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Published online by Cambridge University Press: 06 January 2021
1 See Justin Gillis, Herbal Remedies Turn Deadly for Patients, WASH. POST, Sept. 5, 2004, at A1.
2 See Rob Stein, Alternative Remedies Gaining Popularity, WASH. POST, May 28, 2004, at A1 (describing the results of this government-funded study of 31,000 adults from around the country).
3 See Colloton, Meghan, Comment, Dietary Supplements: A Challenge Facing the FDA in Mad Cow Disease Prevention, 51 Am. U. L. Rev. 495, 512-24 (2002)Google Scholar (providing a detailed history of the agency's regulatory efforts from 1941 through the enactment of the Dietary Supplement Health and Education Act in 1994); see also Gilhooley, Margaret, Herbal Remedies and Dietary Supplements: The Boundaries of Drug Claims and Freedom of Choice, 49 Fla. L. Rev. 665, 672-78 (1997)Google Scholar.
4 See Advance Notice of Proposed Rulemaking on Dietary Supplements, 58 Fed. Reg. 33,690 (June 18, 1993) (recommending that the FDA establish safe levels for use of vitamins and minerals, that it regulate 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”)); see also Colloton, supra note 3, at 522-23 (noting that the ANPRM focused primarily on the inherent risks of dietary supplements, rather than on issues surrounding health claims for these products).
5 Dietary Supplement Health and Education Act of 1994, Pub. L. No. 103-417, 108 Stat. 4325 (1994).
6 See McNamara, Stephen H., Dietary Supplements of Botanicals and Other Substances, 50 Food Drug L.J. 341, 341 (1995)Google ScholarPubMed (explaining that “[m]any members of the House of Representatives and Senate stated that they had received more mail, phone calls, and constituent pressure on [reducing the regulatory burdens on dietary supplements] than on anything else–including health care reform, abortion, or the deficit”).
7 See, e.g., Cohen, Michael H., U.S. Dietary Supplement Regulation: Belief Systems and Legal Rules, 11 Hastings Women'S L.J. 3, 21 (2000)Google Scholar (“Ideally, one would hope that … the body politic would be seen as a holographic collection of autonomous, responsible beings, intelligently engaged in the individual pursuit of well-being, rather than as a ravenous, gullible and unpredictable horde prey to mesmerizing pill-pushers.”).
8 See, e.g., Gilhooley, Margaret, Deregulation and the Administrative Role: Looking at Dietary Supplements, 62 Mont. L. Rev. 85, 101-02 (2001)Google Scholar (describing and discussing permitted structure or function claims on dietary supplement labels that “are beyond the consumer's ability to assess” and that “relate to important physical functions”); see also Silverglade, Bruce A., Regulating Dietary Supplement Safety Under the Dietary Supplement Health and Education Act: Brave New World or Pyrrhic Victory?, 51 Food Drug L.J. 319, 319-20 (1996)Google ScholarPubMed (criticizing the legislation for purporting to protect the consumer right to purchase supplements despite the fact that there was never any risk that such products, as a group, would be removed from the market).
9 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).
Pub. L. No. 103-417, § 3(a), 108 Stat. 4325 (1994) (codified at 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). By adding herbs and amino acids to the definition of “dietary supplement,” DSHEA brought these ingredients under the umbrella of the Proxmire Amendment, which has prevented the FDA from classifying dietary supplements as drugs. See Vitamin and Mineral Amendments of 1976, Pub. L. No. 94-278, § 501, 90 Stat. 401 (1976) (codified at 21 U.S.C. § 350(a), (c)).
10 See Gilhooley, supra note 3, at 701; McNamara, supra note 6, at 343 n.7 (citing FDA's Compliance Policy Guide, Botanical Products for Use as Food, No. 7117.04). The FDA later withdrew this guidance document without comment. See Dietary Supplements: Notice of Withdrawal of Regulatory Guidance, 60 Fed. Reg. 19,597 (Apr. 19, 1995).
11 See 21 U.S.C. § 321(s)(6). The FDCA subjects food additives to premarket review in order to determine whether such substances are safe for use. 21 U.S.C. §§ 348(a)-(c). The FDA has, however, exempted from premarket approval requirements substances added to food that are generally recognized as safe (“GRAS”). See 21 C.F.R. § 170.30(a) (2004).
12 The statutory definition of a “drug” generally depends on intended use rather than on the mere fact of pharmacological activity. See, e.g., United States v. Article of Drug Bacto-Unidisk, 394 U.S. 784 (1969); United States v. Loran Med. Sys., Inc., 25 F. Supp. 2d 1082, 1086 (C.D. Cal. 1997) (fetal cells injected to stimulate insulin production); Zitter, Jay M., Annotation, What Is “Drug” Within Meaning of § 201(g)(1) of Federal Food, Drug, and Cosmetic Act, 127 A.L.R. Fed. 141 (1995 & 2004 Supp.)Google Scholar. The FDA generally selects its regulatory approach for an individual product based on its intended use rather than on the essential attributes of the product. See LARS NOAH & BARBARA A. NOAH, LAW, MEDICINE, AND MEDICAL TECHNOLOGY: CASES AND MATERIALS 6-50 (2001) (discussing product categories, intended use, and the various factors driving the FDA's regulatory approach).
13 21 U.S.C. § 355 (premarket review provisions of the FDCA); see also Merrill, Richard A., The Architecture of Government Regulation of Medical Products, 82 Va. L. Rev. 1753, 1761-76 (1996)CrossRefGoogle Scholar (providing a detailed discussion of how the current new drug approval process evolved from earlier approaches).
14 See 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.
15 See 21 U.S.C. § 343(r)(6)(B); see also FDA, Center for Food Safety and Applied Nutrition, Structure/Function Claims Small Entity Compliance Guide (Jan. 9, 2002), available at http://www.cfsan.fda.gov/∼dms/sclmguid.html (providing examples of permissible claims and advice about divining the difference between structure and function claims and impermissible disease claims). Neither the statute nor its legislative history elaborate on the type or quantity of evidence that would be sufficient to provide such substantiation. The FDA has, however, enforced the substantiation requirement in cases where manufacturers make claims that cross the line from structure or function claims to therapeutic drug claims. For example, in 2003, the agency initiated regulatory action against the manufacturer of Coral Calcium Supreme, which was advertised as a cure for colon cancer, multiple sclerosis, heart disease, and lupus. See Healy, Melissa, Coral Calcium Scrutinized: Regulators Say Some Supplement Sellers Make Outrageous Claims About Its Benefits, L.A. TIMES, Sept. 29, 2003Google Scholar, at F1 (observing that the product continued to be available on the market pending a court challenge although the manufacturer was forced to stop airing its infomercials).
16 See 21 U.S.C. § 343(r)(6)(C). The decision to permit structure or function claims for supplements is quite remarkable given that the statutory definition of a drug includes those products intended to treat or prevent disease and those products intended to affect the structure or function of the body. See 21 U.S.C. § 321(g)(1)(C).
17 See 21 U.S.C. § 321(g)(C) (“The term drug’ means … articles (other than food) intended to affect the structure or function of the body of man … “).
18 See 21 U.S.C. § 343(r)(6)(C) (2000). For example, a bottle of St. John's Wort may contain a structure or function claim such as “promotes mental well-being,” but may not claim that the product is effective in alleviating the symptoms of clinical depression. A label on a bottle of Saw Palmetto extract may state that the product “promotes prostate health” but may not claim that it treats the symptoms of benign prostatic hyperplasia. See FDA, Letter to Jonathan W. Emord, Dietary Supplement Claim for Saw Palmetto Extract and Benign Prostatic Hyperplasia: Denied, May 26, 2000, available at http://www.cfsan.fda.gov/∼dms/dspltr01.html.
19 The FDCA defines a “drug” as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man” and “articles (other than food) intended to affect the structure or any function of the body of man.” See 21 U.S.C. § 321(g)(1)(B)-(C). The definitional provisions specifically exempt foods and dietary supplements from regulation as drugs, even if their labeling contains certain types of health claims permitted under DSHEA. 21 U.S.C. § 321(g)(1)(D). Even so, the FDA occasionally has argued that a component of a supplement product is inherently a drug. See, e.g., Pharmanex v. Shalala, 221 F.3d 1151 (10th Cir. 2000).
20 21 U.S.C. § 342(f)(1)(A), (C).
21 See Barton Hutt, Peter, FDA Statutory Authority to Regulate the Safety of Dietary Supplements, 31 Am. J.L. & Med. 155 (2005)CrossRefGoogle Scholar.
22 See Cohen, Peter J., Science, Politics, and the Regulation of Dietary Supplements: It's Time to Repeal DSHEA, 31 Am. J.L. & Med. 175 (2005)CrossRefGoogle ScholarPubMed.
23 See McCann, Michael A., Dietary Supplement Labeling: Cognitive Biases, Market Manipulation & Consumer Choice, 31 Am. J.L. & Med. 215 (2005)CrossRefGoogle ScholarPubMed.
24 See Ziker, Dana, What Lies Beneath: An Examination of the Underpinnings of Dietary Supplement Regulation, 31 Am. J.L. & Med. 269 (2005)CrossRefGoogle Scholar.
25 See Bass, Scott & Marden, Emily, The New Dietary Ingredient Safety Provision of DSHEA: A Return to Congressional Intent, 31 Am. J.L. & Med. 285 (2005)CrossRefGoogle ScholarPubMed.
26 See Hahn, Martin, Functional Foods: What Are They? How Are They Regulated? What Claims Can be Made? 31 Am. J.L. & Med. 305 (2005)CrossRefGoogle Scholar.
27 See Onel, Suzan, Dietary Supplements: A Definition that is Black, White, and Gray, 31 Am. J.L. & Med. 341 (2005)CrossRefGoogle Scholar.
28 See Mehlman, Maxwell J., Quackery, 31 Am. J.L. & Med. 349 (2005)CrossRefGoogle ScholarPubMed.
29 See FDA, Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk, 69 Fed. Reg. 6788 (Feb. 11, 2004)Google Scholar. Several dietary supplement firms that manufacture ephedra-containing products challenged the ban, alleging that the rule is arbitrary and capricious. See NVE, Inc. v. Dep't of Health and Human Serv., No. 04- CV-999 (D.N.J 2004); Nutraceutical Corp. v. Crawford, No. 2:04CV00409 (D. Utah); see also Phil Wallace, Utah Firms File Lawsuit Challenging Ephedra Ban, FOOD CHEM. NEWS, May 10, 2004, available at 2004 WL 67505224.
30 See Nutraceutical Corp. v. FDA, 2005 WL 852157 (D. Utah).
31 See id. at 6.
32 See id. at 1.
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