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Dietary Supplements: A Definition That is Black, White, and Gray

Published online by Cambridge University Press:  06 January 2021

Suzan Onel
Suzan Onel*
Affiliation:
Kirkpatrick & Lockhart Nicholson Graham LLP, FDA Practice; University of Pennsylvania, 1986; University of Virginia
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Extract

The Dietary Supplement Health and Education Act of 1994 (“DSHEA” or “the Act”) was a seminal event in the world of food and drug law. The Act took a controversial category of product traditionally regulated by FDA as either a food or a drug, depending upon the product claims and formulation, and created a new regulatory category called “dietary supplement” that was placed within the “food” definition. As such, products meeting the “dietary supplement” definition benefited in two significant ways, (1) dietary supplements could make “structure/function” claims traditionally within the realm of drug products; and (2) unlike food ingredients, dietary ingredients could be used in dietary supplements without being either approved food additives or generally recognized as safe (“GRAS”) ingredients. These legislative provisions significantly changed the legal, corporate, and consumer landscape, allowing products to enter the marketplace with broadbased claims without FDA premarket review or approval of the ingredients, formulation, or product claims.

Type
Article
Information
American Journal of Law & Medicine , Volume 31 , Issue 2-3 , June 2005 , pp. 341 - 348
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2005

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References

1 Dietary Supplement Health and Education Act of 1994, Pub. L. No. 103-417, 108 Stat. 4325 (1994) [hereinafter DSHEA].

2 DSHEA § 3(a).

3 Id.

4 Id.

5 Id.

6 See, e.g., Letter from Felicia B. Satchell, Director, Division of Standards and Labeling Regulations, CFSAN, FDA to Jason S. Crush, Docket No. 1995S-0316 RPT 162 (Aug. 29, 2002) (on file with American Journal of Law & Medicine).

7 Coalition to Preserve DSHEA, Citizen Petition, “Erroneous Interpretation of the Statutory Definition of the Term Dietary Supplement’” (Docket 2004P-0169), April 8, 2004.

8 Federal Food, Drug & Cosmetic Act, 21 U.S.C. § 321(ff)(2)(A)(i) (2000); DSHEA § 3(a)

9 21 U.S.C. § 350 (c)(1)(B)(i).

10 DSHEA §§ 3(a), 3(c).

11 United States v. Ten Cartons, 888 F. Supp. 381, 393-94 (E.D.N.Y. 1995), aff’d, 72 F.3d 285 (2d Cir. 1995).

12 Id.

13 Id.

14 See, e.g., Courtesy Letter from Susan J. Walker, Dir., Div. of Dietary Supplement Programs, FDA, to Sara Katz, President, Herb Pharm. (Jan. 15, 2004) (regarding herbal mouthwash), available at http://www.fda.gov/ohrms/dockets/dailys/04/July04/071204/071204.htm; Courtesy Letter from Susan J. Walker Dir., Div. of Dietary Supplement Programs, FDA to Michael Pelton, Vice President, Biotech Corp., Inc. (May 5, 2004) (regarding anti-hair thinning topical solution) available at http://www.fda.gov/ohrms/dockets/dailys/04/June04/062904/062904.htm; Courtesy Letter from Susan Walker, Dir., Div. of Dietary Supplement Programs, FDA to Gladys Valencia, Dir., HerbsForever, Inc. (June 21, 2004) (regarding massage oils for topical external use) available at http://www.fda.gov/ohrms/dockets/dailys/04/June04/062904/062904.htm.

15 21 U.S.C. § 321(ff)(2)(B), DSHEA § 3(a).

16 See, e.g., Courtesy Letter from Susan J. Walker Dir., Div. of Dietary Supplement Programs, FDA, to John Morley, President, Natural Factors Nutritional Products, Inc. (Aug. 4, 2004) (regarding SlimStyles™ Weight Loss Drink Mix with PGX™), available at http://www.fda.gov/ohrms/dockets/dailys/04/aug04/081004/081004.htm; Courtesy Letter from Susan J. Walker Dir., Div. of Dietary Supplement Programs, FDA, to Ira W. Berman, Chairman, CCA Industries, Inc. (Aug. 4, 2004) (regarding Mega-T Chewing Gum), available at http://www.fda.gov/ohrms/dockets/dailys/04/aug04/081004/081004.htm; Warning Letter from John B. Foret, Dir., Division of Compliance and Enforcement, Office of Nutritional Products and Dietary Supplements, FDA, to Cynthia Davis, Exec. Vice President, US Mills, Inc. (June 5, 2001) (regarding New Morning Organic GingkOs and Organic Ginseng Crunch cereal products) available at http://www.fda.gov/foi/warning_letters/g1320d.pdf; and Courtesy Letter from John B. Foret, Director, Division of Programs and Enforcement Policy, Office of Food Labeling, FDA, to Myron Cooper to Hain Food Group (June 21, 1999) (regarding Kitchen Prescription soup line).

17 Letter from Joseph A. Levitt, Dir., Center for Food Safety and Applied Nutrition, FDA to Brian D. Perkins, President, McNeil Consumer Products (Oct. 28, 1998) (on file with author).

18 Id.

19 21 U.S.C. § 321(ff)(3)(A); DSHEA § 3(a).

20 21 U.S.C. § 321 (ff)(3)(B)(i)-(ii); DSHEA § 3(a).

21 21 U.S.C. § 321(ff)(3)(A).

22 2001 U.S. Dist. LEXIS 4598 (D. Utah Mar. 30, 2001).

23 Id. at 8-9 (“Pharmanex argues … that the relevant article’ is the dietary ingredient contained in Cholestin, known as red yeast rice … the article’ was never in fact approved by FDA as a new drug, and marketing Cholestin as a dietary supplement is lawful.”).

24 Id. at 5 (“FDA determined that the relevant article’ … is lovastatin based on evidence that … Pharmanex manufactures Cholestin in a manner designed to ensure that the product contains significant amounts of lovastatin, and … Pharmanex promotes Cholestin for its lovastatin content.”).

25 Id. at 2 (“This court found that Cholestin is a dietary supplement’ … based on the determination that § 321(ff)(3)(B) refers unambiguously to finished drug products, rather than their individual constituents.”).

26 See Pharmanex v. Shalala, 221 F.3d 1151 (10th Cir. 2000).

27 Letter from William B. Schultz, Deputy Commissioner for Policy, FDA to Stuart M. Pape), 21 (May 20, 1998) (regarding Pharmanex, Inc., Administrative Proceeding Docket No. 97P-0441 (upheld on remand from 10th Circuit by District Court in Pharmanex v. Shalala (Mar. 30, 2001)), available at http://www.fda.gov/ohrms/dockets/dockets/97p0441/97p0441.htm.

28 Id.

29 21 U.S.C. § 321(ff)(3)(B)(ii).

30 I. SCOTT BASS & ANTHONY L. YOUNG, DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT: A LEGISLATIVE HISTORY AND ANALYSIS (FDLA 1996).

31 Id.

32 21 U.S.C. § 321(ff)(B)(2) (“an article authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public.”).

33 140 CONG. REC. S14801 (daily ed. Oct. 7, 1994).

34 Informal Telephone Conversation with FDA (2002).

35 21 U.S.C. § 321(ff)(2)(C); DSHEA § 3(a).

36 21 C.F.R. § 101.3(g) (2005).

37 See e.g., Warning Letter from David J. Horowitz, Acting Director, Office of Compliance, Center for Drug Evaluation and Research, FDA to James Ascher, Sr., President and CEO, B.F. Ascher & Company, Inc. (Oct. 16, 2001)(regarding Melagesic™ PM Caplets, which were marketed as a combination drug-dietary supplement containing acetaminophen and melatonin); Warning Letter from David J. Horowitz, Acting Director, Office of Compliance, Center for Drug Evaluation and Research, FDA to Klee Irwin, President and CEO, Omni Nutraceuticals, Inc. (Oct. 6, 2001) (regarding Inholtra Joint Pain Caplets, which were marketed as a combination drug-dietary supplement containing acetaminophen and glucosamine sulfate).

38 DSHEA, supra note 1.

39 Id.

40 See GEN. ACCT. OFF., FOOD SAFETY: IMPROVEMENTS NEEDED IN OVERSEEING THE SAFETY OF DIETARY SUPPLEMENTS AND “FUNCTIONAL FOODS” 9 (2000), available at http://www.gao.gov/archive/2000/rc00156.pdf.