Of Health and Human Services 21 Cfr

SUMMARY: The Food and Drug Administration (FDA) is adopting general requirements pertaining to: (1) The use of health claims that characterize the relationship of a substance to a disease or health related condition on the labels and in labeling of foods in conventional food form (conventional foods), and (2) the content of petitions regarding the use of such health, claims pertaining to specific substances in such food. This action is being taken in response to provisions of the Nutrition Labeling and Education Act of 1990 (the 1990 amendments) that bear on health claims for conventional foods. However, in the Dietary Supplement Act of 1992 (the DS Act), Congress imposed a moratorium on the implementation of the 1990 amendments with respect to dietary supplements with only very limited exceptions. Therefore, these final rules do not apply to dietary supplements of vitamins, minerals, herbs, or other similar nutritional substances. Elsewhere in this issue of the Federal Register, FDA is issuing final rules that respond, at least, with respect to conventional foods and, to the extent that they would permit claims, with respect, to dietary supplements, to the 1990 amendments' directive that the agency consider 10 topics associating substances with diseases or health-related conditions. Those final rules have been developed in accordance with the general principles of the requirements in this document. concerning restaurant firms consisting of 10 or less individual restaurant establishments for whom these sections will become effective on May 8, 1994. a proposed rule to establish, general requirements pertaining to: (1) The use of health claims that characterize the relationship of a substance to a disease or health-related condition on the labels and in labeling of both conventional foods and dietary supplements, and (2) the content of petitions regarding the use of such health claims pertaining to specific substances in food. The proposed rule was issued in response to provisions of the 1990 amendments (Pub. L. 101-535) that bear on health claims. With respect to health claims, the 1990 amendments amend the Federal Food, Drug, and Cosmetic Act (the act) by adding a provision (section 403(r)(1)(B) of the act (21 U.S.C. 343(r)(1)(B))) that provides that a product is misbranded if it bears a claim that characterizes the relationship of a nutrient to a disease or health-related condition, unless the claim is made in accordance with section 403(r)(3) or (r)(5)(D). Congress enacted the health claims provisions of the 1990 amendments to …