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Dietary Supplements: Reports Reviewed by Tia Powell and Barbara A. Noah

Institute of Medicine, Dietary Supplements: A Framework for Evaluating Safety (Washington, D.C., 2005)

Published online by Cambridge University Press:  01 January 2021

Tia Powell  and
Barbara A. Noah J.D.
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Extract

The Institute of Medicine’s 2005 publication, Dietary Supplements: A Framework for Evaluating Safety, is authoritative and thorough, and thus representative of other reports by the Institute of Medicine (IOM). What makes this report particularly interesting, however, is the rich political subtext that exists in the interstices of the report, popping up here and there in brief comments and barely suppressed yelps of exasperation. To understand this context, it is useful to reflect for a moment on the special nature of the IOM and its relationship to government.

IOM is part of the National Academy of Sciences, and is a private, non-governmental organization that does not receive direct federal funding for its work. Rather, IOM studies are often funded by contract with governmental entities that request reports on particular topics. As a case in point, the dietary supplement study was requested and paid for by the FDA.

Type
Reviews in Medical Ethics
Information
Journal of Law, Medicine & Ethics , Volume 33 , Issue 4 , Winter 2005 , pp. 857 - 865
Copyright
Copyright © American Society of Law, Medicine and Ethics 2005

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References

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FDA, Advance Notice of Proposed Rulemaking on Dietary Supplements, 58 Fed. Reg. 33,690 (1993) (recommending that the FDA establish safe levels for use of vitamins and minerals, that it regulate drugs amino acid-containing dietary supplements as drugs, and that various other types of supplements be evaluated under the food provisions of the statute in order to determine whether they are generally recognized as safe [GRAS]).Google Scholar
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“Definition of certain foods as dietary supplements, 21 U.S.C. § 321, is amended by adding at the end the following: The term dietary supplement: (1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: (A) a vitamin; (B) a mineral; (C) an herb or other botanical; (D) an amino acid; (E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or (F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E).” 21 U.S.C. § 321 ff 2000. The statute further defines dietary supplements as products that are labeled as “dietary supplements” and are not represented for use as a conventional food or as a sole item of a meal or the diet. See 21 U.S.C. § 321(ff).Google Scholar
21 U.S.C. § 321(s)(6). The FDCA subjects food additives to pre-market review in order to determine whether such substances are safe for use. See id. § 348(a)-(c). The FDA has, however, exempted from pre-market approval requirements substances added to food that are generally recognized as safe (“GRAS”). See 21 C.F.R. § 170.30(a) (2004); also see generally Noah, L. and Merrill, R. A., “Starting from Scratch? Reinventing the Food Additive Approval Process,” Boston University Law Review 78 (1998): 329–95, at 392–95.Google Scholar
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A company wishing to sell a supplement containing a “new dietary ingredient,” (defined as one not marketed before October 15, 1994) however, must file a notification with the FDA at least 75 days prior to market introduction, which provides the basis for the manufacturer's conclusion that the supplement will “reasonably be expected to be safe” and must demonstrate only that “[t]here is a history of use or other evidence of safety.” 21 U.S.C. § 350b(2). If the agency finds the notification inadequate, it can prevent marketing only by initiating formal enforcement proceedings, under the provisions of DSHEA.Google Scholar
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FDA, Ephedrine Final Rule, 69 Fed. Reg. 6788 (2004). Several dietary supplement firms that manufacture ephedra-containing products challenged the ban, alleging that the FDA's rule is arbitrary and capricious. See Wallace, P., “Utah Firms File Lawsuit Challenging Ephedra Ban,” Food Chemical News, May 10, 2004, available at 2004 WL 67505224 (describing several legal challenges).Google Scholar
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Id. at 1319. The court also objected to the FDA rule because it considered all ephedrine-containing supplements to pose an unreasonable risk despite wide variations among products in amounts of active ingredients and recommended dosages. Another industry challenge to the Ephedrine Final Rule remains unresolved. See NVE, Inc. v. HHS, No. 04-CV-999 (D.N.J. 2004).Google Scholar
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Id. at 26–27. The U.S. Centers for Disease Control and Prevention are working to collect more comprehensive data on supplement use.Google Scholar
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See id. at 35 (observing that such assumptions ignore the fact that herbal products in particular vary in their concentration and potency of active ingredients and that modern consumers lack the knowledge and experience of traditional healers). DSHEA itself reinforces this misconception-the statute only requires premarket submission of safety data for supplements containing a “new dietary ingredient.” For these products, manufacturers must submit evidence to FDA 75 days prior to marketing that demonstrates that “[t]here is a history of use or other evidence of safety.” 21 U.S.C. § 350b(2).Google Scholar
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