Food Supplements 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
	Food Standards Australia New Zealand	Application A470 - Formulated Beverages Draft assessment report regarding an application to amend standards for formulated beverages to allow for the addition of a number of vitamins, minerals, and food additives. Includes discussion of related risk assessments and risk management considerations. Attachments include "Draft Variations to the Australia New Zealand Food Standards Code," "Nutrition Assessment," "Risk Assessment - Micronutrients," "Dietary Modelling Methodologies for Nutrient Intake Assessment," "Risk Assessment - Food Additives," and more. (more) Deadline: Wednesday, July 6, 2005 Publication Date: Wednesday, May 25, 2005	Jun 29, 2005
	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
	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; Folic Acid (Folacin) Final rule providing for the safe use of folic acid in certain foods, including those that require its addition for a standard of identity, breakfast cereals, infant formulas, medical foods, and foods for special dietary use. It also incorporates folic acid specifications consistent with the Food Chemicals Codex. Includes discussion of comments to the proposed rule. (more) Publication Date: Tuesday, March 5, 1996	Aug 5, 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 Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3 Final rule regarding the use of vitamin D3 as a nutrient supplement in certain cheese and cheese products at levels up to 81 IU/30 g cheese. Includes discussion of the safety assessment. (more) Deadline: Friday, November 18, 2005 Publication Date: Wednesday, November 16, 2005	Nov 18, 2005
	Food and Drug Administration	Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3 Corrections to a final rule regarding the use of vitamin D3 as a nutrient supplement in calcium-fortified fruit juices and fruit drinks. Includes responses to comments on the final rule. (more) Deadline: Friday, July 22, 2005 Publication Date: Wednesday, June 22, 2005	Jun 27, 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
	Food and Drug Administration	Food Standards: Amendment of Standards of Identity for Enriched Grain Products to Require Addition of Folic Acid Final rule that amends the standards of identity for certain enriched grain products, enriched bromated flour, enriched vegetable macaroni, and enriched vegetable noodle products to require fortification with folic acid. Comments received in response to the proposed rule are addressed, as is the economic impact, including discussion of the costs and benefits of different regulatory options. (more) Publication Date: Tuesday, March 5, 1996	Aug 5, 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: 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 Food Additive Safety, Center for Food Safety and Applied Nutrition, Food and Drug Administration	Guidance for Industry: Frequently Asked Questions About GRAS Answers to frequently asked questions regarding the GRAS classification of food ingredients. Includes discussion of criteria for GRAS status, GRAS notification, and other related topics. (more) Publication Month: December 2004	Jan 10, 2005
	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
	Joint FAO/WHO Expert Committee on Food Additives	Joint FAO/WHO Expert Committee on Food Additives Sixty-third Meeting Geneva, 8-17 June 2004: Summary and Conclusions Summary and conclusions of this meeting held to evaluate certain food additives and ingredients, flavoring agents, and a natural consituent of food. Includes specifications information, acceptable daily intake values, and other toxicological recommendations for some food additives and ingredients, heavy metal (As, Pb, Cd, and Hg) limits for some food additives, safety evaluation results for certain flavoring agents, and toxicological recommendations for glycyrrhizinic acid. Annexes include a list of members, further information needs, and general considerations. (more) Publication Date: Thursday, June 17, 2004	Jun 24, 2004
	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
	German Federal Institute for Risk Assessment	More Folic Acid, Less Salt and Junk Food! Release regarding an agreement between European national food safety agencies and the European Food Safety Agency on preventing food- and nutrition-related diseases. Access to the Common statement of representatives of national food safety agencies and institutions involved in nutrition in European countries and Norway, adopted January 13, 2004 in Paris, is provided. This document discusses points on salt, folic acid, and obesity and overweight. (more) Publication Date: Tuesday, January 20, 2004	Mar 16, 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
	European Commission	Proposal for a Regulation of the European Parliament and of the Council on the Addition of Vitamins and Minerals and of Certain Other Substances to Foods Proposed regulation to harmonize national rules of Member States regarding the addition of vitamins, minerals, and some other substances to foods. Includes definitions and discussion of conditions for adding vitamins and minerals, restrictions on the addition of vitamins and minerals, purity criteria, maximum and minimum amounts, labeling and advertising, mandatory addition of vitamins and minerals, restricted and prohibited substances, and other relevant issues. Annexes include "Vitamins and minerals which may be added to foods," "Vitamin formulations and mineral substances which may be added to foods," and "Substances and whose use in foods is prohibited or subject to conditions." There is also a Basic Impact Assessment Statement. (more) Publication Date: Saturday, October 11, 2003	Nov 12, 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
	Codex Committee on Food Additives and Contaminants (36th : 2004 : Rotterdam, The Netherlands), Codex Alimentarius Commission	Report of the 36th Session of the Codex Committee on Food Additives and Contaminants The report includes the Committee's decisions and draft documents on topics related to risk analysis, exposure assessment of contaminants and toxins, risk management of aflatoxin in peanuts and tree nuts, of lead in foods, of inorganic tin in canned foods, maximum levels of cadmium in certain grains and vegetables and of deoxynivalenol, levels for radionuclides in foods, standards for food additives, contaminants, and toxins, active chlorine, mycotoxins, and more. (more) Publication Month: April 2004	Apr 30, 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	Substances Affirmed as Generally Recognized as Safe: Menhaden Oil Tentative final rule regarding the GRAS uses of menhaden oil. The final rule has been published as 70 FR 14530, available through GPO Access here. (more) Publication Date: Thursday, January 15, 2004	Jan 20, 2004
	Food and Drug Administration	Substances Affirmed as Generally Recognized as Safe: Menhaden Oil Final rule that amends the regulations for the GRAS use of menhaden oil to state that it not be used in combination with other added oils that are significant sources of eicosapentaenoic acid and docosahexaenoic acid. (more) Publication Date: Wednesday, March 23, 2005	Mar 25, 2005
	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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