The undersigned submits this petition under Sections 402(a), 403(a), and 701(a) of the Federal Food, Drug and Cosmetic Act (FDCA) to request that the Commissioner of the Food and Drug Administration (FDA):
Develop and promulgate regulations or other guidance for industry on the safetyrelated information required on labels for functional foods;
Develop an enhanced system to record and analyze reports of health problems associated with functional foods;
Issue regulations to clearly establish the nature and extent of evidence companies need to adequately support structure/function claims;
Require manufacturers of functional foods to provide notification of the use of novel ingredients to the FDA prior to marketing;
Require manufacturers of food products making structure/function claims on labels or on labeling to provide notification to the FDA within 30 days after marketing begins;
Require all foods with structure/function claims to carry the disclaimer currently required on dietary supplements that make such claims; and Establish an advisory committee to reevaluate the current labeling approaches for foods with novel ingredients to determine whether the istinctions between structure/function claims and health claims are understood by consumers and identify other changes needed to improve consumer understanding of health-related
1 GAO/RCED-00156 (July 2000) [hereinafter GAO Report].
2 Id. at 4.
3 Id. at 5. The GAO further recommended that the FDA clarify the boundary between conventional foods, including functional foods and dietary supplements, particularly the
circumstances under which dietary supplements may be marketed in food form. The GAO explained that the failure to have a clear boundary means that “unsafe products could come to market because companies did not develop a sufficient level of evidence on their safety.” While
acknowledging that the FDA has been attempting to do this on a case-by-case basis, e.g. in its letters to Benecol and Hains, the GAO concludes that the FDA needs to clarify this boundary through regulations or guidance. Id. at 25-26.
2 claims.
