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FDA Statutory Authority to Regulate the Safety of Dietary Supplements

Published online by Cambridge University Press:  06 January 2021

Peter Barton Hutt
Peter Barton Hutt*
Affiliation:
Covington & Burling, Washington, D.C., and Harvard Law School
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Extract

For almost a century, the Food and Drug Administration (FDA) has regulated nutrients and other dietary supplement ingredients and products under the food provisions initially of the Federal Food and Drugs Act of 1906 and now of the Federal Food, Drug and Cosmetic Act of 1938 (“FD&C Act”), as amended. Congress amended the FD&C Act through the Food Additives Amendment of 1958 and the Color Additive Amendments of 1960 to strengthen FDA authority over food ingredient safety. In 1976, Congress enacted the Vitamin-Mineral Amendments which provides that FDA may limit the contents of dietary supplements only for safety reasons. In 1994, Congress enacted the Dietary Supplement Health and Education Act (“DSHEA”) to continue the regulation of dietary supplements under the food provisions of the FD&C Act but to replace the food additive provisions with separate safety requirements for dietary supplements and dietary ingredients.

Type
Article
Information
American Journal of Law & Medicine , Volume 31 , Issue 2-3 , June 2005 , pp. 155 - 174
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2005

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Footnotes

†

He served as FDA Chief Counsel during 1971-1975.

References

1 This article reviews the safety provisions applicable to dietary supplements but does not consider the labeling provisions for these products. For discussion of the statutory provisions applicable to various types of food claims, see Barton Hutt, Peter, U.S. Government Regulation of Food with Claims for Special Physiological Value, in Mary K. Schmidl & Theodore P. Labuza, Essentials Of Functional Foods 339 (2000)Google Scholar.

2 Federal Food and Drugs Act of 1906, 34 Stat. 768, 21 U.S.C. §§ 1-15, repealed by 52 Stat. 1040, 1059, § 902(a).

3 Federal Food, Drug, and Cosmetic Act, Pub. L. No. 75-717, 52 Stat. 1040 (1938).

4 Food Additives Amendment of 1958, Pub. L. No. 85-929, 72 Stat. 1784 (1958).

5 Color Additive Amendments of 1960, Pub. L. No. 86-618, 74 Stat. 397 (1960).

6 Vitamin Mineral Amendments, Pub. L. No. 94-278, Title V, 90 Stat. 401, 410 (1976).

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

8 The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Pub. L. No. 107-188, 116 Stat. 594 (2002).

9 Federal Food and Drugs Act of 1906, 34 Stat. 768 (1906), 21 U.S.C. §§ 1-15, repealed by 52 Stat. 1059, § 902(a); Federal Food, Drug, and Cosmetic Act of 1938, 52 Stat. 1040 (1938).

10 DSHEA §§ 4, 9, 21 U.S.C. §§ 342(f), 342(g).

11 DSHEA § 8, 21U.S.C. § 413.

12 21 U.S.C. §§ 301, 303, 304, 308.

13 Dietary Supplement Health and Education Act § 4, 21 U.S.C. § 342(f)(1).

14 Continental Seafoods, Inc. v. Schweiker, 674 F.2d 38 (D.C. Cir. 1982).

15 DSHEA § 4, 21 U.S.C. § 342(f)(1).

16 Norwich Eaton Pharmaceuticals, Inc. v. Bowen, 808 F.2d 486 (6th Cir. 1987) (holding that de novo review of agency action is an exception unless otherwise required by statute).

17 DSHEA § 4.

18 United States v. Dotterweich, 320 U.S. 277, 278-79 (1943).

19 Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk, 69 Fed. Reg. 6788 (Feb. 11, 2004).

20 Tolerance for Poisonous or Deleterious Substances in Food, 21 U.S.C. § 346.

21 Food Additives Amendment of 1958, Pub. L. No. 85-929,, 72 Stat. 1784 (1958).

22 Substances Generally Recognized as Safe, 62 Fed. Reg. 18,938, 18,939 (proposed April 17, 1997).

23 Southeastern Minerals v. Harris, 622 F.2d 758, 760 (1980).

24 DSHEA§ 4, 21 U.S.C. § 342 (f)(1)(B).

25 21 U.S.C. § 342 (f)(1)(D).

26 See tables infra pp. 172-74.

27 21 U.S.C. §§ 342(f)(1).

28 21 U.S.C. § 342(f)(1).

29 Federal Food and Drugs Act of 1906, § 201(f)(1), repealed by 52 Stat. 1059 § 902(a); 21 U.S.C. § 321(f)(1).

30 21 U.S.C. §§ 321(g)(1)(B)-(C).

31 For a more extensive review of the development and FDA regulation of dietary supplements, see Barton Hutt, Peter, Government Regulation of Health Claims in Food Labeling and Advertising, 41 Food Drug Cosm. L.J. 3 (1986)Google Scholar.

32 Id. at 7.

33 PETER BARTON HUTT AND RICHARD A. MERRILL, FOOD AND DRUG LAW: CASES AND MATERIALS 161(2d ed. 1991); Barton Hutt, Peter, Government Regulation of the Integrity of the Food Supply, 4 Ann. Rev. Nutrition 1 (1984)CrossRefGoogle Scholar.

34 Hutt, supra note 33.

35 Id.

36 FDA TC2-A (November 5, 1945).

37 E.g., 44 Fed. Reg. 16,126 (March 16, 1979) (proposed monograph for nonprescription vitamin-mineral drugs).

38 The last sentence in the definition of a dietary supplement preserves this distinction by providing that a dietary supplement “shall be deemed to be a food” except when it is intended for drug use. 21 U.S.C. § 321(ff).

39 21 U.S.C. § 343(j).

40 See supra notes 31 & 33 and accompanying text.

41 21 U.S.C. § 350(c)(3).

42 21 U.S.C. § 201(ff).

43 E.g., 21 U.S.C. §§ 342(f) & 350b.

44 E.g., FDA has stated that the same structure-function claim may be used on cranberries regardless of whether the product is labeled as a dietary supplement or a conventional food. Food Labeling; Requirements for Nutrient Content Claims, Health Claims, and Statements of Nutritional Support for Dietary Supplements, 62 Fed. Reg. 49,859, 49,860-49,861 (proposed September 23, 1997).

45 21 U.S.C. § 321(ff)(1).

46 21 U.S.C. § 321(ff)(1).

47 21 U.S.C. §§ 321(ff)(1)-(2).

48 21 U.S.C. § 350b(c).

49 21 U.S.C. § 342(a)(1).

50 21 U.S.C. § 342(a)(1).

51 21 U.S.C. § 342(f)(1)(D).

52 United States v. Lexington Mill & Elevator Co., 232 U.S. 399 (1914).

53 Flemming v. Florida Citrus Exchange, 358 U.S. 153, 161 (1958).

54 21 U.S.C. § 342(a)(3)-(6).

55 21 U.S.C. § 321(s)(6).

56 See infra Part IV.B.

57 21 U.S.C. § 379(e).

58 21 U.S.C. §§ 342(f), 350b.

59 21 § 342(f)(1)(A).

60 21 U.S.C. § 321(s).

61 Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk, 69 Fed. Reg. 6788, 6788 (Feb. 11, 2004).

62 Nutraceutical Corp. v. Crawford, No. 2-04CV409 TC (D. Utah April 13, 2005).

63 21 U.S.C. 342(f)(1)(C).

64 76 Stat. 780, 782 (1962).

65 21 U.S.C. § 355(e).

66 21 C.F.R. § 2.5.

67 Forsham v. Califano, 442 F. Supp. 203, 207-209 (D.D.C. 1977).

68 21 U.S.C. § 342(g).

69 21 C.F.R. pt. 110.

70 68 Fed. Reg. 12,158 (Mar. 13, 2003).

71 21 U.S.C. § 350b(c).

72 21 U.S.C. § 342(f).

73 21 U.S.C. § 342(f)(1)(D).

74 21 U.S.C. § 342(a)(3)-(6).

75 21 U.S.C. § 321(s)(6).

76 21 U.S.C. § 379(e).

77 21 U.S.C. § 342(f)(1)(A).

78 21 U.S.C. § 350b.

79 21 U.S.C. § 350b(a)(2).

80 21 U.S.C. § 350b(a)(2).

81 21 C.F.R. § 190.6.

82 21 U.S.C. § 342(f)(1)(B).

83 For example, Letter from James T. Tanner, Ph.D., Acting Director, Division of Programs and Enforcement Policy, Office of Special Nutritionals, Center for Food Safety and Applied Nutrition, to Mr. Sam Berkowitz , Advanced Plant Pharmaceuticals, Inc. (September 24, 1997) (addressing the safety of pokeweed mitogen as a dietary ingredient); available at http://www.cfsan.fda.gov/∼dms/dsingrd.html.

84 21 U.S.C. § 342(f)(1)(C).

85 21 U.S.C. § 342(g).

86 21 U.S.C. § 371(a).

87 21 U.S.C. § 334.

88 21 U.S.C. § 332.

89 21 U.S.C. § 333(a).

90 21 U.S.C. § 336.

91 21 C.F.R. pt. 7, subpart C.

92 21 U.S.C. § 375.

93 The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Pub. L. No. 107-188, 116 Stat. 594 (2002).

94 21 U.S.C. § 333(h).

95 21 U.S.C. § 350c.

96 21 U.S.C. § 350d.

97 21 U.S.C. § 381(m).

98 21 U.S.C. § 342(f)(1).

99 U.S. v. Two Plastic Drums, 984 F.2d 814 (1993).

100 Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402 (1971).

101 21 U.S.C. § 342 (f)(2).

102 21 U.S.C. § 335.

103 United States v. Dotterweich, 320 U.S. 277, 278-79 (1943).

104 21 U.S.C. § 321(ff).

105 21 U.S.C. at §§ 321(ff)(2)(B), 321(ff)(2)(C), & 350(c)(1)(B). DSHEA amended Section 411(c)(1)(B) of the FD&C Act to delete the limitation imposed by the Vitamin-Mineral Amendments of 1976 that a dietary supplement may not simulate a conventional food.

106 21 C.F.R. § 101.36 (2004).

107 21 C.F.R. § 101.9.

108 Nutrition Labeling Health and Education Act of 1990, 101 Pub. L. No. 535, 104 Stat. 2353 (1990).

109 21 U.S.C. § 342(a)(1).

110 21 U.S.C. §§ 342(a)(3)-(6).

111 21 U.S.C. § 348.

112 21 U.S.C. § 321(s).

113 21 U.S.C. § 321(s).

114 21 U.S.C. § 321(s); 21 C.F.R. § 170.30.

115 Compare 21 U.S.C.§ 321(p)(2).

116 21 U.S.C. § 348(b)(1).

117 21 U.S.C. § 348; 21 C.F.R. § 170.3(i).

118 Peter Barton Hutt, Regulation of Food Additives in the United States, in FOOD ADDITIVES (A. Larry Branen et al. eds., 2002).

119 Id.

120 Substances Generally Recognized as Safe, 62 Fed. Reg. 18,938, 18,941-18,942 (proposed April 17, 1997).

121 21 C.F.R. pts 182, 184.

122 21 C.F.R. § 170.30(d).

123 Noah, Lars & Merrill, Richard A., Starting From Scratch?: Reinventing the Food Additive Approval Process, 78 B.U. L. Rev. 329, 359 (1998)Google Scholar.

124 21 C.F.R. § 170.30.

125 21 C.F.R. § 170.35.

126 Substances Generally Recognized as Safe, 62 Fed. Reg. 18,938. (Apr. 17, 1997).

127 Food & Drug Administration, Guidance for Industry: Frequently Asked Questions About GRAS (December 2004), available at http://www.cfsan.fda.gov/∼dms/grasguid.html#Q11.

128 Id.

129 Hutt, supra note 118.

130 Id.

131 Id.

132 Id.

133 United States v. Nova Scotia Food Products Corp., 568 F.2d 240 (2d Cir. 1977); National Confectioners Ass’n v. Califano, 569 F.2d 690 (D.C. Cir. 1978).

134 21 U.S.C. §§ 321(s), 348.

135 See supra notes 85, 89, 97 and accompanying text.

136 21 U.S.C. § 342(f).

137 Supra note 99 and accompanying text.

138 Supra note 18.

139 See supra note 19 and accompanying text.

140 See tables infra pp. 172-74.

141 21 U.S.C. § 342(a)(1).

142 21 U.S.C. §§ 342(a)(2)-(6).

143 Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food, 21 C.F.R. pt. 110.

144 68 Fed. Reg. 12,158 (Mar. 13, 2003).

145 21 U.S.C. § 342(f)(1)(A).

146 21 U.S.C. § 341(f)(1)(C).

147 21 U.S.C. § 321(s).

148 21 U.S.C. § 350b.

149 Supra notes 85, 89, 97 and accompanying text.

150 21 U.S.C. § 342(f).

151 Supra note 19 and accompanying text.

152 See supra note 99 and accompanying text.

153 Supra notes 99 & 100.

154 Supra note 18.

155 21 U.S.C. § 342(f)(2).

156 21 U.S.C. § 342(f)(1)(C).