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This article was originally published in The Tan Sheet

Executive Summary

DIETARY SUPPLEMENT HEALTH CLAIM STANDARDS REPRESENT "APPROPRIATE BALANCE" between "the congressional concern for consumer protection, food fraud, public health, and sound science, on the one hand, and the desire to provide the consumer with information on the other," FDA asserted in a proposed rule implementing dietary supplement health claim requirements under the Nutrition Labeling & Education Act. Published in the June 18 Federal Register, three days after FDA was statutorily required to issue the proposal, the reg noted that dietary supplement health claims would be subject to "the same standard that applies to food in conventional form." NLEA implementing regs for conventional foods were issued on Jan. 6. FDA noted that many comments received by the agency urged the adoption of a "more lenient standard" for allowing health claims for dietary supplements compared to conventional foods. Commenters argued that using an identical standard "would restrict the amount of health information available to consumers and . . . that such information is important to consumers in deciding which products to buy," the agency related. Other comments suggested that restrictions "will cost the nation millions of dollars in health care expenditures that could have been saved through disease prevention," the agency said, and that "FDA should place more weight on the potential benefits of the health information than on eliminating all possibilities of consumer misunderstandings." FDA disputed comments asserting that the agency is "conducting validity assessments for health claims in an unduly restrictive manner, and that health claims are more difficult to get approved than to get a new drug claim approved." FDA said it "knows of no standard and procedure for dietary supplements that would both be more lenient than the standard and procedure for foods in conventional food form and yet still have the characteristics that FDA considers necessary under" the NLEA. The proposal makes dietary supplements subject to the "general requirements that apply to all other types of food with respect to the use of health claims" in labeling and "the content of petitions for obtaining approval of such health claims." The June 18 notice was mandated by the Dietary Supplement Act of 1992, which imposed a moratorium on FDA implementation of the NLEA for supplements until December 1993. The proposal carries a 60-day comment period and becomes effective Dec. 18. FDA estimated the cost of the proposed reg on dietary supplements at $ 20 mil. The notice allows the same health claims authorized under the NLEA for foods: calcium-osteoporosis, sodium-hypertension, dietary fat-cancer, and dietary saturated fat and cholesterol and coronary heart disease. However, only one of these claims is applicable to supplements -- calcium-osteoporosis. Separately, FDA announced that it would authorize health claims for folic acid and the prevention of neural tube defects in a proposal slated for publication in July, and would also consider the relationship between antioxidant vitamins and cancer (see following story). Like health claims for foods, claims for dietary supplements will be allowed if the "totality of publicly available scientific evidence" supports the claim and there is "scientific agreement among qualified experts that the claim is supported by such evidence." Specific criteria that must be met before a substance can be the subject of a health claim are: that the ingredient be associated with a disease or health-related condition for which the general U.S. population is at risk, that the ingredient be a food, and that use of the ingredient be "safe and lawful under applicable food safety provisions." To accommodate supplements, FDA proposed adding the phrase "regardless of whether the food is in conventional food form or dietary supplement form" to the requirement that the substance be a food. In the proposal, FDA defines the term "dietary supplement" as a "food, not in conventional food form, that supplies a component to supplement the diet by increasing the total dietary intake of that component." The agency noted that the definition is a departure from its previous position that the term "dietary supplement" be applied only to "supplements composed of essential nutrients." The expansion of the definition, FDA explained, was to accommodate substances such as herbs, which "contain few essential nutrients" but are used for taste or aroma. The requirement that a substance subject to a health claim be a food, FDA said, is to "assure that health claims are made for substances that are, in fact, foods" and not drugs. For example, the agency said, "some vitamins have therapeutic effects when consumed at levels far above those that are normally characteristic of food. When the vitamins are intended to be consumed at those levels to have those therapeutic effects, they are drugs and not foods." FDA noted that a good example of this is niacin, which at "very high levels" can be used to treat elevated cholesterol levels. "The levels of niacin that are necessary to have this treatment effect are far in excess of those at which there is tissue saturation for niacin's vitamin function." Thus, a claim for niacin's cholesterol-lowering effect "is not a health claim" allowed under NLEA. FDA emphasized, however, that it "will not consider a dietary supplement to be a drug simply because it contains vitamins or minerals at levels above those found in food." But "if a claim reveals that the product is intended for a use other than for its taste, aroma, or nutritive value," then it will not be treated as a food. In response to comments suggesting that FDA use a committee to review health claim petitions for herb products, the agency said "it has tentatively decided not to adopt the requested mechanism for evaluating the validity of claims for herbs and botanicals." "The mechanism would involve a significant transfer of agency authority for health claims, and there is no basis" for such a transfer, FDA declared. The comments had urged that an "expert panel" would "relieve FDA of all responsibility for initial review" of health claim petitions for herbal products. The agency suggested that the herbal product industry may, however, "work through committees in preparing well-supported petitions for submission to FDA." FDA added that "while [it] may use advisory committees in the future to review petitioned-for health claims, as it is currently doing with folic acid, the agency would expect such committees to be broader in scope than simply herbs."

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