Guidelines for the promotion of Dietary Supplements: Examining government regulation five years after enactment of the dietary supplement health and education act of 1994

Food and Drug Law Journal

Volumn 54, Issue 4, 1999, Pages 567-586

  Pinco, Robert G ^a   Halpern, Todd H ^a  

^a LLP   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

NON PRESCRIPTION DRUG;

DIET SUPPLEMENTATION; DRUG INFORMATION; DRUG LEGISLATION; DRUG MARKETING; FOOD AND DRUG ADMINISTRATION; HEALTH CARE POLICY; LAW SUIT; REVIEW; UNITED STATES;

ADVERTISING; DIETARY SUPPLEMENTS; GUIDELINES; HEALTH PROMOTION; HUMANS; INTERNET; UNITED STATES;

EID: 0033367080     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (121)

1. Pub. L. No. 103-417, 108 Stat 4325 (codified at 21 U.S.C. §§ 321, et. seq. (Supp. 1999)).
2. The Hartman Group has reported that sales of dietary supplements in the United States, for the period of July 1998 to June 1999, reached $10.4 billion (a 3% increase over sales for the previous period). See Herbs & Supplements: A Year in Review, The Hartman Group, Bellevue Washington (1999) (cited in Supplement Sales at $10.4 Billion, NAT. FOODS MERCHANDISER (Oct. 1999)).
3. The Hartman Group has reported that sales of dietary supplements in the United States, for the period of July 1998 to June 1999, reached $10.4 billion (a 3% increase over sales for the previous period). See Herbs & Supplements: A Year in Review, The Hartman Group, Bellevue Washington (1999) (cited in Supplement Sales at $10.4 Billion, NAT. FOODS MERCHANDISER (Oct. 1999)).
4. Pub. L. No. 103-417(2), 108 Stat. 4325-26, 21 U.S.C. § 321 (1994), note (15)(A) (setting forth congressional findings).
5. The FDCA defines labeling as all labels and other written, printed or graphic matter: 1) on any article or any of its containers or wrappers; or 2) accompanying such article. 21 U.S.C. § 321(m).
6. Pub. L. No. 103-417(2), 108 Stat. 4325-26, 21 U.S.C. § 321 (1994), note (13) (setting forth congressional findings).
7. 35 F. Supp. 2d 1341 (D. Utah 1999).
8. 164 F.3d 650 (D.C. Cir. 1999).
9. FDA had a limited view of what could qualify as a food supplement, and it attempted to classify the sale of any dietary ingredient that generally was not recognized as safe as unapproved food additive. The courts upheld this theory in the context of a supplement that combined two dietary ingredients. See, e.g., United States v. 42/194 kg. Drums of Pure Vegetable Oil, 961 F.2d 808 (9th Cir.), cert. denied, 506 U.S. 940 (1992) (supplement containg Evening Primrose Oil and Vitamin E held to be an unapproved food additive). Courts rejected FDA's theory, however, when the supplement contained only one ingredient. See, e.g., United States v. Two Plastic Drums . . . Black Currant Oil, 984 F.2d 814 (7th Cir. 1993).
10. DSHEA altered the definition of a food additive by excluding "an ingredient described in paragraph (ff) [the dietary supplement definition] in, or intended for use in, a dietary supplement." 21 U.S.C. § 321(s)(6).
11. See Id. § 321(ff).
12. A drug is defined, in part, as any article (other than food) intended to affect the structure or any function of the body of man. A dietary supplement is not a drug solely because its labeling bears such a claim, however, as long as it complies with the requirements of section 403(r)(6) of the FDCA. Id. § 321(g).
13. See id. § 321(ff).
14. Historically, FDA has alleged that literature displayed by retailers in conjunction or in connection with the sale of a product constitutes product labeling; as such, literature claims have been capable of converting dietary supplement products into unapproved new drugs. See, e.g., United States v. Kordel, 164 F.2d 913 (7th Cir. 1947), aff'd, 335 U.S. 345 (1948); United States v. 250 Jars, etc., of U.S. Fancy Pure Honey, 218 F. Supp. 208 (E.D. Mich. 1963).
15. Specifically, DSHEA provides that "labeling" does not include certain publications (e.g., articles, book chapters, official abstracts) that are reprinted in their entirety and used in connection with the sale of dietary supplements to consumers. Such publications, however, are excluded from the labelling definition only if they: 1) are not false or misleading; 2) do not promote a particular manufacturer or brand of a dietary supplement; 3) are displayed or presented with other such items on the same subject matter, so as to present a balanced view of the available scientific information on a dietary supplement; 4) if displayed in an establishment, are physically separate from the dietary supplements; and 5) do not have appended to them any information by sticker or by any other method. 21 U.S.C. § 343-2.
16. Id. § 342(f)(1).
17. Id. § 342(g).
18. 42 U.S.C. § 287c-11 (1998).
19. Pub. L. No. 103-417, 108 Stat. 4325, § 12. The Commission on Dietary Supplement Labels issued its final report Nov. 24, 1997. The agency responded in the proposed rule on the regulation of structure/function claims, 63 Fed. Reg. 23,624 (Apr. 29, 1998). See infra note 68 and accompanying text.
20. 21 U.S.C. § 321(ff). In addition, the product must: 1) be intended for ingestion; 2) not be represented for use as a conventional food or as a sole item of a meal or the diet; and 3) be labeled as a dietary supplement. Id. § 321(ff)(2). This prevents, for example, vitamin products intended to be applied inside the nose from being dietary supplements. See United States v. Ten Cartons, More or Less, of an Article . . . Ener-B Vitamin B-12, 888 F. Supp. 381 (E.D.N.Y.), aff'd, 72 F.3d 285 (2d Cir. 1995).
21. 21 U.S.C. § 321(ff)(3)(B)(i).
22. Id.
23. Id. § 321(ff)(3)(A).
24. 35 F. Supp. 2d at 1341.
25. See id. at 1346.
26. Letter from William B. Schultz, FDA Deputy Commissioner for Policy, to Stuart M. Pape, Partner, Patton Boggs, L.L.P., Dkt. No. 97P-0441 (May 20, 1998).
27. See 21 U.S.C. § 321(ff)(3)(B)(i).
28. Pub. L. No. 101-535, 104 Stat. 2352 (codified at 21 U.S.C. §§ 321, 337, 343, 345, 371).
29. 21 C.F.R. § 101.14(a)(1) (1999).
30. As discussed infra Section V, the April 29, 1998 proposal relating to the use of structure/function claims proposes to amend the definition of disease. 63 Fed. Reg. at 23,624, 23,625.
31. The April 29, 1998 rule proposed amending this definition to make it consistent with the definition of the proposed rule, which is significantly broader.
32. 21 C.F.R. § 101.14.
33. Id. § 101.72.
34. Id. 101.79.
35. Id. § 101.4.
36. Public Health Service, U.S. Dep't. of Health and Human Services, Recommendations for the Use of Folic Acid to Reduce the Number of Cases of Spina Bifida and Other Neural Tube Defects, 41 MMWR No. RR-14 (Sept. 11, 1992), cited in 58 Fed. Reg. 2606 (Jan. 6, 1993).
37. Public Health Service, U.S. Dep't. of Health and Human Services, Recommendations for the Use of Folic Acid to Reduce the Number of Cases of Spina Bifida and Other Neural Tube Defects, 41 MMWR No. RR-14 (Sept. 11, 1992), cited in 58 Fed. Reg. 2606 (Jan. 6, 1993).
38. Id.
39. 58 Fed. Reg. at 2606.
40. 61 Fed. Reg. 8752 (Mar. 5, 1996). FDA's initial rejection of the claim purportedly was based on a concern that folate consumption might have harmful effects on persons suffering from anemia. The agency has claimed that its change in position was caused by new scientific studies that purportedly alleviated this concern. Others, including the authors, believe that the change was the result of tremendous political pressure.
41. Pub. L. No. 105-115, 111 Stat. 2296.
42. 21 U.S.C. § 343(r)(3)(C)(i).
43. Id. § 343(r)(3)(C)(ii).
44. Id. §§ 343(r)(3)(C)(iii), (iv).
45. See 63 Fed. Reg. 34,084-34,112 (June 22, 1998).
46. Id. at 34,093.
47. Id.
48. Letter from Rep. Dan Burton (R-IN) to Michael Friedman, Lead Deputy Commissioner, Food and Drug Administration (Aug. 13, 1998).
49. 164 F.3d 650.
50. Id. at 652.
51. Id. at 653.
52. Id.
53. Id. at 654.
54. Id.
55. Id. at 654.
56. Id. at 661. FDA issued a Federal Register notice requesting scientific information related to the four substance-disease relationships at issue in Pearson. The agency stated that it will use the data and information to determine the suitability of the health claims, as per the court's order. See 64 Fed. Reg. 48,841 (Sept. 8, 1999).
57. Two other circuit court cases addressed challenges to the regulatory regime governing the use of health claims. In Nutritional Health Alliance v. Shalala, 144 F.2d 220 (2d Cir 1998), cert. denied, 119 S.Ct. 589 (1998), the court rejected plaintiff's argument that the procedure constituted an unconstitutional prior restraint on free speech and dismissed plaintiff's challenge to the general regulation as unripe due to the absence of a specific proposed health claim. The Tenth Circuit dismissed plaintiffs' complaint in National Council for Improved Health v. Shalala, 122 F.3d 878 (10th Cir. 1997) for lack of standing, due to their failure to identify a single claim they wished to make.
58. 21 U.S.C. § 343(r)(6)(A).
59. Id. § 343(r)(6)(B).
60. Id. § 343(r)(6)(C).
61. Id. § 343(r)(6).
62. Id. § 321(g)(I)(C).
63. S. REP. No. 361, 74th Cong., 1st Sess. 3 (1935), reprinted in 3 LEGISLATIVE HISTORY OF THE FEDERAL FOOD, DRUG, & COSMETIC ACT AND AMENDMENTS 660.
64. S. REP. No. 361, 74th Cong., 1st Sess. 3 (1935), reprinted in 3 LEGISLATIVE HISTORY OF THE FEDERAL FOOD, DRUG, & COSMETIC ACT AND AMENDMENTS 660.
65. See, e.g., Nutrilab v. Schweiker, 713 F.2d 335, 338 (7th Cir. 1983).
66. Id.
67. That is, as long as the provisions of 21 U.S.C. § 343(r)(6) are satisfied.
68. See infra Section V.
69. A negative safety determination, however, should convince most manufacturers to forgo the use of the ingredient in question unless the ingredient is used at substantially lower levels than those reviewed by FDA, and the manufacturer has proof of safety.
70. Dietary supplements may claim a benefit related to a classical nutrient deficiency disease, such as scurvy, provided the prevalence of the disease in the United States also is disclosed. 21 U.S.C. § 343(r)(6).
71. 63 Fed. Reg. at 23,624.
72. See 64 Fed. Reg. 36,824 (July 8, 1999).
73. Id. at 36,825.
74. 21 U.S.C § 343(r)(6).
75. Id.
76. 63 Fed. Reg. at 23,627.
77. Id.
78. Id. at 23,620.
79. See 64 Fed. Reg. at 36,824.
80. There were informal estimates that grass-root supporters of DSHEA legislation generated over one million letter of support from consumers.
81. The report of hundreds of adverse events purportedly being associated with ephedra has come under sharp scrutiny from Congress. See Letter from Rep. Christopher Shays (R-CT) to Michael Friedman, Lead Commissioner, Food and Drug Administration (Dec. 10, 1997). FDA's lack of confidence in those reports is best exemplified by its failure to finalize a proposed rule restricting the sale of ephedra supplements, proposed more than two years ago. See 62 Fed. Reg. 30,677 (June 4, 1997).
82. 21 U.S.C. § 321(m).
83. FTC Dietary Supplement Advertising Guide for Industry (1998) (FTC Guide).
84. Id.
85. 15 U.S.C. § 45 (1988).
86. Id. §§ 52, 55.
87. FTC Guide, supra note 80, at 2.
88. Id.
89. Id., at 3.
90. 15 U.S.C. § 55.
91. FTC Guide, supra note 80, at 4.
92. Id. at 6.
93. Id.
94. Id.
95. C. Lee Peeler & Susan Cohn, The Federal Trade Commission's Regulation of Advertising Claims for Dietary Supplements, 50 FOOD & DRUG L.J. 349, 350-51 (1995).
96. FTC Guide, supra note 80, at 6.
97. Id. at 7.
98. In the Matterof Schering Corp., Docket No. 9232, Federal Trade Commission, 1991 FTC LEXIS 427.
99. Id. at 64.
100. Id. at 66.
101. Id. at 68.
102. Id.
103. Id.
104. Id.
105. Lichtwer Pharma U.S., Inc. v. Chattem Inc., decision of the National Advertising Division of the Council of Better Business Bureaus (Nov. 1998).
106. Id.
107. See, e.g., Jodie Bernstein, Prepared Statement at Internet Pagejacking Press Conference (Sept. 22, 1999); 〈www.ftc.gov/opa/1999/9909/atarizjodie.htm〉.
108. Id.
109. Id.
110. Federal Trade Commission, "Operation Cure.all" Targets Internet Fraud (June 24, 1999); 〈www.ftc.gov/opa/1999/9906/opcureall.htm〉.
111. An example would be, "If you responded to an advertisement like this, you could get scammed."
112. Federal Trade Commission, Prepared Statement Before the Telecommunications, Trade, and Consumer Protection Subcommittee of the House Committee on Commerce, Consumer Protection in Cyberspace: Combating Fraud on the Internet (June 25, 1998); 〈www.ftc.gov/os/1998/9806/test.623.htm〉.
113. Federal Trade Commission, FTC Announces "Operation Waistline" (Mar. 25, 1997); 〈www.ftc.gov/ opa/1997/9703/waistlin.htm〉.
114. Id.
115. Id.
116. Id.
117. Better Business Bureau, National Advertising Division Advertising Inquiry Process (Dec. 1, 1999); 〈www.bbb.org/advertising/advertiserAssist.html〉.
118. Id.
119. Id.
120. Conversation between Mr. Pinco and the Texas Attorney General's Office (July 1999).
121. Id.