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FDA PREPARES TO LIMIT ACCESS TO SUPPLEMENTS: COUNCIL FOR RESPONSIBLE NUTRITION POSITION STATEMENT

 WASHINGTON, Nov. 12 /PRNewswire/ -- The Council for Responsible Nutrition (CRN) issued the following:
 Consumers have a basic right to access safe, quality-made dietary supplements and to access truthful and nonmisleading information about these products. Senior U.S. Food and Drug Administration (FDA) officials state publicly (at congressional hearings, in response to congressional inquiries and in the media) that they recognize most vitamins and minerals are safe within a broad range of intakes and that the agency does not intend to impose severe limitations on these products.
 But, at the same time, FDA's June 18, 1993 Advance Notice of Proposed Rulemaking (ANPR) flatly contradicts these top FDA officials. Further clouding this matter are numerous statements -- again made by top FDA officials -- that the ANPR should not elicit such concern, as it only presents concepts from an internal report issued by the agency's Task Force on Dietary Supplements. FDA has requested comments on the ANPR.
 It's time to set the record straight by looking at exactly what FDA has said. Failure to take FDA's words seriously now could impede 100 million Americans' access to dietary supplements in the future.
 The bolded excerpts below are taken from the ANPR and illustrate discrepancies between FDA's soothing "not to worry" rhetoric and the agency's official document. FDA's proposal could lay the groundwork for future, more restrictive regulations that could deny product and information access.
 -- Vitamins and Minerals
 FDA is considering whether it should "establish safe levels of use for
vitamins and essential minerals in dietary supplements." These levels would be "the maximum daily safe supplemental intake for a given vitamin or essential mineral, called a `dietary supplement limit' (DSL)." (Federal Register, June 18, 1993, "Dietary Supplements; General Requirements for Nutrition Labeling; Proposed Rules" p. 33694, column 3).
 The subject of vitamin and mineral safety is not a real issue. Most vitamins -- including vitamins C and E, all the B vitamins and beta- carotene -- are safe within a broad intake. When safety issues arise, they are generally due to therapeutic use of vitamins at levels up to several hundred times the Recommended Dietary Allowance (RDA). A few vitamins -- especially vitamins A & D -- and most minerals have a narrower range of safety. The Council for Responsible Nutrition has taken self-regulatory action by recommending upper limits in those new cases where limits are appropriate.
 Moreover, the dietary supplement industry has an excellent safety record. FDA has not needed to take action in this area, except for rare product recalls due to inadvertent formulation errors or product contamination.
 FDA says that one approach to establishing upper limits "would be for the agency to propose to affirm as GRAS (with certain specific exceptions) the highest RDA levels listed by the National Academy of Sciences." (Federal Register, June 18, 1993, "Dietary Supplements; General Requirements for Nutrition Labeling; Proposed Rules" p. 33695, column 1).
 The RDA is the wrong tool to evaluate safety. It is only intended to measure nutritional adequacy. To set safety limits for vitamins and minerals on a standard that does not consider optimal intakes would arbitrarily and capriciously restrict availability of vitamins and minerals. This would fly in the face of scientific data that supports a role for supplements in disease prevention, usually at more generous levels than the RDA. Under the FDA scenario, consumers may still be able to buy a 60 mg. tablet of vitamin C to assure basic adequacy, but may be denied access to 500 mg. to help protect against cancer, cataracts and other chronic diseases.
 The dietary supplement limits concept is reminiscent of FDA's failed attempt in 1973 to limit dietary supplements to no more than 150 percent of the RDA of any nutrient and to classify all higher levels as drugs. This FDA proposal also led directly to passage of the Rogers-Proxmire amendments to the Food, Drug and Cosmetic Act in 1976.
 As further evidence of laying the groundwork for taking a more restrictive approach, FDA cites a Life Sciences Research Office, Federation of American Societies of Experimental Biology (LSRO/FASEB) report on "Guidelines for Safety Evaluation of Nutrients" which "concluded that, in the absence of toxicological testing, nutrients cannot be assumed to be free of adverse effects even at intake possible from normal diets." (Federal Register, June 18, 1993, "Dietary Supplements; General Requirements for Nutrition Labeling; Proposed Rules" p. 33694, column 2)
 If any product presents demonstrated safety concerns, it should be addressed on a case-by-case basis, but FDA must set forth the scientific basis for those concerns. Supplements have a long history of safe use at recommended levels of intake.
 -- Other Dietary Supplements
 Amino acids are currently approved by FDA only for specific food additive uses. The ANPR states that:
 "FDA considers all other uses of amino acids in food to represent unapproved and therefore unlawful uses of food additives." (Federal Register, June 18, 1993, "Dietary Supplements; General Requirements for Nutrition Labeling; Proposed Rules," p. 33696, column 2)
 According to the ANPR, all dietary supplement ingredients are "food additives" which ignores several recent federal court judgments to the contrary. FDA has repeatedly attempted to classify several nutrients as food additives and thus to ban them from the market on the grounds that they have not been pre-cleared by FDA. The courts have ruled that "special dietary foods" are required to be safe and wholesome, but do not have to be formally pre-cleared by FDA.
 "The (Dietary Supplement) Task Force recommended that amino acid- containing dietary supplements be regulated as drugs." (Federal Register, June 18, 1993, "Dietary Supplements; General Requirements for Nutrition Labeling; Proposed Rules," p. 33696, column 2)
 "FDA intends to bring amino acid-containing supplements into compliance with the law ... FDA will consider whether the drug uses of particular amino acids are so well-established and widespread as to justify rulemaking to establish as a matter of law that these products are drugs." (Federal Register, June 18, 1993, "Dietary Supplements; General Requirements for Nutrition Labeling; Proposed Rules," p. 33697, column 3)
 The Food, Drug and Cosmetic Act does not expressly recognize dietary supplements as a distinct regulatory category. Dietary supplements are encompassed within the category of "foods for special dietary use." Over the years, FDA has attempted to regulate dietary supplements sometimes as foods, sometimes as food additives and sometimes as drugs.
 -- The Need for a Rational Regulatory Framework to Protect Consumer
 Access
 The ANPR should be withdrawn by FDA because it proposes unreasonable and arbitrary restrictions on the consumer's ability to access dietary supplements and information about the health benefits of these products. New legislation is needed now, or FDA may continue its misguided policy of restricting access to products that consumers want and need to make healthy dietary choices. Congress must help create a new regulatory framework for supplements based on advances in sound science, safe, high-quality products and accurate, truthful and non-misleading consumer information.
 -0- 11/12/93
 /CONTACT: Mary Burnette of the Council for Responsible Nutrition, 202-872-1488/


CO: Council for Responsible Nutrition; Food and Drug Administration ST: District of Columbia IN: HEA SU:

KD-DT -- DC019 -- 3720 11/12/93 13:24 EST
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Date:Nov 12, 1993
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