Dietary Supplements Policy and Actions

Format	Author(s)	Title / Description	Date added	Details
	United Kingdom Food Standards Agency	Agency Revises Chromium Picolinate Advice Release regarding the Food Standards Agency's changed advice to consumers about chromium picolinate supplements in light of a new statement by the Committee on Mutagenicity. (more) Publication Date: Monday, December 13, 2004	Dec 13, 2004
	Burdock, George A.; Kliewer, Steven A.; Morrow, Jason D.	Botanical Dietary Supplements: Scientific Perspectives and Public Health Pitfalls Congressional science briefing regarding dietary supplement legislation. Includes three presentations: "Dietary Supplements and a Method for Determining Safety and Efficacy," "How Do Interactions Between Prescription Drugs and Botanical Dietary Supplements Have Potential to Harm Us?", and "Safety of Dietary Supplements from a Clinical Pharmacology Perspective and What It Means to the U.S. Public". (more) Publication Date: Monday, January 31, 2005	Jul 7, 2005
	Center for Food Safety and Applied Nutrition, Food and Drug Administration	Center for Food Safety and Applied Nutrition 2006 Program Priorities Workplan outlining CFSAN's high priority areas for 2006, including: Ensuring Food Defense; Ensuring Food Safety; Improving Nutrition; Ensuring Dietary Supplement and Cosmetic Safety and Management Services; and, Priority Ongoing Activities. Resulting from a prior Request for Comments. (more) Deadline: Wednesday, May 3, 2006 Publication Date: Wednesday, May 3, 2006	May 3, 2006
	Task Force on Consumer Health Information for Better Nutrition, Food and Drug Administration	Consumer Health Information for Better Nutrition Initiative: Task Force Final Report Report of this task force that was part of the Consumer Health Information for Better Nutrition Initiative. It includes the transmittal memorandum, an overview and executive summary of the situation and the work of the Task Force, and several attachments. Attachments include "Possible Regulatory Frameworks for Qualified Health Claims in the Labeling of Conventional Human Food and Dietary Supplements," "Guidance: Interim Evidence-Based Ranking System for Scientific Data," "Consumer Studies Research Agenda -- Improving Consumer Understanding and Product Competition on the Health Consequences of Dietary Choices," "Guidance: Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements," "?One-Year? Time Line for Qualified Health Claim Activities," "Task Force Membership," "Stakeholder Meetings Summary," and "Public Dockets Comments Summary". (more) Publication Date: Thursday, July 10, 2003	Jul 15, 2003
	Food and Drug Administration	Dietary Supplement Health and Education Act of 1994 Public Law 103-417, 103rd Congress. This act amends the Federal Food, Drug, and Cosmetic Act with regards to dietary supplements. (more) Publication Date: Tuesday, October 25, 1994	Jul 21, 2003
	Center for Food Safety and Applied Nutrition, Food and Drug Administration	Dietary Supplements This website provides access to information on dietary supplements from CFSAN, including announcements, questions and answers, warnings and safety information, information on adverse event reporting, industry information and regulations, and more. (more)	Feb 26, 2004
	Food and Drug Administration	Dietary Supplements Containing Ephedrine Alkaloids Final Rule Summary This page provides summary information regarding FDA's evaluation of and final rule regarding ephedrine alkaloids.	Feb 9, 2004
	Office of Nutritional Products, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition, Food and Drug Administration	Dietary Supplements: Ephedrine Alkaloids This page provides links to alerts, information from public meetings, and proposed and final regulations relating to ephedrine alkaloids. (more)	Jan 7, 2004
	Food and Drug Administration	Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting College Park, MD: Public meeting to discuss and receive comments on FDA's premarket notification program for new dietary ingredients in dietary supplements. The comment period for the notice was reopened in 69 FR 77258, available through GPO Access at http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2004_register&docid=fr27de04-79. The transcript from this meeting is now available. (more) Event Date: Monday, November 15, 2004 Publication Date: Wednesday, October 20, 2004	Oct 22, 2004
	Center for Food Safety and Applied Nutrition, Food and Drug Administration	Fact Sheet: I. FDA's New Interim Final Rule Prohibiting Use of Certain Cattle Materials that May Carry the Risk of Bovine Spongiform Encephalopathy in Human Foods and Cosmetics and II. FDA's Proposed Rule on Recordkeeping Requirements for Human Food ... Fact sheet with questions and answers regarding this interim final rule and proposed rule. Publication Date: Friday, July 9, 2004	Jul 22, 2004
	Food and Drug Administration	FDA Announces Major Initiatives for Dietary Supplements Release regarding three regulatory initiatives to further implementation of the Dietary Supplement Health and Education Act of 1994 (DSHEA). Includes discussion of the initiatives and links to related documents and fact sheets. (more) Publication Date: Thursday, November 4, 2004	Nov 5, 2004
	Food and Drug Administration	FDA Announces Plans to Prohibit Sales of Dietary Supplements Containing Ephedra This page provides links to FDA documents related to its planned prohibition of the sale of products containing ephedrine alkaloids. (more)	Jan 5, 2004
	Food and Drug Administration	FDA Warns Distributors of Dietary Supplements Promoted Online for Weight Loss Release regarding FDA's warning to distributors of dietary supplements over the Internet regarding false and misleading claims for weight loss products. Includes a link to follow to access copies of the warning letters that were sent. (more) Publication Date: Thursday, April 1, 2004	May 3, 2004
	Food and Drug Administration	Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk; Final Rule This FDA final rule includes background information, discussion of the scientific evaluation, an analysis of impacts, and more. (more) Publication Date: Wednesday, February 11, 2004	Feb 13, 2004
	Food and Drug Administration	Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3 Final rule that amends the food additive regulations "to provide for the safe use of vitamin D3 as a nutrient supplement in meal replacement bars, other- type bars, and soy-protein based meal replacement beverages represented for special dietary use in reducing or maintaining body weight." Includes discussion of the safety assessment. (more) Publication Date: Wednesday, June 29, 2005	Jul 1, 2005
	Food and Drug Administration	Food Labeling: Health Claims and Label Statements; Folate and Neural Tube Defects Final rule that authorizes the use of health claims on food and dietary supplement labels regarding the association between adequate folate intake and the risk of neural tube defects. Includes discussion of this association, a summary of comments in response to the proposed rule and the FDA's responses, and discussion of the economic impact of this rule. (more) Publication Date: Tuesday, March 5, 1996	Aug 4, 2004
	Food and Drug Administration	Food Labeling: Health Claims; Dietary Guidance Advance notice of proposed rulemaking, issued to solicit comments regarding the regulation of health claims and dietary guidance statements in the labeling of conventional foods and dietary supplements. The comment period has been extended. See 69 FR 3868, available through GPO Access. (more) Publication Date: Tuesday, November 25, 2003	Dec 4, 2003
	Federal Trade Commission	FTC Launches "Big Fat Lie" Initiative Targeting Bogus Weight-Loss Claims Release regarding law enforcement actions against companies making false weight-loss claims in advertisements for products including dietary supplements. Includes links to related documents on the individual cases. (more) Publication Date: Tuesday, November 9, 2004	Dec 16, 2004
	Center for Food Safety and Applied Nutrition, Food and Drug Administration	Guidance for Industry and FDA: Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements Guidance document that outlines FDA's interim procedures for responding to qualified health claim petitions. Publication Date: Thursday, July 10, 2003	Oct 25, 2004
	Center for Food Safety and Applied Nutrition, Food and Drug Administration	Guidance for Industry: A Dietary Supplement Labeling Guide Questions and answers regarding the labeling of dietary supplements, including coverage of such topics as statement of identity, net quantity of contents, nutrition labeling, ingredient labeling, claims, premarket notification of new dietary ingredients, and more. Appendices include "Daily Values for Adults and Children 4 or More Years of Age," "Daily Values for Infants, Children Less Than 4 Years of Age, and Pregnant of Lactating Women," "Nutrient Content Claims," "Authorized Health Claims," "Qualified Health Claims," and more. (more) Publication Month: April 2005	Apr 22, 2005
	Center for Food Safety and Applied Nutrition, Food and Drug Administration	Guidance for Industry: Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims: Small Entity Compliance Guide Guidance document that explains the legal requirements set forth in 21 CFR 101.9 and 101.36 regarding the declaration of trans fatty acids on the nutrition labels of foods and dietary supplements. (more) Publication Month: August 2003	Aug 22, 2003
	Center for Food Safety and Applied Nutrition, Food and Drug Administration	Guidance for Industry: Structure/Function Claims Small Entity Compliance Guide Guidance document on regulations related to structure/function claims and distinguishing structure/function claims from disease claims for dietary supplement labeling. (more) Publication Date: Friday, January 11, 2002	Jan 13, 2003
	Center for Food Safety and Applied Nutrition, Food and Drug Administration	Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance Draft guidance for industry regarding the substantiation of nutritional deficiency, structure/function, or general well-being claims on dietary supplements. Includes discussion of identifying the meaning of a claim, the relationship of the evidence to the claim, quality of evidence, and the totality of the evidence. (more) Publication Month: November 2004	Nov 5, 2004
	Food and Drug Administration	HHS Launches Crackdown on Products Containing Andro: FDA Warns Manufacturers to Stop Distributing Such Products Release regarding measures taken by the U.S. Department of Health and Human Services and the Food and Drug Administration regarding androstenedione, including warning companies to stop distributing dietary supplements that contain this substance. (more) Publication Date: Thursday, March 11, 2004	Mar 12, 2004
	Hubbard, William K.	Letter Regarding the Relationship Between the Consumption of Crystalline Glucosamine Sulfate and a Reduced Risk of Osteoarthritis (Docket No. 2004P-0060) Letter that denies a petition for a health claim regarding dietary supplementation of crystalline glucosamine sulfate and the risk of osteoarthritis. (more) Deadline: Friday, August 12, 2005 Publication Date: Thursday, October 7, 2004	Aug 12, 2005
	Hubbard, William K.	Letter Regarding the Relationship Between the Consumption of Glucosamine and/or Chondroitin Sulfate and a Reduced Risk of: Osteoarthritis; Osteoarthritis-related Joint Pain, Joint Tenderness, and Joing Swelling; Joint Degeneration; and Cartilage ... Letter that denies a petition for qualified health claims regarding glucosamine or chondroitin sulfate and the risk of osteoarthritis, joint degeneration, cartilage deterioration, and osteoarthritis-related joint pain, tenderness, and swelling. (more) Deadline: Friday, August 12, 2005 Publication Date: Thursday, October 7, 2004	Aug 13, 2005
	Schneeman, Barbara O.	Letter Responding to Health Claim Petition Dated December 19, 2003: Chromium Picolinate and Insulin Resistance (Docket No. 2004Q-0144) Letter regarding proposed health claims for chromium picolinate and a reduced risk of several diseases and health-related conditions. Includes discussion of the safety review. (more) Deadline: Friday, September 2, 2005 Publication Date: Thursday, August 25, 2005	Sep 2, 2005
	Hubbard, William K.	Letter Responding to Health Claim Petition dated November 3, 2003 (Martek Petition): Omega-3 Fatty Acids and Reduced Risk of Coronary Heart Disease (Docket No. 2003Q-0401) Letter regarding a qualified health claim on dietary supplements and conventional foods regarding the consumption of eicosapentaenoic acid [EPA] and docohexaenoic acid [DHA] omega-3 fatty acids and a reduced risk of coronary heart disease. Includes discussion of FDA's review of the qualified health claim, including a safety review, issues associated with fish and mercury, and other related issues. (more) Publication Date: Wednesday, September 8, 2004	Sep 10, 2004
	Hubbard, William K.	Letter Responding to Health Claims Petition dated June 23, 2003 (Wellness petition): Omega-3 Fatty Acids and Reduced Risk of Coronary Heart Disease (Docket No. 2003Q-0401) Letter regarding a qualified health claim on dietary supplements and conventional foods regarding the consumption of eicosapentaenoic acid [EPA] and docohexaenoic acid [DHA] omega-3 fatty acids and a reduced risk of coronary heart disease. Includes discussion of FDA's review of the qualified health claim, including a safety review, issues associated with fish and mercury, and other related issues. (more) Publication Date: Wednesday, September 8, 2004	Sep 10, 2004
	Engle, Mary K./Bureau of Consumer Protection, Federal Trade Commission	[Letter to Internet Advertisers of Products Claiming to Affect Cortisol] Letter regarding marketing claims that products cause weight loss or produce other health benefits by affecting cortisol that are not supported by scientific evidence. (more) Publication Date: Friday, October 1, 2004	Oct 8, 2004
	NSF International	NFL/NFLPA Supplement Certification Information on this program that provides certification to dietary supplements and functional foods for the National Football League (NFL) and National Football League Players Association (NFLPA). Includes discussion of the criteria for certification and a list of banned substances. (more)	Jun 29, 2004
	Taylor, Christine L.	Phosphatidylserine and Cognitive Dysfunction and Dementia (Qualified Health Claim: Final Decision Letter) Letter in response to a petition to authorize health claims regarding the effects of phosphatidylserine consumption on dementia and cognitive dysfunction in the elderly. Includes discussion of the safety review, the scientific evidence, and other issues. (more) Publication Date: Tuesday, May 13, 2003	Oct 13, 2003
	Office of Nutritional Products, Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition, Food and Drug Administration	Regulatory Strategy for the Further Implementation and Enforcement of the Dietary Supplement Health and Education Act of 1994 This document outlines FDA's strategies for monitoring and evaluating product and ingredient safety, quality assurance and CGMP, and monitoring and evaluating product labeling. (more) Publication Month: November 2004	Nov 5, 2004
	Food and Drug Administration	Sales of Supplements Containing Ephedrine Alkaloids (Ephedra) Prohibited This page provides links to documents related to FDA's final rule prohibiting the sale of supplements that contain ephedrine alkaloids. (more)	Apr 16, 2004
	Brackett, Robert E.	Statement of Robert E. Brackett, PH.D. Director, Center for Food Safety and Applied Nutrition, Food and Drug Administration Before the Committee on Governmental Affairs Subcommittee on Oversight of Government Management, the Federal Workforce, and ... Testimony at the hearing "Dietary Supplement Safety Act: How is FDA Doing 10 Years Later." Includes discussion of the regulation of dietary supplements and an overview of recent enforcement actions. (more) Publication Date: Tuesday, June 8, 2004	Jun 30, 2004
	Food and Drug Administration	Use of Materials Derived From Cattle in Human Food and Cosmetics Interim final rule to prohibit the use in human food, including dietary supplements, and cosmetics of specified risk materials, cattle small intestine, material from nonambulatory disabled cattle, material from cattle not inspected and passed for human consumption, and mechanically separated (beef). Includes discussion of the analysis of economic impacts of this interim final rule. Amendments to the interim final rule have been published in 70 FR 53063, and comments are requested on the amendments. (more) Deadline: Monday, November 7, 2005 Publication Date: Wednesday, July 14, 2004	Jul 22, 2004
	White House Commission on Complementary and Alternative Medicine Policy	White House Commission on Complementary and Alternative Medicine Policy Final Report This report presents the Commission's recommendations on complementary and alternative medicine. Topics addressed include coordination of research, education and training of health care practitioners, information development and dissemination, access and delivery, coverage and reimbursement, wellness and health promotion, and coordinating Federal efforts. (more) Publication Month: March 2002	Aug 15, 2002

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