========================================================================= Date: Fri, 12 Nov 2004 17:46:04 -0500 Reply-To: FDA-DSFL@VM.CFSAN.FDA.GOV Sender: FDA-DSFL Electronic Newsletter From: Dietary Supplement/Food Labeling Electronic Newsletter Subject: FDA-DSFL Newsletter November 2004 (#8) MIME-Version: 1.0 Content-Type: text/plain; charset=ISO-8859-1; format=flowed Content-Transfer-Encoding: 7bit * * Dietary Supplement/Food Labeling Electronic Newsletter * * * * * * * FDA-DSFL@vm.cfsan.fda.gov * * * * WHAT IS "FDA-DSFL"? FDA-DSFL is an electronic newsletter from the Food and Drug Administration's Office of Nutritional Products, Labeling, and Dietary Supplements (ONPLDS), in the Center for Food Safety and Applied Nutrition (CFSAN). Its purpose is to give interested parties access to key information and updates on dietary supplements, food labeling and nutrition issues. +++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ FOOD AND DRUG ADMINISTRATION (FDA) CENTER FOR FOOD SAFETY AND APPLIED NUTRITION (CFSAN) OFFICE OF NUTRITIONAL PRODUCTS, LABELING, AND DIETARY SUPPLEMENTS (ONPLDS) **** DIETARY SUPPLEMENT & FOOD LABELING ELECTRONIC NEWSLETTER **** November 2004 (#8) IN THIS ISSUE: HIGHLIGHTS * 1. Public Meeting: New Dietary Ingredients Meeting on November 15, 2004 * 2. Press Release: FDA Announced Major Initiatives for Dietary Supplements * 3. Regulatory Strategy for the Further Implementation and Enforcement of the Dietary Supplement Health and Education Act of 1994 * 4. Draft Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act * 5. Speech: FDA Acting Commissioner Lester M. Crawford before Council for Responsible Nutrition Annual Conference, October 25, 2004 ONPLDS MANAGEMENT UPDATE * 6. Barbara O. Schneeman, Ph.D., Director, CFSAN's Office of Nutritional Products, Labeling, and Dietary Supplements (ONPLDS) * 7. Camille E. Brewer, M.S., R.D., Associate Director, ONPLDS * 8. Susan Walker, M.D., Director, Division of Dietary Supplements, ONPLDS, and CFSAN Lead Scientist for Dietary Supplement Safety * 9. Kathleen Ellwood, Ph.D., Director, Division of Nutrition Labeling and Programs, ONPLDS, and CFSAN's Lead Scientist for Nutrition * 10. Updated Description of ONPLDS, Including Organizational Chart and Contact Information RESOURCES FOR EDUCATORS AND CONSUMERS * 11. New and Improved - "How to Understand and Use the Nutrition Facts Label" * 12. Power of Choice * 13. "What Dietary Supplements Are You Taking: Does Your Health Care Provider Know? - It Matters and Here's Why" FOOD LABELING AND NUTRITION * 14. Qualified Health Claim to Decrease Risk of Coronary Heart Disease * 15. Qualified Health Claim for Omega-3 Fatty Acids * 16. Food Label and Package Survey 2000 - 2001 DIETARY SUPPLEMENTS * 17. Bovine Spongiform Encephalopathy (BSE) Safeguards INFANT FORMULA * 18. FDA Alerts Consumers Not to Feed Infants Chinese Infant Formula PUBLIC MEETINGS & HEARINGS * 19. U.S. Preparatory Meeting for 26th session of the Codex Committee on Nutrition and Foods for Special Dietary Uses * 20. Food Advisory Committee/Dietary Supplements Subcommittee (on osteoarthritis) * 21. Nutrition Subcommittee of the Food Advisory Committee (on health claims and trans fat) * 22. "Dietary Supplement Safety Act: How is FDA Doing 10 Years Later?" ======================================================================= ~~~~~~~~~~~ HIGHLIGHTS ~~~~~~~~~~~ 1. Public Meeting: New Dietary Ingredients Meeting on November 15, 2004 FDA has announced a meeting and is soliciting comments on FDA's premarket notification program for new dietary ingredients (NDIs). The public meeting will be held on November 15, 2004, from 9:00 a.m. to 5:00 p.m. at FDA's Center for Food Safety and Applied Nutrition, Harvey W. Wiley Building, 5100 Paint Branch Pkwy., College Park, MD 20740. Attendees must register to attend. Individuals wishing to speak must register before November 9, 2004. Attendees may register on site on November 15, 2004. Written or electronic comments must be submitted (before or after the meeting) by December 3, 2004. FDA is soliciting comments from industry, consumers, and other interested members of the public concerning the content and format requirements for NDI notifications made under the Federal Food, Drug, and Cosmetic Act. FDA is holding this meeting to give the public an opportunity to provide information and views on the topics outlined in the Federal Register. The agency intends to consider all comments received during the meeting and made to the docket in determining whether any future action is necessary or appropriate. * Federal Register Notice: Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting: http://www.cfsan.fda.gov/~lrd/fr041020.html * Meeting Information and Pre-Registration Form: http://www.cfsan.fda.gov/~dms/ds-ndi.html 2. Press Release: FDA Announced Major Initiatives for Dietary Supplements FDA announced three major initiatives designed to further implement the Dietary Supplement Health and Education Act of 1994 (DSHEA). These initiatives -- a regulatory strategy, an open public meeting, and guidance for industry -- are significant steps FDA has taken in the implementation of DSHEA. *Press Release: http://www.cfsan.fda.gov/~lrd/fpsupp.html 3. Regulatory Strategy for the Further Implementation and Enforcement of the Dietary Supplement Health and Education Act of 1994 FDA's strategy for dietary supplements outlines the steps the agency plans to take to continue implementing and enforcing the Dietary Supplement Health and Education Act of 1994 (DSHEA). The strategy sets forth a series of research plans and measures, including guidance for industry, regulations, and science-based compliance and enforcement mechanisms. The strategy focuses on three areas: monitoring and evaluating product and ingredient safety; ensuring product quality; and monitoring and evaluating product labeling. * Federal Register-Notice of Availability: http://www.cfsan.fda.gov/~lrd/fr04119a.html * Regulatory Strategy: http://www.cfsan.fda.gov/~dms/ds3strat.html * Fact Sheet: http://www.cfsan.fda.gov/~dms/ds3strfs.html * Questions and Answers: http://www.cfsan.fda.gov/~dms/ds3strqa.html 4. Draft Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act FDA's Guidance for Industry is intended to describe the amount, type, and quality of evidence FDA recommends a manufacturer or distributor have to substantiate a claim under the Food, Drug, and Cosmetic Act (the Act). The Act requires dietary supplement manufacturers and distributors to have substantiation that structure/function, nutrient deficiency, and general well-being claims on the label of a dietary supplement product are truthful and not misleading. * Federal Register-Notice of Availability: http://www.cfsan.fda.gov/~lrd/fr04119b.html * Draft Guidance for Industry: http://www.cfsan.fda.gov/~dms/dsclmgui.html * Fact Sheet: http://www.cfsan.fda.gov/~dms/dsclmfs.html * Questions and Answers: http://www.cfsan.fda.gov/~dms/dsclmqa.html 5. Speech: FDA Acting Commissioner Lester M. Crawford before Council for Responsible Nutrition Annual Conference, October 25, 2004 In an industry-sponsored meeting, Dr. Crawford discussed where FDA stands with respect to ensuring full implementation of the Dietary Supplement Health and Education Act (DSHEA); some of the ways that the agency is pursuing its goals of protecting American consumers from products with false or misleading claims or containing unsafe ingredients; and empowering consumers with the knowledge to improve their own health through informed dietary choices. *Dr. Crawford's Prepared Remarks: http://www.fda.gov/oc/speeches/2004/crn1025.html ~~~~~~~~~~~~~~~~~~~~~~~~~~~ ONPLDS MANAGEMENT UPDATE ~~~~~~~~~~~~~~~~~~~~~~~~~~~ 6. Barbara O. Schneeman, Ph.D., Director CFSAN's Office of Nutritional Products, Labeling, and Dietary Supplements (ONPLDS). On April 12, FDA Acting Commissioner, Dr. Lester M. Crawford, announced that Dr. Barbara O. Schneeman was named to be Director of ONPLDS. She joined FDA on May 3, 2004. As director, Dr. Schneeman oversees the development of policy and regulations for conventional food standards, infant formula and medical foods, nutrition labeling, and dietary supplements. Dr. Schneeman comes from the University of California, Davis, where she served as a member of the faculty since 1976, the last three years as the Associate Vice Provost for University Outreach, she also held professorial appointments in the Departments of Nutrition, Food Science and Technology and Internal Medicine in the School of Medicine. Dr. Schneeman received her B.S. degree from the University of California, Davis, in food science and technology, and her Ph.D. in nutrition from the University of California, Berkeley. She has many professional activities and honors to her credit. * Press Release: http://www.cfsan.fda.gov/~lrd/fpschnee.html 7. Camille Brewer, M.S., R.D., Associate Director, ONPLDS Camille Brewer has been appointed as Associate Director for ONPLDS. As a part of the Office of the Director she will be involved with priority setting, budget and office management, and development of education programs for ONPLDS. Ms. Brewer joined FDA in 1992. Since 1996, she served as the International Activities Coordinator for Food Safety at CFSAN. She organized and led FDA and interagency federal teams in over 26 food safety missions around the world. Ms. Brewer was the lead drafter of the calories, calories from fat, sodium and potassium sections of the 1993 final rule on nutrition labeling. Additionally, she was the principal author of a series of proposed and final rules on the labeling of conventional foods and dietary supplements from 1993 through 1997. Ms. Brewer earned her Masters Degree in Public Health Nutrition at the Case Western Reserve University in Cleveland Ohio. She received the FDA Award of Merit in 2001 for her work in domestic and international Food Safety and again in 2004 as part of a team responsible for outreach on the Bioterrorism Regulations. She is a registered dietitian. 8. Susan Walker, M. D., Director, Division of Dietary Supplements, ONPLDS, and CFSAN's Lead Scientist for Dietary Supplement Safety Dr. Walker is the Director of ONPLDS' Division of Dietary Supplement Programs. In addition to being the Division Director, Dr. Walker has been appointed as the CFSAN Lead Scientist for Dietary Supplement Safety. Dr. Walker is CFSAN's first Lead Scientist for Dietary Supplement Safety. CFSAN established a cadre of Lead Scientists to assist the Center in identifying high priority, unmet scientific needs. These individuals take the initiative and work with the Center's Management Council to focus Agency attention on emerging issues. As the Lead Scientist for Dietary Supplements, Dr. Walker is able to focus on science and public health issues and serves as an advocate for the Center's science programs. Dr. Walker also provides scientific advice to the Center Director, the Center Deputy Directors and the Management Council. She serves as a liaison to external groups and the scientific community on matters and inquiries related to dietary supplements and serves, as needed, as the Agency's spokesperson for matters in this area. Dr. Walker received her B.S. degree from the University of Michigan in Ann Arbor, and her M.D. degree from the Uniformed Services University of Health Sciences in Bethesda, Maryland. She was a clinical team leader in the Center for Drugs prior to coming to CFSAN two years ago. 9. Kathleen Ellwood, Ph.D., Director, Division of Nutrition Labeling and Programs, ONPLDS, and CFSAN's Lead Scientist for Nutrition As Director of ONPLDS' Division of Nutrition Programs and Labeling, Dr. Ellwood is responsible for scientific and regulatory review of nutrition labeling issues, such as health claims and nutrient content claims; and changes to the Nutrition Facts panel. Moreover, she develops guidance documents, promulgates and administers regulations, and sets policy related to nutrition labeling. In addition to being the Division Director, Dr. Ellwood has been appointed as the CFSAN Lead Scientist for Nutrition. In this capacity, she will serve as an advocate for and facilitator of nutrition policy and related science across CFSAN and with top FDA officials and other officials throughout the federal government, scientific and research communities, and food industry. Dr. Ellwood received her Ph.D. in nutritional biochemistry from the University of Maryland. She was the National Program Leader for Human Nutrition at the U.S. Department of Agriculture's Agricultural Research Service prior to coming to CFSAN. 10. Updated Description of ONPLDS, Including Organizational Chart and Contact Information CFSAN'S Office of Nutritional Products, Labeling, and Dietary Supplements has updated its organizational chart, contact information, and the description of various components and their responsibilities. This information can be found at: http://www.cfsan.fda.gov/~dms/onplds.html ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ RESOURCES FOR EDUCATORS AND CONSUMERS ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ 11. New and Improved - "How to Understand and Use the Nutrition Facts Label" The Guidance on "How to Understand and Use the Nutrition Facts Label" has been updated and improved. It is intended to make it easier for consumers to use nutrition labels to make quick, informed food choices that contribute to a healthy diet. This updated version includes a new approach to the percent daily value, a general guide to calories, and help with added sugars. A Spanish translation will be available in the near future. *To view "How to Understand and Use the Nutrition Facts Label" see: http://www.cfsan.fda.gov/~dms/foodlab.html 12. Power of Choice The Power of Choice (POC), an after-school program jointly developed by FDA and USDA's Food and Nutrition Service, guides pre-teens towards a healthier lifestyle by engaging them in skill-based activities that lead to smarter food and physical activity choices in real-life settings. * For more information: http://www.cfsan.fda.gov/~dms/lab-poc.html 13. "What Dietary Supplements Are You Taking: Does Your Health Care Provider Know? - It Matters and Here's Why" is the name of a new educational brochure targeted towards consumers who are taking or considering taking dietary supplements. The purpose of the brochure is to encourage consumers to talk with their doctor or other health care provider to sort reliable from questionable information about dietary supplements. Dietary supplement users are urged, among other things, to: remember safety first; learn to spot false claims; consider that the term "natural" doesn't always mean safe; and check with their health care providers before taking a supplement, especially when combining or substituting them with other foods or medicine. Included in this brochure are three assessment tools that allow users to list the supplements, over-the-counter, and prescription drugs they are taking --important information that should be discussed with their health care team. This brochure will be posted on CFSAN's Website soon. ~~~~~~~~~~~~~~~~~~~~~~~~~~~ FOOD LABELING AND NUTRITION ~~~~~~~~~~~~~~~~~~~~~~~~~~~ 14. Qualified Health Claim to Decrease Risk of Coronary Heart Disease FDA announced the availability of a qualified health claim for monounsaturated fat from olive oil and reduced risk of coronary heart disease (CHD). FDA intends to consider exercising enforcement discretion for the following qualified health claim: "Limited and not conclusive scientific evidence suggests that eating about 2 tablespoons (23 grams) of olive oil daily may reduce the risk of coronary heart disease due to the monounsaturated fat in olive oil. To achieve this possible benefit, olive oil is to replace a similar amount of saturated fat and not increase the total number of calories you eat in a day. One serving of this product contains [x] grams of olive oil." *Press Release: http://www.cfsan.fda.gov/~lrd/fpolive.html 15. Qualified Health Claim for Omega-3 Fatty Acids On Sept. 8, FDA announced the availability of a qualified health claim for reduced risk of coronary heart disease (CHD) on conventional foods that contain eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) omega-3 fatty acids. Typically, EPA and DHA omega-3 fatty acids are contained in oily fish, such as salmon, lake trout, tuna and herring. These fatty acids are not essential to the diet; however, scientific evidence indicates that these fatty acids may be beneficial in reducing CHD. FDA recommends that consumers not exceed more than a total of 3 grams per day of EPA and DHA omega-3 fatty acids, with no more than 2 grams per day from a dietary supplement. The EPA and DHA omega-3 fatty acid qualified health claim is the second qualified health claim that FDA has announced for conventional food. In 2000, FDA announced a similar qualified health claim for dietary supplements containing EPA and DHA omega-3 fatty acids and the reduced risk of CHD. * Press Release: www.cfsan.fda.gov/~lrd/fpqhco3.html. * Questions & Answers: http://www.cfsan.fda.gov/~dms/labo3qa.html 16. The Food Label and Package Survey (FLAPS) 2000 - 2001 FLAPS is an FDA study of processed, packaged food labels in the United States food supply. FLAPS provides the most reasonable and comprehensive overview of label information on food products in the United States today. The FLAPS database includes all significant information from product labels, including the ingredient list, nutrition label, claims, as well as food safety and other statements about the product. Using the FLAPS data, FDA can monitor the food industry's response to its food labeling regulations and support agency policy, regulatory, and food safety decisions. * For More Information: http://www.cfsan.fda.gov/~dms/lab-flap.html ~~~~~~~~~~~~~~~~~~~~~ DIETARY SUPPLEMENTS ~~~~~~~~~~~~~~~~~~~~~ 17. Bovine Spongiform Encephalopathy (BSE) Safeguards On July 9th U. S. Department of Agriculture (USDA), Department of Heath and Human Services, and FDA issued a joint press release announcing three actions being taken to further strengthen existing safeguards that protect consumers against the agent that causes bovine spongiform encephalopathy (BSE, also known as "mad cow disease"). The documents outlining these actions were (1) a joint USDA/FDA Advance Notice of Proposed Rulemaking proposing strengthened BSE safeguards, (2) an Interim Final Rule (IFR) banning the use of specified risk materials in cattle-derived materials in human food, dietary supplements, and cosmetics, and (3) a proposed rule on record-keeping related to this IFR. * Press Release: www.cfsan.fda.gov/~lrd/hhsbse4.html * Commonly Asked Questions About BSE in Products Regulated by FDA's CFSAN: http://www.cfsan.fda.gov/~comm/bsefaq.html * Fact Sheet about FDA's New Interim Rule and Proposed Rule on Prohibited Cattle Materials in Food and Cosmetics July 9, 2004: http://www.cfsan.fda.gov/~comm/bsefact2.html * Interim Final Rule Prohibiting Use of Certain Cattle Materials that May Carry Risk of Bovine Spongiform Encephalopathy in Human Foods and Cosmetics July 14, 2004: http://www.cfsan.fda.gov/~lrd/fr04714a.html * Proposed Rule on Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing Material From Cattle July 14, 2004: http://www.cfsan.fda.gov/~lrd/fr04714b.html * Advance Notice of Proposed Rulemaking July 14, 2004: http://www.cfsan.fda.gov/~lrd/fr04714c.html ~~~~~~~~~~~~~~~ INFANT FORMULA ~~~~~~~~~~~~~~~ 18. FDA Alerts Consumers Not to Feed Infants Chinese Infant Formula The Food and Drug Administration is warning consumers not to feed their infants infant formula from China because the safety and nutritional adequacy of infant formula from China is unknown. Recently, infant formula from China by the name of Guan Wei Yuan was found for sale in an Asian retail market in New York. * Talk Paper: http://www.fda.gov/bbs/topics/answers/2004/ANS01299.html ~~~~~~~~~~~~~~~~~~~~~~~~~~ PUBLIC MEETINGS & HEARINGS ~~~~~~~~~~~~~~~~~~~~~~~~~~ 19. U.S. Preparatory Meeting for 26th session of the Codex Committee on Nutrition and Foods for Special Dietary Uses A public meeting was held on September 9, 2004, in preparation for the 26th Session of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU). The next session of this Codex committee was in Bonn, Germany from November 1-5, 2004. Dr. Barbara Schneeman headed the U.S. delegation. At the public meeting, Dr. Schneeman presented the U.S. draft positions on approximately 10 agenda items for the upcoming session and invited comments from meeting participants. Among the items to be discussed at the next session are the revision of a Codex standard for infant formula, draft guidelines for vitamin and mineral food supplements, definitions for dietary fiber and trans-fatty acids, risk analysis as applied to the work of this Codex committee, and approaches to the scientific evaluation of health claims. * Meeting Notice: http://www.fsis.usda.gov/Frame/FrameRedirect.asp?main=/oppde/rdad/frpubs/04-022n.htm * Information on Codex Meetings: http://www.codexalimentarius.net/web/current.jsp 20. Food Advisory Committee/Dietary Supplements Subcommittee (on osteoarthritis) The meeting of the Food Advisory Committee and its Dietary Supplements Subcommittee was held on June 7 - 8, 2004. FDA sought input concerning the etiology of osteoarthritis (OA), potential modifiable risk factors and the relevance of certain types of scientific studies used to substantiate the substance-disease relationship. * Federal Register Notice: http://www.fda.gov/OHRMS/DOCKETS/98fr/04-10589.htm * Transcript and Summary Minutes: http://www.fda.gov/ohrms/dockets/ac/cfsan04.html 21. Nutrition Subcommittee of the Food Advisory Committee (on health claims and trans fat) On April 27-28, 2004, a meeting of Nutrition Subcommittee of the Food Advisory Committee was held. The subcommittee discussed the scientific issues and principles involved in using ``total fat'' as a disqualifying level for foods that receive a health claim for coronary heart disease; and to discuss evidence supporting a possible daily value (DV) for trans fatty acids. * Federal Register Notice: http://www.cfsan.fda.gov/~lrd/fr040329.html * Transcript and Summary Minutes: http://www.fda.gov/ohrms/dockets/ac/cfsan04.html 22. "Dietary Supplement Safety Act: How is FDA Doing 10 Years Later." On June 8, U.S. Senate Committee on Governmental Affairs, Subcommittee on Oversight of Government Management, the Federal Workforce, and the District of Columbia held a hearing entitled, "Dietary Supplement Safety Act: How is FDA Doing 10 Years Later?" The Subcommittee examined the challenges and successes FDA has experienced since the passage of the Dietary Supplement Health and Education Act of 1994, which established a new regulatory framework for dietary supplements. The information generated from this hearing will be used to determine what, if any, steps are needed to make FDA more effective. CFSAN Center Director Bob Brackett testified at the hearing for FDA. * Testimony: http://www.fda.gov/ola/2004/dssa0608.html NOTE: * TO GET PAST ISSUES OF FDA-DSFL, go to Electronic Information Networks: http://www.cfsan.fda.gov/~dms/infonet.html. ******************************** FDA Web Page Addresses: * Dietary Supplements http://www.cfsan.fda.gov/~dms/supplmnt.html * Food Labeling and Nutrition http://www.cfsan.fda.gov/label.html * Infant Formula http://www.cfsan.fda.gov/~dms/inf-toc.html * Qualified Health Claims http://www.cfsan.fda.gov/~dms/lab-qhc.html * Center for Food Safety and Applied Nutrition http://www.cfsan.fda.gov/list.html Other Federal Government Links: * Federal Trade Commission http://www.ftc.gov/ * Office of Dietary Supplements, NIH http://dietary-supplements.info.nih.gov/ * US Department of Agriculture - Food Safety and Inspection Service http://www.fsis.usda.gov/index.htm - Food and Nutrition Service http://www.fns.usda.gov/fns/ Non-Federal Government Links: * National Academy of Sciences http://www.iom.edu/iom/iomhome.nsf/Pages/FNB+Reports Please forward this issue to colleagues and friends and tell them how to subscribe. 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