Food Supplements and Health Claims

Format	Author(s)	Title / Description	Date added	Details
	Food and Drug Administration	1993 Federal Register Vol. 58 Part IV: Dept. of Health and Human Services This page provides access to Part IV of Federal Register Vol. 58 No. 3 (1993), "Food Labeling; General Provisions; Nutrition and Labeling; Label Format; Nutrient content Claims; Health Claims; Ingredient Labeling; State and Local Requirements; and Exemptions; Final Rules". Documents are available in pdf and Microsoft Word format. (more) Publication Date: Wednesday, January 6, 1993	Apr 22, 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: 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 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
	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	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

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