[Federal Register: August 11, 1995 (Volume 60, Number 155)]
[Notices]
[Page 41454-41459]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]

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[[Page 41454]]

Nicotine In Cigarettes And Smokeless Tobacco Products Is A Drug
And These Products Are Nicotine Delivery Devices Under The Federal
Food, Drug, And Cosmetic Act

U. S. Food and Drug Administration Department of Health and Human
Services August, 1995

[[Page 41455]]
PREFACE

    The Food and Drug Administration (FDA) has conducted an extensive
investigation and has engaged in comprehensive legal analysis regarding
the agency's jurisdiction over nicotine-containing cigarettes and
smokeless tobacco products. The results of that inquiry and analysis
support a finding at this time that nicotine in cigarettes and
smokeless tobacco products is a drug, and that these products are drug
delivery devices within the meaning of the Food, Drug, and Cosmetic
Act. Nonetheless, because the agency recognizes the unique importance
of the jurisdictional issue as well as the factual justification for
any proposed rule in this area, the agency invites comment on these
matters. Comments submitted will receive full and serious
consideration.
    Elsewhere in the same issue of the Federal Register in which this
document is published, the agency is issuing a proposed regulation of
nicotine-containing cigarettes and smokeless tobacco products under the
restricted device provisions of the Act. Comments should be sent to
FDA's Dockets Management Branch and identified with the docket number
95N-0253J. Comments should be submitted by the date identified in the
Federal Register.
    Traditionally, the FDA has initiated enforcement actions in cases
where the agency determines that a product is a drug or a delivery
device. Because the agency has elected to embark on this initiative
through rulemaking, no enforcement action will be brought pending
completion of that process.

[[Page 41456]]
SUMMARY TABLE OF CONTENTS

INTRODUCTION

PART ONE: LEGAL ANALYSIS OF JURISDICTION OVER TOBACCO PRODUCTS

I. CIGARETTES AND SMOKELESS TOBACCO PRODUCTS ``AFFECT THE STRUCTURE
OR ANY FUNCTION OF THE BODY'' BECAUSE THEY HAVE PHARMACOLOGICAL
EFFECTS AND LEAD TO ADDICTION.
II. TOBACCO MANUFACTURERS ``INTEND'' THAT THEIR PRODUCTS HAVE
ADDICTIVE AND SIGNIFICANT PHARMACOLOGICAL EFFECTS.
III. NICOTINE-CONTAINING CIGARETTES AND SMOKELESS TOBACCO PRODUCTS
ARE DRUG DELIVERY SYSTEMS THAT ARE APPROPRIATELY REGULATED AS
DEVICES

PART TWO: FINDINGS

EVIDENCE THAT CIGARETTES AND SMOKELESS TOBACCO ARE INTENDED TO
AFFECT THE STRUCTURE AND FUNCTION OF THE BODY
I. NICOTINE HAS DRUG EFFECTS ON THE BODY
II. STATEMENTS, RESEARCH, AND ACTIONS BY TOBACCO COMPANIES

PART THREE: REGULATORY OBJECTIVES

APPENDICES

[[Page 41457]]
DETAILED TABLE OF CONTENTS

INTRODUCTION.....................................................     vi
PART ONE: LEGAL ANALYSIS OF JURISDICTIONOVER TOBACCO PRODUCTS....      1
INTRODUCTION AND SUMMARY.........................................      2
I. CIGARETTES AND SMOKELESS TOBACCO PRODUCTS ``AFFECT THE
 STRUCTURE OR ANY FUNCTION OF THE BODY'' BECAUSE THEY HAVE
 PHARMACOLOGICAL EFFECTS AND LEAD TO ADDICTION...................      6
II. TOBACCO MANUFACTURERS ``INTEND'' THAT THEIR PRODUCTS HAVE
 ADDICTIVE AND SIGNIFICANT PHARMACOLOGICAL EFFECTS...............     10
  A. OBJECTIVE INTENT IS THE APPROPRIATE STANDARD................     11
  B. THE EVIDENCE DEMONSTRATES INTENT TO AFFECT THE STRUCTURE OR
   FUNCTION OF THE BODY..........................................     21
    1. The Addictive, Psychoactive, and Other Pharmacological
     Effects of Nicotine Are Widely Known and Foreseeable by Any
     Reasonable Person in the Position of a Tobacco Manufacturer.     22
    2. Consumers Use Tobacco Products to Obtain the
     Pharmacological Effects of Nicotine and to Satisfy Their
     Addiction to Nicotine.......................................     29
    3. Tobacco Manufacturers Know That Nicotine Has
     Pharmacological Effects and That Consumers Use Tobacco for
     Those Effects, and Have Acted to Facilitate That Use........     30
III. NICOTINE-CONTAINING CIGARETTES AND SMOKELESS TOBACCO
 PRODUCTS ARE DRUG DELIVERY SYSTEMS THAT ARE APPROPRIATELY
 REGULATED AS DEVICES............................................     60
CONCLUSION.......................................................     65
APPENDIX TO LEGAL ANALYSIS.......................................     68
PART TWO: FINDINGS...............................................     71
I. NICOTINE HAS DRUG EFFECTS ON THE BODY.........................     73
  A. NICOTINE HAS PHYSIOLOGICAL AND CENTRAL NERVOUS SYSTEM
   EFFECTS.......................................................     74
  B. NICOTINE IS ADDICTIVE.......................................     78
    1. Major Public Health Groups and Leading Experts Concur.....     78
    2. Epidemiological Data Establishes That Tobacco Users
     Display the
 [[Page 41458]]
     Clinical Symptoms of Addiction..............................     86
    3. Laboratory Studies Establish That Nicotine Produces
     Pharmacological Effects Similar to Those of Other Addictive
     Substances..................................................     94
    4. Nicotine's Sensory Effects Are Secondary to its
     Psychoactive Effects........................................    102
    5. Other Factors Associated with Tobacco Use Are Secondary...    106
  C. MARKETED TOBACCO PRODUCTS DELIVER PHARMACOLOGICALLY ACTIVE
   DOSES OF NICOTINE.............................................    108
    1. Amount of Nicotine Necessary to Produce a Physiological
     Response in the Central Nervous System......................    108
    2. Nicotine Delivery From Currently Marketed Tobacco Products    110
  D. CONSUMERS USE TOBACCO PRODUCTS FOR DRUG EFFECTS.............    115
    1. To Satisfy Addiction......................................    115
    2. To Affect Mood and Control Weight.........................    118
II. STATEMENTS, RESEARCH, AND ACTIONS BY TOBACCO COMPANIES.......    121
  A. INDUSTRY STATEMENTS ON NICOTINE'S DRUG EFFECTS..............    122
    1. Statements That Nicotine's Drug Effects Are Essential to
     Tobacco Use.................................................    123
    2. Statements Recognizing That Nicotine Is Addictive.........    143
    3. Statements That Tobacco Products Are Nicotine Delivery
     Systems.....................................................    156
  B. INDUSTRY RESEARCH ON THE DRUG EFFECTS OF NICOTINE...........    160
    1. Industry Research on Nicotine's Effects on the Brain......    164
    2. Industry Research on Nicotine Delivery to the Blood and
     Brain.......................................................    174
    3. Industry Research Establishes That Nicotine Produces
     Pharmacological Effects Similar to Those of Other Addictive
     Drugs.......................................................    179
  C. INDUSTRY RESEARCH ON THE CONSUMER'S NEED FOR AN ADEQUATE
   DOSE OF NICOTINE..............................................    183
    1. Industry Research on Importance of Supplying Sufficient
     Nicotine to Provide Consumer Acceptance and ``Satisfaction''    183
    2. Industry Research to Determine the Minimum and Maximum
     ``Dose'' of Nicotine Required by Consumers of Tobacco.......    188
    3. Industry Research on How Consumers ``Compensate'' to
     Achieve an Adequate Dose of Nicotine........................    198
    4. Industry Research and Knowledge of Tobacco Users'
     Inability to Quit...........................................    206
  D. INDUSTRY PRODUCT DEVELOPMENT RESEARCH TO ENSURE AN ADEQUATE
   DOSE OF NICOTINE..............................................    213
    1. Industry Emphasis on Nicotine in Product Development
     Research....................................................    213
    2. Industry Research on Maintaining Adequate Nicotine
     Delivery When Lowering Tar..................................    222
[[Page 41459]]
  E. INDUSTRY MANIPULATION AND CONTROL OF NICOTINE DELIVERY IN
   MARKETED TOBACCO PRODUCTS.....................................    232
    1. Industry Manipulation and Control of Nicotine in
     Cigarettes..................................................    232
    2. Industry Manipulation and Control of Nicotine in Smokeless
     Tobacco.....................................................    273
  F. INDUSTRY ALTERNATIVE TOBACCO PRODUCTS.......................    289
    1. Industry Development of Nicotine Substitutes That Mimic
     Nicotine's Drug Effects.....................................    289
    2. Industry Research on Acetaldehyde As a Reinforcer.........    298
    3. Industry Development of Alternative Cigarettes That
     Deliver Nicotine............................................    302
  G. INDUSTRY KNOWLEDGE THAT NICOTINE'S SENSORY EFFECTS ARE
   SECONDARY TO ITS PHARMACOLOGICAL EFFECTS......................    311
  H. INDUSTRY FAILURE TO REMOVE NICOTINE FROM TOBACCO DESPITE
   AVAILABLE TECHNOLOGY..........................................    318
PART THREE: REGULATORY OBJECTIVES................................    324


APPENDICES

1. Background on Nicotine Pharmacology
2. Corporate Relationship Between Brown and Williamson and British-
American Tobacco Co.
3. FDA Letters to Tobacco Manufacturers
4. Bibliography of Industry-Funded Research
5. Marketing of Cigarettes and Smokeless Tobacco in the U.S.
6. Citizen Petitions and Submitted Comments
7. Statement by David A. Kessler, M.D., Commissioner of Food and
Drugs, on Nicotine-Containing Cigarettes, before the Subcommittee on
Health and the Environment, Committee on Energy and Commerce, U.S.
House of Representatives, March 25, 1994
8. Statement by David A. Kessler, M.D., Commissioner of Food and
Drugs, on the Control and Manipulation of Nicotine in Cigarettes,
before the Subcommittee on Health and the Environment, Committee on
Energy and Commerce, U.S. House of Representatives, June 21, 1994
9. Remarks by David A. Kessler, M.D., Commissioner of Food and
Drugs, The Samuel Rubin Program, the Columbia University School of
Law, March 8, 1995
10. Additional Documents