps in understanding. An American Can- cer Society (ACS) study sholred respondents a list of selected causes of death and asked Ivhich \j.as respon- sible for the greatest number of deaths (Marttila & Kiley, Inc. 1993). The stud\, found that onlv one in fi1.e Americans could corrtctl\' identif\, cigar&c smoking as the listed cause associated \jith the most deaths. Sim- lar studies in other countries (Hill and Gray,, I%-!; Gallup Canada, Inc. 19%; En\-ironic5 Research Group Limited lY91; Health and Welfare Canada lW1 [unpublished data]) ha\-e found a similar lath of kno\~~lt~dgc. These studies indicate that the public continues to underestimate the magnitude of the risks arising from tobacco use. The resulting inabilitl, of consum- ers to make fullv informed decisions about tobacco use could be interpreted as a failure on the part of the manufacturer to achie\.e informed consent from users of the product. To date, this issue has not been legall!, adclressed, and the pre\-iouslv discussed notion of in- formed choice, lvhich carries clearer legal implications, is generallv in\,oked. Further Regulatory Steps Although some of the aforementioned product regulations address the chemical constituents of to- bacco use, none directly broaches the issue of whether tobacco, as a nicotine deliverv svstem, should be sub- ject to federal regulation as an addictive product. In March 1994, the Coalition on Smoking OR Health ([CSH] composed of the American Heart Association, the American Lung Association, and the American Cancer Society) filed a petition with the FDA to de- clare all cigarette products to be drugs under section 201 of the Federal Food, Drug, and Cosmetic Act (CSH 1994a). This petition follo\ved an earlier one bv the same coalition requesting the classification of lov,-tar and low-nicotine cigarettes as drugs and similarlv clas- sifying the proposed nelv I~.]. Revnolds Tobacco Com- pany "smokeless cigarette" as adrug (CSH 1WX). A felt- [2-eeks earlier, the FDA had made public that it w.as in\.cstigating lvhether it might assert juris- diction ol'er tobacco products (Kessler 1994a). The legal basis for such a mo\`e requires demonstrating that the manufacturers of tobacco products intend to af- fect the structure or function of their customers bod- ies (21 U.S.C. section 321 [g] [l]). The Commissioner of the Food and Drug Administration, David A. Kessler, M.D., had indicated in testimony before Con- oress that there \vas evidence that pointed to this con- Flusion (Kessler lYYJb,c). The FDA has concluded that w,ords used by to- bacco companies to describe some effects of smoking (e.g., "satisfaction," "strength," and "impact") are eu- phemisms that actually describe pharmacologic effects of nicotine (Kessler 1993b, p. 150). Dr. Kessler has noted that cigarettes are sophisticated, carefully de- signed de\.ices. Industry patents disclose a detailed kno\vledgc of nicotine pharmacology and describe as desirable those product refinements that increase the efficiencv of nicotine deli\,erv. One company has pat- ented a series of nicotine analogues having desired pharmacologic effects, much as a conventional phar- maceuCical company might develop a new drug that produces effects similar to those of an existing drug. The FDA has disclosed several specific examples of product manipulation to adjust the delivered dose of nicotine in cigarettes (Kessler 1994~). The Brown & Williamson Tobacco Corporation has used in cigarettes sold in the United States a strain of tobacco (Y-l) that had been geneticallv engineered to have a high nico- tine content. According to a major American tobacco company's handbook on leaf blending and product de\,elopment, ammonia compounds can be used as additives to boost the delivery of nicotine in smoke to enhance the "impact" and "satisfaction" from smoke (Kessler 1994c, p. 365). In an official prosecution memorandum to the U.S. Attorney General, Represen- tative Martin T. Meehan (D-MA) has asserted that product manipulation of Eclipse brand cigarettes has taken place. Meehan cites the addition of high-nicotine-content tobacco near the filter and the addition of potassium carbonate to change the pH of the tobacco (or to enhance absorption through the mu- cous membranes) (Meehan 1994; see "Criminal Pro- ceedings," later in this chapter). Moreover, information obtained from internal industry documents suggests that at least some tobacco companies have long had an accurate and detailed knoivledge of nicotine phar- macology. Dr. Kessler told Congress that "such re- search \~ould be of interest to the industry only if the industrv \verc concerned with the physiological and pharmacological effects of nicotine. Certainly, this is not consistent It-it11 the inc~u5tr\.`5 wprcsentation that nicotine is of interest to it onI\. hecause of flaI.0ur and taste" (Kessler lYYlc, p. 36% Follolz,ing his testimony before Congress, in a speech at Columbia University School of La\l-, Dr. Kessler emphasized the importance of preventing nico- tine dependence among children and teenagers. Call- ing it "a pediatric disease" (David A. Kessler. Remarks. Presented at the Samuel Rubin Program, Columbia University School of Lalz, iXe\v L'ork Cit!; March 8, 1995, unpublished), he outlined a number of specific priorities for public health action: A comprehensi\-e and meaningful approach to preventing future generations of young people from becoming addicted to nicotine in tobacco is needed. Any such approach should: First, reduce the manv a\-enues of easy access to tobacco prod- ucts available to children and teenagers; second, get the message to our \;oung people that nicotine is dddicti\,e, and that tobacco products pose seri- ous health hazards--and not just for someone else; and third, reduce the po'\verful imager\, in tobacco ad\.ertising and promotion that encourages young people to begin using tobacco products (p. 19). On August 10, 1995, the FDA announced the result of its investigation. The agencv stated that e\,i- dence appears to indicate that "nicotine in cigarettes and smokeless tobacco products is a drug and [that] these products are nicotine deli\-cr\- de\?ccs under the Federal Food, Drug, and Cosmetic-Act" (Fc[f~~r~7/ R~;;is~ tcr 1YYJa). In August 1 YYS, the FDA issued in the F& L'r17/ R~`;{isfc,r (1 1 a proposed rule of regulations restricting the sale and distribution of cigarettes and smokeless tobacco products to protect children and adolescents and (2) an analysis of the FDA's jurisclic- tion o\.er cigarettes and smokeless tobacco. The FDA requested comments on its proposed regylations and annlvsis of its jurisiiction, and indicated that it \\-ould give-serious consideration to comments filed \Vith the agencv concerning the evidence amassed during its investigation. The Clinton administration also sug- gested that Congress could eliminate the need for this rulemaking bv passing Ned. legislation to affirm the FDA's authority over tobacco products and address the issue of tobacco use among minors. In its legal analvsis of its proposed jurisdiction over tobacco products, the FDA argued that cigarettes and tobacco products "affect the structure or anv func- tion of the bode" (key language for ini,okihg the agencv's authorizing legislation) and that it is the in- tent oi tobacco manufacturers that their products have addictive effects (Fed~al Rc~yisf~~r 1995a). The argument XZ'~S presented as a logical chain of inference: the ad- dictive properties of tobacco are "widely known and foreseeable" by tobacco manufacturers; consumers use the product to satisfy their addiction; and tobacco manufacturers know of the addiction, know of con- sumers use, and have facilitated that use (Fc~drral Rq- ister lY95a). An extensive analysis, including internal documents from tobacco companies, was used to elu- cidate these assertions (Federal Register 1995a). The FDA presented a further legal discussion of whether the cigarette is a device and postulates that the ciga- rette is "a consciously engineered instrument to effectuate the delivery of a carefully controlled amount of the nicotine to a site in the human body where it can be absorbed" (Federrrl Rqister 1995a). The proposed regulations centered on restricting the availability and appeal of tobacco products to chil- dren and adolescents and consisted of the following provisions: The tobacco industry would be required to spend at least $150 million per year to support smoking pre\,ention education for children. Tobacco sales would be prohibited to those under 18 years of age, and vendors would be required to see photo identification as proof of age. Vending machines, self-service displays, and mail- order sales \vould be prohibited, as would the sale of incli\.idual cigarettes or packs of fewer than 20 cigarettes. The sale or gift of promotional items bearing brand names, logos, or other brand identity bvould be prohibited. Free samples \~ould be banned. Only black-and-Mhite text advertising for cigarette products ivould be permitted in publications for I\-hich more than 15 percent of the readership is under age 18 and in publications with more than 2 million voung readers. Outdoor tobacco advertising kvould be prohibited \\.ithin 1,000 feet of schools and playgrounds. All other outdoor tobacco advertising would have to be in black-and-Mhite text. Sponsorship of sporting or entertainment events using specific brand names or product identifica- tion would be prohibited, although the use of com- pany names would not. The proposed regulations stirred immediate action from the tobacco industrv. Four lan.suits were filed immediatelv after the F~Jcvi7/ Rr,~isf~,~ announcement. A larvsu;t filed bv tobacco companies in federal court in Greensboro, North Carolina, as- serted that the FDA had no jurisdiction o\.er cigarettes. The plaintiffs l\.ere Bro\vn & Williamson Tobacco Cor- poration, Liggett Group Inc., Lorillard Tobacco Con- pan);, Philip Morris, and R.J. Re\,nolds Tobacco Company (Czir7ll Sfrwt /~lfivllrll lYY5).~ Parts of the ad- \ ertising industr!: Ivhich has a large stake in the out- come of the proposed regulations, also filed suit on the grounds of infringement of First Amendment rights (,-lffwrimf7 24di7~~rtisirig Fdt~ri7tioi2 i'. K~5slf~r. Civil Action No. 2:95CVOO593 [M.D.N.C. Aug. 10,1995], cited i/7 10.5 PPLR 3.401 [lY95]). In addition, a smokeless tobacco companv (UII;~& Stiltf5 Tr~lwcio CP 7'. Fwif iril[f Drfiq .-\dllrillj~fl.l7fj~l,l, Ci\.il Action ho. h:Y5CV0066f [M.D.N.C. Sept. 19, 19931) and a trade group repre- senting con\.cnience stores (N~rtior7i7/ A5.5ch-ii7ti~~i1 (If Ctlff- ili~llitvfc~~ S/r)fw il. k'twlflr, Ci\.il Action No. ?!:YSCVOO70h [M.D.N.C. Oct. 1, 19951) filed suit. By the January 2, 1996, close of the public con- ment period on the proposed rules, the FDA had re- cei\-ed more than 95,000 indix-idual comments, the largest outpouring of public response in the agency's history. From March 18 to April 19, lYY6, the FDA re- opened the comment period for the limited purpose of seeking comments on the statements of three former Philip Morris employees about that company's alleged manipulation of nicotine in the design and production of cigarettes and to seek comments on further expla- nations of certain provisions in the proposed rule. The re\ie\v process culminated in a Rose Gar- den ceremony at the White House on August 23,1996, in ivhich President Clinton announced the publication of the final FDA rules. To emphasize that the FDA's central intent was to reduce tobacco use among young people, these final rules essentially regrouped the regu- lations from the original announcement into t\vo cat- egories: reducing minors' access lo tobacco products and reducing the appeal of tobacco products to m- nors. The only notable changes to the former rules \vere that the ban on mail-order sales \\ras eliminated and the ban on vending machines and self-ser\+ce displays was relaxed to allow exceptions for certain nightclub and other "adults-onlv" facilities totallv in- accessible to persons under the-age of 18. Similarly, the limitation to black-and-white text for in-store advertising excepted adults-onlv facilities if the adlw- tising was not visible from the butside. In place of its original regulation requiring the tobacco industry to spend at least 5130 million each year to support tobacco prevention education for chil- dren, the final rules lvere less explicit. The FDA pro- posed to require the six tobacco companies with a significant share of sales to minors to educate that population about the health risks of using tobacco products. This action \\fould be pursued under pro- cesses dictntecl by section 518(a) of the Federal Food, Drug, and Cosmetic Act (FDCA). Cnder the act, the FDA may require manufacturers to inform the consumer about unreasonable health risks of their products. The various provisions were to be phased in be- hveen six months and t\vo years from August 28,1996, the date of publication in the Fcdcr-nl R~yisfcv. Two prin- cipal hurdles to quick and full implementation of the FDA regulations soon emerged. First, as noted above, sel.eral tobacco companies, retailers, and advertisers had sued the FDA to block implementation of the regu- lations. Second, \.arious legislative proposals, which began circulating in Congress both before and after publication of the FDA's final rule, threatened to alter or bar the FDA's regulation of tobacco products. Judicial Developments and the Status of FDA Regulations Three briefs filed on October 15, 1996, on behalf of the plaintiffs in these suits moved for summary judg- ment, arguing that the proposed regulations exceed the agency's jurisdiction and are contrary to congres- sional intent, that tobacco products are not "drugs" or "de\.ices" ivithin the agency's statutory grant of au- thority, and that the advert&g restrictions are a vio- lation of the First Amendment (M~wlcy's Lifipfior~ R~~pol.t~: Toh7cic~ 1996b). On April 25, 1997, the federal district court in Greensboro, North Carolina, ruled that the FDA pos- sessed the authority to regulate cigarettes and smoke- less tobacco products as drug delivery devices under the FDCA (Coyrw Rcnlw, Ii~c. il. U.S. Ford C Dq Ad- ~r~irfistmtirv~, 966 F. Supp. 1374 [M.D.N.C. 19971). The ruling, how-e\w, marked a considerably qualified vic- tory for the FDA. Although the court upheld all of the agency's restrictions involving youth access and label- ing, the court temporarily blocked implementation of most of these pro\,isions. Only the FDA's prohibition on sales of cigarettes and smokeless tobacco to minors and the requirement that retailers check photo identifi- cation of customers who are under 27 years of age es- caped the court's stay. These provisions went into effect on Februarv 28, 1997; and remained in force until March 21, 2000, tl;e date of the Supreme Court decision. Notably, the court in\-alidated the FDA's restric- tions on advertising and promotion ot cigarettes and smokeless tobacco on the basis that thev exceeded the agencv's statutorv jurisdiction. The pertinent federal statut;, 21 G.S.C. section 360j(e), provides, in part, that the government may "require that A de\.ice be re- stricted to sale, distribution or use. upon such other conditions as the Secretarv nmv prescribe." The FDA had argued that it \vas au;hori/ed to restrict the "sale, distribution or use" of tobacco products pursuant to section 360j(e) and that its advertising nncl promotion restrictions lvere valid becd~lse advertisitlg and pro- motion constitutes an "offer of sale" (Cwrlc' R~w/fIf!, p. 13%). Judge William L. Osteen Sr. disagreed. The court reasoned that the \\.ord "sale" as emploved in the statute did not encompass the advertising or pro- motion of a product. The court also ruled that the "section's grant of authoritv to FDA to impose `other conditions' on the sale, distribution, or use of restricted devices [does] not authorize FDA to restrict advertis- ing and promotion" (p. 1398). Furthermore, because the court ruled that the FDA \\`as not authorized to restrict advertising and promotion, the court did not reach or discuss arguments that these prol~isions \.iolated the First Amendment to the United States Constitution. Most important, holzcver, Judge Ostetn agreed lvith the FDA's contention that tobacco products fall x1-ithin the "drug" and "dc\,ice " definitions of the FDCA. To position its authority ivithin these defini- tions, the FDA had to 1iai.e demonstrated that tobacco products are "intended to affect the structure or an\' function of the body" (21 U.S.C. section 331 Is111 Ilclj. Judge Osteen ruled that the effects of tobacco prod- ucts are "intended" I\-ithin the meaning of the FDCA and that tobacco products affect the structure or funs- tion of the body \\-ithin the meaning of that act. Thy court also ruled that pursuant to its "de\.ice authori- ties," the FDA could regulate tobacco products as medical devices. Both sides in the case appealed the decision to the Fourth Circuit of the United States Court of Appeals in Richmond, Virginia. The go\,ernInent and the tobacco companies presented oral arguments to a three-member panel of this court on August 11, 1997. The case became inacti\ e follmz-ing the death of one of the panel judges on Februarlr 22, 19%. A neI\ judge ivas appointed, and on June?, 1998, the three- member panel conducted a second hearing on the appeal. The Court of Appeals Ruling on FDA Authority On August 11, 1998, the Fourth Circuit Court of Appeals overturned the lower court decision and ruled in a 2 to 1 decision that the FDA lacks the authority to regulate tobacco products (B~OXIII G Willin TO~CCO COI./L ~1. Food & Drq Adnlirli~f,,atiorz, No. 97-1604 [4th Cir. lY%]). The majority opinion (Judge H. Emory Widener Jr.) found that the FDA had based its deter- mination of authority solely on literal interpretations of "drug" and "device" in the FDCA but did not con- sider statutorv language as a whole, the legislative his- tory, and thee history of evolving congressional regulation in the area, including consideration of other relevant statutes. Judge Widener held that there is an internal inconsistency in the FDA's claim of authority to regulate tobacco under the FDCA, since a declara- tion that cigarettes are unsafe (the basis of the FDA's claim) necessitates a ban on cigarette sales-an action that lsould be opposed by polverful economic and political forces. Widener reasoned that although the FDA M-ould ha\,e the authority to grant exemptions to the ban because potential public health benefits might out\veigh harms, such exemptions M-ould undermine the agency's essential vie\\, that cigarettes are unsafe. The only exemption open to the FDA would thus be based on social and economic rather than health- related considerations. A rvell-known catch \~ould then corme into play: social and economic consider- ations are within the pur\.icc\~ of Congress, not the FDA. Judge Widener pointed out that Congress had been a\vare for decades that the FDA lacked the au- thority to regulate tobacco on social and economic grounds, had rejected attempts to gi1.e the FDA such authority, and had enacted numerous pieces of legis- lation that did not grant such authority. The dissenting opinion (Judge Kenneth K. Hall) took the position that the intrinsic contradiction in the FDA's authority under the FDCA is irrelel,ant: ". ivhether the regulations contravene the statute is a question ~,holl>, apart from IVhtther any regulations could be issued. It is no argument to say that the FDA can do nothing because it could have done more" (BIVZ'II & W~//~~~~~~S`CIII, p. 48). The opinion proposed that the FDA's current position is a response to "the increasing level of knoll.-ledge about the addicti1.e nature of nicotine and the manufacturer's deliberate design to enhance and sustain the addictive effect of tobacco products" (p. JO). Judge Hall stated that prec- edents in administrative la\v clearly indicate latitude for an agency to change its approach in the light of ne\v information. He further asserted that earlier toll- qessional action clid not ha\.e the benefit of the lel,el h of elidense gathered LX. the FDA in forming its cur- rent position. Finall\,, iie pointed out that the term "sale, distribution and LIW" (p. 58) is not full\. defined in the FDCA and is therefore subject to agencl' inter- pretation. This term "can reasnnabl!~ be construed to include all aspects ot a product's journev from the fac- tow to the store and to the home" (p. 5X). Thus, the judge reasoned, the authorit!, to regulate tobacco pro- motion should be upheld. The full Fourth Circuit Court of Appeals declined to rc\-ie\\- this rc\.ersal. The i?o\.ernment petitioned the United States Supreme ?ourt for re\-ielv, and the United States Supreme Court accepted the case in April 1999. Oral ar:;unient l\.ds held December 19YY, and the Court, in a 5 to 1 deci- sion, upheld the Fourth Circuit's decision on hlnrch 2 1 , 2000. The U.S. Supreme Court Ruling on FDA Authority On March 21, 2000, b\, a 5 to 1 \ ate, the United States Supreme Court affi&ned the Fourth Circuit dc>- c&ion and o\.erturncd the FDA's asserticon of jurisdic- tion o\-er cigarettes and smokeless tobacco products (F~J0tf 1717rf nIX&' .,~il~lli,li~tr'iltic,r, ;`. RULi'Ii & 1t'i//i,7,775clIl Td'ilii0 Corp., 53Y U.S. [20001, 120 s. c-t. I31 1. ,J.s a result, the FDA no longer has regulator\. author- itv to enforce the final rule it issued in 1 YYh. Justice Sandra Da\' O'C onnor \\.rotc the majorit\. opinion for the Court. In ruling h acrainst the FDA, she noted that "The agencv has ampI\, demonstrated that tobacco use, particularl\, among childi-en and adoles- cents, poses perhaps thi single most significant threat to public health in the United States" (p. 1315). Ne\ - ertheless, the majoritv ruled that Congress had pre- cluded the FDA from asserting jurisdiction o\.er tobacco products as customarilv marketed because "5uch authoritv is inconsistent \vi;h the intent that Con- gress has expressed" (p. 1297) in the Federal Food, Dmg, and Cosmetic Act and other tobacco-specific statutes. Justice O'Connor noted the unusual nature of both the case the Court \j.as deciding and the role of tobacco in the United States. She tvrote: Otving to its unique place in American historv and society, tobacco has its o\vn unique political historv. Congress, for better or for \vorse, has created a dik- tinct regulatorv scheme for tobacco products, squarelv rejected proposals to gi\pe the FDA juris- diction o\-er tobacco, and repeatedly acted to pre- clude anv agencv from exercising significant policymaking autllorit!. in the area (p. 1315). Justice Stephen Breyer wrote the dissenting opin- ion. He disagreed lvith the majority view that Con- gress never intended the FDA to have the authority to assert jurisdiction over tobacco products. In summa- rizing \vhy the four justices in the dissent believed the FDA had acted la\vfully, Justice Breyer tvrote: The upshot is that the Court today holds that a regu- latory statute aimed at unsafe drugs and devices does not authorize regulation of a drug (nicotine) and a de\.ice (a cigarette) that the Court itself finds unsafe. Far more than most, this particular drug and de\,ice risks the life-threatening harms that administrati\,e regulation seeks to rectify (p. 1331). Legislative Developments In an effort to claiify the public health perspec- ti\.e on potential legislation, on September 17, 1997, President Clinton outlined the principles he believed must be at the heart of any national tobacco legisla- tion (1 lohler lYY7): .A comprehensi\.e plan to reduce youth smoking, includin;: tough penalties if targets are not met. Full authority for the FDA to regulate tobacco products. An end to the tobacco industrv's practice of marketing and promoting tobacco-to children. Broad document disclosure (especially of those documents relating to marketing tobacco to children). Progress to\zard other public health goals, such as reducing environmental tobacco smoke (ETS), ex- panding smoking cessation programs, strengthen- ing international efforts to control tobacco, and pro\,iding funds for health research. Protection for tobacco farmers and their communities. A number of bills intended to enable the enact- ment of the June 20,1997, multistate settlement agree- ment Tvere introduced into the U.S. Senate in late 1997 and earlv 1998. In March 1998, the Senate Commerce Cornmit;ee bill introduced bv Senator John McCain (R-AZ) became the focus oi all settlement-related legis1atiL.e activity in the Senate. The Commerce Committee endorsed a preliminary version of a sub- stitute bill, S. 1415, on March 30, 1998, bv a wrote of 19 to 1. On Ma\ 1, 1998, the Commerce Committee's \`el-- sion of the bill-S. 1115.IiS (the "McCain Committee Bill")--Mas reported by Senator McCain to the full Senate. Among other things, the McCain Committee Bill would have done the follo\ving: o Required the tobacco industry to pay $516 billion ($147.5 billion more than was specified in the June 20th multistate settlement agreement) over 25 years to help states and the federal government bear the medical costs of smoking-related illness. o Raised cigarette taxes by $1.10 per pack over five years. . Preserved the FDA's ability to regulate the tobacco industry in ways that the June 20th agree- ment did not. o Drastically reduced cigarette marketing, advertis- ing, and promotion (Kelder 199X). In addition, the Floor Manager's Amendment to the bill would have established a detailed regulatory scheme to be administered by the FDA (S. 1415.RS [Floor Manager's Amendment of May 18, 1998, 105th Cong., 2nd Sess.]). First, the FDA could designate de- monstrablv safer products as "reduced risk tobacco products": The category "state" includes the District of Columbia. Source: National Cancer Institute, State Cancer Legislative Database, unpublished data, August 31, 1998. regulate smoking in restaurants; ot these, onlv Utah and Vermont completely prohibit smoking in restau- rants, and California requires either no smoking or separate \.entiIation for smoking areas (CDC, Office on Smoking and Health, State Tobacco Acti\,ities EL-aluation System, unpublished data). In 1991, Maryland proposed a regulation that lvould prohibit smoking in most \vorkpIaces in the state, including restaurants and bars (M~7ryl17111l Rqi~fcr 1991). Despite strong support among both nonsmohers and smokers for restrictions on public smoking in the state (Shopland et al. lYY5), this proposal bias aggressi\.ely challenged bv the tobacco industrv (Spavd lY94), \vhich questioned the state's legal authoi-it! to.regulate smok- ing through administrati\.e rule rather than la!\. [n earl\, 1995, the original regulation It-as modified by Iegisld- tive action to permit some esceptions for the hospital- itv industry, and the rules ivent into effect. In October 1491, the state of Washington also enacted an ektensi\.c indoor Ivorkplace ban. In this instance, a temporar>, injunction \vas dismissed b\, the state court, and the ban event into effect \vithout litigation (CSH lYY4b). In North Carolina, legislation Ivas enacted on Jul\ 15, lYY3 (HB 9571, that required that smoking be per- mitted in at least 20 percent of space in state-controlled buildings but also formally required nonsmoking areas. An important preemption clause prohibited local regulatory boards from enacting more restrictive regulations for public or pri\,ate buildings after Octo- ber 15,1993. During that three-month "ivindn\v of op- portunity," 89 local agencies passed nei2' measures providing some increased protection from ETS. De- spite the rush to ne\v restrictions, researchers estimated that bv the year 2000, the preemption \~ould prevent 39 percent of priorate emplovees in North Carolina from being protected from ETS iConlisk et al. 1995). Local Ordillaiices The modern era of local ordinances for clean in- door air began in the early 1970s (Pertschuk 1993). In 1977, Berkeley, California, became the first community to limit smoking in restaurants and other public places (Table 5.1). After the release of the 1986 Surgeon General's report on the health consequences of ETS, the rate of passage of local ordinances accelerated (Figure 3.3). Bv 1988, nearlv 400 local ordinances to restrict smokini had been enacted throughout the United States (Pertschuk and Shopland 1989). The trend toward smoke-free local ordinances has accelerated since 1989 (Rigotti and Pashos 1991; Pertschuk 1993). As of June 30, 1998, public smoking \vas restricted or banned in 820 local ordinances. Of those that specified \vhich agency was responsible for enforcement, 44 percent cited health departments or boards of health, 19 percent named city managers, 3 percent said police departments, and 6 percent identified other agencies (Americans for Nonsmokers' Rights, unpublished data, June 30, 1998). The effectiveness of various enforcement mechanisms and the Ie\rel of compliance achieved are not known. Data from Wisconsin suggest that implementation may be just as important as legislation in achieving policy goals (Nordstrom and DeStefano 1995). One study examined the impact a local ordinance had on restaurant receipts (CDC 1995a). Contrary to some prior claims, an analysis of restaurant sales after a ban on smoking in this community (a small suburb of Austin, Texas) showed no ad\,erse economic effect. In a series of ecologic analyses, Glantz and Smith (1994, 1997) analyzed the effect of smoke-free restaurant and bar ordinances on sales tax receipts. Over time, such ordinances had no effect on the fraction of total retail sales that [Vent to eatin g and drinking places. The authors asserted that claims of economic hardship for restaurants and bars that establish smoke-free policies ha\.e not been substantiated. Private Sector Restrictions on Smoking in Workplaces T\VO national data sets are available to ascertain the level of workplace smoking restrictions among pri- vate firms in the United States. A survey conducted by the Bureau of National Affairs, Inc. (19911, estimated that 85 percent of large workplaces had policies restricting smoking. The percentage of smoke-free \vorkplaces has increased dramatically, from 2 percent in 1986 to 7 percent in 1987 and to 34 percent in 1991. Similarly, data from the 1992 National Survey of Worksite Health Promotion Activities indicated that 87 percent of workplaces with 50 or more employees regu- lated smoking in some manner and that 34 percent were smoke free (USDHHS 1993). The 1995 Update of the Business Responds to AIDS Benchmark Survey con- ducted by CDC also found that 87 percent of worksites with 50 or more employees had a smoking policy of some kind (National Center for Health Statistics 1997). The prevalence of smoking policies in small \vorkplaces, tvhere the majority of Americans work, is less \velI studied. A comprehensive examination of workplace smoking policies from the NCI's tobacco use supplement to the Current Population Survey (n = 100,561) indicated that most indoor workers sur- vexed (81.6 percent) reported that an official policy go;,erned smoking at their \vorkplaces, and nearly half reported that the policy could be classified as "smoke-free"-that is, that smoking XVL?S not permit- ted either in ivorkplace areas or in common public- use areas (Gerlach 1997). This proportion \.aried by sex, age, ethnicity, and occupation: blue-collar and service occupations had significantly less access to smoke-free environments. Though data Ivere not spe- cifically reported by wrorkplace size, the range of occu- pations suggests that the survey included a substantial proportion of persons who M'ork in smaller workplace environments. But for all workplace sizes, the data suggest that access to smoke-free environments could be substantially improved. Effectiveness of Clean Indoor Air Restrictions Although it is generally accepted that regulatory changes influence nonsmokers' exposure to ETS and smokers' behavior, relativelv felt eifaluation studies quantify these effects o\,er- time. Evaluating such changes is hampered bv the complex interaction of social forces that shape behavior, bv the decline in smoking and smoke exposure in the overall popula- tion, and by the overlapping effects of concomitant regulatorv policies (e.g., a new law for clean indoor air passed at or around the time of an increase in the cigarette excise tax). Controlling for such potential confounding factors in studies is difficult. Population-Based Studies Efiects 011 Nonsmokers' Exposure to ETS Despite the widespread implementation of re- strictions against public smoking, few population- based studies have examined whether these restrictions have reduced nonsmokers' exposure to ETS. One such study from California used data col- lected in 1YYO and 1991 to examine the association be- tween the strength of local ordinances for clean indoor air and cross-sectional data on nonsmokers' exposure to ETS in the workplace (Pierce et al. lY94b). Expo- sure to ETS in the workplace ranged from 25 percent of workplaces in areas with a strong local ordinance to 35 percent in areas with no local ordinance. Figure 5.3. Cumulative number of local laws and amendments enacted for clean indoor air, 1979-1998 1487 1989 19Yl lY93 1995 1997 Year IV&c: Ordinances must specifically mention these locations to be counted. Therefore, other ordinances may cover these areas without being included in these figures. *Before 1983, there were four lvorkplace ordinances: one passed in 1975, one in 1979, and two in 1980. These are not included in this chart, because data for consecutive years only became available beginning in 1983 for workplaces. Source: American Nonsmokers' Rights Foundation, unpublished data, June 30, 1998. In measuring the impact of a state\\ide law for clean indoor air, researchers in Missouri examined self- reported data on EPS exposure from 1 YYO through 1993 (Brownson et al. 199%). Nonsmokers' exposure to ETS in the workplace declined slightly the vear the la\~ \~as passed and substantiallv more after the la\2 [vent into effect. Exposure to ETS in the home remained con- stant o\.er the stud\, period; this finding suggests that the declining ivorkplace exposure \vas more likelv linked to the smoking regulations than to the nl.erajl declining smoking pre\.alence obser\-ed during the study period. Despite improvements o\~er time, ETS exposure in the ivorkplace remained at 35 percent in the final vear of the stud\, (1993). Other data from California indicate that nonsmokers employed in w,orkplaces \lith no policy or a polic!, not co\.ering their part of the \i-orkplace \vere eight times more likel) to be exposed to ETS (at \2-ark) than those employed in smoke-free tvorkplaces (Borland et al. 1992). Attitudes Toward Restrictions and Bnrzs Studies ofalrareness and attitudes toivard Ivork- place smoking restrictions and bans hat-e been cow ducted in cross-sectional samples of the general population and among employees affected b!; bans. In a 1989 survey of 10 U.S. communities, most respon- dents favored smoking restrictions or smoke-free environments in all locations, including rzorkplaces, government buildings, restaurants, hospitals, and bars (CDC 1991). Although support for smoking restric- tions was higher among nonsmokers, across the 10 communities, 82-100 percent of smokers fairored re- strictions on smoking in public places. Support \vas highest for smoking bans in indoor sports arenas, hos- pitals, and doctors' offices. A 1993 survey from eight states showed greater support for ending smoking in fast-food restaurants and at indoor sporting e\-ents than in traditional restaurants and indoor shopping malls (CDC 1994a). Support for proposed changes may differ from support for actual, implemented changes. yet in stud- ies of smoke-free hospitals, patients, emplovees, and physicians have overwhelminglv supported ihe policv (Rigotti et al. 1986; Becker et al: 1989; Hudzinski ana Frohlich 1990; Baile et al. 1991; Offord et al. 1992). In some instances, a majority of smokers support a smoke-free hospital (Becker et al. 1989). Studies of smoking restrictions and bans in other industries also have found that nonsmokers overwhelmingly favor smoke-free workplaces (Petersen et al. 1988; Borland et al. 1990b; Gottlieb et al. 1990; Sorensen et al. 1991b). Time-and consequent habituation-can make changes more acceptable. In a prospective study of a smoking ban in a large workplace, Borland and colleagues (1990b) found that attitudes of both non- smokers and smokers toward the smoke-free work- place rzere more favorable six months after such a policy ivas implemented. Although most smokers re- ported being inconvenienced, they also reported that they recognized the overall benefits of the policy. Two studies from Massachusetts found that one and two vears after t\vo local 1aM.s for clean indoor air were enacted, 65 percent of the businesses surveyed favored the la\y (Rigotti et al. 1992, 1994). The authors con- cluded that a self-enforcement approach achieved high le\,els of abvareness (about 75 percent) and intermedi- ate levels of compliance (about 50 percent) (Rigotti et al. 199-l). Effects of Restrictiorls ad Bans OH Nousmokers' Exposure to ET5 As has been found in population-based research, studies conducted in individual workplaces have found that smoke-free lvorkplaces have been effective in reducing nonsmokers' exposure to ETS. Effective- ness has been measured bv the perceived change in air quality in the workplace after a smoke-free policy \vas instituted (Biener et al. 1989; Gottlieb et al. 1990) and hy measurement of nicotine vapor before and af- ter such a policy (Stillman et al. 1990). Conversely, Ivorkplace policies that allow smoking in designated areas without separate ventilation result in substan- tial exposure to ETS for nonsmokers (Repace 1994). An analysis of the effects of a smoke-free ivorkplace in The Johns Hopkins Medical Institutions found that concentrations of nicotine vapor had de- clined in all areas except restrooms at one to eight months after the ban (Stillman et al. 1990). In most areas, nicotine concentrations after the ban were be- loll- the detectable level of 0.24 pg/m'. Effects of Restrictions on Smoking Behavior An additional benefit from regulations for clean indoor air may be a reduction in smoking prevalence among workers and the general public. For example, in a multivariate analysis, moderate or extensive laws for clean indoor air were associated with a lower smok- ing prevalence and a higher proportion of quitters (Emont et al. 1993). Another study also found an as- sociation between local smoking restrictions and smok- ing preiralence (Rigotti and Pashos 1991). SUP~YUI G~ik~hii'. /L~jkvr .Y Table 5.2. Summary of studies on the effects of a smoke-free workplace on smoking behavior Authors/year Location AndreIvs 1983 Boston, Massachusetts Rigotti et al. 1986 Boston, Massachusetts Industry Hospital Hospital pediatric unit Sample size 965 93 Rosenstock et al. 1986 Puget Sound. Washington Petersen et al. 1988 Becker et al. 1989 Biener et al. 1989 Scott and Gerberich 1989 Borland et al. 199Ob Connecticut Baltimore, Maryland I'ro\.idencc, Rhode Island Midlvestern United States Australia Health maintenance organization Insurance company Children's hospital Hospital Insurance company Public service Centers for Disease Control 1YYOc Gottlieb et al. lY90 Pueblo, Colorado Psychiatric hospital 1,032 Government agency Hudzinski and Frohlich 19`~O Stillman et al. 1990 Baile et al. 1941 Borland et al. 1991 Ne\v Orleans, Louisiana Baltimore, .Llar~~land Tampa, Florida ,Austrnlia Sorensen et al. 1YYla Hospital Hospital Hospital Telecommunicatiolis companv Telephone company Brenner and lLIielck 1992 Goldstein et al. 1992 Augusta, Georgia National random sample Hospital Offord et al. lYY2 Wakefield et al. 1992b Rochester, Minnesota Hospital Australia Representative sample Jefferv et al. 1994 Minneapolis-St. Paul, Minnesota Diverse Lvorksites 447 1,210 704 535 452 2,113 1,158 1,946 2,877 349 620 1,120 439 1,997 10,579 1,929 32 worksites; total number of individuals not reported Change in individual or overall smokers' consumption Change in prevalence Not reported -8.5% at 20 months follow-up -2.3 cigarettes per shift (I' < 0.01) at 12 months folloiv-up; no change in No significant change o\rerall consumption -2.0 cigarettes per day (I' < 0.003) at 4 months follow-up No significant change -5.6 cigarettes per day at 12 months follo~v-up No change at 6 months follow-up 1.6'; at 13 months follokv-up -1.2'yr at 6 months follow-up -3.9 cigarettes per day at lvork at 12 months follo~r-up 22.5';; of smokers decreased consumption at 7 months follo\v-up No significant change -5.1 ?ir at 7 months follow-up -7.9 cigarettes per day in smokers ot 25 or more cigarettes per da\. at 6 months follow-up -1 .O'Z at 6 months follow-up -3.5 cigarettes per day at lvork at 13 months folio\\--up; -1.8 cigarettes per day over 24 hours -4.0% at 13 months follow-up 12.0% reduction in consumption of 15 or more cigarettes per day at lvork at 6 months follolv-up (I' < 0.001) -3.4% at 6 months follow-up 25% of smokers no longer smoked at work at 12 months follo\v-up -3.3 cigarettes per day at 6 months follorv-up (I' = 0.0001) Not reported -5.5'; at 6 months follow-up 407 of smokers decreased consumption at 4 months follow-up -3.5 cigarettes per day at 18 months follow-up (I' < 0.05) -1.5% at 4 months follow-up -3.1% at 18 months follow-up Not reported 21% of smokers quit at 20 months follow-up -1.8 cigarettes per day in men, -1.4 cigarettes per day in women Cessation proportion of 30% 57% of smokers reported they had cut down on number of cigarettes smoked Not reported 9% of smokers stated they had quit because of the ban -2.9% at 30 months follow-up -5 cigarettes per day on workdays vs. leisure days Not reported -1.2 cigarettes per day -20 at 24 months follow-up In recent !.cars, researchers ha1.e increasingly recognized the role of the enr-ironment' in influencing indi\-idual smoking behavior through perceived cues (NC1 1991; McKinlay 1993; Brownson et al. 1995b), many of xvhich ha1.e their origins in generally held rules about acceptable beha\,iors (i.e., social norms) (Robertson 1977). Smokers frequently respond to environmental cues when deciding kvhether to smoke at a given time (NC1 1991). For example, a smoker may recei\,e a per- sonal, habit-deri\.ed cue to smoke after a meal or on a Iyork break, but this cue may be \2-eakened (and even- tually even canceled) by a social, policy-derived cue not to smoke if the person is in a smoke-tree restaurant or worksite (Brownson et al. lY95b). Numerous studies have assessed the potential effects of workplace smoking bans on employee smoking behavior (Table 5.2). These studies have been conducted in health care settings (Andrekvs 1983; Rigotti et al. 1986; Rosenstock et al. 1986; Becker et al. 1989; Biener et al. 1989; CDC 1990~; Hudzinski and Frohlich 1990; Stillman et al. 1990; Baile et al. 1991; Goldstein et al. 1992; Offord et al. lY92), government agencies (Gottlieb et al. 19YO), insurance companies (Petersen et al. 1988; Scott and Gerberich lY8Y), and telecommunications companies (Borland et al. 1991; Sorensen et al. 1991a) and among random samples of the working population (Brenner and Mielck 1992; Wakefield et al. 1992b). Most of the studies based in hospitals or health maintenance organizations that banned smoking found a decrease in the average num- ber of cigarettes smoked per day. Se\.eral of the has- pita1 studies found significant declines in the overall prevalence of smoking among employees at 6-20 months follow-up (Andrelvs 1983; Stillman et al. 1990). Studies of smoking behavior in other industries ha\,c found similar results; in most settings, daily consump- tion, overall smoking pre\,alence, or both had de- creased at 6-20 months after \vorkplaces were made smoke free. In a population-based study of California resi- dents, the prevalence of smoking \vas 14 percent in smoke-free \vorkplaces and 21 percent in rzrorkplaces with no smoking restrictions (Woodruff et al. 1993). Consumption among continuing smokers eras also lower in smoke-free bvorkplaces, and the percentage of smokers contemplating quitting was higher. In 1992, Patten and colleagues (1995,) follo\ved up a large sample of persons (first inter\,ie\ved in 1990) to deter- mine the influences a change in lvorksite setting might have had on smoking. These researchers observed a statistically nonsignificant increase in smoking `The term "en\.ironment" is detincd Ivoaill!- to Include the Itpi, wcidl, tvmnorllii, dn~l ph\3ical en\ ircwmtwt (Clleadk et dl. 1 W.2). prevalence among the group that changed from a smoke-free fvorkplace to one at which smoking was permitted. The prevalence of smoking among other groups was unchanged or had declined. Although these results are tentative, particularly in view of sam- pling difficulties during the follow-up interview, they signal the potential impact workplace policies can have on smoking behavior. Case Studies of State and Local Smoking Restrictions Recent reviews have presented case studies on the passage of state and local laws for clean indoor air (Samuels and Glantz 1991; Fourkas 1992; Jacobson et al. 1992; Traynor et al. 1993). These studies describe the issues that states and local communities dealt with in enacting smoking restrictions in public places. In a case study of six states, the ability of key leg- islators to support legislation and the existence of an organized smoking prevention coalition were key de- terminants of lz.hether statewide legislation was en- acted for clean indoor air (Jacobson et al. 1992). Although the enactment of such legislation was not waranteed when these factors were favorable, enact- 0 ment \vas unlikely when they were unfavorable. Two other factors \vere cited as key in enacting legislation in the six states studied: an active executive branch that pressured the legislature to act, especially by mak- ing such legislation an executive policy priority, and existing local ordinances that created a policy environ- ment favorable to the enactment of statewide smok- ing restrictions. The study found that coalitions that succeeded in enacting legislation to restrict smoking in public places featured organized commitment, including both a full-time staff and a professional lobbyist. Success- ful coalitions also had established close working rela- tionships M.ith key legislative sponsors to develop appropriate policy alternatives and to coordinate leg- islative strategy. Finally, effective coalitions used me- dia and grassroots campaigns to mobilize public sr~pport for smoking restrictions. Another important component in the legislativ-e debate was how the issue of smoking restrictions was framed. In all six states reviewed, the tobacco industry tried to shift the focus from the credibility of the scien- tific evidence on the health hazards of ETS to the con- troversial social issue of personal freedom; specifically, the industry lobbied extensively for including nondis- crimination clauses in legislation to restrict smoking (Malouff et al. 1993). Another common strategy that the tobacco industry has used is to support the pas- sage oi state la\ys that preempt more stringent local ordinances (Brolvnson et al. 1993b). Because of the possible countereffect of preemp- tive legislation and because of the difficulty in enact- ing statelyide legislation, public health ad\rocates have suggested that advocates for reducing tobacco use should devote more resources to enacting local ordinances (Samuels and Glantz 1991; Fourkas 1992; Minors' Access to Tobacco Jacobson et al. 1992). A local strategy can usually im- pose more stringent smoking restrictions than state- M,ide legislation does. Like the study of Jacobson and colleagues (1992) on statewide initiatives, a study of local initiati\res found that two key ingredients for success ivere the presence of a strong smoking pre- \,ention coalition and sympathetic political leadership Ii-ithin the elected body (Samuels and Glantz 1991). Introduction Minors' access to tobacco products is an area of regulation relativelv free from the social and legal de- bate that often arises from other regulatory efforts. E\.en the staunchest opponents of reducing tobacco use concede that tobacco use should be limited to adults and that retailers should not sell tobacco products to children and adolescents. \r'et as \vas discussed in de- tail in the Surgeon General's report on smoking among young people, a significant number of minors use to- bacco, and a significant number of them obtain their tobacco through retail and promotional transactions, just as adults do (USDHHS 199-l; CDC 1996a,b; Kann et al. 1998). Whether intended exclusi\,elv for adults or not, these commercial transactions are supported bv vast resources. The multibillion-dollar tobacco in- d&try spends a large proportion of its marketing dol- lars to support a vast network of wholesale and retail activity. In 1997, cigarette makers spent $2.44 billion on promotional allo\vances to the wholesale and re- tail trade and an additional $1.52 billion on coupons and retail value-added promotions (FTC 1999). These figures were 42 percent and 26 percent, respectively, of the entire $5.1 billion spent on advertising and pro- moting cigarettes in the United States that year. In general, the availability of cigarettes to the adult population has not been a regulatory issue since the first quarter of the 20th century (see Chapter 21, although recent FDA statements about nicotine levels in cigarettes have raised the possibility of some regu- lation of adult use (see "Further Regulatory Steps," earlier in this chapter). The primarv regulatorv focus for cigarette access has been on reducing the'sale of tobacco products to minors (Forster et al. 1989; Hoppock and Houston 1990; Thomson and Toffler 1900; Altman et al. 1992; CDC 1992a; Cummings et al. 1 c)92; F~~fcrn/ RL's~s~P~ 1993, 1996). Broad-based public support for limiting minors' access to tobacco has de- \,eloped in the relatively brief time (since the mid- 1980s) that this issue has been in the public eye (DiFranza et al. 1987, 1996; CDC 1990a,b,c, 1993a, lYY-la, 1996a,d; Jason et al. 1991; Hinds 1992; Keay et al. 1993; Landrine et al. 1994, 1996; USDHHS 1994). Reducing the commercial availability of tobacco to minors is a potential avenue for reducing adoles- cent use. Groiying evidence suggests that tobacco products are widely available to minors. Uniformly, surveys find that teenagers believe they can easily obtain cigarettes (see, for example, Forster et al. 1989; Johnston et al. 1992; CDC 1996a; Cummings et al. 1998; University of Michigan 1999). As noted, this access is by no means confined to borrowing cigarettes from peers or adults or stealing them at home or from stores; purchase from commercial outlets is an important source for minors who use tobacco. An estimated 255 million packs of cigarettes were illegally sold to mi- nors in 1991 (Cummings et al. 1994), and daily smok- ers aged 12-17 vears smoked an estimated 924 million packs of cigarettes in 1997 (DiFranza and Librett 1999). Be&Teen 20 and 70 percent of teenagers who smoke report purchasing their own tobacco; the proportion \,aries by age, social class, amount smoked, and fac- tors related to availability (Forster et al. 1989; Response Research, Incorporated 1989; CDC 1992a, 1996a,d; Cummings et al. 1992, 1998; Cummings and Coogan 1992-93; Mark Wolfson, Ami J. Claxton, David M. Murray, and Jean L. Forster, Socioeconomic status and adolescent tobacco use: the role of differential avail- ability, unpuL7lished data). In a re\,iew of 13 local o\er-the-counter access studies published betivern 1987 and 1993, illegal sales to minors ranged from 32 to 87 percent Gtli dn approximate r\.eiglited-a\.erage of 67 percent. Several local studies published in 1996 and 1997 found somewhat lolver over-the-counter sales rates to minors: 22 percent (Klonoff et al. 1997) and 2Y percent (CDC 1996) in twro separate studies in California and 33 percent in Massachusetts (DiFranza et al. 1996). Nine studies of vending machine sales to minors published between 1989 and 1992 found ille- gal \.ending machine sales ranging from 82 to 100 per- cent Lvith an approximate ueighted-average of 88 percent (USDHHS 1994). Comparison of the results of these research studies lyith the results of later statewide Synar surveys (see below) is problematic for four reasons: (1) the research studies M'ere generally local surveys of a to\vn, city, or county, lvhereas the Synar surveys are based on statewide samples; (2) the sam- pling methods vary across the research studies; (3) store inspection methodologies \.arv; and (4) some of the research studies contain results of se\.eral surveys, often pre- and post-intervention (CSDHHS 1998a). Several factors suggest that rvidespread reduc- tion in commercial a\-ailability may result in reduced prevalence or delayed onset of tobacco use by young people: the reported importance of commercial sources to minors, the easv commercial availabilitv that has been demonstrat&, and the reductions in commercial a\,ailability demonstrated \vhen legal re- strictions have been tightened, as outlined belo\y (Ja- son et al. 1991; DiFranza etal. 1992; Hinds 1992; Forster et al. 1998). One psychological study supports the po- tential impact of limiting minors' access to cigarettes (Robinson et al. 1997). In this investigation of 6,967 seventh graders of mixed ethnicit, the best predictor of experimentation lvith cigarettes \j'as the perception of easv availability. Regular smoking \vas hea\.ilv in- fluenced by cost (see Chapter 6). Direct studies of factors that influencs minors' access bar-e produced mixed results, ho\l.e\rer. Set.- era1 investigators found that state lairs on minimum age for purchasing tobacco products did not bv them- selves ha1.e a significant effect on cigarette smoking among youth (Wasserman et al. 1991; Chaloupka and Grossman 1996). Other studies ha\,e pro\.ided el.i- dfnce in single communities (~~ithout comparison groups) that compliance lvith youth access regulations does lead to reductions in regular smoking by adoles- cents (Jason et al. 1491; DiFranza et al. 1992). In a nonrandoniired, controlled community trial (three intervention and three control communities), Rigotti and colleagues (lY97) found that although illegal sales rates to minors decreased significantlv more in the control communities than in the intervention commu- nities, there was no difference between control and intervention communities in either self-reported access to tobacco from commercial sources or in smok- ing behavior among youth. The authors suggest that illegal sales rates were not reduced sufficiently in the intervention communities to cause a decrease in com- mercial access that was substantial enough to impact youth smoking. Noting that these studies were lim- ited by their scope or sample size, Chaloupka and Facula (1998) analyzed data from the 1994 Monitor- ing the Future surveys on 37,217 youths. Using per- sonal and ecologic variables in a two-part multivariate model to estimate cigarette demand by youth and av- erage daily cigarette consumption, the investigators found thatadolescents are less likely to smoke and that those who smoke consume fewer cigarettes in the fol- lowing settings: where prices are higher, in states that use cigarette excise tax revenues for tobacco control activities, where there are stronger restrictions on smoking in public places, and in states that have adopted comprehensive approaches to measuring re- tailer compliance \vith youth access laws. The authors concluded that comprehensive approaches, including enforcement of minors' access laws, will lead to a re- duction in youth smoking. A large, community-based clinical trial-seven intervention and seven control communities-also found an intervention effect (Forster et al. 1998). In this study, communities that developed ne\v ordinances, changes in merchant poli- cies and practices, and changes in enforcement prac- tices experienced a significantly smaller increase in adolescent smoking than did the control communities. Further exploration of this issue may be required to substantiate the impact of the enforcement of minors' access 1acz.s. As commercial sales to minors are decreased, there is e\.idence that minors may shift their attempts to obtain cigarettes to "social" sources, e.g., other ado- lescents, parents, or older friends (Hinds 1992; Forster et al. 1998). One study found that adult smokers aged 18 and 19 years were the most likely group of adults to be asked by a minor for cigarettes (Ribisl1999). This study did not assess how frequently minors asked other minors for tobacco. There is also evidence, how- ever, that minors who provide tobacco to other minors are more likelv to purchase tobacco than other minors w,ho smoke (Wolfson 19971, and in any event, some of the cigarettes provided by minors to other minors were initiallv purchased from commercial sources (Forster et al. 1997). Whether the source is social or commer- cial, it is clear that a comprehensive approach to re- ducing minors' access is needed; smokers of all ages in addition to tobacco retailers must a\.oid pro\isio:l of tobacco to minors. Efforts to Promote Adoption and Enforcement of Minors' Access Laws Public organizations at the federal, state, and lo- cal levels ha1.e become acti1.e in encouragin;: state and local jurisdictions to adopt and enforce minors' access la\vs. The NCI-ACS collaboration knnlvn as ASSIST (American Stop Smoking Inter\.ention Stud)-) has iden- tified reducing minors' access to tobacco products ai one of its goals for its 17 demonstration states;. The Robert Wood Johnson Foundation's SmokeLess States program also encourages funded states to address minors' access. The USDHHS has ividel\- distributed a model state la\v as a result of an in\.estijiation b\, the Office of Inspector General (OIG) reporting little Or nc) cnforcenient of state lalvs on minimum ages for tw bacco sales (OlG 1990; USDHHS IYYO). C;,vi~~iii~~ C//J ~TOhiiO Flw: fIl'i'i'llt;il~~ h'iiclfi,lc' ~4tftfiitrc~ri iri C/lilifJl~~l ,711~j \i)llf/2, a report from the Institute ot Mcdicint~ (IOM), includes an estensil e study of minors' access and a series of recommendations about state and local lalvs in this area (Lynch and Bonnie 1991). A group of 75 state attorneys ieneral formed a Ivorking group on the issue and released a set of recommendations re- garding retail sales practices and legislation aimed at reducing tobacco sales to minors (Working Group of State Attorneys General 1991). Efforts to curb illegal sales to minors ha1.e also occurred at the federal level. The former FDA pro- gram (see description in Chapter 7) Leas a major effort for several years. Probably the most sustained and tvidespread attention to the issue of minors' access lairs and their enforcement \vas precipitated by the C.S. Congress, lvhich in 1992 adopted the Sonar Amendment as part of the Alcohol, Drug Abust; and h;lental Health Administration Reorganization Act (Public La\v 102-321, sec. 1926), lvhich amended the public Health Service Act. This provision requires states (at the risk of forfeiting federal block grant funds for substance abuse pre\w~tion and treatment) to adopt laws establishing minimum ages for tobacco sales, to enforce the law, and to sholv progressi1.e reductions in the retail availabilitv of tobacco products to minors. The implementation df the Synar Amendment, l,vhich initiallv was to go into effect during fiscal year 1991, leas delayed because regulations about how states Lvere to i&plement the statute had not yet been final- ized. During the considerable lag betw.een passage of the amendment and the issuance of final regulations, advocates for Synar-like restriction of youth smoking and those opposed to the Synar approach used the draft regulations to encourage states to adopt laws that in these parties' differing viekvs M'ere the minimum necessar\ for states to comply tvith the Synar Amend- ment (P:l~~fw~/ Rqi.r a re\ie\v of comments from the health commu- nit\,, state agencies, and the tobacco industry. Respon- sibilit,, for im~~lement~~tion was placed with the Substance Abuse and Mental Health Services Admin- istration (SXMHSA), ivhich in the course of 1996 con- ducted t\z.o technical assistance meetings with states and issut>d three separate guidance documents. Un- der these regulations, the Synar Amendment requires the 50 states, the District of Columbia, and U.S. juris- dictions to do the follo\ving: Ha1.r in effect a lalz prohibiting any manufacturer, retailer, or distributor of tobacco products from sell- ing or distributing such products to any person under the age of 18. Enforce such Iaivs in a manner that can be reason- able expected to reduce the extent to which tobacco pr&ucts are available to persons under the age of 18. Conduct annual random, unannounced inspections to ensure compliance with the law; inspections are to be conducted to pro\ride a valid sampling of out- lets accessible to underaged youth. De\-elop a strategy and time frame for achieving an inspection failure rate of less than 20 percent among outlets accessible to underaged youth. Submit an annual report detailing the state's ac- ti\,ities in enforcing the late, the success achieved, methods used, and plans for future enforcement. III the event ot noncompliance with these regu- lations, the Secretary of Health and Human Services is directed bv statute (42 U.S.C. section 300X-26[c]) to mal\c reducvti~,ns of from 10 percent (for the first applicable fiscal year) to 40 percent (for the fourth applicable fiscal \,ear) in the noncompliant state's fed- eral block grant for substance dhse programs. Al- though no additional monies ha\,e been appropriated to offset the costs of complying \\,ith these regulations, states mav use block grant funds for certain Synar- related administrative activities, such as developing and maintaining a list of retail outlets, designing the sampling methodology, conducting Synar survev in- . spections, and analyzing the sur\`ey results. In the several years following the issuance of the final Synar regulation, some significant advances have been made in enforcement of youth access laws. All states have laws prohibiting sale or distribution and they are enforcing those laws (USDHHS 1998a). Fur- ther, the median rate at which retailers failed to com- ply with laws prohibiting tobacco sales to minors in 1998 was 24.4 percent compared Ivith the median rate of 40 percent in 1997 and pre-1997 studies that found violation rates ranging from 60 to 90 percent (LSDHHS, in press). In the course of implementing Synar, every state has been required to establish a sam- pling methodology that measures the statewide retailer \,iolation rate lvithin a known confidence inter\.al and to establish inspection protocols for conducting the statelride sur\rey of tobacco retailers. These protocols include restrictions on the ages of minor inspectors and to establish procedures for recruiting and training of both minor inspectors and adult escorts. Addition- ally, the random, unannounced inspections conducted by the states in compliance M'ith the Synar regulation provide the largest body of stateivide data available on the level of retailer noncompliance. Tlventy-tw.0 states and tLt-0 U.S. jurisdictions modified their vouth access lairs iz.ithin a vear of implementing Synar inspections. These changes im- proved the states' ability to enforce the 1~71~ by clarify- ing responsibilitv for enforcement, defining violations, clarifying penalties, restricting vending machine sales, and establishing a list of tobacco vendors through re- tail licensure or vendor registration (USDHHS, in press). In spite of these acl\.ances in enforcement of youth access larvs, states also encountered difficulties while attempting to comply bsith the Svnar mandate. The Synar regulation does not allow fo; the allocation of federal dollars (e.g., the Substance Abuse Preven- tion and Treatment Block Grant) to be used for enforce- ment. For many states, this proved to be a significant problem, because enforcement of youth access laws had not been previouslv vielved as a priority, and states M'ere unwilling to redjrect already limited funds for prevention and treatment services to IaM enforcement. Some states addressed the problem by earmarking re\.enue derived from fines, fees, or taxes. Other states implemented collaborative enforcement efforts among several agencies so that the financial burden would be shared. And still other states relied heavily on the use of volunteer youth inspectors and adult escorts (USDHHS lYY8a). As the FDA became active in the youth access issue, a few states were able to use FDA funding for enforcement to cover some of the cost of Synar inspections in 1998. Another obstacle to enforcement involved devel- oping a valid random sample of tobacco outlets in the state when there was no accurate or current list of ven- dors available. Although a few states addressed this problem by working to pass retailer licensing laws at the state level, states initially had to build lists by rely- ing on information from wholesale tobacco distribu- tors and vending machine distributors and by searching existing lists that inadvertently identify to- bacco vendors (e.g., convenience store association membership lists) (USDHHS 1999). Other less frequently cited obstacles to enforcc- ment included fear of lawsuits from cited vendors, concerns \2-ith the liability issues associated with work- ing nith vouth, and opposition to conductingenforce- ment from state and local officials, law enforcement, and the general public in regions of the country where the economy is tied to the production of tobacco (USDHHS 1999). In addition to federal and state efforts targeting illegal tobacco sales to minors, a great amount of local activity has occurred. Many local ordinances have re- sulted from the lvork of various groups, particularly in California, Massachusetts, and Minnesota (DiFranza 1994a,b; Kropp 1995; Forster et al. 1996, 1998). These ordinances-which may, for example, prohibit vend- ing machine sales or all self-service sales of tobacco, require the tobacco sellers to be aged 18 years or older, require checking identification before sale, specify civil penalties for violators of the minimum-age law, require posting that law at the point of purchase, and require compliance checks with a specified timetable-permit creatilre responses at the local level to the minors' ac- cess problem. Compared with state officials, local of- ficials deal with fewer retailers and a more limited set of constraints and are freer to tailor their policy to lo- cal conditions. Tobacco interests are less influential at the local level, because industry representatives are more likely to be perceived as outsiders, and their cam- paign contributions are less likely to be important to local officials; moreover, community members and local advocacy groups are often more effective against tobacco interests at this level than they are in statewide policy arenas (Sylvester 1989). Policy implementation is also likely to be more consistent at the local le\rel, be- cause local advocates can monitor the process and be- cause enforcement officials are more likely to 1~ax.e been a part of the policy's adoption. Ho\ve\.er, many of the policies at the federal, state, and local le\rels are inter- related: the federal Synar Amendment is implemented through state lalvs and has led to enforcement at the state and local level (USDHHS 1998a). The former FDA enforcement program operated through contracts \vith state agencies or organizations to conduct compliance checks in communities across the states. State agen- cies often fund local coalitions and projects, and local efforts influence and support efforts at the state le\.el. For example, much of the local activity in California and Massachusetts ~\rould not 1~aL.e been possible \\-ithout actions implemented at the state level, spe- cifically designated funding. LaM-s enacted bv states pertaining to minors ac- cess to tobacco as oi December 31, 1999, ha\ e been compiled bv the CDC (CDC, Office on Smoking and f-Iealth, Sta;e Tobacco Activities Tracking and El-alua- tion System, unpublished data)(Table 5.3). Dates of enactment or amendment indicate that some legisla- ti\Te change occurred in all but one state from Januar\ 1990 to December 1997 (National Cancer Institute, Stati Cancer Legislative Database, unpublished data, Octo- ber 6, 1998). Restrictions on Distribution of Samples Tobacco product samples pro\.ide a lolv-cost or nn-cost initiation to their use and thus encourage ex- perimentation at early ages. Many states or other ju- risdictions have laws that prohibit not onlv sales but also any samples distribution of tobacco to minors, lvhereas some laws specify exceptions permitting par- ents or guardians to provide tobacco to their children. All states have a specific restriction on the distribu- tion of free samples to minors, and a fe\v states or lo- cal jurisdictions prohibit free distribution altogether because of the difficulty of controlling who receives these samples. A ban on product sample distribution can extend to coupons for free tobacco products. In Minnesota, the attorney general levied a $95,000 civil penalty against the Brown & Williamson Tobacco Cor- poration for allowing such coupons to be redeemed in the state (Minnesota Attorney General 1994). The re- ports from both the IOM (Lynch and Bonnie 1994) and the Working Group of State Attorneys General (1994) recommended a ban on the distribution of free tobacco products. The final FDA rules issued in August 1996 Tvould have prohibited the distribution of free samples (see "Further Regulatorv Steps," earlier in this chapter). The proposed multistate settlement pre- sumed congressional legislation that would uphold those rules (see "Legislative Developments" and "Mas- ter Settlement Agreement," earlier in this chapter). Regulation of Means of Sale Hobv tobacco can be sold may also be regulated to make it more difficult for minors to purchase it. His- toricallv, the first such restrictions adopted have been regulations of cigarette vending machines, which are an important source of cigarettes for younger smok- ers (Response Research, Incorporated 1989; Cummings et al. 1992, 1998; CDC 1996d). These regulations have taken the form of total bans, restrictions on placement (e.g., being \\sithin \,ielv of an employee instead of in coatrooms or entrances, or not being near candy or soda machines), restrictions on the types of businesses I\.here \-ending machines may be located (e.g., limited to liquor-licensed businesses, private businesses, or businesses lvhere minors are not permitted), and re- strictions on characteristics of the machines themselves (e.g., requiring electronic locking devices or coin slugs purchased over a sales counter) (Forster et al. 1992a; DiFranla et al. 1996). The final FDA rules would have prohibited vending machines except in certain night- clubs and other adults-only facilities totally inaccessible to persons under age 18. The proposed multistate settle- ment anticipated legislation supporting this prohibition. Forty-one states and the District of Columbia ha\.e lalvs that restrict minors' access to vending ma- chines, including two states, Idaho and Vermont, that ha\,e enacted legislation totally banning vending ma- chines. However, many of the state vending machine 1aMs are weak. For example, 21 states and the District of Columbia do not restrict placement if the machine is supervised, and Ne\v Jersey bans vending machines in schools only (CDC, Office-on Smoking and Health, unpublished data, 2000). However, more than 290 lo- cal jurisdictions, including New York City, have been able to adopt and enforce outright bans on cigarette vending machines or to severely restrict them to loca- tions, such as taverns, where minors are often excluded (American Nonsmokers' Rights Foundation, unpub- lished data, 2000). Representatives of tobacco manufacturers and retailers have strongly opposed bans on cigarette vend- ing machines and have argued instead for weaker re- strictions, if any, especially for what they term "adult" locations (Minnesota Automatic Merchandising Council 1987; Adkins 1989; Parsons 1989; Grow 1990; Moylan 1990; Pace 1990; Gitlin 1991). Many of these locations, including bars and other liquor-licensed Table 5.3. Provisions of state laws relating to minors' access to tobacco as of December 31,1999 Minimum age for tobacco State sales Tobacco Vending license machine required restrictions Alabama Alaska Arizona Arkansas California' 19 1Y 18 18 18 yes yes+ 110 yes 110 Colorado Connecticut' Delaware? District of Columbia Florida' 18 18 18 18 18 no yes+ yes yes+ ves Georgia Hawaii Idaho Illinois' Indiana' 18 18 18 18 18 yes 110 no no 110 Iowa' 18 Vt'S+ Kansas 18 vest Kentucky' 18 yes+ Louisiana' 18 yes Maine lti ves Maryland Massachusetts' Michigan' Minnesota Mississippi' 18 18 18 18 18 vest ves yes ves yes no yes yes yes yes ves Yes yes yes yes yes yes yes' yes yes ves ' yes yes yes ves no no VES ves yes Enforcement Sign-posting authority requirements* yes no no Yes no no Yes no Yes Yes Yes Yes Yes yes Yes yes yes no no'l' yes 110 Yes yes yes yes no yes yes 110 yes Yes yes yes no Yes yes no yes yes yes yes no yes yes ves no no no yes yes Prohibits purchase, possession, and/or use by minors Yes ye9 yes yes yes yes yes Yes no Yes yes yes yes yes yes yes yes yes yes** yes yes no yes-- yes yes"" *Refers to the requirement to post the minimum age for purchase of tobacco products. -Excludes chewing tobacco or snuff. TExcept minors at adult correctional facilities. `Some or all tobacco control legislation includes preemption. `Requires businesses that ha\-e vending machines to ensure that minors do not have access to the machines; however, the lall- does not specify the type of restriction, such as limited placement, locking device, or supervision. "Signage required for sale of tobacco accessories, but not for tobacco. **Except persons rvho are accompanied by a parent, spouse, or legal guardian 21 years of age or older or in a private residence. ++A pupil may not possess tobacco on school property. Source: Centers for Disease Control and Pre\.ention, Office on Smoking and Health, State Tobacco Activities Tracking and Elraluation System, unpublished data. Table 5.3. Continued State Missouri Montana' Nebraska Nevada' Ne\v Hampshire Ne\v Jersey' Ne\v Mexico' New, York' North Carolina' North Dakota Ohio Oklahoma' Oregon' Pennsyl\.ania' Rhode Island South Carolina' South Dakota' Tennesseei Texas Utah' Vermont Virginia' Washington' West Virginia' Wisconsin' Wvoming' Total Minimum age Tobacco Vending for tobacco license machine sales required restrictions 1X 18 IS 18 18 110 ves 18 18 18 18 18 vet; ves ves ves ves 18 18 18 18 1X no ves yes" ves 4i VeS WS' no ves *lO?C* i : \,t`S`" Vt?S' WS no Vt?S- yes- ves no no ves yes ves no vesT no ves no 35 ves \'es vcs ves VeS 18 18 18 18 18 18 18 18 18 18 18 ves ves \'t?S ves VCS 31 yes no yes yes 14 Enforcement authority no yes I10 VPS \'fS yes VtTS ves 110 no no ves Vt`S no ves no yes ves ves ves ves ves ves ves 110 no 33 Sign-posting requirements yes yes no no ves ves ves ves yes no yes yes yes no yes no no yes ves no yes yes yes no yes yes 36 Prohibits purchase, possession, and/or use by minors no ye@ yes no yes no yes no yes yes no yes yes no# yesqT no yes Yes yes yes yes yes yes yes yes yes 42 **A pupil mav not possess or use tobacco on school property "Except ven&ng machines. "A retail license exists for those retailers 12-ho manufacture their o\vn tobacco products or deal in nonpaid tobacco products. " On any public street, place, or resort. businesses, do not prohibit minors entry and ha1.e been shorz-n to be readily accessible to underaged buy- ers (Forster et al. 1992b; Wakefield et al. lYY2a; Cismoski and Sheridan 1993). Because less-restrictive measures must be consistently implemented to be ef- fective, and because such implementation is difficult, the USDHHS (1994) and the IOM (Lynch and Bonnie 1994) recommend a total ban on cigarette vending machines. The 1996 FDA rules Lvould have excluded locations that are inaccessible to minors, but the multistate settlement proposed a total ban. Restrictions on vending machines are a category of regulation of self-service cigarette sales. A general ban on self-service would require that tobacco be physically obtained from a salesperson and be stored so that products are not directly accessible to custom- ers. In one study of 4X9 over-the-counter purchase attempts, minors \vere successful at purchasing in 33 percent of locations where cigarettes ivere behind the counter and 15 percent of locations bzhere cigarettes were openly available (Forster et al. 19%). In another study, stores that did not give customers access to to- bacco products were less likelv to sell to minors (12.8 percent) than stores that permitted direct contact lvith tobacco products (30.6 percent)(Wildev et al. lYY5a). Finally, data suggest that shoplifting is an important commercial source of tobacco to underaged vouth (Cummings et al. 1992, 1995; Cismoski and Sheridan 1994; Lynch and Bonnie 1994; Forster et al. lYY5; Wilde! et al. 1995b; CDC lYY6d; Rosl\,ell Park Cancer Insti- tute 1997). Shoplifting mav be deterred bv regulations that specify that until the moment of purchase, single packs, any amount less than a carton, or all tobacco products must be physically handled by an emplo\,ee onlv (Cismoski 1991; Wildev et al. 1YYSa; Cald\veil et al. iY96). Several states have addressed the issue of self- service sales of tobacco products. For example, Idaho and Minnesota restrict self-service sales to onlv those stores that do not allo\v minors to enter and that ob- tain most of their sales from tobacco. Texas prohibits self-service sales in any location accessible to minors. Three hundred and ten localities have chosen to re- strict tobacco sales by prohibiting self-service displays (American Nonsmokers' Rights Foundation, unpub- lished data, 2000). Opposition to this measure is generally organized by tobacco distributors and retailers, who fear the loss of slotting fees-payments (often substantial) to retailers for ad\,antageous placement of tobacco products and for point-of- purchase advertising in their business (Gersten 1994; Thomas A. Briant, letter to Litchfield Tobacco Retail- ers, February 16, 1993; Cald\vell et al. lYY6). The 10M recommends a ban on self-service displays (Lynch and Bonnie 19941, and the Working Group of State Attor- nevs General (1994) recommends to tobacco retailers that they eliminate such displays. That this recom- mendation is not unreasonably burdensome has been demonstrated by one study in which 28 percent of re- tailers in 14 communities complied voluntarily (Forster et al. 1995) and by another study involving 15 cities in northern California (Kropp 1995). The 1996 FDArules would also have prohibited self-service displays except in certain adults-only facilities; thq proposed national settlement further stipulated that in non-adults-only facilities, tobacco products must be out of reach or otherwise inaccessible or invisible to consumers. Anecdotal reports have suggested that single or loose cigarettes are sold in some locations. Such sales are often prohibited by state or local law, at least im- plicitly because single cigarettes do not display the required state tax stamp or federal warning. Fre- quently, single cigarettes are kept out of sight and are available onlv by request. Researchers in California found that e\;en after a state law explicitly banned the sale of single cigarettes, almost one-half of tobacco re- tailers sold them to their customers (Klonoff et al. 1994). The study found that the stores that made loose ciga- rettes available sold them to almost twice as many minors as the); did to adults. That finding lends sup- port to the argument that single cigarette sales are an important avenue to addiction for some youth. A re- cent studv in Central Harlem has produced similar results: 7il percent of the licensed outlets sold single cigarettes to minors (Gemson et al. 1998). The IOM, the 1996 FDA rules, and the proposed multistate settle- ment ha\,e all recommended that the sale of loose or single cigarettes be explicitly prohibited (Lynch and Bonnie 1YYq). Regulation Directed at the Seller All states now have a law specifying the mini- mum purchaser's age for legal sale of tobacco prod- ucts. For all but two states, that age is 18; Alabama and Alaska specify age 19. Almost two-thirds of the states and many local jurisdictions require tobacco retailers to display signs that state the minimum age for sale. Some regulations specify the size, wording, and location of these signs. Other regulations specif!, the minimum age for salespersons; these regulations recognize the difficulty young sellers may experience in refusing to sell cigarettes to their peers. Most of these laws define violation either as a criminal offense (e.g., misdemeanor or gross misdemeanor), \2-ith accompanving penalties, or as a civil offense, \Vith specified ci\-il penalties (e.g., fines and license suspension). Ci\-il offense 1alt.s are thought to make enforcement easier and are therefore more likely to be carried out, since they do not generall) require court appearances. Many state or local lalvs specify penalties onlv against the salesperson. Apply- ing penalties to business oIl,ners, \j.ho generalI\. set hiring, training, super\?sing, and selling policiis, Is considered essential to pre\.enting the sale of tobacco to minors, although tobacco retailers ha1.e \,igorousl\ opposed these measures (Skretnv et al. 1990; FeighcrL - et al. 1991; McGrath 199Ja,b). More than one-half of the states and some local jurisdictions require that tobacco retailers obtain li- censes for over-the-counter sales, but smokeless to- bacco is exempted by 13 of these states (CDC, Office on Smoking and Health, unpublished data). Licen- sure sometimes is simpl!. a mechanism tor collecting taxes or generating re\.enue; in other states and cities, conditions are attached that relate to minors' access. In addition to civil penalties, retail licensure for tobacco represents another approach ior facilitating \,outh ac- cess la\v enforcement efforts and strengthen.ing sanc- tions for \.iolators of the la\\.. Retail liccnsure can facilitate the identification of retailers. The lack of a current and accurate list of tobacco \-endors has been cited by manv states involved in Svnar enforcement as d serious `impediment to efficient enforcement (USDHHS 1999). Retail licensure can also create an incentive for retail compliance. License suspensions or revocations could be imposed as penalties for via- lation of youth access lakes, resulting in revenue loss for retailers. Licensure \~ould also provide a source of funds to pav for enforcement and retailer educa- tion when licensing fees or fines for violations are ear- marked for such education purposes. Finally, retail licensure provides a mechanism for administrative adjudication of vouth access law violations. License holders byho fail-to comply M.ith the law could be held accountable before the licensing authoritv. No published empirical research examines the effects of tobacco retail licensure on either enforcement efforts or retail compliance. Studies on policies tar- geted to increase retail compliance, however, suggest several specific elements of licensure policies that should be present in order to increase the likelihood of positive effects. The points below outline the wavs in xvhich licensure policies could be used to enhance retail compliance efforts. Licensure la!vs must explicitly link the privilege of selling tobacco products to retail compliance with youth access laws (Levinson 1999). Licensure should cover both retail stores and vend- ing machines (Levinson 1999). License holders should be required to renew their license annually (LeLinson 1999; USDHHS 1999). License holders should be fined for violation of I\;outh access laws (Levinson 1999). Fines should be high enough to encourage vendors to comply with youth access laws but not so high as to risk loss of community or judicial support for the imposition of penalties (Lynch and Bonnie 1 YY1). Fines should be graduated so that greater conse- quences are associated \vith increased number of \ iolations. Repeated violations should lead to li- cense suspension or re\,ocation (CDC 1995a; NC1 1l.d.). License fees should be sufficient to cover the aver- age cost of compliance checks (CDC 1995a). The re\`enue from fines should subsidize the costs of enforcement (Working Group of State Attorneys General 1994). In addition to these items, several other policy elements have been suggested for incorporation into licensure la\vs. These licensure policy components should communicate clear and consistent messages about the illegality of tobacco sales to minors and should promote societal norms intolerant of youth ac- cess la\v violations (Kropp 1996). These elements in- clude mandatory posting of warning signs within clear sight of consumers, mandatory checking of age iden- tification, state provision of merchant and clerk edu- cation about vouth access law requirements (i.e., consequences for violations and techniques for im- proving merchants' and clerks' skills at detecting un- derage youth and refusing sales), restrictions or bans on self-service displays, and ensuring that clerks are at or above the legal purchase age. Without enforcement provisions, however, li- censing laws are not effective measures to restrict mi- nors' access. Before 1996, only 16 states with licensing laws specified the agency with enforcement responsi- bility, despite recommendations (USDHHS 1990; Lynch and Bonnie 1993; Working Group of State At- torneys General 1994) that states adopt a licensing re- quirement that has civil penalties and a designated enforcement agent. In its 1998 report, SAMHSA indi- cates that all but one state requiring licenses have a designated enforcement agency (USDHHS IYY8a; see "Enforcement of Laws on Minimum Ages for Tobacco Sales," later in this chapter). State laws and local ordinances can be a mecha- nism for increasing retailer awareness of youth access laws and retailer ability to comply with the law. Of- ten referred to as responsible vendor laws, this type of legislation can require retailer education and training as a condition of retail tobacco licensure or simply re- quire education and training for all tobacco vendors. Numerous studies have shown the potential benefit of comprehensive merchant education and training programs in helping to reduce illegal sales to minors (Altman et al. 1989, 1991, 1999; Feighery 1991; Keay 1993; Cummings et al. 1998). In many instances, rep- resentatives of tobacco retailers have supported the passage of responsible vendor laws (McGrath 1995a,b; Thomas A. Briant, Letter to Lit&field Tobacco Retail- ers, February 16, 1995) when these laws also exempt business owners from penalties or specify lower pen- alties for tobacco sales to minors if owners ha\,e trained their employees. Under such conditions, employee training would relieve retailers of responsibility for on- going supervision and monitoring of employee behav- ior and likely result in decreasing the impact of youth access laws. It should be noted, however, that as a result of both Synar and FDA attention to the problem of youth access to tobacco, several states have Lvorked to ensure the modification of youth access and/or re- tail licensure la\ys to mandate vendor education and training without the incorporation of clauses reliev- ing retailer responsibility (USDHHS 1998a). These ef- forts recognize that responsible vendor lags ha\,e the potential to be an effective rva); to increase the ability of retailers and clerks to comply with the larv bv accu- rately detecting underage purchases and confidently and safely refusing sales. The general availability of tobacco products in retail outlets that have pharmacies has led to some concerns. In the United States, stores that have phar- macies usually sell tobacco products, contrary to a 1971 policy recommendation of the American Pharmaceu- tical Association (1971) that cited the inconsistency of selling cigarettes with their function as health institu- tions. A few small chains and a growing number of independent stores with pharmacies are tobacco free, but all large chains and most independent stores sell tobacco products. Pharmacies (and stores that have pharmacies) that sell tobacco products are as likely as other outlets to sell to minors (Brown and DiFranza 1992). On the other hand, a study has shown that pharmacists who work in stores that do not sell to- bacco have a better understanding of the dangers of tobacco than do pharmacists who work in stores that sell tobacco, and they also feel more confident that they can help customers who use tobacco stop (Davidson et al. 1988). Two-thirds of pharmacists surveyed in Minnesota believed that members of the profession should not work in stores that sell tobacco products (Martinez et al. 19931, and many felt that the contigu- ity of tobacco products and pharmaceuticals produces professional dissonance (Taylor 1992; Kamin 1994). Both the Canadian Medical Association and the Ameri- can Medical Association are opposed to tobacco sales in pharmacies and in stores that have pharmacies (Staver 1987; Sullivan 1989). The Canadian provincial government of Ontario banned such sales in 1994 (An Act to Prevent the Provision of Tobacco to Young Per- sons and to Regulate its Sale and Use by Others, Stat- utes of Orleans, ch. 10, sec. 3[61 [1994] [Can.]). Regulation Directed at the Buyer State and local jurisdictions are increasingly im- posing sanctions against minors who purchase, at- tempt to purchase, or possess tobacco products (CDC 1996~; Forster et al. 1996). These laws are favored by some law enforcement officials and tobacco retailers because of the potential deterrent value (Parsons 1989; Talbot 1992). Some advocates for reducing tobacco use argue, however, that such laws are part of an effort to deflect responsibility for illegal tobacco sales from re- tailers to underaged youth; that these laws are not an efficient substitute for laws regulating merchants, be- cause so many more minors than retailers are involved; and that sanctions against minors are more difficult to enforce than those against retailers (Carol 1992; Cismoski 1994; Lynch and Bonnie 1994; Mosher 1995; Wolfson and Hourigan 1997). Other advocates have insisted that some of the responsibility must devolve on the purchaser and that laws prohibiting possession should be vigorously enforced (Talbot 1992). Although not taking a stand on the advisability of purchase and possession laws, the Working Group of State Attor- neys General (1994) recommended that such laws should be considered only after effective retail regula- tions are already in place. Enforcement of Laws on Minimum Ages for Tobacco Sales Although laws on the minimum age for tobacco sales have been part of many state statutes for decades, only in the past few years has attention been focused on enforcing these laws by federal, state, or local agen- cies (Lynch and Bonnie 1994; Fc,tf~rnI Rc:gi5fer 1996; LSDHHS, in press). As more information has become a\-ailable about the implementation and effects of v-ari- ous minors' access lalvs, it is becoming clear that orga- nized enforcement efforts are essential to realizing the potential of these Ialvs. Enforcement of minimum-age la\vs is more likely to occur Ivhen enforcement is self- supporting through license fees and revenues from pen- alties and tvhen the penaltv schedule includes civ,il penalties that are large enough to be tffectiv-e but are seen as reasonable and simple to administer (Working Group of State Attorneys General 199-l). La\v enforce- ment officials have sometimes balked at applving crim- nal penalties against clerks and retailers for selling tobacco to minors. Enforcement ma\' be more effecti\.e if sanctions can be imposed on managers or business owners rather than, or in addition to, salespersons (Working Group of State Attorncvs General IYYJ). Moreov,er, the lY92 enactment of the Svna~ Amendment (Public La\v 102-321, sec. 1926, discussed in the introduction to this section) has forciblvr Lxo~~gl~t this issue to the fore, because the amendmei~t requires states to enact and enforce legislation restricting the sale and distribution of tobacco products to minors. As a result, all states have law-s prohibiting the sale and distribution of tobacco to minors and all states enforce these law through a statewide coordinated program. Additionally, all states have no\z designated a lead agencv and all but one ha\-e an agency respon- sible for enforcing their minimum-age laiv (Table 5.4) (USDHHS, in press). In addition to federal and state enforcement efforts, a number of local jurisdictions around the countrv have begun activ,ely enforcing the law against tobacco sales to minors, and local ordi- nances can include a schedule of required compliance checks (Lynch and Bonnie 1994; Working Group of State Attorneys General 1994; Forster et al. 1996; DiFranza et al. 1998). Compliance checks are most often carried out by having an underaged buyer, under the supervision of a law enforcement officer, licensing official, or some other designated adult, attempt to purchase tobacco. In jurisdictions where the minor is held legally at fault if a purchase is made (and where no exceptions are made for compliance checks), minors participating in compliance checks are sometimes instructed not to complete the purchase even if the salesperson is will- ing; in these cases, the retailer is considered to be in noncompliance with the youth access law if the pur- chase is entered into the cash register (Hoppock and Houston 1990; Cummings et al. 1996). Selreral innolrative civil enforcement approaches have been attempted in California. The district attor- neys in Sonoma and Napa Counties have used the Cali- fornia Business and Professions Code section 17200 to file civ,il lawsuits against store owners whose outlets repeatedlv sold tobacco to minors. Civil enforcement has prol.ed to be more efficient than criminal citations and has resulted in fines and penalties as well as reduc- tions in tobacco sales to minors (Kropp and Kuh 1994). Increased emphasis on enforcement, coupled w,ith passage of laivs against possession of tobacco by minors, may result in enforcement resources being selectively funneled to apprehending underaged smokers rather than penalizing the merchants who sell tobacco to these minors. A survey of 222 police chiefs in Minnesota rev,ealed that although more than 90 per- cent \vere enforcing the law against minors' posses- sion, 10 percent reported applying penalties to minors, and onlv 6 percent reported any enforcement against merchants (Forster et al. 1996). A vigorous and multidimensional campaign has been mounted by the tobacco industry and its allies to prevent or undermine effective enforcement of minors' access laws and to resist the proposal that retailers be held accountable for their stores' compliance. Since 1992, laws sponsored by the tobacco industry but os- tensiblv intended to bring states into compliance with requirements of the Svnar Amendment have been passed in Georgia, Idaho, Kentucky, Louisiana, Mary- land, Mississippi, North Carolina, Oklahoma, South Dakota, and Tennessee (DiFranza 1994~; DiFranza and Godshall 1993). Tobacco industry representatives and their allies have lobbied successfully for the inclusion of language such as "knowingly" or "intentionally" in the lavv prohibiting sale of tobacco to minors; the impact of such language may be to render the law unenforceable. Industry interests have sought to in- clude various restrictions on how, how often, and by whom enforcement or compliance testing can be con- ducted. Examples of these restrictions include oppos- ing employing teens in compliance testing or requiring that only very young teens can function as buyers, in- sisting that enforcement be done only by the alcohol control authority or some other state agency, oppos- ing compliance checks carried out by advocacy groups or for public health research, and opposing require- ments that compliance checks occur on a specified schedule. The industry has further proposed imme- diate reentry and confrontation after an illicit sale-a procedure that could compromise collecting evidence. Industry representatives have also consistently main- tained that merchants ought not to be responsible for the costs incurred in complying with minimum-age Table 5.4. Agencies responsible for enforcing state laws on minimum age for tobacco sales as of fiscal year 1998 State/Territorv Lead agency Alabama Alaska Arizona Alcoholic Beverage Control Board Department of Health and Social Services, Division of Alcoholism and Drug Abuse Department of Health Services, Office of Substance Abuse and General Mental Health Arkansas California Colorado Connecticut Department of Health, Bureau of Alcohol and Drug Abuse Prevention Department of Health Services Department of Human Services, Alcohol and Drug Abuse Division Department of Mental Health and Social Serlrices, Office of Addiction Services Delalvare District of Columbia Department of Public Safet\j, Alcoholic Beverage Control Commission Department of Human Ser\~ices, Addiction Prevention and Recovery Administration Florida Department of Business and Professional Regulation, Division of Alcoholic Be\,erages and Tobacco Georgia Halvaii Department of Public Safety Department of Health, Alcohol and Drug Abuse Division Idaho Department of Health and Welfare, FACS Di\zision, Bureau of Mental Health and Substance Services Illinois Liquor Control Commission Indiana Family and Social Ser\,ices Administration, Di\.ision of Mental Health Iowa Department of Public Health, Di\,ision of Substance Abuse and Health Promotion Kansas Department of Social and Rehabilitation Seri-ices, Alcohol and Drug Abuse Services Kentucky Department of Alcoholic Beverage Control Enforcement agency Alcoholic Beverage Control Board Attorney General's Office Department of Health Services, Office of Substance Abuse and General Mental Health Tobacco Control Board Department of Health Services State and local law enforcement Department of Revenue Services Department of Public Safety, Alcoholic Beverage Control Commi&ion Department of Consumer and Regulatory Affairs and the Metropolitan Police Department Department of Business and Professional Regulation, Division of Alcoholic Beverages and Tobacco Department of Public Safety Department of Health with Department of the Attorney General Department of Health and Welfare, FACS Division, Bureau of Mental Health and Substance Services No one agency responsible for enforcement Indiana Alcoholic Beverage Commission Excise Police Department of Public Health, Division of Substance Abuse and Health Promotion Department of Revenue, Alcoholic Beverage Control Board Department of Agriculture (specified state law) with the Department of Alcoholic Beverage Control (appointed) Source: C.S. Department of Health and Human Services, in press Table 5.4. Continued State/Territory Louisiana h4aine \laryland h4assachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada Nel\- Hampshire New Jersey New Mexico New York North Carolina Korth Dakota Lead agency Department of Rei-enue and Taxation, Office of Alcoholic Beverage and Tobacco Control Department of Mental Health and Mental Retardation, Office of Substance Abuse Department of Health and Mental Hygiene, Alcohol and Drug Abuse Administration Department of Public Health, Bureau of Substance Abuse Serl-ices Department of Communit\~ Health, Bureau of Substance Abuse Serl.ices Department of Human Services, Chemical Dependency Program Di\.ision Department of Mental Health, Di\-ision of Alcohol and Drug Abuse Department of Mental Health, Di\?sion of Alcohol and Drug Abuse Department of Public Health and Human Ser\-ices, Di\.ision of Addicti\.e and Mental Disorders Department of Health and Human Services Attorney General of the State of Ne\,ada Department of Health and Human Services, Bureau of Substance Abuse Services Department of Health and Senior Services Department of Regulation and Licensing, Alcohol and Gaming Division Department of Health, Office of Alcoholism and Substance Abuse Services Department of Human Resources, Division of Mental Health, Developmental Disabilities and Substance Abuse Services Department of Human Services, Division of Mental Health and Substance Abuse Services Enforcement agency Department of Revenue and Taxation, Office of Alcoholic Beverage and Tobacco Control Department of Mental Health and Mental Retardation, Office of Substance Abuse State Comptroller's Office Department of Public Health, Tobacco Control Program with the Attorney General's Office Department of Community Health, Bureau of Substance Abuse Ser\,ices Department of Human Services, Chemical Dependency Program Di\,ision Office of Attorney General Department of Mental Health, Division of Alcohol and Drug Abuse Department of Public Health and Human Services, Division of Addictive and Mental Disorders Nebraska State Patrol State Attorney General Department of Health and Human Services, Bureau of Substance Abuse Services Department of Health and Senior Services with local health agencies Department of Regulation and Licensing, Alcohol and Gaming Division (statutory), Department of Health and Department of Public Safety (by executive order) 37 local county health units and 10 district offices of the state's Department of Health Local police and sheriff's departments State and local law enforcement agencies are responsible for enforcing state and local laws prohibiting tobacco sales to minors. The Department of Human Services, Division of Mental Health and Substance Abuse Services, is responsible for conducting compliance surveys. State/Territory Ohio Oklahoma Oregon Pennsyl\,ania Rhode Island South Carolina South Dakota Tennessee Texas Ltah Vermont Virginia - \Vashington West Virginia Wisconsin Wyoming American Samoa Guam Marshall Islands Lead agency Department of Alcohol and Drug Addiction Services Alcoholic Beverage Laxv Enforcement Commission Department of Human Resources, Office of Alcohol and Drug Abuse Programs Department of Health, Office of Alcohol and Drug Abuse Programs Department of Health, Di\-ision of Substance Abuse Department of Alcohol and Other Drug Abuse Serlrices Department of Human Str\-ices, Division of Alcohol and Drug Abuse Department ot Agriculture Commission on Alcohol and Drug Abuse and Department of Health Department of Hum,ln Ser\.ices, Di\,ision of Substance Abuse Department of Liquor Control Department of Agriculturt~ and Consumer Serl-ices Department of Social and Health Ser\,ices, Dii-ision of .~lcohol and Substance Abuse Department of Health and Human Resources, Di\-ision of Alcoholism and Drug Abuse Department of Health and Family Serl?ces, Bureau of Substance Abuse Services Department of Health, Di\,ision of BehaL-ioral Health and Substance Abuse Program Department of Humm and Social Serv-ices, Social Services Di\,ision Department of Mental Health and Substance Abuse Office of the Attornev General - Enforcement agency Department of Alcohol and Drug Addiction Services Alcoholic Beverage Law Enforcement Commission Oregon State Police Department of Health, Office of Alcohol and Drug Abuse Programs Department of Health, Division of Substance Abuse (The Division of Substance Abuse transferred from the Rhode Island Department of Health to the Department of Mental Health, Retardation, and Hospitals on September 1,1998.) Department of Revenue and Taxation Di\,ision of Alcohol and Drug Abuse coordinates enforcement with the Attorney General's Office and 66 county state's attornevs Department of Agriculture State Comptroller Department of Human Services, Division of Substance Abuse Enforcement and Licensing Division of the Department of Liquor Control Alcohol Be\.erage Control Board Liquor Control Board Alcohol Be\,erage Administration Department of Health and Family Services, Bureau of Substance Abuse Serlrices Local law enforcement agencies Department of Public Health Department of Mental Health and Substance Abuse Chief Prosecutor of the Office of the Police Comntissioner Table 5.4. Continued State/Territory Lead agency Micronesia Department of Health Northern Marianas Department of Public Health Palau Ministrv of Justice, Bureau of Public Safet! M.ith Ministrv of Commerce and Trade (responsible ior licensing) Puerto Rico Department of Health, Mental Health and Anti-Addiction Ser\+ces Administration Virgin Islands Department of Health, Di\-ision of Mental Health, Alcoholism and Drug Dependent\ Ialvs, such as the costs of making tobacco inaccessible to minors or of ha\ing merchants monitor their ON'II staff (DiFranza 1991~; DiFranza and Godshall 1YY-L). Despite, or in some cases in response to, these indus- trv efforts, many states ha1.e successfully strengthened their youth access laws and/or removed industry- inspired loopholes and provisions for affirniati1.e de- fense. Six states amended state lal\- to permit minors to participate in compliance checks conducted for en- forcement purposes. Tlventy-three states IIOIV ha1.e this provision in their minors' access la\v. T\VO states passed legislation that will provide a more accurate list of tobacco retailers for compliance checks and three states added provisions that address funding for en- forcement and education programs (USDHHS, in press). The reports from both the 10M (Lynch and Bonnie 1994) and the Working Group of State Attor- new General (1994) include strong recommendations that active enforcement of minors' access la\vs be implemented, that merchants be held responsible for sales in their stores, and that access la\vs supported by the tobacco industry be rejected. Using another type of enforcement, some pri\.ate groups and states have conducted lawsuits against commercial outlets that violate minors' access laws. `4 selection of these cases, one of which also named a tobacco company as a codefendant, is discussed in "Enhancing Prohibitory Regulation by Private Litiga- tion," later in this chapter. Traditional law enforcement agencies often re- sist conducting tobacco enforcement for a number of reasons. Thev believe that tobacco enforcement diverts limited resoirces from other more pressing crime and Enforcement agency No single agency; enforcement by local police and health departments Department of Public Health Bureau of Public Safety Department of Treasury Department of Licensing and Consumer Affairs that the public does not support the use of officers for such enforcement. They have also argued that the ill- feeling of members of the business community gener- ated by the issuance of citations negatively affects other enforcement efforts. Finally, the officers themselves frequently resist because they do not want to facilitate potential job loss for a clerk for \vhat they perceive to be a "minor" infraction or because they believe that prosecutors and judges lvill be reluctant to penalize (USDHHS 1999). Other agencies can be a suitable alternative for the conduct of enforcement. Chief among them are public health departments, tzrhich recognize the im- portance of conducting enforcement, and alcohol bev- erage control agencies (ABCs), which are highly experienced in conducting undercover compliance checks. ABCs retain a staff of inspectors that are fa- miliar tvith the protocols that may be employed dur- ing retail inspections (i.e., consummated and unconsummated buys). ABCs also tend to recognize a connection betbveen alcohol and tobacco enforcement and accept the importance of conducting tobacco in- spection for practical reasons if not for health reasons. This, in turn, results in less of a philosophical resis- tance to actually issuing citations for violations. Fi- nally, because ABC authorities regularly engage in enforcement directed at retailers, tobacco enforcement conducted by this agency will not likely generate as negatixre a backlash from retailers and the general public as enforcement conducted bv traditional law enforcement (USDHHS 1999). State Settlements All four states that settled their la\vsuits against the tobacco industry in 1997-1998 tvon youth access re- strictions in their settlement agreements. (The e\,ents leading up to these four settlements, along with their implications as a litigational tool for reducing tobacco use nationw,ide, are discussed in "Recovery Claims by Third-Party Health Care Payers," later in this chapter.) For example, the tobacco industry defendants in the state of Florida case agreed to support IWLV state la\vs or regu- lations to prohibit the sale of cigarettes in vending machines, except in adult-onlv locations or facilities (Floriiin ~1. AIIIUI'CITII fi~Iwcco Co., cii.il Action No. 95-1166 AH, sec. II.A.2 [Fla., Palm Beach Cty. Aug. 35, 19973). The industry also agreed to support new state laws in Florida to increase civil penalties for sales of tobacco products to minors (including retail license suspension or revocation) and to strengthen civil penalties for the possession of tobacco by minors. The Florida settlement (sec. lI.B) further requires the tobacco industry to pay 5200 million for a two-vear pilot program to reduce to- bacco use by minors, -including enforcement, media, educational, and other vouth-directed programs. L'outh access provisions of the Texas settlement that pertain to nelv state laM-s mirror the terms of the Florida agree- ment (fil.~~?s il. A11wriii7~7 fi~clborio CO., No. 5YhCV-9 1 (E.D. Tex. Jan. 16, 19981, sets. 7[a-cl). The state of Minnesota LVOII the most compre- hensive array of public health and youth access restric- tions to date IThen it settled its case after a highly publicized trial in 1998 (h/li~~rwwf~? ~1. Plri/ifT h-lw~i~ I/K., iit& irk 13.2 TPLR 3.39). One provision of the Minne- sota settlement forbids tobacco manufacturers from di- rectlv or indirectly opposing state statutes or regulations intended to reduce tobacco use bv minors. A list of 1egislatil.e proposals col.ered b!' the prohibi- tion is attached to the settlement agreement (Schedule B) and includes the folIoEying measures: Expansion of self-service restrictions and remo\,al of the current exception for cigars. Amendment of the current law, for restricting youth access to vending machines to clarify that machines w?th automatic locks and machines that use tokens are covered. "Enhanced or coordinated funding" for enforce- ment efforts under sales-to-minors provisions of the criminal code or the statute and ordinances invol\,- ing youth access. La~vs to "encourage or support the use of technol- ogy to increase the effectiveness of age-of-purchase laws" (e.g., programmable scanners or scanners to read drivers' licenses). Restrictions on wearing, carrying, or displaying to- bacco indicia in school-related settings. Establishment or enhancement of nonmonetary in- centi\:es for youth not to smoke (e.g., expand com- munity services programs for youth). Moreover, prohibiting tobacco companies from challenging the enforceability or constitutionality of current Minnesota laws encompasses some key youth I access statutes, such as those pertaining to the sale of tobacco to minors (Minnesota Statutes sec. 609.685) and the distribution of samples (Minnesota Statutes sec. 325.77) (Mirzrrcsotn ~1. Pl~ilip Movris Iuc., cited ill 13.2 TPLR 3.39, sec. IV.A.2). Another injunctive provision, forbid- ding the tobacco industry from targeting children through advertising, promotion, or marketing, also prohibits the industry from "taking any action the pri- mary purpose of which is to initiate, maintain or in- crease the incidence of underage smoking in Minnesota" (Miri!~~sc~fn ~1. Philip Morris ~IIC., No. Cl-94 8363 [Minn., Ramse]l: Cty. May 8, 19981, cifclf ir? 13.2 TPLR 2.112, 2.113 [1998]). The Minnesota settlement also includes a large industry-funded program to reduce teen smoking. The program includes counteradvertising, classroom edu- cation, community partnerships, research, advocacy, and prevention components (Milztwofn ~7. Philip Mor- ris Ir~c., cjf~`~1 irz 13.2 TPLR 3.39, sec. VIII.A.2). Although Mississippi (the first state to settle) did not initially secure public health restrictions, it later imported some of those contained in the sweeping- Minnesota settlement by exercising the "most favored nation" clause (discussed in "Recovery Claims by Third-Party Health Care Payers," later in this chapter) in its original settlement agreement (I'R Newswire 1998a). Intended to ensure that Mississippi would re- cei1.e the benefits any later similar settlement might receive, the most favored nation clause also enabled the state to substantially increase the dollar amount of- its settlement with the industry. Furthermore, although the revised agreement prohibits Mississippi from gain- ing any additional monetary benefit based on future state settlements, it does not limit the incorporation of additional public health provisions or financial adjust- ments in the event that Congress adopts national to- bacco legislation. Preemption of Local Action by State Policy As noted earlier in this section (see "Efforts to promote Adoption and Enforcement of Minors' Access La~vs"), the initiati1.e to address minors' access, as 1vell as many creati1.e solutions, has come from the local Ic\.el. In state legislatures, the balance of po\\`er be- t\j-een forces for and against reducing tobacco use is most often tipped in favor of tobacco USC. The re\.erse is often true at the local le\-el, \Vhere jurisdictions 1ial.e enacted inno\.ative approaches that l1aL.e been c\-alu- ated by researchers. At the state level, ho\ve\-er, to- Lmxo industry representati\.es ha\ e sought to preclude legislative or enforcement authority at the local lel,el b!r including preemption language, usualI!. attached to rveak statelvide restrictions. As of 1998, 30 states had preempti\ e tobacco COP trol larvs, although they \.ar\' \videl\. in the kind of re- !/r~olds fi&ncco CP., No. 94- 08273 CA [XI] (Fla., Dade Cty. Oct. 31, lYY4], cifd i\z 9.5 TPLR 2.147 [1994], (7ff'ij 672 So. 3d 39 [lY%]), seeks damages for the full range of costs that flo~v from tobacco-caused diseases. The C~75tt7r10 case in\,olws a much larger number of plaintiffs than E~r~q/c~, but each plaintiff seeks a much smaller recol-cry To date, both Ca.ita/w and E/~Slc~-t~pe claims ha1.e been brought under the more complex Rule 23(b)(3) class action procedures designed for the resolution of indi\?dual claims that share common legal or factual issues. Courts have generallv been reluctant to allow these procedures for Gsff7rlo-type claims, \zith the courts particularly concerned about the individualized proceedings on behalf of millions of addicted smok- ers, each making relatively small claims, that \vould follow from a favorable resolution of the common is- sues (Cnst~~rzo 7'. Ar~wic-nrz Toh7c~o Co., 85 F.3d 734 [5th Cir. 19961; Srr~ll ~1. Loriflnni 72~twcca Co., 1998 WL 398176 [N.Y.A.D. 1 Dept. July 16, 19981; Rilrr~ljs 71. A,rlcricnr~ T'd~acco Co., No. (X-5903 [E.D. Pa. Aug. 22, 19973, \`a- cated 176 F.R.D. 479 [1997], iitcll ii1 12.4 TPLR 2.227 (19971). The possibility oi using the simpler class ac- tion procedure for Cas~~~w-type claims, lvhich Mould seek a single judicial order setting up an insurance- tvpe fund that claimants could draw on as they used addiction-related medical or pharmaceutical ser\?ces, has not been fully explored. By contrast, courts have been more lvilling to permit Rule 23(b)(3)-type proce- dures for Ellgle-type claims, where class action proce- dures promise to simplify the trials of a smaller (but still very large) number of serious individual claims E/qle, 672 So. 2d 39; Bur,ir~ u. Philip Morris Cos., No. 92- 1405 [Fla., Dade Cty. Mar. 15, 19941, cited irr 9.1 TPLR 2.1 119941; Richnvdsoll ZJ. Philip Morris, luc., No. 9614505O/CE212596 [Md. Cir. Ct. Baltimore City Jan. 28, 19981). For a class action of either type to be certified, iour technical requirements must be met. First, the members of the proposed plaintiff class must be so numerous that joining each plaintiff to the suit would be impractical. Second, the claims of each member of the class must turn on some questions of law or fact that are common to all the members of the class. Third, claims of the class representatives must not be antago- nistic to those of the other members of the class. Fourth, the representative plaintiffs and their attorneys must be able to fairly and adequately represent the interests of the entire class (Federal Rules of Civil Pro- cedure, Rule 23[a]). Where members of the class have conflicting interests, the class may be divided into sub- classes represented by different attorneys (Federal Rules of Civil Procedure, Rule 23[c][4][A]). Besides meeting these four requirements, a Rule 23(b)(3) class action needs to surmount two other sig- nificant hurdles. First, the court must determine that the action is "manageable," meaning that a reasonable plan for trying the entire case, including the individual claims, can be devised. Second, the common issues must "predominate" ol'er the individual issues, leav- ing the court to make the judgment whether the hen= efits likely to be obtained from trying the case as a class action outweigh the difficulties likely to be encoun- tered in doing so (Federal Rules of Civil Procedures, Rule 23[b][3]). Once a Rule 23(b)(3) class is certified, the class representatives must undertake the onerous and ex- pensii,e process of notifying each member of the class. This is necessary because Rule 23(b)(3) class members have the significant right to opt out of the class and pursue their claims individually. The class action device soives the problem 01 aggregation, reduces the imbalance of resources often found between the parties, achieves economies of scale and avoids duplicative litigation. The great advan- tage of the class actions being pursued in the third M'ave of tobacco litigation is that resources arc expended on behalf of thousands or millions oi clasr members rather than on behalf of a single individua (Kelder and Daynard 1997). This advantage provide! more of a level playing field and means that thf tobacco companies b4ll not be able to successfull~~ pur- sue their usual first- and second-LVal-e strategy of forc- ing opponents to spend exorbitant suins of nione\ until, nearlv bankrupted, the\ are forced to I\-ithdral\ (Kelder anA Daynard 19971.. In its unanimous deci- sion, the appellate court in Bwir~, after considering and rejecting defense objections to the plaintiffs' request for class certification, alluded to the great promise that the class action strategy holds for plaintiffs challeng- ing the tobacco industr\r: ". if \ve \vere to construt' the rule to require each person to file a separattl la\\,- suit, the result 1Vould be o\~er\~helinin;: and financiall\, prohibiti\,e. Although defendants ~vould not lath tlli> financial resources to defend each separate la\\-suit, the t.ast major-itv of class niemberh, in less ad\.dnta~cwus financial positions, ~voulcl he depri~~t~d of 4 rcwied\. We decline to promote such a result" ([ivcjiri, ~-rf(`il ii7 9.1 TPLR 2.4). But \zith these benefits come ne\\. problems. Only coninion issues can be dealt \I-ith in d class pr<1- reeding, thus leal.ing incli\.iduali/ed features to Lw dealt \Vith in separate trials. As noted, some or indn\ potential class members may choose to opt out of thi> class to pursue indi\~idual cases, thcrebv reducin;: the ad\.antage of eliminating duplicatix e litigation. If wine class members are more se\.erel\, injured than others, intractable conflict niav arise ol.er distributing the proceeds (Coffee 1986, 1987). If the injur\, is con- tinuing outside the class, as it is in the case of tobacco use, there is the problem of providing for future plain- tiffs (Hensler and Peterson lYY3). These problems are o\.erlaid and compounded bv issues in\.ol\,ing the le- gal agents representing the plaintiffs. Class actions are organized and managed bv entrepreneurial la\v- vers, and their interests and those of the client class mav diverge (Coffee 1986). Finally, there is the dan- ger-that the class action de\?ce ele\,ates the stakes so high that defendants and plaintiffs settle \vithout reso- lution of other (nonmonetarv) merits of the claim. Just t\.hich of these problems aresufficiently salient to dis- courage use of the class action device in the several 1 arieties of tobacco cases is still an issue. C~starzo ~1. A~wicnrl Tobm-c-o Co., filed March 2Y, 1993, in federal court in New, Orleans (MacLachlan IYY4-951, was an unparalleled attempt by a coalition of traditional plaintiffs' Ialvyers, mass disaster lalvvers, and class action specialists from around the country to diminish the organizational advantages enjoved by the tobacco industrv during the first two waves bf tobacco litigation. Each'of a coalition of 62 law firms pledged s100,OOO annuallv to fund a massive class action suit, ~`11 behalf of millions of nicotine-dependent smokers, charging the tobacco industr\, tvith promoting addiction and thus disabling smokers from quitting (Janofsky lYY-la; Shapiro lY91a; Curriden 1995). The plaintiffs requested damages for economic losses and emotional distress, as \2-ell as medical monitoring and injuncti\-e relief. In Februarv 1995, the district court granted the plaintiffs' request for class certification conditionall\~ and in part (Ci7rt~7r70, citc>il ij~ 10.1 TPLR 2.1). Judge Okla Jones II granted certification for is- sues of fraud, breach of warrantv (express or implied), intentional tort, negligence, stiict liability, and con- sumer protection issues. Certification was denied for other issues, including the questions of causation, in- jury,., and defenses regarding the claims of each smoker. Normally, a trial judge's decision to certify a class is not subject to re\.ie\\, bv a higher court until the trial court has reached a final disposition of the Ivhole case, \\.hich max. be vears later. But Judge Jones in Cat;tnfm granted sieciai permission to allo\~ the defendants to appeal his class certification decision to the United States Court of Appeals for the Fifth Circuit (Collins 19Y)sc). On May 23, 1996, a three-judge panel of the appellate court \.acated Judge Jones' decision and re- manded the case back to the district court M'ith instruc- tions to dismiss the class action. The court of appeals reasoned that the variations in the state laws of the SO states in \vhich the injuries occurred classwide, com- bined Lvith trial management problems not addressed by the district court, justified decertification of the nationrvide class (Cnsfarw, X4 F.3d 734). The coalition of labvyers that forlned around C~7stor7o opted to pursue another approach and began to file stateM-ide class actions shortly after the decerti- fication bv the court of appeals. Bv mid-1998, the coa- lition hack filed 26 such cases (To&y 1998). Another class action, Errg/c P. R.1. Rcyr&ds ~)hncco Co., No. 9408273 CA (20) (Fla., Dade Cty.), cited ill 9.3 TPLR 3.293 (1994), filed in a Florida state court May 5, 1993, on behalf of smokers suffering from "diseases like lung cancer and emphysema," sought billions of dollars in damages from the seven leading tobacco companies, the Council for Tobacco Research U.S.A. Inc., and the Tobacco Institute, a tobacco-financed public relations association (Janofsky lYY4a, p. 11). The suit alleged that by denying that smoking is addictive and by suppressing research on the hazards of smok- ing, the tobacco industry has deceived the public about the dangers of using tobacco products (Janofsky 1994~). On October 31, 1993, E,Is/P, filed by a personal injury la\vver ~`110 chose to remain apart from the Crr.stnw coalition, had the distinction of becoming the first tobacco-related class action laxvsuit to be granted class certification (EIIS/U P. R.]. RI'L/IIO/I~S 7?h~-c-c~ Co., No. Y4- (IX273 CA [XI [Fla.. Dade Ctv. Oct. 31, IY`H], iif~il ir7 Y.5 TPLR 2.117 [199-l]). When the defendants sought to oirerturn the class certification, the Florida Supreme Court upheld it, pairing the \vay for the case to go to trial (R.1. Rr~/rzolds Co. ~7. Elr~lc, 672 So. 2d 39 [Fla. Ct. App. 19961). A jury selection for the trial began on July 6, 1998 (Eior~or~ist 1998). Recovery Claims by Third-Party Health Care Payers In the late 197Os, a number of scholars and advo- cates began urging legal theories and statutory reforms that would permit third-party health care payers to col- lect the expenses of caring for tobacco-caused disease from the manufacturers themselves (Garner 1977; Daynard 1993a,b, 1994a; Gangarosa et al. 1994). Such claims involve complex questions about ascertaining the amount of tobacco-caused injury and the apportionment of damages attributable to each defendant. The stakes in these potential cases are undoubtedly large: one study estimates that 7.1 percent of total medical care expenditures in the CTnited States is attributable to smoking-related illnesses (CDC 1994~). Another study estimates that tobacco use is responsible for about 18 percent of all Medicaid expenses (Clymer 1994). How- ever, calculation of such effects invites the counter- argument (albeit amoral) that tobacco's costs to the state are offset in part by the savings afforded bv the prema- - ture deaths of smokers (Geyelin 1995). Beginning in 1994, the go\rernments of three states-Minnesota, Mississippi, and West Virginia- as well as Blue Cross and Blue Shield of Minnesota, filed lawsuits to secure reimbursement from the tobacco industry for health care expenditures for ail- ments arising from tobacco use. Three years later, 11 states had filed such legal actions. Since this settle- ment has not vet been embodied in the congressional legislation necessary to give it the force of lalv (see "Legislative Developments" and "Master Settlement Agreement," earlier in this chapter), four states- Florida, Minnesota, MississipQi, and Texas-have settled their claims with the tobacco industrv. Addi- tional third-party payers-such as labor union pen- sion funds and Blue Cross and Blue Shield plans (whose joint case is described in detail in "Common- Law Claims," earlier in this chapter) in states other than Minnesota-also began to file suit against the industry in 1997 and 1998. Medicaid Reimbursement Cases Mississippi filed suit on May 23, 1994, against tobacco manufacturers, wholesalers, and trade groups on the basis of common-law theories of restitution, unjust enrichment, and nuisance to recover the state's outlays for treating the tobacco-related illnesses of welfare recipients (Janofsky 1994a; Woo 1994~; Moore ~1. Anwicnrz Tobacco Co., Cause No. 94:1429 [Miss., Jack- son Cty. Feb. 21, 19951, riterl ~JI 10.1 TPLR 2.13 [1995]). The first state to do so, Mississippi, embraced a strat- egy that merited the attention of other third-party claimants. Rather than proceeding in a trial court on a theory of subrogation (whereby the state would have acted in the place of injured smokers to recover claims the state had paid to those smokers), Moore chose to proceed in equity (i.e., before a single judge in a nonjury proceeding) on theories of unjust enrichment and restitution (Kelder and Daynard 1997). Moour's equity claims were grounded in the notion developed in the literature that the State of Mississippi had been injured directly by the behavior of the tobacco industry because Mississippi`s taxpayers had been forced to pay the state's Medicaid costs due to tobacco-related illnesses. The state planned to use statistical analysis to il- lustrate the percentage of Medicaid costs that can be attributed to tobacco use. If the lawsuit succeeded, the defendants would pay for Medicaid costs under a formula that calculates liability according to market share (Lew 1994). The lawsuit sought tens of millions of dollars in damages, including punitive damages as ~vell as recoverv for future tobacco-related expendi- tures (Woo 1994~). Lawyers from 11 private plaintiffs' la\\, firms participated in the suit. Instead of Qromis- ing the private lawyers a percentage of the potential damages, the state sought to compel the tobacco com- Qanies to Qav the lalvvers' fees (Woo 1994~). SuQerficially, th;s state case (and that of other states) resembled subrogation claims, in which a party 11-110 Qays a claim (tvyically an insurer) may pursue that claim, acting in ;he place of the original claimant and subject to the defenses that might be raised against him or her. But the Mississippi complaint avoided asserting the claims of the health care recipients; in- stead, it asserted the proprietary claims of the state as a health care funder (distinct from any claims of those tvhose health was injured by tobacco). This proprietary stance is significant because, as detailed earlier in this section, the tobacco companies M'on many of the first- and second-wave cases by as- serting the defenses of assumption of risk and con- tributory negligence or by asserting that the smoker's w+llfulness, not the industry's misbehavior, was the proximate cause of the smoker's smoking and conse- quent illness. These defenses should not be available to the tobacco industry in medical cost reimbursement wits because these suits are not brought on behalf of injured smokers. They are brought, instead, on behalf of the states themselves to recol'er the medical costs they have been forced to pay to care for indigent smok- ers. The tobacco industry cannot plausibly argue that the states chose to smoke or that they contributed to the financial harm caused to them (Daynard 1994b; Kelder and Davnard 1997). The decision in the Mississippi medical cost re- imbursement suit demonstrates that this commonsense argument can prevail, even in states that lack sQecia1 legislation that creates an independent cause of action for the state. The tobacco industrv defendants in Mtu)rt' ;I. .-ln~c~.icnrf E~Iwrco Co. filed a m&ion for judgment on the pleadings on October 11, 1993. The defendants argued that, under MississipQi lalv, assignment/sub- rogation \vas the state's exclusi\,e remedy for Qursw ing the recoverv of medical benefits from potentialI>- liable third parties. Further, the defendants argued that because Mississippi's counts for restitution, indemnit!; and nuisance in the complaint did not assert a subro- il i/z 13.2 TPLR 2.112): o Disband the Council for Tobacco Research. . . . . . . . . . . . . Not pay for tobacco placement for mo\ies (a pro- vision that inherently extends hevond Minnesota's borders). Stop offering or selling in .Minnesota nontobacco merchandise, such as jackets, caps, and T-shirts, bearing the name or logo of tobacco brands. Remove all tobacco billboards in Mimiesota within six months and eliminate such ads on buses, taxis, and bus shelters. Refrain from targeting minors in future advertis- ing and promotions. Refrain from misrepresenting the evidence on smoking and health. Refrain from opposing in Minnesota certain new la\vs designed to reduce youth tobacco use, as well as clean indoor air laws that could adversely affect the industry. Institute new lobbying disclosure rules for Minnesota. Release internal indexes to millions of previously secret industry documents, thereby providing a means for attorneys and researchers to find relevant information more easilv. Maintain at industry expense for 10 years a deposi- tory of millions of tobacco documents in Minne- apolis and another such depositor\, in Great Britain. Instruct retailers in Minnesota to move cigarettes behind the counter to restrict minors' access to those cigarettes. Pay out SllO million in fees to the pri\.ate attor- neys \~ho represented the plaintiffs. Gi1.e Minnesota its Olin MFN clause, limited to improi.ed public health pro\-isions in future state settlements. Through the MFN process, many of the public health concessions that Minnesota obtained from the industry are also being incorporated in the prior state agreem;nts (Branson 1998). The Florida case (f lori[fl? 7'. ,;2/11~`rjt~/r Tr&~~cct~ Crl., No, 95-1166AO [Fla., Palm Beach Cty. Feb. 21, 19951, c-if~~j i/l 10.1 TPLR 3.1 119951 [Complaint]; Geyelin 1995) was the first conforming \vith a statute tailored for the purpose of establishin, 0 such a claim. In Mav 1994, Florida amended this little-used statute, \vhi& pro- \-ided for recoverv bv the state from third parties responsible for Medicaid costs, to permit the state to sue on behalf of the entire class of smokers on Medic- aid, tc, dse statistical proof of causation, to bar assump- tion of risk as a defense, and to permit recovery according to the defendants' share of the cigarette mar- ket (Rohter 1994; Woo 1994a). Apparently having sec- ond thoughts about the statute (which had passed by a wide margin), the state legislature considered repeal- ing it, eliciting a vow from Florida's Governor Lawton Chiles to veto a repeal (Hwang 1995a). After an un- successful last-minute attempt by the tobacco compa- nies to have the Florida Supreme Court bar state- agencies from initiating a lawsuit under the statute,- Florida filed its medical cost reimbursement suit on February 21,1995, seeking $4.4 billion (Florida, citcn ill 10.1 TPLR 3.1; Geyelin 1995). The complaint in the Florida lawsuit contains extended factual allegations regarding the defendants' knowledge (or lack of knowledge) about the harmful-- ness of tobacco. Raising the familiar causes of action, the complaint also emphasizes the tobacco industry's alleged violations of consumer protection laws. Spe- cifically, it criticizes the industry's use of advertising to target minors. The Florida Supreme Court narrowly upheld the liability law, on which the state's case is based, in a 3 to 3 ruling that produced equivocal results for both sides. The court agreed with the defendants that the state could only use the law to recover damages in- curred since July 1, 1994, and that the names of indi- vidual Medicaid recipients would have to be supplied- so that the tobacco companies could challenge their- claims (il~c~,lr!/ fin Hmltl7 Cnw Arin~i~7isfmfltior7 ZJ. Asod- ~ltcll I~~tllr~fr~ic~ of Flrjrilla, 678 So. 2d 1239 [Fla. 19963). But the majority decision left most of the law's key provisions intact. The presiding state circuit court judge, Harold J. Cohen, next ordered both parties to try to resol\,e the dispute by engaging in mediation, ivhich broke off after four days and produced no re- sults (Kennedy 1996). Judge Cohen then dismissed 15 counts of the state's 1%count claim against the tobacco industry in a ruling issued September 1996 (Floriiln P. AIIIPV~~~/I Ebnc-co CU., No. CL 95-1466 AH [Fla., Palm Beach Cty. Sept. 16,1996]). The following month, ho\v; ef'er, he rejected the defendants' request to depose the hundreds of thousands of Medicaid recipients supplied to the court by the state in compliance with the supreme court decision. The judge held that the hundreds of thousands of recipients need only be iden- tified by case number, not by name (Florirln ~1. A~wi- ~1711 7i,b[7i-cc~ Co., No. CL 95-1466 AH [Fla., Palm Beach Cty Oct. 18, 39963, citcrl i/l 11.7 TPLR 2.236 [1996]). 11~ yet another setback for the defendants, Judge Cohen permitted the state to add a count of racketeering to its claim (MacLachlan 1996-1997). Florida settled its case on August 25,1997, for at least $11 billion o\-er 25 years, \vith annual payments of at least $340 million continuing thereafter. It ob- tained its own MFN clause, as \vell as an additional 5200 million for a tlvo-year initiative to reduce youth smoking, an agreement to ban cigarette billboards and transit advertisements, and an agreement by the in- dustr!, to lobby for a ban on cigarette \.ending ma- chines. As a consequence of Mississippi's MFN clause, Florida received similar benefits. The Texas suit \vas inno\.atil.e in that it was brought in federal rather than state court. The case 12-as also the first to include claims under the federal RICOAct. On Januarv 16,1998, Texas settled its claims for at least $14.5 billion o\-er 25 vears. \j,ith annual payments of at least 5580 million continuing thereaf- ter, as xvell as public health provisions similar to those negotiated bv Florida and its o\j.n MFN clause. Although West Virginia \\.as one of the first three states to file a suit against the tobacco companies, its case did not fare as neatlv as those of Mississippi, Clin- nesota, and the later-arri\.ed Florida and Texas. Filed on September 20, 1994 (McGnm~ ~1. A~~wim~~ Tohcc-o Co., No. 94-1707 [W.Va. Cir. Ct. Kanal\ha Cty. Sept. 20, 19941, citc~d i,l 9.4 TPLR 3.516 [1994]), West Virginia's suit named 23 defendants, including Kimberlv-Clark Corporation, de\,eloper of a process once ised in Europe-but never, according to a company spokes- person, in the United States-to control nicotine lev- els in tobacco products (Hrvang and Ono 19951, and United States Tobacco Company, the largest manufac- turer of chewing tobacco and snuff. The West Virginia action "asks the Court for damages to cover \vhat West Virginia has paid providing medical care to people af- flicted M.ith tobacco-related illness, and what the state will pav in the future for tobacco victims. The lalvsuit i also seeks punitive damages to prevent a repetition of such conduct in the future" (West Virginia Attorney General 1994, p. 2). Citing an "intentional and LIIICOII- scionable campaign to promote the distribution and sale of cigarettes to children," the complaint also re- quires that the defendants be enjoined from "aiding, abetting or encouraging the sale of cigarettes to minors" (p. 4) and be fined $10,000 for each violation of the injunction. West Virginia's complaint is signed hv lawyers from five private firms, including a promi- nent asbestos litigation firm that is also involved in the Mississippi case. Unlike the Mississippi and Minnesota claims, the West Virginia case met M'itli early difficulties. On kqa!: 3, 1995, Kanawha Countv Circuit Court Judge Irene C. Berger dismissed 8 of the suit's 10 counts, including fraud, misrepresentation, and conspiracy, as being outside of the state attorney general's powers. Ironically, Berger's decision is based in part on a decision that Attorney General Darrell V. McGraw Jr. himself, the named plaintiff in the suit, authored when he srr\,ed on West Virginia's Supreme Court, holding that the state attorney general lacked common-law authority (i.e., he could bring only statutory claims). The t\vo remaining counts of the West Virginia action dealt lvith consumer and antitrust charges (Mac- Lachlan 1995a). On May 13, 1996, Judge Berger permitted the West Virginia Public Employees Insurance Agency Fi- nance Board to join as co-plaintiffs. This ruling "es- sentiallv re\-i\-ed" (Meol~y'.~ Litipfiorr Rrprfs: Thcco 1996`~) the case by pro\.id;ng the state with a means of hiring legal counsel after the tobacco companies won an October 1995 order barring the attorney general from retaining priorate law firms on a contingency fee basis (MacLachlan 1995a,b,c). Among the numerous other states currently try- ing to recoup Medicare expenditures, Oklahoma stands out for an innovation in its suit. The Oklahoma suit names, among other defendants, three industry lalv firms: Shook, Hardy and Bacon of Kansas City, Missouri; Jacob, Medinger and Finnegan of New York; and Chadbourne and Parke of New York. Shook, Hardy and Bacon has represented tobacco companies since 1953 (Kelder and Daynard 1997). The suit ac- cuses the la\v firms of helping the tobacco companies conceal the health risks of smoking and alleges they kept documents confidential by falsely claiming they lverc protected by attorney-client privilege (Oklnhon7n iI. R.]. Rc!/rlol[l~ Tobncccl CO., NO. CJ961499L [Okla., Cle\.eland Cty. ALIT. 22, 19961, citeii in 11.7 TPLR 3.901 [19961). Other notable settlements mentioned earlier in this chapter include the Liggett Group Inc.`s 1997 settlement with most of the states, in return for a frac- tion of future profits, public admissions of the dan- gers and addictiveness of nicotine and the past misbehairior of the industry, and disclosure of secret industrv documents (Tohocco Products Lifipfiorr Re- ,t~ortcr 1497a). The same year brought in another key settlement-that of R.J. Reynolds Tobacco Company and a dozen California cities and counties, which had alleged that R.J. Reynolds' Joe Camel campaign was aimed at minors (see "A Critical Example: Joe Camel," earlier in this chapter). R.J. Reynolds agreed to dis- continue the campaign in California and to give the plaintiffs 19 million for a counteradvertising campaign (M~~i~~j/lj, citc,d irr 12.5 TPLR 3.349). In October 1997, the industry settled the first phase of a class action brought on behalf of nonsmoking flight attendants for substantial money and other concessions (Broi,~, iit& ill 12.6 TPLR 3.397). This case is discussed in detail in "Claims of Nonsmokers," later in this chapter. Finally, at the time of lyriting, a group of state attorneys \vere holding discussions about settling some or all of the remaining state cases. According to pub- lished reports, as a starting point "the states have de- cided to use the [public health] concessions gained by Minnesota as part of its $6.5 billion settlement" (Meier 1998a). Other Third-Party Reimhrrsemelrt Cases Although the parties seeking recovery in Medic- aid reimbursement cases are public officials, the cases are based on private law theories of recovery-that is, the officials proceed not as auth0ritatiL.e public regu- lators but as holders of rights conferred by the general la%v. Such use of private la\v reco\`ery as an instru- ment of state policy suggests further possibilities of analogous suits bv private funders of health care and mav provide incentives for attorneys to organize such suits. Health insurers, rvidely seen as reluctant to en- force their rights to recoup from third parties, may be mindful of such opportunities in an increasingly com- petitive health care setting. Indeed, Blue Cross and Blue Shield of Minnesota was a co-plaintiff lvith the State of Minnesota in its action against the tobacco industrv. In 1996, the Mill- nesota Supreme Court unanimouslv rejected an indus- trv challenge that co-plaintiff I31ue Cross and Blue S&eld could not remain in the cast`. This ruling per- mitted the insurance company and the state to pursue their claims directlv against the defendants, rather than on behalf of individual smokers (Mi/lrlc~lfrr il. f%ili/~ Morris Irlc., 551 N.W.2d 490 [Minn. 19961). When the industrv settled \vith the State of Minnesota in May 1998, it also settled M.ith Blue Cross and Blue Shield ot Minnesota-for 5469 million to be paid over a five- year period Weinstein 1998a). In March 1998, two Minnesota health mainte- nance organizations filed a separate suit against the industry, Mith claims paralleling those in the Minne- sota case that was still in trial (Howatt 1998). The fol- lowing month, Blue Cross and/or Blue Shield Plans in 37 states combined in three legal actions to sue the major tobacco companies and their public relations firms to recover damages allegedly caused by a con- spiracy to addict their insurance plan members to ciga- rettes (e.g., Blzrr CKW nr7ii B/z~r Shield, cited irk 13.2 TPLR 3.51; Nl7fiorral Law ]olm7/ 1998). These plans are alleging that tobacco companies conducted an "ongoing conspiracy and deceptive, il- legal and tortious acts " that have resulted in the plain- tiffs suffering "extraordinary injury in their business and property," having been required to expend many millions of dollars on costs attributable to tobacco- related diseases caused by defendants who "know- ingly embarked on a scheme to addict millions of people, including members of the [Blue Cross and Blue Shield] Plans, to smoking cigarettes and other tobacco products-all with the intent of increasing their an- nual profits. . [and forcing] others to bear the cost of the diseases and deaths caused by the conspiracy" (Blrre Cross ad Hue Shield, p. 3.32). The plans allege a conspiracy to hide the health effects of tobacco products, violations of federal rack- eteering laws and of antitrust laws, and unjust enrich- ment, among other theories (Tohncco Pron~cts Lif@tioll Rqmrter 1998). They request damages in the forms of payments for treatments of tobacco-related diseases, court orders to require corrections of unlawful behav- ior, damages in excess of $1 billion for past and future harm, and other forms of relief. Bankruptcy trusts representing the interests of injured plaintiffs who have made claims against the asbestos industry filed suit against the tobacco indus- try in late 1997 (Bourque 1997). The trusts allege that they paid claims to victims of asbestos exposure whose injuries were substantially caused by either active or passi\.e exposure to cigarette smoke. Alleging the unjust enrichment of the tobacco companies at the ex- pense of the trusts, the latter seek to recover expendi- tures and payments made to the asbestos settlement class and seek punitive damages against the defen- dants (T~J~ICCO Products Lifipfioll Reporter 1997b). The trusts allege that among persons exposed to asbestos, direct or indirect exposure to tobacco smoke is a substantial contributing factor in both the devel- opment of cancer and the frequency and severity of symptoms of asbestosis, a disease from which many asbestos Lvorkers suffer. The trusts also allege that to- bacco companies knew or should have known that their products would cause these injuries (Fnlise ~1. Auuicnrl Tobacco Co., No. 97-0-7640 [E.D.N.Y. Dec. 31, 19971, c-ifcd ill 12.8 TPLR 3.504 [1997]). The asbestos trusts accuse the tobacco companies of suppressing the truth concerning the nature of their products and their carcinogenic effects. They allege that tobacco industry products were at least partly re- sponsible for the illnesses suffered by asbestos plain-- tiffs. The trusts thus want the tobacco companies to pay a share of the billions of dollars in damages- awarded to those plaintiffs (Bourque 1997). Small Claims Tribunals to Recover the Cost of Quitting Related to these expansil-e addiction suits are a series of more limited claims based on the addicti1.e properties of cigarettes. As \Vith large suits, small claims for the recol-er>- of costs related to quitting to- bacco use depend on lvhether judges and juries ac- cept the addiction argument that underlies the product liability portion of the third Ii-a\-e of tobacco litigation. In this scaled-dorm \.ersion, claims for modest amounts might be brought in small claims courts, ob- iiating some of the litigation ad\.antages enjo\ ed b\ the manufacturers. In one case, an individual smoke1 sutxl Philip Morris Companies Inc. for 51,154 in a \Vasliington State small claims court to reco\.er the costs of consulting a doctor, buvin g nicntine patches, and joining a health club-all acti\-ities undertaken to help the plaintiff quit smokin, ~7 cigarettes (Haves 1993; Janofskv 1993). Because the court rejected the suit on the pi-eiiminarv ground that the statute of limitations had expired, tl;e suhstanti1.e merits of the claim l\.c`rt' nnt considered (Montgomerv 1993). In July 1998, an AusGalian appellate court al- !oIved a formerlv addicted smoker to proceed before the Nelz South Wales consumer claims tribunal \\`ith a S1,OOO claim for the cost of a stop-smoking proq-am, as \vell as for mental suffering caused b\, the addic- tion and the effort to quit (Australian Nei1.s Netivork 19%). Were a timely small claims case to succeed, the recoverv b~ould be small. Incentives for lalvvers to bupplv and plaintiffs to consume the legal ser\,ices needed to pursue such a claim might be provided IX, statutorv provision allow%ig ivinning plaintiffs to re- cover atiorneys fees. Or if such claims could be suffi- ciently standardized and simplified, they might proceed without lawyers (e.g., by preparing "kits" to enable plaintiffs to represent themselves). Other Cost Reduction Procedures Several other procedures have been used or may he a\:ailable to reduce the costs-for plaintiffs, their attorneys, and the courts-of resolving individual claims. -One such procedure is to combine pretrial and )>erhaps trial proceedings for se\,eral, or e\`en many, cases. In July 1998, a California court ordered that proceedings in a varietv of actions pending in \.arious California courts be colnbined (Associated Press 1998). Earlier, a Tennessee court ordered several pending in- ~1 ividual cases to be combined for trial (Mn.v Grt Liti- ~`~lfjoll Rryort~ 1998). Asbestos trials have occasionally ,\ combined hundreds and e\ en thousands of indi\ idual claims (Ac~/l[l~, frlc. P. .Gztc, 710 A.2d 944 [Md. Ct. Spec. App, 1998]). These procedures permit courts to achieve substantial efficiencies M'ith the formalities of class action certification. Efficiencies can also be obtained bv case management orders that set firm schedules for tr-ials and pretrial proceedings (111 IY Ci~czr-cftr Cr?ses, iitc,li if? 11 .I TPLR 2.3). Another procedure available in some jurisdic- tions is "offensive collateral estoppel," lvhich exempts future plaintiffs from retrying issues on which specific defendants 1ial.e lost in prior trials (Blorlilrl.-TorzXue Ll?lJclr~lrt,~r-ic's i'. Ulrii'rrY+l/ oj /lli/7OiS FolfJ?L~nfiorl, 402 U.S. 313,91 S. Ct. 113-l [1971]). This device has not yet been used in tobacco litigation. Claims of Nonsmokers .~lthou~h most litigation in\lol\-ing adverse health effects from exposure to ETS has not directly in\.ol\.ed tobaccn companies, a line of cases has devel- nped during the 1990s naming tobacco companies as detcndants and targeting the companies' beha\,ior in attempting to, as a British-American Tobacco Company Ltd. document from 1988 put it, "keep the controversy aIi1.e"-referring to the industry's common strategy of shifting the focus from persona1 health to personal freedom (Boy 1988; Chapman lY97). Claims of nonsmokers asserting damages from ETS ha\,e been filed on behalf of both indi\,idual and class plaintiffs. As nonsmokers, alleged victims of ETS are not \-ulnerable to the defense that they knowingly subjected themselves to the dangers of tobacco use. Hllt/~xr ~7. Anrcricnt~ Tot~nrrc~ Co. ([Miss., Jones Cty. May 12, 19931, c-ifctl irf 9.3 TPLR 3.335 [19941 [Amended Complaint]), filed May 13, 1993, seeks damages from six tobacco companies and others for the lung cancer death of Burl Butler, a nonsmoker and "paragon of clean li\ing" (Greising and Zinn 1993, p. 331, who al- legedly contracted the disease after inhaling custom- ers' tobacco smoke for 35 years while working at his barber shop (Kraft 1994). Butler became the first case in which documents allegedly stolen from Brown & Williamson Tobacco Corporation by one of its former employees were admitted into evidence, despite objections by the defendants that attorney-client privilege prohibited disclosure. Lawyers for Butter's estate contend that "the documents v,:ill show, among other things, that tobacco companies manipulated and suppressed scientific research for years to mislead their customers about smoking's dangers" (Ward 19%). State Circuit Court Judge Billy Joe Landrum postponed commencement of the trial 1.111 motion bv the plaintiffs to allolv ne\v defendants to be added to Gie action. The amended complaint now contends that manufactur- ers of talcum polvder used by Butler in his barber shop "knelr or should have knolvn that En\.ironmental To- bacco Smoke can act synergistically ryith Talc, to cause respiratorv diseases, including lung cancer, and other health problems" (Rrltl[xr. il. Philip M0l.G [i7c`., Civil Action No.:945-53 [Miss., Jones Cty. Mar. 3,1996], cited ir7 11.3 TPLR 3.307, 3.315 [lYy6] [Second Amended Complaint and Request for Trial by Jury]). A new trial date has not vet been set. Another case involved a Ivoman who had never smoked but Lvho \vas subjected to prolonged and re- peated exposure to ETS since childhood and died of lung cancer in 1996 at the age of 4-l (BIlckir7@flrii il. R.]. Rqt,rdd~ Thcr~~ Co., 713 A.2d 381 [N.H. lY%]). Two years before her death, Roxanne Ramsey-Buckingham sued the major tobacco companies and a local store in strict liabilitv and under Restatement (Second) of Torts, section 389. She alleged "that the defendants kne\v or should ha1.e knon-n that it \vas unlikelv that their prod- ucts tvould be made rtasonablv safe prior to their cus- tomarv and intended LISA, an`? that it \vas foreseeable that i&. Ramse);-Buckir~Rham ~vould be endangered by ETS from the defendants' cigarettes" (1-7. 383). A superior court judge dismissed her larvsuit in 1995 on the basis that New Hampshire does not recognize a strict liabilitv cause of action under section 384. Holvever, the- Nelv Hampshire Supreme Court reili- stated the lar\.suit in Ma!. 1998, ruling that "section 389 is not a form of strict liability because it requires the defendant's kno\vledge of the product's danger- ous condition and does not require that the product be defecti1.e. The comments to section 3X9 make it clear that a bystander, assuming he is \vithin the scope of foresceabilitv of risk, is o\veci a dutv under larz. and ma!' rec0l.e; on a sholj,ing of breacii, dam age, and causation" (p. 38.5). The case ~vas sent back to the trial court for further proceedings. One case that Ivas triecl before a jury in March 1998 resulted in a I-erdict for the defendants. In that case, R]R Nol~i~o Holtlir7;;s, Corps. ~1. Dlirrj1 (657 N.E.Zd 1220 [Ind. 19951) a nonsmoking nurse \vho I\-orked for 17 years at a Veterans Administration Hospital died of lung cancer at the age of 56. Her IvidoIver sued a group of tobacco companies, claiming that her exposure to ETS from her patients at the hospital had killed her. A six-person jury returned a L'erdict for the defendants. Intervielved after the trial, some of the jurors explained that thev had had doubts as to ivhether the cancer that killed Xlrs. Wiley had originated in the lungs or, as the tobacco companies' lawyers had argued, in the pancreas and had then spread to the lungs (Dieter 19~8). The most prominent ETS case with tobacco corn- pany defendants has been Broiu u. Philip Morris &IS., which was brought against the six major cigarette manufacturers in 1991. Seven current and former non- smoking flight attendants, who contracted lung can: cer or other ailments and who face an increased risk of disease as a result of exposure to ETS on airplanes, filed a class action suit on behalf of thousands of flight at- tendants harmed by exposure to ETS on flights that predated the federal ban on smoking on domestic air- line flights. In 1992, a Dade County circuit judge dis: missed the class action aspect of the complaint, but t\vc years later, a three-judge panel of the District Court 01 Appeal of Florida, Third District, unanimously reversed the order of dismissal and ordered that the class action allegations be reinstated (Broifl, rited iir 9.1 TPLR 2.1). In late December 1996, the Circuit Court for Dade County authorized the mass notification of some 150,000 to 200,000 flight attendants so they could ei. ther sign up as plaintiffs or exclude themselves fron the case to pursue their own suits if they wished. Ir June 1997, jury selection in the trial began. More thar three months later, midway through the companies presentation of their defense, the parties announced 2 proposed settlement whereby the defendants woulc pay $300 million to establish the Broin Research Foum dation. The settlement would permit flight attendanti harmed by ETS exposure aboard airlines to sue tht tobacco companies, regardless of statute of limitation< issues. In the event of such individual actions, the de fendants \zould assume the burden of proof on the is sue of Lzrhether ETS exposure is capable of causing disease in nonsmokers. Dade County Circuit Judg Robert I'. Kave appro\,ed the proposed settlement or February 3, iYy8, calling it "fair, reasonable, adequate and in the best interests of the class," but challenger to the settlement have appealed (Broil? P. Phi/i/l Morri Ccls., No. 9 l-49738 CA (221 [Fla., Dade Cty. Feb. 3,1y981 iitc,ll ;,I 13.1 TPLR 2.79 119981). As of August 1998, thl appeal ivas pending. One Jvorkplace setting that has generated sub stantial exposure to ETS has been casinos. In 1997 nine casino dealers filed a class action lawsuit again5 17 tobacco companies and organizations. The lawsui seeks tens of millions of dollars in damages and clas certification of up to 45,000 casino dealers working il Nevada, along with their estates and family member: The plaintiffs in this case, B~~ilill~l 1'. Au7u~m77 Toh-c Co. (No. CV-N-97-0057%DWH [D. Net. 1997]), are also seeking to get medical monitoring for the dealers \vhl ha\-e had years of exposure to ETS on the job. In Apri IWS, a federal judge denied all of the motions to dismiss b!~ the defendants, except for The American Tobacco Company, Lvhich has merged \Vith Brolvii Cy: \Villiamson Tobacco Corporation. In April lYY8, a group of nonsmoking casino \j.orkers filed a lalz-suit in Nell ]erse\r Superior Court against several tobacco companies and the industrv's trade association, the Tobacco Institute, because ;he r\-orkers lvere being made sick bv their exposure to - ETS at \\rork (Smothers 1998). In a unique case from California, the Cit!, Attor- nev of Los Angeles filed suit in Jul\, lYY8, against I6 tobacco companies (those that sell cigarettes, iisars, or pipe tobacco) and 15 retailers on the grounds that the\. are \.iolating Proposition 65, an initiati\.e statute pas-sed bv the \,oters of California in lYS6. That la\\., l\nolvn as the Safe Drinking Water and Toxic Enforce- ment Act of lY86 and contained in California Health ~~iid Safetl. Code section 252-lY.6, pro\-ides that "no pc'rxon in the course of doin ;q business shall Aiic>~\ingl! and intentionallv expose anv indi\-idual to a chemical hnolvn to the sta;e to cause cancer or reproducti\,e tox- lcit\, \vithout first gi\,ins clear and reasonable lj~arn- ins to such indi\idudl." The laljwlit specificall>, lists 46 chemicals referred to as carcinogenic constituents of tobacco smoke and 8 (arsenic, cadmium, carbon disulfide, carbon monoxide, lead, nicotine, toluene, and urethane) as reproducti\.c toricants. The tit\, attornev's complaint cite< a nuinbei of prominent government studies: 7`/1~, HPO/~~I CO,IW ~jiic'lws ofIw~~lii~ltnr,t/ SljwkirlS, the lY86 report of the U.S. Surgeon General on smoking and health; Elli'/r.rlil,r2c',it111 fiJh7cco S~~mx-~~: Mens~rri,~~ E.r/~cw~irc~; 171111 Aw~~ir~<~ H~wltl~ Eif~cts, published in 1986 bv the National Research Council; X~~s/ljintorq H~nltl~ Efik-t~ IJ~ I'~75.~i;v SJrrcJkiJ~;;: LlirlS Cflrlccl- izliif Otiw Diwr-df,r;, a report issued bv the C.S. Environmental Protection Agwcv in Januarv iYY3; c111d H~~7ltl1 Ef(trfs of ES~TCIS~LTL to E,lill,.orllllr'rlt~7/ Toht~~~(~ _. ~~~wX-~~, published bv the California En\ironmcntaI Pro- tection Agency in September lYY7. The complaint al- leges that "N&withstanding this ovemhelming boci~ of governmental information, and notlvithstanding their W\I~ kno\vledge of these facts since at least lY81, the T~~ICCO Defendants ha1.e each know?ngly and intention- ~11I\, concealed from, and thercbv decei\~cd, e\-cry non- imoking individual exposed to en\ironmentaI tobacco illloke bv the sale and use of tobacco products in Cali- fornia. Bv these acts of kno\vin g and intentional con- cealment and deception, the Tobacco Defendants, `IIlL their agents, the Retailer Defendants, have each incli\~iduall!~ \.ioIated Proposition 65" (Cdiforl7in iI. Phili{J M0/.ri4 Ir7i., No. BC 194217 [Calif., Los Angeles Cty. July 11, 19981, cifcd ii/ 13.4 TPLR 3.195 [lYYX]). The City of Los Angeles' la\vsuit will likely ben- efit from a court decision rendered in 1997 in a federal court located some 3,000 miles a\vav. A nonsmoker in Florida filed a la\vsuit against \,arious tobacco com- panies, alleging that she suffers from severe emphy- sema and an arra\- of other injuries as a result of prolonged exposure to ETS from the normal and fore- seeable use of the companies' products. The compa- nies filed a motion to dismiss her case, contending that the Federal Cigarette Labeling and Advertising Act preempts claims based on state IaM- duties to dissemi- nate information relating to smoking and health. A judge in the L'.S. District Court for the Southern Dis- trict of Florida denied the motion to dismiss, conclud- in;: that the ff~t`rdl act's preemption of state regulations "L>aseJ on smoking and health" does not prt~t~mpt regulations in\.ol\ing ETS. "The Court finds it unlikel\~ that C`ongress intended the word `smok- ing' tc> mi'atl inhalin;: second-hand smoke," since the "Congressional reports make clear the purpose of the [ tedernl act] is not to inform non-smokers of the haz- ards of breathing second-hand smoke but rather to inform smokers and potential smokers of the dangers of acti\,eI\. smoking" ( l&ol/~ir~ i'. P/~ili/~ Morris, Iuc., No. Y6-l/81-GIL'-KI,XG, 1997 WL 535218 [S.D. Fla. Aug. IX, IYY7]). The court also ruled that the federal act did not LX, implication preempt a claim based on harm from ETS (SITeda 199X). ETS Crises Ayniust h'orltobncco Parties Injunctive relief from ETS. In 1976, Donna Shimp (see "Legal Foundation for Regulation of Pub- lic Smoking," earlier in this chapter), an office worker in Ne\\, Jersey, sought inter\rention from the courts to pro\?dc her relief from exposure to ETS at her worksite (Slrijlr/l, 368 A.2d 408). The court ruled that the evi- dence \~as "clear and o\wM-helming. Cigarette smoke contaminates and pollutes the air, creating a health hazard not merelv to the smoker but to all those around her rz,ho must re@ upon the same air supply. The right of an indi\+dual to risk his or her own health does not include the right to jeopardize the health of those who must remain around him or her in order to properly perform the cluties of their jobs" (p. 415). In granting an injunction to ensure that Shimp be provided a smoke-free \\.orkpIace, the Ne\v Jersey Superior Court provided a clear example of taking seriously the health concerns of nonsmokers \vho are forced to breathe ETS. The Sl7itrr/~ decision preceded most ot the medical stud- ies that have demonstrated the ad\.vrse health effects of ETS. In the 22 vears since Q~\JI/J, Ia~vsuits designed to protect nonsmdkers from the health hazards caused by involuntary exposure to ETS ha\-e escalated. A 1982 decision from the Missouri Court of Ap- peals gave additional momentum to nonsmoking Lvorkers seeking legal relief from on-the-job exposure to ETS. In S~llit/l (643 S.W.Zd 101, the Missouri Court of Appeals reversed a trial court's dismissal of a laiv- suit brought bv a nonsmoking ivorker lvho \z.as seek- ing an injunction--a form of direct interlwltion by a court-to pre\.ent his emplover from exposing him to tobacco smoke in the lvorkpiace. The court of appeals ruled that if Paul Smith lvere to pro1.e his allegations at trial, then "by failing to exercise its control and as- sume its responsibilitv to eliminate the hazardous con- dition caused b>r tobacco smoke, defendant [Western Electric Co.] has breached and is breaching its duty to provide a reasonably safe \vorkplace" (p. 13). A- though the nonsmoking lvorker e\.entuaIlv lost his case after it ivas sent back to the trial court, the court of appeals decision remains as a precedent that t\.ill help similar cases survi\,e motions to dismiss (S\\&a 199X). The follo\zGig !`ear, a nonsmoking social \\,orker in Attleboro, Massachusetts, \j'as granted a teniporar\ restraining order (w,hich bv la\v could last no more than 10 days) against smoking in the open office area lvhere she lrorkecl ivith about 3Y c[o\vorkers. 13 of \vhom smoked. In LcXv (ciftvl i/r 1 .2 TPLli 7.82), a sup- rior court judge denied a motion bv the emplover to dismiss the case, ruling that "an emplover has no dut\ to make the it-ork place safe if, and oniv if, the risks at issue are inherent in the \\.orh to be done. Otlierl\,ise, the employer is required to `take steps to pre\.ent in- jury that are reasonable and appropriate under the cir- cumstances'. AccordingI!; this court cannot sav that plaintiff's claim fails to make out a legally cognizable basis for relief" (p. 2.83). The case lads settled in Janu- arv 19% \vhen the emplover, the Con~mon~~ealth of Massachusetts, agreed to bro\.ide the plaintiff, Marie Lee, and the other nonsmoking \\,orkers there, \t-ith a separate nonsmoking area \\,ith \-entilation separate from the \-entilation in the smoking area. As it turned out, only 4 of the office's f0 lsorkers chose to \\.nrk in the smoking area (Siveda 1998). Hnirdicay DiscrizzzirzntiozzlAzzzf~ric~zzs With Disabilities Act A new' theor!, for ensuring ETS protection for nonsmokers in\-ol\,ed using the ADA. As the ratio- nale for applving the ADA to the r\rorkplace, parmet and colleagues (1996) explained: "The ADA was en- acted in 1990 to provide a `clear and comprehensive national mandate for the elimination of discrimination against individuals with disabilities' [42 U.S.C. section 12101(b)(l)]. The act prohibits discrimination against individuals bvith disabilities on the job [42 U.S.C. sec- tion 12112(a)] and in places of `public accommodation' 142 U.S.C. section 12182(a)], as well as by state and lo- cal governments [42 U.S.C. section 121321" (p. 909). Initially, some plaintiffs did not succeed in ac-1 quiring relief from ETS under the ADA. For example, in Hnrtuc~r C. Virgi/zio Electric mil Powr Co. (831 F. Supp. 1300 [E.D. Va. 1993]), an employee suffering from bron- chial asthma sued his employer, contending that in failing to ban smoking at the workplace, the companq had violated the ADA by discriminating against him because of his disability. Harmer contended that after- he requested a smoke-free work environment, the com- pany retaliated against him by reducing his job au-- thoritv and failing to promote him. Though recogn&g Harmer's disability, the district court dis- missed the claim, saying that he "still must show that he is entitled to a complete smoking ban as a reason= able accommodation to his disability, and he is unable to do so" (p. 1306). This \vas so "because the manv smoking limitations that the employer had put in plac;, coupled \vith improvements such as the installation of air filtration devices, were sufficient to enable the plaintiff to Lvork. Of course, a patient more severeI\. disabled might have required further accommoda- tions" (Parmet et al. 1996, p. 912). In hm'y i'. Cnrni~rr of Dr~`nlil.s, f/lc. (8'79 E SUFJT 610 [N.D. Tex. 1995]), two women hypersensitive to ETS filed suit under the ADA, contending that the>- lvere effecti\,elv precluded from attending musical performances a; the defendant's establishment because smoking \x.as permitted there. After a one-day, jurv- \vai\,ed trial, a federal judge ruled against the plain- tiffs, but noted that they should have brought theil claim under the ADA's reasonable accommodation provision, instead of the section of the act that bar: the establishment of rules that "screen out" disabled people (p. 643). A different result had occurred in a case from Con necticut. In Stnrrv~ P. McLhjzn/d'.i COY/J. (51 E3d 353 136 Cir. 199533, plaintiffs brought an action under the ADA 42 U.S.C. section 12101, saying that the presence of to- bacco smoke in the defendants' restaurants was prevent ing the plaintiffs from having the opportunity to benefi from the defendants' goods and services. The plain- tiffs, all of ivhom have adverse reactions to ETS, alsc alleged that the defendants' restaurants are places o- public accommodation under 42 USC. section 12181- \ttcr a district judge granted the, deienclants motion to Jismiss the case, the United States Court of Appeals for tilt' Second Circuit rc\-ersed, ruling that "1x-e find that t~l,lintiffs' complaints do on their face state a cogni7ablr ilainl against the defendants under the Americans l\.ith l>i~,lbilities Act" (p. 3.551. The court noted that "the de- ti~miiiiation of \\.liether a particular modification is `rea- 5c)nable' in\ ol\.es a fact-specific, case-I~\.-case inquir\. tllat considers, among other factors, the cffecti\.eness of the modification in light of the nature of the disabiliti. 111 question and the cost to the organization that \IDLII~I Implement it [p. 3561. We see no reason It-h\., undei tile appropriate circumstances, a ban on smokil;:_ could ni)t be a reasonable n~odification" (p. 337). An Illinois \voman suffering from chronic se\ ere allergic rhinitis and sinusitis sought a smoke-free I\-ark ivi1-ironnient and sued her former eniplo\-er after it "repeatedI\, refused to provide" the plaintiff \\.ith a I-c,lsonable~acconi~io~lation to her disabilit\.. Afttxr til- ill:; an ADA claim lvith the Equal Emplv\~mtwt Op p~lrtuiiity Commission anJ a I\-orker'h conipensatic~n claim, she fvas terminated. A federal judge in H~~~If~vc~r. :` ~/iii:lcw rlllillirl .-hJiir7tl3~. l/Ii (No. 95 c -Llw, 1995 \\ L (383613 [N.D. III. No\.. 17, 19951) granted the dt,- ttwdants' motion to dismiss, sa\.in;: that the plaintiff "Jot5 not, and cannot, allege that hw sensiti\ iti. to IETS] substantialI>- limits her abilit!, to find empjo>.- mcnt as a typist generallv. Thus, Hornever is not a qualified indil-idual ivith a disability, and, accordingI!; 1\ not entitled to the protection of the ADA" (p. 3). Ho\ve\ er, the Cnited States Circuit Court of Ap- ptsals for the Se\.enth Circuit unanimousI\, re\,ersed the district court's rolling and sent the case back fol trial. Noting that the district court had ignored Hornever's claini that she \vas disabled in that hcl hwath&g, an essential life activity, ij.as affected bv ETS, the court of appeals ruled that "II.~ cannot sa\- it this \tase that it \vould be impossible for her to sl;ol\- that ~c'I. chronic se\rere allergic rhinitis and sinusitis either alone or in combination M.ith ETS substantiallv limits llclr abilitv to breathe" (Horllcy/o. 71. St~7111~1/ Tult'hirr il.+ Y'( ;llfc's, l;~c., 97 E3d 959, 962 iith Cir. 19&l). In October lYY7, a Ne\\. York jurv alvarded `~~(),300 to an asthmatic prison guard, Keith Muller ( \1dicr il. Cnsfcllo, No. `M-CV-832 (FJS) CCJD,, 1996 WL I'llclii [N.D.N.Y. May 20, 1996]), w.110 had been fired after he had made numerous complaints about the ef- tc'ct of ETS exposure on his health. While ser\,ing as a `ilrrectional officer, Muller had become seriously ill- l~~cluding numerous occasions ivhen he had to be taken t ! 1 `1 hospital directlv front the prison xvhere he `\orked-after being &posed to ETS. After Muller's tl.c'ating phvsician hacl recommended that he lvork in a smoke-free en\.ironment, the Nets York State Depart- ment of Correctional Services instead provided him lz.ith a mask that, according to Muller, made him even niore ill. Furthermore, Ivearing the mask had subjected Muller to lvidespread ridicule, putting him in even greater personal danger from the breakdown in the respect that the inmates had for him. Whereas a judge in 19% had barred the plaintiff's negligence and civil rights claims in Mlrllw ~1. CosfcTllo, the court allo\ved Muller's ADA claim to proceed. Ruling on posttrial motions, the judge reduced the a\vard to 5300,000 because of the cap on compen- satory damages contained in 32 U.S.C. section lWlaib)(3). The court also rejected the defendant's motion to \,acate or reduce the verdict as excessive, ruling that the "plaintiff submitted evidence of dis- crimination that had taken place o\`er a period of Vears during \\.hich time he \vas forced to endure mental suttering, embarrassment, econoniic hardship, actual termination and physical injure. In view of this evi- dciice, the Court finds that the jury alvard of $300,000 is not c\cessi\,e and does not shock the conscience as a matter of la\\." (,l/l~/ll~ ~1. Cwfc,llr), 997 F. SLIDE. 299, 303 IN.D.N.1'. 19981). In a more recent case, three asthmatic women SLI~C~ ReJ Lobster and Rubv Tuesdav restaurants un- der the ADA. The plaintiffs in Etlwnrils 7'. GMRI, Illi. (No. 116693 [Md., Montgoniery Cty. Nov. 26, 19971, c-/tvA irk 13.1 TPLR 3.1 [199X]) said that they attempted to patronize the defendants' restaurants but were forced to 1eaL.e because of the ETS there. In their com- plaint, the plaintiffs stated that the defendants' "fail- ure to establish a police prohibiting smoking in their restaurants throughou;the state discriminates against the Plaintiffs on the basis of their disability in their use and enjoyment of" the restaurants (p. 3.3). The 1990s have seen the development of cases in 1%.hich a nonsmoker li\ing in an apartment or condo- minium unit is being adverselv affected by smoke en- tering his or her d\velling sp&c from elsewhere. In June 1998, a Boston Housing Court judge ruled in fa- \.or of nonsmoking tenants ~.ho bvere being e\-icted for nonpavnient of rent W-58 Gi7ir15I~~ro1iglr Strwt Rc- irlf1/ Trrl5f tl. Rtue il/ltf Krisfv Hnik, No. 9842279, Bos- toll Housing Court [1998lj. After pleading with the landlord for sweral months to do something about the problem of smoke from a first-floor nightclub constantlv entering their second-floor apartment and disrupting their ability to use and enjov their apartment, the tenants got no relief. Attrr the\, \vith- held their monthly rent pa!,mcnts of S1,150, tll-e land- lord brought an action in housing court seeking their eviction. The court ruled that "the e\.idence does dem- onstrate to the Court that the tenants' right to quiet enjoyment [of their apartment] \vas interfered lvith be- cause of the second hand smoke that \~as emanating from the nightclub belor%r" (p. 34). The court ruled that "as the tenants describe the second hand smoke Lvithin their apartment at nighttime, the apartment would be unfit for smokers ancl non-smokers alike" (p, 7). That interference M.ith the quiet enjoyment of the tenants' apartment was a defense to the effort to evict them, Also, the court found for the tenants in the amount of $3,350-the same amount that the ten- ants had withheld over the course of three months. In Lk~orki~7 7'. Paley (Y3 Ohio App. 33 383, 638 N.E.2d 636 [Ohio Ct. App. 199311, D\vorkin, a non- smoker, entered into a one-year lease lvith Paley to reside in a two-familv d\velling; the lease leas later renewed for an additional one-vear term. During the second year, Paley, a smoker, mo\.ed into the d\velling unit below Dlvorkin's. T\VO Lveeks later, Dlvorkin lvrote to I'alev to tell her that her smoking \vas annov- ing him and causing him phvsical discomfort, noting that the smoke came through-the common heating and cooling systems shared by the t\vo units. Within a month, Dlvorkin vacated the premises. Eight months later, he brought a legal action to terminate the lease and recover his securitv deposit from Palev. The larv- suit, rvhich alleged that I'alev had breached the co\`- enant of quiet enjovmcnt and statutory duties imposed on landlords (including doing "\\.liate\,er is reasonabl\r necessarv to put and keep the premises in a fit and habitable condition," p. 387) \~a5 dismissed on a mo- tion for summar> judgment. I-lol\.e\,er, the Cuyahoga County Court of Appeals re\,ersed the dismissal, concluding that a re\ielv of the affidavits in the case "reveals the existence of general issues of material fact concerning the amount of smoke or noxious odors being transmitted into appellant's rental unit" (p. 387). The case leas thus sent back to the trial court. In June 1998, a prominent Ne\v York law firm, Weil, Gotshal & Manges LLI', sued the o\vner and land lord of the office building lvhere it is located, as \j,ell as the tenant located one floor below, because of ETS seepage into its office space. The firm alleges in its lawsuit, that as a result of the smoke infiltrating into its 29th floor offices, "some of WG&M's partners, as- sociates and employees have suffered illness, discom- fort, irritation and endangerment to their health and safety, and/or 1laL.e been unable to use or occupv their offices or lvorkstations on the WG&M 29th Floor Man\: landlords are not waiting to be sued. The Building &vners and Managers Association Interna- tional, a trade association for 16,000 office landlords and owners, has been advising its members to lessen their risk of ETS liability by banning smoking when- ever possible. During the past two years, the propor- tion of member office buildings that banned smoking increased from 68 to SO percent (White 1998). United States Supreme Court Ruling on ETS in Pvisorls -Eighth Amendment Issues Perhaps the most frequent area of litigation in- \.ol\,ing exposure to ETS has come in a setting where the exposure is both involuntary and inescapable- prisons. A landmark case that eventually reached the United States Supreme Court started in Nevada when a nonsmoking prisoner was housed in the same cell as a hea1.y smoker (McKiulwy 51. A~zdcusorz, 924 E2d 1500 [9th Cir. 19911). The nonsmoker brought a civil rights lawsuit against the prison officials, claiming that his Eighth Amendment right to be protected from cruel and unusual punishment was being violated due to his constant exposure to ETS. Although his case was thro\vn out initially by a district court in Nevada, the lawsuit \vas reinstated bv the United States Court oi Appeals for the Ninth Circuit. The court ruled that e\-en if the inmate could not show that he suffered from serious, immediate medical symptoms caused by ex- posure to ETS, compelled exposure to that smoke is nonetheless cruel and unusual punishment if at such le\-els and in sucli circumstances as to pose an unrea- sonable risk of harm to the inmate's health. On June 18,1993, the Supreme Court ruled in a 7 to 2 decision that McKinney's case could go forward. The Court affirmed "the holding of the Court of Ap- peals that McKinney states a cause of action under the Eighth Amendment by alleging that petitioners [the prison officials] have, w.ith deliberate indifference, ex-m posed him to levels of ETS that pose an unreasonable risk of serious damage to his future health" (Hc//i~l~ P. AkKi/7rwy, 113 S. Ct. 2175 [1993]). ETS aud Child Csstod!y Cases Disagreements between parents who are divorc- ing can, of course, cover a wide variety of subjects. One of the issues that has increasingly become a sig- nificant subject of disputes that have ended up before- a judge in probate court has been the exposure to ETS on the part of a child or children caught up in a custody battle. O\,er the past 11 years, there have been recorded cases in at least 20 states (Siveda 1998). One of the earliest \~as Wilk il. WI'IX- (If{ w Wili iI. Wilk, 7X1 S.W.Zd 217 [MO. App. 19891). The trial court in this case granted primary custody of the children to the mother, who had been advised by a doctor that the children, one of tvhom leas asthmatic, should not be taken to the father's home because he smoked. The fvlissouri Court of Appeals ruled that the trial court did not err in a\varding custodv of the minor children to the mother. In a case from Kansas, an ex-isif-e \\.ith custnd\~ sought permission to 1iioL.e ii.ith her children to aii- other state; the ex-husband responded \yith a motion to obtain custodv. The district court did make the change bv al\-arding custodv to the es-husband after finding &at the ex-Irife's s&oking had harmed the children. The es-\\.ife appealed, arguing that thwe had been no evidence to pro\e that her smoking had cc~used her children's health problems. The court of appeal% affirmed the district court's change of custody, notins that there Ivas e\ridence that her smoking had harmed the children: "That finding is supported b\, the testi- IIIOII~~ of three doctors that s~con&l~and smoke aggra- \.atei the children's health problems and placed them at risk for further health problems" (/\I VI' .~I~/I~~(./I[J~~, 913 P.2d 221 [Kan. Ct. App. Mar. 22, 19961). In some cases, the smoking issue is not sufficient to produce a change of custodv. For example, in H~~/uI i'. HCIIII (Ol-A-Ol-9209-CHO0363, lYY3 WL21983 [Term. Apt). Feb. 3, 1993]), the trial court a\varded custodv of ~3 five-vear-old child to the father. The mother appealed the divorce decree, arguing before the Court of Ap- peals of Tennessee that the father smoked around the child. The court said that "Other than exposure to vio- lent movies and cigarette smoke, no e\ridence is cited that the father has neglected or mistreated the child" (17. 2). The trial court's judgment \vas affirmed, with the mother being accorded visitation rights. In Bngqcff ;`. Snthcr-lnlrd (No. CA 88-224,1989 WL 5399 [Ark. App. Ian. 25, 1989]), a nonsmoking father attempted to ob- tain a change in custody on the basis of, among other things, the fact that the mother smoked in the pres- ence of children who were allergic to smoke. Although the lower court had found that circumstances were not 5~) changed as to warrant a change in custody, it did acknowledge that smoking was detrimental to the chil- dren. The mother was forbidden to smoke in the home or allow anyone else to smoke in the home; the judge "made it clear that he would exercise continuing ju- risdiction over the parties to insure compliance with that order" (p. 3). Rulings in other cases ha\re been the product of compromise. In !Vor?llclitt il. Ri'orfllcrltt, a 1997 case, a nonsmoking father objected to ETS around his 2-vear-old son, \~ho has asthma and has had repeated res 3iratorv infections, bronchitis, allergies, and ear- -k aches (Slveda 1998). As part of a joint custody agree- ment, a Warren County, Tennessee, judge ordered the mother to keep her son array from ETS. Each parent was to ha\.e custodv for six months per year. Victims of Smoking-Related Fires Smoking is the leading cause of deaths and inju- ries by residential fire. According to the Building and Fire Research Laboratory of the National Institute of Standards and Technology, cigarettes start more fatal fires than anv other ignition source, causing about 30 percent of ali fire deaths in this country. For example, in IYSY, 11,000 cigarette-ignited fires caused 1,220 deaths, 3,358 injuries, and $481 million in property damage (Karter lYY3). In lc)84, Congress passed the Cigarette Safety Act (Public La\%. Y&567), creating a Technical Study Group to assess the feasibilitv of dewloping a less incendi- ar\' cigarette. The g&p concluded that changing a standard cigarette's diameter, paper porosity, and to- bacco density \vould produce a cigarette that would not transfer enough heat to cause a fire when dropped on most upholster\; (Technical Study Group on Ciga- rette and Little Cigar Fire Safety 1987). The tobacco industr>z maintains that e\`en if such cigarettes could be manufactured, \,\rhen smoked they would not burn as thoroughly as current brands, meaning that fire-safe cigarettes \~ould deliver more tar, nicotine, and car- bon monoxide to the smoker (Levin 1987). The prospect of technologies for making less in- cendiary cigarettes raises the question of whether the manufacturers might be held liable for failure to in- corporate such a feature. Until now, product liability litigation for fires caused by cigarettes has met with no more success than smokers' claims for injuries to health. The first such case to produce a judicial deci- sion, Lnrllke ~1. Fufo~inr~ Coy. (709 P2d 684 [Okla. 1985]), involved a fire started when a cigarette ignited a sofa, resulting in severe burns to much of the plaintiff's body. The Oklahoma Supreme Court applied the so- called consumer expectation test to find that the ciga- rettes in question were not dangerous to an extent beyond what ivould be expected by the ordinary con- sumer. The consumer expectation test, which evolved from comments to section 402A of the Restatement (Second) of Torts, today sur\ri\res as the law in a mi- nority of jurisdictions (American Law Institute 1995). The prevailing \ie\v, endorsed bv the current draft of the Restatement (Third) of Torts; would determine li- abilitv for defective product design bv a risk-benefit standard that evaluates the qualitv oi the manufac- turer's design decision by revie!iing whether the manufacturer properlv \veighed the comparative costs, safety, and mechanical feasibility of one or more alter- native designs (Green 1995). In La~lke, the court found that evidence regarding the feasibility of manufactur- ing a less incendiary cigarette was irrelevant to con- siderations of consumer expectation, but such e\,idence might be found persuasive in a jurisdiction following a risk-benefit standard for determining design defects. Whether the tobacco companies suppressed research and product de\,elopment regarding fire-safe cigarettes is under investigation bv the antitrust division of the U.S. Department of Justice (Shapiro 1994~). Fire claims by smokers \~ould face many of the familiar obstacles to recovery but, as two pending claims illustrate, many of the potential plaintiffs in fire litigation are not smokers but third parties untainted by the decision to smoke. In K~~rrrc~! il. Philips Morris Cns. ([D. Mass. May 11, 19921, cilcil 111 7.2 TPLR 3.65 [1992]), suit \vas brought on behalf of a kvoman M.ho died in a fire started by her husband's cigarette. The plaintiff's attorneys focused "on the issue of additives and other manufacturing techniques that cigarette makers use to ensure that cigarettes kvill stay lit even if they aren't being smoked" (Wilke and Lambert 1992). On February 16,1996, Judge Robert E. Keeton granted summary judgment" in favor of Philip Morris, hold- ing that even under the more forgi\.ing standard of liability for design defect, "fatal gaps" existed in ev- dence submitted by the plaintiff in supporting her claim that adoption of an alternative design by the company would ha1.e prevented the fire started by Mr. Kearney's cigarette (&YZY,IC!/ ~7. P/li/i;j Mm-l-is Irlc., 916 F. Supp. 61,66 [D. Mass. 19961). Another cigarette-caused fire claim seeks recov- ery based on the fire-related injuries recei\fed bv a 21-month-old infant trapped in her child car &at (Ski~~uu~r~ ~1. Phi/i/~ Morris Cm., Cause No. 26291 [Tex., Johnson Cty. Oct. 7, 19941, iif& ill 10.1 TI'LR 3.91 [19951). Enhancing Prohibitory Regulation by Private Litigation En,forciug Minors' Access Lazus Enforcing these widespread and important statutes is typicallv left to government officials who have com- peting commitments and limited sanctioning powers. A pioneering suit, brought by tobacco activists against a Massachusetts convenience store chain, sought to supplement this ineffectual arrangement by private enforcement. The initiative first took the form of a test: case, sponsored by the Tobacco Products Liability Project, charging that Philip Morris was engaged in a "civil conspiracy" with the convenience store chain to sell cigarettes to minors. A divided Massachusetts- Supreme Court found the conspiracy unproven (Kyte 71. Philip Morris lw., 408 Mass. 162, 556 N.E.Zd 1025 [Mass. 19901). The plaintiffs then refocused the suit- directly against the convenience store chain, alleging- that it had violated the Massachusetts Consumer Pro- tection Act, which allows consumers to bring civil suits- directly against vendors for money damages and in- junctions. The suit terminated in a settlement in which the chain agreed to demand proof of age from would-m be cigarette purchasers. In 1992, the Tobacco Prod- ucts Liability Project launched a project to research the legal basis for such suits in all 50 states and to provide informational and strategic support for such litigation (LeMr 1992). After the settlement in K$c, the attorney general in Massachusetts, acting under the state's consumer protection laws (Mass. Ann. Laws ch. 93a, sec. 1) bee gan to conduct tests using minors posing as custom- ers to gauge retailer compliance with state bans on- tobacco sales to persons under 18 years of age (Mass.- Ann. Laws ch. 270, sec. 6). Settlements were reached \2-ith several supermarket chains in 1994 for monetary damages as well as implementation of measures de- signed to reduce the risk of further illegal tobacco sales to minors (Tobacco Products Liability Project 1996). By 1998, state attorneys general offices in 26 states began working M.ith the National Association of Attornevs General and the Tobacco Control Resource Ceniel (1998) to develop approaches to prevent illegal tobacco sales to minors. K,I& presents an instance of a lawyer functioning as a private attorney general to secure the enforcement of underenforced public standards. This case suggests- that restrictions on sales to minors might be enforced more effectively by establishing informational net-- works and incentives (such as the recovery of attor- neys' fees) to facilitate widespread and routine Although selling cigarettes to minors is prohib- ited in all states and the District of Columbia, retail store employees frequently ignore the law (Le\v 1992). A summary judgment is a judgment granted kvithout a formal trial \vhen it appears to the court that there is no genuine issue of fact and that the moving party is entitled to judgment as a matter crt ld\\. exertions by la\v!.ei-s. Such pri\.ate enforcement is a \j.ell-established feature of a number of regulatorv re- (rimes, including consumer credit regulations, securi- 0 I ties la\\Ts go\,erning insider trading, and bounties paid ior apprehending persons ivlio defraud the goi.eni- ment. In de\-ising such strategies, the risks of underuse, o\.eruse, and abuse must be identified to frame a scheme of incenti\,es that vields optimum results. One state's highest court has upheld the legal \.aliditv of using the civil provisions of consumer pro- tection statutes to enforce penal lal1.s prohibiting tn- bacco sales to minors. The California Supreme Court held that a pri\-ate and for-profit enterprise had stand- ing under that state's consumer protection lal\,s to maintain a pi-i\-ate action in the public interest, e\`en though the underl\?ng penal statute contained no pro- \%ions for a private right of action (Stcll~ >i)lctlr ,-ldrlic-- tio17, lric-. il. Lffch Sfow. /r7i., 17 Cal. 4th 553, 557, 71 Cal. Rptr. 2d 73i [19YH]). State and local lalvs restricting the ad\w-tising and promotion of tobacco products (see "Ad\.ertising and Promotion," earlier in this chapter) provide an- other occasion for pri\,ate initiati\.es. The California Supreme Court held that federal preemption did not extend to bar a suit claiming that the "Joe Camel" ad- \.ertising campaign targeted minors and thus violated California's ban on unfair business practices (see "A Critical Example: Joe Camel," earlier in this chapter) i.t2~777gir1i, 875 I?2d 75). This suit, like Kl/tc~, in\-ites con- sideration of the benefits and costs of the pri\.ate at- torney general device. Such an evaluation must compare the performance of pri\-ate efforts \\.ith ac- tual rather than idealized go\.ernmental regulatory ac- tixity. For example, the FTC did secure a consent decree against the Pinkerton Tobacco Company ([/I rt' Pirkertm 70hncc0 Co., 115 F.T.C. 60, 1992 F.T.C. LEXIS 35 [Jan. 9, 19921) to cease promotion of its smokeless products at a televised tractor pull. On the other hand, after FTC staff lawvers recommended in 1993 that the FTC charge R.J. Re$nolds Tobacco Company v,`ith LIS- ing the Joe Camel campaign to promote cigarettes to children, the commissioners \.oted 3 to 2 to take no action (fTC:lV~tclr lY91). The presence of pri\,ate attornew general may add to the limited resources of public ;egulators. The U.S. Department of Justice recently settled a Iat\-suit against Madison Square Garden for circumventing the 1971 federal ban on broadcast advertising of cigarettes bv placing cigarette advertising \\rhere it u,ould be dis- piayed in television broadcasts. The case ended lj.ith a consent decree in \vhich the arena admitted no rvrongdoing but agreed to remove cigarette advertis- ing from sites IThere it \~ould be seen on television (Thomas and Sch\i-artz 1995). The government's en- forcement capacity in this area could be amplified if there \vere sufficient incentives for private litigants. The International Dimension of Tobacco Litigation Tobacco Litigation Abroad The first ancl second Lva\res of tobacco litigation \vert` uniquelv L:.S. phenomena, but the third wave has an international dimension that its predecessors lacked. Only a fe\z. years after a 1990 survey reported that "there has been no history of tobacco litigation in the [European Community]" (Cooper 7 990, p. 291), counterparts of many of the third-M-ave litigation ini- tiati\.es ha\,e appeared in other countries. In Austra- lia, emplo!,ees injured by ETS have recovered substantial damages from their employers (Daynard lYY4a). A public interest group, the Consumer's Fed- eration of Australia, secured a judicial declaration that the Tobacco Institute of Australia Ltd. had falsely claim4 that "there is little evidence and nothing which pro\.es scientifically that cigarette smoke causes dis- ease in non-smokers" (Davnard 1994a, p. 60). A French public interest group, acting as private attorneys gen- eral, successfully enforced bans against tobacco adver- tisements on radio and teleirision (Gol/ulni~z P. Societc Natior7i7lf~ D'Erploi~i7tin77 It7d77strirllc de Tahncs et All771r7c~ftc~ [SE/T,-11 [Tribunal de Grande Instance de blontargis Dec. 19, 19961, cifctl irl 11.8 TPLR 3.1073 [ 1YYhj). In Canada, a class action suit based on addic- tion \%`as filed against Canada's three largest tobacco manufacturers. To sholv that the tobacco companies knr\v of nicotine's addictiveness, the suit relied on documents unco\rered in the United States Wan Rijn lYY5). In England, the Legal Aid Board granted cer- tificates of eligibility for legal aid to fund 200 cases brought bv smokers alleging that tobacco manufactur- ers had failed to meet their legal duty to minimize the risks of smoking (PR Newskvire 1995). Legal Aid`s \i,illingness to finance the litigation comes after a three- year battle for funding, led by the British group Ac- tion on Smoking and Health (Milbank 1995). Foreign Plaintiffs ilz the American Courts Overseas sales are an increasingly important sec- tor of the American tobacco industry: exports grew from 8 percent of total production in 1984 to 35 per- cent in 7YYh (MacKenzie et al. 1991; U.S. Department of Ag-iculture lY%). The absence of lvarnings on the packaging of exports and the aggressi\ e promotional acti\-it? might help foreign plaintiffs \I-ho brought claims in U.S. courts ol'erconic some of the barriers that ha1.e protected tobacco companies from domestic plaintiffs. Holyever, such litigation r~ould face other formidable obstacles, including the problem of estab- lishing a substanti\rt right to reco\`er according to for- eign law and an expanded notion of the responsibilities of multinational corporations for merchandise sold o\`erseas. Such an expansion seems unlikely in the light of the reluctance of U.S. courts to provide a fo- rum for foreign victims of corporate misconduct. This reluctance was dramatized in the litigation arising from the 1984 chemical plant explosion in Bhopal, 1~ dia (Jasanoff 1985; Cassels lYY3; Calanter 1994). Al- though the U.S. courts decided that the case should be tried in India rather than in the United States ([II IP' Ll/ricl/f cd~idc~ c~J!`/l. G175 I-1 /f7/lt Di!i.i75tH 17t ~hOj"71, I,l,fii7 irl Deimlw~, 19&i, 634 F. Supp. 8-12 [S.D.N.\i 1%6], izff'cl it! prt 809 E2d 1 Y5 [2d Cir. 19871, c-c~`t. ~l~/~ic~l, G-X C .S. 871, 10X S. Ct. 199 [lYX7]), the L'.S. parent cornpan! ITas required, as a condition of moving the case to India, to submit to the jurisdiction of the Indian courts. A number of rulings in the Bhopal litigation also cre- ated the basis for enhanced liability of U.S. multina- tional corporations for their over&s operations. In a later proceeding, a U.S. court ackno\zledged that a for- eign government might establish itself as the esclu- si\-e representative of \.ictinis of a mass tort (R~?rlo Ri ;I. LIt~ioi~ Cilrl~l'tft~ CIWII~. LT Ol~istiis Co., 984 F.23 582 (3d Cir. 19931). If any of the current third-It-al-e claims flourish, foreign claims lvill likelv be presented to U.S. lalvyers and filed in U.S. courts.. On Mav 12, 19Y8, the Republic of Guatemala be- came the first nation to file a Iall-suit against the U.S. tobacco industry for the recovery of public health care expenses (Davis 1998) (Gi~~tcr~~~~ln ~1. Ti)l~ic.cj l~l,fitl~tc, [D.C. May 12. 19981, zitcd i/j 13.3 TPLR 3.121 [lY%]). Counterthrust: Tobacco Industry Initiation of Litigation and Other Tactics In its 1993 la\t.suit filed in U.S. District Court in Greensboro, North Carolina, the tobacco industry accused the EPA of using improper procedures, inclu& ing statistical manipulation, to arri1.e at a predeter- mined conclusion and sought "a declaration that EPA's classification of ETS as a Group A [kno\vn human1 carcinogen and the underlving risk assessment are arbitrary, capricious, vio1atiL.e of the procedures re- quired bv laiv, and unconstitutional" (FIIIPCIIWII K~Pnxr~ CtwjJt'ri7fii'L' Sfabili~nfio~l Corp. i'. UJlifrLf sti7tes. Etwirnfl- \rrr,rtnl PnJtrv-tiorr AScrrcy [M.D.N.C. June 22, 19931, cited i/l 8.2 TPLR 3.97 [1993]). As discussed earlier in this chapter (see "Health Consequences of Exposure to ETS"), on July 17, 1998, U.S. District Judge William L. Osteen Sr. issued a ruling whereby the court annulled Chapters l-6 and the Appendices to EPA's Rrspir~tory Htvlth Effects of Pmsiuc Snmkir~g: LUJI~ Cn~mr nrzd 0th~ Disodcrs (EPA 1992; Meier 1998b). The judge reached his conclusion only after having denied the EPA's mo- tion to dismiss the case even though the EPA had never taken, and indeed had no authority to take, final agency action (e.g., the adoption of a regulation restricting smoking) based on its report (F/wCurd Tobacco Coop- c~r'~7fiw Sffltli/iznfiorl Corp. P. Clrlifd Sfates E~wirafzrw/zfn[ Prc~ft~ctior~ AXLVC!/, 857 E Supp. 1137 [M.D.N.C. 19941). This lawsuit, filed in 1993, was not the first in- stance of the tobacco industry attacking scientists and their rzrork on ETS. Internal industry memos were cited in an article in April 19% in the !&/l .%wf ]OUYH~/: "Determined to keep reports about second-hand smoke from mushrooming, the tobacco industry mo- bilized a counter attack in the mid-1980s to systemati- callv discredit anv researcher claiming perils from passi1.e smoke" (Twang 1998). In a February 25,1985, letter, Anthony Colucci, who was a top scientist at R.]. Revnolds Tobacco Company, wrote to H.E. Osmon, a dir&tor of public affairs at R.J. Reynolds: `I. we an- ticipate that if [then-EPA scientist James] Repace runs true to form there \viIl be a good deal of media copy \z,ritten about their [Repace's and naval researcher Alfred LoMyrey's] analyses and thus wc should begin eroding confidence in this w,ork as soon as possible" (H\z.ang 1998). A British-American Tobacco Company memo from lY88 details a meeting at which Philip Morris unveiled its plans to organize the "selection, in all pos- sible countries, of a group of scientists either to criti- cally re\,ie\v the scientific literature on ETS to maintain controversv, or to carry out research on ETS. In each countrv a group of scientists lvould be carefully se- lectecl,-and organized by a national coordinating sci- entist" (Boyse 1988, p. 2). The Philip Morris plan begins by draining up a list of "European scientists wrho have had no previous association with tobacco companies" (p. 2). The scientists are then contacted and asked if they are interested in problems of Indoor Air Quality: tobacco is not mentioned at this stage. CVs are obtained and obvious "anti-smokers" 01 those M.ith "unsuitable backgrounds" are filtered out. The remaining scientists are sent a literature pack containing approximately 10 hours of reading matter, including "anti-ETS" articles. The\ are asked for a genuine opinion as independent consultants, and if thev indicate an interest in pro- ceeding further a Philip Morris scientist makes contact. Philip Morris then expects the group of scientists to operate ivithin the confines of dcci- sions taken by PM scientists to determine the gen- eral direction of research, r\,hich apparentI\. \I-ould then be "filtered" L7y la\vyers to eliminate areas of sensitivity (p. 3). As this obserlw notes. "Although the industr\. is in great need of concerted effort and action in the, questionable" (Boyse lYW,`p. 27-l. Chapman (IWT) has described this 198X memo as one that "pr~~mi5e.s to blo\v apart the facade that the tobacco industr\ carries out neutral research into passi1.e sniokins" (p. I S6Y). A study published in Ma\- IYYK in tht> /~~1/~.~~111 cli t//c ArrwriiIT,! -Mdiid .-\~sclillllj~ll,-(Bdl.nt"; and Bern 1 `NX) concluded that of the 31 percent (3`) out of 106j oi ar- ticles re\.ie\ved that concluded that ETS is not harmful tn health, 7-l percent (2Y out of 39) of these \\ere \\.ritten by authors ivith tobacco industrv affiliations. In this surve!; the authors included articles \vhose stated or implied purpose \zas to re\-ie\\- the scientific cx.idencc that ET5 is associated mith one or more health outcomes. rirticles were excluded if thev did not focus specificnll!~ on the health effects of ETS or if thev \sere not \vritten in English. The authors noted, "In Inultiple logistic rc- gression analvses controlling for article qualit!; ptw revierv status,-article topic, and year of publication, the 0nlv factor associated ivith concluding that paisi1.c smoking is not harmful leas Lvhether an author \j'as affiliated \vith the tobacco industrv" (p. 1566). The au- thors also found that the "conclusi& of re\.ie\v articles are stronglv associated with the affiliations of their ELI- thors. Authors of re\ie\v articles should disclose pu- tcntial financial conflicts of interest, and readers should consider authors' affiliations i\,hen deciding ho\z. to iudge an article's conclusions" (p. 1366). Other Idusty-Syorrsored Oyyositiolr to Stntc Tobacco Control lllitiativrs lzmi Advocates Tobacco interests have used the courts proactively against other measures to prel'ent smok- iilg. The proliferation of third-rvnve litigation against the tobacco industry has been matched by a more ag- :$essive use of litigation bv tobacco interests. For VY- alnjple, the industry and iis allies filed a prccmpti\-t` ~lldllenge, on state constitutional gro~~iids, 10 the Arguably,, the most s\veeping litigation measure taken by, the tobacco industry ~vas initiated on August IO, lYY?, \vhen Philip Morris and others filed suit to block the FDA from regulating the sale, promotion, and distribution of cigarettes to minors. Discussed earlier in this chapter (see "Further Regulatory Steps"), the suit challenged the agenc\r's authorit\ to regulate ciga- rettes under the Federal Food, Drug, and Cosmetic Act. The la\rsuit further charged that the proposed regula- tions \vould violate the tobacco companies' freedom of speech and xvould impair their ability to compete (Collins lYY5b). Tobacco companies ha\,e also used litigation tac- ticdllv to iimpede the flon- of darnaging information. Bro\v~n & Willianxon Tobacco Corporation brought suit against a paralegal aide accused of stealing confiden- tial and potcntiall~~ incriminating documents ilVj/flft, Torrilrlf & COIII~S 7'. h'ilh7777s, 8Y2S.W.2d 5X4 [Kv. lY%]). The documents, scxme of xhich w'ere ultimately ob- taintvl Lx. members of Congress, ha\ t` sho1z.n that the tob,\ic~~-m,,nui,lc~tu~-t'r~ not c~nlv knc\v of both the addiiti\,tx and the ial-cino;gtwic prc~yerties i>f tptmding on the outcome of a litigation, similarly situ~ilted injurd parties, for example, may abandon or mcdih-or con\-ersely, inay decide to continue-their ri5h-cl'edting beha\.ior or may be either encouraged to make ~~ Iq+il claim or discouraged from claiming. Law- I crs ma\ be encouraged to mount or discouraged from &ountii;;: claims or defenses. Unin\,olved actors (such ds pi>tcn&l business partners) 1~1~0 anticipate dealing 11 ith parties or potential parties may respond to liti- CT ition signals b\, mdif\ing (or e\`en terminating) their h` dc,ilin;ls \\.ith those parties. Such signals may be de- r-i\ cd not onI\- from ,iuthoritati\.c decisions but also frc>m the pro&s of the litigation itself, Lvhich may ex- hibit ad\.antages to be gained or costs to be a\,oided. For example, iie\\`s organizations \.ielving the fierce and e\pcvisi\.e industr\f response to critical depiction ni;1\. hesitate to yortrav industrv practices negatively (Fr&dtmnn and Ste\.e& 1995). . Xlore often, third-,,,d,.e tobacco litigation pro- \-ides dramatic e\.idence of the indirect, dnticipatory effects of litigation on reducing tobacco use. In early 1995, three pron-tinent manufacturers recoiled from business dealings \vith cigarette makers to avoid the rish of getting embroiled in liability litigation. The .M~in\~illc Corporation sued R.J. R&nolds Tobacco Company for a declaratory judgment that the corpo- ration does not have a contract to supply fiberglass for cigarette filters (Appleson 1995). A fexv days later, Harlev-Davidson, Inc., responding to a 1993 suit by the Lorillard Tobacco Company to enforce an agree- ment licensing the rnoforcyclc maker's name for a brand of cigarettes, countersued, alleging that tobacco liability risks reduced Lorillard's ability to fulfill its contract (Rose and Hlvang 1995). Papermaker Kimberly-Clark Corporation (which had been named a dct'endant in the West Virginia health care provider suit), the x4,orld leader in tobacco papers, decided to sell its cigarette paper business. The company denied that liability fears or shareholder acti\%m played any part in its decision, but anal>`sts said that such con- cerns tvere dominant factors (Collins 199_?a). Other companies, such ds Pfizer, ha\,e dopted policies "pro- hibiting units from doing business tlrith Big Tobacco dnd its suppliws" (Mallory lc)93, p. 39). .~llL3tllty set ot ,liti~rs rt5ponsi\ c` to 5ignal5 about liability arc in3urer5. I'rt5ulllabl~~, \ irtuall!, ,111 of the suppliers and professionals \\-hco ser\`e cigarette mak- Cl-S Ccll-n` liaI?ilit!* insurance. Pht? tOhCC0 lll~1lllfZlCtLl~- crs themsel\.es ha\-e been insured for at least some liability risle, altllougll the iilllOullt 0t' insurance co\`- erase of the tobacco companies is unkno\z.n (Reidv and Carter lYY5). lf an!; of these insured parties are found liable for promoting or sellin, 0 tobacco products, the il7t;Llrers ccjil be e\pt~cted to contest Cot erase, using aS defensty against liability to the insured llldllv of the same arguments that plaintiffs use to establish the li- ability of the insured. If, tor example, liability involves attribution to the industry (It I\llLliVldgc Of a CZlLlSill link to disease or concealment of that information, then to defeat col'erage, the insurer ma\' likelvise claim that the insured had \\~ron#ullj~ and kilo\\-insly obtained co\-el-agf fL)r J business practice lvhose dangers xvere concealed from the insurer. "In effect," note tivo ana- Ivsts, "the insurance industrv L\.ill ha1.e to pro1.e the \`erv thing the polic\.holder -is trying to deny in tile tobacco-related suits" (Reid,, andCarter 1995, p. S38). Thus a "breakthrough" bv tobacco plaintiffs may lead to a "second front" of liability battles bet\Veen tobaCC0 defendants and their insurers. Indeed, in lC)Yh. Imperial Tobacco Limited (No. j00-05-01~08~-Yh~ [Canada S. Ct., Pro\. of Quebec, Dist. of Montreal Jan. 12, IYYhl, c-lfc'ti irk 11. 1 Tl'Lli 3.3`1 [ IYY~]) filed suit in the Superior Court of Queb~i a g a i ii s t t iv 0 To r 0 ii t 0 - I2 a 5 e d I i d b i 1 i t \' i n 5 u r rl n 5 t' comy~l~~ies-A~~~erii;ln Home Insuranic Cr)mpan\, and Commercial Union Assurance Cornpan\, of Cai7ada-demandi~~~ that the!. pa>' legal CO~tS~dllcI any damages arisin;; from a clays action suit filed against Imperial in Ontario b\. \,tr. Da\-id CapLIt<) and three other persons in IYYj. The Canadian class I1c- tion suit, \\,hich has not Fct beell resol\-ed, See!+ ~ldlll- ages on behalf of nicotine-acidicted persons \t.hr-, ll~l\Y suffered because of their addiction to nicotine. lrnpe- ria[ claims to ha\.e hacl policies issued b\, the insurers obligating them to reimburse Imperial for ICgdl i,)StS incurred in the class action and to pa\' dll\' turther cost4 thev may incur in this matter. The tobacco compan!. is, in essence, asking the Superior CoLlrt of QLIebec ford declaration that the ti\-o named insurance companies must pav all of Imperial's It,` )`711 ices and all SLlI-llS a,-ardeJ b\i an e\.entual finding of liability b\, the Olltario co& c fih~ccc~ f'r~~f~rcf~ Lifr;, 011 the jLttLil-e profitability and sol\,enc\. of the tobacco COIlI- patlies. T&~,lcco cases are close]\, tracked bi, ini.est- ment an,il\,sts, and "t'\.en intcrinl-e\.rnt5 in pi`ripheral cases can propel share prices in one direction or an- other" (Orcv 1495, p. 7'0). The overhang of potenti,il liability cas;s a shadow on tobacco stocks. Opinions differ about just hovv much these stocks are discountecl for liability, but there is general agreement that the re- mo\.al of the liability shadow would be worth man\! billions in increased stock value. This volatile corubj- nation of possible liability and latent value means that any breach in the previously impregnable liability, ramparts ~~oulcl inaugurate a period of pronounccci instability among tobacco investors. Some analysts imagine a zone of agreement that would locate a com- prehensive settlement, which would in turn unlocl\ the unrealized value of tobacco stocks while provid- ing generously for the victims of tobacco. Howetrer, because present litigants cannot preclude future plaintiffs, it remains unclear whether litigation can provide the finality and closure that a comprehen- sive settlement would require. Litigation can set off ramifying effects and in general advance a formerlk sluggish or obstructed state of affairs, but it is not clear whether it can contain these effects or design an all-encompassing resolution or policy. Criminal Proceedings Another arena in which attention is being given to the acti\,ities of the tobacco industry is the criminal justice system. Since lYY5, the C.S. Department of Jus- tice has conducted an ongoing investigation of the al- lt>ged \.ioIation of federal criminal laws by tobacco companies, tobacco company executives, tobacco inclListr~-sLlppclrted trade and scientific associations, and other entities that have conducted business M'ith the tobacco industry. The Justice Department initiated a formal in\,es- tigation of the tobacco industry in response to the fil- ing in 1YY-l of a comprehensil~e legal analysis, referred to as a prosecution memorandum, by Representative Martin T. Meehnn (D-MA) kvith the U.S. Attorney Gen- eral (t-lohler 1YY-I; Mallory 1991, 1993; Meehan lY91; Schlvartz 1c)Y-l; Miga 1995; Reuters 1996; Rodriguez and Taylor lYY8). The prosecution memorandum pe- tition& the Justice Department to consider allegations that tobacco companies, tobacco company executi\.es, and others had \.iolated multiple criminal la\vs by pro- \-iding false information to the FDA and the U.S. Sur- geon General (18 U.S.C. section I001 ), committing perjury- in testimony before Congress (18 U.S.C. sec- tion IQ1 ), perpetrating mail and \Vire fraud (18 ti.S.C. sections 1341 and 1313, respectix.ely), engaging in de- cepti1.e ad\.ertising practices (15 ti.S.C. section 52), and \.iolating federal conspiracy and racketeering law,s (18 L .S.C. sections 371 and 1962, respecti\.ely) (Meehan 1994; Shane 1997; Cor/70r0f[~ Crirlti, Rf~prff~r 1998; Clifford E. Douglas. The criminal in\,estigation of the tobacco industry. Speech to the 13th Annual Confer- ence of the Tobacco Products Liabilitv Project; Mav 31, - 1998; Boston; unpublished data). Nature, Extent, and Focus of the Criminal Investigation The Justice Departmtnt'q in\.estigation began `as a preliminar~~ inquire focused on nlleg?d perjur\. ari>- ing out of testimonv deli\ wed under o;lth b\, Se\.t'tl :obacco comp nv execu tiws l\,ho stated before a con- gressional subc&mittee on April 14, 1994, that the\, did not believe that nicotine is addicti1.e. The initi;ll inquirv was later expanded to a formal grand jurv in- \.estigation to address broader allegations that tobacco, companies had, among other things, \iolatcd 1 S L .L;.C. section 1001. Section 1001 prohibits the making ot f,3lsc stc3tc- men& to agencies and officials of the federal go\.erii- ment (Hilts 1995; Novak and Freedman 19Y5; Appleson 1996; Blum 1996; Freedman 1996; Thomas and Sch\vartz 1996; Stohr 1 YY7). In contrast to the le\,cl of proof required for a she\\-ing of perjur); section 101) 1 does not require a sho\2%ig that a person ktio\vingl\r lied under oath. It alsoallo\vs prosecution for the witI;- holding of information. Besides addressing potential section 1001 \riolations, the in\,estigation continues to focus on other allegations of criminal conduct, includ- ing fraud, conspiracv, and racketeering (Cole and Tay- Ior 19%; Car-pwatr Ct'irw Rcprfcr 1998; Da\,is and Duff! 1998; Douglas, unpublished data; Duffy and Taylor 1998; Meier 1998~). As of mid-1998, txvo federal grand juries \vere con- sidering evidence of alleged tobacco industry \vrong- doing. One grand jury was assigned to hear evidence presented by prosecut& from the Fraud Section of the Justice Department's Criminal Division regarding the broad allegations of criminal misconduct described abo\,e. The second grand jurv \\`as assigned to review information presented bv the b.5 attornev for the East- ern District of Ne\v York: The \vork of thesecond grand jury concerned a related criminal in\Testigation Lvhose focus is an alleged conspiracy by major tobacco manu- facturing companies to suppiess legitimate medical re- search and promole biased research through the itldustrv-sponsored Council for Tobacco Research. The Justice department coordinated these complementar); investigations (Cohen and Gevelin 1996; Thomas and Schrzartz 1997; Da\,is and Duf;v 19%). A third criminal investigation was begun in 1995 to determine \vhether a major cigarette manufacfur- ing company may have committed securities fraud by failing to disclose all it knew about nicotine. Under securities lal\-s, companies are required to disclose sig- nificant information that may affect their stock price. The third in\.estigation was initiated by the U.S. attor- ney for the Southern District of New York, following the publication of an investigative news article that reported that, based on a revie\\r of 2,000 pages of pre- \-iwtsl\, undisclosed documents, Philip Morris Com- panic; Inc. had conducted many years of secret rescarih into the pharmacologic effects of nicotine on the hut31~3n brain and central nervous system (Freed- man and Lambet-t 1995; Hilts and Collins 1995). The securities frc3~td in\.estigation subsequently was con- \olidated \\.ith the main Justice Department investi- gation (Philip Morris Companies Inc. 1998). Federal prosecutors have interviewed witnesses, compiled comprehensi\-e company dossiers, and is- suej subpoenas, all under the supervision of the U.S. .Attorne\. General. Selw-al of the major cigarette manu- tdituriiig iomptiies, such as R.J. Revnolds Tobacco Cornpan!. and Philip Morris Companies Inc., as well as others, confirmed publicly that they are the subject of Wet-al criminal investigations relating to the mat- ters described abo1.e and that employees of the com- panies ha\,e recei\.ed requests for information, including orders to produce internal documents and subpoenas to testify before the grand juries (Goshko 1995; Hilts 1995; Miga 1995; Associated Press 1996a,b; Bloomberg Business Nexus 1996a,b; Federal Filings- Do\\ Jones Nc\z,s lW6; Johnston 1996; Jones 1996; Reuters 1996: Thomas and Schwartz 1996; Tribune Ke1z.s Ser\,ices 1996; Weiser and Schwartz 1996; Shaffer 1997; Philip Morris Companies Inc. 1998). In an April 1998 announcement that it had reached a cooperation agreement with a cigarette manufacturing company in support of the criminal in\,estigation, the Justice Department identified five main subject matter areas on which it was focused (U.S. Department of Justice 19%). These were industry kno~~ledge of the health consequences of smoking cigarettes and the addictive nature of nicotine; the tar- geting of children and adolescents by the industry; the manipulation of nicotine by the industry; control of research by the Council for Tobacco Research, includ- ing special projects conducted under the auspices of the council; and la\v);er involvement in directing re- search or crafting false or misleading statements by any of the tobacco ckmpanies to the Congress, the FDA, and the American consumers concerning the above. The announcement ot the cooperation agreement leas interpreted by legal experts as a sign that the crimi- nal inr,estigation \vas accelerating and the Justice De- partment \vas likely lo file broad conspiracy charges against major cigarette companies in the future (Cole and Taylor 19%; Cor/wrufv Crir~rc Rqwrfcv, IYY8; Dou- glas, unpublished; Duffc and Tavlor IYYK; Keil 1YY8; Lwin and Ostrotz. 1998;~Sch~vart; 1998a). Key Sources of Evidence The gathering of evidence by the Justice Depart- ment was advanced by the increased availability of an array of outside resources. These included the results of the exttnsi\re in\,estigation of the tobacco industrv conducted by the FDA from 1991 to 19%. The FDA's administrative record and investigative files lyei-e made al.ailable to the Justice Department, pro\.iding prosecutors and in\.estigators w.ith a significant hod! of information concerning tobacco manufacturers' knowledge of the addicti1.e nature of nicotine and of the manipulation and control of Ihe substance (Fc~l~~r-~rl RC~ijff'f 1995b, lYY6). I Another important source of information for JUS- tice Department officials \vas the \.oluminous hearing record procluced o\.er a l&month period in IYYJ bv the Subcommittee on Health and the En\~ironment &f the Committee on Energy and Commerce in the U.S. House of Representati\.es (19Y5a,b,c,d). The subcom- mittee, chaired bv U.S. Representati\,e t-lenr!, A. Waxman (D-CA), yield numerous hearings in \\.hich testimony \vas obtained from a \-arietv of ~vitnesscs, including the commissioner of the FDA, other federal government health officials, experts in nicotine addic- tion, tobacco company representati\ es, and former tobacco company scientists, among many othc23. In addition, Representative lVaxman made available bun- dreds of prer-iously secret nicotine research docume:i ts from the largest cigarette manufacturer by reading them into the public record on the floor of the House of Representatives in Julv 1995 (Associated Press 1995; C~~)~gw.ssio,lr~/ RrTiclr[l lYY%a,b; Schlz-artr lY)c)5). A third significant source of e\,idence in suppwt of the Justice Department's criminal inx~esfigation lvas the emergence of internal tobacco companvhx- ments and testimonv obtained in pri\,ate lal\.suits brought against tobacco industry defendants. Start- ing in 1994, these civil cases xvere initiated by state at- torneys general, private classes of allegedly addicted and injured smokers, and individual plaintiffs, as de- scribed earlier in this chapter (see "The Third Wa1.e of Tobacco Litigation"). The simultaneous litigation of numerous civil suits and the Justice Department's pursuit of its criminal investigation have produced a notable synergy. Millions of pre\riously undisclosed tobacco industry documents that were obtained through the discovery process in civil lawsuits became, in many instances, readily accessible to federal pros- ecutors (Curriden and Rodrigue 1997; Geyelin 1998; Meier 1998~; Rodriguez and Taylor 1998; Scherer and Ryba k 1998; Schwartz 19%~). Initial Results of the Criminal Investigation The Justice Department's ongoing investigation resulted in a first conviction in 1998. Under the terms of an agreement with the government, a biotechnol- ogv company, DNA Plant Technology Corporation, pliaded guilty to a misdemeanor charge of conspir- ing to break a law that had made it illegal to export tobacco seeds. The company was found to have cl>- gaged in such unlawful conduct in cooperation with a leading cigarette manufacturing company, identified as an unindicted coconspirator, with whom it had contracted to patent and develop a genetically altered tobacco code-named k-l, M-hich contained appioxi- mately twice the nicotine of ordinary tobacco. Accord- ing to the Justice Department, the prosecution memorandum submitted by Representative Meehan, and the FDA, one of the goals of the cigarette con- pany in conspiring with the biotechnology company ~\`as to de\,elop a reliable source of supply of high- nicotine tobaccos that could then be used to control and manipulate the nicotine levels in several popular cigarette brands (Meehan 1991; Failers/ Rqi.sfcr 1995b, 1996; Meier 1998d; Neergaard 1998; Schwartz 199Pb; Schn'artz and Connolly 1998; Taylor 1998; Taylor and Rodriguez 19%; Weinstein 1998b). Beginning in 1997, the threat of criminal liability led certain individuals associated lvith the tobacco in- dusty, such as Thomas S. Osdene, Ph.D., former Di- rector of Research for Philip Morris Companies Inc., and Roger R. Black, current Director of Leaf Blending for Bran-n & Williamson Tobacco Corporation, to decline to anslver questions under oath, choosing instead to invoke the Fifth Amendment right against self-incrimination (Gevelin 1997; Meier 1997; Weinstein 1997a; Anderson 1998). Some officials sought immu- nity from prosecution in exchange for their coopera-- tion. Such offers \vere met with mixed responses from the Justice Department. Typically they were rejected, but in one publicized instance a request for immunity \vas granted (Geyelin 1997; Stohr 1997; Weinstein 1997a). The Justice Department granted immunity to Janis A. Brax.0, a scientist formerly with DNA Plant- Technology Corporation and coholder of the patent for a high-nicotine tobacco plant called Y-l, del,eloped for Bro~-n & Williamson Tobacco Corporation. prognosis for Future Actions Through the Criminal Justice Process Federal prosecutors possess considerable discre- tion both in terms of bringing charges against alleged r2-rongdoers and, in the t\rent a strong case is dew- aped, in seeking concessions from criminal targets in the plea-bargaining process. In light of these options, the Justice Department may seek to require tobacco manufacturing companies to modify their ad\,ertising ancl marketing practices so as to render them unap- pealing to young people, stop manipulating nicotine or using nicotine-enhancing chemicals, pay the fed- eral government significant monetary penalties, and submit to regulation by the FDA (C~/X~JX~~~ C~irlw RI,- IwrYtlr 1998; Douglas, unpublished data ). Gi\ren the breadth and complesity of the crim- nal investigation of the tobacco industry, as \vell as the substantial burdens of proof that prosecutors must satisfv pursuant to the federal criminal statutes noted abov;, it is not possible to predict the outcome of the current criminal investigatik.e process. From its incep- tion, the investigation \vas anticipated to be a lengthy, complicated operation, in part because of the government's responsibilitv to process and re\.itw millions of pages of documents obtained from the to- bacco industry and other sources (Thomas and Schwartz 1996). With the Justice Department's accumulation of a growing bodv of evidence, including company documents and-grand jury testimony, as well as the cooperation of the Liggett Group Inc. in support of the government's investigation, some legal experts have described the investigation as likely to result in further action (Cole and Taylor 1998; Cor/~or,atc CrirlltT Reporfr~ 1998; Douglas, unpublished data; Duffy and Tavlor 1998; Keil 1998; Levin and Ostrow 1998; Schwartz 1998a). One recent indicator that the issu- ance of indictments might be near was the delivery by Justice Department officials of letters to Brown & Williamson Tobacco Corporation and its officials, for- mally notifying them that they are the targets of a criminal investigation and that they face possible prosecution (Davis and Duffv 1998; Meier 1998~; Milrll ' Stwrf ~ollrr?n/ 1998). Further criminal action against the tobacco in- dustry also raises the likelihood of diluting the influ- ence of the industry's political lobby, thereby strengthening the abilitv of public health proponents to advocate for more `stringent regulation of the manufacture, sale, distribution, advertising, and pro- motion of tobacco products (Douglas 1998). Comment After 40 years in lvhich two waves of product liability litigation proved unavailing, there has been a recent upsurge of in\,estment and innovation in to- bacco litigation. This third \vave of litigation departs from its predecessors in various wavs: . It mo\`es away from exclusi\,e reliance on smokers as plaintiffs, because so many cases have been de- cided against them as the victims of their own, in- formed behavior choices. Plaintiffs now include states, cities, pension funds, priaiate health care pro- \,iders, and persons exposed to ETS, none of whom can be blamed for smoking in the face of warnings. o It multiplies the range of legal issues. Instead of focusing exclusively on common-law tort doctrine, third-\va\~e litigation also invokes various statutory claims under consumer, antitrust, and other pro- tecti1.e legislation. o It expands from the classic private lawsuit by a dis- crete plaintiff to the class action device. o It expands from solely seeking monetary damages to including claims for injunctive relief, medical monitoring, and the recovery of attorneys' fees. o It shifts from a pure model of private law to mixed strategies in lvhich private law is used to effectu- ate public policy by defending public fiscal inter- ests and by enhancing the performance of statutory and regulatory controls of tobacco. . It enlarges the roster of claimants' lawyers from those M'ho specialize in representing individual plaintiffs in personal injury cases to include mass tort specialists and entrepreneurial securities class action 1aMyers. These attorneys, who typically practice in larger firms than individual plaintiff at- torneys and have greater financial resources, are joined in more complex coalitions, including alli- ances M'ith government lawyers. Considerable uncertainty surrounds each of the several third-wave litigation initiatix-es and their potential contribution to reducing tobacco use. The prospect of using private law in these ways has cap- tured attention only recently. In a wide-ranging 1993 revie\\, of tobacco policy (Rabin and Sugarman 1993), virtuallv all of the attention to private law was devoted to smokers' product liability litigation. The ne\ver le- gal theories that are no~v a\.ailable to plaintiffs have considerable potential. Just ho\~ these initiatives will fare depends both on developments within the legal system and on forces outside it. Normally, la\z incorporates and reflects public opinion. In a setting Mhere smoking declines and be- comes disreputable, particularly among the educated and influential (Zimring lYY3), where smokers are in- creasingly \,iewed either as victims of coercion and addiction or as a minority group becoming more dis- tanced from others (Gusfield lYY3), and where evi- dence accumulates that the tobacco companies aggressively recruit new smokers and suppress knowl- edge of harmful effects of smoking, the law can be ex- pected to respond to pressures to extend accountability and to provide remedies, if not to smokers then to those who are otherwise adversely affected by smoking. However, other forces are working against an enlarged role for the civil justice system in the effort to reduce tobacco use. Important groups, displeased with the expansion of legal accountability, hai.e mounted a protracted and influential campaign to curtail the civil justice system and \\Teaken the position of claimants within it (Galanter 1993, 1994). Apart from these ex- ternal constraints, the \Tery magnitude of tobacco injurv-the vast number of potential claimants involved-raises apprehension about the courts' in- stitutional capacities to respond. Driven by the desire to conserve their scarce resources, courts \vill find \vavs to ration the judicial attention bestolled on any & able set of related cases (Sanders 1992). As the size of the potential victim class increases, the chances tor individualized judicial resolution clecrease. It has been argued that the litigation about Agent Orange, the Conclusions Bhopal disaster, and asbestos-related injury should be viewed as instances in which the sheer number of claims "simply overwhelm[edl the capacity of legal institutions to meet victim compensation needs" and led to improvisation of formulaic administrative solu- tions (Durkin and Felstiner 1994, p. 159; cf. Henderson and Twerski 1991, on judicial aversion to such mas- sive projects). A balanced assessment of the possible contribu- tion of private law initiatives to the effort to reduce tobacco use must consider not only the costs and ben- efits of the various initiatives but also the likelihood of accomplishing similar results by other institutional means (Komesar 1994). Typically, private law involves high transaction costs (Galanter 1994). Private law is by definition the creature of independent actors whose operations are not centrally managed and are at most partially and intermittently coordinated; each actor is trying to maximize its own gains as it defines them. No single initiative or the sum of such efforts will nec- essarily produce an optimal policy to reduce tobacco use. Yet private law may be a valuable component in reducing tobacco use precisely because it is an arena in Mhich multiple courses of action are advanced bv energetic champions who are open to new ideas ani ~.ho, independent of government, can undertake in- novative and even risky initiatives without securing official approval or competing for priority with other political commitments. Such initiatives may thus be able to stimulate and shape policy solutions. Other than as an agent or catalyst, however, it seems unlikely that the judicial forum, in a setting involving politi- calls powerful actors and an unpredictable number of inclioate future claimants, will itself provide the ulti- mate policy resolution. Aduertisiug and Promatiou 7. Since 1964, numerous attempts to regulate ad- vertising and promotion of tobacco products have had only modest success in restricting such activity. 7 &. Current regulation in the United States is con- siderably less restrictive than that in several other countries, notably Canada and New Zealand. 3 . Current case law supports the contention that ad- LJertising does not receive the protections of free speech under the First Amendment to the Con- stitution that noncommercial speech does. Product Regdrztiorr Minors'Access to Tobacco 1. Warning labels on cigarette packages in the United States are lveaker and less conspicuous than those of other countries. 7 -. Smokers receive very little information regard- ing chemical constituents when they purchase a tobacco product. Without information about toxic constituents in tobacco smoke, the use of terms such as "light" and "ultra light" on pack- aging and in advertising may be misleading to smokers. 3. Because cigarettes \vith 10~. tar and nicotine con- tents are not substantiallv less hazardous than higher-vield brands, co&umers may be misled by the implied promise of reduced toxicity un- derlying the marketing of such brands. 4. Additives to tobacco products are of uncertain safety Cohen used in tobacco. Kno\vledge about the impact of additi\,es is negligible and lvill remain so as long as brand-specific information on the identitv and quantitv of additives is unavailable. . 5. Regulation of tobacco product sale and promo- tion is required to protect young people from in- fluences to take up smoking. Clear1 indoor Air Regulation 1. Although population-based data sho~v declining ETS exposure in the workplace over time, ETS exposure remains a common public health haz- ard that is entirely preventable. ? -. Most state and local laws for clean indoor air re- duce but do not eliminate nonsmokers' exposure to ETS; smoking bans are the most effective method for reducing ETS exposure. 3. Beyond eliminating ETS exposure among non- smokers, smoking bans have additional benefits, including reduced smoking intensity and poten- tial cost savings to employers. Optimal protec- tion of nonsmokers and smokers requires a smoke-free environment. I. Measures that have had some success in reduc- ing minors' access include restricting distribu- tion, regulating the mechanisms of sale, enforcing minimum age laws, having civil rather than criminal penalties, and providing merchant edu- cation and training. Requiring licensure of to- bacco retailers provides both a funding source for enforcement and an incentive to obey the law \2Then revocation of the license is a provision of the 1aM. 3 -. The effect of reducing minors' access to tobacco products on smoking prevalence requires further e\,aluation. Litigation Apyronches 1. Tlz-o historic \vaves of tobacco litigation were ini- tiated by private citizens, were based largely on theories of negligence and implied warranty, and 17ere unsuccessful. 7 A. A third \va\`e has brought in new types of claim- ants, making statutory as well as common-law claims and using more efficient judicial proce- dures. Although several cases have been settled for substantial money and have yielded public health provisions, many other cases remain un- resolved. 3. Private law initiative is a diffuse, uncentralized activity, and the sum of such efforts is unlikely to produce optimal results for a larger policy to reduce tobacco use. 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Chapter 6 Economic Approaches Introduction 295 Supply of Tobacco and Tobacco Products 295 Tobacco Price Supports 298 Minimum Prices, Nonrecourse Loans, and Quotas .iOO Effects of Price Supports on Market Prices 300 Assessments to Offset Federal Costs of Price Supports 307 Discussion 302 Evolution of the U.S. Cigarette Industry 3Oi7 Economic Implications of Concentrated Tobacco Production 308 High Tobacco Concentration and the Impact of Pre\.ention Policies 308 Discussion 3 7 7 Trade Policy, Tobacco, and Tobacco Products .i 77 Past Tobacco-Related Trade Polic\z ,372 Section 301 of the Trade Act of 19>4 3 17 Multinational Trade Agreements ,370 Discussion and Recent De\.elopments 378 Economic Impact of the L.S. Tobacco Industrv ,320 Effect of Price on Demand for Tobacco Products 322 Studies Using Aggregate Data 32.3 Studies Using Indi\.idual-Level Data 327 Behavioral Economics Studies of Cigarette Demand 3.15 Studies of Smokeless Tobacco Use and Price 33.5 Cigarette Prices and Other Substance Use 336 Discussion 331 Taxation of Tobacco Products 337 Rationales for Tobacco Taxation 338 Historical or Comparative Standard 338 Cigarette Taxes and Cigarette Prices 347 International Tobacco Taxes 345 Discussion 350 Fairness Standard and Optimal Cigarette Taxes 350 Equity, Incidence, and Distribution of the Tobacco Tax Burden 350 Estimates of the Costs of Smoking 352 Theoretically Optimal Cigarette Taxes 353 Cigarette Taxes and Health 355 Tobacco Taxation and Revenues 33; Conclusions 359 References 360 Introduction This chapter revielvs recent research on economic ,ispects of tobacco production and the use of tobacco products in the United States. Much of the chapter tocuses on the impact of \.arious go\.ernmentaI policies related to tobacco. As z\-as the case lvith the regulatorv effects examined in Chapter 5, the "inter\,en- iions" recounted here require a broader detinition and 2 different set of measurement tools (see Chapter 1). Supply of Tobacco and Tobacco Products The chapter first considers the suppI\' of tobacco ;1nd tobacco products. The histor\, of tobacco ancl the wolution of the cigarette industrv in the United States .ire brieflv discussed. More comprehensi\.c summa- ries can be found in the 1992 Surgeon General's report Srlwliirlg (7/1(1 H~ltll i/l flw .+~l~`rii~~; (U.S. Department of /Health and Human Services [LSDHHS] lYc)2) and in w-era1 sources cited herein. Tobacco-related suppI\.- 5ide policies are revic\ved in mow detail. In particular, the tobacco support program is cIowl\- examined, and rt5 economic implications are discussed. That section i\ follolved bv a discussion ot the impact of tobacco taxes and other prevention policies on prices in the highly concentrated U.S. cigarette markets. U.S. trade policy relating to tobacco and tobacco products is re- \ie\Yed, followed by a discussion of the domestic and international impact of these policies. Finally, the economic impact of tobacco on the U.S. economy and its implications for policy are described. In the second part of the chapter, economic stud- ies of the denland for tobacco are reviewed. Although se\ era1 factors affect the demand for tobacco products, this section focuses on the effects of tobacco prices (par- ticularI\~ as they are raised by increasing tobacco taxes) on demand. Recent econometric and other informa- tiw studies of the demand for tobacco products are described. (A more detailed re\.iewr of early studies is contained in the 19x9 Surgeon General's report RLK'IIC- iq file, Hb?lf/f c0l75c'ij111'1121'5 of .smbkiry: 25 Yt?nrs of 1'wgw+ [USDHHS lYHY].) The third part of the chapter focuses on the most important economic policv in the campaign to reduce tobacco use-higher cigarette excise taxes. This sec- tion re\,ielVs the aIternati\.e rationales for imposing cigarette and other tobacco taxes, including a histori- cal or comparati\.e approach, one based on the eco- nomic costs of cigarette smoking, one focused on the health benefits of higher taxes, and one based on the re\.enue potential of the taxes. Discussion of the ap- propriate Ie\,el of the taxes suggested by each approach folio\\-s its re\ier\-. Tobacco is a truly American plant. The first kno\ln elridence of tobacco use is depicted in car\.ings on a Mayan temple in Chiapas, Mexico, that date from 4.~2. 600-900 (Wagner 1971). Europeans \vere first in- troduced to tobacco in 1492 \z,hen American Indians presented gifts of the substance to Christopher Colum- bus. On Columbus' return home, tobacco \\`as intro- duced to Spain and throughout Europe. Tobacco \%`as widelv grown bv earlv English settlers in America and i was exported from the colonies to England, Inhere it \vas reexported to manv other destinations. Colonial tobacco exports to England grew from 100,000 pounds in 1620 to 100 million pounds just before the Re\-nlu- tionary War, making tobacco the single most important commodity exported from the colonies to England (Johnson 1984). Indeed, tobacco \vas so important in some colonies that it M'as sometimes used as the unit of account (Johnson 1984). The high tariffs imposed by England on tobacco and other imports from the colonies contributed to the start of the Revolutionary War. In the newly formed Cnitcd States, tobacco soon became the leading agri- cultural export commodity. The tobacco industry play4 a significant part in the U.S. economy of the 19th and earlv 20th centuries. Although tobacco con- sumption has declined in recent years, it is still eco- nomicallv important in major tobacco-producing states. In many kvays, tobacco is an ideal crop to gro". It gro\Vs under a \,ariety of soil and climatic condi- tions and thrives under specific but fairly co~~~n~o~~ cir- cumstances. The tobacco plant has prodigious leaf growth yet takes up relatively little field space, and the financial return for tobacco is both absolutely and relatively high compared with other agricultural com- modities (Goodman 1993). For example, in 1993, the per acre value of tobacco in the United States, 53,780, was well above the values for other crops (Grise 1995). Because of these factors, tobacco is grown in more than 120 countries and thus is the most widely grown non- food crop in the world (cotton acreage substantially exceeds that of tobacco, but tobacco is grown in about twice as many countries as cotton is). In the United States, tobacco is a highly profitable crop for other rea- sons, including agricultural price supports that guar- antee relativelv high prices; the availabilitv of loans from government, or tobacco companies, o; both; the provision of seed, fertilizer, and other agricultural in- put from external sources; and export subsidies (Food and Agriculture Organization of the United Nations 1990). Counter to these proii table arrangements, to- bacco grooving is relatively labor-intensive, demands heavy use of fertilizers and pesticides, and often re- quires the use of fuel for tobacco curing. Tobacco is a storable product, and its quality ini- tially improves with age. After being harvested, tobacco goes through several steps in a processing course, in- cluding sorting and grading (according to tvpc and quality) and curing and drying by \-arious techniques (including flue, fire, sun, and air curing). Most of this processing is done on the tobacco farm before the prod- uct is sold to the producers of cigarettes and other to- bacco products. Several types of tobacco are gr0lt.n in the United States and throughout the world. Burlev and flue- cured tobacco, the primarv ingredients in cigarettes, are the most important of the domestically grolvn types of tobacco; they account for about 93 percent of total production (Tables 6.1 and 6.2). Most burle!, tobacco is grolvn in Kentucky and flue-cured tobacco is gro\zn primarily in North Carolina. These tlvo states account for about two-thirds of domestically grolvn tobacco. Although several other types of tobacco are grown in 14 other states, about one-quarter of the to- tal domestic production is concentrated in Georgia, South Carolina, Tennessee, and Virginia. Other im- portant types of domestically gro\yn tobacco include Maryland tobacco, an important component of ciga- rettes because it burns slol~ly; fire-cured tobacco, which is used in snuff; dark air-cured and sun-cured tobaccos, which are used in chewing tobacco and small dark cigars; and other types used for cigar leaf (Johnson 1984). In 1992, the United States had about 124,000 farms producing tobacco, down sharply from 330,00()1 in 1964 (U.S. Department of Agriculture [USDA]- 1998a). Tobacco was grown on an estimated 644,000 acres in 1999, down sharply from its recent peak of 836,000 acres in 1997. In 1998, tobacco farms produced- almost 1.5 billion pounds of tobacco at a total value of approximately $2.7 billion. After inflation is accounted for, however, the value of domestically grown tobacco has fallen since 1980. More than 1.4 billion pounds of- domestically grown tobacco were used in 1998, with less than two-thirds of this used domestically, while the remainder was exported (Table 6.3). Domestic consumption of domestically grown, unmanufactured tobacco fell steadily from the 1950s through the early 199Os, from a peak of almost 1.6 bil- lion pounds in 1952 to about 900 million pounds in 1993 (Table 6.3). After rising for a few years, domestic consumption of domestically grown tobacco fell to just o\`er 900 million pounds in 1998. Declining prevalence of tobacco use is not the only-or even the main- factor behind the long-term decrease; domestically pro- duced cigarettes contain about 35 percent less tobacco than they did 40 years ago (Womach 1994b). Further- more, the use of imported tobacco in domestically pro- duced cigarettes has greatly increased in recent years. III 1950, the imported tobacco content of domes&call? produced cigarettes was approximately 6 percent. By 1993, this proportion had risen to about 40 percent. The increased use of foreign tobacco is partly due to impro\,ements in the quality of this tobacco, its rela- tively low price, reduced barriers to trade in tobacco, and the increased market penetration of lower-quality generic cigarettes, which include a higher share of im- ported tobacco. The decline in the domestic use of tobacco grown in the United States has been offset somewhat by in- creased exports of domestically grown tobacco. HoM': ever, unmanufactured exports peaked at 765 millioli pounds in 1978 and have fallen fairly steadily since; in 1998, total exports were 539 million pounds (Table 6.3), The largest export markets for U.S.-grown tobacco in recent years have been Japan, Germany, the Nether- lands, and Turkey (USDA 1998a). The combination of declining U.S. tobacco ex- ports and increased tobacco production in foreign countries (particularly Argentina, Brazil, Malawi, and Zimbabwe) has reduced the U.S. share in world to- bacco exports. In 1960, the United States' share of world tobacco exports was 27 percent. By 1997, this share had fallen to 11 percent. Moreover, in 1993, the United State: Table 6.1. Burlev tobacco woduction and value, 1975-1998 Crop year 1973 1976 1977 1978 1979 1980 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998' Production (million lbs.) 640 664 613 614 472 558 726 777 327 673 542 420 428 468 498 592 637 700 627 568 480 516 629 590 Average price Real price to farmers to farmers* (cents/lb.) (cents/lb.) 105.5 196.1 114.2 200.7 120.0 198.0 131.2 201.2 133.2 200.0 165.9 201.3 180.7 198.8 181.0 187.6 177.3 178.0 187.6 180.6 159.7 148.4 156.5 142.8 156.3 137.6 161.0 136.1 167.2 134.8 175.3 134.1 178.X 131.3 181.5 129.4 181.6 125.7 184.1 124.2 185.5 121.7 192.2 122.5 188.5 117.4 190.3 116.7 Farm value (million $) 675.1 758.3 735.6 805.8 685.6 925.7 1,311.9 1,406.4 934.4 1,264.4 865.6 657.3 669.0 753.5 832.7 1,037.g 1,174.7 1,270.5 1,138.6 1,045.7 890.4 991.8 1,185.7 1,123.3 Real farm value* (million $1 1,254,s 1,332.7 1,213.9 1,235.8 944.4 1,123.4 1,443.2 1`457.4 938.1 1,217.0 804.4 599.7 588.9 636.9 671.5 794.0 862.5 905.6 788.0 705.6 584.3 632.1 738.7 688.9 *Real price to farmers and real farm value are obtained by dividing the nominal average price and farm value by the national Consumer Price Index; the average of 1982-1984 is the benchmark. `Subject to revision. Sources: U.S. Department of Agriculture 1996,1999a; U.S. Department of Labor 1999. lost to Brazil its historically dominant position as the leading exporter of tobacco (Womach 1994b). These trends for domestically grown, unmanufac- tured tobacco have not been observed for domestic pro- duction of the chief manufactured tobacco product--the cigarette (Table 6.3). Although total annual domestic consumption fell fairly steadily from a 1982 peak of 634 billion cigarettes to an estimated 435 billion in 1999, total domestic cigarette consumption peaked in 1996. The difference is the result of large increases in the export of domestically produced cigarettes. In 1985, the United States exported 58.9 billion cigarettes. Exports peaked in 1996 at more than 240 billion cigarettes, al- most one-third of total domestic production in that year. Since 1996, however, cigarette exports have fallen, to an estimated 150 billion by 1999. Table 6.2. Flue-cured tobacco production and value, 1975-1998 Crop year 1975 lYi6 1977 lY78 1979 1980 1981 1982 1983 lYX4 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 199# Production (million lbs.) Average price Real price to farmers to farmers* (cents/lb.) (cents/lb.) 1,415 1,316 1,124 1,206 Y74 1,086 1,141 994 855 850 789 667 683 796 838 920 882 901 892 X07 854 897 1,014 815 99.8 185.5 110.1 194.0 117.6 194.1 135.0 207.1 140.0 192.8 144.5 175.4 1 66.3 78.5 T- i / Y 81.1 71.9 52.7 58.7 61.3 67.4 67.3 72.3 72.h f-8.1 83.1 85.0 78.6 73.3 59.8 39.3 39.7 36.3 35.0 128.0 126.5 123.0 116.3 111.6 117.7 116.9 107.2 107.7 Farm value (million $) Real farm value+ (million $) 1,412.2 2,624.Y 1,452.Y 2J53.4 1,321.8 2,181.2 1,628.l 2,497.l 1,363.3 1,877.5 1,569.3 1 ,YO4.5 1,903.6 2JIY4.2 1,774.3 1,838.6 1,521.0 1,527.2 1,539.4 1,481.6 1,356.3 1,260.5 1,018.5 929.3 1,083.`) 954.2 1,283.9 1,085.3 1,402.g 1,131.3 1,539.2 1,177.6 1,519.7 1,115.8 1,555.l 1,108.4 1,499.5 lJ37.7 1,370.3 924.6 1,532.l 1,005.3 1,645.l 1,048.5 1,744.l 1,086.7 1,430.o 877.3 "Real price to farmers and real farm \.alue are obtained by dividing the nominal average price and farm value by the national Consumer Price Index; the a\w-age of 1982-1984 is the benchmark. +Subject to revision. Sources: U.S. Department of Agriculture 1996, 1999a; U.S. Department of Labor 1999. Tobacco Price Supports Despite being such a profitable crop, tobacco, like other C.S. crops, has benefited from agricultural price supports that have been in place for much of the 20th centurv. In the lY2Os, before these supports ivere in place, iobacco cooperatives had formed in various re- and consequently raise tobacco prices and the inconw of tobacco farmers. These and other agricultural coop- eratives were largely responding to the steep reduc- tions in the prices of tobacco and other agricultur~~L products during the recession of 1921. The cooperrograms also ga1.e tobacco farmers some ability to counteract the economic powrer of the highly concentrated cigarette producers (Warner 1988). Minimum Prices, Nonrecourse Loans, and Quotas The federal program for tobacco price supports involves specific economic inter\-entions and assis- tance. To stabilize the price and quantity of tobacco produced, the program guarantee5 minimum market prices and establishes marketing quotas. Minimum (or support) prices are essentially determined by past tobacco prices adjusted for changes in cost indexes. When unable to find a pri\.ate buver at a price at or above the support level, a tobacco farmer is eligible for a nonrecourse government loan from a local price stabilization cooperati\.e. This t\.pc of loan a1low.s fol a commodity, in this case tobacco, to be used as collat- eral for the loan at the support price. Cnder annual contracts lvith the cooperati\.es, USDA's Commoditv Credit Corporation loans funds it has borro\ved from the U.S. Treasury (in the past, at less than market rates of interest [Johnson l%-!]). Each cooperati1.c` processes and stores the tobacco it has recei\,cd as the farmer's collateral, and the Commoditv Credit Corporation collects interest on the loan. The cooperati1.e then at- tempts to sell the tobacco. If the cooperatil-e can re- cei\ve a price above the support price, the proceeds arc used to repay the loan, and anv excess receipts go to the tobacco tanner. This pro&s has created the ap- pearance that tobacco farmers are not bein;; dircctl\' subsidized (Johnson 1984). Marketing quotas, determined b!r the C.S. Secre- tarv of Agriculture, are intended to be sufficient to meet th; domestic and foreign demand for U.S. tobacco at a price abolre the go\,ernment support price. Originally, tobacco could be grolvn only on land that had been assigned a quota, tvhich \vas based on that farm's pro- portion of tobacco produced lvhen the program IVES initiated (with a limited amount of new production allowed each vear). Consequently, almost the onlv rvay to begin growing tobacco \vas to buv or rent a farm that had been granted the right to gro\\' tobacco. In 1961, farmers m-ho grerv flue-cured tobacco approved intracounty lease and transfers of allotments; burley tobacco farmers followed suit in 1971. For the first several decades, these quotas were implemented through national acreage allotment systems. The acre- age allotments were replaced by poundage quotas in 1965 for flue-cured tobacco and in 1971 for burley to- bacco. The switch to poundage quotas increased flex- ibility for tobacco growers. In any given year, tobacco farmers could sell up to 10 percent more than their quota if yields exceeded expectations (because of fa- vorable weather conditions, for example). In the fol- lowing year, however, farmers would have to sell proportionately less than that quota. The opposite would apply when yields fell short of expectations. If yields fell short for several years, tobacco farmers could accumulate excess quotas up to an amount equal to their normal quota. This arrangement resulted in a more stable supply of flue-cured and burley tobacco (Johnson 1984). Every three years, tobacco farmers vote on whether to continue the price support program and whether to approve any substantive changes in the system. If the referendum is approved by a two-thirds majority, tobacco farmers are subject to marketing quotas. Effects of Price Supports on Market Prices Despite the numerous factors that affect the sup- ply and demand for tobacco, the quota and price support svstem keeps market prices at or above the support le\.el. This effect has been evident-and its correction attempted-almost from the outset. As a result of the Agricultural Adjustment Act of 1933, to- bacco prices increased almost immediately. These in- creases resulted from limits on output achieved by \.oluntarv agreement. In 1934, Congress passed the Tobacco Control Act (Public Law 73-483) to deter non-m cooperatilse tobacco farmers from overproducing and taking ad\.antage of the relativelv high prices result- ing from the reduced supplies of participating farm- ers. This act led to sharp reductions in tobacco production and consequently to a steep rise in tobacco prices. In early 1936, however, the United States Su- preme Court found sections of the Agricultural Ad- justment Act unconstitutional, which led Congress to repeal the Tobacco Control Act as well. In 1935, Congress enacted the Tobacco lnspec- tion Act (Public LaM 74-314), which required the USDA to provide tobacco grading (or quality evaluation) ser- \?ces at no cost to tobacco growers. In 1936, the Soil Conserl,ation and Domestic Allotment Act (Public Laib 74-461) was passed. This act covered tobacco, as we1 as most other agricultural products covered by the Agricultural Adjustment Act of 1933, and rewarded farmers for diverting production from soil-depleting crops (including tobacco) to soil-conserving crops. The limited success of the Soil Conser\ration and Domes- tic Allotment Act led to the passage in 1938 of the sec- ond Agricultural Adjustment Act (Public La\z 75-430). The neIv act included quotas for tobacco and other agricultural products and imposed penalties on farn- ers \vho violated their quotas. Even ivith subsequent amendments, the tobacco price support program es- tablished by the Agricultural Adjustment Act of 1938 is essentially the same today. The Agricultural Adjustment Act of 1938 set the support price at 75 percent of parity (ivherc paritv re- flects a\rerage tobacco prices from 1919 through 1429). At the beginning of World War II and later through the Agricultural Act of 1949 (Public Law 81-4391, this proportion ivas raised to YO percent of paritv, I\ hich was based on average prices for the preceding 10 vt'ars. In 1960, fo slow the rate of gro\\.th in tobacco irices, Congress set nell- support le\-cls based on the 1YSY le\,el and a three-vear moving al~erage of prices paid b\ farmers. Sinqilarlv, in 1980, the support prices for tlih eight loliest qualitv grades of tobacco l\.ere louvered directlv. Assessments to Offset Federal Costs of Price Supports Until new legislation \~as passed in the IYXOs, the costs to the federal government from operating the tobacco support program were substantial. In 1981 alone, the total administrative cost of the program was $13.1 million. Moreover, the federal government, through the Commodity Credit Corporation, bore all costs if the local cooperatives were unable to sell the tobacco they received as collateral for the nonrecourse loans. By April 1982, losses from unpaid loan princi- pal totaled $57 million, and interest losses amounted to $591 million by the end of 1981 (General Account- ing Office [GAO] 1982). These losses spurred opposi- tion to the tobacco support program, which Izras being threatened with dissolution. To reduce some of the costs of operating the program, in 1981 Congress amended the Tobacco Inspection Act, imposing fees on tobacco growers sufficient to cover the cost of the grading services provided by the USDA. Far more significant changes to the tobacco sup- port program were introduced by the No Net Cost Tobacco Program Act of 1982 (Public Law 97-218), which was mandated bv the Agriculture and Food Act of 1981 (Public Law 97-98). The act M'as intended to reduce the losses of the tobacco support program bv imposing an assessment on every pound of tobacco brought to market under the loan program. The as- sessments \vere supposed to generate revenues suffi- cient to offset all future losses from these loans. Thus, aside from the administrative costs, the tobacco sup- port program leas supposed to operate at no net cost to taxpayers. Other changes were introduced through the act. Rather than distributing excess receipts from the sale of loan tobacco to farmers, these profits were retained bv the Commodity Credit Corpora6on. Farm- ers of flue-cured tobacco could sell their right to grow tobacco In other active tobacco grokvers in the same county; moreover, institutional owners of these rights ivere required to sell them by December 1984. Finally, the U.S. Secretary of Agriculture 12ras given the author- it\, to sloiv the grolvth in the support price by allow- ing the price to increase by as little as 65 percent of the increase implied by the parity formula. These changes led four relatively small associations of tobacco groby- ers (grolt-ers of cigar tobacco in three areas) to stop participating in the support program (Miller 1994). Initially, assessments were expected to be rela- ti\el\f lo\\, because of the size of past losses. However, as a iesult of the tobacco support program, U.S. sup- port prices w'ere well above tobacco prices in world markets, lvhich led producers of cigarettes and other tobacco products to increase their use of imported to- bacco. At the same time, reductions in quotas were limited bv statute. Consequently, the quantity of to- bacco prdduced exceeded the quantity demanded at the support price, and the surplus was used as collat- eral for nonrecourse loans (Miller 1994). By 1985, with a growing stock of U.S.-grown tobacco under loan, the no-net-cost assessment on flue-cured tobacco was high: 25 cents per pound (Miller 1994). (The assessment on burley tobacco would have been 30 cents per pound but was limited to 4 cents by legislation.) The high assessments, the growing importance of imported tobacco in the production of cigarettes and other tobacco products, the increasing stocks of tobacco under loan, and the falling quotas of the early to mid- 1980s created a crisis for tobacco farmers and the to- bacco support program (Northup 1993). Congress responded by making several changes to the support program (Tobacco Program Improvements) contained in the Consolidated Omnibus Budget Reconciliation Act of 1985 (Public Law 99-272). The 1985 act lowered the tobacco support price by 26 cents per pound for both flue-cured and burley tobacco. In adciition, both buyers and sellers of surplus tobacco were required to bear part of the burden of running the program (grow- ers of other types of tobacco continued to be respon- sible for the'full assessment). These changes were meant to encourage the use of domesticall\ gro\Vn to- bacco ol'er imported tobacco in the manuiacturing of cigarettes and other tobacco products (Miller IYY1). Also as a result of this legislation, the amount of flue-cured and burley tobacco that could be sold ivith- out penaltv leas reduced from 110 percent of quota to 103 percelit. The formulas used to determine the sup- port prices ior flue-cured and burley tobacco \z.ere also changed. These prices bvere nolv based on their levels in the preceding vear, and adjustments 12-ere to be made from a fi\.e-year iloving average 0i prices and changes in the cost of production. Past prices ~,ould be given two-thirds weight, and the remainder n~oul~l be based on production costs (tvhich included general \,arinble expenditures but excluded costs of land, overhead, assessments, and other expenses not directlv related to tobacco growing). The legislation also brdught the major cigarette manufacturers into the quota-setting process, because they t~ould be annually providing the U.S. Secretarv of Agriculture M.ith their intended purchases of tob&co. These manufacturers would be penalized if they did not purchase at least YO percent of this intended amount. When these changes took place, U.S. cigarette com- panies agreed to buy all future surplus stocks Of tobacco (for the next eight years for flue-cured tobacco and the next five vears for burlev tobacco). Some of the exist- ing stocks under loan \vere sold at sharp discounts; the federal go\`ernment absorbed the losses. These changes Lvere somervhat successful in reducing surplus tobacco stocks as \vell as the amount of tobacco brought under loan in any gi\.en year. O\w the nwt ii\.e years, stocks of tobacco declined bv nearlv 10 percent, and total loan outlavs fell bv nearlv 90 percent. -To fund deficit reduction of the federal budget, the Omnibus Budget Reconciliation Act of 1YYCl (Pub- lic La\v 101-508) added further marketing assessments on all commociity price support programs betiveen 1991 and lYY5; the marketing assessments Ivere sub- sequently extended through 1998 (USDA 1997~). To- bacco grot\.ers and buyers each paid an additional assessment equal to 0.5 percent of the support price level. These additional assessments generated esti- mated relrenues Of more than $28 million in iiscal vear 1997 (Womach 1999). To further curb the use of imported tobacco, the Omnibus Budget Reconciliation Act of 1993 (Public Larz 103-66) included the requirement that, beginning in 1993, domestically produced cigarettes include a minimum of 75 percent domestically grolvn tobacco. If this lals leas violated, the cigarette manufacturer was assessed on the amount of foreign-grown tobacco used in excess of the 25-percent limit. The assessment rate \~as determined by the difference betw,een a\rcrage prices of imported and domestic tobacco. Those pro- ducers M,ho used `III excess of imported tobacco were iurther required to make up the shortfall by purchas- ing tobacco stocks under loan. The act also subjected imported tobacco to the no-net-cost assessments be- ginning in lYY4. Effective September 13, 1995, ho\%.- e\rer, the domestic content requirement was dropped as part of a presidential tariff-rate quota proclamation because of its inconsistency with the General Agree- ment on Tariffs and Trade (GATT). In general, the tobacco quotas have fallen in re- cent years, while support prices, after adjustment fol inilation, have fallen sharplv (Tables 6.4 and 6.5). A> of March 31, 1995, the principal and interest value 01 tobacco loan inventory was $1.6 billion (Robert H Miller, Tobacco loan status report, unpublished data) Mhich was down significantly from the $2.75 billior held as of June 30,1986 (Warner 1988). The no-net-cost assessment for the 2000 crop o flue-cured tobacco is 2.5 cents per pound for the pro ducer and 2.5 cents per pound for the purchaser. Simi larly, the no-net-cost assessment for the 2000 crop o burley tobacco is 3 cents per pound for both the groove and the buyer. In fiscal year 2000, the federal government bud geted approximately $14 million for administering th tobacco support program (Womach 1999). In total, tk directlv tobacco-related activities of the USDA gener ated an estimated $174 million in net revenues in fi+ cal venr lYY9. The positi1.e net revenues are the rcsu! of re\.enues generated by the loan program and var' ous assessments that more than offset the expenditure on the tobacco program and other tobacco-relate activities (including subsidized tobacco crop insurance tobacco inspection and grading, tobacco research, dat collection and analysis, and other activities) (Womac 14Y9). Discussion Selreral conclusions emerge from analyses 0i t!- tobacco support program. The program's success i stabilizing tobacco prices is particularly e\%lent ~,.hc they are compared with the prices of other agricultur commodities (including those covered by their 01% support programs). One result of the price stability that output has also been relatively stable. As Johns? (1984) notes, "growing tobacco has been as close to sure thing as one can find in U.S. agriculture" (p. 5: The quantity of tobacco grown domestical- is artiiicially 10~. as a result 0i the supply restriction created by the tobacco support program. Consequent' Table 6.4. Characteristics of the tobacco support program: flue-cured tobacco, 1975-2000 Year 197j I Y76 -... lY// -> I')/b 1 Y79 1 W) 1981 192 1983 1 w4 I')85 1986 1987 I 'MS IWY 1 Y90 1991 1992 1993 1994 1995 1996 1997 1998 1 YY9 2000 National marketing quota (million lbs.) National Real average average support support price price* (cents/lb.) (cents/lb.) No-net-cost assessment+ (cents/lb.) Producers Buyers 1,4Y I 1,26S 1,116 1,117 1,095 1,094 1,013 I ,o 13 y 10 804 775 7,Y 707 754 891 S/S 878 892 PI2 803 93s xi4 974 813 666 533 93.2 106.0 113.8 I21 .o 139.3 141.5 158.7 169.9 I hY.Y I W.C) 1hY.Y 143.8 143.5 144.2 14h.S I4X.S 152.8 133.0 157.7 138.3 139.7 160.1 163.1 162.8 163.2 164.0 173.2 186.3 lS7.8 185.6 178.1 171.7 174.6 176.1 170.6 lh3.5 137.Y$ 131.2 126.3 121.Y 118.4 113.8 112.3 111.2 109.1 106.8 104.8 102.0 101.0 99.9 98.0 95.6" 3.0 7.0 7.0 2.50 2.50 2.00 1.13 1.12 1 .oo 1 .oo I .oo 1.00 3.00 0.80 1 .oo 1 .oo 1 .oo 1 .oo 2.50 1.50 2.00 1.13 1.12 I .oo I .oo 1.00 3.00 5.00 I .80 1.80 1 .oo 1 .oo 1.00 2.50 *Real a\`erage support price is obtained by di\Gding the nominal support price by the national Consumer Price Index; the average of 1982-1984 is the benchmark. `No-net-cost assessment includes marketing budget deficit assessments from 1991 through 1998. IThe effective support price in 1985 Leas 165.0 cents/lb. by reduction of certain grades. `I'reliminarv estimate. Sources: Us. Department of Agriculture 1997b, IY99a,b. Table 6.5. Characteristics of the tobacco support program: burley tobacco, 1975-2000 1975 1976 977 978 979 1 980 981 982 1 983 983 985 986 987 1 988 989 Year 1990 1991 19Y2 1993 1994 1993 1996 1997 1998 1999 2000 National National Real average marketing average support quota support price* price+ (million lbs.) (cents/lb.) (cents/lb.) 670 96.1 178.6 635 109.3 192.1 636 117.3 193.6 614 124.7 191.3 614 133.3 183.6 614 145.9 177.1 660 163.6 180.0 680 175.1 181.5 647 175.1 175.8 582 175.1 168.5 524 148.8 138.3 493 14X.8 133.x 464 148.8 131.0 473 150.0 126.8 5x7 153.2 123.5 601 155.8 IIY.2 724 158.4 116.3 668 164.Y II 7.5 602 168.3 116.5 536 171.4 115.7 546 1/2..i 113.2 631 173.7 110.7 704 17h.0 109.7 635 177.8 1OY.l 4.51 178.9 7 07.3 247 180.5 105.2" No-net-cost assessment7 (cents/lb.) Producers Buyers 1.0 3.0 9.0 4.0 2.75 2.00 0.80 1.00 1.00 I .oo I .oo I .oo 4.50 1 .oo 1 .oo 1 .oo 3.00 3.00 3.00 1.25 2.00 0.80 1.00 1 .oo I .oo I .oo 3.50 3.60 I .oo 1 .oo 1 .oo 3.00 3.00 3.00 *The support price \vas reduced from 178.8 cents/lb. and the no-net-cost assessment was reduced from 30 cents/lb. bv Public La\v F-157, sec. 6 (IYH5). +Real average support price is obtained by dividing the nominal support price by the national Consumer Price Index; the a\.erage of IYP2-1984 is the benchmark. iNo-net-cost assessment includes nlarketin;: budget deficit assessments from 1991 through 1998. Vi-eliminary estimate. Sources: U.S. Department of Agriculture lYY7a; 1998a,b; 1999a. 2000. prices for domesticall\, grow\-ii tobacco are artificiallv high. Some estimates of the distortions resulting from the support program \1-cre pro\.ided by Sumner and Alston (1985) in their analysis of the economic conse- quences of renio\-ing the tobacco price support svstem. Their estimates 12.ere based on a detailed simultaneous equations model of the supplv and demand for tobacco and tobacco products (cigarettes) that allows for sub- stitution bet\\-een domestic and foreign tobacco in ciga- rette production. The authors estimated that domestic tobacco output K-ould rise by 5&100 percent or more if supplv restrictions \vere eliminated. This large in- crease in the quantitv of tobacco supplied should lead to sharp reductions iii- tobacco prices. As a result of the increase in output, tobacco prices I\Y~LI~CI fall b\. 3-30 percent, and the \-ariabilitv of tobacco prices ~vnulcl in- crease. Ho\\.el.er, o\.erall rel'enues from tobacco grow\-- ing ~vould rise bv 15-60 percent or more. Moreo\.er,this analysis predicted that the sharp drop in domestic tobacco prices that \\~oulcl follo\\~ the removal of supplv restrictions ~~0~11d lead domestic producers of cigaiettes and other tobacco products to use less foreign-gro\\,n tobacco. These estimates as- sumed the elimination of the program in 1983 and thus do not take into account the more recent changes in its operation. More recent estimates from Zhang and co- leagues (2000) suggest that the conclusions of Suninel and Alston (1985) still applv. For example, thev esti- mated that the price support program raised tobacco leaf prices by 36 cents a pound in 199-l. This price is about 21 percent above the estimated price in the ab- sence of the support program. The removal of the support program should also make domestic tobacco growers more competiti\.e in world markets. In the 198Os, U.S. tobacco prices ex- ceeded world market prices by JO-60 cents per pound (Warner 1988). Although part of the differential can be explained by the higher quality of U.S. tobacco, a significant factor is the U.S. tobacco support program. Sumner and Alston (1985) predicted that U.S. tobacco exports would have grown bv about 100 percent if the tobacco support program hai been eliminated in 1983. This change would have had an ad\rcrse impact on foreign tobacco growers, as producers of foreign ciga- rettes and other tobacco products increased their use of tobacco grown in the United States. Although the artificially high prices resulting from the support program tend to increase the income of small tobacco farmers, thev likely recei\re relativelv less benefit from the program than the tobacco quota owners. Because most small tobacco farmers rent some or all of their allotments from the quota o\vners at a significant cost (Watkins 1990), these farmers pav rents equix-alent to the excess value created by the support program. In the absence of the program, reduced in- come for these farmers lvould likely be offset by the resulting reduced rent they paid. Quota owners, on the other hand, have been estimated to lose about $800 million annually M'ere the support program eliminated (Sumner and Alston 1985). Despite the differing likely effects on quota own- ers and small tobacco growers, eliminating the tobacco support program \~ould probably not alter existing trends in the concentration of tobacco production into larger farms (Sumner and Alston 19%). Rucker and colleagues (1995) ha1.e estimated that eliminating the program's intercounty restrictions on the transfer of tobacco quotas I\-ould ha\ e little o\serall impact beyond redistributing lvealth from some tobacco growers and quota 011 ners to others. (Consequently, these research- ers suggest that the restrictions have remained in ef- fect not because the gains associated with them are large but because the political costs of removing them are.) Moreo\.er, remo\%~g supports would cause a mo\.ement a\vav from regions \vhere the costs of grow- in;; tobacco ari relativelv high torz-ard those where costs arc relati\.el>. Io~v. -The loss of income to quota o\\`ners \zo~ild lead to reductions in personal income of up to 2-3 percent for counties that are highly de- pendent on tobacco; larger losses would occur in the relati\.elv high-cost counties. However, total incomes would rise in areas that experienced a great expan- sion ~JI tobacco growing. In comparison, the effect of altering another government program would be con- siderable. Increases in cigarette excise taxes are also likely to bring significant losses to quota owners. Sumner and Wohlgenant (1985) estimated that dou- bling the federal cigarette excise tax in 1983 would louver quota oM.ners' lease income by an average of 13 percent, or about $44 million. As a result of the sharp drop in the price of to- bacco, cigarette prices could fall. Tobacco costs, how- ever, are a relatively small component of cigarette prices. Grise (1995) estimates that the 40- to 50-cent per pound drop in tobacco prices resulting from the elimination of the support program r~ould reduce ciga- rette prices by only l-2 percent. Zhang and colleagues (2000) estimaie an even smaller impact, concluding that cigarette prices are 0.52 percent higher than they would be in the absence of the support program. As noted by Sumner and Alston (19851, a reduction in cigarette prices would lead to a rise in U.S. cigarette exports. Moreo\.er, estimates of the price responsiveness of ciga- rette demand (described in "Effect of Price on Demand for Tobacco Products," later in this chapter) suggest that the reduction would lead to an increase of no more than 1 percent in cigarette smoking. At least part of the increase \voulcl come from increased smoking among young people. Opponents of the tobacco support program sug- gest that it can be removed w+th little impact on the farmers it is intended to benefit. For example, the less than 2-percent reductions in cigarette price that would result from eliminating the support program could be more than offset by an increased excise tax on ciga- rettes. A portion of the revenues generated from the tax hike could be used to help tobacco farmers diver- sify into other crops (through low-interest loans, grants, or other programs) or to purchase the farmer's tobacco base to retire it from tobacco growing (Northup 1993). Similarly, some of the funds could be used to develop nonfarm businesses, train farmers for other occupations, provide income support, and offer other economic support for local economies in transition (Womach 1994a). Critics also point out that the support program creates indirect political consequences: the depen- dence created by the support program results in a strong political constituency, composed of tobacco farmers and holders of tobacco allotments, that can impede legislation to reduce tobacco use (Taylor 1984; Warner 1988; Zhang and Husten 1998). In the absence of the support program, tobacco growing \vould likely become much more concentrated (Sumner and Alston 1985). Warner (1988) has observed that the reduction in numbers would lead to reduced political influence. Moreover, he describes the apparent inconsistency present when one arm of the federal government seem- ingly endorses tobacco production by continuing an economic support program even as another engages in numerous activities to reduce tobacco use (Warner 1988). Evolution of the U.S. Cigarette Industry Through much of the 19th century, most of the demand for tobacco products centered on smokeless tobacco and cigars (see Chapter 2). Cigarettes were relatively less popular, although the demand for them increased gradually during the middle of the century (USDHHS 1992). The watershed year for the cigarette, however, was 1881, when James Albert Bonsack an- nounced his de\,elopment of a machine that replaced hand-rolling as the primarir means of making ciga- rettes. The mechanization df production significantly reduced the costs of manufacturing cigarettes and, consequently, reduced cigarette prices. The steep de- clines in cigarette prices relati1.e to the prices of other tobacco products, due largely to Eonsack's cigarette machine, contributed significantly to the rapid rise in the popularity of cigarettes during the late 19th and early 20th centuries (Wagner 1971). James Buchanan Duke was the first cigarette pro- ducer to acquire rights to the new machines, which he- installed in 1884. Duke entered into long-term con- tracts with Bonsack to use the machines at a cost lower than Bonsack would make them available to other producers. Because of the resulting substantial cost advantage in production for his company, Duke successfully waged price wars with other producers while still earning relatively high profits. Over the next decade, the Duke family formed a holding company, which was composed of their firm and several corn-- petitors they had acquired. By 1889, as a result of its aggressive pricing and marketing strategies, the hold- ing company effectively monopolized U.S. cigarette markets (controlling more than 90 percent of the mar- ket), as well as portions of the markets for other to- bacco products. Eventually, in an attempt to avoid antitrust prosecution under the Sherman Act, the Dukes converted the holding company into The Ameri- can Tobacco Company. By 1901, The American Tobacco Company dominated all of the U.S. tobacco market< except cigars. The company was also a considerable presence in cigarette markets around the world. In response to allegations that The American To- bacco Company was abusing its market position, the U.S. Department of Justice charged the firm with vio- lating the Sherman Act. In 1911, the Supreme Court dissolved the company, thereby creating several new firms from the conglomerate, including a new Ameri- can Tobacco Company (which later became American Brands, Inc.), Liggett & Myers Tobacco Company, R.J. Reynolds Tobacco Company, and Lorillard Tobacco Company. The American Tobacco Company was also divested of its foreign holdings (Imperial Tobacco Ltd. and British-American Tobacco Company Ltd. [B.A.T. Company]). Imperial Tobacco Ltd. eventually rno; nopolized cigarette manufacturing in Great Britain, and B.A.T. Company concentrated on manufacturing in British colonies and elsewhere. Both companies ultimately resumed some operations in the United States (Johnson 1984). Although Imperial Tobacco Ltd. eventually dropped out of U.S. markets, B.A.T. Indus- tries PLC, the parent company of B.A.T. Company, owns Brown & Williamson Tobacco Corporation, a large U.S. cigarette manufacturer. R.J. Reynolds Tobacco Company (which had nc cigarette production after the breakup) soon devel- oped a new type of cigarette by using burley tobacco, which was quickly copied by the other producers. By the lY2Os, the cigarette producers were competing `tsgressi\.elv in promoting their main brand-for ex- ample, R.J. Revnolds Tobacco Companv's Camel, The .\merican Tobacco Compan>"s Lucky Strike, and Liggett Cy: Myers Tobacco Company's Chesterfield. In addition, firms on the competiti\,e tringe attempted to compete through price \vith their so-called IO-cent brands (Robert 1967). (For a more detailed discussion L,f the domestic operations of U.S. cigarette firms be- fore World War II, see the Surgeon General's report $iwX-i/7,y (712~1 H~wltl~ ir7 t/7(, A~7c~riin5 [USDHHS 19921). The U.S. Department of Justice e\,entually chal- lenged the four producers' coordinated \vholesale and retail pricing practices. In IY-ll, on the basis of con- juct starting as earl\ as 1933, these producers xvere I:harged \vith \,iolatin g the Sherman Act bv conspir- ing to restrain trade in an attempt to monopolize the Industry Their \vholesale tobacco-yurchasitig prac- tices Ivere deemed to be monopsonistic-that is, char- -1cteristic of a market situation tvhere one buver exerts .I disproportionate influence-and their retail pricing \\-a~ thought to reflect collusi\.e beha\,ior. In 1916, bas- ~ng its decision on the no\,el legal concept of "conscious parallelism," the Supreme Court upheld a jury deci- ,ion that found the firms guiltv. The uniformit\~ of ;>rices at both the \vholesale and ;he retail le\,el (a result that could occur in anv highly competiti\.e market), the near-SVnchronoLis increases in prices, and the rais- ing of 12-holesale prices \vheii labor costs irei-e falling .vere vieived bv the court as evidence of tacit collusion. As a result, the firms xvere fined up to $250,000 each, a relati\.elv minor penaltv compared \zith their profits. Jol;nson (lY83) and others have noted that the Court's decision \vas not supported by purely eco- nomic reasoning. There rvas little if any evidence that cigarette firms \vere jointly restricting output to raise cigarette prices and, consequently, profitability. Simi- larly, there \vas no evidence that the firms limited their \\rholesale purchases of tobacco to depress to- bacco prices and production costs and, consequently, to increase profits. The Court's decision had little impact on the sub- sequent structure of the U.S. cigarette industrv. The practical result has been that, from 1916 until today, the combined market shares of the six major firms (five after the merger of Bro\vn & Williamson and Ameri- can Brands, Inc.) has exceeded YY percent, although indi\,idual market shares ha\.e changed significantly (Table 6.6). More important in changing relati1.e market shares ivas the release of information during the 1950s and 1960s on the health consequences of cigarette smoking. In the lYX)s, Philip Morris Companies Inc., 1i.J. Re~~nolds Tobacco Company, and Lorillard Tobacco Companv aggressi\,elv marketed filtered cigarettes (Marlboro, Winston, a'nd Kent, respectii,ely), xvhich lvere percei\,ed as less dangerous than standard unfiltered cigarettes; The American Tobacco Companv and Liggett & Mi,ers Tobacco Company \vere not as rable 6.6. Domestic market shares of U.S. cigarette firms, selected years R.J. Philip Brown & American Year Reynolds Morris Williamson Brands Lorillard 1913 0.2 NA* NA 35.3 77 1 &k. 1925 31.6 0.5 NA 31.3 1.9 i 9-10 21.7 9.6 7.8 29.5 5.4 1955 23.8 8.5 10.5 32.9 6.1 1970 31.8 16.8 16.9 19.3 8.7 1975 32.5 23.8 17.0 14.2 7.9 IY80 32.8 30.8 13.7 10.7 9.8 1985 31.: 35.8 11.X 7.4 8.2 1991 27.8 43.4 11.1 7.0 7.3 1996 24.6 47.8 17.2 NA x.-l Liggett & Myers 34.1 26.6 20.6 15.6 6.5 4.4 2.2 5.0 3.4 1.9 Total 91.7 91.8 94.6 99.4 100.0 99.8 100.0 99.9 100.0 99.9 -X.4 = Not available. %xwces: Tennant 1950; O\wton 1981; Clarifeld lY83; Standard & I'oc)r's lYXc), 1993; Federal Trade .`Ornmission 1997. s~~cc~ssful in marketing their competing brands (Johnson 1981). Similarly, after the 1964 release of the U.S. Surgeon General's first report on the health conse- quences of cigarette smoking, and after the Federal Trade Commission's (FTC) publishing of tar and nico- tine content in the late 1 Y6Os, Philip Morris Companies Inc. and R.J. Reynolds Tobacco Company introduced and aggressively marketed lo\v-tar and lobv-nicotine cigarettes (again, products percei\,ed as healthier than existing cigarettes), whereas the other companies \vere less successful. As a result of the brand loyalty these two firms Lt'ere able to establish at this time, they came to dominate cigarette markets; in 1996, the two firms had a combined market share of 73.3 percent. Another notable change in the tobacco industry, beginning in the lY6Os, was the di\.ersification of the cigarette-manufacturing companies. Perhaps in part to offset the impact that the campaign to reduce tobacco use had on the industrv's profitability, the six major domestic cigarette producers acquired or merged !2-ith U.S. firms in a \,ariety of nontobacco markets, includ- ing food, alcoholic beverages, and transportation. Both U.S. and international cigarette producers significantly expanded their international acti\-ities. Di\.crsification was relativelv easv because of the high profitabilitv from _ - cigarettes and the lo~v long-term debt of these firms (Overton 1981). By 1972, no major domestic cigarette companv ivas completelv dependent on tobacco for its revenue (Johnson lY84). Durin, 0 the l%Os, diversifica- tion strategies and successes among the six firms var- ied markedly; some firms returned to a focus 011 cigarettes and other tobacco products, \\.hereas others di\.ersified further. B\, the late l%Os, a three-tiered classification of \Vorld cigarette producers, based on their international activities, had emerged: those in- volved in most global tobacco markets (Philip Morris Companies Inc., B.A.T. Industries PLC, 1i.J. Reynolds Tobacco Company, and Rothmans International Tobacco Ltd.); those \\ith some international, but not global, activities (including American Brands, Inc.); and smaller firms concentrating primaril!, on their domestic mar- kets (including Liggett & Myers Tobacco Company and Lorillard Tobacco Company) (L'SDHHS lYY2). Economic Implications of Concentrated Tobacco Production The concentration of production among relati\d) few firms in the cigarette industry has implications for cigarette pricin,, ~7 marketing, product de\.elopment, and other activities. Clearly, the cigarette industrl, is an oligopoly; no more than six firms ha1.e controlled vir- tually all cigarette output in the United States for the past 80 vears (Table 6.6). Economic theory suggests that fir& in oligopolistic industries have substantiat market pobver in that their production decisions wilt have a significant impact on price. Moreover, these firms recognize their interdependence. That is, each firm recognizes that its pricing and marketing strate- gies have a significant impact on the sales and profit- ability of its competitors, as well as on its own sales and profitability. Consequently, each firm understands that its competitors are likely to respond to any changes in its own pricing, marketing, or other strategies. Economic theory provides several possibilities regarding the conduct and performance of firms in an oligopolistic industry. At one extreme, if entry is easy and if sunk (nonrecoverable) costs are low, firms in an oligopolistic industry will behave competitively. That is, firms will have little market power (their output decisions will have little impact on market prices), prices will reflect the costs of production, and firms will not earn excessive profits. At the other extreme, firms could behave collusively, jointly restricting out- put, raising prices well above costs, and earning very high profits. Most theoretical models of oligopolistic industries suggest behavior between the two extremes: prices and profitability will be above and output will be below Ivhat would result from highly competitive behavior, and output will be higher and prices and prof- itability will be lolver than their levels in a monopo- lized or highly collusive industry. Casual empiricism suggests that cigarette prices ha1.e historically been bye11 above costs, thereby allow- ing cigarette producers to achieve a rate of return ~-41 above that earned in most other industries. Even after the health consequences of cigarette smoking became apparent, the U.S. tobacco industry led all U.S. indus- tries in profitability (Miles 1982). Moreover, in the t\vc major antitrust cases brought against the cigarette in- dustry in the 20th century, firms were found guilty ir 1911 of monopolization and in 1946 of a conspiracy tc restrain trade (collusion). Most industry analysts sug- gest that the primary source of market power in the cigarette industry is the entry barriers resulting fron? marketing efforts, tvhich create significant brand loy- alties that are nearly impossible for a nets producer tc overcome. High Tobacco Concentration and the Impact of Prevention Policies The high concentration of the cigarette industrk and the apparent market polver this concentratior engenders have implications for the effects of changes in cigarette taxes and other prevention policies on the pricing, marketing, and other strategies of cigarette firms. For example, the historically high profitabilitv of existing cigarette producers pro\.ides them Lvith thk resources needed to s~~ccessf~~llv de\-elop and market new' products, as leas seen in ;he de\.clopment and introduction of filtered cigarettes in the lY5Os and lots- tar and lolv-nicotine cigarettes in the 1YhOs in response to the initial reports linking cigarette smoking to lung cancer. More recently, in response to the increased alrareness of the harmful effects of en\-ironmental to- bacco smoke (ETS) on nonsmokers and the ~~idesprcad restrictions on smoking that ha\-e been designed to protect nonsmokers, R.J. Re\,nolds Tobacco Cornpan\, introduced its Eclipse brand in se\ era1 test markets beginning in mid-lYY6, and Philip Morris Companies Inc. is currentI>, testing its Accord brand in the Lnitccl States and Japan. Both are ostensibl\, "smokt~lt~ss" cig,3- ret&s, primarilv heating rather than burning tobacco; consequently, both generate less secondhancl smoke than con\.entional cigarettes. Economic theor\, can predict sonic effect\ of in- creases in excise tax&on price, output, and profitabil- itv. At one extreme, tax increases in a perfectl\ competiti\.e market \vith constant costs of production should result in price increases of the same magnitude rzith no impact on long-run profitabilitv. Reductions in output \\.ould depend on the effect that price has on demand. At another extreme, standard models for a monopolized market suggest that producers; and consumers \ynuld share the burden of the tax increase but consumers \vould pav a greater share of the tax, because demand is less s&iti\-e than production to price. Output and profitabilit!, t~ould fall, Ivith smallet reductions in both-again because demand is less sen- sitive to price. Recent advances in the theoretical and empirical study both of oligopolistic behavior and of the supplv of addictii.e goods haire vielded se\,eral interesting predictions. Perhaps most interesting is the possibility that prices ITi increase by more than the amount of the tax increase i~hen excise taxes are raisecl. Several early studies of these relationships pro- duced generally inconsistent conclusions concerning hoM' much cigarette prices rzould increase after an in- crease in cigarette taxes (Barzel 1976; Johnson 1978; Sumner 1981; Sumner and Ward 1981; Bulo\~ and Pfleiderer 1983; Bishop and \Ibo 1985; Sulli\,an lY85; Sumner and Wohlgenant 1983; Ashenfelter and Sullivan 1987). One general Meakness of these stud- ies w'as their failure to account for the dynamic inter- action of firms in an oligopolistic industrv. Instead, the studies generally assumed that rules fo; the firms' behavior \vere established, and then, \vith obselved prices and taxes, the studies lvorked back\\-ard to determine the degree of competition within the indus- trv (Harris 1987). More recent studies have addressed these weak- nesses. Harris (1987) used the estimates obtained from se\,eral studies of cigarette demand and supply to e\raluate the impact of doubling the federal cigarette excise tax in 1983; moreover, Harris' framework al- lo\ved the change in the tax to affect the interaction of firms in the industrv. Using data on wholesale and retail cigarette prices as well as the costs of produc- tion, Harris concluded that the ii-cent increase in the tax 14 to a 17-cent increase in the retail price of ciga- rettes. He further argued that the price increase above the tax hike could not be accounted for by increases in production costs. Instead, this increase was attributed to the recognized interdependence of cigarette firms in an oligopolistic industry; that is, the firms recog- nize that their profitability \vould rise if all could suc- cessiull~ restrict output and raise prices. However, because foi-ma1 agreements on output and prices are illegal, the firms are alert to other bases on which they can coordinate their behavior. Harris suggested that such a base \\`as the announced increase in the federal ta\, scheduled for January 1, 1983, lvhich served as a ioordinnting mechanism for a joint oligopolistic price increase. As Bnrnett and colleagues (1995) note, Har- ris' analvsis fails to account for existing trends in ciga- rette prices. Barnett and colleagues argue that Harris attributed too much of the coordinated rise in price to the increase in the federal tax, because the upward trend in prices predates the consideration of the tax hike. The authors suggest that producers used the in- troduction of discount cigarettes in 1981 to coordinate the earlier price hikes for premium brands, because the lolver-priced "generic brands" would keep more price-sensitil-e smokers in the market. The spirit of this argument is the same as Harris', because both sug- gested that certain e\,ents served as focal points allow- ing firms to engage in more collusive behavior without appearing to establish a formal agreement. Keeler and colleagues (Sung et al. 1994; Barnett et al. 19%; Keeler et al. 1996) used national- and state- lc\.el data to estimate the effects of cigarette tax in- creases on price. Their empirical models have been used to examine the interaction of cigarette supply and demand in determining cigarette prices. By using alternative assumptions about firm behavior, these studies formally account for the oligopolistic aspects of the cigarette industry in their empirical models of cigarette supplv. At least some of these models also account for the+addictive nature of cigarette demand. In a study using data on all U.S. states from 1960 through 1990, Keeler and colleagues (1996) conclude c~\\~la~~i thti li\.pnthL5i\ a5 follo~\3: iigdrette firms Lvit1-t nl,lrht't ~cJ\\ t't- ma\. s;ft relati\ el\, low prices to "hook" i~~ti5uiilt~r5 on thtsir ddciiiti\-e product, thus raising the tature ciemdnc-l for their (-igdt-ettes; policies (including tCl\ incrc~,tssrsJ that reduce future smoking also reduce the tit-tns' prufitabilitv of maintaining lo\v prices. Nev- tWhele+s, the relativelv lo\v prices of these for~vard- looking firms (comp,~;ed \vith those of more myopic firms) I\-ill still c~ceecl the marginal and average costs of pr~dustion and distribution. A similar hypothesis lids been ~tscci to explain studies that found Ihat ciga- rette producers appear to ad\,ertise beyond the profit- tn~~simi~ing le~,el (Sholtxlter 1991). These firms rnal be engC~ging in excessive ad\.crtising (i.e., more than can be recouped through brand switching among cur- rent smokers) to attract new consumers and hoping to I,itcr bcnetit from a hi,gher demand for cigarettes as `i- result of these tie\vlv addicted consumers. The rapid incr&ses in cigarette prices since the e,irl\ I %X)5, I\.liich are only pnrtlv explained bv incrcdst~s in taxes and costs, thus reflect I-7rofit-maximizing beha\-ior b>f ;i highly concttitr~~tcd cigarette industr\~ that anticipate5 dtueas.ed future ~lemand as xiditiotiC~l c'iforts to rcduw tobaccn ust' are implemented (Kecket c't ,il. 1-W). ;Itl empiric-al dppliiation of this model tc tlic ti5liips bc`t\x.twi industrv concentratioti~ tri5tt-iiti~~n5 c>ii iigdrctte ad\~ertising, cigarette pricr~. ,Incl mdrket po\\.er. One such analysis supports the ion\ twticIndl \\,isdoni that advertising is an important ic)tiipt`titi\ e strategy in de\~elopin, u and m;lintainin$ br,incl io\~dIt~~ for firms in the cigarette indt.tstr\ ~N~u\~~ii ~IW?). Another analvsis, using nn empiricA niodt>l that ;Illo\\5 firms in an oligopolistic indurtrv tc h;l\ t` some cicyt-et> of market polver, conclucies ;lial dd\.cdi5iti~q raist5 market po\vet- and, consequetitl~- pr~~tit,lbilit\ in the cigarcttt> industrv (TremblCtv anti Tretnbl,~\~ iW3). A likelv eupl,wati& of this ef&ct i> that b\, tostcritig lov;llt\T to existing brdncls, cigdrettt ad\ vr;isiii:g raises LGrri&s to other brand5 that try tc tlntct- the market and shCue in the profits. Se\-et-al studies (Porter 19X6; Mitchell ant? ~~lulherin lc)Sti; Eckard Ic)c)l) ha\,e ~oncl~~deci that bnn- niti;; ii ~arrtte acl\~crtising from television and radii h mdclv the industr\- c`\ cn less conipetiti\x!, thercbv fur tlitlr raising pt-nfit~iL%lit\,. One such stud\, atfribufeti the incrtuses in cigitdte prices after thedadL.ertisitis bdn to the rcduiecl cotnpt~tition taultin~ front the L7d1- (Porter I%%). This cotiilu5ion ~vas supported, tc) wnic Discussion effecti\-ely in foreign markets (this t),pe of association is exempt from antitrust lal~ under the Webb-Pomertne .4ct). As Grise (1990) notes, trade in tobacco and tobacco products would be even higher if not for general trade policies and, in particular, widespread agricultural and industrial policies that protect domestic tobacco grow- ers and producers of tobacco products. Numerous countries have policies that support domestic tobacco growing; in the United States, examples are the tobacco support program and the short-lived mandatory mini- mum content of domestic tobacco in domestic ciga- rettes. Likewise, both tariff and nontariff barriers to trade in tobacco and tobacco products ha\re been erected around the \vorld. These barriers include quo- tas, restricted product lists, exchange controls, prior deposits, mixing regulations, licensing requirements, and limits on advertising and other promotional ac- tivities (Grise 1990). Moreover, in se\,eral countries (in- cluding Japan, South Korea, and Thailand), various aspects of the manufacture and distribution of cigarettes have long been controlled by go\rernment monopolies that have largely prevented the import of foreign ciga- rettes (GAO 1992). When tariff and nontariff barriers to trade are used to protect domestic tobacco and tobacco products, to- tal supply of these products is usuallv louver than it would be others-ise, lvhereas domestic supplv is higher. In the case of tobacco products, this arrang&ent has public health benefits resulting from the generally higher prices and reduced consumption of the pro- tected products. Domestic suppliers benefit b!r sup piying more at higher prices. Foreign suppliers, howei'er, are likely to lose in this arrangement, because their access to these markets is limited and costs of sup- plying the markets are higher. In addition, restrictions on advertising and promotion in gi\ren countries are likely to make it difficult for nelz firms to successfully enter newlv opened markets lvhere existing brands are firmly entrenched (Chaloupka and Corbett 1998). Past Tobacco-Related Trade Policy In general, tobacco products exported from the United States are specifically exempted from federal laws and regulations concerning the export of poten- tially harmful products, including the Federal Hazard- ous Substances Act (Public La\v 86-613), the Toxic Substances Control Act (Public Law 94-469), and the Controlled Substances Act (Public La\v 91-513) (GAO 1992). Similarly, although federal regulations (1) re- quire that all cigarette packaging and advertising in the United States contain health rtarning labels and (2) prohibit television and radio cigarette advertising, there are no federal regulations or laws concerning the packaging or advertising of domestically produced cigarettes that will be exported (GAO 1992). Various U.S. policies and programs have been used to help domestic tobacco growers and cigarette companies expand into foreign markets (Connolly and Chen 1993). These policies include the USDA's Food for Peace Program, which sent more than $1 billion in domestically produced tobacco to developing countries in the 1970s and early 198Os, and the 1984 Export Credit Guarantee Program, which exported domestically grown tobacco and helped U.S. cigarette producers enter Mideast markets (including AIgeria, Egypt, Iraq, and Turkey) (Taylor 1984). Perhaps the most impor- tant, however, is Section 301 of the Trade Act of 1974 (Public Law 93-618) and its subsequent amendments. Section 301 of the Trade Act of 1974 The Trade Act of 1974 was initiated by the Nixon administration when it sought permission to begin the Tokyo Round of GATT. GATT, an international trade agreement honored by nearly 120 countries, governs various aspects of international trade. (GATT is dis- cussed in greater detail in "Multinational Trade Agree- ments," later in this chapter.) The first of these agreements was reached among 23 nations shortly af- ter the conclusion of World War II. Since then, seven rounds have occurred, including the Uruguay Round, which concluded in April 1994 after more than seven years of negotiations. The Trade Act of 1974 included in its final legis- lation various measures with the stated purpose of- promoting free trade. One of these measures was Sec- tion 301, \vhich gave the President the authority to in- vestigate cases where trade and other practices of foreign countries were considered unjustifiable, unrea- sonable, or discriminatory in that they limited the abil- ity of U.S. firms to sell their goods and services in foreign markets. Section 301 expanded the authority given to the President by the Trade Expansion Act of 1962 (Public La\v X7-794). That earlier legislation allowed for inves- tigations of unjustifiable trade sanctions (those that di- rectly violated GATT). Consequently, the act applied only to goods covered by GATT (which at the time ex- cluded agricultural products, including tobacco). Set-m tion 301 expanded presidential authority to include trade in all C.S. goods and services and allowed the in- vestigation of practices that were unreasonable but did not necessarily violate GATT. If negotiations were not- successful in ieducing or eliminating the unjustifiable or unreasonable limits on trade, Section 301 authorized the President to impose retaliatory trade sanctions. Ini- tially, Section 301 recei\,ed little attention, although it rz-ould later become a rvidely used tool of U.S. trade policy (Nivola 1993). Section 301 of the Trade Act of lY73 \vas strength- ened by the Trade and Tariff Act of 1984 (Public Lab\ 98-573) and the Omnibus Trade and Competiti\.eness Act of 1988 (Public La\1 100418). NOM. known as "Su- per 301," the section required the U.S. Trade Repre- sentati\,e to annually identify countries and their practices that consistently limited market access to ti.S. firms. More important, if negotiations failed to elimi- nate the unfair trading practices of these countries, mandatory retaliatory measures \vere to be imposed unless the President deemed these measures harmful to U.S. economic interests. Four Section 301 cases in the late 1980s dealt \j.ith cigarettes: cases against Japan in 1985 and Taiil-an in 1986 were initiated by the U.S. Trade Reprtsentati\,t at the President's request, and cases against South Korea in 1988 and Thailand in 1989 ivere the result of the U.S. Cigarette Export Association's petitioning of the U.S. Trade Representati\,e. Threats of retaliatorv sanctions under Section 301 led to agreements tvith each country; as a result, U.S. cigarette firms \vere per- mitted access to those markets. The opening of the markets resulted in aggressive tobacco ad\,ertising by U.S. firms (Roemer 1993). Each of the four newly "opened" countries has la\vs, regulations, and ordi- nances concerning cigarette advertising and promo- tion. The go\,ernments of some of the countries ha\,e alleged that U.S. cigarette companies have violated restrictions on advertising and promotion. A brief review of the four Section 301 cases fol- lows; more details are contained in reports from the GAO (1990, 1992), and an empirical analysis of their impact on cigarette smoking is contained in Chaloupka and Laixuthai (1996). Jayall The tobacco industry in Japan is largely monopo- lized by the company Japan Tobacco Inc. In 1979, Ja- pan was the subject of two Section 301 cases, one involving cigars, which was prompted by the Cigar Association of America, and a second related to pipe tobacco, which was initiated at the request of the As- sociated Tobacco Manufacturers. The two cases were resolved in an agreement with Japan, which reduced market restrictions and lowered import duties (GAO 1990). Before 1986, the domestic cigarette monopoly Leas protected from foreign competition through tar- iffs of 28 percent on all imported cigarettes and through Japanese distribution practices, which discriminated against imported cigarettes. The threat of Section 301 sanctions led to an October 1986 agreement that elimi- nated Japanese cigarette tariffs and changed excise tax payment procedures and other distribution practices that adversely affected imports of U.S. cigarettes. Ex- isting Japanese policies related to cigarette advertis- ing and other promotional practices were not affected by the agreement. The agreement resulted in a significant expan- sion of U.S. cigarette firms in Japan. Japanese imports of U.S. cigarettes more than tripled in 1987 alone and Fontinued to rise in 1988 and 1989, by which time the market share of U.S. firms leas more than 15 percent (Grise 1990). This growth appeared to have slowed or stopped in the early 1990s. Total U.S. cigarette exports to Japan ranged from 54.0 billion to 57.7 billion annu- alla during 1991-1993. A dotvn\vard trend during the 1970s and 1980s in per capita cigarette consumption in Japan appears to have re\,ersed itself after theJapanese cigarette markets \verc opened to U.S. firms. Overall per capita consump- tion appears to have remained steady or increased slightly in recent years. However, among Japanese \lomen, smoking prevalence rose from 8.6 percent in 1986 (before the agreement) to 18.2 percent by 1991. The 1991 rates \vere even higher among young adult women (27 percent) (Connolly and Chen 1993). Part of this increase may be the result of adver- tising and promotional activities by U.S. cigarette firms in Japan. Between 1987 and 1990, total expenditures on cigarette advertising and promotion by U.S. ciga- rette companies in Japan nearly doubled. Most of these expenditures tvere on television advertising, which is allowed in Japan (but subject to some restrictions). Before the agreement, the domestic monopoly did not engage in extensive advertising. Afterward, it signifi- cantly expanded its advertising and promotional ef- forts. As a result, cigarette advertising moved from 40th to 2nd place in total television advertising in Ja- pan (Sesser 1993). Tnizvafr Virtually all aspects of the tobacco industry in Tai- wan are controlled by a state-run monopoly. In 1986, the U.S. Trade Representative threatened Taiwan with retaliatory trade sanctions over several governmental policies that limited the market access of U.S. cigarette companies. These policies included quotas and tariffs 011 im}wlkd 'is< IrcttLls, `1 twii 011 the rt?ail salt ot ini- pc~rted cigarettes, and a ban on print ad\-t\rtisin;: of imported cigarettes. An agreement \\`a~ reached in De- cember 1986 that reduced tariffs and eliminated other barriers, thcreb!. allort+ng C.S. cigarette companies greater access to the TaiIvanese cigarette market. The agreement also contained se\-era1 restrictions relating to cigarette packaging (rzhich \vas required to haIre a specified health \f,ai-ning label) as ~~ell as ad\,ertising and promotional acti\-ities (e.g., the distribution of free samples IVES limited and poiiit-of-t7urchase promo- tions \vere restricted to licensed establishments). The agreement greatlv increased C.S. cigarette companies' access to the Tai\\anese cigarette market. In 1987 alone, total L'S, cigarette shipments to Taitvan increased 3+fold, and the market share of U.S. ciga- rette companies rose from 2 to 17 percent (Grist 1 YYO); by lYY7, the mark& share of imported cigarettes had risen to 30 percent (Hsieh ancl \r'in lYY8). Moreover, TaiLvan's imports of relati\.elv higher-quality U.S. to- bacco rose, as the portion of U.S. tobacco in Tairvanese cigarettes increased from 35 to 55 percent to better com- pete \z,ith imported cigarettes (Grise 1YYOi. Ho\:,ever, per capita consumption of cigarettes, after increasing somet\-hat during the 19705 and earlv IYHOs, tell from 1957 through 1996, due to public and $1 ate antismok- ing policies (Hsieh and \I'in 1998). Smoking pre\-alence among Tailvancse \~omen significantI\, increased in the late lY8Os and has remained stables throughout the 1990s (Hsieh and l'in lc)Y8). Adwrtising and promotion of U.S. cigarettes af- ter the agreement are likelv to ha\-<, contributed to the large rise in the market share of U.S. cisarctte compa- nies in T, but fcil somel\.hat in the next three \`ears. Ne\-ertheless, total spending rose b)' -l3.8 per&t from 1 Y87 to IYYO (GAO 1 YY2). Gi\,eii preagreement restrictions on ad\.ertis- iii:< and promotion. almost all of these r\peiiditurc>s rzould have been for poj,it-of-I-7Lirchase and magazine ad\.ertising. Xd\.ertising by the Tailvanese cigarette moiiapolv. ho\j.e\.er. ~vds limited elen further after the ageement. Authorities in TaiI\,an ha\-e alleged that point-of- purchase promotional acti\.ities bv L'S. cigarette com- panies ha1.e violated the terms of the lYX6 agreement (GAO 1992). The agreement limits these activities to li- iensed \~.holesale, distribution, and retail establishments, Lvhich the Taiivan Tobacco & Wine Monopoly Bureau defines as those with a permit registering them as profit-seeking enterprises. Taiwanese authorities con- tend that U.S. cigarette firms have distorted this defi- nition to include unlicensed retailers selling cigarettes, resulting in Midespread advertising and unauthorized sales of U.S. cigarettes (GAO 1992). After 1987, the government of Taiwan enacted several strong tobacco control policies, largely in re- sponse to the liberalization of cigarette trade resulting from the Section 301 agreement (Hsieh and Yin 1998). Many of these policies were initially rejected by the U.S. Trade Representative as unfair or discriminatory toward the tobacco industry and in violation of the 1986 agreement. One contentious issue pertained to the health warning labels proposed for cigarette ad- iwtising and packaging. The Taiwanese government initially proposed a set of strong, rotating health warn- ing labels that would appear on the front of cigarette packaging and on all advertising. In response to the U.S. Trade Representative's opposition, the content of the label M'as changed to "excessive smoking is dan- gerous to health," and the label was placed on the side of packaging (Hsieh and Yin 1998). Eventually, in 1992, the labels were changed to include six rotating warn- ings communicating more specific information about Ihe hazards of smoking. The dispute over the Smoking-Hazards Pre\:en- tion Act, introduced in 1991 \z.ith the stated aim of pro- tecting the public health by pre\,enting and controlling damage from tobacco products, \vas even more COP tcntious (GAO lYY2). The aim of the act \yould be ac- complished by prohibiting smoking bv those under IS vears of age, banning \w~ding machine sales of to- bacco products, limiting the tar and nicotine content of all cigarettes, rquiring that the packaging of all to- bacco products include not only health warning labels- but also tar and nicotine content in Chinese, and ban- ning all tobacco aj\.ertising and certain other promo- tional activities. The act \vas immediately challenged- by the U.S. Trade Representative as a unilateral \,iola- tion of the 1986 agreement that allowed U.S. cigarette companies to ad\,ertise in Taiwan (GAO 1992). Sesser (lY93) reports that a confidential position paper drafted by the U.S. Trade Representative in January 1992 stated that the proposal was an attempt to protect the Tai- ilanese cigarette monopolv from foreign competition and that the various measures proposed would have little impact on smoking. In July 1993, the Clinton administration's US. Trade Representative, Michael Kantor, stated that his office would not challenge the act if it was enacted (Sesser 1993). Six years after its introduction, the Smoking-Hazards Preirention Act l\.as finall\- enacted j\,ith compromise clauses that permit cigar&e ad\,ertising in magazines (Hsieh and l'in 19YS). South Karen South Korea's Tobacco & Ginseng Corporation controls all aspects of that countr\,`s tobacco grn\\-ing and production, l\.hich hacl traditionall\, been prw tected bv high tariffs imposed on foreign cigarettes. In lY82,-South Korea enacted and aggressi\.elv en- forced legislation making it a criminal offense t(, sell, bu),, or possess foreign cigarettes (Edd!, and Walden lYY3). Beginning in 1987 , almost all cigarette ad\.er- tising and other promotional activities \j.ere banned b!. the Tobacco Monopol?. Act. After petitioning b!z the U.S. Cigarette Export Association in Januarl. 1988, the U.S. Trade Representati\.c in\.estigatcd these prac- tices. In response to the threat of retaliator\, sanctions on South Korean textile eNports to the United States, a Record of Understanding \~as signed hi. the t1x.o coun tries in May lY88. This agreement opened South Ko- rt'an cigarette markets to C.S. firms b\. eliminating the ban on the sale of foreign cigarettes, I-educing tlic tar- iff on imported cigarettes, alIn\\-in g tht> distribution of free samples, and allolviii s some print acl\-ertising of cigarettes and the sponsorship of sporting e\wits. The agreement also prohibited ad\-ertising that targeted \vomen and voung people (smoking is prohibited in South Korea-for persons under 30 wars of age). Fi- nall\J, all cigarette packagin g and niagazine ad\.ertis- ins i\.ere required to include a health \\.arning label. Although cigarette smoking had been increasing steaclilv in South Korea during the 19X&, the rate of oroiztl; in smoking more than tripled ~vhen cigarette h markets M'ere opened to foreign competition (Roemer 1993). Much of the increase appeared to have been the result of dramatic increases in smoking pre\.alence among voung people. From 1988 to 1989 alone, smok- ing pre\,alence among male teenagers rose frotll I8 to 30 percent, and smoking pre\.alence among female teen- agers increased from 2 to 9 percent (Sesser 1993). hluch of the increase in consumption \~as accounted for bv the increased use of imported cigarettes. Import share in the market rose from 0.06 percent before the agree- ment to nearlv 8.5 percent in 1993 and continued to in- crease steadilv (U.S. Department of Commerce, Tobacco Export Task Force Analvsis, unpublished data, No\.em- ber 13,1995). Part of th; increase mavbe attributable to an increase in adjrertising bv U.S. cigarette companies in South Korea after the liberalization of cigarette trade. In late 1988, South Korea passed the Tobacco Business Act (effective January 1, 19891, xl-hich limited ad\,er- tising and promotional efforts to p"int-of-yurchasc ad\-crtising, magazine adlrertising, and sponsorship of public e\.ents (GAO 1992). In 1991, the Korea Tobacco Association (comprising the U.S. Cigarette Export As- sociation firms and the Korean tobacco monopoly) out- lined a self-regulating voluntary marketing agreement to comply \vith the Record of Understanding and the Tobacco Business Act. Ne\,erthelcss, the South Korean government in- dicates that some promotional activities of U.S. ciga- rette companies \,iolate the spirit of the Tobacco Business Act. These allegations concern distribution of free cigarettes, advertising placement for televised c\.t`nts sponsored bv U.S. tobacco firms, the distribu- tion of nontobacco. "gifts" bearing company trade- marks, r7nd the targeting of youth. Although no formal actions related to these I,iolations were initiated, the Koreans did begin renegotiating the Record of Under- standing i\,ith the United States in 1995. In August lYY'i, the UniteJ States government agreed to modify the market access agreement \\rith the Koreans to al- ln\v them greater flexibilitv to impose nondiscrimina- tnr!, health-based measures that restrict the use of tobacco products, including limitations on tobacco product ad~.ertising. Perhaps the most publicized and contentious Section 301 dispute Ilas initiated by the U.S. Trade Representati\-e in response to petitioning by the U.S. Cigarette Export Association in April 1989 over Thailand's \,irtual ban on the import of cigarettes and complete ban on cigarette ad\,ertising and other pro- motional activities in that country. The complaint cited \-arious restrictions on the importation and sale of ciga- rettes and referred to discriminatory duties and taxes on cigarette imports (GAO 1992). `All aspects of the domestic tobacco markets in Thailand are controlled by a go\.ernment-run monopoly, which stopped its 0w.n cigarette advertising and promotion in April 1988. Ho\j.ever, foreign companies continued their activities, \vhich prompted a total government ban on cigarette ad\,ertising in Thailand in February 1989. The formal investigation began in May. After no agreement could be reached, the U.S. Trade Representative consented to submit the complaint to the GATT dispute resolu- tion process. The panel created by GATT investigated the U.S. complaint that the import barriers and advertising restrictions lvere a \riolation of the international agreement's principles. In October 1990, the GATT Council sustained the panel's recommendations and ruled that the ban on imports \\.as a \.iolation of the GATT treaty. However, the council upheld the high Thai cigarette excise taxes (applied to both domestic and foreign cigarettes) and the right of the government to restrict the overall supply of cigarettes. Regarding the Thai advertising ban, the council noted that GATT allows member nations to use lrarious policies to pro- tect public health if the policies are applied to both domestic and foreign products. A cigarette advertis- ing ban that made it difficult for new foreign firms to compete with existing domestic firms was ruled justi- fiable under the treaty, because alloying advertising could stimulate the demand for cigarettes, particularly among youth (Contracting Parties to the General Agreement on Tariffs and Trade 1991; Roemer 1993). This decision teas based on Article XX of GATT, which states that: Subject to the requirement that such measures are not applied in a manner which p1-ould constitute a means of arbitrary or unjustifiable discrimination between countries where the same conditions pre- vail, or a disguised restriction on international trade, nothing in this Agreement shall be construed to prevent the adoption or enforcement by any contracting parties of measures necessary to protect human health [or] necessary to secure compliance with 1aM.s or regulations which are not inconsistent with the provisions of this Agreement. The GATT ruling led to an agreement in No\,en- ber 1990 betlveen the Cnited States and Thailand that allowed the importation of U.S. cigarettes into Thai- land. Imported cigarettes were then subject to the same laM-s and regulations as those marketed by the Thai Tobacco Monopoly (GAO 1992). Thus, U.S. cigarettes would be taxed the same and subjected to the same supply restrictions, and the adlpertising and promo- tion of these cigarettes (including the use of cigarette company logos, trademarks, and other symbols on nontobacco products) \vould be prohibited. The Thai government, however, has indicated that U.S. cigarette companies have tried to circumvent the ban on pro- motional activities bv tactics such as sponsoring sport- ing events and placing cigarette logos or symbols in televised programming. No formal complaints ha\,e been filed. After its SLICC~SS in upholding the ban on adver- tising and promotion, the Thai government in 1992 enacted two la\vs restricting smoking: the Non Srnok- ers Health Protection Act and the Tobacco Products Control Act. The first act restricted smoking in desig- nated public places. The second \vas a comprehen- sive act that required that all tobacco products disclose their ingredients, allowed the Ministry of Public Health to determine all aspects of labeling, including health warnings, and banned the following: smoking by those under 18 years of age (imposing fines on viola- tors); vending machine sales; distributing free samples, exchanges, and gifts of cigarettes; tobacco advertising (including, under the Thai definition of advertising, the use of cigarette logos and other symbols on nontobacco products) except in international maga- zines and live telecasts originating outside Thailand; advertising products with the same name as tobacco products; producing, importing, advertising, and sell- ing products imitating tobacco products; and selling cigarettes not complying with th? labeling provisions (Roemer 1993). The cigarette trade agreement that opened the- Thai cigarette market to US. firms has led to a rise in imports from less than 1 percent of the market before- the agreement to about 4 percent in 1993. Because of- current trends, this change is likely to increase sub- stantially in the future (e.g., U.S. cigarette exports to Thailand rose by more than 56 percent from 1992 to 1993). Part of the increase may be the result of in- creased smoking prevalence among women and young people in Thailand (USDA 1994a). Multinational Trade Agreements The North American Free Trade Agreement In 1993, the United States approved the North American Free Trade Agreement (NAFTA), a compre- hensive agreement that eliminated most of the barri- ers to trade between the United States, Canada, and Mexico; implementation began January 1, 1994. This agreement further reduced already low trade barrier: betrveen the United States and Canada resulting fron an earlier free trade agreement. More important, the nect agreement substantially reduced existing trade barriers between the United States and Mexico b) eliminating all nontariff barriers to trade and by phas- ing out most tariffs. Mexican tariffs on U.S. tobaccc and tobacco products were initially set at 50 percent the 1998 rate was 25 percent. Supporters of the agree ment argued that it would lower prices, lead to a ne increase in jobs (particularly in export industries), ant spur economic growth in all three countries. Oppo nents countered that U.S. firms would have an incen tive to shift production to Mexico to reduce labor ant other operating costs, thereby leading to a net reduc - tion in C.S. employment. Before the agreement, some trends in tobacco production in the United States, Canada, and Mexico \vere similar. Total tobacco production and acreage de\.oted to tobacco grooving in 1990 lrere rvell belo\\ their 1981 levels in all three countries, but doIvnlvard trends in the United States had reversed b\r 1987. Sim- larl"; in recent years, tobacco production in Mexico has been expanding (USDA 1997cl). During the 1980s and earlv 199Os, cigarette consumption fell sharplv in both the United States and Canada but rose in Mixico. At least part of the increase in the Mexican demand fnt cigarettes resulted from increases in income, \vhich contributed to a shift to the consumption of higher- quality cigarettes among Mexican smokers (USDA 1992). Since 1991, ho\Vel.er, cijiarettc imports into Mexico have fallen as consumer purcliasins po\\.t't declined; no imports \vere expected in 19% (USDA 1997d). Trade in tobacco among the three countries \vas relati\,elv limited before the agreement. Mesican e\- ports of iobacco to the United States I\-ere about 3 per- cent of total esports, or less than 2 percent of total U.S. tobacco imports. Similarly, less than 1 percent of L.S. tobacco imports came from Canada, and about 7 per- cent of U.S. tobacco exports event to Canada. Finally, almost no tobacco \vas exported from the Cnited States to Mexico (USDA 1992). Trade in tobacco products (mainly cigarettes) \j.as even more limited before the agreement. In 1990, just over 0.1 percent of total U.S. cigarette exports \Vetit to blexico, and only 0.07 percent \2-ent to Canada. Simi- larly, there \vas no trade in cigarettes betlveen Canada and Mexico. The only exception \vas for exports of cigarettes from Canada to the United States, ~~hich \vere almost 64 percent of total Canadian cigarette ex- ports and almost 20 percent of total Canadian produc- tion (USDA 1992). However, as is discussed later in this chapter (see "International Tobacco Taxes"), most of these cigarettes M'ere reintroduced into a Canadian black market to evade the significantly higher Cana- dian cigarette taxes (Sweanor and Martial 1994). Because of the earlier free trade agreement be- tween the United States and Canada, NAFTA does not appear to have had a significant impact on trade in tobacco and tobacco products between the tw.0 coun- tries. If anything, the reduction in Canadian cigarette taxes in 1994 has led to a substantial reduction in Ca- nadian cigarette exports to the United States, as the smaller differential in cigarette prices reduced the in- centive to export cigarettes to the United States for bootlegging back into Canada. The agreement's elimination of Mexican import li- censes on tobacco and cigarettes, and gradual reduction in Mexican tariffs on tobacco and tobacco products, holyever, \vere expected to increase Mexican imports of both flue-cured and burley tobacco as well as ciga- rettes from the United States (USDA 1992). The elimi- nation of U.S. tariffs on Mexican tobacco and the impro\.ed quality of this tobacco wrere also expected to result in increased Mexican tobacco exports to the United States. I'ri\,atization of the unmanufactured tobacco industry in Mexico, however, has changed the nature of the industry and has led to an improvement in the quality of Mexican leaf tobacco (USDA 1997d). The slog\- elimination of tariffs and the improved qual- ity of domestically grobvn tobacco, coupled with the decline in the \-alue of the peso, appear to have lim- ited the impact of NAFTAon trade between the United States and Mexico in tobacco and tobacco products. This ma\ change, ho\\-e\-er, as tariffs are further re- duced and, el,entually, eliminated and if the peso con- tinues its recent strengthening against the dollar. This latest GATT agreement, which concluded in April 1991, in\rol\,ed 117 countries, and many other nonmembers have agreed to abide by its provisions. Formal appro\.al of the agreement by the U.S. Con- gress came at the end of 1994. Se\,eral basic principles are outlined in GATT: a commitment to achieving free trade by limiting and eventually eliminating tariff and nontariff barriers to trade, the notidiscriniinator); application of any restric- tions on trade to all member countries, the compensa- tion of trading partners for any damages resulting from changes in trade barriers, and the negotiated settle- ment of any trade disputes through an orderly pro- cess rather than through retaliation. However, GATT has had no enforcement power. Since the conclusion of its first round in 1947, GATT has led to sharp reductions in tariffs and other impediments to trade in manufactured goods. Before the most recent round, GATT had not been applied to trade in agricultural commodities or services. The 1994 Uruguay Round, however, significantly expanded GATT's coverage to include trade in agricultural prod- ucts, ser\,ices, and more. Moreover, the new agree- ment created the World Trade Organization, a permanent forum for GATT members to address trade- related issues among member countries. This forum strengthened GATT's ability to resolve trade disputes. Supporters of the GATT treaty have argued that it Lvill lead to a substantial increase in world trade to the economic benefit of all countries inv-olved. For example, President Bill Clinton stated in the introduction to the L~LI~LI~!. Round .~gret~niciits .,\ct that the treat), ~\.htw fullv implemented, ~~.ou]d add 5100-X1(1 billion to the L.Sl econoni\. annuall\, and \j,ould create hundreds of thousands of ne\v jobs. He \\-ent 011 to note tll`lt be- cause the United States is the \rorld's largest trading nation, it \VOLII~ be the biggest bencficiari~ of the treat\ CC .S. Congress 1 YYl). The Urugua!, Round of GATT \j'as expected to benefit the U.S. tobacco industry by reducing the his- torically high tariffs on tobacco and tobacco products imposed in numerous countries and bv reducing other lvidelv used nontariff barriers to trad-e. For example, the European Communitv \\uLII~ reduce tariffs on ci- gars by 50 percent, tariffs & cigarettes and other manu- factured tobacco products bv 36 percent, and tariffs on unmanufactured tobacco bv 20 percent, and the Philippines \\.auld reduce tariffs on leaf tobacco, ci- gars, and cigarettes bv 10 percent (USDA 1YWb). Sim- larlv, foreign access to U.S. markets \\.ould rise, as U.S. tariifs on cigar lvrappers lvould be eliminated. At the same time, U.S. tariffs on cigar filler and binder to- bacco, cigars, and most cl+ `crirettes 1~0uld be reduced by JS percent; tobacco stems and refuse LX, 20 percent; and other unm~~nuiacture~l toL?acco and smoking to- bacco bv 15 percent (USDA 39Y4b). More important, Section 472 of the Lrugua!, Routid Agreements Act allon.ed the President of the United States to \\.ai\.e Section I lOri(a) c)f the Omnibus Budget Reconciliation Act of lYY3 if he determined that this action \vas necessarv or appropriate to conipl\~ \t.ith international trade aqeements that include thi> United States. As noted pre\.iousl>., the IYY3 lcgisla- tion recluiring that cigarettes manufactured in the United States include a minimum of Z percent dc)- niesticall\, gro\\`n tobacco or face penalties \\.a.5 \\.ai,.ed b>, President Clinton's tariff rate-quota proclamation in September 199-I. The redactions in t~~bacco-rcl`ite~l trade barriers achie\.ed in the Uruguay Round appear to ha\.e had a dramatic impact on global trade in tobacco and tobacco products (Chaloupka and Corbctt IYY8). From IYW to 1997, for example, there \~as a 12.5percent increase in unmanufacturecl tobacco exports globall\~, follows ing a decade of almost no grol\.th; similarli; global cigarette exports rose bv 12 percent from 199.3 to I YYh, l\Iiile glo- bal cigarette c&sumption rose by, 5 percent (Chaloupka and Corbett 1998). As discussed pre\~iousl~~, ho\Ve\,er, the GATT Council's resolution of the tobacco-related dispute bet\\-een Thailand and the Cnited States clearl\* indicates that the adoption and implementation of strong tobacco control policies aimed at improving public health is consistent L\.ith the liberalization of trade. Discussion and Recent Developments The threat of retaliatory trade sanctions undel Section 301 of the Trade Act of 1974 has successfu]]\- opened some foreign markets to U.C cigarette manL]- facturers, thereby significantly expanding trade in to. bacco products between the United States and these countries. Chaloupka and Laixuthai (1996), in their empirical examination of these agreements, concluded that the market share of L.S. cigarette companies in the affected countries 1~2s 600 percent higher, on a\.- erage, in 1991 than it should have been in the absence of these agreements. More important, they concluded that o\.erall cigarette smoking rose as a result of the Section 301 agreements. Chaloupka and Laixuthai (I 9%) estimated that per capita cigarette consumption in 19Yl \vas 10 percent higher, on al'erage, in the four countries than it should ha\,e been had the markets remained closed to U.S. cigarettes. They attributed the increase in smoking to gwater competition in the cig- rette markets, resulting in 1oIrer cigarette prices and increased cigarette ad\,ertising. In addition, they pre- dieted that similar actions in other historically clowd countries ~~-0uld lead to similar increases in cigarettt smoking:. SimilarI>., the imylemcnt~itioli of multinationa algrwnients liberalizing trade, including trade in tr> bacco and tobacco products, is likely to further increase L`.S. clports of tobacco and tobacco products to COLIU tries around the \\wrld. A probable consequctic~~ 0 this incrt>ase is that the prices of cigarettes and othe tc>bacco products \\.ill fall as trade barriers are reduce-c or eliminated and competition is enhanced. As is di\ cusst~l in dt,tail later in this chapter (see "Effect of Prim4 on Demand for Tobacco Products"), reductions in prier \\.ill stimulate the uw of cigarettes, particulnrl\r ~llll~i~l~ `lclolt+xcYlts `17ld \ oun g adult5 Bcc~lLlse ot the sLlL~~t~ discour- dge the esecuti\.c branch from assisting U.S. tobacco conipan\i efforts to open forei, `~711 tobacco mdrket5 t Knenier~ lYY3J. Later that \sear. as ;I result of the U.S. Trade Reprewnt,lti\ c'\ in\ cstigdtion ot Thdil~iiid'~ trdde practices, `3 public hedrin, l' 011 the i`l5C' L\ `15 IlCld Sumerous congressmen, public health officials, and others (including former L;.S. Surgeon General C. E\,erett Koop) testified against tobacco-related U.S. trade policies (Eddy and Walden 1993). Although nei- ther effort Leas successful (the bill did not pass, and the hearing produced ii0 change in trade policy), both linhcd the issue vf the health consequences of tobacco LIW to U.S. trade polis\,. The 1990 GAO report, for ex- Ll~npl~, \\.as the direct ;csult of the failed 1989 bill. More rcientlv, interagencv discussions betlveen the cjtfic`e of the U.S. Trade Ripresentative and offi- ci,jls from the USDHHS ha\,e pursued the harmoniza- tion of trade and health policv Lvhile representatives tram the LSDHHS ha\ e participated in recent nego- tiations \\.ith T;lii\-an, South Korea, and others concern- in;: cigart>ttc trade issues (Holzman 1997). Moreover, the U.S. Trade Reprtsentati\~c has shown greater sen- siti\ it\, to public health concerns and has not opposed nr,nililcrimin~t~~r~, tobacco control legislation in other c~~untrics (Bloom .I YYX; National Cancer Policy Board IYYS). This position has been formalized as pait of the Doggt'tt Amendment to the Department of Commerce and Relattd Aseiicies Appropriations Act, 1998, that allo\\,s for the uw of Section 301 ill \`ery limited cir- cumst,inces. Specifically, the Doggett Amendment, spconsored b\, Lloyd Doggett (D-TX), states that: None of the funds pro\icled bv this Act shall be a\.ailable to promote the sale or export of tobacco or tobacco products, or to seek the reduction or remo\-al by anv foreign country of restrictions on the marketing of tobacco or tobacco products, ex- ccpt for restrictions \1.hich are not applied equally to all tobacco or tobacco products of the same type (Public Lar\~ 105119, Section 61X). Similar glidelines rz.ere Distributed by the Clinton administration to all diplomatic posts in February 1998. These guidelines state that: In light of the serious health consequences of to- bacco use, the U.S. Government \vill not promote the sale or export of tobacco or tobacco products or seek the reduction or removal by any foreign country of iiondisci~iiiiiiiator~ restrictions on the marketing of tobacco or tobacco products. At the same time, the U.S. Government will continue to seek elimination of discriminators trade prac- tices and lvill stri1.e to ensure that U.S. firms are accorded the same trcatnient in fowign countries ~5 that countrv's o\vn firms and firms from other countries (The National Economic Council and The N~ltion,ll Styurit\. Council of the White House, Final Guiclelincs on IHealth, Trade, and Commer- cial Issues, facsimile transmission to all diplomatic and consular posts, February 16, 1998). Moreo\,er, as part of the guidelines, U.S. diplomatic "posts are encouraged to assist and promote tobacco- control efforts in host countries." Several important issues remain unresolved. Perhaps most important is the opening of Chinese ciga- rette markets to U.S. and other multinational tobacco companies as part of China's World Trade Organiza- tion accession. With more than 300 million cigarette smokers (67 percent of men but only 7 percent of lvomen), China is a particularly attractive market for international cigarette producers. In recent years, U.S. and other multinational tobacco companies have en- tered the Chinese tobacco markets through joint ven- tures with the Chinese government's tobacco monopoly, the China National Tobacco Corporation (Holzman 1997). Economic Impact of the U.S. Tobacco Industry Tobacco grooving played a key role in the devel- opment and groll-th of the U.S. economv. Throughout much of the 20th century, holve\,er, the-importance of tobacco to the overall economy has diminished sig- nificantly, although its regional and local importance in some areas remains high. Several recent studies provide more detailed c\.idence concerning the eco- nomic importance of tobacco to the U.S. economv. A recent study by American Economics Cr&p, Inc. ([AEG] 19%), lrhich i1.a~ funded bv the tobacco industry, provides some information concerning the impact of tobacco on the U.S. economy in 1994. The report updates similar pre\,ious reports by other firms, including that by Price Waterhouse (lYY2). AEG di- vided the macroeconomic effects of tobacco into those affecting the core sector, \\,hich includes tobacco pro- duction and distribution, and those affecting the sup- plier sector, ivhich consists of industries producing and distributing intermediate goods for the core sector (in- cluding the goods and services used in cigarette prc>- duction). The analysis also separately considered expenditure-induced impacts, Lvhich depend on the multiplier effects associated with spending by those in the core and supplier sectors, and tobacco-related tax revenues, including those raised by tobacco taxes, general sales taxes on tobacco products, and income and other taxes on tobacco industrv emplovees and firms. The studv estimated that in 1494, mori than I .8 million persons were employed, earning $54.3 billio in wages and benefits, as a result of the tobacco busj ness in the United States. Total estimated tax revenue from tobacco were almost $36 billion in 1994. The rt port concluded that tobacco made a significant contr bution in every state and the District of Columbia. Several recent studies, however, have indicate, that these estimates significantly overstated the ccc nomic impact of tobacco on the U.S. economy. At th request of the Coalition on Smoking OR Health (CSH Arthur Andersen Economic Consulting (1993) rc viewed the Price Waterhouse estimates for 1990. The concluded that, as a result of several methodologic: flaws, the Price Waterhouse "employment and job lo: figures are grossly inflated" (p. 1). For example, of th 681,351 jobs Price Waterhouse attributed to tobacco i its core and supplier sectors, only 259,616 were direct1 related to tobacco growing, manufacturing, warehou: ing, and wholesaling. Of the difference, 166,791 wer retail jobs and 254,944 were supplier jobs, most of whit Lvere not devoted full-time to tobacco. Thus, statin that these jobs depended on tobacco was inaccurate. Other studies questioned the Price Waterhous assumption that every one job that is dependent o tobacco creates, through the multiplier effect, an add tiona12.35 jobs throughout the economy. This assume effect would result because those who purchase tobacc products would generate income for those who produc and those who distribute tobacco, who in turn woul spend this income on other goods and services-thereb generating income for others, as this effect spread eve further. Warner (1994) and Arthur Andersen Econom Consulting (1993) noted that this multiplier effect likely to significantly overstate the impact of tobaccf because it implicitly makes the incorrect assumptio that money spent on tobacco would not be spent else Lvhere in the absence of tobacco. Instead, those func not spent on tobacco would be spent on other gooc and services, creating jobs and generating income th; ~rould also be spent. Warner and Fulton (1994) addressed these issue by using a macroeconomic model to consider the nl impact of tobacco on the economy of one state, Mich gan. The Price Waterhouse study had estimated thi direct tobacco-related employment in Michigan w: 7,721 in 1YYO and that all tobacco-related employmel in Michigan totaled 69,575. Warner and Fulton (198 estimated that in 1992 in Michigan, 7,843 jobs direct1 depended on tobacco but that only an additional 11,28 jobs lvere either indirectly related to tobacco or induce by spending from those whose jobs were dependeI on tobacco. (This estimate for indirect tobacco-relate jobs did not consider [as the Price Waterhouse estimai did] the impact of income deri\,ed from tobacco pro- duction and distribution in the rest of the nation and spent on products produced in Michigan.) These re- searchers further estimated that, in the absence of to- bacco, total employment in Michigan should ha\.e risen b!, about 5,600 because of a redistribution of spending aLcay from tobacco products to other goods and ser- I-ices, including those more integral to the Michigan economv. As a result of the changes in employment, total incbmes in Michigan ~\fould have been $226 mil- lion higher in 1992 in the absence of tobacco. This amount resulted not only from incomes associated xvith nelv jobs but also from higher incomes for those \lith existing jobs (in part because of a change in job mix from lolver-income to higher-income jobs in the absence of tobacco). Warner and colleagues (1996) extended this analysis to examine the impact of tobacco on the re- gional economies of the United States. The research- ers examined the effects of reducing or eliminating domestic expenditures on tobacco on nine regional economies (the eight regions defined bv the L'.S. Dc- partment of Commerce, Bureau of Economic Anal\,- sis, subdi\.iding the Southeast into tit-o parts based on tobacco grooving and producing). The\, estimated that the elimination of spending on tobacco products in 1993 IVould ha\,e led to 303,000 fexver jobs in the South- east tobacco region, 12-bile increasing jobs in all othci regions bv about the same amount. B\, the \`ear 2000, they estimated that, under this scenario, the ioss in jobs in the tobacco region ~~ould fall to about 222,000 as the regional economy adjusts, \Vhile the net impact nationally \vould be an increase in jobs of 133,000. A more realistic scenario-one that doubles the recent rate of decline in tobacco use-is estimated to ha1.e smaller effects on employment. Warner and colleagues (1996) estimated a loss of 36,600 jobs in the tobacccl region by the year 2000, an amount equal to 0.2 per- cent of total regional emplovment. They concluded that the industry's claims concerning job losses resulting from reduced tobacco use are significantly overstated and that the impact of tobacco on employment should not be a primary concern, given the magnitude of the toll it takes on health. The AEG and Price Waterhouse reports \vere lim- ited also because thev presented static estimates of the economic impact of tobacco (Arthur Andersen Economic Consulting 1993). That is, the reports ignored underly- ing trends in the domestic demand for cigarettes, trends in the import and export of tobacco and tobacco prod- ucts, and changes in agricultural and manufacturing technologies that themselves are reducing employment in tobacco grooving and manufacturing. Warner and Fulton (199-I) considered these factors by predicting the net impact that eliminating tobacco-related revenues t~,ould have on the Michigan economy if existing down- \\,ard trends in tobacco sales continued: by 2005, the loss of re\`enue from tobacco in Michigan would yield a net gain of 1,500 jobs in the state. A similar issue was considered in two recent re- ports of the USDA (1993, 1997~). The reports noted that the large declines in tobacco production through- out the 1980s had a relatively minor impact on the macroeconomics of major tobacco-growing regions. Indeed, total personal income, adjusted for inflation, gre\l- bv 13-57 percent from 1979 through 1989 in the nine major regions analyzed; the average growth in all U.S. tobacco-grooving counties was 28 percent (USDA 1993). This phenomenon M'as attributed to the relatil-elv small share of tobacco in these diverse re- gional economies (on average, less than 1 percent of total income ivas accounted for by tobacco in tobacco- cTro\\.ing counties). E\,en though acreage devoted to b tobacco grooving has declined over time, rising prices ha\,e helped to keep gross income from tobacco grow:- in;: relati\.clv stable, lvhile clearlv reducing the share of tobacco iti local economies (USDA 1997~). Critics of higher cigarette excise taxes and other policies to reduce tobacco USE have argued that the ni~lcroeconomic consequences of these policies would be significant, particularly for some state and local economies. For example, economist Dwight R. Lee predicted that the 75-cent increase in the federal ciga- rette excise tax included in the proposed 1993 Health Securitv Act should lead to a loss of about 82,000 jobs and 51 .G billion in incomes in the tobacco sector, which \j-ould cause an additional loss of 192,000 jobs and an attendant loss of income throughout the economy (U.S. House of Representatives 1994). He further noted that southern states lvould be particularly hard hit by this tax increase. Similar arguments, based on the AEG and Price Waterhouse analvses, were made in the recent debate over proposed national tobacco legislation. For rea- sons noted pre\Tiously, predictions based on these es- timates are almost certain to substantially overstate the effects of higher tobacco taxes and stronger preven- tion policies on the U.S. macroeconomy. As discussed previously, Warner and colleagues' (1996) regional analysis of the economic role of tobacco concluded that tobacco has a negative net economic impact in all but the most tobacco-dependent region. Thus, it ap- pears inappropriate to raise concerns about adverse economic impact in opposing policy measures that ~~~ould cliscourage tobacco use. Moreo\w, nidn\. supporters ot legislation calling for increases in the ciiarettc excise ta\ ha\ e urged that measures be included to mitigate the p, from ages 12 through 20 and then declines dramatically, \vith initiation being unlikely after age 25. On the basis ot this model, the analysis found that increases in ciga- rctte prices had no impact on teenagers' decision5 tcl begin smoking. Douglas (1998) extended this I\-ark by estimating a model of the hazards of smoking in- tiation and cessation using data from the cancer risk factor supplement to the lY87 National Health Inter- \rie\v Sur\:ey. Douglas also finds little empirical c`\ i- dence that higher cigarette prices ~~~ould reduce smoking initiation. Ho\ve\rer, the ini.estigators noted that their estimated price effects \\ere likelv to be bi- ased do\vn\vard because of problems tvith the mea- surement of the price variables thev emploved. Douglas did find, ho\ve\.er, that increas& in cigarette prices significantly in&ease the likelihood of smoking cessation, concluding that a lo-percent increase in price lvould reduce the duration of smoking by approxi- mately 10 percent. More recent work by Tauras confirms the findings that higher cigarette prices induce smoking cessation (Tauras 1999; Tauras and Chaloupka 1999a). Using the longitudinal data on young adults from the Monitor- ing the Future project, Tauras (1999) estimated paramet- ric and semi-parametric duration models that allow for multiple cessation attempts bv voung adult smokers. His estimates indicate that thi likelihood of an initial cessation attempt and the probabilities of subsequent attempts rise as cigarette prices rise, \vith an average price elasticity of cessation of 0.333. In a somewhat less sophisticated analvsis using the same data that exam- ined the potential-for gender differences in the effects of price on cessation, Tauras and Chaloupka (IYYYb) concluded that the likelihood of smoking cessation among both voung adult men and young adult women rises significantlv as cigarette prices rise. Hu and colleagues (1995a) used data from the 19851991 California Behavior Risk Factor Surveys to estimate smoking prevalence and average cigarette consumption through equations that accounted for the interdependence of smoking and other behavioral risk factors. Using txvo-part methods, Hu and colleagues found that their estimates of the price elasticity of smoking prevalence were significantly lower when allowing for the interdependence of smoking and other behavioral risk factors (such as drinking and obesity), rzrhereas their estimates of the effect of price on aver- age cigarette consumption bv smokers were unaf- fected. The analysis estimated-that the price elasticity of demand \tras -0.46 overall, -0.21 for smoking preva- lence, and -0.22 for cigarette consumption. More recently, data from the 1976-1980, 1983, 1985, and 1987-1992 National Health Interview Sur- \`evs have been used to study the effects of prices on snioking among adults (CDC 199X). Researchers found that both the probability of smoking and the a\`erage cigarette consumption among smokers M'ere inversely related to cigarette prices, \\,ith an overall estimated price rlasticitv of demand of -0.25. In addition, they found significant differences in price responsiveness for \.arious subpopulations, including those defined by ract/ethnicity, age, family income, and gender. They found that blacks are ttl-ice as responsive as ivhites to changes in cigarette prices and that Hispan- ics are e\`en more price sensitive. Similarly, the re- searchers' estimated price elasticity of -0.58 for young adults (aged 18-24 years) is lvell above that estimated for the full sample, lvhereas individuals with family incomes at or belolv the sample median \vere about 70 percent more responsive to price than those with higher family incomes. Finally, they found that men are much more price responsive than \vomen. To determine Irhether smokers engage in any form of compensating behavior in response to higher cigarette taxes, E\rans and Farreliy (1998) focused on the data from the 1979 Smoking and 1987 Cancer Con- trol Supplements to the National Health Interview Sur\,ey. These supplements \l-ere unique in that they collected information on the brand of cigarettes smoked. This information was converted into detailed data on tar and nicotine content, length of cigarette, and type of filter. The investigators found that continuing smok- ers engage in compensating beha\?or in response to higher cigarette taxes. That is, they found that smok- ers in high-tax states were more likelv than smokers in lo\\.-tax states to smoke higher-tar alid higher-nicotine cigarettes as \vell as longer cigarettes. This compensat- ing beha\,ior bv continuing smokers left their average dailv tar and nicotine intake unchanged. Moreover, younger smokers \2-ere much more likely to engage in this compensating behavior, so much so that the higher taxes led to an increase in average daily tar and nico- tine intake among continuing young adult smokers. Recent research by Chaloupka and colleagues fo- cused on the price responsiveness of cigarette smoking among adolescents and young adults. Chaloupka and Wechsler (1997) used 1993 data from 16,277 students in 140 U.S. colleges and universities to estimate the price elasticity of cigarette smoking among young adults. Using two-part methods, the investigators separately estimated the effects of prices on smoking prevalence and on average consumption among smokers after con- trolling for restrictions on cigarette smoking and limits on youth access to tobacco. College students, who were mostly aged 18-22 vears, were very responsive to changes in cigarette pi-ices. The estimated price elastic- ity of smoking prevalence in this population was -0.53, and the elasticity for average cigarette consumption was -0.58, for an overall price elasticity of demand of -1.11. Chaloupka and Grossman (1996) employed simi- lar methods to examine cigarette smoking among more than 110,000 voung people participating in the 1992, 1993, and 199i Monitoring the Future surveys of 8th-, IOth-, and 12th-grade students. Like several other re- searchers, Chaloupka and Grossman found that smok- ing bv vounger persons is vcrv responsive to changes in cigaiette prices. Their estimated elasticitv of smok- ing prevalence for this sample of mostlv 12- through 18-year-olds \~as-0.675, rvith an overall e&mated price elasticity of demand centered on -1.313. Chaloupka and Pacula (1999) used these data to look at the differential response by gender and race, concluding that Young men and young African Americans are more respon- sive to price than young \vomen and voung iyhites. Most recently, Tauras and Chaioupka (John A. Tauras and Frank J. Chaloupka. Price, clean indoor air laws, and cigarette smoking: evidence from longitudi- nal data for young adults, unpublished data, July 1, 1998) used data from the longitudinal component of the Monitoring the Future sur\.eys to estimate the ef- fects of price on young adult smoking. Using 35 pan- els formed from the 1976 through 1993 high school senior surveys, they estimated models controlling for unobserved state and individual factors affecting ciga- rette demand. For their sample ofvoung adults, mostly aged 18-32, Tauras and Chaloupka estimated an over- all price elasticity of demand centered on -0.79. Taken together, these estimates imply that increases in ciga- rette prices Mould lead to relatively large reductions in smoking among adolescents and young adults. This conclusion is supported by recent studies by Lewit and colleagues (1997) and Evans and Huang (William N. Evans and Lynn X. Huang, Cigarette taxes and teen smoking: new evidence from panels of rc. peated cross-sections, unpublished data, April 15,1998; Harris and Chan 1999; Gruber 2000). Lewit and co]- leagues used data for ninth-grade students in 1990 and 1992 collected in the 22 North American communities from the Community Intervention Trial for Smoking Cessation (COMMIT). They found that both youth smoking prevalence and youth intentions to smoke are inversely related to cigarette prices, with estimated price elasticities of -0.87 and -0.95, respectively. Evans and Huang estimated a somewhat smaller effect of -0.20 for high school seniors by using annual, state- level measures of smoking prevalence aggregated from the 1977 through 1992 Monitoring the Future surveys, However, they concluded that this had increased over- time, estimating an elasticity of -0.50 for the period from 1985 through 1992. Harris and Chan (1999), LIS- ing data from the 1992-1993 Tobacco Use Supplement to the Current Population Survey, provide consistent- evidence that price responsiveness falls with age. Their estimated elasticities range from -0.996 for 15- to 17- vear-olds to -0.329 for 27- to 29-year-olds. Gruber (2000) reaches a somewhat different conclusion using data from the 1991 through 1997 Monitoring the Future survevs, the 1991,1993,1995, and 1997Youth Risk Be, ha\,io; Surveys, and the 1991 through 1997 Vital Sta- tistics Natality Detail files for teens giving birth before their 19th birthday. His estimates indicate that older teens are relatively more responsive to price than younger teens (approximately 17 to 18 years of age compared M.ith approximately 13 to 16 years of age) His estimated price elasticity of smoking prevalence for older teens centers on -0.67, ivhile he finds thal younger teens, on average, are not sensitive to price In addition, he concludes that price sensitivity among older teens is greatest for more socioeconomically dis advantaged groups, such as voung blacks or those witk less educated parents. In contrast, DeCicca and colleagues (Phili DeCicca, Donald Kenkel, and Alan Mathios, Puttiq out the fires: \vill higher taxes reduce youth smoking? unpublished data, April 1998) concluded that highe cigarette taxes have a verv small impact on smokin: initiation among youth. -Using data from the 1988 1990, and 1992 waves of the National Education Longi tudinal Study (NELS) of 1988, and treating each wav separately, the investigators estimated price elasticitie for youth smoking prevalence comparable to those di: cussed abo\,e. Horvever, when they used the 1ongitL dinal data to examine the onset of daily smokin Reducirl,o Tobacco U_se betlveen 8th and 12th grade among youth not smok- ing in 8th grade, DeCicca and colleagues found little effect of price. In a separate analvsis of the same data, Dee and E\.ans (Thomas S. Dee and William N. E\rans, A comment on DeCicca, Kenkel, and Mathios, unpb- lished data, May 10, 1998) come to the opposite con- clusion. Dee and El-ans made t\l-o adjustments to the construction of the sample used bv DeCicca and colleagues-including respondents \vith missing data on some co\Tariates (about 20 percent of the sample) and redefining several variables based on the categori- cal data. After making these changes, Dee and E\,ans estimated a price elasticity for the onset of smoking of -0.63, consistent M'ith several of the other recent stud- ies of vouth smoking based on cross-sectional data. in response to Dee and E\.ans, DeCicca and co- leagues (Philip DeCicca, Donald Kenkel, and Alan Mathios, Putting out the fires: \\ill higher taxes reduce vouth smoking?, unpublished data, August 1998) COP ducted a reanalysis of NELS data b!, using an aItern,i- tive approach to dealing Lvith the problem of missing data. Their reanalysis produced some\vhat more sig- nificant estimates for the effect of cigarette taxes on the onset of daily smoking betlveen 8th and 12th grade; the implied price elasticities from alternati\.e specifi- cations ranged from -0.023 to -0.X5. Ho\\-e\.er, smaller, less significant effects are found for models that employ cigarette prices. After obtaining separate estimates based on race and ethnicity, DeCicca and col- leagues concluded that higher cigarette taxes ha\,e little impact on smoking onset bv black and \2-hite vouth but significantly reduce on.& among Hispanic $outh and youth of other races. The use of longitudinal data to research the impact of cigarette tax and price changes on smoking initiation is clearly an important and ap- propriate step. The differing conclusions from earlier studies of the same data suggest, hobyever, that these discordant results should be Meighed cautiously against the prevailing findings of recent studies. Finally, two recent studies by Ohsfeldt and col- leagues (1997, 1999) examined the impact of cigarette and other tobacco taxes on the probabilities of ciga- rette and smokeless tobacco use by males 16 vears of age and older using data from the 1985 and 1942/1993 Current Population Surveys. To account for the po- tential reverse causality between demand and tobacco control policies (including taxes), the researchers esti- mate a simultaneous equations model. They find con- sistent evidence that higher cigarette taxes reduce the probability of smoking. Behavioral Economics Studies of Cigarette Demand Behavioral economics is the relatively new ap- plication of the principles of consumer demand theory to experimental psychology (Hursh and Bauman 1987). In a laboratory setting, behavioral economists study- ing addictio~i-related behaviors focus on the impact of unit price on drug dependence, including nicotine dependence. Price, in this literature, is defined as the response required to receive one dose of the drug (Bickel et al. 1993; Bickel and Madden 1999). As in standard economic theory, a key prediction of this branch of behavioral economics is that drug consump- tion is in\.ersely related to price. One advantage of this experimental approach in the analysis of cigarette demand is that it allows researchers to study the ef- fects of differences in cigarette prices that are many times larger than the price differences observed in cross-sectional data, time series data, or both. One limi- tation, hoive\,er, is that these methods are generally applicable onlv to dependent individuals. Thus, for temple, their do not pertain to initiation. In a seiies of papers, Bickel, DeGrandpre, and their colleagues reported the results of research on ciga- rette smoking in their behavioral economics labora- tar!' (Bickel et al. 1991, 1992; DeGrandpre et al. 1992, 1991; Bickel and DeGrandpre 1996). In the experi- ments, nicotine-dependent smokers were rewarded \vith two puffs on a cigarette after the completion of a specified number of responses. The total number of puffs received is the measure of consumption, and the number of responses required is the measure of price. The number of responses required to receive two puffs varied from 100 to 3,200, thereby allowing the research- ers to study the impact of price on demand over a large range of prices. As in the econometric and other stud- ies described previously, this experimental approach found an inverse relationship between cigarette smok- ing and price. More interesting, however, is the nature of the relationship between price and consumption. The investigators found that the price elasticity of demand rose as price rose. That is, the percentage reduction in consumption for a given percentage rise in price was larger at higher prices. Studies of Smokeless Tobacco Use and Price Although numerous studies have examined the impact of cigarette prices and smoking prevention policies on cigarette smoking, relatively few studies ha\,e examined the corresponding issues for smoke- less tobacco use, and \.irtually none consider such use in di\Terse culture groups. Similarly, few analyses have examined the possible substitution of smokeless to- bacco products or cigarettes in response to changes in their relative prices. Ohsfeldt and colleagues begin to address these gaps in the literature in two studies of smokeless to- bacco use (Ohsfeldt and Boyle 1994; Ohsfeldt et al. 1997, 1999). Using state-level data for males aged 16 years and older who had participated in the Septem- ber 1985 Current Population Survey, Ohsfeldt and Boyle examined the impact of various tobacco taxes on the prevalence of smokeless tobacco use. Their analysis, which controlled for other determinants of demand, found that higher taxes on smokeless tobacco were associated with lower use of smokeless tobacco. The prevalence of smokeless tobacco use, however, was positively related to cigarette excise taxes. The inves- tigators suggested that these findings might partly explain the growth in smokeless tobacco use among young males during the 1980s. During this period, when cigarette excise taxes ivere rising more rapidly than smokeless tobacco taxes, comparatively larger increases occurred in cigarette prices. As the research previously described indicates, increases in cigarette prices significantly reduce cigarette smoking. Ohsfeldt and Boyle's analysis, howe\rer, suggested that tobacco use overall might not be significantly reduced, because some smokers might turn to using the comparatively less expensive smokeless tobacco products. These find- ings were generallv confirmed by the analysis by Ohsfeldt and colleagues (1997) of the individual-level data from the September 1985 Current Population Sur- vey and their subsequent analvsis of data from the September 1992, January 1993, dnd May 1993 surveys (Ohsfeldt et al. 1999). The authors concluded that higher smokeless tobacco taxes reduce the probability of smokeless tobacco use but that higher cigarette taxes, while reducing the probability of smoking, increase the likelihood of smokeless tobacco use. Similarly, using data on young males from the 1992, 1993, and 1994 Monitoring the Future suri'eys of 8th-, lOth-, and 12th~grade students, Chaloupka and colleagues (1997) concluded that both the pre\.alence and the frequencv of smokeless tobacco use are in- xrersely related toits price. Thev estimated an overall price elasticity of smokeless tobacco demand by young males of -0.39, with more than two-thirds of the effect on the prevalence of smokeless tobacco use. Cigarette Prices and Other Substance Use Little is known about the relationships between cigarette prices and other substance use, whereas much is known about the impact of cigarette price on smok-m ing. Economists define two goods as complements if an increase in the price of one good reduces the con- sumption of not only that good but also the consump-- tion of the other. Conversely, substitutes are goods for which an increase in the price of one results in an increase in the consumption of the other. A few very- recent econometric studies have examined the relation- ship between cigarette prices and other substance use (Pacula 1998a,b; Chaloupka et al. 1999; Farrelly et al. 1999; Pacula et al. 2000). Research on patterns of substance use among youth generally concludes that youth begin with to- bacco, or alcohol, or both and that some youth progress to marijuana and other illicit drug use (Kandel 1975; Kandel and Yamaguchi 1993; USDHHS 1994). Other research concludes that cigarette smoking is a signifi- cant predictor of both the probability and the frequency of other drug use (USDHHS 1988; Henningfield et al. 1990). This research suggests that cigarettes and other substances are complements for one another and that higher cigarette prices, by discouraging smoking among youth, could significantly reduce youth and adult drinking and illicit drug use. Pacula (1998a), in the first econometric examinaj tion of this "gateway hypothesis," used data from the National Longitudinal Survey of Youth to examine tht impact of cigarette prices in earlier years on curreni marijuana use by young adults. Her estimates are con- sistent with the gateway hypothesis; that is, higher pas cigarette prices (which are expected to reduce past ciga, rette smoking) reduce the likelihood that a young aduf currently uses marijuana. However, she finds no rela tionship between contemporaneous cigarette price! and marijuana use (Pacula 1998b). Chaloupka ant colleagues (1999) used data from the 1992 through 199~ Monitoring the Future surveys of Bth-, IOth-, and 12th grade students to examine the relationship betweel current cigarette prices and current cigarette smokin; and marijuana use. They found that higher cigarettl prices, in addition to reducing current cigarette smok ing, also reduce current marijuana use. Farrelly an4 colleagues (1999) found similar evidence for adult using several of the recent National Household Sur \`eys on Drug Abuse. In addition, they found tha higher cigarette prices reduced alcohol use. More rE cently, using a longer time series of data from the Monk toring the Future surveys of 12th-grade student! Pacula and colleagues (2000) found little impact c Reducing Tobacco Usr cigarette taxes on youth marijuana use. The growing evidence suggests that cigarettes and marijuana are not substitutes for one another, implying that higher ciga- rette prices Mill not lead to increased marijuana use, with several studies implying the opposite-that higher cigarette prices will reduce both cigarette and marijuana smoking. Much more research is needed, however, to firmly establish these relationships. Discussion A few general conclusions can be dra1z.n from these studies of the effects of cigarette prices on smok- ing. First, increases in cigarette prices lead to signifi- cant reductions in cigarette smoking; most studies, using a wide variety of data and methods \1-ith \,arious strengths and weaknesses, predict that a IO-percent increase in price \2-ill reduce o\,erall cigarette consump tion bv 3-3 percent. Second, the effects of increases in Taxation of Tobacco Products cigarette prices are not limited to reductions in average cigarette consumption among smokers but include sig- nificant reductions in smoking prevalence. These ef- fects on smoking prevalence constitute both an increase in smoking cessation among smokers and a reduction in smoking initiation among potential young smokers. Third, although evidence concerning the effects of prices on adolescent smoking is mixed, the majority of the e\,idence from recent studies indicates that ado- lescents and young adults are significantly more re- sponsive than adults to changes in cigarette prices. Most recent studies found that adolescents and young adults \vere tivo to three times more sensitive than adults to price. Ongoing research, particularly that based on longitudinal data, will help clarify this issue. Finally, the limited number of studies of smokeless tobacco use suggest that increases in smokeless tobacco prices lvould reduce the prevalence of smokeless to- bacco use. As the preceding section indicates, numerous studies of the demand for cigarettes confirm a funda- mental principle of economics: increased tobacco prices will reduce tobacco use. In general, several fac- tors will determine the retail prices of cigarettes and other tobacco products. For example, factors that re- duce the supply of tobacco will raise the prices of to- bacco products. As described previously, these factors include tobacco price support programs, market po\l-er and collusive behavior among firms in the markets for tobacco products, and restrictions on trade in tobacco and tobacco products. The most important policv- related determinants of prices, however, are taxes on tobacco products. In the United States, tobacco is taxed in various ivays by the federal, state, and local governments. The most important of these are the excise, or per unit, taxes imposed on cigarettes and the general sales tax (an ad valorem tax) applied to cigarettes and other tobacco products in most states. Ad valorem taxes are a fixed percentage of the price and thereby increase or de- crease as price changes. Excise taxes, on the other hand, do not change over time ri,ith prices. Tobacco taxes have relatively low administrative costs and can generate substantial revenues. In recent years, increased taxation of tobacco products has been used as a strategy to reduce tobacco consumption and thereby to improve public health. For example, the health benefits of tax-induced reductions in smoking were often cited by supporters of the federal cigarette excise tax proposed as part of the Clinton admini- stration's proposed Health Security Act of 1993, which included an increase of 75 cents per pack. (The act did not pass.) Similarly, anticipated large reductions in youth smoking were, in part, the rationale for tax in- creases of up to $2.00 per pack proposed as part of most proposals for national tobacco legislation and the average 52.00 state and federal tax set as a goal for 2010 by the Healthy People 2010 initiative. The health benefits of higher taxes were also the focus of the large voter-initiated tax increases in Arizona, California, Massachusetts, Michigan, and Oregon, as well as the large legislated tax increases in Alaska, Maine, and elselvhere. Rationales for Tobacco Taxation Alternative approaches have been used to deter- mine the appropriate level of cigarette and other to- bacco taxes. One such approach is the historical or comparative standard, which looks at the relative value of these taxes over time or cross-sectionally. A second approach is to use an efficiency standard based on the external costs of smoking; this approach implies that tobacco taxes can be thought of as "user fees" suffi- cient to cover the external costs of tobacco use. This approach, however, raises questions concerning the fairness of such taxes. A further argument has been made for substantial increases in tobacco taxes, because these tax hikes Mould lead to substantial reductions in the morbidity and mortality associated with ciga- rette smoking. Finally, because taxes on cigarettes and other tobacco products are a relatively simple way to generate revenues, it has been suggested that these taxes can be set at levels that maximize their returns. Each of these alternatives will be discussed. Historical or Comparative Standard Federal Tobacco Taxes Tobacco has been taxed in North America since the British government first imposed taxes during co- lonial times. Beginning in 1794, the U.S. government imposed tobacco taxes that periodically rose \vith rev- enue needs and subsequentlv fell because of consumer opposition. Since 1864, \vhen cigarette and other to- bacco taxes were included in a package to finance the Civil War, taxes on tobacco in one form or another have remained a part of the federal tax system. Taxes con- tinued to rise and fall over the next 87 years, generally increasing with revenue needs during the Spanish- American War, World Wars I and II, and the Korean War (Table 6.10). The final Lear-related increase in the federal excise tax per pack of cigarettes w'as from 7.0 cents to 8.0 cents per pack on November 1,1951, lvhere it remained for the next three decades. The most recent federal tax increases were moti- vated by a need to raise revenues for a different purpose-to reduce the increasing federal budget defi- cit. The first of these hikes in the federal cigarette ex- cise tax came as part of the Tax Equity and Fiscal Responsibility Act of 1982 (Public Lalz- Y7-248), xvhich temporarily doubled the per pack tax to 16.0 cents, effective January 1, 1983. The tax was to revert to 8 cents on October 1, 1985, but after several extensions, the 16-cent tax was made permanent in 1986. As the result of two I-cent increases included in the Omni- bus Budget Reconciliation Act of 1990, the tax per pack was increased to 20.0 cents on January 1, 1991, and- then to 24.0 cents on January 1, 1993. Finally, as a re- sult of the 1998 budget agreement, federal cigarette excise taxes are scheduled to rise by 10 cents per pack in 2000 and by an additional 5 cents per pack in 2002.- Also as part of the Consolidated Omnibus Bud- get Reconciliation Act of 1985, taxes of 8.0, 24.0, and- 45.0 cents per pound were imposed on chewing to- bmacco, snuff, and pipe tobacco, respectively. These were the first new federal taxes on chewing tobacco and snuff since 1965, when the taxation was set at 10 cents per pound. These taxes are currently 12.0,36.0; and 67.5 cents per pound (Table 6.11). This assessment amounts to approximately 2.7 cents per 1.2-ounce can of snuff, 2.3 cents per 3-ounce pouch of chewing to- bacco, and 6.3 cents per 1.5-ounce pouch of pipe to- bacco. Tobacco for roll-your-own cigarettes is not taxed at the federal level. State aud Local Tobacco Taxes All 50 states and the District of Columbia cur- rently impose excise taxes on cigarettes. The first of these was a tax levied by Iowa in 1921. It was fo!- lowed in 1923 by taxes in Georgia, South Carolin% South Dakota, and Utah. On October 1, 1969, NortE Carolina became the last state to impose a tax on ciga- rettes. As of May 1, 2000, these taxes ranged from 2.E cents per pack in Virginia to S1.ll per pack in New York (Table 6.12). Forty-four states currently imposs taxes on tobacco products other than cigarettes (Tabh 6.13); only 17 states imposed such taxes in 1964. Ir general, these other taxes are ad valorem taxes. The general sales tax in most states applies to cigarette: and other tobacco products, with the tax base in mos states including the excise tax. As of November 1,199s these sales taxes added 8-25 cents per pack to the pricl of cigarettes (Table 6.12). In eight states, 450 cities ant counties impose additional taxes on the sale of ciga rettes, and 85 of these also tax other tobacco product: The largest of the local cigarette taxes are those im posed in Chicago (combined county and city taxes c 34 cents per pack) and New York City (8 cents pe pack). At least until the 195Os, state taxes on cigarette were enacted and raised to generate revenues rathe than to discourage consumption. The average ye; such taxes were initiated in the six major tobaccc producing states (1939) slightly predates the averag year for the other states (1940) (Warner 1981). Befor the widespread publicity on the health consequence of smoking, the average tax rate in the six tobacco stat6 was only slightly lower than that in the other statt (2.5 vs. 2.9 cents per pack). Since the release in the mid-1950s of the first reports describing the adverse health effects of cigarette smoking, and even more so since the 1964 release of the initial Surgeon General's report on smoking and health, state governments have actively used cigarette taxes as a principal tool in their Table 6.10. Federal cigarette excise taxes, selected dates, 1864-2002 Effective date June 30, 1864* Aoril 1, 1865+ 1 August 1,1866t March 2,1867 July 20, 1868 March 3,1875 March 3,1883 August 15,1897 June 14,1898 Julv 1, 1901" Julv 1, 1910 October 4, 1917 February 25,1919 July 1, 1940 November 1,1942 November 1,195l January 1,1983 January 1,199l January 1,1993 Tax per pack of 20 cigarettes (cents) 4.0, 8.0, x.0+20'; 10.0 3.0 0.8, 2.-I 3.5 1 .o 2.4,1.0 2.0 3.0 1.08,2.16 2.5 1.1 6.0 6.5 7.0 8.0 16.0 20.0 24.0 campaigns to reduce tobacco use. For example, the grew substantially over this period. By May 1, 2000, number of tax increases has risen from an average of the simple average of cigarette taxes in the six largest less than three per year in the early 1950s to an aver- age of more than eight per year in the late 195Os, and a tobacco-growing states was 7.1 cents compared with record 22 states increased their cigarette taxes in 1965 (Table 6.14). Similar activity occurred during 1967- 46.5 cents in the remaining states and the District of 1970, tlhen antismoking ads were broadcast under the Columbia. Fairness Doctrine and after cigarette advertising on television and radio was banned in 1971. The once- negligible difference in cigarette excise tax rates be- tM-een the tobacco-producing states and other states January I,2000 34.0 January 1,2002' 39.0 The use of increased cigarette and other tobacco taxes to discourage all tobacco use was even more ob- v,ious in the late 1980s and earlv 1990s. In November 1988, California v,oters approved the Tobacco Tax and Health Protection Act (Proposition 99), the then- largest single increase (25 cents per pack) in any state excise tax on cigarettes. New taxes were also imposed on other forms of tobacco. The novel feature of this tax hike M'as that 20 percent of the new revenues gen- erated by the tax increase was earmarked for tobacco- related education activities and 5 percent was allocated to tobacco-related research. The success of Proposition 99 in California led to a similar voter-approved measure in Massachusetts. In November 1992, voters passed Question 1, which raised the state cigarette tax from 26 cents to 51 cents per pack and increased the state tax on chewing Table 6.11. Federal excise tax rates (cents/pound) on chewing tobacco, snuff, and pipe tobacco, selected years, 1986-2002 Year Chewing tobacco Snuff Pipe tobacco *Lower rate applied to cigarettes valued at $6 or less 1986 8.0 24.0 45.0 per 100 packs of 25 each. `Lower rate applied to cigarettes valued at $5 or less per 100 packs of 25 each. $Lower rate applied to cigarettes valued at $8 or less per 1,000. Higher rate applied to cigarettes valued at more than $12 per 1,000. "Lower rate applied to cigarettes valued at $2 or less per 1,000. `Scheduled. Source: Orzechowski and Walker 2000. 1991 10.0 30.0 56.25 1993 12.0 36.0 67.5 2000 17.0 51.0 95.67 2002* 19.5 58.5 109.69 *Scheduled. Sources: Advisory Commission on Intergovernmen- tal Relations 1991; Bureau of Alcohol, Tobacco and Firearms 2000. Table 6.12. State cigarette excise taxes and sales taxes (cents/pack) aDplied to cigarettes State Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware District of Columbia Florida Georgia Hawaii Idaho Illinois Indiana IoM-a Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Excise tax rate May 1, 2000 16.5 100.0 58.0 31.5* 87.0 20.0 50.0 24.0 65.0 33.9 12.0 100.0 28.0 58.0 15.5 36.0 24.0 3.0 20.0 74.0 66.0 76.0 75.0 18.0 18.0 17.0 - Sales tax November 1, 1999 11.0 0 16.0 13.0 25.0 0 19.0 0 19.0 17.0 8.0 15.0 11.0 20.0 13.0 11.0 13.0 15.0 11.0 18.0 16.0 18.0 20.0 19.0 19.0 11.0 L State Excise tax rate Sales tax May 1, November 1, 2000 1999 Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin Wyoming 18.0 34.0 35.0 52.0 80.0 21.0 111.0 5.0 44.0 24.0 23.0 68.0 31.0 71 .o 7.0 33.0 13.0 41.0 51.5 44.0 75 -. 82.5 17.0 59.0 12.0 0 13.0 20.0 0 17.0 14.0 13.0 10.0 18.0 13.0 12.0 0 17.0 23.0 13.0 11.0 21.0 18.0 15.0 15.0 11.0 23.0 15.0 16.0 11.0 *Arkansas tax can rise to 33 cents if the state does not appropriate adequate funds for breast cancer research and control. Sources: Orzechowski and Walker 2000; Centers for Disease Control and Prevention, Office on Smoking and Health, State Tobacco Activities Tracking and Evaluation System, unpublished data. tobacco by 25 percent. Although Massachusetts law recommended that at least part of the funds be all prevents funds raised by the tax from being earmarked cated to activities related to reducing tobacco use. for tobacco-related education and prevention efforts, More recently, Michigan voters in 1994 enactc the funds are placed into a Health Protection Fund, Proposal A, which changed the financing for MicI and the wording of the approved measure strongly gan public schools. Part of this plan included raisir the general state sales tax (Ivhich is applied to ciga- rettes and other tobacco products) from 4 to 6 percent and tripling the state excise tas on cigarettes to 73 cents per pack, representin g the largest single increase in cigarette taxes ever implemented in the United States. NeM taxes kvere also imposed on \.arious other tobacco products. Six percent of the ne\v revenues \vere ear- marked for health impro\,ement actilrities, including tobacco-related education and pre\.ention efforts. III November 1994, Arizona \.otcrs appro\.ed the Tobacco Tax and Health Care Act, \\-hich included <3 40-cent increase in the state cigarette tax \vith enrmark- ing provisions similar to those in California, Massa- chusetts, and Michigan. At the same time, ho\ve\,er, \-oters in Colorado rejectecl a tax hike of JO cents pei- pack \\ith similar features. In No\,ember 1996, Oregon voters approved Measure 41, \1-hich increased cigarette taxes bv 30 cents per pack, raised the tax on other to- bacco products from 35 to 65 percent of i\.holesale price, and dedicated a portion of the increased re\`- enue to tobacco use pre\,ention and education. Sim- lar large cigarette-tax increases, including some that dedicate significant funds to tobacco control acti\.ities, haire been recently legislated in a number of states, including Alaska, Maine, Nelv Jersey, and I'Ke\\, York. In addition, in 1998, \.oters in California appro\.ed an additional 50-cent per pack increase in the state ciga- rette tax. The relative ease \\ith \2-hich cigarettes and other tobacco products can be transported and the potential profits from illegal acti\,itv of this kind have limited state and local governments' abititv to further raise tobacco taxes. The large disparities-in price resulting from differences in tobacco taxation create incenti\.es to (1) smuggle on a casual level (invol\ring small quan- tities for personal use) or on an organized le\,el (in- \,olving large quantities, generally for resale); (2) purchase cigarettes through tax-free outlets, including military stores and American Indian reservations; and (3) illegally divert cigarettes within the usual distri- bution system by forging tax stamps, \vhich results in underreporting. Altogether, this "butt legging" (ACIR 1977) can result in a net loss of revenues \vhen tobacco taxes are increased. Although casual smuggling has always been a problem, states reported that organized smuggling activities rose significantly after the cigarette tax hikes of the late 1960s. In response to state pressure, the Trafficking in Contraband Cigarettes Act of 1978 (Pub- lic Law 95-575) was enacted. This act, w-hich dealt onlv with the organized smuggling of cigarettes, prohib- ited the single-transaction transport, receipt, shipment, possession, distribution, or purchase of more than 60,000 cigarettes not bearing the tax indicia of the state in lvhich the cigarettes \vere initially sold. The ACIR (1985) suggests that the law was even more effective than its proponents predicted. Casual smuggling, ho\\-e\,er, may become a more significant problem as the differences betlveen cigarette taxes in neighboring states increase as the result of some of the recent large tax hikes in some states. Se\.eral econometric analyses of cigarette demand ha\.e carefullv considered the effects of price differen- tials on organized and casual cigarette smuggling on state cigarette sales (Baltagi and Levin 1986, 1992; Chaloupka and Saffer 1992; Becker et al. 1994; Saba et al. 1995; Jackson and Saba 1997; Yurekli and Zhang X00). In general, these studies concluded that smug- gling has a significant, but small, impact on cigarette demand, implving that a state cigarette tax increase \\ill lead to s&me smuggling. Yurekli and Zhang (3000). for example, estimate that, on average, 6 per- cent of state cigarette tax revenues were lost due to smu~gting activities in 1995. However, given the mag- nitude of these estimates, Merriman (1994) and Baltagi and Le\ in (1992) estimated that state cigarette taxes AI-C belo\\. their rel,enue-maxin~izing levels. Thus, states can raise cigarette taxes and generate increased re\.enues, even as cigarette sales decline and interstate smuggling increases. Cigarette Taxes and Cigarette Prices Increases in cigarette and other tobacco taxes re- sult in higher prices for these products. Most ciga- rette taxes, howe\-er, are excise taxes; unless they are increased regularlv o\`er time, the value of the tax will fall in real terms (ifter analysis accounts for the effects that inflation, as measured by the Consumer Price In- dex, has on the tax). Because taxes are an important component of price, one of the consequences of an ex- cise tax system w.ith relati\rely infrequent increases is that, at least during the period between excise tax in- creases, the real price of cigarettes will fall over time as the prices of other goods and services increase more rapidly. When trends are examined in real cigarette prices o\`er the past four decades, three clear periods are ob- served (Table 6.15). The first is 1955-1971, when states lvere increasing taxes not only to raise revenues but also to discourage smoking. The real value of state taxes during this period approximately doubled from 13.1 cents (1982-1984 dollars) to 26.4 cents per pack. This increase was more than sufficient to offset the re- ductions in the real federal tax (from 29.9 cents to 19.8 Table 6.13. State tax rates on tobacco products other than cigarettes as of January 1,200O State Taxes on other tobacco products Alabama Cigars retailing for: a) ~3.5 cents each or less, 5150 per thousand; b) >3.5 and 55 cents each, $3.00 per thousand; c) >5 and 28 cents each, $4.50 per thousand; d) >8 and 110 cents each, $7.50 per thousand; e) >10 and 520 cents each, $15 per thousand; f) >20 cents each, $20.25 per thousand. Little cigars: 2 cents for each 10 or fraction thereof. Smoking tobacco: a) 11.125 ounces, 2 cents; b) >0.125 ounces and <2 ounces, 5 cents; c) >2 ounces and <3 ounces, 8 cents; d) >3 ounces and 14 ounces, 11 cents; e) 3 cents additional tax for each ounce or fraction part thereof over -l ounces. Chelving tobacco: 0.75 cents of each ounce or fraction thereof. Snuff: a) ~0.625 ounces, 0.5 cents; b) >0.625 ounces, and 11.625 ounces, 1 cent; c) >1.625 ounces and 12.5 ounces, 2 cents; d) >2.5 ounces and 53 ounces, 2.5 cents; e) >3 ounces and 15 ounces (cans, packages, gullets), 3 cents; f) >3 ounces and 15 ounces (glasses, tumblers, bottles), 3.5 cents; g) >5 ounces and 56 ounces, 4 cents; h) 1 cent additional tax for each ounce or fraction thereof over 6 ounces Alaska Arizona 73? of \\-holesale price. Cigars retailing for: a) 15 cents, 6.1 cents for each 3 cigars; b) >3 cents, 6.1 cents each. Little cigars: 12.9 cents for each 20 or fraction thereof. Smoking and che\ving tobacco and snuff: 6.5 cents per ounce or major fraction thereof. Arkansas California* Colorado Connecticut* Delaware District of Columbia Plug tobacco: 1.6 cents per ounce or fraction thereof. 23% of manufacturers' invoice price. 61.56? of \vholesale price.* 20') of manufacturers' price. 20") of manufacturers' price. 15'; of \Vliolesale price. None. *Little cigars taxed at the same rate as cigarettes. `California rate reset at beginning of each fiscal year; Ne\v Hampshire rate reset semiannually. TMaryland tax becomes effective July 1, 2000. Sources: Orzechowski and Walker 2000; Centers for Disease Control and Prevention, Office on Smoking and Health, State Tobacco Activities Tracking and E\raluation System, unpublished data. Table 6.13. Continued State Florida Georgia Taxes on other tobacco products Smoking tobacco, chelving tobacco, and snuff: 25% of wholesale price. Little cigars: 1%.eighing 53 pounds per 1,000, 2 mills each. All other cigars: 13'5 of wholesale price. 40'7 of lvholesale price. 405 of wholesale sales price. 18"; of M-holesale price. 15'; of \vholesale price. 22'; oi ivholesale price. 10"; of original invoice price from the manufacturer to the wholesaler. hone. Cigars: a) a list price of $120 per thousand or less, tax is 8% of net invoice price; b) a list price of o\.er S120 per thousand, tax is 20% of net invoice price. Smoking tobacco: 33 T of net invoice price. Cheitring tobacco and snuff: 62' ; of Mholesale sales price. Cigars and smoking tobacco: 16 (; of Lvholesalc sales price. All other products 15'; of ivholesale price. 75(; of lvholesale price for smokeless tobacco products. 15% of wholesale price for cigars and pipe tobacco. 16? of Mholesale price. 35'; of lzholesale price. 157 of manufacturers' list price. IO? of manufacturers' price. 12.5% of bvholesale price. 15? of wholesale price. 302 of M-holesale price. Chewing tobacco and snuff: 17.9? of wholesale price invoiced to retailer. 482 of wholesale price. 25% of product value. 20% of wholesale price. 2% of wholesale price. 28% of wholesale price. 17% of \2-holesale price. Cigars, cheroots, stogies, etc., weighing >3 pounds per thousand retailing for: a) 14 cents each, $10 per thousand; b) >-1 cents each, $30 per thousand. Little cigars: 9 mills each. Smoking tobacco: 403 of factory list price. Chewing tobacco and snuff: 307 oi factory list price. Hawaii Idaho Illinois Indiana 10M'il* Kansas Kentucky Louisiana hlaine* Maryland' Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire+ New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Table 6.13. Continued State Taxes on other tobacco products Oregon* Pennsylvania Rhode Island South Carolina South Dakota Tennessee* Texas 65':; of ivholesale sales price. None. 20c; oi w,holesale price. Cigars, cheroots, stogies, etc., retailing for: a) 15 cents each, $11 per thousand; b) >5 cents each, S20 per thousand. Little cigars: 2 cents ior each 8 or fraction thereof. Smoking tobacco: 36'4 of manufacturers' price. Chewing tobacco and snuff: 5% of manufacturers' price. 10% of wholesale price. 6% of wholesale price. Cigars: Tax on cigars and tobacco is based on weight per 1,000 and retail selling price. a) 23 pounds per 1,000, 1 cent for each 10 cigars; b) >3 pounds per 1,000 and retailing for 13.3 cents each, $7.50 per 1,000; c) >3 pounds per 1,000, retailing for >3.3 cents each and containing a substantial amount of nontobacco ingredients, $11 per thousand; d) >3 pounds per 1,000, retailing for >3.3 cents each and containing a substantial amount of nontobacco ingredients, $15 per thousand; Utah Vermont Virginia Washington West Virginia Wisconsin Wyoming e) Chelving, pipe, or smoking tobacco, and snuff: 35.213% of the manufacturers' list price exclusi\:e of anv trade discount, special discount, or deal. 35'; of manufacturers' selling price delilwed into state. 41c; of distributors' price. None. 74.9'; of Ivholesale price. None. 2OY of u\-holesale price. All other products 2O'r of rvholesale price. cents per pack); as a result, cigarette taxes continued to account for about 50 percent of cigarette prices. During the 197Os, howe\rer, the real price of ciga- rettes dropped significantly because of the stability of cigarette excise taxes and the relati\,ely rapid increases in the prices of other goods and serv-ices. During this period, the real value of the federal cigarette tax (which was unchanged in nominal terms) fell bv more than 50 percent, and the real value of state taies dropped by nearly as much. The net result \vas a decline of 38.5 percent in the real price of cigarettes. Moreo\,er, during this period, taxes as a share of cigarette prices- fell from 46.8 to 33.1 percent, because the nontax com- ponent of real price was relatively stable. Since 1981, however, the real price of cigarettes has increased sharply, from 69.3 cents to 127.1 cents- per pack in November 1992, and further in early 1993. Important factors behind this increase were the fed- eral tax increases in 1983,1991, and 1993, which tripled- the nominal value of the cigarette excise tax. Also important M'as the steady rise in the real value of av- erage state excise taxes on cigarettes, from a low of Table 6.14. Number of increases and decreases in state excise taxes on cigarettes, July 1,1950-May 1,200O 1950 1951 1952 1953 1954 1955 956 1 957 958 959 960 961 962 963 964 965 966 967 Year 1968 1969 1970 1971 1972 1973 1974 1975 Increases (Decreases) Year 2 7 (1) 0 2 3 11 5 (1) 8 4 15 3 (2) 17 (1) 2 13 5 22 4 (1) 12 8 20 7 16 5 2 2 5 1976 1 1977 4 1978 1 (1) 1979 3 1980 2 1981 6 (1) 1982 10 1983 13 1984 1 1985 11 1 Y86 6 1987 13 1988 3 1989 14 (1) 1990 8 1991 13 (1) 1992 7 1993 15 (2) 1994 8 1995 5 1996 2 1997 9 1998 2 1999 3 2000 1 Increases (Decreases) Sources: Orzechowski and Walker 2000; Centers for Disease Control and Prevention, Office on Smoking and Health, State Tobacco Activities Tracking and Evaluation System, unpublished data. 14.0 cents per pack in 1982 to 19.4 cents per pack in 1993. However, even with the increases in the real values of the federal and state taxes on cigarettes, taxes as a share of price fell substantially from 1981 to 1993 Reducing Tobncco Use (from 33.1 to 24.9 percent). The most important factor behind the rise in real cigarette prices, then, was the sharp rise in nontax (i.e., manufacturer-added) price components. In 1981, the real value of the nontax por- tion of average cigarette prices was 46 cents. By 1993, this amount was 79.5 cents, which is an increase of more than 70 percent. As described earlier in this chap- ter, in "High Tobacco Concentration and the Impact of Prevention Policies," much of this increase was attrib- utable to the less than perfectly competitive supply side of the cigarette market. The result of the increases in both the tax and the nontax components of ciga- rette prices was an increase of almost 85 percent in the real price of cigarettes from 1981 to 1993. Real cigarette prices declined sharply as a result of "Marlboro Friday" in April 1993, when wholesale cigarette prices, first ior Marlboro then soon after for other premium brands, were cut by 25 percent. More recently, however, real cigarette prices have risen sig- nificantly. These increases are partly the result of in- creases in state and federal cigarette excise taxes over the past few years. More important, however, are the significant increases in wholesale cigarette prices be- ginning in 1997. These prices increased by more than 12 percent between March 1997 and April 1998, return- ing to their 1992 nominal level (USDA 1998a1, in part the result of increased costs associated with tobacco industry settlements with Mississippi, Florida, Texas, and Minnesota. Wholesale prices increased an addi- tional 45 cents per pack in November 1998, on the day the Master Settlement Agreement was announced. This increase, the largest in history, was followed nine months later by an additional 1 g-cent per pack increase (USDA 2000). International Tobacco Taxes Among industrialized countries around the world, the United States has one of the lowest average prices and taxes on cigarettes (Table 6.16). As of December 31, 1996, the average tax in the United States was 66.0 cents per pack, well below the taxes imposed in almost every other industrialized country. At that time, taxes in various other countries, in U.S. dollars, ranged from $5.23 per pack in Norway to 47 cents per pack in South Africa. Most developed countries have at least double the average tax in the United States. Some in- teresting features of these taxes include earmarking for tobacco-related education and other health-related activities (in Denmark, Finland, Iceland, Peru, and else- where), the creation of state-based Health Promotion Foundations in Australia and the Health Sponsorship Council in Ne\v Zealand to fund sporting and artistic Table 6.15. Cigarette taxes and cigarette prices, 1955-2000 (cents/pack) Taxes as a percentage of average prices Real average federal tax+' Real Weighted Average Average Real average average federal cigarette average cigarette Year state tax*+ taxt price* state tax+" price' 1955 3.5 8.0 22.7 13.1 84.7 1956 3.8 8.0 23.2 14.0 85.3 1957 3.9 8.0 23.8 13.9 84.7 1958 4.0 8.0 25.0 13.8 86.5 1959 4.2 8.0 25.6 14.4 88.0 1960 4.7 8.0 26.1 15.9 88.2 1961 4.7 8.0 26.1 15.7 87.3 1962 5.1 8.0 26.9 16.9 89.1 1963 5.2 8.0 26.8 17.0 87.6 1964 5.6 8.0 27.9 18.1 90.0 1965 5.9 8.0 28.2 18.7 89.5 1966 6.9 8.0 30.0 21.3 92.6 1967 7.1 8.0 30.5 21.3 91.3 1968 8.4 8.0 32.3 24.1 92.8 1969 9.1 8.0 32.8 24.8 89.4 1970 10.2 8.0 37.1 26.3 95.6 1971 10.7 8.0 38.9 26.4 96.0 1972 11.6 X.0 30.0 27.8 95.7 1973 12.1 8.0 10.3 27.3 90.8 1974 12.1 8.0 41.8 24.5 84.8 - *State taxes are an average of taxes in all taxing states (42 in 1955; 50 in 1970 and thereafter) and the District of Columbia, weighted by tax-paid cigarette sales in those states. `Nominal and real average state and federal tax data are for the fiscal year ending June 30. %ice reflects the median retail price for cigarettes (including generic brands) in all taxing states, generally as of November 1 of the state fiscal year. %`ercentages cannot be calculated directly from the tax and price information, because taxes are weighted average taxes for the entire fiscal year, whereas prices and percentages are generally as of November 1. `Real cigarette taxes and prices are obtained by dividing the nominal taxes and prices by the national Consumer Price Index; the average of 1982-1984 is the benchmark. 7Preliminary estimate. Source: Orzechowski and Walker 2000. 48.7 47.4 48.8 48.0 46.6 48.9 48.6 48.3 49.4 49.3 49.8 51.4 50.8 49.2 48.9 47.7 16.8 47.7 18.4 47.6 29.9 29.4 28.5 27.7 27.5 27.0 26.8 26.5 26.1 25.8 25.4 24.7 24.0 23.0 21.8 20.6 19.8 19.1 18.0 16.2 events previously backed by the tobacco industry, and the differential taxes on cigarettes w+th high-tar and high-nicotine content used in previous years in the United Kingdom (Roemer 1993). One consequence of the differences in cigarette taxes and prices across countries is the potential for casual and organized cigarette smuggling and other forms of tax evasion. The cigarette industry, for ex- ample, frequently argues that cigarette tax increases Table 6.15. Continued Year Weighted average state tax*+ Average federal tax+ Average cigarette price$ Taxes as a percentage of average price5 Real average state tax+' Real average federal taxtA Real average cigarette price' 1975 12.2 8.0 44.5 44.5 22.7 14.9 82.7 1976 12.4 8.0 47.9 41.4 21.8 14.1 84.2 1977 12.5 8.0 49.2 40.5 20.6 13.2 81.2 1978 12.9 8.0 54.3 37.1 19.8 12.3 83.3 1979 12.9 8.0 56.8 35.5 17.8 11.0 78.2 1980 13.1 8.0 60.0 34.3 15.9 9.7 72.8 1981 13.2 8.0 63.0 33.1 14.5 8.8 69.3 1982 13.5 8.0 69.7 29.9 14.0 8.3 72.2 1983 14.7 12.0 81.9 26.8 11.8 12.0 82.2 1984 15.3 16.0 93.7 33.2 14.7 15.4 91.1 1983 15.9 16.0 97.8 32.3 14.8 14.9 90.9 1986 16.2 16.0 104.5 30.8 14.8 14.6 95.3 1987 16.9 16.0 110.0 29.9 14.9 14.1 96.8 1988 18.2 16.0 122.2 28.1 15.4 13.5 103.3 1989 21.8 16.0 127.5 26.5 17.6 12.9 102.8 1990 24.7 16.0 131.1 26.4 18.9 12.2' 110.3 1991 25.9 16.0 153.3 25.6 19.0 11.7 112.6 1992 26.5 20.0 173.5 25.6 18.9 14.3 123.7 1993 28.0 22.0 183.7 23.9 19.4 15.2 127.1 1994 31.5 24.0 169.3 31.4 21.3 16.2 114.2 1995 31.2 24.0 175.8 31 .o 20.5 15.7 115.4 1996 31.7 24.0 179.6 31.6 20.2 15.3 114.5 1997 31.8 24.0 185.4 30.5 19.8 15.0 115.5 1998 34.1 24.0 195.0 31.5 20.9 14.7 119.6 1999 36.4 24.0 217.5 28.2 21.8 14.4 130.6 2000 39.891 29.Oq 292.6 22.1 23.241 16.9_ 170.58 will actually lead to reductions in tax revenues due to nonexistent or relatively weak policies concerning smuggling and other tax evasion (British-American cigarette smuggling and their lack of enforcement Tobacco Company Limited 1994). The smuggling (ACIR 1977,1985; Joossens and Raw 1995; Joossens et problem is exacerbated by the relative ease with which al., in press). Joossens and Raw (1995, 1998) argued tobacco products can be transported, the potential prof- that many of these other factors can be as important its from this illegal activity, the presence of corruption as price differences in spawning cigarette smuggling. and organized crime, the widespread street selling, the For example, they noted that there is little evidence of availabilitv of tax-free and duty-free cigarettes, and the smuggling in some of the highest priced European Table 6.16. Average retail cigarette price and total taxes per pack (U.S. dollars/pack), selected countries, December 31,1996 Country Norlvay United Kingdom Ireland Denmark Finland Australia Sweden Ne\v Zealand Canada (highest provincial taxes) Singapore Hong Kong France Belgium Germany Canada (average provincial taxes) Austria Netherlands United States (highest state taxes) Italy Canada (lowest provincial taxes) United States (average state taxes) Greece Portugal United States (low-est state taxes) Thailand Tailvan Brazil Spain South Africa Average retail price 7.05 3.27 3.94 1.75 4.54 4.50 4.47 4.17 4.09 3.72 3.62 3.47 3.23 3.18 3.00 2.8-l 2.66 2.65 2.17 2.02 I .90 1.82 1.77 1.60 1.58 1.45 1.43 1.08 1.04 Total taxes 5.23 4.30 4.16 4.02 3.48 2.92 3.13 2.79 2.97 1.87 1.76 2.61 2.39 2.28 1.97 2.11 1.94 1.24 1.59 1.12 0.66 1.33 1.43 0.34 0.89 0.62 1.06 0.81 0.47 Tax as a percentage of retail price* 74 82 84 85 77 65 70 66 73 50 49 75 74 72 66 74 73 47 73 55 35 73 81 21 56 43 74 75 45 Notes: (al Figures given are for a package of 20 of the most popular price category; (b) exchange rates are from the Bank of Canada Official Exchange Rates as of December 31, 1996. *The tax as a percentage of retail price refers to the portion of the average retail selling price that composes all applicable taxes and other fees imposed on the product. Source: Smoking and Health Action Foundation (Canada), unpublished data, April 30, 1997. countries, including France, Nor\\-a\; Sl\.eden, and the United Kingdom, ivhereas there is &tensi\.e et-idence of smuggling in countries \vith relati\.ely lo\r prices, such as Spain and Ital\,. Merriman and colleagues (in press) pro\-ide empiri&l evidence that the perceil-ed le\.el of corruption explains more of the 1 ariance in experts estimates of the magnitude of cigarette smug- gling than do cigarette prices. Moreo\w, Joossens and colleagues (Joossens and Rain 1498; Joossens et al., in press) concluded that much of the smuggling that does occur in Europe and elselihere is encouraged by mul- tinational tobacco companies. Thursb\ and Thursb\T (1994) prrn.ided empirical support for this argument, based on their analysis of data from the United States from tvhich thev concluded that increases in federal cigarette excise taxes lead to increased comnicrcial cigarette smuggling. Perhaps the most interestin, 0 international con- parison is betlvcen cigarette tax polic\ in the United States and Canada. In 1970, a\-w-age taxes (includin;: sales taxes) on cigarettes \\.rre 30 cents per pack in Canada and 30 cents per pack in the United States. BL- 1980, the al'erage Canadian tax, 46 cents per pack. ~va7; double the U.S. tax. Real prices in both countries had fallen sharplv throughout the lY7Os, but after lY80, the gap bet\\Teen' the tivo countries \\.idened rapidI\,. One main reason for this change w.as the adoption oi an ad valorem tax bv the federal and pro\,incial jio\wnments in Canada. As a result, cigarette taxes in Canada doubled bet\veen 1980 and 1981, leading to a 25 percent increase in real cigarette prices. In response to pressure from the cigarette industry, hoi\-e\,er, the ad \,alorem tax structure j\.as replaced \vith an excise tax system in 1984. `The growth in Canadian taxes slolved o\w the next fe\v vears. Most taxing took place at the pro\in- cial rather than the federal level. In 1988, ho\ve\w, the Canadian federal government committed to an aggressive campaign to reduce tobacco use; highlight- ing the campaign \vas a ban enacted that vear on to- bacco advertising. In 1989, the federal tax;vas raised b>, 2 cents per cigarette, and another hike of 3 cents per cigarette occurred in 1991. At the same time, pro- vincial taxes \yere increasing rapidlv. By early 1991, the average tax per pack of cigareties lx-as $2.96 (in U.S. dollars), lvhich is more than five times the a\er- age U.S. tax. The large disparities in Canadian and U.S. ciga- rette prices led to substantial smuggling, which \vas enabled by the long stretches of unmonitored border between Canada and the United States, the relativeI\ wak border controls, and the high concentration of the Canadian population near U.S. borders (S\vcanol and Martial 1943). Much of the black market trade that resulted 12-as in Canadian-produced cigarettes that had been exported to the Cnited States (exports were not subject to the Canadian taxes) and then smuggled back into Canada. Relatively little black market trade in\-ol\-ed cigarettes produced in the United States; U.S. cigarettes use a blend of tobacco different from Cana- dian cigarettes and are less desired by Canadian smok- ers (Siveanor and Martial 1993). In a short-lived effort to reduce the smuggling problem, a tax of 80 cents per pack \vas applied to Canadian cigarette exports in mid- February 1992. This tax \vas repealed six weeks later, although preliminary evidence indicated that it had btwl successful in reducing smuggling (Sweanor and Martial iYY4). After the repeal of the export tax, Ca- nadian cigarette exports to the United States rose dra- maticall\: and smuggling increased again. In response to an aggressive industry-sponsored campaign, the federal tax on cigarettes in Canada was reduced bv SJ.00 per carton on Februarv 9, 1993. More- o\-er, the federal go\.ernment agreed to match provin- cial reductions in taxes up to an additional $10.00 per carton. Quebec immediatelv louvered its provincial tax b! Sl 1 .OO per carton for a &tat tax cut of $26.00 per carton, leading to a 50-percent drop in price. By Au- gust 1991, four other provinces had reduced cigarette taxes substantially. These cuts reduced the average Canadian tax per pack from $2.96 before the federal tax cut to 91.97 as of December 31, 1996 (in U.S. dol- lars), lvhich \vas an amount still well above the aver- age U.S. cigarette tax of 66 cents per pack at that time. The Canadian experience \vas cited by the tobacco industrv during the recent debates over the proposed national tobacco settlement as evidence that a black market in cigarettes would develop in the United States in response to large cigarette tax increases. However, there is little evidence to support this contention. Given that Canadian cigarette taxes xvere reduced because of smuggling from the United States, it is likely that these taxes lvould be increased if the United States were to adopt large tax increases, making it unlikely that wide- spread smuggling of cigarettes from Canada into the United States ~vould occur. Cigarette prices in Mexico, hot\-e\.er, are rvell below. those in the United States, and large increases in U.S. prices could make smuggling cigarettes from Mexico a highlv profitable lrenture. TO date, ho\zre\-er, no empirical evidence supports the con- tention of significant smuggling of cigarettes from Mexico into the United States. Furthermore, unlike the U.S.-Canadian border, the border between the United States ancl Mexico is relativ-elv short and heavily guarded, making it much more- difficult to smuggle large quantities of a bulk\, product like cigarettes. Finally, se\-era1 relati\.ely eas\. options exist for limiting cigarette smuggling (Joossens and \ran der MerIve 1997; Joossens et al., in press). These include prominent tax-paid markings on all tobacco products and sizable increases in the penalties for cigarette smuggling. The ACIR (19851, for example, concluded that the Trafficking in Contraband Cigarettes Act (Pub- lic Law 95-575), which prohibited the transportation, receipt, shipment, possession, distribution, or purchase of large quantities of cigarettes that did not bear the tax indicia of the state in which the cigarettes are found, led to a significant reduction in interstate cigarette smuggling resulting from interstate price differentials. Discussion If one applies Cook and Moore's (1993) discus- sion of alcohol taxes to cigarette taxes, a provocati\,e question arises when one compares previous cigarette excise taxes \\ith current ones: whv is the current tax rate deemed appropriate ivhen it ii just over one-half the level that \\`as deemed appropriate in lY51? Un- less it is in the public interest to tax cigarettes at a much lower rate norv than then (an odd notion, given that in 1951 much less evidence ~vas available on the health hazards of smoking), a case can be made for restoring taxes to their earlier levels. Similar arguments can be made at the state level, particularlv in those states Lvhere taxes have not changed or ha;e been increased modestlv and infrequentlv over time. Other, comparative- standards for appropriate taxes could be used. For example, as sl1oiz.n in Table 6.12, state excise taxes on cigarettes differ substantially; these differences reflect several factors, including the importance of tobacco for the local economv. At an- other level of comparison, large differences betiveen cigarette taxes in Canada and the United States ga\-e rise to a significant black market trade, \\,hich in turn resulted in reductions in Canadian taxes. At the glo- bal level, cigarette and other tobacco taxes in the United States are among the lokyest in industrialized coun- tries around the lvorld. Such comparisons suggest that relativelv high taxes mav be appropriate in some ar- eas and lorz- taxes appropriate in others. On the other hand, one could argue that the taxes on all tobacco products should be equivalent. This last issue is dis- cussed in greater detail in the next section, "Fairness Standard and Optimal Cigarette Taxes." Taxes on smokeless tobacco products are much lower than taxes on cigarettes, particularly at the fed- eral level. The limited research suggests that increases in cigarette excise taxes mav have reduced cigarette smoking but also may have contributed to an increased use of smokeless tobacco products (Ohsfeldt and Boyle 1994; Ohsfeldt et al. 1997, 1999). Some public health advocates and others have therefore called for the equalization of taxes on tobacco (CSH 1994; U.S. House of Representatives 1994). Fairness Standard and Optimal Cigarette Taxes Fair tax policy is an issue that is often debated- but difficult to apply when "optimal" taxes of poten- tially hazardous substances are discussed (Cook and Moore 1993). For taxes on cigarettes and other tobacco products, part of the debate revolves around the per- ceived health benefits and reductions in social costs associated with higher taxes. In their analysis of economic interventions to re- duce alcohol abuse, Cook and Moore (1993) noted that several criteria can be included to judge fairness by those on both sides of the debate. These criteria in- clude a horizontal equity criterion, which suggests that equals should be treated equally; a vertical equity cri- terion, lvhich suggests that those with the greatest abil- itv to pav should be taxed more heavily; and a benefit ciiterion-, which suggests that those who receive the greatest benefit from government activities should be tased more heavily. If the basic notion is accepted thai people Mrho are otherwise similar should be taxed dif- ferently because one uses more tobacco products thar the other (a notion that \,iolates the horizontal equit) criterion), then other questions about fairness nrisc These include questions concerning the allegec regressility of the taxes and the external costs of smok ing and other tobacco use (Cook and Moore 1993). Equity, Incidence, and Distribution of the Tobacco Tax Burden As has been discussed previously, increases il cigarette excise taxes are passed on to consumer through higher cigarette prices. Primarily because c the less than perfectly competitive nature of the ciga rette industry, prices have increased by more than rc cent increases in cigarette taxes. Because consumers wi pay at least the full amount of a tax increase in highs cigarette prices, some questions of fairness revolv around the distributional effects of the tax hike. To ur derstand these effects, it is useful to look at the relatior ship betIveen tobacco use and income (or expenditures (As Cook and Moore 119931 note, income or expend tures are not the only scale on which fairness can L- judged, but they are the most commonly used.) A 1990 report by the Congressional Budget Office (CBO), lvhich used data from the 1985-1985 Consumer Expenditure Surve); made se\,eral obser- vations. For example, expenditures on tobacco prod- ucts increased Ivith income except for people in the highest income quintile. As a percentage of posttax income, however, spending on tobacco rras highest in the lowest income quintile (4.0 percent of posttax in- come) and fell almost proportionatelv 11-ith increased income. Also, if expenditures on tobacco are consid- ered as a percentage of expenditures on all goods and services, ho\ve\.er, the share of tobacco expenditures fell graduallv over the first four income quintiles (from 1.6 to 1.1 p¢) and dropped sharplv onlv in the 1 - top quintile (to 0.7 percent). Thus, the CBO notes, if annual familv expenditures are more reflecti1.e of life- time income than annual familv income, then expen- ditures on tobacco are onlv sljghtlv regressi\.e 0l.t'~ income classes. Finally, the CBO noted that vounger tamilies spent a higher percentage of income on to- bacco products and that their share of spending on tobacco products as a percentage of total expenditures \vas higher as ivell. To examine the distributional impact of cigarette excise tax increases on consumers, the CBO simulated iThat the effects on expenditures w,ould be lvere the 1990 federal excise tax on cigarettes ( 16 cents per pack) doubled. At first glance, the simulated increase ap- peared to fall most hea\,ily on the lo\\-est income cate- gories, thereby implying that cigarette taxes are regressive. However, irhen income tax brackets and transfer payments (discussed in the next section, "Es- timates of the Costs of Smoking") Lvere indexed to ac- count for the price increases associated M.ith excise tax hikes, lolvering individual income taxes and raising transfer payments, the apparent regressilrity of the tax \vas reduced. When looking at the tax increase rela- tive to expenditures rather than income, the CBO coil- eluded that cigarette taxes \vere approximatel\ proportional rather than regressive. Finally, the CBO noted that the largest share of the simulated tax increase was paid for by families in the third and fourth income quintiles and that the smallest share was paid by fam- lies in the lowest income (first and second) quintiles. All of the CBO estimates lvere based on measures of current income. Lyon and Schwab (1995) used an alternative approach that used measures of permanent or lifetime income to examine the distributional effects of cigarette and other "sin" taxes. This approach could account for the intertemporal nature of cigarette con- sumption decisions. The investigators concluded that cigarette excise taxes are as regressi\.e as \vas implied by studies based on current income. Although cigarette taxes fall most heavily on louver income groups, two recent studies suggest that increases in cigarette taxes may reduce the perceived regressivity of these taxes. A study using data from the British General Household Survey concluded that people in the lowest income groups were the most re- sponsive to price increases (Townsend et al. 1994). Simi- lar findings have been obtained in the United States using data from 13 of the National Health Interview Surl,eys conducted from 1976 through 1993 (CDC 1998). The price elasticitv of cigarette demand by those at or belol~ the median;ncome M'as estimated to be approxi- matelv 70 percent higher than that for persons above the m;dian. Another study found that less educated persons \1-ere more responsive than more educated persons to cigarette price changes (Chaloupka 1991). Gi\.en the high correlation between income and edu- cation, the three studies implied that increased ciga- rette taxes l\,ould reduce observed differences in smoking among socioeconomic groups (i.e., that smok- ing pre\,alence is higher in the lower socioeconomic groups) and wrould thereby counter the perception that cigarette taxes are regressi\re. Recent research from de\.eloping countries supports the hypothesis that lolzper income populations are relatively more sensi- tive to price (Jha and Chaloupka 1999; see Chaloupka et al., in press, for a thorough review). Indeed, while cisnrette taxes mav fall more heavily on lower income groups, an increase in the cigarette tax, because of the greater price sensitivity of louver income smokers, may actually be progressive. Moreover, given the estimates from these studies, the health benefits resulting from reductions in smoking stimulated by increased ciga- rette taxes Lvould be disproportionate117 larger in the lowest income populations. Finally, as the CBO report pointed out, although the potential regressivity of cigarette taxes is of some concern, the U.S. tax system is a mix of many different taxes. increased progr&sivity of other taxes and trans- fer programs could be used to compensate low income families for the tax increase. The CBO considered three alternative changes-a 5-percent increase in food stamp payments, a lo-percent increase in the earned income tax credit, and a combination of the two-to offset the potential regressivity of an increase in the cigarette excise tax. In each case, the CBO concluded that these changes would spend about 15 percent of the net revenues resulting from the tax increase. A simi- lar idea \vas implicit in the proposed Health Security Act of 1993, which proposed a federal tax increase of 75 cents per pack to partiallv finance the provision of health insurance and the expansion of benefits to the uninsured and underinsured, most of whom are in lo\\ er sniioeic~tiotiiii grc'ups. Like\\ ista, se\.eral rf- cent proposals for national tobacco legislation contain pro\~isions that r~ould offset the potential regressi\Tity of large increases in cigarette taxes. Estimates of the Costs of Smoking An alternati1.e approach to the question of fair- ness deals \vith the notion that smokers and other to- bacco users impose costs on nonusers. One of these costs is the health consequences for nonsmokers of exposure to ETS. A second is the financial external effect caused by collectively financed programs (e.g., Medicaid and Medicare) Mhere payments in and out are not tied to changes in costs and life expectance caused bv smoking. Thus it can be argued that it ~vould be fair fir smokers and other tobacco users to pay for the consequences of their use. Cigarette and other to- bacco taxes are one relatively efficient approach for attaining this result. Ho\ve\,er, to set taxes at a level sufficient to co\.er fhe costs of cigarette smoking and other tobacco ~1st~ requires an estimaCe of these costs. All studies of the economic costs of tobacco LISA' have focused on Ihe costs of cigarette smoking. The Office of Technology Assessment (U.S. House of Rep- resentati\.es 1YY-l) has noted that although measuring these costs is an inexact science, three general compo- nents are included: . The direct costs of pro\idin, 0 health care ser\-ices to those persons L\.ith smokin, ~r-reldW diseases. Such costs include expenditures for pre\.enting, detecting, diagnosing, and treating smoking- related diseases and medical conditions. o The indirect morbidit\; costs associated \vith lost earnings from \\,ork because of smoking;-related illness. o The indirect mortality costs related to the loss of future earnings from premature death from smoking-related causes. Researchers ha1.e tried to estimate the economic costs of cigarette smoking bv using data from the United States (Rice et al. 1986; %anning et al. 1989, lY91; Hodgson 1992; CDC 1991; U.S. House of Representa- tives 1991; Miller et al. 1998, 1999) and elservhere (see Lightlvood et al., in press, for a comprehensi\,e retie\<.). In addition, as part of the research resulting from Propo- sition 99, se\.eral recent studies ha\.e estimated these costs for California (California Department of Health Ser\-ices 1 YY3; Rice and Max lW2; %lav and Rice 1 YY5). Most of the estimates of the economic costs of smoking have been prevalence based. That is, the,] are based on the estimated prevalence of smoking- related illnesses in a given year and on the costs asso. ciated with those illnesses. Because of the long lags between smoking initiation and the onset of mo\t smoking-related illnesses, these estimates reflect his. torical trends in smoking and thus cannot be used to predict the impact of changes in smoking prevention policies except over long periods. However, this ap- preach has been widely used because of its relative]\ simple methodology and the availability of reliab(c data (Rice et al. 1986). Several of the recent estimates of the costs of smoking have been incidence based (Oster et al. 1984; Manning et al. 1989, 1991; Hay 1991; Hodgson 19Y2). That is, these studies attempt to estimate the average additional costs of smoking over the smoker's lifetime. Cost estimates would differ by the person's age, sex, and level of smoking (i.e., a heavy smoker would ha\.e higher lifetime cosfs than a relatively light smoker with the same characteristics). These estimates of the costs of smoking can be useful for policymakers, who can estimate the change in the costs of smoking associated with a change in smoking behavior resulting from a change in policies to reduce smoking. However, these estimates are sensitive to assumptions about future costs and about issues suc11 as technological change and its diffusion (Hodgson 1988). Many of the studies of the economic costs oi smoking ha\,e included notablv different direct costs in their computations. For example, most include the costs of hospital and nursing home care, physicians' fees, and medications used to treat smoking-related illnesses. One such study estimated that these costs in 1993 \vere $50 billion and that 13.3 percent of them \z'ere paid through public sources (CDC 1994). Ho\\.- e\`er, some studies of direct costs have been limited to the costs associated \vith lung cancer only, Lvhereas 0th ers examined a more comprehensive list of smoking- related illnesses, including cardiovascular disease and chronic obstructi1.e pulmonary disease. Other more recent studies have sought a broader measure of the direct costs of smoking by comparing the differences betlveen total health care spending b> smokers and nonsmokers. The most sophisticated of these recent studies control for other risk factors like]\ to be correlated \vith smoking in an effort to isolate the impact of smoking on medical expenditures (Miller et al. 1998, 1999). These recent studies estimateci- smoking-attributable medical care costs of between $53 billion and S73 billion for 1993, or between 6.5 percent and 11.8 percent of all U.S. health care expenditure5. RedlrcirlLq Thmo USC It is likely, however, that these studies have un- derestimated the direct costs of smoking for a variety of reasons (Warner et al. 1999). For example, they ignore other significant economic costs, including the costs of transportation associated with obtaining medical care and the costs of nonmedical care associ- ated with accommodating a person ivith a smoking- related chronic illness. These estimates also generally fail to account for other medical care costs related to cigarette smoking, such as burn care from injuries in smoking-related fires and perinatal care for low-birth- weight infants of mothers \vho smoke. Few studies have attempted to include the direct costs for non- smokers of diseases related to exposure to ETS, and none of these studies has tried to estimate the intan- gible costs of smoking-related illnesses (i.e., the pain and suffering associated \vith the illness and the grief experienced by family and friends). A human capital approach is generally used to estimate the indirect morbiditv and mortalitv costs associated with cigarette smoking. This apbroach views an individual as producing a stream of output or earnings computed at market value or as the im- puted value of housekeeping services. Thus, the value of a person is reflected by his or her earnings, and the lifetime value for that person is equal to the discounted stream of future earnings (Max and Rice 1995). This approach places a relatively high value on morbidity and mortality among young adults, men, and the more educated because of the relatively higher earnings that would be lost by these smokers (Markandya and Pearce 1989); moreover, lost earnings may not be an accurate reflection of the value people place on their health or on their lives. Furthermore, the human capi- tal approach is in contrast to the "willingness-to-pay" approach, which tries to estimate the value a person assigns to reducing his or her risk of premature death. A more controversial component in the compu- tation of the lifetime costs of smoking concerns the treatment of transfer payments. These transfer pay- ments include the reduction in income taxes and in- surance premiums paid by smokers because of reduced earnings associated with smoking-related illnesses, the value of Social Security and private pensions foregone because of smoking-related premature deaths, higher health care costs associated with smoking-related illnesses and paid bv public and private insurance plans, and increased Asick pay and disability benefits paid during smoking-related illnesses. Particularly ob- jectionable to many people is the idea that foregone Social Security and private pension benefits from smok- (frs who die piematurely from smoking-related illnesses should be considered "benefits" to nonsmokers. As Harris (U.S. House of Representatives 1994) and oth- ers have noted, premature deaths are not considered a benefit when policymakers determine what levels of funded research are appropriate for reducing prema- ture deaths from other risk exposures (CSH 1994; Warner et al. 1995, 1999). Nevertheless, several recent estimates of the costs of smoking have considered these foregone benefits in their computations of the economic costs of cigarette smoking (Manning et al. 1989, 1991; Shoven et al. 1989). These studies aim to provide a complete accounting of the costs of smoking to answer the question of whether payments by those who have ever smoked into collectively financed systems such as Medicare and Social Security equal receipts by those \\,ho have ever smoked. Theoretically Optimal Cigarette Taxes As \vas just discussed, several estimates of the optimal or fair tax on cigarettes are based on the vari- ous studies of the costs of smoking. In the context of the preceding discussion, an optimal tax is one that equates the total revenues from these taxes to the net external costs of cigarette smoking. These estimates have ranged from those implying that current taxes more than cover the external costs of smoking (Man- ning et al. 1989) to those that have suggested that cur- rent taxes are far too low. For example, one such study that included the costs of the long-term intellectual and physical consequences resulting from smoking-related low birth weight among infants born to mothers who smoke indicated that $4.80 was an appropriate tax on a pack of cigarettes (Hay 1991). Another study (Pigou 1962) advanced a similar notion in providing a theoretical justification for taxes on goods with market prices not fully reflecting the social costs associated with their production and con- sumption. From that perspective, these taxes could be viewed as improving economic efficiency by rais- ing a smoker's marginal cost of smoking to a level nearer the social marginal cost. For some goods, taxes could generate revenues that exceed total external costs because the taxes would be based on marginal rather than average external costs (Cook and Moore 1993). Estimates of optimal taxes on cigarettes imply that smokers are fully informed about the risks associated with cigarette smoking (Cordes et al. 1990). If smokers underestimate these risks, then even higher taxes could be appropriate to discourage people from smoking. This issue may be particularly relevant for an addic- tive product such as cigarettes if, when people take up smoking, they do not fully understand the addictive properties oi consumption and the implications of addiction for future choices. Gruber and Koszegi (2000), for example, concluded that if these "internali- ties" are taken into account, they suggest sizable addi- tional taxes of one dollar or more per pack of cigarettes. Among the most widely cited recent estimates of the optimal tax are the studies of the economic costs of cigarette smoking by Manning and colleagues (1989, 1991). These incidence-based estimates used data from the RAND Corporation's Health Insurance Experiment and the 1983 National Health Interview Survey. To calculate the optimal tax on cigarettes, the analyses estimated both the lifetime external costs associated with cigarette smoking and the perceived "savings" that result from smokers' dying earlier and not realiz- ing their pension and Social Security benefits. Using their midrange estimates, Manning and col- leagues (1989, 1991) concluded that for a new smoker, the total external cost of smoking was 43 cents per pack of cigarettes in 1986. This estimate comprised 1 cent in extra costs for sick leave, 2 cents in costs for smoking- related fires, 5 cents in added costs for group life insur- ance, 9 cents in lost tax revenues (to finance retirement and health benefits), and 26 cents in spending on addi- tional medical care. These costs would be offset, how- ever, by an estimated 27 cents per pack in external savings resulting from smoking-related premature deaths. Converting these figures to 1995 dollars (based on the medical service price index and the gross national product deflator), the CRS estimated a net external cost of 33 cents per pack for cigarettes, which is approxi- mately two-thirds of the average federal, state, and lo- cal taxes on cigarettes of 30 cents per pack in late 1993 (Gravelle and Zimmerman 1994). The CRS thus con- cluded that smokers were more than paying their wav. Critics of the studies of Manning and colleagues (1989, 1991) contend that many of the assumptions made in obtaining the estimates are inappropriate. If the analyses had not included the effects of unrealized pension and Social Security benefits of smokers who die prematurely, the resulting external costs of smok- ing would have amounted to approximately 89 cents per pack in 1995 dollars. Moreover, the studies of Manning and colleagues (1989,1991) made a debatable distinction between in- ternal costs (those borne by the smoker) and external costs (those that smokers impose on nonsmokers). For example, the lost productivity costs described in those analyses were treated as internal costs, whereas only the higher, collectively financed, group premiums for health, life, and otherinsurance that nonsmokers paid to cover smoking-related costs not reflected in the pre- miums paid by smokers were considered external costs. More controversial, however, was these analy- ses' assumption that the cost of ETS was an internal cost. This assumption was based on the argument that the family is the economic unit involved in making smoking and other decisions and that the health con- sequences of ETS are largely confined to the nonsmok- ing spouses of smokers. As Manning and colleagues (1991) note, when this assumption is modified to treat the consequences of passive smoking as external costs, the estimated external costs of smoking rise signifi- cantly. For example, under the assumptions of Gravelle and Zimmerman (1994) concerning prices, the estimates of Manning and colleagues (1991) imply that including the relatively conservative estimate of 2,400 lung cancer deaths from ETS would add approximately 31 cents per pack (in 1995 dollars) to the external costs of smoking. Similarly, updating the researchers' esti- mates of the costs of neonatal care for smoking-related low birth weight would add more than 4 cents per pack. Doing the same for deaths from smoking-related fires would add 20 cents per pack and for smoking-related fetal deaths would add 31 cents per pack. These estimates probably understate the true costs of ETS. After reviewing the literature on the links between ETS and heart disease, Glantz and Parmley (1995) concluded that 30,000-60,000 persons die pre- maturely from heart disease related to ETS. Including these numbers in estimates by using the same assump- tions used in the CRS report would add at least an- other 70 cents to the estimate of the optimal tax. Moreover, the CRS report ignored the 150,000-300,000 cases of ETS-linked lower respiratory tract infections in children up to 18 months old and the ETS-linked worsening of asthma in 200,000 to 1 million children (Environmental Protection Agency [EPA] 1992). ln- eluding these costs \vould lead to an even larger opti- mal tax. Finally, the estimates excluded the long-term developmental consequences suffered by infants with smoking-related low birth weight (Hay 19911; were these costs included, the optimal cigarette tax would be nearlv SS per pack. Using the human capital approach, Manning and colleagues (1989,199I) estimated that the life of a nonsmoker who died prematurely from ETS exposure was worth $1.66 million. In a recent cost-benefit evaluation of the proposed Smoke-Free Environment Act of 1993 (introduced in the 103rd Congress but not passed), the EPA (Mudarri 1994) used the willingness- to-pay approach and obtained a $4.8 million baseline estimate of the value of a life. The EPA also used this approach to include the effects of ETS on heart dis- ease and children's health when calculating the value of benefits from reduced ETS exposure. By using the willingness-to-pay approach and making some relatively conservative assumptions, the EPA estimated that the total benefits from the reduced ETS exposure that Lvould result from a ban on smok- ing in all worksites ITas $39-71 billion per year. This estimate assumed that the ban would reduce the num- ber of current smokers by 3-6 percent, the number of future smokers by 5-10 percent, and consumption among continuing smokers by lo-15 percent; the re- sulting total long-run reduction in consumption would be la-22 percent. The combined effect of these reduc- tions in smoking and of the creation of designated smoking areas was predicted to reduce out-of-home exposures to ETS by 90 percent and in-home exposures by a midrange estimate of 6 percent. Estimates from the 1992 EPA report on ETS and lung cancer suggested that 73 percent of exposures to ETS occur outside the home and that 27 percent occur in the home. The total reduction in ETS exposure rvas thus predicted to be 66 percent; if it were applied to estimated total ETS costs of $58.7-106.9 billion, this reduction ~rould vield the EPA's estimated cost benefits of $39-71 billion. Gi\,en current cigarette sales of about 24 billion packs per year, this estimate implied that the per pack external costs of ETS lvere between $2.33 and $4.45. This estimate is likely to be lo\y, because the short-term and long-term costs of fetal and perinatal exposure to ETS lvere not included in the EPA's computations. Viscusi (1995), hoM-ever, reached a much different conclusion in analyzing the social costs of smoking. This investigator updated much of the analysis by Manning and colleagues (1989, lYYl), used a willingness-to-pav approach, and included the same ETS risks used in the EPA's analysis (Mudarri 1994). Viscusi, however, ar- gued that the EPA approach overestimated the risks of ETS by failing to account for the change in the tar con- tent of cigarettes and the changes in cigarette consump- tion per smoker. Noting that the average tar content of cigarettes declined from 46.1 mg per cigarette in 1944 to 12 mg per cigarette in 1994, Viscusi asserted that the health risks associated with cigarette smoking, as well as the risks from exposure to ETS, are linearly related to the tar content of cigarettes. Although presenting no evidence for either assertion, he contended that esti- mates of the health risks based on consumption of higher-tar cigarettes and exposure to ETS from higher- tar cigarettes need to be adjusted to reflect the decline in tar content. When not adjusting for tar, Viscusi ob- tained an estimate for the per pack external costs of ciga- rette smoking well above the average tax on a pack of cigarettes; when adjusting for tar, he concluded that current cigarette taxes exceed the external costs of smoking. A clear consensus is lacking regarding the opti- mal tax on cigarettes. Optimal tax calculations from prevalence-based estimates that include the direct and indirect costs of smoking-related morbidity and mor- tality are likely to be inappropriate, because the calcu- lations include lost productivity and other costs that should arguably be considered internal costs. Similarly, optimal tax calculations from the recent incidence- based estimates probably underestimate the optimal tax, because these calculations exclude many of the external costs of smoking. Nevertheless, because of the grooving evidence of the substantial health conse- quences of exposure to ETS (including fetal and peri- natal exposure), a tax that would generate sufficient revenues to cover all external costs from smoking is likely well abo1.e the current average of federal, state, and local taxes on cigarettes. Cigarette Taxes and Health As the review of studies on cigarette demand demonstrated, increases in cigarette prices lead to sub- stantial reductions in cigarette smoking by deterring smoking initiation among youth, prompting smoking cessation among adults, and reducing the average ciga- rette consumption among continuing smokers. Be- cause of the substantial health consequences of cigarette smoking and the health benefits of smoking cessation, these reductions in cigarette smoking would lead to significant improvements in health by reduc- ing smoking-related morbidity and mortality. Thus, increases in cigarette excise taxes, which would result in increases in cigarette prices, would be an effective policy tool in improving health. Several recent studies have provided some esti- mates of the health benefits resulting from cigarette tax increases. For example, Warner (1986) used pub- lished estimates of price elasticity (Lewit et al. 1981; Lewit and Coate 1982) to estimate the impact of higher cigarette excise taxes on smoking and health. The study predicted that a sustained, real 15 percent tax- induced increase in cigarette prices in 1984 (which would have been equivalent to restoring the federal tax to its real value in 1951-a nominal tax of 32 cents per pack) would deter 800,000 young people from smoking and encourage about 2.7 million adults to quit. Using the conservative assumption that one of every four lifelong smokers dies prematurely of a smois oftIll> ~V~~~7lfl~ ofNiltio,14,"are comrnodi- ties which are no where necessaries of life, \vhich are become objects of almost universal consumption, and which are therefore extremely proper subjects of taxa- tion" (1976, Book V, p. 474). As described earlier in this chapter (in "Ration- ales for Tobacco Taxation"), various lti\,els of go\rern- rnent have long used cigarette and other tobacco taxes to raise revenues. Such policy is supported by eco- nomic theory. An economically efficient way to raise revenues while minimizing the M.elfare losses associ- ated with the price distortions resulting from taxes is to impose relatively higher taxes on goods with more inelastic demand (one for which the percentage reduc- tion in demand is smaller than the percentage increase in price) (Ramsey 1927). As described earlier in this chapter (in "Effect of Price on Demand for Tobacco Products"), the numerous studies of cigarette demand and the limited studies of the demand for other to- bacco products have implied that overall demand, at least in the short run, is inelastic. Thus, large increases in tobacco taxes can generate substantial increases in revenues, particularly in the short run. Since 1960, the dollar amount of federal revenues generated by tobacco taxes has increased significantly, from $1.9 billion to nearly $5.9 billion in 1997. Over this same period, state revenues from tobacco ha1.e also increased significantly in nominal terms, from slightly less than $1 billion to more than $7.5 billion. As new sources of tax revenues have been identified, however, tobacco revenues ha\,e constituted a smaller propor- tion of total revenues. Tobacco taxes accounted for 3.36 percent of all federal revenues in 1950, but they rvere only 0.44 percent of revenues in 1989 (CBO 1990). Similarly, total federal tobacco tax revenues as a share of the gross national product fell from 0.55 percent in 1950 to 0.08 percent in 1989. Merriman (1994) considered whether cigarette excise taxes are set to maximize the revenues from these taxes. More specifically, Merriman tested the idea that elected officials, in an effort to maximize their own utility, mav increase taxes on some goods to the point lyhere re\:enues from these taxes begin to decline (Buchanan and Lee 1982). Using published estimates of cigarette demand (Becker et al. 19941, the study found that cigarette excise taxes in every state were Mel1 below, the revenue-maximizing level of these taxes, at least as of 1985. Furthermore, these estimates of the marginal revenue effects of higher taxes were loljrer-bound estimates, because they held constant other states' taxes (a consideration that allowed for increases in the casual and organized smuggling of cigarettes in response to a tax hike in a given state). Coordinated state tax increases, as a result, would gen- erate even higher re\`enues. Grossman (1993) considered this issue of maxi- mizing the federal excise tax on cigarettes. Using pub- lished estimates of cigarette demand (Chaloupka 1991; Becker et al. 19941, Grossman predicted that in the long run, a real federal tax rate of $1.26 would maximize federal tax revenues at S16 billion and would gener- ate even larger immediate increases in revenues. Like- xvise, Becker and Grossman (1994) suggested that the long-run revenue-maximizing value of the federal ciga- rette excise tax is 95 cents per pack in 1994 dollars. This tax would generate approximately $12 billion in total revenues and would raise considerably more than in the short run. These estimates were consistent with the prediction that a sustained real increase of 75 cents in the federal tax on cigarettes would in the long run lead to a net increase in cigarette tax revenues of just over $16 billion (Gravelle and Zimmerman 1994). Other studies, however, have predicted that higher federal taxes would generate much greater rev- enues (Harris 1994; Womach 1994a). For example, Harris has predicted that raising the federal tax to $2.00 per pack would have generated nearly $20 billion in additional revenues annually, on average, from 1995 through 1999, xvhereas Chaloupka (1998) estimates that a $1.50 increase lvould, in the short run, raise $22.5 billion annuallv. The differences among the predicted revenue ef- fects of higher cigarette taxes mav be attributed to dif- ferent assumptions used to obtain these estimates as well as to differences in the period for which the pre- dictions are made. For example, two studies (Gross- man 1993; Becker and Grossman 1994) have assumed a linear demand function for cigarettes. One of the implications of this function is that the price elasticity of demand rises as price rises. Thus, when the effects of a large increase in the cigarette excise tax are pre- dicted, cigarette demand is assumed to become more responsive to price. This assumption implies that there is an inverted U-shaped relationship between cigarette taxes and revenues: increasing cigarette taxes from relatively low levels will initially lead to increased rev- enues; beyond some point, further increases in taxes will lead to even larger reductions in demand, thereby causing revenues to fall. The same basic argument is implicit in the well-known Laffer curve, Lvhich relates income tax rates to income tax revenues. The assumption of a linear demand function for cigarettes is in contrast to the assumption made by some other analysts that the price elasticity of demand is constant over the range of prices under consider- ation. Because almost all of the studies described in this section found that the demand for cigarettes is inelastic, the assumption of a constant elasticity im- plies that even very large increases in taxes \~111 al- ways generate large increases in revenues. The differences in revenues predicted by these two assumptions, although only minor \vhen analv- ses predict the impact of relati\,ely small cigarette tax increases, grow with the size of the tax increase. Be- cause either assumption could be questioned, the rev- enue effects of a tax increase will likelv fall some\yhere between the predictions obtained from the t\vo (Grossman et al. 1993). The limited evidence from the behavioral economics literature suggests, hoL1-ev-er, that the effects of large increases in cigarette prices \vill lead to larger reductions in cigarette demand than pre- dicted by the assumption of a linear demand function (Bickel et al. 1991). A second key factor leading to the differences discussed here is the distinction between the short-run and long-run effects of the tax hikes. Economic theory implies that the demand for most consumer goods will be more responsive to price in the long run than in the short run. For cigarettes and other tobacco products, additional factors increase the likelihood that the long- run effects of an increase in price on cigarette demand will exceed the short-run effects-that is, price elastic- ity will increase in a manner similar to the increase for other, nonaddictive goods and services. Increased cigarette taxes will thus lead to smaller increases in revenues in the long run than in the short run. That adolescents and young adults are more re- sponsive to prices than older adults are and the fact that cigarette smoking is an addictive behavior are of particular importance when predicting the short-run and long-run revenue effects of higher cigarette taxes, Age difference in price elasticity implies that sustained real tax increases will lead to greater reductions in smoking prevalence and consumption as the number of adolescents and young adults who have not yet decided to smoke replaces the number of older adults who already smoke. The assumption of addiction implies that price has a cumulative effect on consump- tion: the price increase immediately reduces current consumption by discouraging young people from ex- perimenting or-continuing to experiment with smok- ing, as well as by encouraging current smokers to smoke less; futureconsumption is then reduced by the continuously fewer current smokers who also continue to smoke less in the face of a sustained real increase in price. The cumulative effect of price on consumption thus exceeds the immediate effect. This sequence ulti- matelv leads to reduced revenues. in summary, federal and most state excise taxes on cigarettes are undoubtedly well below their revenue- maximizing levels. Thus, relatively large increases in these taxes would lead to substantial gains in revenues, particularlv in the short run. Moreover, because of the relatively inelastic demand for cigarettes, increases in cigarette taxes are an economically efficient means of generating substantial revenues while imposing rela- tively small lvelfare losses. But if there is little argu- ment that large increases in cigarette taxes would generate substantial increases in tax revenues in the short run, there are some questions on the revenue- maximizing values of these taxes and the long-run stability of revenues generated by large increases in cigarette taxes. Part of the difficulty in estimating the effects of large taxes on cigarettes is that there is little experience in the United States with relatively large increases. Sim- larly, it is unlikely that the long-run effects of the more recent large tax increases have been fully played out. The short-term experience in Canada is of limited use in addressing these issues. Cigarette taxes in Canada increased more than 500 percent between 1982 and 1992, Mhich increased real cigarette prices by 170 percent, and total smoking fell by 38 percent (Sweanor and Martial 1994). Because of the effects of other, contemporane- ous activities to reduce tobacco use, the impact of the large price increases on smoking were consistent with the estimates from the studies of U.S. cigarette demand described in this chapter. Moreover, total federal and provincial revenues generated by Canadian cigarette taxes \vere 240 percent higher in 19Y2 than in 1981 e\ren M.ith the concomitant considerable black market in cigarettes. This experience suggests that large increases in cigarette taxes in the United States would generate sizable tax revenues for manv vears. . I Conclusions 1. The price of tobacco has an important influence 3. 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Chapter 7 Comprehensive Programs Introduction 373 Conceptual Frameworks 373 Description of Comprehensive Programs 374 Program Goals for Reducing Tobacco Use Statewide 374 Program Components for Reducing Tobacco Use Statewide 375 Community Intervention Trials 376 Statewide Interventions 387 Community Mobilization 382 National Programs 383 ASSIST 383 IMPACT 384 SmokeLess States Program 384 National Programs to Reduce Youth Access to Tobacco 381 States Currently Funded in the Nationwide Program to Reduce Tobacco Use 385 Examples of Major State Programs 385 Minnesota 386 California 387 Massachusetts 389 Arizona 391 Oregon 392 Maine 393 Programs Funded by State Settlements With the Tobacco Industry 391 Mississippi 391 Florida 395 Texas 397 Minnesota Settlement Program 397 Programs Meeting the Needs of Special Populations 398 Programs for the African American Community 398 Programs for Women 400 Federal and State Programs 401 Religious Organizations 401 Special Efforts to Reduce Chewing Tobacco Use 402 Components of Community Programs 403 Community Advocacy and Mobilization 403 Electronic Networking 403 Direct Advocacy 405 Media Advocacy 407 Countermarketing 309 Summary 47 6 Conclusions 11 T References 318 Introduction A comprehensive approach to reducing tobacco use recognizes that individual behavioral choices occur in a larger, complex context: a social setting of family, community, and culture; a complex economic and physical environment; formal and informal gov- ernment policy; and the prevailing legal atmosphere (Green and Richard 1993). The specific programs re- vie\\Ted in prior chapters can be better understood as part of a general framework for health promotion (World Health Organization [WI-IO] 1986; Ht~lfll Pmnofiolr Illferrlntiorznl 1997). Using such a frame- work, this chapter will review- community-based intervention studies and the current models for con- prehensive tobacco prevention and control that are funded by specific excise taxes or by settlements with the tobacco industrv. The evaluation of multicomponent interwntions and socioecological models of health promotion poses a special problem (Green and Kreuter 1991; Sanson- Fisher et al. 1996; Nutbeam 1998). The most effective models of health promotion are social movements that evolve (Kickbusch 1989; Allison and Rootman 1996; Downie et al. 1996; Nutbeam 1998). Thus, the nature and complexity of health promotion interventions do not fit the tightly defined, controlled, and presumably reproducible research model that is more suitable for epidemiologic testing (Elder et al. 1993; Mittelmark et al. 1993; Baum 1995; Allison and Rootman 1996; Conceptual Frameworks Macdonald et al. 1996; Nutbeam 1996, 1998). None- theless, surveillance data, periodic surveys, and other administrative data from multiple sites permit these interventions, as well as "natural experiments," to be studied. Traditionally, per capita consumption data, adult prevalence surveys, and surveys of tobacco- related behaviors among young people have been the core of this surveillance approach. Recently, a broader arrav of legislative, economic, media, and program data-has emerged to enhance sur\,eillance of the social environments that influence the use of tobacco prod- ucts. For example, the WHO's Glliilrlirzes ,fw Co~ztrol- /i/r;; 1711d MoJrifoiir7~~ thr TohnCro E@?JJ7iC (WHO 1998) provides detailed recommendations on the types of data that should be monitored for both planning and e\,aluating tobacco control efforts. For the United States, the Centers for Disease Control and Prevention (CDC) has published background information on sources of national surveillance data (Giovino et al. lYY4). The Federal Trade Commission provides annual estimates of trends in the tobacco industry's advertising and promotion expenditures. Surveillance data on protobacco influences are not well monitored, however, particularly at the state level. Finally, Wakefield and Chaloupka (1999) have provided a con- ceptual framework for the monitoring of comprehen- sive tobacco control programs, particularly those that focus on preventing teenage smoking. From its formation in the mid-1970s, health pro- motion has emerged as an approach that offers greater potential for change in the health-related behavior of populations than does health education (Green and Richard 1993; Downie et al. 1996; Hcnltlz Pronto- fioil IJ7termfional 1997). Health promotion emphasizes social, economic, and other environmental influences as the primary determinants of health behavior change (WHO 1986; Downie et al. 1996; Hmltl7 PmJ~~ofioJl /i~f~~rr~~tiom/ 1997). Though such health promotion strategies have been characterized as a ne\v approach to public health, ecological and policy-oriented approaches are similar to the public health methods of the latter part of the 19th century and the early de- cades of the 20th century (Kickbusch 1989; Green and Richard 1993; Mullan 2000). As the role of individual risk behaviors, such as tobacco use, was increasingly understood in the middle of the 20th century, individu- ally focused educational strategies gained primacy (Green and Richard 1993). These strategies produced some important changes in health behaviors, but their limits \2-ere realized in the cardiovascular disease prevention programs that took place in the United States during the 1970s and lY8Os (see "Community Intervention Trials," later in this chapter) (Green and Richard 1993; Luepker 1994; Winklebv 1994; Fisher 1995; Schmid et al. 1995; Susser 1995). - The shift from a health education approach that targets the individual to a health promotion approach that uses social, policy, and environmental strategies has several advantages. First, by recognizing that many environmental determinants of health behavior Description of Comprehensive Programs are not under the direct control of the individual, the ecological focus avoids blaming persons who fail to modifv their behavior. Second, many educational strateiies are more effective with better-educated, wealthier persons and may thereby increase the dis- parities in health between population groups and fail to reach those in greatest need. Third, regulatory and policy interventions can be more cost-effective than multiple efforts to modify individual behavior. The importance of comprehensive economic, policy, and regulatory interventions to reduce tobacco use has long been recognized by international experts (WHO 1979). For example, the evolving WHO guide- lines for such interventions have increasingly empha- sized policy and legislative measures, stressing that these types of health promotion and health protection strategies are essential elements of any national effort to reduce tobacco use (WHO 1998). In an extension of the WHO's efforts, the National Cancer institute (NCI) released a blueprint for related public health ac- tion in the United States (NC1 1991). This monograph stressed that the application of social environmental approaches should not compete \vith individual ap- proaches but should be combined synergistically with them. Similarly, the Center for Substance Abuse Pre- vention (CSAP) of the Substance Abuse and Mental Health Services Administration (SAMHSA) published guidelines that provide the concept, structure, and operations of a community-based approach to reduce tobacco use among youth (SAMHSA 1998a,b). To fur- ther help states overcome common obstacles to enforcing youth access laws, CSAI' also has prol,ided a document that provides strategies to address prob- lems such as interagency and intraagency issues, in- sufficient or uncoordinated resources, or lack of data sources (U.S. Department of Health and Human Ser- vices [USDHHS] 1999). More recently, the CDC (1999a) has synthesized a comprehensive framework for state- wide programs to reduce tobacco use. This framework integrates four program goals with four program com- ponents; optimally, each of the goals lvould be fully addressed in the implementation of each of the com- ponents. The framervork, described in the next sec- tion of this chapter, recognizes that comprehensive pro- grams will continue to evolve, in response both to new information and to new circumstances. In addition, the framework represents a distillation of evidence and judgment that have been discussed in detail in the ear- lier chapters of this report and that have been tested in the community-based trials and the comprehensive programs discussed later in this chapter. Program Goals for Reducing Tobacco Use Statewide 1. Preuerrt ilritiatiorr amorlg yomg people. The hallmarks of this goal are o Decreasing young people's access to tobacco products. o Increasing prohealth messages. o Reducing protobacco messages. o Increasing the price of tobacco products. Some of the mechanisms for decreasing young people's susceptibility to tobacco use are promoting vouth empowerment activities, providing school health education, offering positive alternatives, deglamorizing tobacco use, and in\,olving parents and families. 2. Promotr quitting among adults and yo1411g people. An environment that supports efforts to quit using tobacco can be fostered by o Increasing access to culturally appropriate, effective cessation services (e.g., by expanding insurance coverage). 9 Increasing the price of tobacco products. o Increasing restrictions on environmental tobacco smoke (ETS). o Increasing prohealth messages. o Decreasing protobacco messages. 3. Eiimiuate exposure to ETS. The continued ex- pansion of policies to eliminate exposure to ETS can be achieved by o Developing support for implementation. o Enforcing voluntarv private policies. o Enforcing public pilicv and public regulation. o Expanding coverage o? public areas. 1. Iderztify and eliminate disparities nmoq popla- tim groups. Intrinsicallv linked to achieving the first three goals, elimina;ing disparities entails Increasing the price of tobacco products through culturally acceptable programs. Decreasing exposure to ETS. Increasing prohealth messages. Decreasing protobacco messages, particularly those aimed at population subgroups. Increasing the availabilitv of culturally acceptable cessation services. increasing protective factors among young people. Decreasing young people's access to tobacco products. Development, funding, and implementation the major elements-some of which appear in several of these goals-are critically linked to com- munity involvement and, as noted, to a culturallv appropriate approach. Program Components for Reducing Tobacco Use Statewide Community interventions. Working through social organizations, systems, and networks promotes an environment that facilitates indi- vidual health choices and establishes freedom from tobacco use as the norm. The term "commu- nity" encompasses a diverse set of entities, includ- ing medical societies; schools; school districts; departments of education; voluntary health agen- cies; civic, social, and recreational organizations; businesses and business associations; city and county governments; public health organizations; labor groups; managed care systems; faith com- munities; and organizations for racial and ethnic minority groups. Community-based activities can include sup- porting legislated removal or restriction of stimuli to use tobacco (such as advertising and promotion, easy access to tobacco products via self-service display and vending machines, and ongoing ex- posure to ETS) as well as providing positive alter- natives (such as promoting cessation, encouraging prevention advocacy, developing role modeling through parents and adults, and fostering youth empowerment). By changing the community set- ting and institutions with which adults and young people interact, community-based activities work to denormalize, deglamorize, and discourage to- bacco use and to provide access to resources that increase users' abilitv to control their addiction and use of tobacco. This approach has the potential to effect substantial, sustained, populationwide change in tobacco use behavior. Collrlterlnnrketing. Changing a social environ- ment that fosters a norm of tobacco use is an essential element of national, state, and local pro- grams. This change requires strategies to counter the billions of dollars spent in advertising and pro- motion that reach young people and adults with misleading images about tobacco. Countermarket- ing efforts can include using media advocacy, paid media, and counteradvertising; increasing prohealth promotions and sponsorships; and pro- viding information on the tobacco industry's mar- keting and promotional tactics. These public health messages should use a strategy that targets all age groups and populations. In a comprehen- sive strategy, education messages will be mutu- ally reinforcing: clean indoor air messages will provide added motivation for adults to quit smok- ing; cessation messages for adults will discourage tobacco use among young people and accentuate the problem of addiction; and youth prevention messages will increase the salience of the tobacco issue among parents and community leaders. Program policy ad regulatiou. Areas in which policy and regulation to reduce tobacco use have been applied include minors' access, tobacco pric- ing, advertising and promotion, clean indoor air, product regulation, product labeling, ingredient disclosure, and policies on insurance coverage for cessation services. Policies and regulations can be established at the federal, state, and local lev- els (see Chapter 5). Ideally, policies and regula- tions need to be implemented at both the community level and statewide. Educating the public about policies and regulation is crucial to acceptance, but such education must be sup- ported by adequate enforcement. 4. Surveillarlce aud evaluatiorz. Surveillance and evaluation efforts are necessary to make the ongoing refinements that lead to more effective pre- vention strategies. In addition to traditional surveillance methods, nontraditional approaches- such as monitoring the promotional activity of the tobacco industry at the state and local levels, moni- toring the economic impact of smoking laws and other ETS policies, and performing periodic surveys of public opinion on program interventions-are critical for reducing tobacco use. The conceptual framework for comprehensive efforts to reduce tobacco use has been used to develop the current generation of statewide programs. However, even the most comprehensive programs Community Intervention Trials currently in place have not been able to fully imple- ment all recommended components. Policy and regu- lation components are especially hampered, since many state and local actions are limited by federal mandates and preemptions (see "Preemption of Local Action by State Policy" in Chapter 5). Moreover, only two states, California and Massachusetts, have imple- mented comprehensive programs for a sufficient time to provide evaluation data on the overall efficacy of the emerging comprehensive model. The following sections summarize the history and development of community-based, statewide, and other large-scale efforts to reduce tobacco use and con- clude with a review of existing data on the efficacy of the comprehensive model. Large-scale trials to prevent cardiovascular disease have been a major source of data on population- based approaches to reducing tobacco use. An empha- sis on the importance of addressing social and cultural determinants of smoking behavior grew directly out of early work on cardiovascular disease epidemiology. The Seven Countries Study, which was started in the mid-1950s by Keys and colleagues (Aravanis et al. 1970; Blackburn et al. 1970; Buzina et al. 1970; Fidanza et al. 1970; Kimura and Keys 1970; Taylor et al. 1970a,b), examined risk factors for cardiovascular disease in populations around the world and documented that disease rates and risk factors differed markedly across cultural and social environments (WHO 1982). In that study, more than 12,500 men aged 40-59 years from Finland, Greece, Italy, Japan, the Netherlands, the United States, and Yugoslavia were recruited for a pro- spective study of the relationship between personal behaviors (e.g., diet, physical activity, smoking) and risk of cardiovascular disease (Aravanis et al. 1970; Blackburn et al. 1970; Buzina et al. 1970; Fidanza et al. 1970; Kimura and Keys 1970; Taylor et al. 1970a,b). Al- though the most striking differences in lifestyle across cultures were in the composition of the men's diet, smoking was found to be a significant risk factor. This study, and many other early studies of cardiovascular disease epidemiology, encouraged researchers to start community trials to modify the identified risk factors in whole population groups (WHO 1982). Two landmark community trials that began in 1972 grew directly out of the work of the Seven Coun- tries Study investigators: the Stanford Three-Commu- nity Study (Farquhar et al. 1977) and the Finnish North Karelia Study (Puska et al. 1985). A third, less directly tied to this early work, was the Israeli Community Syn- drome of Hypertension, Atherosclerosis and Diabetes (CHAD) program (Gofin et al. 1986) begun in 1971. In addition, two worksite trials focusing on population- level changes in cardiovascular disease risk factors developed out of the Seven Countries Study and from related early work on cardiovascular disease epidemi- ology: the Belgian Heart Disease Prevention Project (Kornitzer et al. 1980) and the United Kingdom Heart Disease Prevention Project (Rose et al. 1980). Though investigators in these initial studies recognized the im- portance of the social and cultural environment in modifying risk factors for cardiovascular disease, in- cluding smoking (Farquhar 1978; WHO 1979; Farquhar et al. 1981,1985; Rose 1981; McAlister et al. 1982; Puska et al. 1985), the smoking cessation techniques of the time were primarily individually oriented (McAlister et al. 1976; Meyer et al. 1980). The Stanford and North Karelia studies shared some community organizing and conceptual perspec- tives in their planning (WHO 1982). Logistical and cultural differences between the United States and Fin- land dictated significantly different implementation, however. In the Stanford study, an intervention that Rducirlg Tobacco Use primarily used mass media was compared with the same mass media intervention plus intensive face-to- face counseling for high-risk individuals and was also compared with a control community that received no intervention. In the initial results, the community cohort receiving both the mass media and the face-to- face counseling for high-risk smokers had a signifi- cantly greater decrease than the control community in the prevalence of smoking (-50 vs. -14.9 percent) and in the number of cigarettes smoked (percentage reduc- tion of 51.6 vs. 21 .O percent) (Farquhar et al. 1977,1985; Maccoby et al. 1977; Meyer et al. 1980). In the Finnish study, the people of North Karelia province requested the intervention because of concerns raised by the results of the Seven Countries Study, in which residents of their province had participated (Puska et al. 1985,1995). The intervention had a strong focus on community organizing and environmental modification, together with multiple educational com- ponents using mass media and other strategies (McAlister et al. 1982; Puska et al. 1985). Although the intervention's early efforts had a greater emphasis on increasing direct cessation services than on prevent- ing smoking, the importance of nonsmoking environ- ments and other environmental changes \yas clearly recognized and emphasized (Koskela 1981). The five- year follow-up results of the studv found no signifi- cant difference in smoking prevalence between the North Karelia province and Kuopio, a comparison province with similar baseline smoking rates (Puska et al. 1979). Ten years on, a significantly greater re- duction in smoking prevalence was observed among men in North Karelia than in Kuopio (Salonen et al. 1981; Puska et al. 1983a,b; Vartiainen et al. 1986). The intervention trial has been continued, and new pre- vention and population-based cessation strategies have been added (Vartiainen et al. 1986; Korhonen et al. 1992,1993). Analyses of 20-year trends (from 1972 to 1992) in smoking in the two provinces found a sig- nificantly greater decline in smoking prevalence for adult men in North Karelia (from 52 to 32 percent) than in Kuopio (50 to 37 percent) and in southwestern Fin- land. Smoking prevalence for adult women increased at similar rates in both provinces (increasing from 10 to 17 percent in North Karelia and from 11 to 19 per- cent in Kuopio) (Vartiainen et al. 1998). The 20-year difference in trends in men between the two provinces appeared to be primarily related to cessation during the first 10 years and to prevention during the last 10 years. The CHAD program had a somewhat more indi- vidually focused intervention model directed at reduc- ing the risk factors for cardiovascular disease among residents in Israeli housing projects (Abramson et al. 1981). The health care providers serving the interven- tion communities provided risk factor screening and counseling for families, couples, and individuals liv- ing in the four adjacent housing projects. The resi- dents of comparison housing areas received usual care from their providers. In the intervention communi- ties, group discussions were held to provide social support and increase group influences on individual lifestyle changes. Comparisons between community health surveys conducted at baseline (1969-1971) and after five years (1975-1976) showed a significantly greater decline in smoking prevalence among men but not among women in the intervention communities than in control communities (Gofin et al. 1986). At the lo-year follow-up (1981), the prevalence of smoking had declined significantly between 1976 and 1981 among both men and women in the CHAD follow-up cohort, whereas no change or a slight increase in smok- ing had occurred among adults in Israel overall (Gofin et al. 1986). The Belgian Heart Disease Prevention Project was a controlled, multifactorial trial involving men aged 40-59 years at baseline at Belgian worksites (Kornitzer et al. 1980). Thirty pairs of factories were studied, with one site from each pair randomly assigned to the in- tervention group and one site to the control group. At baseline screenings for risk factors for cardiovascular disease, individuals in the upper two deciles of risk were identified and received semiannual individual counseling from the medical staff. Medical advice to quit smoking w'as reinforced in the factories by anti- smoking posters, written messages, and health educa- tion conferences encouraging workers to quit smoking and to encourage the same to their friends who smoked. Changes in smoking prevalence at the intervention and control worksites were monitored among both the high-risk individuals and in random samples of the total worksite populations. After two years of inter- vention, a significantly greater percentage of the high- risk smokers quit in the intervention group than in the control group (18.7 vs. 12.2 percent), but no difference was observed in the random samples. The United Kingdom Heart Disease Prevention Project was started in 1971 with 24 pairs of English and Welsh factories. Each member of the pair was ran- domly assigned to intervention or control status (Rose et al. 1980; Bauer et al. 1985). At baseline and in 1977- 1978, risk factor screening for cardiovascular disease was conducted among men aged 40-59 years in the intervention sites and in a lo-percent random sample of similarly aged men at the control sites. Over a five- to six-year period, all men in the intervention sites received healthy lifestyle ad\.ice by mail and bi worksite posters. Men in the inter\,ention sites found at baseline to be at high risk for cardiovascular dis- ease \vere provided medical counseling on risk factor change, including smoking cessation. At the end of the intervention in 1977-1978, a small but significant reduction in smoking prevalence had occurred among the high-risk smokers in the intervention site (Rose et al. 1980). Five intervention and five control worksites were resurveyed in 1983, approximately 12 years after the baseline screening and at least 5 years afier the end of the intervention program (Bauer et al. 1985). There was no significant difference in the prevalence of smok- ing between intervention and control factories, but the smokers at the intervention sites reported smoking sig- nificantly fewer cigarettes per day. The initial design and implementation of the North Karelia and Stanford Three-Community trials led to the design of several other cardiovascular disease prevention trials around the world. These included the Swiss National Research Program from 1977 to 1980 (Gutzwiller et al. 1985), the South African Coronary Risk Factor Study from 1979 to 1984 (Steenkamp et al. 1991), and the Australian North Coast Healthy Lifestyle Programme from 1978 to 1980 (Egger et al. 1983). The early trials also influenced the development of two communitywide mass media-based smoking cessation trials implemented in Australia in the 198Os, in Sydney from 1983 to 1986 and in Melbourne from 1983 to 1986 (Pierce et al. 1986, 1990; Macaskill et al. 1992). In the Swiss trial, two towns in the French- speaking and two towns in the German-speaking regions of the country were assigned to either interven- tion or reference status (Gutzwiller et al. 1985). Baseline surveys of risk factors for cardiovascular disease were conducted among random samples of residents aged 16 to 69 years in all four towns in 1977-1978 and repeated at the final assessments in 1980-1981. In the interval, communitywide health education and health promotion interventions were conducted in the two intervention towns, including media campaigns, counseling of high-risk individuals, and community organization efforts to encourage environmental and social changes. The prevalence of smoking in the con- munities declined from 32.8 to 27.4 percent in the intervention towns and from 37.1 to 35.3 percent in the reference towns, a significant net effect of 3.6 percent decline. In the South African Coronary Risk Factor Study, three rural communities, matched in size, socioeco- nomic status, and cultural factors, were assigned to low-intensity prevention, high-intensity prevention, and control status (Steenkamp et al. 1991). Both the low- and the high-intensity sites received a mass media educational campaign using so-called small media, such as posters, billboards, mailings, and coverage in local newspapers. In the high-intensitv community, high-risk individuals, including smokers, received personal interventions from health care pro- viders. Risk factors for cardiovascular disease were measured in a cohort of residents aged 15 to 64 years from each community in 1979 and in 1983. The baseline prevalence of smoking was higher among men (49.2 vs. 44.4 percent) and women (17.0 vs. 14.5 percent) in the high-intensity intervention community than in the control community, but the difference was not sta- tistically significant. After the four-year intervention, the net change in smoking prevalence in the high- intensity community, relative to the control commu- nity, was not significant for men but was significant for women. Women in both the low- and the high- intensity intervention communities had significantly higher rates of quitting than women in the control com- munity, but no differences were observed for men. The Australian North Coast Healthy Lifestyle Programme replicated the design of the Stanford Three-Community Study (Egger et al. 1983). In 1978, three communities in northern New South Wales, Aus- tralia, were assigned to a media intervention, media intervention plus community program, or control sta- tus. A two-year study for preventing cardiovascular disease was conducted, including a smoking cessation component called "Quit for Life." The media inter- ventions used professional commercial media and advertising techniques and a social marketing and health promotion framework involving print, posters, radio, television, and other advertising techniques. The community programs for smoking cessation in- cluded promotions of smoking cessation organizations, kits handed out by doctors, distribution of self-help materials, and telephone help lines. The smoking ces- sation campaigns also incorporated other community activities-such as organized runs, stress management training, and computerized health testing-that con- veved the overall program's broader theme of healthy lifestyles. Risk factors for cardiovascular disease, in- cluding smoking, were measured in random samples of residents aged 18 years and older in each commu- nitv in 1978 (baseline), 1980, and 1981. In the multiple log&tic regression analysis model, which controlled for baseline differences among the three communities in age and sex distributions, there was a statistically greater decline in smoking in the two intervention com- munities than in the comparison community, with the largest differences among young smokers. Declines in the prevalence of smoking in the area assigned to media inter\-ention plus communitv program ranged from 15.7 percent among men aged- 1 H-25 irears to 6.1 percent among women aged 65 Jrears and older. In the 1980s. a community~~ide mass media- based smoking cessation campaign i1.a~ conducted in Sydney and Melbourne, Australia (D\z.ver et al. 1986; Pierce et al. 1986). The Sydney campai@ began in mid- 1983, and the Melbourne campaign began one yeal later (during the preceding year, Melbourne \vas used as a control citv for the Svdnel, campaign). The "Quit for Life" campaigns in\.ol\.ed inno\.ati\,e and pro\`oca- tive smoking cessation messages deli\ cred through paid spots on the radio, on tele\.ision, and in net\-spa- pers. These messages \~ere supported bv a telephone "Quit Line," self-help "Quit Kits," and a Iiospital-based "Quit Centre," all of \j.hicti \\`ere promoted at the end of the paid ad\~ertiscmcnts used in the campaigns. The campaigns ivei-e c\,aluated through monthlv random telephone sur\.evs in the tit.0 iommuniticsl In addi- tion, a cohort of-rcsijents was inter\ it>r\.cd in April- June 1983 and again in Ma\ IYXI. In the c.ohort, 23 percent of smokers in S\,dne\- and Y percent in Melbourne quit during the initial (control) ve`ar before the campaign \Vas begun in Melbourne (Pierce et al. 1986). The monthI\' pre\,alence estimates demonstrated an approximatelv l-percent decline in Svdnev in com- parison with the rest of Australia CD\\ v& et-al. 1986). The media campaigns Lvere continued through 1986, along rvith additional programs in conjunction with physician-, school-, and communitv-based activities. Long-term evaluation of trends in smoking in the t\vo cities from 1981 to 1987 suggests that the sustained campaigns mav have contributed to a decline in smok- ing prevalenceof about 1.5 percentage points per year in both communities among men but had little impact on women (Pierce et al. 1990). An analysis of the campaign's potential differential impact across educa- tional levels suggested that the Australian mass media and community campaigns did not contribute to an increase in the gap in smoking pre\,alence bet\veen educational groups (Pierce 1989; Macaskill et al. lYY2). The lack of a consistently positive effect from these initial community trials was attributed more to an incomplete understanding of comprehensive interlren- tions and to the relatively ITeak, quasi-experimental designs of the studies than to concern about the effi- cacy of the overall approach (Farquhar 1978). The con- tinuing enthusiasm for the potential efficacy of the communitywide approach was reflected in both na- tional and international reviews and guidelines (Blackburn 1983; WHO 1982; USDHHS 1983; National Cholesterol Education Program Expert Panel 1988; Shea and Basch 19YOa,b). Similarly, the positii e results from the Australian communitywide antismoking media campaigns and smoking cessation data from the North Karelia trial encouraged the planning of smoking-specific community efforts in the United States in the late 1980s. Three major community-based trials for prevent- ing cardiovascular disease were funded by the Na- tional Heart, Lung, and Blood Institute (NHLBI) in the early 1980s: the Stanford Five-Citv Project, the Min- nesota Heart Health Program, and the Pawtucket Heart Health Program. Each had comparison and in- ter\-ention communities and stronger designs and e\.aluation methodologies than the studies initiated in the 1970s. Each study \vas developed by an indepen- dent team of investigators, and the NHLBl maintained a collaborati\.e research relationship among the stud- ies (Winklebv et al. lYY7). All three shared common inter\rention approaches that lasted five to eight years and focused on the major risk factors for cardiovascu- lar disease (hypertension, cigarette smoking, high di- ctarv fat, obesity, and sedentarv lifestyle). Each project used mass media, community mobilization, and mul- tiple educational channels, such as health care provid- ers, schools, lvorksites, and \-oluntarv agencies. The programs integrated individual and social change ap- proaches, cmploving some combination of social learn- ing theory, social neti,vork diffusion theory, and social marketing to guide the planning and implementation of the interventions (Bandura 1977; McGuire 1973; Rothman lY7Y; Rogers 1983). The three projects dif- fered initially in their relative emphasis on specific modalities (Stanford emphasized media; Minnesota, population screening; and I'aivtucket, community or- ganizations) (Shea and Basch 1990a1, but frequent col- laborations among projects decreased these differences over time. Manv innovative strategies were devel- oped, and the piocess evaluations on specific smok- ing prevention and cessation interventions were posi- tive (Glasgow et al. 1985; Sallis et al. 1985; Altman et al. lY87; Elder et al. 1987,19Y3; King et al. 1987; Lando et al. lYYO,1991; Perry et al. 1992; Pechacek et al. 1994). n`onetheless, the overall impact of the three interven- tions on smoking prevalence \vas modest. The Stanford Five-City Project began \1-ith baseline survevs in 1979. Five cities in Northern California were selected on the basis of location, size, and media mar- kets (Farquhar et al. 1985). Monterey and Salinas shared a media market and \vere assigned to the intervention group. The three control cities (Modesto, San Luis Obispo, and Santa Maria) Mere isolated from the me- dia market of the intervention communities. The communitvlvide educational campaigns began in 1980 in collaboration 12.ith existing communitv organizations. The two treatment cities recei\,ed con- tinual exposure for five years; each vear, four to five separate risk factor education campaigns took place, one of which focused on smoking. Evaluations in- cluded independent, cross-sectional population samples aged 25 to 74 years surveved at baseline and at 25, 51, and 73 months, as well as a cohort formed from the baseline survey that M'as resurveyed at 17, 39, and 60 months. Initially, the cohort samples in the intervention con;munities experienced a significantly greater decline in smoking prevalence than those in the control communities (-7.66 \`s. -3.76 percent) (Farquhar et al. 1YYO; Fortmann et al. 1993). Bv the end of the intervention in 1986, the cross-sectional surveys showed no such difference in declining prevalence. At the final folloiv-up in 1989-1990, a more rapid though nonsignificant decline was detected in the control communities than in the intervention com- munities (Winkleby et al. 1996). In the Minnesota Heart Health Project, three pairs of communities were selected, with one of each pair assigned to educational intervention and the other to comparison status (Jacobs et al. 1986; Murray et al. 1994). The communities Lvere matched on size, com- munity type, and distance from the Minneapolis- St. Paul metropolitan area. After a lh-month baseline assessment period, a 5- to 6-year intervention program was started in November 1981 in the first education site, Mankato, Minnesota (Luepker et al. 1994). The second and third education sites, Fargo-Moot-head on the North Dakota-Minnesota border and Bloomington, Minnesota, were started 22 and 28 months later in 1983. The staggered entry alloLved for a gradual develop- ment of the intervention program and a stronger e\.alu- ation design (Luepker et al. 1994). Starting in 1980, annual cross-sectional survevs among residents aged 25 to 74 years were conducted in all six sites. A ran- dom sample of residents surveyed before the start of the education program \vas resurveyed. For long-term smoking cessation, the cross-sectional survey data provided evidence of an intervention effect for M'omen but not for men; no such effect was obserlred for ei- ther sex in the cohort sample (Luepker et al. 1994; Lando et al. 1995). Unexpectedly, large declines in smoking prevalence, especiall\; among men, \vere ob- served in comparison communities. In the Pawtucket Heart Health Program, the impact of a communitywide program for reducing risks for cardiovascular disease in Pawtucket, Rhode Island, was compared with trends in a nearby matched community in southern Massachusetts (name Ivithheld to honor a confidentiality agreement with the city gov- ernment) (Carleton et al. 1995). Pawtucket was selected as the intervention site from among a pool of nincX potential northeastern New England cities; thcl comparison site had similar sociodemographic char- acteristics. Surveys of risk factors for cardiovascula, disease were conducted with random samples ot residents aged 18 to 64 years in the two communitieh at two-year intervals, beginning in 1981 and continL1. ing until 1993. Communitywide educational strategies emphasized public awareness campaigns, behavior change through existing community resources and volunteers, and community activation to promote in- volvement and environmental changes (Elder et al. 1987, 1993; Lefebvre et al. 1987). During the seven- year intervention program from 1984 to 1991, more than 500 community organizations were involved, including schools, religious and social organizations, larger worksites, and city government departments. Overall projected risk for cardiovascular disease declined significantly in Pawtucket during the educa- tional program, but the prevalence of cigarette smoking declined only slightly and did so more !n the comparison than in the intervention communitv (Carleton et al. 1995). Concurrent \vith the community-based cardiovascular disease prevention trials in the United States, an antitobacco community education program ivas initiated in India (Anantha et al. 1995). The trial ivas conducted between 1986 and 1992 in the Karnataka State. One intervention area (117 villages) and tLt.0 control areas (136 and 120 villages) were se- lected \\?thin the Kolar District. A baseline survey was conducted in 1986, and follow-up surveys were con- ducted t\vo and fi1.e years later. Villages \yere ran- domly sampled in each of the three areas, and the to- bacco use habits of all residents of each household were assessed. A subsample of the villages selected at baseline \,vas resur\,eyed t\1-o and five years later to provide cohort follow--up. After the baseline survey, a three-year educational campaign used health worker staff from Primary Health Centres to visit each village at least once a lveek and deliver health education mes- sages about the risks of cigarette smoking and other forms of tobacco use, particularly chewing. Handbills, photographs, posters, and films m multiple languages rvere used to reinforce health education counseling de- livered to individuals and small discussion groups. Among tobacco users in the intervention area, preva- lence declined 26.3 percent for men and 36.7 percent for \vomen. The proportional reduction in the preva- lence of any tobacco use was significantly greater in both men and \vomen in the intervention area than in the t\1-o control areas (10.2 vs. 2.1 and 0.5 percent for men and 16.3 vs. 2.9 and 0.6 percent for M-omen). The Federal Republic of Germany began the Ger- man Cardiovascular Prevention (GCP) Studs in the mid-1980s (GCP Studv Group 1988). The se\ren-year prevention campaign in the GCP Studv targeted more than 1 million people in six intervention regions lvhose demographic and socioeconomic structure reflected that of the West German population. The reference population was sampled from the total West German population. The goal of the campaign was to reduce four risk factors for cardiovascular disease (hyperten- sion, hypercholesterolemia, smoking, and obesitv) bv using a multifaceted prevention program. Public health services, voluntary welfare federations, institutions for adult education, sports and consumer associations, and other existing communitv resources and facilities \vere used extensively. The campaigns sought the in\.ol\re- ment of health care providers and emphasized consunl- ers' access to them. Special emphasis M'as placed on improving community knorzrledge and awareness of healthy nutrition, the benefits of physical activity, and the importance of quitting smoking. To identify per- sons at high risk for hypertension and hvpercholester- olemia, screenings were conducted at social t\,ents, in factories, and at other communitv settings in close cooperation with physicians, pharniacists, and health insurance companies. To discourage smoking, non- smoking restrictions were extended in public places, and educational campaigns M'ere conducted in the media and in community settings to promote smoking cessation and to help smokers quit. For the e\.nluntion of risk factor trends, representative samples of residents aged 25-69 years from the intervention regions and of the national population of West Germany were sur- veyed before the intervention (May 1984 to March lY86), at midstudy (February 1988 to April 1989), and at the end of the intervention (April 1991 to April 1992) (Hoffmeister et al. 1996). In the national reference sample, the prevalence of smoking declined from 34.0 percent at baseline to 33.5 percent at the end of the study. In the intervention region, the prevalence of smoking declined from 35.4 percent at baseline to 32.5 percent at the end of the study, for a net change of -6.7 percent (P < 0.001). The decline occurred exclusively among men (net change of -7.9 percent, I' < 0.001). Among women, the prevalence of smoking increased in both the intervention regions and nationwide, and no inter- vention impact was noted (net change of -1 .X percent). Using a somewhat different design, the Com- munity Intervention Trial for Smoking Cessation (COMMIT) was started in the late 1980s (COMMIT Re- search Group 1991). COMMIT focused solely on smok- ing cessation and built on the initial experience in the ongoing trials to prevent cardiovascular disease. COM- MIT M'as planned as a randomized community trial with 11 pairs of communities and had adequate statistical popver to detect relatively small intervention effects (Gail et al. 1992). One community of each pair was randomly allocated to the intervention program, and the other was monitored as a control. The 11 interirention com- munities received a four-year educational program that focused on adult cessation, with special empha- sis on "hea\,):" cigarette smokers (those who smoked 23 or more cigarettes per day). The intervention philosophy of the trial assumed that a comprehensive communitw~ide strategy would make it difficult for residents in the 11 targeted sites to avoid exposure to messages about the importance of nonsmoking and w,ould alert smokers to the many opportunities for cessation. Interventions focused on four primarv edu- cational channels: media-based and communitywide e\~ents, health care providers (e.g., physicians and den- tists), \x,orksites and other organizations, and cessa- tion resources. Within these channels, the centrally de\.eloped protocol specified 58 mandated activities, designed to be carried out largely by community vol- unteers and local staff or agencies with limited external wsources (Lichtenstein et al. 1990-1991). Intervention acti\.ities started after the baseline survev and random- ization, beginning M.ith community mobilization in Januarv 1989 and continuing lvith protocol-defined inter\wtion through December 1992. A telephone sur- vey \\-a~ conducted in each of the 22 sites to estimate baseline prevalence and identify cohorts of heavy and light-to-moderate smokers. Cohort members were contacted annually bv telephone, with a final assess- ment in early 1993. A final prevalence survey was conducted in all 22 communities from August 1993 to January 1994. There was a high degree of community owner- ship rvithin the 11 intervention sites (Bracht et al. 1994; Lichtenstein et al. 1996), and program staff and com- munity organizations diligently delivered the 58 man- dated activities. Hence, the modest effects observed in this trial were sobering for the public health com- munity (Fisher 1995; Susser 1995). No cessation effect was observed for the "heavy" smokers for whom the trial was specifically designed (COMMIT Research Group 1995a). Among the evaluation cohort of light- to-moderate smokers, a significantly greater propor- tion quit in the intervention than in the control communities (30.6 vs. 27.5 percent) over the four-year intervention period, and the effect w'as strongest among the less educated residents of the communi- ties, O\,erall the prevalence of smoking declined slightly (but nonsignificantlv) more in the intervcn- tion cdmmunities (3.5 percentage points) than in the comparison communities (3.2 percentage points) (COMMIT Research Group lYY5b). The quality and statistical power of the overall trial design (Gail et al. 1992) make it unlikely that any true intervention effects were missed. The COMMIT intervention pro- tocol sought to apply the most effective smoking ces- sation strategies as defined bv the published literature (Lichtenstein et al. 1990-1991; COMMIT Research Group 1991). The investigators were limited, however, in their ability to be involved in many of the recom- mended ecological and policy-oriented health promo- tion strategies (WHO 1979; Green and Richard 1993) because of restrictions imposed by federal funding of the study (Fisher 1995; Susser 1995). In addition, process data showed that implemented protocol did not have a significant impact on many important in- termediate variables (e.g., physician and dentist coun- seling rates, worksite smoking bans, public attitudes toward smoking) (Glasgow et al. 1997; Ockene et al. Statewide Interventions 1997; Taylor et al. 1998). Therefore, the failure of the COMMIT interventions to use certain strategies or to change intermediate social and policy variables suggests that the study was not an adequate test of the efficac-, of the social-environmental approach to reducing to- bacco use. Several reviewers have provided some perspec- tives on the modest smoking cessation effects observe(j in these community trials (Green and Richard 1YY3; Luepker 1994; Winkleby 1994; Fisher 1995; Susse, 1995). Common themes are (1) the difficulty in oh- serving intervention effects because of the largtx secular declines in risk factors for cardiovascular dis- ease, including smoking, that occurred during tllc, period when the trials were implemented and (2) tllc need for a more comprehensive health promotion a~>- preach. A more complete understanding is needed ot why such modest and mixed smoking cessation effects have been observed in numerous well-designed and well-implemented communitywide trials. Concurrent with the implementation of the corn- munity intervention trials, a broader national move- ment to reduce tobacco use began to emerge in the 1980s. Unlike the communitv intervention trials, this movement, and the large-scale inter\.cntions that developed from it, was not structured around research hypotheses and preplanned evaluation designs. Rather, the movement was characttri7ed by commu- nity mobilization at the national, state, and local levels and encompassed the principles of health pro- motion as a social movement that evolves (Kickbusch 1989; Allison and Rootman 1996; Dolvnie et al. 1996; Nutbeam 1998). Funding for these efforts came from both federal and private sources; hoLyever, an impor- tant manifestation of this national mo\.ement \vas the establishment of statewide interventions funded by increases in cigarette excise taxes or settlements \Vith the tobacco industry. Such increases Lvere the result of voter initiatives, beginning M'ith those in California in 1990 and Massachusetts in 1993. The next section of this chapter reviews the main elements of the na- tional movement. Community Mobilization A significant step in organizing the movement to reduce tobacco use w'as the founding in 1981 of the Co.as to be set aside for preventing tobacco use. Further, this legisla- tion authorized the Commissioner of Health to launch a major state\Vide initiative-the Minnesota Tobacco- Use Prevention Initiative-to promote nonsmoking and established state aid for school-based programs to prevent tobacco use. The legislation allocated funding to support the school-based programs at the rate of SO.52 per student during the 1985-1986 school year and SO.54 per student during future years. School districts \vere authorized to use these nets funds for staff in-service training, cur- ricula and materials, community and parent alvareness programs, and e\,aluation. Three principles guided the state's tobacco con- trol programs. First, a broad base of public support was developed by the collaboration of the Minnesota Coalition for a Smoke-Free Society 2000, the Associa- tion for Nonsmokers-Minnesota, \wluntary health agencies, health professionals, and insurers. Second, the program maintained a positive approach that stressed the consequences of tobacco use rather than attacked the tobacco industry or blamed smokers. Third, the program focused on preventing tobacco use among adolescents and young \vomen ~t.ho had not yet become addicted to cigarettes or smokeless tobacco. The mass media campaigns were the most vis- ible component. The campaigns included paid televi- sion, radio, and outdoor/transit advertising directed at two target populations: 12- to 13-year-old boys and girls and 18- to 24year-old women. The goal of the media campaign was to change a social climate that encouraged the use of tobacco. Advertisements fo- cused on increasing the awareness of the negative as- pects of tobacco use that are most important to young people-unpleasant social and personal consequences, such as bad breath, smelly clothes, and addiction. To foster community tobacco control programs, T/w Mirlrwsofo PIorr for Nor7srrmkirzg nrzd Hcalfh recom- mended that schools, health services, and other community organizations be involved in providing prevention and education programs about tobacco use. A granting program was established in 1986 to fund 21 proposals from local organizations that could dem- onstrate a coordinated approach for involving multiple local organizations in the prevention effort. A second cycle of local projects was funded in 1988. Schools throughout the state were involved in an intensive effort to plan, implement, and evaluate effec- tive programs for students from kindergarten (K) to grade 12 and in technical institutes. Since the start of these programs in the 1986-1987 school year, the per- centage of school districts addressing smoking in grades K-4 steadily increased but remained fairly constant in grades 5-10. The number of school districts in the state rz.ith a tobacco-free policy, howelrer, steadilv increased. Each of the main program elements- funded by the Minnesota Tobacco-Use Prevention Initiative has been e\.aluated (Minnesota Department of Health 1989, 1991). L'outh and adults targeted by the program were a\\`are of the media campaign, and the evaluation data suggested that the campaign improved young people's attitudes tolvard tobacco use (Minnesota Department of Health 1991). There \vas a steady increase in the number of school districts wfhose curricula included components for pre\,enting tobacco use (Minnesota Department of Health 1991). Nonetheless, a prospec- tive study indicated that schools using the prevention curricula pvere not more effective in reducing adoles- cent tobacco use than bvere a randomized control group of schools (Murray et al. 1992). In that study, a com- parison of trends in adolescent tobacco use in Minne- sota and Wisconsin betbveen 1986 and 1990 found a slightly larger (but nonsignificant) net decline in Min- nesota: The investigators suggested that greater reach and penetration of preventive efforts may be required to produce statelride reductions in adolescent tobacco use (Murray et al. 1992). California In November 1988, the Tobacco Tax and Health Promotion Act (Proposition 99) \vas passed by Cali- fornia voters, thus mandating the start of California's Tobacco Control Program. The program is the largest and most comprehensive undertaken in the United States to reduce tobacco use. Initially, the program defined three long-term objectives: (1) to reduce the initiation of cigarette smoking by children and youth under age 19 from the 1987 rate of 26.4 percent to no more than 6.5 percent bv 1999, (2) to reduce cigarette smoking among adults aged 20 years and older from the 1987 rate of 26.0 percent to 6.5 percent by 1999, and (3) to reduce smokeless tobacco use among males aged 12-21 years from the 1987 rate of 8.9 percent to no more than 2.2 percent by 1999 (Tobacco Eclucation Oi,ersight Committee 1991). The excise tax rate on cigarettes in California rose from $0.10 to $0.35 on Janu- ary 1, 1989, Lvhen Proposition 99 \\`as implemented. On Januarv 1, 1993, the tax increased to $0.37, \vhere it remained in 1999. Funding for tobacco control efforts began during fiscal year lY8Y (July 1989-June 1990). The fiscal year 1999 budget in California was $126.8 million ($3.90 per capita) for tobacco control activities funded bv the Department of Health Services and the Departn&t of Education. The NCI's planning frame\vork (NC1 1991) was used to establish the program's target groups, in- tervention channels, and interventions to reach them (Bal et al. 1990). Community mobilization is a key part of California's extensiire program for reducing tobacco use. Community-based programs are the responsibil- itv of the California Department of Health Services and 6i local health departments (58 county and 3 city). These local agencies, advised by local coalitions, es- tablished multiple subcontracts with community- based organizations to conduct events, programs, and presentations for diverse racial and ethnic groups (To- bacco Education Oversight Committee 1991). Local lead agencies have been a cornerstone of the program by mobilizing communities to eliminate exposure to ETS, by closing channels for minors' access to tobacco, and by advising local policymakers. The local lead agencies receive approximately 20 percent of funds allocated for education programs to achieve these ends. The statewide media campaign, which receives about 12 percent of funds, has been the program's most visible element. Launched in 1990, the media cam- paign has focused primarily on changing public opin- ion to denormalize tobacco use. In particular, it has sought to raise public awareness of the tobacco industry's manipulative and deceptive marketing tactics and of the dangers of ETS. Although young people are a direct target audience for some campaign messages, the campaign has focused more on chang- ing social norms and reducing adult tobacco use to influence youth, many of whom begin using tobacco to be more adultlike. Funding for the statewide me- dia campaign was about 924 million ($0.75 per capita) in 1998 but has varied considerably over the years, as is discussed later in this section. About 16 percent of education funds are spent on competitive grants to community-based organizations. More than tlvo-thirds of these grants have targeted racial and ethnic minoritv communities. The competi- tive grants program has-had multiple funding cycles, and 46 separate projects were funded in 1993. In ad- dition, the competitive grants program funds several state\vide projects, such as the Tobacco Education Clearinghouse of California, which distributes library and video materials, and the California Tobacco Con- trol Resource Partnership, Lvhich provides technical assistance and training to local lead agencies. The com- petitive grants program has also been used to estab- lish regional linkages among local governments and local nongovernmental organizations. Twenty-four percent of the education funds go to school-based programs to prevent tobacco use and are distributed through the California Department of Education. The project estimated that it would reach approximately 350,000 students through programs implemented be- tkveen 1993 and 1996. The single largest share, by far, of the education funds-59 percent through 1996-goes to the medical care programs. This percentage is notably higher than the 35 percent specified by the legislation (Novotny and Siegel 1996). As a result of this redistribution, the portions of the program that deal with reducing to- bacco use-designated for 20 percent of the fund- have never been fully financed. In the first year, 16.5 percent of funds were allocated for such program efforts; in the second cycle, 12 percent were allocated; in the third, 10 percent. This diversion of funds was the result of executive decisions and was strongly sup- ported by the tobacco industry and the California Medical Association. After the third diversion, civil action was initiated by Americans for Nonsmokers' Rights, supported by the American Lung Association and the ACS, to prevent the reallocation. The Sacra- mento Superior Court found in favor of the plaintiffs in early 1995. The state appealed, and the judgment for the plaintiffs \vas upheld in December 1996 (A~~rcri- cfl115 for Norrsmoke~s' Ri~llfS i'. stfite of Cdifmifl). The complicated course of these events, as de- tailed by Novotny and Siegel (1996), has highlighted the role of the tobacco industry in countering efforts to reduce the use of its products and the opposing strat- egy of health advocates. Begay and colleagues (1993) have pointed out that since Proposition 99 passed, the tobacco industry's political expenditures in California have risen tenfold, from $790,050 in the 1985-l 986 elec- tion to S7,615,091 in the 1991-1992 election, during which the tobacco industry contributed more heavily to candidates for the California legislature than to can- didates for the U.S. Congress. In a further analysis, this same research group (Traynor et al. 1993) detailed the specific industry strategies to prevent local con- trol of tobacco use. Using case studies, they docu- mented the industry's use of front groups to conceal its involvement, its organization of local referenda to defeat or suspend local ordinances, and its financing of local election campaigns to repeal ordinances by popular vote. Glantz and Begay (1994) have also analyzed the relationship between campaign contri- butions and votes on individual tobacco-related bills in the California legislature. Using a "tobacco policy score" (p. 1178) that ranked legislators according to their stance for or against reducing tobacco use, they found a significant relationship between the amount of money received from tobacco sources and a protobacco position. This ongoing documentation of tobacco industry influence, though not a formal part of the California Tobacco Control Program, has been one of its notable features, and it provides a model of health advocacy for other states and localities. The program, xvhich has e\,olved considerably since 1989, remains a multifocal, multichannel ap- proach to the broad range of issues that confront large- scale efforts to reduce tobacco use (Tobacco Education and Research Oversight Committee 1995; Pierce et al. 1998a). In 1993, the California Tobacco Control Program was revised, and program priorities ivere refocused (Pierce et al. 1998a). Four broad priority areas, or policy themes, Ivere established for use in the program planning and funding decisions: . Protecting people from exposure to ETS. . Revealing and countering tobacco industry influence. o Reducing young people's access to tobacco products. o Providing cessation services. The California Tobacco Control Program contin- ues to place its primary emphasis on a broad statewide infrastructure that reaches into communities across the state. The program's basic structure is composed of a state-level office and several statewide and regional programs that foster a collaborative grassroots approach to serve a decentralized structure of community pro- grams across the state (Pierce et al. 1998a). Surveillance and evaluation activities to assess program performance and impact were established as part of the initial program structure (Bal et al. 1990; Tobacco Education Oversight Committee 1991). The evaluation is composed of large triennial surveys (Pierce et al. 1994, 1998a) and smaller ongoing sir- veys (Pierce et al. 1998b), a more targeted evaluation of program components (Independent Evaluation Consortium 19981, and a wide array of local program evaluation efforts. Evaluation is complicated, how- ever, by the multiplicity of prevalence surveys avail- able and by potential error from using data from surveys with differing methods (Novotny and Siegel 1996; Siegel et al. 2000). Establishing specific rela- tionships between large-scale social interventions and a change in tobacco use is difficult, but the temporal relationship between the decline in California's to- bacco consumption and the efforts generated by Proposition 99 can be clearly observed. Per Capita Cigarette Consurnptiolt Before the implementation of the program in 1989, the rate of decline in monthly per capita ciga- rette consumption was 0.42 packs, which was signifi- cantlv greater than the rate of 0.36 in the rest of the couniry (Pierce et al. 1998a,b). From Januarv 1989 through December 1993, the decline in California in- creased significantly, to 0.65 packs, while the decline in the rest of the United States increased nonsignifi- cantly, to 0.45 packs. Until early 1992, the media pro- gram M'as the only part of the tobacco control program that M'as fully implemented. An econometric analysis (Hu et al. 1995) has estimated that of the 1,051-million pack decrease in sales between 1990 and 1992, approxi- matelv 232 million (22 percent) \vere attributed to the media campaign and the remaining 819 million (78 percent) to the excise tax increase. Between 1993 and 1996, the rate of decline in per capita consumption in California slokved significantly, to 0.17, but virtually halted altogether in the rest of the country (at 0.04 packs) (Pierce et al. 1998b3). Consumption decreased more rapidly in California than in the rest of the coun- try, even though the California cigarette excise tax changed only slightly during this period (from $0.35 in 1993 to $0.37 in 1994). Between 1993 and 1996, how- ever, expenditures for tobacco control were reduced by more than 50 percent from their initial funding lev- els in fiscal year 1990 and 1991. During 1989-1993, spending for advertising and promotions by the tobacco industry exceeded tobacco control expendi- tures in California by a ratio of about 5 to 1; from 1993 to 1996, that ratio increased to nearly 10 to 1 (Pierce et al. 1998b). Adult Smoking Prevalence Data on adult patterns of smoking pre\,alence are not as consistent or as easy to evaluate as consump- tion trends (Novotny and Siegel 1996). Nevertheless, the trends in these data are consistent with the pat- terns noted in the per capita consumption analyses. From 1989 to 1993, smoking prevalence declined in California almost twice as rapidly as in the rest of the country (Pierce et al. 1998b). However, from 1993 to 1997, the rate of decline in California appeared to ~10~`. Overall, smoking prevalence has declined from 26.7 percent in 1988 to 16.7 percent in 1995 in California and from 30.2 percent in 1988 to 24.7 percent in 1995 in the rest of the country (CDC 1996; Pierce et al. 1998b). A recent analysis of trends in adult prevalence of smok- ing in California compared with the rest of the United States observed a significant decline in smoking preva- lence in California from 1985 to 1990 and a slower but still significant decline from 1990 to 1994, a period in which there was no significant decline in the remain- der of the nation (Siegel et al. 2000). Youth Tobacco Use Prevaleuce The lack of consistent youth smoking surveil- lance data between California and other states has impeded the evaluation of program impact on tobacco use among young people in California. Holz-ever, one multivariate analysis of data from the school-based Monitoring the Future survey of Sth-, 1 Oth-, and 12th- grade students showed that irom 1992 to 1994, the in- crease in youth smoking rates that was experienced nationwide was slowed significantly in California (I' < 0.001, controlling for price, smoking policies, and other nonprogram effects) as a result of the combined effect of the tax increase in 1994 and the implementa- tion of the state's tobacco control programs (Chaloupka and Grossman 1996). Pierce and colleagues (1994) have concluded that the media campaign was successful in stopping the rise in teen smoking that had been oc- curring in California before the campaign launch. Results from other analyses of youth tobacco use data are consistent with the result found by Chaloupka and Grossman (1996). In data reported by the Califor- nia Independent Evaluation Consortium, between 1991 and 1996, rates of smoking during the past 30 days among California youth in the 8th and 10th grades in the Monitoring the Future survey increased, but the increase in California was less pronounced than in other states (Independent Evaluation Consortium 1998). Among Sth-grade youth, since 1993 the preva- lence of smoking during the past month has varied from 12 to 14 percent in California while steadily in- creasing from 17 to 22 percent in the rest of the coun- try. Similarly, among IOth-grade youth, past-month smoking prevalence in California has been about 18 to 19 percent since 1992 while increasing from 22 to 32 percent in the rest of the country. Data from the telephone-based California Youth Tobacco Survey in- dicate that the prevalence of smoking during the past 30 days among 12- to 17-year-olds increased from ap- proximately 9 percent in the early 1990s to 11.9 per- cent in 1995. Prevalence declined gradually after 1995, to 10.9 percent in 1997, while increasing in the rest of the country (Pierce et al. 1998a). Other Fidiugs Since the start of the program in 1990, numerous changes in intermediate outcomes have been noted related to changes in social norms; clean indoor air policies in public places, worksites, and bars; and vol- untary policies to ban smoking in homes. Massachusetts In November 1992, Massachusetts voters ap- proved an initiati\,e petition known as Question 1, establishing the Health Protection Fund with revenue generated from a 25-cent increase in the state's ciga- rette excise tax and a 25-cent increase in the wholesale price of smokeless tobacco products. Revenues have been used to fund the Massachusetts Tobacco Control Program, a comprehensive set of activities and services that emphasize prevention programs at the local level and that focus on young people. The Massachusetts program was modeled, in part, on California's pro- gram. The overall goal of the program was to reduce tobacco use in Massachusetts by 50 percent by the end of 1999 (Abt Associates Inc. 1995). With the passage of Question 1, the excise tax on cigarettes in Massa- chusetts rose from $0.26 to $0.51 on January 1, 1993. This tax was fully absorbed by the industry through wholesale price reductions (CDC 1996). However, in October 1996 the cigarette tax increased to $0.76 per pack (with comparable increases on smokeless tobacco products), where it currently remains. Funding for tobacco control efforts began with a large media campaign in October 1993. In late 1993 and early 1994, funding for local agencies was begun, and several statewide initiatives were undertaken to provide direct services, as well as technical assistance, training, and materials for localities. Starting in late 1994, with the first year of complete implementation, the program received $43.1 million (33.7 percent) of the $127.8 million placed in the Health Promotion Fund created by the revenues from the excise tax increase. Other key programs receiving appropriations from the Health Promotion Fund were those for comprehensive school health education ($28.8 million, or 22.5 percent of the Health Promotion Fund in fiscal year 1995), drug education ($5.0 million, or 3.9 percent), and other health-related programs ($50.7 million, or 39.7 percent) (Abt Associates Inc. 1995). After the first funding year, the program's budget declined to $41.8 million in 1995- 1996 and to $36.8 million in 1996-1997. Funding was increased for other programs receiving appropriations from the Health Promotion Fund (Abt Associates Inc. 1997). Community-based education activities and pre- vention activities are two main elements of the Mas- sachusetts program. The state's 10 regionally based, primary care Prevention Centers have added a com- ponent for reducing tobacco use and provide ongoing technical assistance and training to local community programs. Local community initiatives have included programs to increase community awareness about the hazards of tobacco use, to promote tobacco-free workplaces and public facilities, and to enforce local regulations and ordinances for reducing tobacco use; needs assessments in the community; mobilization of youth service agencies to prevent and reduce tobacco use among children and adolescents; funding of community-based agencies to Lvork Lvith at-risk adult populatiot&, including cultural and linguistic minority groups, women of childbearing age, and blue-collar workers; and funding of school-based health centers (Abt Associates Inc. 1995). Per Capita Cigarette Corrszmption As in California, Massachusetts has experienced a persistent pattern of I c ecline in per capita cigarette consumption. Before the 1993 implementation of these tobacco control programs, per capita cigarette con- sumption was declining in Massachusetts at a rate approximately equivalent to that of the rest of the coun- try (6.4 percent in Massachusetts and 5.8 percent in the states other than California [CDC 19961). Between 1992 and 1997, per capita consumption in Massachu- setts declined by 31 percent (from 117 to 81 packs per adult), while the decline in the remaining 48 states was only 8 percent (Abt Associates Inc. 1997). Between 1993 and 1996, the decline in per capita consumption has been more consistent in Massachusetts than in California (CDC 1996). Although program funding declined about 15 percent in Massachusetts from 1995-1996 to 1996- 1997 (Abt Associates Inc. 1997), it declined less than in California. Adult Smoking Prevalence Adult smoking prevalence has been monitored in Massachusetts both by the annual survey conducted through the Behavioral Risk Factor Surveillance Sys- tem (BRFSS) and by special Massachusetts Adult To- bacco Surveys conducted in 1993,1996, and 1997. Data from the BRFSS indicate that adult smoking prevalence in Massachusetts declined from an average of 23.5 percent for 1990-1992 to 20.6 percent in 1997. In the rest of the country (excluding California), prevalence declined from 24.1 percent in 1990-1992 to 23.4 per- cent in 1993-1995 (CDC 1996; Abt Associates Inc. 1997). The Massachusetts survey produced different preva- lence estimates but corroborated a similar decline in the prevalence of smoking among adults in Massachu- setts (from 22.6 percent in 1993 to 21.1 percent in 1996 and 20.6 percent in 1997) (Abt Associates Inc. 1997). Youth Tobacco Use Prevalence As in California, the observed nationwide in- crease in the prevalence of smoking among young people from 1992 to 1994 was significantly less ev- dent in Massachusetts (Chaloupka and Grossman 1996). Follow-up data from the Youth Risk Behavior Survey (YRBS) indicated that the prevalence of cur- rent smoking among Massachusetts high school stu- dents (grades 9 to 12) declined from 35.7 percent in 1995 to 34.4 percent in 1997 while increasing from 34.4 to 36.1 percent nationwide (CDC 1996, 1998). Data from the YRBS and other survey sources suggest a dif- ferential pattern by age: the prevalence of current smoking increased in Massachusetts among older stu- dents in a manner similar to that of the rest of the coun- try but declined among younger students. Between 1993 and 1996, the prevalence of smoking during the past 30 days among 8th-grade students in Massachu- setts declined from 26.5 to 26.0 percent but increased from 16.7 to 21.0 percent nationwide (Briton et al. 1997). For Massachusetts, the prevalence of current smoke- less tobacco use among 9th-12th graders decreased from 8.4 percent in 1995 to 6.0 percent in 1997; for males, the decline was from 15.1 to 10.3 percent (Kann et al. 1998). In the nation as a lvhole between 1993 and 1996, lifetime use of smokeless tobacco among 9th- 12th graders decreased from 25 to 20 percent, and cur- rent use decreased from 9 to 6 percent (Briton et al. 1997). The most recent data from the 1999 YRBS in Massachusetts indicated a continuing decline in the prevalence of current smoking, down to 30.3 percent among 9th-12th graders (GoodenoLv 2000); however, national comparison data for 1999 are not yet available. A 1996 survey of 12- to 14-year-olds in Massachu- setts and a national comparison sample (Houston Herstek Fa\,at, Youth exploratory 1996, Massachusetts Department of Public Health, presentation of findings, unpublished data) found that Massachusetts youth had significantly higher le\Tels of agreement \vith issues addressed in the state media campaign. For example, 59 percent of Massachusetts youth but only 35 percent of youth in the national sample agreed M'ith the state- ment, "Smoking cigarettes decreases vour stamina and smokers have a hard time keeping up in sports." Re- sults from a longitudinal survey of Massachusetts youth provided additional support for the efficacv of the Massachusetts antismoking media campa-ign (Siegel and Biener 2000). In a four-year follow,-up of youth aged 12 to 15 vears in 1993, this studv found that among the younger-adolescents (aged 12 tb 13 years at baseline), those exposed to antismoking advertisements were significantly less likely to progress to established smoking. However, among older adolescents (aged 14 to 15 years at baseline), exposure did not prevent pro- gression to established smoking. Other Findings There have been multiple changes in intermedi- ate measures of program impacts related to youth access, protection of nonsmokers from ETS, and avail- ability of cessation services (Abt Associates Inc. 1999). For example, by 1999, nearly two-thirds of Massachu- setts residents lived in cities and towns with some kind of smoking restriction in restaurants, and 26 percent were protected bv complete bans. Prior to the start of the program, less than 1 percent of Massachusetts resi- dents lived in towns with complete bans. Additionally, the local restaurant smoking restrictions were found to be more restrictive in communities receiving funding from the Massachusetts Tobacco Control Program. Arizona In November 1994, Arizona voters passed Propo- sition 200, which increased the state cigarette excise tax from $0.18 to $0.58. Revenues from the tax increase were earmarked for the state's Medicaid program (70 percent of revenues), for programs for preventing and reducing tobacco use (23 percent), for research on pre- vention and treatment of tobacco-related disease and addiction (5 percent), and for an "adjustment account" (Arizona Tobacco Tax and Health Care Act 1994, sec. 2C4) to offset lost revenue to other state programs currently funded by revenue from the existing $0.18 excise tax (2 percent). The petition drive to place the initiative on the November 1994 state ballot and the campaign to win voter approval was led by the Ari- zona for a Healthy Future coalition. Although public support for the initiative was strong when it was first proposed in 1993 (71 percent in favor, with 56 percent indicating strong support), the initiative was vigor- ously opposed in a well-funded advertising effort on television, in posters, and by direct mail. Proposition 200 was narrowly approved, garnering approximately 51 percent of the vote (Nicholl 1998). With the passage of Proposition 200, analysts estimated that the revenues earmarked for tobacco prevention and education programs would be ap- proximately $25 million per year (Meister 1998). However, measures passed during the 1995 session gave the legislature control over the funds and lim- ited expenditures to $10 million per year (Madonna 1998). Additionally, multiple restrictions were placed on hots the funds could be used, and an advisory com- mittee was appointed that included legislative and business representatives hostile to the program (Meister 1998). Although the Coalition for Tobacco- Free Arizona led an effort to keep the goals of the newly created Arizona Tobacco Education and Prevention Program (AzTEPP) "comprehensive," the program efforts were narrowed to a focus on youth prevention; adult cessation activities were restricted to pregnant women and their partners. Not until the fiscal year that began on July 1, 1997, with a new governor and health department director, were the programmatic restrictions lifted from the health department and the program allowed to proceed with the implementation of the "draft" comprehensive tobacco control plan originally proposed by the Coalition for Tobacco-Free Arizona. The expenditures of AzTEPP reflect the political history of the program: $9.7 million in fiscal year 1996, $18.2 million in 1997, and $28.2 million in 1998. Al- though the countermarketing campaign has expanded (with spending increasing from $7.4 million in 1996 to $13.2 million in 1998) (Riester and Linton 1988), the greatest expansion in the program has been in the scope and focus of the local programs (Meister 1998) (with funding increasing from $1.7 million in 1996 to $9.4 million in 1998). Recent program efforts have focused on all of the elements in the coalition's draft comprehensive tobacco control plan (Meister 19981, thereby expanding its adult cessation activities (discussed at the fourth annual AzTEPP meeting in February 19991, but one of the factors that had been minimized in earlv health department efforts was evaluation. Only recently have baseline data coilec- tion surveys been initiated (Meister 1998); as a result, no outcome data have been reported on the program, and subsequent evaluation efforts will be compro- mised by the lack of baseline data collected before the start of the multiple large-scale program efforts. Respondents to an initial statewide telephone survey conducted in 1998 (Arizona Cancer Center 1998); about two and a half years after the media campaign's launch, reported that the advertising cam- paign, which stressed how damaging tobacco use is and how unappealing it is to the user, to peers, and to the opposite sex, had influenced their attitudes in the intended direction. For example, HO percent of young people reported that the advertisements made them think about the negative aspects of tobacco use, and 58 percent of pregnant or postpartum women said the advertisements made them uncomfortable around smokers. Young people who had been exposed to the television advertisements in the previous 30 days were less likely to be susceptible to using tobacco than were youth who had not seen the advertisements. The campaign's impact on reported behaviors is less clear, especially among young people. Among respondents who were using tobacco at the start of the campaign, 23 percent of adults, 37 percent of pregnant or post- partum women, and 27 percent of young people said the advertising campaign had convinced them to try quitting. However, 23 percent of young people also reported that the campaign had convinced them to irzcwnsc their tobacco use. Cummings and Clarke (1998) noted that such an unintended effect, if it is real, might represent young smokers' negative reaction to a narrowlv focused youth campaign with no messages directed at changing broader social norms. In response to a request from the Arizona Joint Legislative Audit Committee, the State Auditor Gen- eral conducted a performance audit of the AzTEPP (State of Arizona, Office of the Auditor General 1YYY). This audit noted that evaluations of the state and local levels of programs have not yet produced an adequate assessment of the program's tobacco control efforts. Thus, the audit recommended that the program needed to improve its evaluations to measure its ef- fectiveness in preventing youth from starting to use tobacco, encouraging and assisting tobacco users to quit, and reducing exposure to secondhand smoke. Specifically, the audit found that the program had been unable to establish a baseline on tobacco use among youth and had only preliminary assessments in place to assess cessation services. The program has estab- lished adequate methodologies to measure the preva- lence of adult smoking; however, follow-up results are not yet available. Thus, the audit concluded that "The program's evaluation approach to date leaves it far short of knowing whether its programs are working" (p-ii). In response to this audit, the Arizona Department of Health Services (AzDOHS) has implemented changes in its surveillance and evaluation systems. Expanded surveillance systems for youth have been planned and will be implemented in 2000; however, no baseline data are available on youth smoking rates, For adults, a baseline survey of adults was conducted in 1996 and repeated in 1999. Using methodology simi- lar to that used by the state BRFSS, the 1996 and 199~ Arizona Adult Tobacco Surveys were conducted by telephone interviews on representative samples of more than 4,500 adults in Arizona aged 18 years and older. Results from these surveys indicate that the prevalence of smoking among adults declined from 23.8 percent to 18.8 percent overall (AzDOHS 2000). Among adults aged 18 to 24 years, a significant de- cline was observed also, from 27.5 percent in 1996 to 21 .O percent in 19YY. Both of these rates compare very favorably to national trends, where rates overall among adults have not declined in recent years and rates among younger adults have been increasing. Finally, smoking rates among Hispanics declined from 23.5 percent to 13.6 percent, which was the largest decline seen in any race/ethnic group in the state. Multiple other indicator variables suggest that these changes may be related to increases in smoke-free policies, ad- \?ce from doctors and dentists, and exposure to tele- \,ision antismoking information. Finally, these declines in smoking prevalence are consistent with declines in per capita sales (Orzechowski and Walker 2000) that indicate that declines in Arizona since 1996 are larger than those observed in the rest of the country. Oregon On November 5, 1996, Oregon voters approved Measure 44, raising the state cigarette excise tax from SO.38 to $0.68 (with a proportional increase in the tax rate on other tobacco products) and designating 90 percent of the increased revenue for the Oregon Health Plan (to expand insurance for medically underserved state residents) and the remaining 10 percent for a statewide tobacco prevention and edu- cation program managed by the Oregon Health Divi- sion. Survey data indicated that support for the initiative was increased by having the new revenue earmarked in this way (CDC 1997; Nicholl1998). The Oregon campaign to place the initiative on the Novem- ber 1996 ballot was initially led by the Committee to Support the Oregon Health Plan, tvhich represented primarily the private health care sector. Nonprofit and public health organizations added their support and worked in a loosely organized network led by the ACS. Later in the campaign, both groups combined efforts and resources. The measure had strong support from state media (receiving endorsements from all major newspapers and a majority of the smaller ones), from leading business groups, and from the governor, who conducted a three-day supportive media tour before the election. The Oregon Health Division used its existing Oregon Tobacco Control Plan as the model for the new statewide program. Revenue from Measure 44 dur- ing the 1997-1999 biennium was projected to be $170 million; of this, 10 percent (approximately $17 million) per biennium was appropriated to fund the Tobacco Use Reduction Account administered by the Oregon Health Division. The resulting Oregon Tobacco Pre- vention and Education Program has eight elements: (1) local community-based coalitions, (2) comprehen- sive school-based programs, (3) statewide public awareness and education campaigns, (4) a cessation help line, (5) tribal tobacco prevention programs, (6) multicultural outreach and education, (7) demon- stration and innovation projects, and (8) statewide leadership, coordination, and evaluation. The 1997-1999 biennium budget for these eight elements is combined into five categories: (1) local coalitions-$6.5 million (38 percent), (2) public aware- ness and education-$4.6 million (27 percent), (3) state- wide and regional projects-$2.75 million (16 percent), (4) schools-$2 million (12 percent), and (5) statewide coordination and evaluation-$1.2 million (7 percent). Evaluation data from Oregon indicate that the program has successfully implemented each of the program elements and is achieving its performance objectives (Oregon Health Division 1999). Local community-based coalitions were created in all 36 Oregon counties. Twenty-four school projects were funded, reaching 58 of the 198 (30 percent) school dis- tricts in the state. Surveys indicated that approxi- mately 75 percent of adults and 84 percent of the young people recalled seeing the state's public awareness campaign. In January 1999, more than 1,500 Orego- nians called the cessation help line. All nine federally recognized Indian tribes in Oregon are now receiving funding to implement prevention and education pro- grams to reduce tobacco use. Multicultural outreach and education programs have been established for Hispanic, Asian/Pacific Islander, and African Ameri- can populations in Oregon. Five demonstration projects have been funded focusing on pregnant women, health care delivery systems, and creative ways to reach youth audiences. The program has also established a comprehensive and multifaceted surveil- lance and evaluation system and has strengthened program management. Trends in per capita consumption in Oregon were compared with the remainder of the country (exclud- ing California, Massachusetts, and Arizona) for the period before program implementation (1993-1996) and after (1997-1998). From 1993 to 1996, consump- tion increased 2.2 percent in Oregon and decreased 0.6 percent in the rest of the country (CDC 1999b). In 1997 and 1998, per capita consumption declined 11.3 percent in Oregon (from 92 to 82 packs per adult). Be- tween 1996 and 1997, per capita consumption in the rest of the country declined only 1 .O percent (from 93 packs per adult to 92 packs per adult). Smoking prevalence among adults in Oregon has been consistent with the observed declines in per capita consumption. Data from the BRFSS indicate that the prevalence of smoking among adults aged 18 years and older in Oregon declined from 23.4 percent in 1996 to 21.9 percent in 1998 (Oregon Tobacco Prevention and Education Program 1999). The proportion of women who smoked during pregnancy, as reported on state birth certificates, dropped from 17.7 percent in 1996 to 15.2 percent in 1998. Data suggest that smoking rates among young people are continuing to increase as in the rest of the country. Maine In June 1997, the Maine legislature approved HP. 1357, An Act to Discourage Smoking, Provide Tax Re- lief and Improve the Health of Maine Citizens, which increased the state cigarette excise tax from $0.37 to $0.74 and earmarked the increased revenue for the Tobacco Tax Relief Fund. The act established the To- bacco Prevention and Control Program within the Maine Bureau of Health and provided $3.5 million in funding for fiscal years 1998 and 1999. The legislative effort to gain passage of the act was a combined effort of the state public health community, legislative lead- ership, and executive branch support. The Bureau of Health has developed the Maine Tobacco Prevention and Control Program to expand the existing ASSIST program structure and to meet the legislative requirement of the 1997 state statute. The legislation specified that the program include an on- going, major media campaign; grants for funding community-based programs; program surveillance and evaluation; and law enforcement efforts regard- ing transportation, distribution, and sale of tobacco products. The program's initial $4.35 million annual budget included $1.6 million for a multimedia cam- paign, $1.25 million for community and school grants, $625,000 for statewide cross-cutting activities, $400,000 for state staffing, $400,000 for evaluation, and S75,OOO for enforcing youth access provisions. In April 2000, legislation was passed in Maine that appropriated additional funds to expand the Maine Tobacco Prevention and Control Program; a total of $18.3 million from the settlement is going to tobacco control. Of this total amount, $8.35 million will be used for community and school-based grants, funding communities and schools to achieve the goal of reducing tobacco addiction and use and resulting disease, with a focus on those at highest risk such as youth and disadvantaged populations. About $6.75 million will be used for cessation and statewide mul- timedia campaigns; 51.2 million is for evaluation for independent program evaluation, research, and out- comes monitoring; $200,000 funds five positions in the Bureau of Health for administering the programs; and $1.8 million for improved prevention and treatment of tobacco-related diseases for those with Medicaid Insurance. Programs Funded by State Settlements With the Tobacco Industry As was discussed earlier in this report (see "Legislative Developments" and "Master Settlement Agreement" in Chapter 51, all 50 states, the District of Columbia, and five commonwealths and territories have settled lawsuits with the tobacco industry to rc- claim statewide costs spent treating Medicaid patients for diseases related to tobacco use. Four of those states settled their individual lawsuits vzith the industry- Mississippi in July 1997, Florida in September 1997, Texas in January 1998, and Minnesota in Mav IYYH- and the remaining parties jointlv settled in November 1998 in the multistate Master Settlement Agreement. Because of a "most favored nation" clause (ex- plained in "Recovery Claims by Third-Party Health Care Payers" in Chapter 5), the four separate settle- ments have been closely linked, particularly in 110~ the terms of their awards affect the kind of compre- hensive programs discussed in this chapter. Most notably, when the State of Florida received in its settlement $200 million that was earmarked for a two-year pilot program to reduce tobacco use among young people, the State of Mississippi, though it had settled its lawsuit earlier, received $62 million for the same type of pilot program specified in its lawsuit. Texas and Minnesota received no such additional aw.ard, because their lawsuits did not specifically set aside funds for a parallel pilot program, although Min- nesota received funds earmarked for smoking cessa- tion and tobacco-related research. Language in the Texas and Minnesota settlements, however, released Florida and Mississippi from existing requirements to use their pilot program funding within two years and to direct their programs exclusively to young people. Because program planning in Florida and Mis- sissippi was already in place when the youth-onlv restriction was removed, an emphasis on preventing tobacco use among young people has been evident in their pilot programs' first years of activities. These activities are described in the next two sections of this chapter. Brief descriptions of settlement-funded plans in Texas and Minnesota follow. This report does not attempt to describe the various plans and legislative proposals that are developing (at the time of this writ- ing) in the 46 states, the District of Columbia, and the five commonv~ealths and territories included in the joint settlement of January 1998. Mississippi The Partnership for a Healthy Mississippi, a nonprofit corporation representing a broad range of public and private interests, plans and manages the state's pilot program. The program's mission is to cre- ate a youth-centered, statewide collaboration dedicated to fostering a healthier Mississippi and eliminating to- bacco use among Mississippi youth. The partnership ivill award grants in five designated areas: (1) commu- nitv/school/youth activities and partnerships, (2) law enforcement, (3) public awareness, (4) health care ser- vices and research, and (5) evaluation. In the first year, with a budget of $23.7 million, approximately 25 community and youth partnership coalitions were funded, and more are planned for the second vear. Local coalitions-one-quarter of whose membership must be young people-are among the stateM-ide and regional organizations supported by community assistance statevvide partner grants to provide training, tobacco prevention activities for ra- cial and ethnic minority groups, and other technical as- sistance. Specific programs that have been funded by the partnership are 4-H Youth Programs, Frontline (an advrocacy organization for 14- to 18-year-olds), com- prehensive school health programs, and a comprehen- sive school health nurses pilot project. In the first two years, $4 million has been allocated to these activities. The law enforcement program has awarded grants to municipalities to enforce the Mississippi Juvenile Tobacco Access Prevention Act of 1997. These awards lvill range (accordin g to population size) from a minimum of 55,000 per municipality to a maximum of $250,000. A total of 512.65 million has been bud- geted over the first trz,o years of the program for these aM-ards. The grants \\-ill require municipalities to con- duct periodic enforcement checks on the illegal sale of tobacco to minors, provide retailer education pro- grams, provide education programs in schools, orga- nize vouth partnerships, and 1% ork \vith communit\ coalitions on enforcement issues. Other enforcement activities are being performed statetridc bv the Mis- sissippi Attorney General's Office. The partnership has budgeted $12.3 million fol a countermarketing media campaign and other pub- lic aw-areness acti\,ities to be conducted during the first t\vo years. The health care ser\.ices and research con- ponent focuses on nicotine addiction and cessation among young people. An expenditure of 55 million is anticipated for the first and second years for training health providers in cessation counseling, for research- ing childhood and adolescent tobacco abuse, and for coordinating cessation services in the state, including a telephone help line. The Mississippi State Depart- ment of Health will manage the e\~aluation of the pi- lot program and \Vill focus on program effecti\-eness in preventing initial tobacco use among young people, helping young people quit smoking, and reducing young people's exposure to ETS. An expenditure of S2 million is anticipated for the first and second years' evaluation activities. Since 1998, the Partnership for a Healthy Missis- sippi has managed the pilot program to reduce youth tobacco use through a seven-member Board of Direc- tors (www.healthy-miss.org) (McMillen et al. 1999). The major youth programs that have been implemented have included (1) the Reject All Tobacco (RAT) pro- gram among students in grades K-3, (2) the Students Working Against Tobacco (SWAT) Program for students in grades 4-7, and (3) the Frontline youth advocacy movement. Community programs have involved 26 community/youth partnership grants, targeted pro- grams in collaboration with statewide organizations, and the school nurse program in 52 Mississippi school districts. Grants have funded 245 municipalities and 74 counties to empower the local law enforcement agen- cies to reduce sales to minors. Cessation services have included the Adolescent and Child Tobacco Treatment Center and a Mississippi Tobacco Quitline. Finally, a "Question It" public awareness campaign has focused on the 12- to 17.year-old audience. The Mississippi State Department of Health has established a consortium of evaluation contracts in- volving multiple state universities to implement program evaluation efforts. The o\rerall coordination is being managed by the Social Science Research Cen- ter at Mississippi State University, with the evaluation of the media component conducted by the University of Mississippi, community programs conducted by Jackson State Universitv, law enforcement component by Mississippi State University, and the school nurses component by Mississippi State University (McMillen et al. 199Y). A baseline Social Climate Survey of To- bacco Control and Tobacco Use was conducted in 1999 among 3,040 adults aged 18 years and older that provided benchmark data on several social norm intermediate indicator variables (McMillen et al. 1999). Sur\.eillance of youth tobacco use patterns is being con- ducted by the Mississippi State Department of Health. The Youth Risk Behavior Survey was conducted among students in grades 9 to 12 in 1993,1995, 1997, and 1999 and among students in grades 6 to 8 and 9 to 12 in 1998 and 1999. Results indicate that in Mississippi, smok- ing rates among students in grades 9 to 12 had been increasing, as in the rest of country, between 1993 and 1997 (Mississippi State Department of Health 2000). Betlveen 1997 and 1999, smoking rates among students in grades 9 to 12 appear to have stopped increasing and leveled off. Among students in grades 6 to 8, smoking rates did not decline betlveen 1998 and 1999. Florida Program planning and implementation initially were managed by the Governor's Office, with direct leadership provided by Governor Lawton Chiles, who 12-as a partv to the state's lawsuit and a member of the small tean; who negotiated the settlement agreement. The Florida Tobacco Pilot Program is now managed by the Office of Tobacco Control within the Florida De- partment of Health. The program has sought the input of Florida youth in planning the program focus and materials and in working toward the main goals of changing voung people's attitudes about tobacco use, increasing youth empowerment through community involvement, reducing young people's access to tobacco products, and reducing youth exposure to ETS. These four goals will be addressed through program compo- nents similar to those of the Mississippi program: . Marketing and communications initiatives are planned to directly counter the tobacco industry's marketing efforts. A commercial advertising firm, working closely \vith teen advisors, has developed the "Truth" campaign, a direct attack on the image of smoking as cool and rebellious. The campaign's multichannel approach-based on techniques used by the tobacco industrv-incluhcs tcle\,isinn, print, and billboard acl\.ertising, as ~fell as consumer items, such as "Truth'`-imprinted T-shirts and stickers. Youth programming and community partnership activities recruited young people to a Teen Tobacco Summit in early 1998 to ad\rise on the overall de- velopment of the program. Chapters of Students Working Against Tobacco are currently active in all 67 counties. Education and training programs focus on school- aged children. Conducted in partnership with communities, schools, voluntary agencies, profes- sional organizations, and universities, these pro- grams ensure that effective tobacco prevention curricula are presented in middle and high schools across the state and that tobacco prevention strat- egies are being implemented in grades K-12 in conjunction with the Sunshine State Standards. Enforcement initiatives are aimed at improving Florida's efforts to reduce the accessibility of to- bacco products to minors. The Florida Department of Business and Professional Regulation, Division of Alcoholic Beverages and Tobacco, provides en- forcement, educational, and marketing initiatives to ensure compliance \vith all tobacco laws. The evaluation and research component monitors the performance of each of the program initiati\,es and the progress of the overall program in meeting goals and objectives. Under the leadership of the Florida Department of Health, and \vith the con- sultation of the Unilrersitv of Miami, baseline data were collected by Florida universities in all major areas before the pilot program began in earlv 1998. In the first full year of operation, the program budget was approximately 570 million, \\ith program component allocations of approximately $26 million for marketing and communications, SlO million for youth programming and community partnerships, S13 mil- lion for education and training, S8.5 million for enforce- ment, and $4 million for evaluation and research. An additional $5 million was budgeted for programs tar- geting minority populations and 53.5 million for ad- ministration and management. In the second year, approximately $45 million more r\.as appropriated for program operations; however, there were significant unexpended funds from the first year of operations that enabled major program components, such as the mar- keting and communications activities, to continue a level of expenditure similar to the first year. Youth Tobacco Use Preualerlce Between 1998 and 1999, the prevalence of i.,I'. rent cigarette use among middle school student\ (grade? 6 to 8) declined from 18.5 to 15.0 percent (CD( 1999~). Among high school students (grades Y to I?), current cigarette use declined from 27.4 to 25.2 pL,1`- cent. However, these declines were significant on], for non-Hispanic white students; the change in cLIr- rent smoking among non-Hispanic black and Hispanic middle and high school students was small and llcjll- significant. Current cigar use declined significantl\ only for middle school students (from 14.1 to 11.9 per- cent), and this decline was almost entirely among males. Similarly, current smokeless tobacco use C~C- clined only among middle school students (from 6.q to 4.9 percent) and remained unchanged among high school students. In early 2000, additional declines in youth to- bacco use were observed (Florida Department of Health 2000). Current cigarette use among middle school students declined to 8.6 percent, or an overall 54-percent decline since the 1998 baseline. Among high school students, current cigarette use declined to 20.9 percent, or an overall 24-percent decline since the 1998 baseline. Although declines between 1998 and 1999 \vere significant only for non-Hispanic white students, the declines observed in 2000 were significant among all racial/ethnic groups, except among the non- Hispanic black and "other" categories of high school students. Declines in current tobacco use, which in- clude the use of cigars and smokeless tobacco, also l\.ere significant. Since the 1998 baseline survey, cur- rent cigar use declined by 46 percent among middle school students and 21 percent among high school stu- dents. Smokeless tobacco use declined by 54 percent among middle school students and by 19 percent among high school students. Declines in current to- bacco use w'ere consistent across grade, gender, and ethnicity as \vell. Using additional data collected as part of the overall program evaluation, the Florida Tobacco Con- trol Program has connected the declines in youth smoking prevalence with program activities (Univer- sitv of Miami 1999). Results suggest that students who reported recei\?ng elements of a comprehensive to- bacco use prevention education in school had greater declines in smoking between 1998 and 1999 than those students who reported not receiving such education in school. Similarly, the Community Partnerships in the 67 Florida counties were classified as "excellent," "a\rerage," or "needing improvement" based upon program record data, and these ratings were linked to data from the Florida Youth Tobacco Survey fur I YY8 and lYY9 in those counties. Declines in smoking prevalence lvere related to the classification, lvith the greatest declines among middle and high school stu- dents in counties rated as "alwage" or "excellent." Similar ratings of counties on the level of local enforce- ment of youth access laws ivere related to vouth smok- ing prei.alence, Lvith the highest le\,els of enforcement in counties with the lotz.est prevalence. Finally, data from the Florida Anti-Tobacco Media E\.aluation (FAME) have indicated that the "Truth" campaign is producing impressi\~e alvareness among vouth and changes in attitudes and knwzledge consistent lvith the campaign themes. BetIveen lYY8 and lYYY, the prevalence of Florida youth aged 16 years and uncle1 1%.ith antitobacco attitudes increased from 59 to 64 per- cent but decreased slightlv nationlvide. National data against trhich to compare the Florida data from 1998 and 19YY are not yet a\.ailnble, but some data suggest that the prevalence of tobacco use among young people mav ha\,e peaked nation- lvide and could be starting to decline (Universitv of Michigan 1998). III addition, the impact of state exiise tax increases that have occurred since the 1 YYX baseline data collection might be assessed. Adult Smoki?lg Preualerzce In 1998, the Florida Behavioral Risk Factor Surveillance System (BRFSS) expanded its assessment of tobacco issues. The tobacco module will enable changes to be assessed in tobacco use prevalence, cessation behalriors, family rules about tobacco use, environmental tobacco smoke exposure at home, and workplace policies regarding smoking. Texas The legislative plan developed by the Texas Interagency Tobacco Task Force (1998) incorporated the CDC recommendations for community and school- based programs to reduce tobacco use. The plan in- cludes a public awareness campaign, cessation and nicotine addiction treatment, programs for diverse or special populations, enforcement of laws to reduce minors' access, surveillance and evaluation, and state- wide program administration. The plan requests $20.75 million for fiscal year 2000 and $61.25 million for fiscal year 2001 to implement, evaluate, and ad- minister the programs proposed. In the fall of 1999, the Texas legislature created an endowment fund of $200 million and requested the Texas Department of Health to conduct a pilot study based upon recommended interventions included in the 1998 tobacco task force plan. This pilot would be funded by int-estment revenue from the endowment fund, approximately S9 million per year. In response to this requirement, the Texas Department of Health has begun an Intervention Effectiveness Pilot Study in conjunction \\ith uni\,ersities in the state. To assess the impact of tobacco use prevention activities in the state, the Texas Department of Health has conducted the Texas Youth Tobacco Survey in 1998 and 1999 among middle and high school students from a sample of students statewide and in eight regions of the state. Results from the 1998 survey indicated 31 percent of middle school students and 43 percent of high school students \yere currently using some form of tobacco products (Texas Department of Health). For cigarettes alone, 21 percent of middle school students and 33 percent of high school students were current smokers. Minnesota Settlement Program In Minnesota, the Minnesota Partnership for Ac- tion Against Tobacco, the Tobacco Work Group of the Minnesota Health Improvement Partnership, and the Minnesota Blue Cross and Blue Shield (which received a separate S469-million settlement award [see "Recov- ery Claims by Third-Party Health Care Payers" in Chap- ter 51) all have developed plans for the statewide effort to reduce tobacco use. In the 1999 Omnibus Health and Human Services appropriation bill, the Minnesota legislature set aside $968 million from the state's tobacco settlement to establish two health-related endowments: one for preventing tobacco use and supporting local public health efforts (S590 million) and the other for tobacco-related medical education and research ($378 million). The interest earned from these endowments will support long-term programs. The 1999 Minnesota Omnibus Health and Human Services bill established an ambitious goal to reduce tobacco use among young people by 30 per- cent bv the vear 2005. In response to this, the Minne- sota Department of Health developed the Mirz~~esotn y~ifll Tol~rrccc, Pww~~ti(~l Illifintiw: Strrrtl;tric Plnrr (Min- nesota Department of Health 1999). This plan defined major activities that will be funded from January 1, 2000, through June 30,2001, in four component areas: Statewide Public Information and Education Cam- paign, Statewide Programs, Community-Based Pre\,ention Programs, and Youth Leadership Projects. The strategic plan established "initial indicators of suc- cess" for each program component to enable program performance to be assessed. The Statelvide Public Information and Educa- tion Campaign Ivill have a proposed budget of $7.5 million for the l&month period. The campaign will include both a media component and grassroots organizing efforts focused on the target audience of 12- to 1 T-year-old youth. The Statewide Programs will be budgeted at $3.55 million for the initial l&month period. Evaluation activities, training, and technical assistance services will be funded along with statewide organizations to support the community-based efforts. The Community-Based Prevention Programs will be budgeted at S4.4 million for the initial 1%month period. Community-based prevention efforts will include tobacco-use prevention activities at the local level and projects that focus on populations at risk. Finally, the Youth Leadership Projects will be budgeted at $1 million for the initial 18-month period and will work in conjunction with the community-based prevention efforts. These activities will seek to em- power Minnesota's youth to take leadership in the planning and implementation of tobacco prevention and control programs at the local level. The Minne- sota Department of Health has established an evalua- tion plan to track progress of the initiative, with the first comprehensive report on program effectiveness to be delivered to the legislature in January 2003. Programs Meeting the Needs of Special Populations The recent Surgeon General's report K~l~~rn) USC? Anzor1g U.S. Rarinl/Efl~lic Mirlorit!/ Gvo~r;j$ provided a summary of the various approaches that have been used to prevent and control tobacco use among racial/eth- nic minority groups in the United States (USDHHS 1998). This report highlighted the need for more re- search on the effect of culturally appropriate programs to address this problem. Few new findings ha\,e emerged since the publication of that report; hence, the elimination of disparities in health among population groups remains hampered by the lack of culturally ap- propriate programs of proven efficacy. Belolv are some examples of community-based interventions that have proven to be effective and that may serve as examples for the development of future program initiatives. Uniting and mobilizing the movement to reduce tobacco use among racial/ethnic groups have not been easy. Tension frequently occurs between various orga- nizations within the community regarding appropriate strategies to achieve particular goals, "turf" disagree- ments, competition for fund-raising dollars, and other issues. Many of these problems were identified during the 1989-1992 COMMIT trial. Though COMMIT researchers did not attribute to internal dissension the program's inability to reach its goals (Thompson et al, 1993), internecine rivalry can splinter community mo- bilization efforts and greatly impair the effectiveness of any program trying to reduce tobacco use. Diverse views and dissent are an expected part of organizing activity. A more serious issue for com- munity mobilization has been a lag in engendering support from all segments of society. Historically, the movement to reduce tobacco use has been dominated by organizations composed of middle- and upper-class white Americans and often led by white males (see Chapter 2). For many years, participation in the move- ment was further limited to organizations concerned with health and medical issues and nonsmokers' rights. In the early 198Os, increasing dissatisfaction was voiced by women and underrepresented communities who felt that their issues and contributions were not adequately integrated into mainstream efforts to reduce tobacco use (Jacobson 1983). In recent years, a number of persons and organizations representing more diverse perspectives have assumed a greater role (see the text boxes "Uptown, " "X," and "Dakota"). Particularly in view of the tobacco industry's targeted marketing to women, African Americans, Hispanics, and young people (USDHHS 1994,1998), such heightened activity is of critical importance to ensure a nonsmoking norm Mithin diverse communities. In some instances- exemplified by the low and declining smoking preva- lence among African American youth (USDHHS lY91)-such a norm may have already taken hold. Programs for the African American Community Several leadership groups, such as the National Black Leadership Initiative on Cancer, which is funded by the NCI, and the National Association of African Americans for Positive Imagery, funded in part by the CDC, have begun to have a voice in activities to re- duce tobacco use in the African American community. For example, in 1989, a strong coalition guided com- munity mobilization efforts to mount a successful cam- paign against the test-marketing of Uptown, a neM brand of cigarettes targeting African Americans (see the text box "Uptown"). A similar community- organized campaign in 1995 resulted in the withdrawal of X, another new brand seemingly intended for the African American community (see the text box "X"). In lYY2 and 1993, the ACS provided funds for community demonstration projects to use Patlrwm~s to FI.CC~OV~: Wi~lj~ill:; tile fi,$t Apimt Tobncco, a self-help guide for African American smokers (Robinson et al. Uptown I n mid-December 1989, R.J. Reynolds Tobacco Company announced that on February 5,1990, it would begin test-marketing a new cigarette in Phila- delphia, Pennsylvania. The cigarette, to be named Uptown, was the first to be marketed directly to African American smokers. Within 10 days of this announcement, the Coalition Against Uptown Ciga- rettes (CAUC) was formed. Using existing church and community organizations and word of mouth, the coalition gre\v to include 26 diverse organiza- tions representing health, religious, and community groups. The group's leaders bvere African Ameri- cans w.ith long-standing ties to the Philadelphia African American community. The Philadelphia chapter of the National Black Leadership 1nitiatiL.e on Cancer, an organization funded in part LX the National Cancer Institute and dedicated to r&luc- ing cancer in the African American community, and the Committee to Prevent Cancer Among Blacks facilitated the coalition's formation. Also acti\.e in the CAUC were se\,eral other organizations that addressed local issues on cancer control. These groups included chapters of the American Cancer Society and the American Lung Association, as \\.ell as the Fox Chase Cancer Center. The CAUC decided that its initial goal \~ould be to limit R.J. Reynolds' ability to use Philadelphia as a test market by convincing African American smokers to boycott the ne\,v cigarette. The coalition mobilized both smokers and nonsmckers in support of this goal by focusing on R.J. Revnolds' strategv to promote tobacco use among Africin Americans. %he coalition initially used local media to reinforce the messages being sent through grassroots channels and did not seek out national coverage, which the coali- tion members believed would hinder their goal of 1992). Awardees used Pnthnys to Frccdoril to bring tobacco control efforts to the African American com- munity. Through these demonstration projects, many ACS divisions began or enhanced their work in the African American community. A recent study in three predominately low- income, African American neighborhoods has demon- strated that culturally appropriate interventions can produce significant declines in smoking behaviors (Fisher et al. 1998). The Neighbors for a Smoke Free building a local, grassroots constituency. On behalf of the CAUC campaign, Dr. Louis Sullivan, then Secretary of Health and Human Services, addressed the Cniversity of Pennsylvania School of Medicine on January 18, 1990. In his remarks, Secretary Sullivan said that "at a time when [African Ameri- cans] desperately need the message of health pro- motion, Uptown's message is more disease, more suffering and more death for a group of people al- ready bearing more than its share of smoking- related illness and mortality" (quoted in Heller lYY0, pp. 32-3). The national media embraced the story. Sec- retary Sulli\,an's remarks were prominently fea- tured in the evening news and were front-page headlines across the country. R.J. Reynolds initially responded by defending their targeted marketing strategy, but the companv later claimed that Up- to\vn \vas not aimed specifically at African Ameri- cans. On January 19, lYY0, R.J. Reynolds canceled the Philadelphia test-marketing of Cptolvn. On Januarv 31, 1990, the company canceled production of the cigarette. The course of events suggests that the Uptown coalition played a decisive role in altering R.J. Reynolds' targeting strategy. A united response from Philadelphia's African American community, an or- ganized local grassroots effort, the strategic alliance \vith a national figure, and media management were associated M.ith product cancellation less than two months after introduction. The episode highlights the importance of timing in measures to reduce to- bacco use. In this instance, a marketing campaign appears to have been derailed in its beginning stages by short-term, high-intensity media advocacy (see "Media Advocacy," later in this chapter). North Side organized residents in wellness councils to encourage nonsmoking in their areas. A citywide advisory council, composed mostly of African Ameri- cans, carried out central planning for the program and provided linkages to community resources and tech- nical assistance to neighborhood councils. The pro- gram implemented a wide range of activities over a 24month period, including smoking cessation classes, billboard public education campaigns, door-to-door campaigns, and a "gospelfest." A quasi-experimental X I n early 1945, the memory of the grassroots vic- torv against Uptown cigarettes (see the previous text box, "UptoMn") served as a rallying cry in the African American community in Boston against the potential threat of a new brand-X cigarettes. As with Uptown in Philadelphia, the first information about this cigarette brand came in local media- in X's case, in articles in the Bo.sto/~ C/oh and the Bostorr Htwld. This distinctive menthol cigarette brand was packaged in the Afrocentric colors red, black, and green and featured a prominent "X," a symbol fre- quently associated with the well-knoMn, deceased African American leader Malcolm X. Community leaders in Boston and throughout the United States thought that the product had the potential to attract young African Americans-a group whose smok- ing rates had dropped dramatically in recent years. The use of "X" on a cigarette brand also \vas seen as a defamation of Malcolm X, a noted nonsmoker. Al- though manufactured and distributed by two com- panies tvithout large marketing budgets, there M'as a fear that even a small success with X cigarettes would stimulate the creation of similar products by the major tobacco companies, which would have significant resources for advertising and promotion in African American communities. The National Association of African Americans for Positive Imagery (NAAAPI) and the Boston- based organization Churches Organized to Stop Tobacco took the lead in opposing X cigarettes. T\VO NAAAPI leaders, Reverend Jesse W. Bro\vn, Jr., and design l\.as used to evaluate the impact of this pro- gram. The three intervention neighborhoods in St. Louis were matched by ethnicity, income, and educa- tion with three comparison zip code areas in Kansas City, Missouri. Baseline and follow-up random-digit dialing telephone surveys were conducted among adults (aged 18 years or older) in the three interven- tion and three comparison areas in 1990 and in 1992. Smoking pre\.alence declined significantly in the St. Louis neighborhoods, from 34 to 27 percent, but declined only slightly in the Kansas City comparison areas, from 34 to 33 percent. Thus, the results of this trial suggest that a culturally appropriate community- organizing approach to smoking cessation that Chary:-b D. Sutton, both of whom had been involved in the Coalition Against Uptown Cigarettes, spoke in Boston in February 1995 about the need for com- munities to mobilize against tobacco marketing, Their visits were covered extensively by print and broadcast media. As a result of NAAAPI's orga- nizing efforts, the manufacturer and distributor of X cigarettes received calls from around the coun- try, most notably from the organizations involved in the African American Tobacco Education Net- work of California. Because the brand's marketing seemed to be confined to the Boston area, NAAAPI decided to demand in writing that X cigarettes be withdrawn immediately to prevent any wider distribution. The manufacturer (Star Tobacco Corporation, Petersburg, Virginia) and distributor (Stowecroft Brook Distribu- tors, Charlestown, Massachusetts) both responded within 10 days to that request, although they contin- ued to insist that the cigarette brand had not been specifically targeted to the African American com- munitv. On March 16,1995, news conferences were held in Boston and Los Angeles by tobacco advo- cates to announce the withdrawal of X cigarettes from the market. The course of events suggests that the actions of activist groups had direct influence on the out- come. As Leas the case writh the Uptown protest, the X experience suggests the critical role of a rapid but organized community response in efforts to pre\,ent the targeted marketing of tobacco products to racial and ethnic minority groups. emphasizes local authority and involvement in pro- gram planning can have a significant impact on the smoking behavior among residents of low-income, African American neighborhoods. Programs for Women The Women vs. Smoking Network, a project of the Advocacy Institute, was the first national network of lvomen's organizations and women's leaders to focus on reducing tobacco use among rvomen. With financial support from the NCl, the network provided technical assistance and information to `Lz'omen's orga- nizations in an effort to interest them in the movement to reduce tobacco use. The network also focused on obtaining media coverage for issues concerning rvomen and smoking. The netxvork's most notable ef- fort was the release of a plan by R.J. Reynolds to mar- ket cigarettes to young, uneducated women (see the text box "Dakota"). Subsequent media attention made this one of the most widely covered tobacco stories of 1990 (Pertschuk 1992). The netwwk XV~S short-lived (1989-19911, however, because of lack of funding. The International Nettvork of Women Against Tobacco (INWAT) \vas established in 1990 as an international organization to counter the marketing and promotion of tobacco products to \vomen and to foster the dc\.el- opment of programs for the pre\rention and cessation of tobacco use among \vomen. Through support from the American Public Health Association, INWAT has 11-orked to dralv attention to issues concerning rz~~men and tobacco and has sought to unite and inform Ivomen's advocates around the \vorld. As a record of its Herstories project, INWAT assisted in preparing an issue of L%r,lll SuwX-itl;< :711d Htv7ltil (INWAT 1994) that \~as a collection of brief essavs about the role of to- bacco in \vomen's li\res in \`arious countries. INWAT has also published and distributed an international directorv that lists tvomen \~ho are advocates for reducing tobacco use and includes their areas of spe- cialization (American Public Health Association 1991). The National Coalition for Women Against Tobacco, lvhose sponsoring organization is the American Medi- cal Women's Association, provides educational mate- rials and advocacy messages to counteract tobacco industry marketing and combat tobacco use among Lvomen and girls (http:// M~w.womeliagainst.org). Federal and State Programs At the federal level, the CDC's IMPACT program awarded three-year cooperative agreements in 1994 to selected national organizations to enhance their work in reducing tobacco use at the national, state, and local levels. Organizations were chosen on the basis of their ability to provide services and outreach to young people, women, blue-collar and agricultural workers, African Americans, Hispanics, Asian Ameri- cans and Pacific Islanders, and American Indians. Among the states, California has made a concerted effort to involve racial and ethnic minority groups and \vomen in its efforts funded-by Proposition 99-to reduce tobacco use (see the section on California, ear- lier in this chapter). In 1990, four organizations were funded to form networks among Hispanics, African Americans, Asian Americans and Pacific Islanders, and American Indians. Members of the networks convene meetings, share experiences, participate in the devel- opment of culturally appropriate materials, and help community organizations reach their respective com- munities. These net\\Torks currently conduct programs and campaigns to build a strong statewide coalition among their respective populations (Tobacco Educa- tion Oversight Committee 2000). California also has funded a statelvide organization, Women and Girls Against Tobacco, to focus on tobacco product market- ing that targets females. Created in 1992, the organi- zation focuses on empowpering women's and girls' organizations to divest themselves of tobacco indus- tr). sponsorship and funding and on eliminating tobacco ad\-crtising in leading magazines with read- ership among voung ivomen (Women and Girls Against Tobacco-, n.d.). Religious Organizations Although not specifically representative of minority or underserved groups, some religious orga- nizations that have an important impact in minority communities have had long-standing invoivement in issues related to reducing tobacco use. The Interfaith Center on Corporate Responsibility, a coalition of 250 Roman Catholic and Protestant institutional investors, pioneered the corporate responsibility movement in the early 1970s. The value of their combined portfo- lios is estimated at $40 billion. In 1981, the Province of St. Joseph of the Capuchin Order was the first mem- ber of the coalition to file a shareholder resolution with a tobacco company on the issue of smoking and health. Since then, the coalition has filed numerous share- holder resolutions with the major tobacco companies. These resolutions are a unique opportunity to engage in a public dialogue with executives of major tobacco companies; the shareholder meetings frequently re- cei\-e media attention. A more recent effort to involve religious organiza- tions and thereby diversify efforts to reduce tobacco use is the formation of the lnterreligious Coalition on Smoking OR Health. The stated purpose of the group is to mobilize the faith communities in the United States to improve the effectiveness of public policy concerning tobacco. The Coalition is con- cerned with policies affecting United States cor- porations in\,olved in the manufacture and sale of tobacco products. The primary focus of the Coalition is educating policy makers within both the legislative and executive branches of the United States fecleral government (Interreligious Coalition on Smoking OR Health 1993, p. 1). Dakota T he Women vs. Smoking Network, under the aegis of the Advocacy Institute, ~`as a project aimed at informing and uniting women's organ- zations to oppose the tobacco industrv's efforts to market its products specifically to women. In No- vember 1989, the network sent a letter to the editor of more than 100 newspapers nationwide. Several newspapers printed the letter, which responded to a Philip Morris advertisement that had previously run in these newspapers as a mock apology to women for alleged "shortages" of their new ciga- rette, Virginia Slims Super. As a result, several ma- jor national papers and ABC Nc~rjs subsequently ran stories on tobacco ad\rertising that targeted lvomen. Soon thereafter, the controversy and media cover- age surrounding the planned test-marketing of Uptown cigarettes to African Americans began (see the text box "Uptown"). In response, many jour- nalists wrote stories on the related issue of targeted marketing to women. These stories prepared the public for the events that followed. In February 1990, an anonymous source sent the Women vs. Smoking NetLvork copies of confi- dential marketing documents for a new cigarette brand, Dakota. The cigarette, produced by R.J. Reynolds Tobacco Company, was scheduled for test- marketing in April 1990. The marketing documents, entitled "Dakota Field Marketing Concepts," con- sisted of more than 200 pages of test-marketing pro- posals from t\yo different ad\,ertising firms. The marketing documents described Dakota, Mhich \vas The coalition was formed in cooperation Lvitli leading organizations within the mainstream tobacco control community. As of Januarv 1991, the coalition had enlisted 16 main religious orianizations, includ- ing Catholic, Muslim, and Protestant denominations, in the effort to support a large increase in the federal excise tax on a pack of cigarettes (Interreligious Coali- tion on Smoking OR Health 1994). Special Efforts to Reduce Chewing Tobacco Use In 1995, Oral Health America established the National Spit Tobacco Education Program (NSTEP), code-named Project Virile Female, as a cigarette ex- plicitly for young women (18-20 years old). The demographic and psychological profile prepared by Trone Advertising Inc. of the typical Dakota smoker described her as a "Caucasian female, 18-20 years old, with no education beyond high school, work- ing at whatever job she can get" (Butler 1990, p. I, citing Trone Advertising Inc.). She aspired to have an ongoing relationship with a man and "to get married in her early twenties and have a family." She spent her free time "with her boyfriend doing \1-hate\,er he is doing." The marketing documents also included specific promotional strategies to attract young women to the new cigarette. Recognizing the value of the documents, staff of the Advocacy Institute negotiated with the Wnsll- ir2$orr Post for front-page coverage of the story in exchange for initial exclusive release of what the institute staff called "Dakota Papers." The Wad- irlglo,~ Posf ran the story on Saturday, February 17, 1990, tvith the headlin;, "Marketers Target `Virile Female': R.J. Reynolds Plans to Introduce Ciga- rette" (Specter 1990). The Advocacy Institute held back further details on the documents until Tues- day, February 20, so that the director of the Women 1's. Smoking Net\vork could appear on CBS T1lis Morriill:; M'ith Dr. Louis Sullivan, then Secretary of Health and Human Services, to "release" the story of the documents. Secretary Sullivan strongly con- demned R.J. Reynolds' plans to target women in its marketing strategies. fan effort aimed at reducing the use of smokeless to- bacco among youth in sports. Oral Health America teamed up former major league baseball players, such as Joe Garagiola, Hank Aaron, and Bill Tuttle, to help get the message out that smokeless tobacco products arc not a safe alternativ-e to smoking. The components of NSTEP include in-stadium events, public service announcements that have been televised during ma- jor league baseball games, printed materials, and edu- cational videos. An external evaluation of NSTEP is being developed to address all levels of the program and its public health impact. Significant successes of the program include the inclusion of spit tobacco on the national tobacco policy agenda, M'ith specific credit to NSTEP and national Within the next fe\v bceeks, representatilres of the Women vs. Smoking Network appeared on NRC Nic~17fl!/ NLTIT, CBS 771is Mov/I~u~, CBS Ew~I~II;; N<~i~~~, the Ml~cNril-Lchwr Ncw~Horl~, Ni~l7tmfcl7, and Nightli77e. Representatives Lvere also interviewed by major national newspapers, including L/S,4 Todny; by numerous local papers; by CBS Radio Network, the Black Radio Network, and National Public Radio; and by local talk S~OM'S. Last, repre- sentatives were asked to testify on the topic at con- gressional hearings. The network follolved up on the publicity bv spotlighting several different projects, including a petition to the tobacco compa- nies to adhere to their o\\`n \roluntarv code of cor- porate ethics. Even the cigarette's proposed name dre\V criti- cism. Groups in North Dakota and South Dakota objected to the name, as did Sioux tribal organiza- tions, because "Dakota" means "friend" or "allv" in the Sioux language. These groups formed a coa- lition of more than 4U organizations and collected 25,000 signatures on a petition objecting to the USC of the word and demanding that R.J. Revnolds cease chairman Joe Garagiola by lawmakers and Secretary of Health and Human Services Donna Shalala. >lore than S70 million in electronic media coverage has been generated directly from NSTEP efforts. In addition, NSTEP activities appear to have substantially in- creased the coverage of smokeless tobacco issues in the print media. Before NSTEP there were approxi- mately 500 print articles annually devoted to smoke- less tobacco; since NSTEP that number has climbed to Components of Community Programs Community Advocacy and Mobilization Electronic Networking Interactive communication technologies, such as computer networks, have been used extensively by advocacy groups for reducing tobacco use. For ex- ample, daily communications played an important selling the cigarette, rvhich had been test-marketed, as planned, beginning in April 1YYO. The Women VS. Smoking Nettvork provided strategic counsel- ing and technical support to the grassroots coali- tion and \vas instrumental in helping arrange a press conference in Washington, DC, in June 1990, which featured then Surgeon General Antonia Novello, Senator Larry Pressler (R-SD), and others objecting to the marketing plan. Although advocacy groups \vere able to gen- crate considerable community and media mobili- zation, R.J. Reynolds continued test-marketing. Advocates felt they had raised national concern about the targeting of cigarette advertising, al- though this impression was not directly verified through survey research. Dakota cigarettes were \vithdra\vn trvo years later, however, because the brand did not sell as well as officials had hoped 04~77c~icn77 Mcrlit-111 iV~w 1992). In this instance, al- though ad\,ocates might attribute the end result to the effective use of the media to promote the agenda for reducing tobacco use, the demise of the Dakota brand \vas probably more attributable to market forces. more than 5,000. One article alone appeared in more than 800 netzspapers on a given Meekend, and NSTEP estimated the value of this media coverage at $15 mil- lion. A recent survey of major league baseball players and coaches found that more than 44 percent of smoke- less tobacco users want to quit in the next six months, perhaps attributable to NSTEP's active participation in educating ballplayers during spring training. part in the response to Philip Morris' Bill of Rights Tour (see the text box later in this chapter). Many active, functioning networks now provide communication services to assist in efforts to reduce tobacco use. The Institute for Global Communications, based in San Francisco, \vas an early provider of issue- specific networks to the general public. PeaceNet and EcoNet, which were dev~eloped in 1 YH6, are among the most widelv used and well known of the institute's networks. As of October 1994, the institute reported a combined membership of 12,000 people from 130 coun- tries (Moore 1994). Within these networks, and others like them, are smaller groups focused on a specific as- pect of an issue or a particular policy. For instance, among HandsNet's 2,500 member organizations, which span the nonprofit sector, is a forum linking 200 community coalitions on substance abuse. This forum, managed by the Boston-based group Join Together and supported by the Robert Wood Johnson Foundation, provides on-line technical assistance to these coalitions. The forum also provides news summaries and infor- mation available on funding opportunities and proposed legislation. Several networks link people who work in health- related areas. In 1993, the Public Health Network pro- vided forums, e-mail service, and databases for its membership, which was composed of nearly 600 users from state and local health agencies and of program directors who were members of the CDC's Public Health Leadership Institute. In 1998, this network was replaced by the Information Network for Public Health Officials. Established by the CDC's Pub- lic Health Practice Program Office, the network links the public health community to the Internet and pro- vides access to on-line information. Planned l'arent- hood Federation of America hosts PI'XNet, a network for its affiliates in regional and national offices, pri- marily for communication within the organization itself. During the lYYOs, the CDC offered the electronic resource WONDER to public health officials, acade- micians, and others so that thev were able to commu- nicate via e-mail with and ha;,e access to the CDC's databases of health data. The advent of the Internet, including Web-based e-mail and list serv technology, has facilitated the exchange of public health informa- tion for health professionals and the public. CDC now offers its health data, materials, databases, electronic journals, and other resources on its Web site at www.cdc.gov. In 1990, the Advocacy Institute founded SCARCNet, a multiuser interactive bulletin board that served the tobacco control community. (The history of the bulletin board's sponsoring organization-the resource center known by the acronym SCARC-is discussed in "Impact of Direct Ad\;ocacy," later in this chapter.) When SCARCNet ceased in January 2000, it had more than 1,000 subscribers and was circulated to thousands of readers throughout the wrorld on vari- ous networks. SCARCNet's most popular feature \~as the "Daily Bulletin," which each day summarized major newspaper and journal stories on reducing to- bacco use (Advocacy Institute 1994). The "Daily Bul- letin" was accompanied by a "Morning Briefing," which put these news stories in perspective for the tobacco control community. The contents of the "Dailv Bulletin" stories were retained and stored in a data- base that is currently available for searching at \vww.tobacco.org. Another notable feature of SCARCNet was the publication of "Action Alerts." These two-page summaries of current issues requir- ing immediate action included objectives for action, suggested actions, media bites, quotes, and talking points and were sent to SCARCNet as needed (on av- erage, twice per month). The conferencing section on SCARCNet, called the "Strategy Exchanges," provided a forum for planning, counseling, and experience sharing. The technology allowed for concurrent but separate discussions on discrete issues, such as clean indoor air, tobacco advertising and promotion, tobacco pricing policies, and minors' access to tobacco prod- ucts. Since its inception in 1990 to its final edition on January 31, 2000, SCARCNet, along with its global counterpart GLOBALink, became an important re- source for the tobacco control community. In Febru- ary 2000, the American Legacy Foundation began its support of a newly designed and enhanced news ser- vice system that harnesses advances in Web technol- ogy to build on SCARCNet's valued features. This system provides users with the leading national news stories and also includes a news service that allows users to receive a customized selection of other stories based on their geographic location and specialty areas of greatest personal interest (e.g., advertising, en- forcement, etc.). SCARCNet has served as a model for other pub- lic health advocacy networks. Examples include Safety Net (an advocacy network for violence prevention) and the Marin Institute's ALCNet (a network for alcohol control advocates), which is modeled closely after SCARCNet. ALCNct has been used for media advo- cacy as Lvell, particularly to facilitate strategy devel- opment to counteract certain alcohol products and promotions. As with other modalities used for social change, the precise role of on-line networks-one element in a multifaceted approach-is difficult to define. Al- though process measures are available (e.g., frequency of interactions and message traffic), they do not assess the basic value of computer links in furthering the agenda for reducing tobacco use, nor is it likely (as is noted at the beginning of this chapter for social inter- ventions overall) that their efficacy can be precisely estimated. Current enthusiasm for the mechanism, however, rvill probably ensure its continuation, and accrued anecdotal experience-to date, quite positive- \vill provide the ultimate judgment. Direct Advocacy History md Actizlitirs National-level activities, including the lz'ork of the Coalition on Smoking OR Health (see "Further Regulatory Steps" in Chapter 5; see also "Communitv Mobilization," earlier in this chapter) and others (see Chapter 2 and USDHHS lYHYb), have played a promi- nent role in the evolving policy changes concerning the reduction of tobacco use. Of equal interest, from the point of vie\v of the potential impact of ad\.ocacy, are decentralized grassroots organizations. The nonsmokers' rights movement originated in the early 1970s (see "From Antismoking to Nonsmok- ers' Rights" in Chapter 2). It consisted of individuals acting on their own and of small grassroots organiza- tions of people irritated bv ETS or con\,inced that theil health suffered from it. &ring this period, the docu- mented adverse health effects of ETS were first being brought to the public's attention (Steinfeld 1972; U.S. Department of Health, Education, and Welfare 1972). As research documenting these health hazards accu- mulated, nonsmokers' rights organizations gre\v in number and strength. Many of the early grassroots organizations used the acronym GASP to represent similar titles, includ- ing the Group Against Smokers' Pollution, the Group Against Smoking Pollution, the Group to Alleviate Smoking in Public Places, and Georgians Against Smoking Pollution. Other acronyms w-ere also used, including FANS (Fresh Air for Nonsmokers), TAPS (Texans Against Public Smoking), and ANSR- pronounced "answer"- (Association for Nonsmokers Rights). Organizations were small, poorly funded, and often run from home by volunteers. Initially, many nonsmokers' rights organizations simply provided a forum for nonsmokers to express their concerns about smoking and ETS. These groups helped legitimize their members' complaints and em- power them to take protective actions. Such actions required courage, assertiveness, and no small measure of tact, since smoking in public areas was normative at the time. Group members might thus learn how to politely ask people to refrain from smoking; or to ob- viate direct confrontation with smokers, groups might provide members with signs, cards, or buttons asking people not to smoke in their presence. Early in the movement, nonsmokers' rights associations adopted public policy change as an important goal. Groups began to work for passage of measures to restrict public smoking. Such regulations are often referred to as clean indoor air laws (see "Clean Indoor Air Regulation" in Chapter 5). To encourage these measures, an early GASP organization produced a "Bill of Rights" that stated, in part, that Non-Smokers have the right to breathe clean air, free from harmful and irritating tobacco smoke. This right supersedes the right to smoke when the tlvo conflict. Non-Smokers have the right to express-firmly but politely-their discomfort and adverse reactions to tobacco smoke. . Non- Smokers have the right to take action through legislativ-e channels, social pressures or any other legitimate means-as individuals or in groups- to pre\:ent or discourage smokers from polluting the atmosphere and to seek the restriction of smoking in public places (Group Against Smokers' Pollution, n.d.1. O\rer time, manv organizations moved to encom- pass broade r policy goals for reducing tobacco use- in particular, thev sought M-ays to decrease tobacco use by minors. Lariely as a consequence of those efforts, direct advocacy and public policy change became im- portant parts of these organizational strategies. In some communities, nonsmokers' rights orga- nizations Marked in isolation. In others, they formed associations lvith medical societies, voluntary health associations, and other organizations; the result was a more intense effort to ensure passage of desired legis- lation. Despite initial obstacles, in many communities nonsmokers' rights associations were a driving force in moving their allies toward a legislative approach to reducing tobacco use. For example, one of the earliest and most influential nonsmokers' rights organizations was California GASP, founded in 1976, which eventu- ally became Americans for Nonsmokers' Rights (ANR). ANR is now the principal national-level tobacco control group devoted primarily to promot- ing legislation for clean indoor air. In California, ANR helped support the passage of such ordinances in many localities. Partly as a result of ANR's work, California has more local ordinances for clean indoor air than any other state. ANR has served as a national consultant to other groups pursuing such legislation. Impact of Direct Adz~ocncy In retrospect, the grassroots organirations can bc> seen as ha\.ing -\lorked to diminish the Iegitimacv of tobacco use in the txye3 of the public anJ the crt~dibil- it\, of the tobacco indu~tr\. Tht> passage ofordinanct~s c3gainst public smoking (see "Clean Indoor Air Regu- lation" in Chapter 5) occurred over se\~eral years, dur- ing cvhich a shift in public opinion about smoking became evident. During the 1960s and 197Os, the right to smoke was largely unquestioned. In more recent vears, declining smoking prevalence and public opin- ion polls have indicated an increasing intolerance for public smoking (USDHHS lY8Yb). The work of non- smokers' rights organizations is coeval with these legal, epidemiologic, and social changes. Sorting out cause and effect is difficult, but the nonsmokers' rights movement seems to have contributed to the changing social norm (Glantz 1987). There were, however, some important exceptions to the emerging nonsmoking norms. By the mid-lY80s, it was apparent that both the traditional educational efforts and the passage of ordinances to protect non- smokers from ETS had a limited effect on young people's smoking-related attitudes and behaviors (USDHHS 1994). Efforts to reduce smoking appeared unable to reduce the prevalence of smoking among teenagers (Lynch and Bonnie 1994), and smoking prevalence among white females began increasing sharply during the 197Os, as did the prevalence of smokeless tobacco use among males. The failure to decrease smoking among young people is as difficult to assess as is the success observed among adults (particularly among adult men). Ana- lyzing the effect of prevention activities on young people must include weighing the hampering effects of advertising and promotional efforts backed bv the tobacco industry's enormous marketing budget (see "Advertising and Promotion " in Chapter 5; DiFranza et al. 1991; Pierce et al. 1991; Lynch and Bonnie 199-I; USDHHS 1994). Whate\.er the interplay of the forces involxred, the result is that protobacco actixitv directed at those entering the market has been generaIl\, suc- cessful. An exception is the continued decline in pre\`a- lence among young African Americans, particularly among young women (USDHHS lY98). Perhaps some of the shortfall in grassroots efforts to reduce tobacco use is associated Lvith the earlv iso- lation of these groups from the established naiional advocacy organization. Anecdotally, there is evidence of a culture clash. When the nonsmokers' rights move- ment emerged in the 197Os, many medical and volun- tary health organizations decried \vhat they perceived as the unprofessional, indecorous, confrontational ap- proach that these activists took to an issue that had previously fallen in the domain of the traditional pub- lic health structure. Some traditional organizations in the public health arena may also have felt that grassroots organizations were infringing on their "turf" and their fund-raising base. For their part, nonsmokers' rights associations objected to lvhat they saw as the overly cautious, mea- sured approach of researchers, medical associations, and volunteer health associations, whose efforts seemed to have done little to solve the problems ot day-to-day exposure to ETS. The grassroots organi- zations urged voluntary health organizations to exam- ine their mission statements and dedicate appropriate resources to cost-effective solutions to reducing to- bacco use. In time, both approaches acknowledged that the lack of coordination and cohesion was a significant barrier to their efforts. The groups noted that, in con- trast, the tobacco industry operated as a monolith through the coordinated efforts of the Tobacco Insti- tute, a lobbying and public relations organization representing the industry. This insight led to the emer- gence of several groups-somewhat disparate in their approaches-that attempted to bridge some of the dis- tance between the grassroots and national approaches to reducing tobacco use. Among the oldest of these groups is DOC (Doc- tors Ought to Care), which was founded in 1977 as a national coalition of health professionals, students, and concerned individuals. DOC groups take an activist approach to public health problems and sponsor com- munity projects and events on reducing tobacco use and other issues. From the outset, members chose COP trontational programs, such as counteradvertising and picketing industry-sponsored sports events, to delegitimize the tobacco industry and focus attention on its acti\-ities bv involving both physicians and voung people in advocacy activities. DOC groups use &tire, ridicule, and parody in their work to appeal to children and teenagers (Blum 1982); for example, they have sponsored "Emphysema Slims" tennis matches featuring appearances by "Martina Nosmokanova." DOC also maintains a large archive of activities related to the tobacco industry, including past advertising campaigns and marketing strategies (Mintz 1995). The acti\+ties of DOC are similar in style, if not content, to those of the Australian organization Billboard Utilising Graffitists Against Unhealthy Promotions (BUGA-UP), which was founded in 1979. BUGA-UP members, some of whom are physicians, have used unconven- tional tactics, such as spray-painting billboards that advertise tobacco products (Jacobson 1983). Another group is Stop Teenage Addiction to To- bacco (STAT), which \vas founded in 1985 with the aim of reducing tobacco use among minors. From its inception, STAT aimed to unite the medical and scientific arm and the grassroots arm of the movement to reduce tobacco use. Although STAT frequently ap- proaches tobacco issues from the activist perspective, the organization has long included key members of the medical and public health establishment in its leadership. DOC, STAT, and other groups have attempted to make the activist, confrontational ap- proach to reducing tobacco use acceptable to the more conservative medical and voluntary health organiza- tions. Partly because of these efforts, an activist approach is now an important component of the move- ment (see the text box "Bill of Rights Tour"). Another impetus for a more unified movement \vas the establishment of the Smoking Control Adlro- cacy Resource Center (SCARC) at the Advocacy Insti- tute in 1987. The Adlrocacy Institute's mission-to study, analvze, and teach public interest advocacy- included a'focus on smoking reduction as a model public interest movement. The institute received fund- ing from the Henry J. Kaiser Family Foundation to establish SCARC. Rather than be a frontline organ- Tation, SCARC proposed to help build the mo\,ement's infrastructure. As such, SCARC \vould be v-ielved as a neutral player and \t,ould not vie I\Tith the movement's other organizations in seeking media, voluntary, or funding sources. Since its formation, SCARC has served three important roles as convener, tobacco industry monitor, and center for strategic development, training, and counseling (Butler 1990). Media Advocacy Media advocacy for reducing tobacco use was developed during the lY8Os by a small number of ac- tivists working primarily in the United States, Canada, Australia, and the United Kingdom. The attendees at the September 1985 International Summit of Smoking Control Leaders resolved to produce a handbook that would provide guidance on using the media to sup- port tobacco control. 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Joint analy- sis of three U.S. cornmunitv intervention trials for reduction of cardiovascula; disease risk. \oLrr,lrll of Clir~icnl Ei'irfl,~ilio/i,~!/ 1997;10(6):645-58. Winkleby MA, Taylor CB, Jatulis D, Fortmann SI'. The long-term effects of a cardiovascular disease prevcn- tion trial: the Stanford Five-City Project. A,tvr-ic-nrl /rlrr~ ~ml of Pi~hlic Hcolth 1996;86(12):1773-9. Women and Girls Against Tobacco. Misaim St~to77o7t. Berkeley (CA): Women and Girls Against Tobacco, n.d. Worden JK, Flynn BS, Seeker-Walker RH. Antismok- ing advertising campaigns for youth [letter]. ]UUIYUII of the Amricarl Medical Asmciotim7 1998;280(4):323. World Health Organization. Cor7trollirz~q the Snmki~~~ Eyiderific: Report c~fflw WHO Expert Commitfcc UII Snrok- it7g Co~tml. WHO Technical Report Series No. 636. Geneva: World Health Organization, 1979. World Health Organization. Prtwwtiot~ (If Corollny Hurt Discasc: Rqmrt ofn WHO Expert Cmrmittre. WHO Technical Report Series No. 678. Geneva: World Health Organization, 1982. World Health Organization. OttaM-a Charter for Health Promotion. Cnrlnlfinrl ]oIrrrlnl of P~hlir Hen/t/~ 1986; 77(Nov/Dec):426-30. World Health Organization. Guidelilws fur Cmtrnllii~g n,rd Mmjtwillg the fi~lmci-o EpiJm~ic. Geneva: World Health Organization, 1998. Chapter 8 A Vision for the Future-Reducing Tobacco Use in the New Millennium Introduction 435 Continuing to Build the Scientific Base 433 The Changing Tobacco Industry 434 The Need for a Comprehensive Approach 435 Identifying and Eliminating Disparities 436 Improving the Dissemination of State-of-the-Art Interventions 436 Tobacco Use in Developing Nations 437 Tobacco Control in the New Millennium 438 References 439 Introduction Tobacco use, particularly cigarette smoking, re- mains the leading cause of preventable illness and death in the United States (McGinnis and Foege 1993). A ma- jor challenge to our nation's public health leaders in the new millennium is to make this disturbing obser- vation a thing of the past. Such a goal is no millennial dream. This Surgeon General's report provides evi- dence that tobacco use in this nation can be reduced through existing modalities of interventions. The substantial body of literature reviewed in this report indicates that each of the modalities-educational, clinical, regulatory, economic, and social-provides evidence of effectiveness. The six major conclusions of this report provide the framework for the development of a coherent, long-term tobacco policy for this nation. Thus, although our knowledge about tobacco control re- mains imperfect, we know more than enough to act now. Widespread dissemination of the approaches and meth- ods shown to be effective in each modality and especially in combination would substantiallv o Reduce the number of young people who will become addicted to tobacco. . Increase the success rate of young people and adults trying to quit using tobacco. o Decrease the level of exposure of nonsmokers to environmental tobacco smoke (ETS). Continuing to Build the Scientific Base o Reduce the disparities related to tobacco use and its health effects among different population groups. o Decrease the future health burden of tobacco- related disease and death in this country. These achievable improvements parallel the health objectives set forth in Healthy People 2010, the national action plan for improving the health of all people living in the United States for the first decade of the 21st century (U.S. Department of Health and Human Services [USDHHS] 2000). Twenty-one specific national health objectives related to tobacco use are listed in Healthy PEOFJ~P 2010, including reducing the rates among young people and adults to less than half of the current rate of use. Attaining all of these tobacco-related objectives will almost certainly require significant national commitment to the vari- ous successful approaches described in this report. The report's major conclusions are not formal policy recommendations. Rather, they offer a sum- mary of the scientific literature about what works. In short, this report is intended to offer policymakers, public health professionals, professional and advocacy organizations, researchers, and, most important, the American people guidance on how to ensure that ef- forts to prevent and control tobacco use are commen- surate with the harm it causes. Beginning with the 1964 Surgeon General's re- port, Snlokirzg a/zd Health (U.S. Department of Health, Education, and Welfare 19641, tobacco control policy in this nation has been built on a foundation of scien- tific knowledge. Each of the subsequent 24 reports of the Surgeon General on tobacco use has documented a vast and growing body of scientific literature. The substantial research reviewed in this report focuses on a key segment of the literature-what has been tried in the decades-old effort to reduce tobacco use. In turn, this focus clarifies which efforts work best. Certainly more research is needed so that these efforts can be more efficient and effective; the key conclusion from this report, however, is that we know more than enough to take actions now to decrease the future health burden of tobacco-related disease and death in this country. In the process of applying our current state of knowledge about preventing and controlling tobacco use, accountability and evaluation of the public health effort will be critical. However, because of the wide array of educational, clinical, regulatory, economic, and social influences that have been and will need to be brought to bear on the tobacco use problem, the direct impact of a specific maneuver on a specific outcome becomes less meaningful as the combined effects be- come more substantial. Investigators tend to work on small, manageable aspects of the tobacco use problem, but the synergistic influence of multiple factors over time will likely extend far beyond the outcomes pre- dicted from these smaller research undertakings. For example, as this report demonstrates, the most effica- cious educational programs are those that take place in a larger community context, one that engenders and supports an environment of nonsmoking. Similarly, although clinical interventions to manage tobacco ad- diction clearly have some specific power to help smok- ers quit, primarily through pharmacological means, the social environment remains a major determinant of whether these new former smokers maintain their ab- stinence from nicotine addiction. Regulatory efforts, on the other hand, raise a host of social and economic issues and can produce broad societal changes-issues and changes, however, that are difficult to isolate, docu- ment, and evaluate. Economic strategies also have a great potential, but being fundamentally political in The Changing Tobacco Industry nature, they require public consensus and changes in social norms before they can be attempted. Finally, the public health advocacy involved in social program modalities is virtually impossible to assess in a pro- spective or controlled research design. The research and evaluation tools of public health must expand to meet these complex issues. Compre- hensive, multifactorial approaches to tobacco control appear to offer the most promise. However, the pen- alty for comprehensive approaches is a loss of statisti- cal power to attribute outcomes to specific activities. Within each of the modalities, appropriate evaluation methodologies are being used (see Table 1 .I). However, many of these methodologies involve retrospective case study, time trend, econometric, and surveillance ap- proaches to evaluate the "natural experiment" as it evolves in the changing social environment. Thus, the traditional biomedical and epidemiologic research methods that have worked so well in defining the health consequences of tobacco use are not well suited to evalu- ating the potentially most efficacious methods to reduce tobacco use. This report documents that this country's efforts to prevent the onset or continuance of tobacco use have faced the pervasive, countervailing influences of tobacco promotion by the tobacco industry. De- spite the overwhelming and continually growing body of evidence of adverse health consequences of tobacco use, the norm of social acceptance of tobacco use in this nation has receded more slowly than might be ex- pected, in part because of such continued promotion. Litigation and legal settlements have produced notable changes in the tobacco industry's public posi- tions on health risks, nicotine addiction, and advertis- ing and promotion limits. Additionally, individual manufacturing companies have become more directly involved in efforts to limit the access of underage per- sons to tobacco products and to prevent young people from initiating tobacco use. In this rapidly changing social and legal environment, it is difficult to project the nature and scope of future changes by the industry or their impact on the national effort to reduce tobacco use. Nevertheless, any analysis of changes in patterns of tobacco use must consider the influence of these indus- try changes. One of the major arenas of potential change will be in the tobacco product itself. The manufactured cigarette that is widely marketed in the developed world was noted to be changing dramatically when this issue was first considered by the Surgeon General in 1981, in Tlrr Clzm@rr~ Cigarelk (USDHHS 1981). Recent public statements by the tobacco industry sug- gest that the pace of changes in the manufactured ciga- rette could be accelerating in the future. The public health implications of changes in manufactured ciga- rettes and other tobacco-containing products will re- quire careful and significant attention from both public health researchers and policymakers. The litigation environment has demonstrated the importance of tobacco industry documents in analyzing the industry's influence. Legal and public health analyses are just beginning to sift through the millions of pages of documents made public as part of the various legal actions undertaken over the last decade. As this process continues, public health contributed to the character, pace, or direction of researchers mav develop better methods to define and changes in tobacco use patterns in this country or evaluate the industry's past activities that may have around the world. The Need for a Comprehensive Approach The evidence of effectiveness summarized in this report emphasizes that public health success in reduc- ing tobacco use requires activity using multiple mo- dalities. A comprehensive approach-one that optimizes synergy from applying a mix of educational, clinical, regulatory, economic, and social strategies- has emerged as the guiding principle for future efforts to reduce tobacco use. The public health goals of such comprehensive programs are to reduce disease, dis- ability, and death related to tobacco use through pre- vention and cessation, as well as through protection of the nonsmoker from ETS. The emerging body of data on statewide tobacco control efforts is coming from programs broadly fo- cused on prevention, cessation, and protection of the nonsmoker from ETS (Chapter 7). Preventing initia- tion among young people is a primary goal of any to- bacco control effort. However, young people will perceive contradictory or inconsistent messages in our prevention efforts if programs do not also address the smoking behavior of millions of parents and other adult role models and the public health risks of ETS. The Centers for Disease Control and Prevention (CDC) recently released Best Pvnctices for Compr- cIIc~~jIz]c Tdmcco Cu17f1.01 PI.O~~MRS (CDC 1999), which recommends that states establish tobacco control programs that are comprehensive, sustainable, and accountable. This document draws upon "best prac- tices" determined by evidence-based conclusions from research and evaluation of such comprehensive pro- grams at the state level. In the review of evidence from these states, it was evident that reducing the broad cultural acceptability of tobacco use necessitates changing many facets of the social environment. Nine specific elements of a comprehensive program are de- fined in the guidance document. Although the im- portance of each of the elements is highlighted, the document stresses that these individual components must work together to produce the synergistic effects of a comprehensive program. A medical analogy might be helpful to under- stand the practical implications of the current state of knowledge about these best practices of tobacco con- trol. If we found a combination of nine therapy ele- ments that effectively treated an almost incurable disease (e.g., advanced lung cancer), we would study the combined therapy in many ways to learn more about how it worked and which aspects of this combi- nation therapy were most effective. However, while we were doing this research, we would give every patient with the disease the full combination of the nine therapy elements. In the same way, with the nine components of Best PJXC~~CCS, we need to continue evaluating ongo- ing comprehensive programs to gain more knowledge about how the components work individually and in combination. But while this research continues, states should be applying all nine components. Best Practices thus provides effective guidance for state-level efforts; a comprehensive national tobacco control effort, however, requires strategies that go be- yond this guidance to states. As documented in ear- lier chapters of this report, a comprehensive national effort should involve the application of a mix of edu- cational, clinical, regulatory, economic, and social strat- egies. In each of these modalities, some of the program and policy changes that are needed can be addressed most effectively at the national level. Identifying and Eliminating Disparities The elimination of health disparities related to tobacco use poses a great national challenge. Although this issue was not a main aspect of the current report, two other recent USDHHS publications have taken this focus. The 1998 Surgeon General's report Tobacco Use Anloug U.S. Racial/Ethnic Minority Groups was the first to address the diverse tobacco control needs of the four major U.S. racial/ethnic minority groups- African Americans, American Indians and Alaska Natives, Asian Americans and Pacific Islanders, and Hispanics (USDHHS 1998). Similarly, Healthy People 2010, released in January 2000, has two overarching goals: increase quality and years of healthy life and eliminate health disparities among different segments of the U.S. population (USDHHS 2000). Both publica- tions not only highlight the significant disparities in health that exist in the United States but also stress the critical need for a greater focus on this issue, both in research and in public health action. Cultural, ethnic, religious, and social differences are clearly important in understanding patterns of to- bacco use, but little research has been completed on the relative effectiveness of interventions for prevention and treatment in some of the population groups or com- munities. Reaching the national goal of eliminating health disparities related to tobacco use will necessi- tate improved collection and use of standardized data to correctly identify disparities in both health outcomes and efficacy of prevention programs among various population groups. Broader historical, societal, and community characteristics can have a significant in- fluence on the manner in which prevention and con- trol strategies that work overall for the population as a whole may impact diverse groups. Many of these broader variables do not lend themselves to traditional measurement methods, nor are they easily assessed at the individual level through the use of traditional epi- demiologic methods. Improving the Dissemination of State-of-the-Art Interventions One of the greatest challenges in tobacco control and public health in general continues to be overcom- ing the difficulty in getting advances in prevention and treatment strategies effectively disseminated, adopted, and implemented in their appropriate delivery systems. Simply stated, our recent lack of progress in tobacco control is attributable more to the failure to implement proven strategies than it is to a lack of knowledge about what to do. The result is that each year in this nation, more than 1 million young people continue to smoke, and more than 400,000 adults continue to die prema- turely from tobacco-related diseases. Within each of the modalities reviewed in this report, some specific research advances in tobacco pre- vention and control strategies have not been fully implemented. Studies are urgently needed to identify the social, institutional, and political barriers to the more rapid dissemination of these research advances. Understanding these barriers and determining how they could be overcome would benefit not only tobacco control but also public health efforts more broadly. Rrducirlg Tobncco Use Tobacco Use in Developing Nations Analyses by the World Health Organization (WHO) have concluded that by 2030, current smok- ing patterns will produce about 500 million premature deaths from tobacco-related disease among people alive today (World Health Organization 1999). WHO further estimates that by 2030, tobacco is expected to be the single greatest cause of death worldwide, ac- counting for an estimated 10 million deaths per year. Although the impact of tobacco-related disease and death has been until recently a problem primarily for the delreloped countries of this lvorld, WHO no\v es- timates that by 2020, 7 of e\`erv 10 tobacco-related deaths will be in the developing'world. This report addresses research on strategies to re- duce tobacco use within our nation's social, legal, and cultural environment. Nev-ertheless, findings from this report may have broad utility in the planning of tobacco control efforts around the world. As Chapter 2 documents, the public health response in this country to the scientific findings about the health consequences of tobacco products has taken more than four decades to emerge. In many parts of the developing rvorld, the problems of tobacco use are similar to those in this country in the 1950s and 1960s. Hence, a key public health question for this millennium may be the fol- lowing: can the time interval be significantly short- ened between when the health risks of tobacco for a developing country are recognized and when a com- prehensive national response is begun? WHO, the World Bank, and the United Nations Foundation, with technical assistance from the CDC, have undertaken major new initiatives to address this problem. The WHO Tobacco Free Initiative is develop- ing an international tobacco control infrastructure, which includes a global tobacco surveillance system, intervention tool kits, and regional technical assistance workshops. The World Bank has published C~rrbill~~ the Epidemic: Gozw~zm~~fs ~2nd the Ecommirs of tobacco Control (Jha and Chaloupka 1999). This document provides an economic analysis that supports a multipronged approach to tobacco control, involving raising excise taxes, promoting policy changes related to the sales and promotion of tobacco products as well as to restrictions on smoking in public places, and M.id- ening access to smoking cessation therapies. The sci- entific findings in this report are consistent with the programmatic recommendations of both the \YHO Tobacco Free Initiative and the World Bank document. A momentous undertaking of WHO and mem- ber states, including the United States, is the develop- ment and negotiation of the Framework Convention on Tobacco Control. If brought to its intended ratifi- cation in the next few years, this agreement would provide a framework within which countries could develop more specific bilateral and multilateral pro- tocols for cooperation on containing the spread of the tobacco epidemic. The framework would enable coun- tries to start from a common understanding of the is- sues, priorities, and strategies necessary to harmonize tobacco control efforts between themselves so that some countries do not benefit at the expense of others. This is the spirit of the other activities of U.S. govern- mental and nongovernmental agencies in their effort to collaborate with WHO and with other countries in their development of surveillance, cessation, preven- tion, mass media, regulatory, economic, and social approaches to global tobacco control. In the near future, emphasis must be placed on the de\relopment of surveillance systems so that coun- tries can know the extent, distribution, and trends of the tobacco consumption problems in their popula- tions. These systems will also track-for international comparison and monitoring of progress-the emer- gence of new forms of tobacco promotion, as well as new legislation, regulations, and programs for coun- tering tobacco use. In the longer term, the gaps must be filled in each country's defenses against the incur- sions of tobacco use on their young people and other vulnerable populations. In particular, there will be a continuing need to ensure that the rapidly expanding knowledge about the efficacy of various tobacco con- trol modalities be made available to the developing world. The challenge to the world is to prevent tobacco use, particularly smoking, from ever becoming the lead- ing cause of preventable illness and death in the world. Dr. Gro Harlem Brundtland, the current director- general of WHO, clearly defined this challenge when she stated, "If we do not act decisively, a hundred years from no\v our grandchildren and their children will look back and seriously question how people claim- ing to be committed to public health and social justice allowed the tobacco epidemic to unfold unchecked" (Asma et al., in press). 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SW American Medical Association Ambient smoke -fin ,-lrlrcriinil Aiii'c'l~ti5i~l~~ Fc?fc7/27ti0/l T' K~~55l~~~~ IS9 American Anti-Tobacco Societv 37 American Broadcasting Cornpan\* 2i-l American Cancer Society 39, 7s;. .?8.3 American Economics Group, Inc. 320-372 American Health and Temperance Association 37 American Health Foundation 782 American Heart .r\ssociation 39, -ib American Indians and Alaska Nati\.es smoking prevalence 97-98 American Lung Association Ii.3 American Medical Association 12 American School Health Association 80 American Stop Smoking Inter~xzntion Studv 82, S-i, 209, 383-384, 385 American Tobacco Company. SW ~7lsc Court cases formation ot 30, 306- Plug War 32 Americans for Nonsmokers' Rights JO.5 Americans with Disabilities Act 73:, 216-221; I-amino-biphenyl 782 Ammonia con~pounds 782 Ammonium carbonate 183 ANR. SW Americans for Nonsmokers' Rights Anti-Cigarette League ot America 32 ,~lllfi~fi+~7i.io ]014f-,11i/ 31 Antideprc+sants Index A ABC. Sc,c, American Broadcasting C-ompan\, ABCs. SW Alcohol be\,crage control agtvcies /iCf/ilidS, /,I(- i' ,4hfe 243 Accord brand 309 ACS. SW American Cancer Societ\, Acupuncture therapy 112 Ad valorem taxes 337 ADA. SW Americans with Disabilities Act .4DAMHA. SW Alcohol, Drug Abuse, and Mental health Administration Reorganiration Act Addiction. Scc~ Management of nicotine addiction; Nicotine addiction Additives to cigarettes 783-783 regulations concerning 773 to smokeless tobacco 7h'i%l# Adolescent Learning Experiences in Resistance Training 77 Adolescents. SW Youth Ad\.ertising. SW O/G Federal Cigarette Labeling ,IIKI Advertising Act; Packaging attempts to regulate 7 6.3-l 70 brand loyalty and 702 broadcast ad\,ertising ban 705-706 commercial speech and 7 ;0-1;_7 constitutionality of regulation 7;7-7;; FCC antismoking broadcast requirement 45 four-pronged test 7 ;.3-[;; FTC staff report concerning 266-767 health claims 39 "Joe Camel" ad campaign 7.5. 7 ;;-1;8 overview of regulatory efforts 74-1.5 potential influence on smoking prevalence 767-702 proposed FTC regulation of 1964 17 public interest benefit from regulation 7 71-l 16 radio and television advertising ban reasonable fit of regulation 7;6-1;; 45 restrictions on 23 smokeless tobacco campaign 67-62 spending by tobacco companies 161 substantial government interest 77-i targeted to women 37 unlawful or misleading 7 7.3-7 74 voluntary code published by the tobacco industry 164 Advocacy campaigns direct advocacy 4(1.&W media ad\.ocacv iOiG109 Advocacy Institute 2%-1-I. 102, 401 AEG. S& American Economics Group, Inc. Affxtive education models 6.3 African Americans cttecti\ ent'ss in sniohlng cei~ation 14. IL-124 Antitobaccoism earlv campaign against cigarettes 3044 Antitrust iacvs 3-233 Anxiety treatment during smoking cessation I24 Anxiolvtics effectiveness in smoking cessation 74,724 Ari7ona Proposition 200, 397 statewide ban on smoking in public places 47 Arizona Tobacco Education and Prevention Program 392-392 Asian Americans and Pacific Islanders smoking prevalence 97-98 ASSIST. Sw American Stop Smoking Intervention Study Australia Consumer's Federation of Australia 277 North Coast Healthy Lifestyle Programme 37%379 warning label requirements 709 Western Australia Tobacco Control Act of 1990 768 Aversive-smoking strategies 707-108 A7TEPP. Sw Arizona Tobacco Education and Prevention Program B Bons,lck, ldmtxs Albert cigarette rolling machine patent 30, 306 Brand loyaltv advertising and 7 62 Brand slvitching 709-770 Brandt, Allan b'i. 34 Broadcast xl\ ertising ban 76.7-766 Broils ~1. Phil/p Morris Cm. 767, 236. 237, 244 Bro\vn & Williamson-British-American Tobacco Company 223 H7fil7nf7 i'. C~rflfo P/fi7ruu7ccfrtim/ /Cormdo/ Ltlf. 786 RIK~;~&~I il. R.]. Rqrmlds Tobnrco Cu. 243 BUGA-UP. Sn, Billboard Utilising Graffitists Against Unhealthy Promotions Bupropion effect on discomfort of nicotine Lvithdrawal 727-722 effects of postcessation change in body weight 722 efficacy for smoking cessation 74.721 relevant process measures 722 side effects 122 Burlev tobacco domestic consumption 296-297 support program 302, 303 Burney, Dr. Leroy E. 39 Buspirone hydrochloride smoking cessation treatment 714 lii/t/~~r i'. :\rirtYiil7ir Th7c-c-c~ co. 24%`4`4 C Califano, Joseph A. 46 Cdlifornid dult smoking pre\,alence 359 per capita cigarette consumption .38S-389 pre\,cwtion and control programs x;-389 Proposition 65 14.5 Proposition YY 3.39, .?a;-388 !wuth tobacco use prevalence 389 California Tobacco Control Program 358 California L'nfair Competition Law 7;; Cl7/ifOl./l/~7 i' P/ii/i/l Mol'ri5 ltli 745 Californians tar honsmokers' Rights 4, Californians tor Scientific Integrity 2.54 Camel cigarettes "Joe Camel" ad campaign 7.3, 7/Y-778 Canada health messages on cigarette packages 786 Tobacco Products Control Act 769, 770, 782 tvarning label requirements 169-770 C~711[7dil711 Clmrt~~r of Rigi7t.i 1717d Fwcdo~~rs 7 70 Cancer. Sw Lung cancer Cancer Pre\,ention Studies 784 Pawtucket Heart Health Program 727, .3;9-.3RO Stanford Five-City Project 7;. 72;. 3;9%380 Carnes Bettv C3rter `G&v ?, 7'- ` Carter: Jimm~v 49 Cnstnr70 i'. h;~ii7ri 7ih?i1-0 CO. 236, 2.3; CAUC. Sw Coalition Against Uptol1.n Cigarettes CBO. SW Congressional Budget Office CDC. Scp~* Centers for Disease Control and Pi-e\-ention Celebrw.ze, Anthony J. 76&7i+d Cellulose acetate fibers 7 52 Center for Corporate Public In\ ol\,ement 47 Center for Substance Abuse and Prwention ,374 Centers for Disease Control and Prevention tr7i~iroJrrrff~/ltl7l Toh7rilJ SWOkf Ill t/i? workplnr~~ 48 Gliillr~/ifw.i for Si/?d H~~iiltl? /'rl',(v'7H?' ii, I'fw~~trt TdJi7~C~~ LIW ililil Adi~ic-tic~Jl 77. 80-82 Initiatives to Mobilize for the Pre\.ention and Control of Tobacco Use program 82 National Tobacco Control Program 385 report development 5 Research to Classroom project 8.5 Third National Health and Nutrition Examination Survey 7 96 CCllff'i?/ HlidSOfl Gl75 C; Elt'Ctrif i'. Pfil!lic- _SL'Fi,ic-c' CLlli7~lli55iOil of New York 7 70 Crr7trnl H1idsoi7 test 7 i_`, 7;.?-7;; Centre for Behavioural Research in Cancer 769 Cessation of smoking. SW also Management of nicotine addiction incidence of 97,99 CHAD. SW Community Syndrome of Hypertension, Atherosclerosis and Diabetes program 717~ Ci7nr7g117~ Ci;wrcttc 434 Chewing gum, nicotine 773-776 Chewing tobacco. SW Smokeless tobacco Chicago Anti-Cigarette League 32 C/7i<~/O D. Lx/ (If Prc5tcu7 7 7.3 Child custody cases ETS rulings 248-249 Children. SW Youth Cl7r7stinr7 fftwld 38 Cigarette advertising. SW Ad\sertising Cigarette brands Accord 309 Chesterfield ad campaigns 37 Dakota 102-40.3 Eclipse 309 "Joe Camel" ad campaign 7 5. 7;;Pl;Y Lucky Strike ad campaigns 3; Next 787 slvitching brands for nicotine fading 709-770 L!ptown 399 x 400 Cigarette fading 709 Cigarette Safety Act 749 Cigarettes. SCCT also Tax issues; Tobacco; Tobacco use additi\,es 782-783 adult per capita consumption linked to major smoking and health events in the U.S. 33 antitobaccoists' \,iews 30-3 7 appeal to women 36-3; attraction of 3-1-36 constituents of smoke 1 i9-782 del,elopment of filter-tip cigarettes 38 distincti\.e features of 35-36 domestic consumption 297,299 domestic market shares of companies 3Oi early medical studies 38 effect of price increases 19 effect of price on demand .322-335 e\ olution of the industrv m-377 tactors involved in incrfased consumption 37 introduction of 30 lolv-price stores 377 pre\,alence of use 97-98 prohibition mo\~ement 32 reduced-tar cigarettes 768 rolling machine in\-ention 30 sales of single cigarettes 274 samples distribution to minors 217 smokeless 309 smuggling acti\-ities 347 use among youth 67-67, 97-98 Cigars appeal of cigarettes over cigars 35-36 Cipollone, Rose 2 7, 226 c;/Jd/~W i'. L;gzCc'tt &Jli/J, Illi. 3-1, 7 72, 7 73, 226-228 Civil Aeronautics Board 46 Class actions 236-738 Class of 1989 Study 76-i.5, 78 Clean indoor air. SW n/so Env-ironmental tobacco smoke attitudes toward restriction, and bans 203 case studies of state and local smoking restrictions 206-20; consequences of exposure to ETS 793, 7 95-7 96 effectiveness of restrictions 202-206 legal foundation for regulation of public smoking 7 9; nonsmokers' exposure to ETS 202-203 overview of regulation 16 prevalence of exposure to ETS 796-79; status of restrictions to limit smoking in public places 7 9/-X-7 Clinical inter\.entions intcnsi\e 7 3. iO.i-17.5 Illillilll`~l I ;. /0_7-1f)T 44; o\,er\.ie\\ ot I? Cliniidl Practice Guidt~line If)?, I.33 Clunidine etfect on discomfort of nicotine \vithdra\\-al 123 efficacv fot- xnoking cessation 74, 7x-773 relevant process niedsures IZ.3 side effcck 77.3 Coalition Against Uptown Cigarettes 399 Coalition for a Smoke-Free Socictv 2000 385-386 Coalition for Tobacco-Free Ari7o1;a ,397 Coalition on Smoking OR Health 2 T, 46, 78;. 401-402 College graduates smoking prevalence 97-95 Collins, Lerov 40 Commercial programs educational programs 82, 8.3 Commercial speech constitutionalitv of regulation 777-17.2 definecl 770 vice evcepfion 7 76 COMMIT. SW Community Intervention Trial for Smoking Cessation Committee of Fifty to Study the Tobacco Problem 3 7 Commodity Credit Corporation .GI)-.?UZ Common-law claims 2.X-737 Community-based inter\.entions overGie\y of 20 Community Intervention Trial for Smoking Cessation 20, 12;-1-7s,.w-.i82 Community programs countermarketing 409-476 direct advocacy 405-40; electronic netkvorking 403%40.i inter\-ention trials 37638.2 for management of nicotine addiction 72;-7z media advocacv 40;-4ol-? multifaceted educational programs 7.3%so Community Syndrome of Hvpcrtensinn, Alher-osclerosis and Diabetes program 3;6-377 Compensatory smoking low-tar cigarettes anil 784 Comprehensive programs communitv interl.entioii trials .i,-b-.~S_7 communitv program components 403-4 IO description .3;4-.iYi, overvielv of 3-27 statetvide interventions .H-40.3 Comprehensive Smokeless Tobacco Hedth Education Act of 1986 75, ro:, 7/5 Comprehensive Smoking Education Act of 198-l 7.5, 76; Computer-generated personalized feedback efficacy in management of nicotine addiction 101, 704, 7 3.2 Congressional BuLlget Office ii I Coirtk~tii~lt 7 Philip Mcvri~ /iii. 13.3 CPJIJIO~ ;I. li./. R~~i/i~~d,l> `Tohiiic~ Cc,. Ii.; Consolidated Anti-Cigarette League ii Cnpitnl Broadcmti77g Co. v. Mitd7ell 165 Capifal Cities Cab/r, Ir7r. il. Crisp 173 Cnstnr7o v. A777ericn77 Tobacco Co. 236, 237 Cer7tml H17dsor7 Gns 6 Electric v. Public Sewice i'. Ul7itd Stntrs Elli~irtrrlrllc,rltrrl Profrrfior7 Aget7cy 195, 252 Tohrro Corp. 197 Food ar7d Drug Ad777inistrnfim7 ~1. Brow77 0 44 Liquorn7nrf 172, l/d. 77.5 44 Liqmwarf, 117~. il. Rncir7e 175 44 Liquor777art, 117~. il. Rl7odc Ish77d 176 Gainsborough Street Rmlty Trust ~1. Reece nr7d Kristy Hailc 247-248 drs Trbacs et All7lr7zettes 252 Guatcvrala ~1. Tobacco Institute 252 Hnir7cs ~7. Liggett Group, I77r. 226, 228-229 Hnrn7er 7'. Virginia Electric nrzd Power Co. 246 He/w7 i'. Hrl7n 249 Hollouny ~1. Brisk&Myers Corp. 177 Ho777eyer v. Sfm7lcy Tulchi77 Associates, Inr. 237 Horowitz v. Lorillard Tobacco Co. 235 1t7 re A7~bzrcl7on 249 117 re Ciprcttr Cases 235, 243 117 rt' Cm-Willim7s Tobacco Co. 253 177 re Kirk Fordicc 05 Goverr7or of Mississippi 253 In re Pl7ilip Morris lr7c. 254 It7 rc Pirdwrtotz Tobmx Co. 251 ln re R.]. Reymlds Tbbarco Co. I77 117 re U17ior7 Carbide Corp. Gas Plat7t Disaster. at Bhopl, lr7dia it7 Dercr77hcr, 7983 252 In re W/k 71. Wilk 249 Knrbizcl77yk ~1. R.]. Reyr7olds Tobncro Co. 23.5 Kenr77ey 7'. Pl7ilip Morris Cm. 250 Kyfe ~1. Pl7ilip Morris Cos. 250 LRfI7kP il. Fufnriilr7 C(JK/J. 249-250 Lnrtiquc 7'. X.1. Rcy77olds Toborro Co. 22.5 Lee il. Deprtri7er7t of Public- Wdfnw 2 97 Lnr7 prevention campaigns -- -- -_I / 6-, , , /h-T9 MLYlk Sfrl?tf'~iPY for Srlrc,h-iiy Co~ltrrll~ Gl/iilc/irri? Medicaid reimbursement cases 1.?8-247 Meehan, Martin T. 2s; Meta-analyses 700 M&w?mfin 1,7c. i'. citu of 5717 Dif::`O 7 7.7 MFN. Set Most favoied nation treatment MHHP. Set, Minnesota Heart Health Program Michigan Anti-Cigarette Society 37 Midwestern Prevention Project 7.5, 78 Miller, William 30 Millerites 30 Minimal clinical interventions efficacy 7 04-7 05 the "five A's" approach 703 overview of 73 40; recommended institutional changes 702-103 relevant process measures 705 role of the clinician 132 underuse of 7 02 Minimum prices 300 Minnesota Coalition for a Smoke-Free Society 2000 38.5-386 legislation regulating smoking in public places 47 programs funded by settlements with the tobacco industry 397-398 Minnesota Blue Cross and Blue Shield Web site 229 Minnesota District Court Web site 229 Minnesota Heart Health Program i&75, 7i-i8, 770. 72/, 379-380 712~' M~I~HPSO~~I Ph for h'01751m1ki~7~ m7d Hcnltl7 386 Minnesota Smoking Prevention Program 70, SL Mii7i7csota il. Philip M71rris Ir7s. 167. 783, 27-7. ?39-24U, 242 Minorities smoking prevalence 97-98 targeted by tobacco advertising 762 Minors. 5,~~ Sales to minors Mississippi programs funded by settlements with the tobacco industrv 394-395 Mississippi Julr&ile Tobacco Access Prevention Act 394-39.5 Monitoring the Future Study 67 MOllr-c i'. Al77iTicnl7 mm-co co. X8-239 Mormons campaign against tobacco 33 Moss, Frank E. 4.5 Moss, John E. 163-764 Most favored nation treatment 239-247 Motivational rwvards intervention 720 MPP. Sw MidLvestcrn Prevention Project Mlillf~i- C'. Costd/o 247 Multifaceted education programs ;.3-SO Multinational trade agreements 376-375 Multistate settlements 760 N NAFTA. 5'~' North American Free Trade Agreement Nasal spra!`, nicotine 778-720 National Anti-Cigarette League 32 Notiorml A5w~-rnt7orr of Corrwrricvm~ Stows P. Kcskr 189 National Cancer Institute 82. 768, 787,374 National Center for Chronic Disease Prevention and Health Promotion 5 National Health Interview Survey 97-99. 784 National Heart, Lung, and Blood Institute .?;9 National Institute for Occupational Safety and Health 48 National Institute on Drug Abuse 61 National Interagency Council on Smoking anal Health 46 National Research Council 48 National Smokers Alliance 254 National Spit Tobacco Education Program 402-403 National Tobacco Control Program 385 National Tobacco Policy and Youth Smoking Reduction Act 760 National Woman's Christian Temperance Union campaign against tobacco 37-34 NCI. Sw National Cancer Institute Negative affecti\,e reaction 701, 230 Kegligence claims 17 Neighbors for a Smoke Free North Side 399 Neuberger, Richard L. 39 New Jersey legislation regulating smoking in public places 47 Newspapers. Sw Media-based programs "Next" brand 787 XHLBI. Sw National Heart, Lung, and Blood Institute Nicotine addiction level 787 change in ratio of tar to nicotine 780-7s7 classification as a drug 78/-/8`s content in cigarettes 751 dependence 729 disclosure requirement 75 FagerstrGm questionnaires 1-79 gum 21.3-726 increasing levels of "free" nicotine 782,783 inhaler 710-727 maintenance programs 7 s.5 nasal spray 778-720 reduced-nicotine cigarettes 2 68 replacement products 785 requirements for disclosure of le\.els 7/s smokeless tobacco as delivery system 67-62 transdermal 726-778 Nicotine addiction. SW illso Management of nicotine addiction stages of process Nicotine fading 7 09-77 i' Nicotine polacrilex 773-276 Nicotine replacement therapies overview of 7 3-74 Niess, Major General Oliver K. 10 No Net Cost Tobacco Program Act 307 Non-Smoker's Bill of Rights 46 Non Smokers Health Protection Act 376 Non-Smokers' Protective League of America 32 Nonrecourse loans 300 Nonsmokers' rights ETS and child custody cases 248-219 ETS cases against nontobacco parties 245-246 ETS claims against manufacturers -743-215 failure to disclose harm from ETS suits against tobacco companies 215 grassroots organizations 105 handicap discrimination/Americans with Disabilities Act -746-24; institution of nonsmoking areas in public places 46-1; legislation against ETS i/ Non-Smoker's Bill of Rights 46 research on ETS 4/-18 ruling on ETS in prisons 248 seepage of smoke from one dlvelling unit to another 2-17-248 victims of smoking-related fires 249-7.76 North American Free Trade Agreement 376-37; North Carolina mass media campaign on smoking pre\ ention i&/9 North Coast Healthy Lifestyle Programme 378~379 North Karelia Study 72?,3,`6-3i8 Nortllcrltt i'. Nortlmtt 249 Nortriptyline effect on discomfort of nicotine withdrawal 7 24 efficacy for smoking cessation 71, 723 side effects 721 Norway mass media campaign on youth smoking 79 NSA. SW National Smokers Alliance NSTEP. SW National Spit Tobacco Education Program NTCI'. SW National Tobacco Control Program 0 Ochsner, Alton 38 Odds ratios 700 Office of Health Promotion and Disease Prevention 5 Office on Smoking and Health 5 Ohrnlik 5'. Ohio Stntr Bnr Assrr. 7 73 Ok1d70~~217 Tdccaskrs A.ssociiltiorz 7'. Crisp 7 73, 7 74, 7 75 Ok/dm~~ il. R./. Rcyr7olds Toohnrco Co. 217 Old Joe. Srr "Joe Camel" ad campaign Omnibus Trade and Competitiveness Act 373 Operant conditioning theory 770 Oral Health America 402 Oral lesions smokeless tobacco and 704 Oregon Measure 44 392 Oregon Health Plan 392-393 Oregon Tobacco Pre\,ention and Education Program 393 Organized cessation treatments 70.5 Osteen, Judge William L., Sr. 790 P Pacific Islanders. &Y' Asian Americans and Pacific Islanders Packaging. SW ~7ls~ Ad\.ertising; Warning labels for consumer education 7Si-78; and informed choice 781, "kiddie" packs [OS plain packaging recomn-\enclations 769 rtagulation ot 1 b8-7 ;(I used in other countries 7(;!%7;0 I'ack\vood, Robert W. 19 Parenting for a Positive Future 83 Pat-tnwhip for a Healthy Mississippi .?91-393 Passi\-e smoking 40 /',7t/lii'i77/> tcr ~rc~Ld~~rr; CV//fJfi/f'q f/k' F/`qirt /Iprir75f fid~,7iiO 19R-399 fi7i'/iifc'i i' ~c7/i2c'51clf7 >>li/it R17>;77. /17i-. 186-7s; Pa\vtucket f~jeart Health Program 72;. 379~.%W PeaceNet 403~4-l Pearl, Rnvmond 38 Pease, D1'. Charles G. 37 Peer-led pre\,ention programs 70 Peer smoking impact on tobacco use by youth 67, 63-6-I P1v177 Ad~c~rtisi/r;; of Bnlti,rwL~, I~Ic. F. Mayor or7d City Ct11[17ci/ of Ralti,lJclrl~ 7 72-7 ;?. 7 74, 7 ;.i-7 76 Pershing, General John Joseph 37 Personalized feedback efficacy in management of nicotine addiction 701, 704, 7.32 Pharmacies tobacco sales and 27 6 Pharmacologic interventions antidepressants 723-724 anxiolytics 723-72-7 bupropion 7 21-122 clonidine 122-723 efficacy 77-I nicotine gum 77.?%776 nicotine inhaler 720-727 nicotine nasal spray 778-720 nicotine polacrilex 773-776 nortriptyline 723-223 o\wview of 7 3-7 4 summary of 724-72.5 transdermal nicotine 776-778 Philip Morris Companies Inc. 306-308, 108 First Amendment rights lai\suit 789 investigation of research 25i "Next" brand 787 Pi~ilip M~v/s //ii. i'. Bl~rrrwlflrnl 253 Plli/i/~ Morris Irrc-. 1'. Grnimr~~ -7.53 I'ililip Momis /II~. 7'. H171.5/1/~71;:`~~1~ 7 8.3, 2.53 Physical dependence 729 Pinkerton Tobacco Company 2.52 Pipe smoking appeal of cigarettes oI,er pipes 35-36 Plug War 32 I'o~i7da~ de PuiJrfo Rim Asoiiofc~~ i'. Toririsrt~ Corqu7,y of Pwrfcl Rico 777, 77.5, 7 /6 Poverty status smoking prevalence and 97-98 PPXNet 40-I Pregnancy cost-effectiveness of smoking cessation 133 environmental tobacco smoke dangers 196 use of transdermal patch during 778 President's Cancer Panel 768, 785 Prwmfit~<~ To2mcc~1 U~c Amoq Yourlj~ Peopk 62, 83 Prevention programs business support 43,15 school-based 65-80 Tobacco Institute smoking education materials 4 Price supports 298-306 Price Waterhouse 320-322 Prisons ruling on ETS 248 [`rivate law potential public health benefits of tobacco litigation 221-225 tort as a private law control 224 U.S. reliance on private law controls 224 T'roblem solving/skills training for smoking cessation 706-707 I'roduct regulation overview of 75-16 t'rograms that Work 85 Project ALERT 71, 72 Project SHOUT 65, 72, i.3 Project TNT. Sw Project `Towards No Tobacco Use Project Tolvards No Tobacco Use 65, 73, 85 Promotion of tobacco products. Sw n/so Advertising spending by tobacco companies 767 Proposition 65 215 Proposition 99 339,38;-388 Proposition 200 397 PllPliC Cifkffl i'. Fedfrill Tldc CUll?lfliSSiUf7 7 68 Public Health Cigarette Smoking Act 45. 165, 767, 7 77, 22; Public health programs for management of nicotine addiction 725-728 Public Health Service Clinical Practice Guideline 703 early study on health effects of smoking 39 Public smoking. Set Clean indoor air; En\ ironmental tobacco smoke Q Co~ffrfli55ic~l? 7 7.5 "Quit Centre" 3i9 "Quit for Life" campaign 3i8-379 Quotas 300 R Racketeer Influenced and Corrupt Organizations Act 233-235 Radio. SLY, ~/se Media-based programs cigarette advertising ban 165-766 Radon Gas and Indoor Air Quality Research Act of 1986 195 Rapid puffing 708 Rapid-smoking strategies 7CG208 Rmfer's Dipf 38, 39 Reduced-tar cigarettes 768, 281-785 Regulatory efforts. See o/so Court cases for advertising and promotion 267-278 clean indoor air regulation 79J-2Oi on FDA authority 7 90-7 92 federal legislation 7 60 Food and Drug Administration regulations 759-l 60 litigation approaches 223-260 minors' access to tobacco 207-223 multistate settlement 760 overview of 7 1-7 8 product regulation 7 78-7 9g public and private litigation 760-167 response from the tobacco industry 101 Relapses early relapse 737 minimal clinical interventions 7 03-l 04 negative affective reaction and 730 problem sol\,ing/skills training Z&Y-7Oi S Safe Drinking Water and Toxic Enforcement Act of lY86 235 Sales taxes 33; Sales to minors agencies responsible for enforcement of state lalvs 218-221 buyer-directed regulation 276 early prohibition legislation 3 7 enforcement of laws 27 Y-222 enforcing la~.s 2X-251 incidence of 20;-208 influencing factors X8 means of sale regulation 217-274 o\,er\.ier\, of regulation lb-77 preemption of local action by state policy 223 regulation of 209-23 restrictions on distribution of samples 277 seller-directed regulation 774-776 state laws relating to 272-27.3 state settlements 222-223 vending machine sales 208 SAMHSA. SW Substance Abuse and Mental Health Ser\,ices Administration Samples distribution 277 Sarokin, Judge H. Lee 278-229 Satiation therapy 708 Save a Sweet Heart program 82 SCARC. SW Smoking Control Ad\.ocacy Resource Center SCARCNet 404.408 School-based prevention programs longer-term follow-up 69-73 multifaceted programs ;3-so shorter-term follo~v-up 6.3%68 summary of research studies 72-73 School Health Policies and Programs Study SO-82 Secondhand smoke 46 Self-help manuals as adjunctive interventions 101 effectiveness of mail-based intervention 125 efficacy 2 00-7 07 o\,erview of 73 relevant process measures 707-702 Self-service displays 274 Senate Commerce Committee bill 791 Seven Countries Study 376-377 Seventh-day Adventists antitobaccoism views 30-37 Sherman Act 306-307 Siiirn/l i'. New /evscy Bell TelephJHe co. 19i,245-246 S/li~J17f171? i'. P/dip Morris cos. 250 Shoplifting deterring 274 SHPPS. SW School Health Policies and Programs Study Skills training for smoking cessation 706-207 S~mll il. Lorillanl Toh~cco Co. 236 Sfllif/l i'. Cvc5tcrx Ekfric co. 797 Smoke Smoke Free Class of 2000 84 Smke sip7ls: TllL~ S,rrrkiry Corrfd Mrdiii Hnr1dhJk a; Smokeless cigarettes 309 SmokeLess States program 209.383 Smokeless tobacco additi\res 783-784 effect of price increases 7 9 effect of price on demand 335-336 efforts to reduce use of 402-403 federal excise taxes ,339 minimal clinical inter\-entions 703-705 oral lesions and 704 prevalence of use 07-62 requirement for disclosure of nicotine content 179 tvarning label requirements 767-768 Smokeless Tobacco Council 223 Smoking. SW Cigarettes; Tobacco use Smoking behavior effects of restrictions 203-206 Smoking Cessation 733 Smoking cessation. SW o/sio Management of nicotine addiction incidence of 97,99 Smoking Control Advocacv Resource Center 40; Smoking-Hazards Prevention Act 324-375 Smoking reduction. SW also Health promotion hygiene movement 30-37 impact of movement 48-50 moral issues -IF--I9 Smuggling activities 347 Snuff. SW n/w Smokeless tobacco increased use of 67 -62 Third-party reimbursement cases 2.3$P?42 Three-Corn~~i~~~~it~ Study .3;6--37,s Tobacco. Sao 17150 Cigarettes; Promotion of tobacco products domestic consumption 296,299 economic implications of concentrated production 308 genetic engineering of 787,258 increase in foreign tobacco use 296-297 minimum prices 300 nonrecourse loans 300 price supports 298-306 prohibition movement 32 quotas 300 samples distribution to minors 217 supply of 295-298 taxation of 337-359 types of 296 TO~IZCC(J: Htdpiri,y l'o~~llz Soy h'c, 473 Tobacco addiction stages of process 62 Tobacco and Cancer Committee 39 Tobacco Business Act 315 Tobaccc~ Corltrol: A BIuppritIt to Pmfect t/w Htwlfl~ of Carmdiar~s 7 i0 Tobacco Control Act 300 Tobacco control coordinators 82 Tobacco industry changes in 434-435 domestic market shares 307 economic impact of 320-322 economic importance of 7 9 evolution of 306-327 response to the science of ETS 252-253 tactics to promote tobacco use 43-44 voluntary code for advertising and marketing practices 264 Tobacco Inspection Act .?OO-307 Tobacco Institute 223 "It's the Law" program 43 smoking education materials 43 Tobacco Monopoly Act 375 Tobacco products effect of price on demand 322-337 Tobacco Products Control Act 769, 770, 782,376 Tobacco Products Liability Project 226, 250 Tobacco Program Improvements 307 Tobacco Sales to Young Persons Act of 1993 168 Tobacco support program overview of 7 9 Tobacco Tax and Health Care Act 341 Tobacco Tax and Health Promotion Act 339,38/-388 Tobacco use. SW n/so Health promotion; Sales to minors in the American colonies 29 bv American soldiers 32-33,47 &minalization of 29 delayed progression of related diseases and 47-42 early history of 29-30,295 early medical studies 38-39 econL>niic influences 47 effect of price increases 79 efforts for control in the future 27, 438 historical aspects 72 influences on 7 and informed consent 186-787 issues in reduction of 6-11 by minorities 97-98 wrerview of historical aspects 72 prevalence of 6, 97-98 reasons for use among youth 62-63 social influences 47 tobacco industry promotion tactics 4314 trends among )iouth 67-62 by youth 97-98 Tobncco USC Anmrg U.S. Rncin//Ethr7ic Mirmify Grotrps 398 Tort as a private law control 224 Toxic Substances Control Act 312 Trade Act of 1974 372-37 3 Trade and Tariff Act 373 Trade Expansion Act 372 Trade policy global production 377 with Japan 373 multinational trade agreements 326-318 past policy 372 recent developments 378-320 Section 301 of the Trade Act of 1975 372-373 lvith South Korea 375 Ivith Tairvan 37.3-37.5 lvith Thailand 375-376 Trade Regulation Rule 763 Trafficking in Contraband Cigarettes Act 347, 3.50 Transdermal nicotine 776-778 Transthcoretical model 729-730 Trask, George dntitob,iccoism \,ic\vs 37 `rwl7~ir7<~ Tohiii-0 Il.i,~ ,?rllf Dt~/`""fcwic~ 703 TVSFP. SLY* Tele\,ision, School, and Family Smoking Pre\ ention and Cessation Project U 2, Underaged smokers. SPL, Salvs to minors Unfair competition defined 7 77 L'nited Air Lines institution of nonsmoking sections 46-J; Cnited Kingdom Heart Disease Prevention Project 376, 3;;-3;8 University ot Vermont School program K-7 Lnpuffables program 83 Upton71 brand 399 Uruguay Round Agreements Act 328 Uruguay Round ot GATT 377-378 U.S. Ci&rette Export Association 372-372 U.S. Department of Health and Human Ser\?ces .i U.S. House of Representatives Web site 229 U.S. National Archives and Records Administration 408 U.S. Supreme Court ruling on ETS in prisons 24s USDHHS. %P U.S. Department of Health and Human Services Uydess, Jan 230 V w Walsh, Dr. James 1. 38 Warning labels. SLOP nl.so Packaging circle-and-arrow format 76; FTC recommendations 767 FTC requirement 47 regulatory requirements 763-765, 767 smokeless tobacco requirements 167-168 used in other countries 769-l 70 Waterloo Smoking Projects 10-X Waxman, Henry A. 2.58 WCTU. See Woman's Christian Temperance Union Webb-Pomerene Act 372 Weight control programs 271 Weight gain bupropion effecti\,eness 7 22 nicotine gum effectiveness 276 nicotine inhaler effectiveness 121 nicotine nasal spray effectiveness 119 relapse and 737 ' transdermal patch effectiveness 778 Wil, Gots/lrll 85 MI?/f~~L'S LLP 71. Lorl\\.5 i&ii Whites smoking prevalence 97-98 WHO. Sw World Health Organization WHO Tobacco Free Initiative 637 Wiiiilicii:Mi7ildr,s il. Browri & Will~nttrsorr Tnbaccc~ Cnr;~ 23.5 Widener, Judge H. Emory, Jr. 290 Wigand, Jeffrey 230 Wiley, Harvey W. 32 Willard, Frances campaign against tobacco 37 lJVi//iillflS i' spt'tf"`~ 7 7s Wilner, Nor\\-ood 2.35 Withdra\val symptoms bupropion effecti\,eness 727-122 clonidine effectiveness 723 nicotine gum rftectiveness 775776 nicotine inhaler effectiveness 720 nicotine nasal spray effectiveness 219 nortriptvline effectiveness 724 relapse and 730-1.37 transdermal patch effectiveness 77 7 LVb/fJitl i'. P/ii/i/l MOrYii lilC. 245 Woman's Christian Temperance Union campaign against tobacco 37-34 Women. SW n/so Pregnancy appeal of cigarettes 36-37 management of nicotine addiction 130 prevention and education programs 4OO-407 responsiveness to cue exposure therapy 108 smoking pre\,alence 97-98 lveight control programs following smoking cessation 7 7 7 lkrf7crl i'S. SlllOkilf<~ Nr~ticYlrk 400, 402403 WONDER 404 Working Well Trial 226-727 Workplaces environmental tobacco smoke exposure 196-797 environmental tobacco smoke litigation 245-246 private sector restrictions on environmental tobacco smoke 202 state restrictions on environmental tobacco smoke 207 worksite programs for management of nicotine addiction 726-22; World Bank 437 World Health Organization 374,437 World Trade Organization 32; Wright, Judge J. Skelly 7 65 WSP. Sw Waterloo Smoking Projects I/t!yf?tt, Tnfwr7f 0 Collrbs i'. Willinrm 2.53 X "X" brand 400 Y Z