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What Lies Beneath: An Examination of the Underpinnings of Dietary Supplement Safety Regulation

Published online by Cambridge University Press:  06 January 2021

Dana Ziker
Dana Ziker*
Affiliation:
Washington, D.C. office of the law firm of Kenyon & Kenyon
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Extract

In response to the increasing attention to the link between health and nutrition, a wealth of information—and misinformation—is becoming available, especially via the Internet. Consumers are advised to carefully assess the reliability of information they use to determine whether a product is safe. Meanwhile, regulators are sorting out the facts themselves, but despite the ever-increasing availability of scientific research, our evolving understanding of nutrition is still supplemented by our perceptions about risk.

The primary framework for the regulation of dietary supplements is the Dietary Supplement Health and Education Act of 1994 (“DSHEA”). Underlying DSHEA is the congressional intent to support two goals: “(1) to facilitate consumer access to dietary supplements, given that many dietary supplements are used by consumers to help them maintain and improve their health; and (2) to give the Food and Drug Administration (“FDA”) the authority to step in where safety problems arise and to ensure proper labeling.”

Type
Article
Information
American Journal of Law & Medicine , Volume 31 , Issue 2-3 , June 2005 , pp. 269 - 284
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2005

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Footnotes

†

The views expressed within are those of the author and do not necessarily represent the views of Kenyon & Kenyon.

References

1 See FDA, Tips for the Savvy Supplement User: Making Informed Decisions and Evaluating Information, at http://www.cfsan.fda.gov/∼dms/ds-savvy.html (last visited May 16, 2005).

2 Dietary Supplement Health and Education Act of 1994, Pub. L. No. 103-417, 108 Stat 4325 (codified at 21 U.S.C. §301 (1994)) [hereinafter DSHEA].

3 Levitt, Joseph A., Regulation of Dietary Supplements: FDA's Strategic Plan, 57 Food Drug L.J. 1, 1 (2002)Google ScholarPubMed.

4 Noah, Lars & Merrill, Richard A., Starting From Scratch?: Reinventing the Food Additive Approval Process, 78 B.U. L. Rev. 329, 331 (1998)Google Scholar.

5 Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301-97 (2000).

6 Noah & Merrill, supra note 4, at 331.

7 21 U.S.C. § 321(f).

8 Food Additive Amendments of 1958, Pub. L. No. 85-929, § 1, 72 Stat. 1784 (1958).

9 Noah & Merrill, supra note 4, at 331-32.

10 Ringel Heller, Ilene, Functional Foods: Regulatory and Marketing Developments, 56 Food & Drug L.J. 197, 198 (2001)Google Scholar.

11 21 U.S.C. § 321(s).

12 See United States v. Two Plastic Drums, 984 F.2d 814, 819-20 (7th Cir. 1993); see also McNamara, Stephen H. & Wes Siegner, A. Jr.,, FDA Has Substantial and Sufficient Authority to Regulate Dietary Supplements, 57 Food & Drug L.J. 15, 16 (2002)Google ScholarPubMed.

13 Two Plastic Drums, 894 F.2d at 819-20.

14 Id. at 819.

15 Id. at 819-20.

16 United States v. Oakmont Inv. Co., 987 F.2d 33, 39 (1st Cir. 1993).

17 McNamara & Siegner, supra note 12, at 15.

18 Id. at 16-17.

19 See, e.g., 21 U.S.C. § 350b(b).

20 21 U.S.C. §§ 321(ff)(1)(A)-(F).

21 21 U.S.C. § 350(c)(1)(B)(i).

22 21 U.S.C. § 350(c)(1)(B)(ii).

23 See 21 U.S.C. § 350b(b).

24 21 U.S.C. § 350b(a)(2).

25 21 U.S.C. § 350b(c).

26 21 U.S.C. § 342(f)(1)(A).

27 21 U.S.C. § 342(f)(1)(C).

28 See Bren, Linda, FDA's Response to Food, Dietary Supplement, and Cosmetic Adverse Events, 37 Fda Consumer Mag., July-Aug. 2003Google ScholarPubMed, available at http://www.fda.gov/fdac/features/2003/403_food.html.

29 21 U.S.C. § 321(g)(1)(B).

30 See Drug Safety and the Drug Approval Process: Hearing before the Senate Committee on Health, Education, Labor, and Pensions (March 5, 2005) (statements of Janet Woodcock, M.D., Acting Deputy Commissioner for Operations, U.S Food and Drug Administration (FDA), Department of Health and Human Services), available at http://www.hhs.gov/asl/testify/t050303b.html.

31 See FDA, Frequently Asked Questions on the Regulatory Process of Over-the-Counter (OTC) Drugs, at http://www.fda.gov/cder/about/smallbiz/OTC_FAQ.htm (Apr. 5, 2004).

32 Id.

33 Id.

34 Rebecca Gelfond, Regulating Homeopathic Drugs: Pragmatic Solutions for the Food and Drug Administration, LEDA at Harvard Law School (Feb. 8, 1999), at http://leda.law.harvard.edu/leda/data/342/Gelfond.html.

35 FDA, supra note 31.

36 Dixie Farley, Benefit vs. Risk: How the FDA Approves New Drugs, FDA Consumer Special Report (Jan. 1995), at http://www.fda.gov/cder/regulatory/applications/default.htm.

37 FDA, supra note 31.

38 Id.

39 See Farley, supra note 36.

40 See id.

41 See generally PETER BARTON HUTT & RICHARD A. MERRILL, FOOD AND DRUG LAW 514- 37 (2d ed. 1991) (discussing the FDA's process for approving new drugs, including estimated costs and timelines for clinical trials).

42 FDA, supra note 31.

43 Id.

44 Id.

45 See 21 C.F.R. § 314.80 (2005).

46 See HUTT & MERRILL, supra note 41, at 523-24 (“The decision to approve a drug for marketing, or to withdraw an earlier approval, requires a weighing of the benefit to be expected from use of the product against the risk inherent in its use … .”).

47 Id.

48 See DSHEA, § 2(8) (finding that “consumers should be empowered to make choices about preventive health care programs based on data from scientific studies of health benefits related to particular dietary supplements”).

49 See FDA, Fact Sheet on FDA's Strategy for Dietary Supplements (Nov. 2004), available at http://www.cfsan.fda.gov/∼dms/ds3strfs.html.

50 Levitt, supra note 3, at 3.

51 See id. at 10.

52 21 C.F.R. § 312.21(a).

53 See Weijer, Charles, The Ethical Analysis of Risk, 28 J.L. Med. & Ethics 344, 354, 356, 358 (2000)Google ScholarPubMed (discussing therapeutic index in the context of risk in medical research).

54 See CHEMISTRY DAILY, THE CHEMISTRY ENCYCLOPEDIA, at http://www.chemistrydaily.com/chemistry/Therapeutic_index.

55 This measurement is of particular importance in the context of FDA approval of generic equivalents of prescription drugs: “The Commissioner of Food and Drugs shall consider the following factors, when supported by well-documented evidence, to identify specific pharmaceutical equivalents and pharmaceutical alternatives that are not or may not be bioequivalent drug products … (c) Evidence that the [generic] drug products exhibit a narrow therapeutic ratio, e.g., there is less than a 2-fold difference in median lethal dose (LD50) and median effective dose (ED50) values, or have less than a 2-fold difference in the minimum toxic concentrations and minimum effective concentrations in the blood, and safe and effective use of the drug products requires careful dosage titration and patient monitoring.” 21 C.F.R. § 320.33 (2004).

56 See generally HUTT & MERRILL, supra note 31, at 514-37 (discussing the FDA's process for approving new drugs, including review of pre-marketing studies).

57 See FDA, Adverse Events Reporting, at http://www.cfsan.fda.gov/∼dms/ds-rept.html.small (last visited May 17, 2005).

58 DAVID ROPEIK & GEORGE GRAY, RISK: A PRACTICAL GUIDE FOR DECIDING WHAT's REALLY SAFE AND WHAT's REALLY DANGEROUS IN THE WORLD AROUND YOU 15 (Laura van Dam ed., 2002).

59 I have previously used the risk perception principles of Ropeik and Gray with relation to the doctrine of informed consent. See Ziker, Dana, Reviving Informed Consent: Using Risk Perception in Clinical Trials, 2003 Duke L. & Tech. Rev. 15 (2003)Google Scholar.

60 ROPEIK & GRAY, supra note 58.

61 Id. at 17.

62 Id.

63 Id.

64 See FDA, Recommendations for Submission of Chemical and Technological Data for Direct Food Additive and GRAS Food Ingredient Petitions (May 1993), at http://www.cfsan.fda.gov/∼dms/opa-cg4.html.

65 See id.

66 21 C.F.R. § 182.1(a) (2004).

67 21 U.S.C. § 348.

68 See FDA, Dietary Supplement Health and Education Act of 1994 (Dec. 1, 1995), athttp://www.cfsan.fda.gov/∼dms/dietsupp.html.

69 Id.

70 Id.

71 21 U.S.C. §§ 355(a)-(b)(1)(A).

72 21 U.S.C. §355(j)(1).

73 Cohen, Michael H., U.S. Dietary Supplement Regulation: Belief Systems and Legal Rules, 11 Hastings Women'S L.J. 3 (2000)Google Scholar.

74 Id. at 17-18.

75 Valuck, Thomas, Note, Keeping Dietary Supplement Regulations Slim and Fit: Finding a Healthy Balance Between Paternalism and Consumer Choice, 2 Geo. J.L. & Pub. Pol’Y 285, 297 (2004)Google Scholar.

76 21 C.F.R. § 314.80.

77 Valuck, supra note 75, at 286.

78 See Heller, supra note 10, at 199.

79 See Levitt, supra note 3, at 9.

80 See McNamara & Siegner, supra note 12, at 23.

81 See id.

82 Valuck, supra note 75, at 296.

83 See Levitt, supra note 3, at 2-3.

84 Id. at 4-5.

85 See FDA, supra note 31.

86 See Unilever Ice Cream, Breyers: Naturally Good, at http://breyers.com/breyers/default.asp?brand=breyers (last visited May 17, 2005).

87 See 21 U.S.C. 321(f).

88 See id.

89 See generally 21 U.S.C. §§ 321(ff)(1)(A)-(F).

90 21 U.S.C. § 350(c)(1)(B).

91 See generally 21 C.F.R. § 182.1 (regulating substances generally recognized as safe); 21 C.F.R. § 314.50 (regulating the content and format of a new drug application).

92 See 21 C.F.R. §§ 182.1, 314.50.

93 Compare 21 U.S.C. § 321(s) with § 355.

94 See, e.g., MedlinePlus Drug Information: Minoxidil Topical, at http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a689003.html (topical); MedlinePlus Drug Information: Temozolomide, at http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a601250.html (capsules); MedlinePlus Drug Information: Dinoprostone (Cervical/Vaginal), at, http://www.nlm.nih.gov/medlineplus/druginfo/uspdi/202198.html (suppositories); MedlinePlus Drug Information: Pamidronate (Systemic), at http://www.nlm.nih.gov/medlineplus/druginfo/uspdi/202662.html (injection); MedlinePlus Drug Information: Norelgestromin and Ethinyl Estradiol (Systemic), at http://www.nlm.nih.gov/medlineplus/druginfo/uspdi/500351.html (transdermal).

95 Compare 21 C.F.R. § 182.1 with § 314.50.

96 See generally 21 U.S.C. § 350(a).

97 Oakmont Inv. Co., 987 F.2d at 39.

98 See Julie Barrows et al., Color Additives: FDA's Regulatory Process and Historical Perspectives, FOOD SAFETY MAG. (Oct./Nov. 2003), available at http://www.cfsan.fda.gov/∼dms/colregu.html.

99 “Although certifiable color additives have been called coal-tar colors because of their traditional origins, today they are synthesized mainly from raw materials obtained from petroleum.” Id.

100 Id.

101 Id.

102 The common expression “the exception proves the rule” is actually a misstatement of the original Latin “exceptio probat regulam,” which translates to the more logical sentiment “the exception probes the rule.” The Latin “probare,” a root for both the English words “prove” and “probe,” means to test or examine. See MERRIAM-WEBSTER's NEW INTERNATIONAL DICTIONARY OF THE ENGLISH LANGUAGE UNABRIDGED (3d ed. 1993). See, e.g., the colorful explanation by Dr. Madsen Pirie: “The origin of the fallacy lies in the changing uses of language. The word prove,’ which is now taken to refer to establishing something beyond doubt, used to mean test.’ Something would be proved’ to establish its quality; and this is the sense which has passed down to us in this fallacy. The exception puts the rule to test and, if it is found to be a valid exception, refutes it instead of proving it in the modern sense of the word.” Dr. Madsen Pirie, The Exception that Proves the Rule, at http://www.adamsmith.org/logicalfallacies/000619.php (last visited May 14, 2005).

103 See 21 U.S.C. §§ 321(ff)(1)(A)-(F).

104 Compare 21 C.F.R. § 330.10 (regulating the safety and efficacy of new OTC drugs) with § 190.6 (regulating the premarket notification of dietary supplements).

105 Consumer Reports, Dangerous Supplements: Still at Large (May 2004), available at http://www.consumerreports.org/main/content/display_report.jsp?FOLDER%3C%3Efolder_id=419337&bmUID=1096600562150.

106 FDA, Food Additives, FDA/IFIC BROCHURE (Jan. 1992), available at http://www.cfsan.fda.gov/∼lrd/foodaddi.html.

107 See generally, Valuck, supra note 75, at 286.

108 Id.

109 FDA, Consumer Research on Nutrition, Diet, and Health, at http://www.cfsan.fda.gov/∼lrd/ab-nutri.html (last visited May 17, 2005).

110 Levitt, supra note 3, at 11.

111 FDA, Tips for the Savvy Supplement User: Making Informed Decisions and Evaluating Information (Jan. 2002), at http://www.cfsan.fda.gov/∼dms/ds-savvy.html.

112 See 21 U.S.C. § 321(g)(1)(B). See also NATIONAL CENTER FOR COMPLEMENTARY AND ALTERNATIVE MEDICINE, WHAT's IN THE BOTTLE? AN INTRODUCTION TO DIETARY SUPPLEMENTS, at question 6, at http://nccam.nih.gov/health/bottle/#q6.