Health Claims Policy and Actions

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
	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	FDA Announces Qualified Health Claims for Omega-3 Fatty Acids Release regarding a qualified health claim for conventional foods regarding EPA and DHA omega-3 fatty acids and reduced risk of coronary heart disease. (more) Publication Date: Wednesday, September 8, 2004	Oct 8, 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
	Food and Drug Administration	Food Labeling: Health Claims; Soluble Dietary Fiber From Certain Foods and Coronary Heart Disease Final rule authorizing whole oat beta-glucan soluble fiber, oatrim, the soluble fraction of allpha-amylase hydrolyzed oat bran or whole oat flour to be considered eligible sources for the health claim on the relationship between soluble dietary fiber and reduced risk of coronary heart disease. (more) Publication Date: Monday, July 28, 2003	Aug 1, 2003
	Food and Drug Administration	Food Labeling: Health Claims; Soluble Dietary Fiber From Certain Foods and Coronary Heart Disease Interim final rule that allows for barley as an eligible source of beta-glucan soluble fiber for a health claim related to a reduced risk of coronary heart disease. Includes discussion of the scientific evidence, costs and benefits of the regulation, and more. (more) Deadline: Wednesday, March 8, 2006 Publication Date: Friday, December 23, 2005	Jan 6, 2006
	Food and Drug Administration	Food Labeling: Nutrient Content Claims, General Principles; Health Claims, General Requirements and Other Specific Requirements for Individual Health Claims; Reopening of the Comment Period Reopening of the comment period until July 6, 2004 and request for comments on specific topics related to this proposed rule first published in 60 FR 66206. (more) Publication Date: Tuesday, May 4, 2004	May 10, 2004
	Food and Drug Administration	Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims FDA's final rule requiring trans fatty acids to be declared on nutrition labels of foods and dietary supplements. Includes background information on nutrition labeling, nutrient content and health claims, discussion of the science behind the rule, further information on the nutrition labeling of trans fat, the final regulatory impact and flexibility analyses, and more. (more) Publication Date: Friday, July 11, 2003	Mar 5, 2004
	Food and Drug Administration	Food Labeling; Health Claims; Dietary Noncariogenic Carbohydrate Sweeteners and Dental Caries Proposed rule to authorize sucralose to be eligible for the health claim relating noncariogenic sweeteners and nonpromotion of dental caries. (more) Deadline: Wednesday, July 27, 2005 Publication Date: Friday, May 13, 2005	May 16, 2005
	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 Evidence-based Ranking System for Scientific Data Guidance document regarding FDA's interim evidence-based ranking system for qualified health claims. Publication Date: Thursday, July 10, 2003	Oct 25, 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
	Office of Nutrition, Labeling, and Dietary Supplements, CFSAN	Guidance for Industry: A Food Labeling Guide Questions and answers regarding food labeling, which are grouped by the food labeling area of interest. Appendices include "Definitions of Nutrient Claims", "Additional Requirements for Nutrient Content Claims", "Health Claims", "Qualified Health Claims", "Additional FDA Resources", "Calculate the Percent Daily Value (DV) for the Appropriate Nutrients", and more. (more) Publication Month: April 2008	Apr 30, 2008
	Center for Food Safety and Applied Nutrition, Food and Drug Administration	Guidance for Industry: Frequently Asked Questions about Medical Foods Questions and answers regarding the definition of and regulations for medical foods. Publication Month: May 2007	Apr 30, 2008
	Office of Regulatory Affairs, Food and Drug Administration	Guide to Nutrition Labeling and Education Act(NLEA) Requirements Information provided as assistance for reviewing food labels for compliance with new requirements for nutrition labeling and nutrient claims. Quick reference attached at the end. (more) Publication Month: August 1994	Oct 11, 2007
	Health and Consumer Protection Directorate-General, European Commission	Health & Nutrition Claims Information about proposed EU legislation related to nutrition and health claims. Deadline: Monday, August 15, 2005	Aug 15, 2005
	Office of Nutritional Products, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition, Food and Drug Administration	Health Claim Notification for Whole Grain Foods with Moderate Fat Content Document that discusses a health claim submitted by Kraft Foods regarding whole grain foods and other plant foods that are low in saturated fat and cholesterol and the risk of heart disease. (more) Publication Date: Tuesday, December 9, 2003	Apr 9, 2004
	World Health Assembly (58th : 2005 : Geneva, Switzerland)	Infant and Young-child Nutrition Resolution regarding infant and young child nutrition, including issues related to the contamination of powdered infant formula with E. sakazakii and other microorganisms. (more) Publication Date: Wednesday, May 25, 2005	May 31, 2005
	Landa, Michael M.	Letter Regarding Eggs with Enhanced Omega-3 Fatty Acid Content and a Balanced 1:1 Ratio of Omega-3/Omega-6 Fatty Acids and Reduced Risk of Heart Disease and Sudden Fatal Heart Attack (Docket No. 2004Q-0072) Letter that denies a petition for a qualified health claim regarding Belovo omega-3 PUFA enriched eggs and reduced risk of heart disease and sudden fatal heart attack. Citations from the petition are included as appendices. (more) Deadline: Saturday, August 13, 2005 Publication Date: Tuesday, April 5, 2005	Aug 13, 2005
	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
	Brackett, Robert E.	Letter Responding to Health Claim Petition Dated August 28, 2003: Monounsaturated Fatty Acids from Olive Oil and Coronary Heart Disease (Docket No 2003Q-0559) Letter regarding a qualified health claim related to the consumption of monounsaturated fatty acids from olive oil and a reduced risk of coronary heart disease. Includes discussion of comments on the health claim and scientific evidence related to the substance, disease, safety, and consideration of a qualified health claim, and other related issues. Includes as an appendix "Intervention Studies that were not used in further review". (more) Publication Date: Monday, November 1, 2004	Nov 5, 2004
	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
	Food and Drug Administration/Federal Trade Commission	Mexico, United States, Canada Combat Weight Loss Fraud Release and fact sheet regarding compliance actions taken as part of the Mexico, United States, Canada Health Fraud Working Group weight loss initiative to combat false weight loss claims and the distribution of false weight loss products. (more) Deadline: Tuesday, November 15, 2005 Publication Date: Monday, October 24, 2005	Nov 15, 2005
	Therapeutic Products Programme and the Food Directorate from the Health Protection Branch, Health Canada	Nutraceuticals/Functional Foods and Health Claims on Foods This Canadian policy paper outlines the basis by which foods with health claims should be regulated as foods or drugs, depending on the types of claims. "Structure/function and risk reduction claims for foods should be permitted while all other products claiming to cure, treat, mitigate or prevent illness should continue to be regulated as drugs." Furthermore, "the requirements for supporting evidence ... would be likely to vary, depending on the risk-benefit profile of the product submitted for review.". (more) Publication Month: November 1998	Jun 6, 2005
	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
	Tarantino, Laura M.	Qualified Health Claims: Letter of Enforcement Discretion - Walnuts and Coronary Heart Disease Letter regarding a qualified health claim for walnuts and reducing the risk of coronary heart disease. Includes discussion of the scientific evaluation regarding this claim and of requirements and conditions for the claim. (more) Publication Date: Tuesday, March 9, 2004	Apr 5, 2004
	Office of Nutritional Products, Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition, Food and Drug Administration	Questions and Answers: Qualified Health Claims for Omega-3 Fatty Acids, Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) Questions and answers that provide information about the new qualified health claim for EPA and DHA omega-3 fatty acids and provide related background information. (more) Publication Date: Wednesday, September 8, 2004	Oct 8, 2004

Copyright © 2008 Joint Institute for Food Safety and Applied Nutrition.

0220 Symons Hall University of Maryland, College Park, MD 20740

• Phone: 301.314.6806
• Fax: 301.405.8390
• E-mail: foodrisk@umd.edu