Dietary Supplement Labeling

Format	Author(s)	Title / Description	Date added	Details
	Elliott, Victoria Stagg	Code Green: Seeing the Side Effects of Alternative Supplements This report discusses side effects of herbal supplements as well as labeling and diagnosis issues. It also includes, under "Additional information," the reasons for taking, adverse reactions, and other drug conflictions of ephedra/ma huang, St. John's Wort, kava kava, yohimbine, and ginkgo biloba. (more) Publication Date: Monday, March 5, 2001	Aug 15, 2002
	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/Research Triangle Institute	Dietary Supplement Sales Database (DSPD) A survey conducted by Research Triangle Institute (RTI) under contract with FDA. The Access database contains labeling and catalogue information of approximately 3,000 dietary supplement products sold in the United States. The database includes information such as the product's name, the name and address of the manufacturer or distributor, the product's ingredients, and claims about the product. Claims may be about the health benefits or nutrient content of the product or may be nutritional support statements. Thus, the database provides information on the range of products available for sale in the United States, where these products are sold, what they contain, and what claims are being made about these products. Also available are the final report of the project, which includes information on the procedures used and a description of the database, and a supplement to the final report, which includes detailed records from the data collection process. (more) Publication Month: October 1999	Aug 16, 2002
	Office of Nutritional Products, Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition, Food and Drug Administration	Dietary Supplements/Food Labeling Electronic Newsletter (FDA-DSFL) Newsletter that addresses dietary supplements, food labeling and nutrition issues. Archives of past newsletters are available. (more)	Aug 7, 2002
	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	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
	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
	Office of Nutritional Products, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition, Food and Drug Administration	Guidance for Industry: Qualified Health Claims in the Labeling of Conventional Foods and Dietary Supplements This guidance document explains the FDA's criteria for considering exercising enforcement for health claims in dietary supplement and conventional foods labeling. It has been superceded by "Guidance for Industry and FDA: Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements" and "Guidance for Industry and FDA: Interim Evidence-based Ranking System for Scientific Data". (more) Publication Date: Wednesday, December 18, 2002	Jan 13, 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
	Center for Food Safety and Applied Nutrition, Food and Drug Administration	Label Claims: Qualified Health Claims This page provides access to FDA information, guidance documents, petitions, and letters of enforcement discretion or denial regarding qualified health claims. (more)	Oct 13, 2003
	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
	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
	International Cyber Business Services, Inc.	Products Containing Ephedrine Table of products that contain ephedrine. It includes product name, manufacturer, the amount of ephedrine per serving, whether caffeine is present, form, and the use/label claim. (more)	Dec 3, 2002
	Schneeman, Barbara O.	Qualified Health Claims: Letter of Denial - Green Tea and Reduced Risk of Cardiovascular Disease Letter regarding a qualified health claim for green tea and reducing the risk of cardiovascular disease. Includes discussion of the scientific evaluation regarding this claim. (more) Deadline: Wednesday, May 17, 2006 Publication Date: Tuesday, May 9, 2006	May 17, 2006
	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
	Office of Nutritional Products, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition, Food and Drug Administration	Summary of Qualified Health Claims Permitted Fact sheet providing an overview of permitted qualified health claims, including required claim statements, eligible foods, and conditions of use. (more) Publication Month: September 2003	Oct 13, 2003
	Center for Food Safety and Applied Nutrition, Food and Drug Administration	Transcript of Public Meeting: Assessing Consumer Perceptions of Health Claims Transcript and presentations from this meeting held November 17, 2005 in College Park, Maryland on consumer research related to health claims on conventional foods and dietary supplements. Talks include "Legal Context of Consumer Research on Health Claims and Other Food"/Nickerson, Louisa; "Overview of Qualified Health Claims (QHC)"/Schneeman, Barbara; "Presentation of FDA Results"/Derby, Brenda; "Federal Trade Commission Research"/Ippolito, Pauline; "International Food Information Council Foundation's Research"/Kapsak, Wendy Reinhardt; "West Virginia University Research Presentation"/Bone, Paula Fitzgerald; France, Karen Russo; "Ohio State Research"/Hooker, Neal; and more. (more) Deadline: Tuesday, February 7, 2006 Publication Date: Thursday, November 17, 2005	Feb 7, 2006
	Cleland, Richard L.; Gross, Walter C.; Koss, Laura D.; Daynard, Matthew; Muoio, Karen M.	Weight-Loss Advertising: An Analysis of Current Trends Report of an analysis of weight loss advertising and claims. Sections include "An Overview," "Collection Methodology and Coding," "Analysis of Weight-loss Advertisements" (including "Claims by Category"), "Historical Comparison: 1992/2001," "Regulatory Framework," "Media Responsibility," and "Conclusion." Appendices include "Product List" and "Examples of Questionable Ad Claims From 2001 Sample". (more) Publication Month: September 2002	Jul 7, 2003

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