Dietary supplement labeling and advertising claims: Are clinical studies on the full product required?

Food and Drug Law Journal

Volumn 64, Issue 1, 2009, Pages 43-67

  Villafranco, John E ^a   Bond, Katie ^a  

^a LLP   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIOXIDANT; ASCORBIC ACID; BETA GLUCAN; CHOLINE; CHONDROITIN SULFATE; CITICOLINE; FOLIC ACID; GLUCOSAMINE; HERBACEOUS AGENT; HUPERZINE A; HUPERZINE B; IRON; LEVACECARNINE; NATURAL PRODUCT; OMEGA 3 FATTY ACID; THIOCTIC ACID; UBIDECARENONE; VINPOCETINE; XANTHOPHYLL; ZINC;

ALZHEIMER DISEASE; BRAIN DYSFUNCTION; CONSUMER; COURT; DIET SUPPLEMENTATION; DRUG LABELING; DRUG LEGISLATION; DRUG MARKETING; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; ISCHEMIC HEART DISEASE; LAW; MEDICOLEGAL ASPECT; NEURAL TUBE DEFECT; PRACTICE GUIDELINE; REVIEW;

ADVERTISING AS TOPIC; CLINICAL TRIALS AS TOPIC; DIETARY SUPPLEMENTS; DRUG LABELING; FRAUD; HUMANS; PRODUCT LABELING; UNITED STATES; UNITED STATES FEDERAL TRADE COMMISSION; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 61949483001     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (140)

1. In relevant part, § 5(a) of the FTC Act prohibits "unfair or deceptive acts or practices in or affecting commerce." See 15 U.S.C. § 45(a)(1) (2000). An advertiser violates § 5's prohibition on deceptive acts or practices if its advertisement contains a material representation or omission that is likely to mislead consumers acting reasonably under the circumstances. See In re Cliffdale Assocs., Inc., 103 FTC. 110, 164-165 (1984). In addition to § 5(a), § 12 of the FTC Act also applies to dietary supplement advertising. That section prohibits the dissemination of "any false advertisement" for the purpose of inducing "the purchase of food, drugs, devices, services, or cosmetics." See 15 U.S.C. § 52(a). Section 12 also provides that any such false advertisement constitutes an "unfair or deceptive act or practice in or affecting commerce" in violation of § 5. See 15 U.S.C. § 52(b).
2. See, e.g., In re Thompson Med. Co., 791 F.2d 189, 194 (D.C. Cir. (1986)) (internal citation omitted).
3. See, e.g., FTC Policy Statement Regarding Substantiation, 49 Fed. Reg. 3099 (Aug. 23, 1984). http://www.ftc.gov/bcp/giiides/ad3subst.htm;
4. see also In re Pfizer Inc., 81 F.T.C. 23 (1972) (1972 WL 127465, at*26).
5. FTC Policy Statement Regarding Substantiation, 49 Fed. Reg. 3099;
6. Pfizer Inc., 81 F.T.C. 23.
7. See Sterling Drug v. FTC, 741 F.2d 1146, 1156-1157 (9th Cir. (1984)).
8. See, e.g., FTC, Dietary Supplements: An Advertising Guide for Industry, at 9 (1998); United States v. Bayer Corp., Civ. Action No. 01-01 (HAA), at 2 (D.N.J. (Jan. 3, 2007)) (consent decree following investigation of Bayer's One-A-Day Weight Smart multi-vitamins).
9. See Sterling Drug, 741 F.2d at 1156; Am. Home Prod. v. FTC, 695 F.2d 691, 710 (3d Cir. (1983)).
10. See Am. Home Prod., 695 F.2d at 710-711. American Home Products held that the requirement that an advertiser support drug efficacy claims with "competent and reliable evidence" substantiation was "imprecise," "unsupportably vague," and unwarranted for an advertiser when the advertiser had no or little record of misrepresenting such claims. Id.
11. See 21 U.S.C. § 343(r)(6) (2000). This provision applies specifically to 1) nutritional deficiency claims, 2) claims regarding an effect on the structure or function of the body ("structure/function" claims) and 3) general well being claims. Id. These types of claims comprise many, if not most, of the dietary supplement claims on the market. Thus, this article focuses, in particular, on the substantiation for these types of claims. The FDCA also allows health claims and qualified health claims for dietary supplements. Such claims relate a nutrient or nutrients with a disease or other health-related condition. See 21 U.S.C. § 343(r)(l), (3) (2000); 21 C.F.R. § 101.14 (2008). They require agency pre-approval and are subject to different substantiation requirements under the FDCA. Id.
12. FTC, In the Matter of Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body: Proposed Rule, at 1 n.l (Aug. 27, 1998) (comments submitted to FDA as part of FDA's rulemaking on structure/function claims) (citing FTC- FDA Liaison Agreement, 4 Trade Reg., Rep. (CCH) ¶ 9851). The FTC's comments stated, "Although the Liaison Agreement does not refer explicitly to dietary supplements, the two agencies follow the same division of roles for dietary supplements ⋯" Id.
13. Id.
14. Dietary Supplements: An Advertising Guide for Industry, at 1.
15. See Press Release, FTC, Business Guide for Dietary Supplement Industry Released by FTC Staff (Nov. 18, 1998), http://www.ftc.gov/opa/1998/11/ dietary.shtm.
16. See, e.g., id. ("The Guide is a restatement of longstanding FTC policies and is not intended to signal any change in the agency's approach to dietary supplement advertising ⋯").
17. See id. The Guide notes, "The examples have been simplified to illustrate one or two specific points. Therefore, advertisers should use these examples as general guidance only."
18. See Dietary Supplements: An Advertising Guide for Industry, at 3.
19. See id. at 3;
20. see also id. at 8-18 (discussing claim substantiation).
21. See id. at 16.
22. Id.
23. See id. at 17.
24. See Letter from Donald S. Clark, Secretary, FTC, to Jonathan W. Emord, Esq., Emord & Associates, P.C. (Nov. 30, 2000), http://www.ftc.gov/ os/2000/12/dietletter.htm.
25. See id.
26. See id.
27. Id.
28. Id.
29. Id.
30. Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act (2008), http://www.cfsan.gov/∼dms/dsclmgu2.html.
31. Id. at 2.
32. Id. at 3. The Substantiation Guide provides the standard definition for "competent and reliable scientific evidence" and notes that FDA will consider the opinions of experts and "what the accepted norms are in the relevant research fields." Id. at 4;
33. see also id. at 8, 15 (further elaborating on the specific types of studies FDA finds to be competent and reliable). The Substantiation Guide also notes, "If there is an existing standard for substantiation developed by a government agency or other authoritative body, [the FDA] may accord some deference to that standard." Id.
34. Id. at 5-6.
35. Id. at 11-12 (emphasis added).
36. See 11 F. Supp 2d 1263, 1274 (S.D. Fla. (1999)).
37. See 11 F. Supp. 2d at 1265.
38. See id. at 1266.
39. Id.
40. Id. at 1266.
41. See id.
42. Id. at 1273.
43. See id. at 1274.
44. Id.
45. See FTC v. QT, Inc., 512 F.3d 858, 861 (7th Cir. (2008)).
46. 448 F. Supp. 2d 908, 912 (N.D. I11. (2006)).
47. Id.
48. 448 F. Supp. 2d at 962.
49. QT, 512 F.3d at 861.
50. Id. at 862.
51. 362 F.3d 1204 (9th Cir. (2004)).
52. Id. at 1208-1211.
53. Id. at 1217.
54. Id. at 1216.
55. Id.
56. Id. at 1217.
57. See id. at 1217 n. 14 (emphasis in original).
58. Id. at 1208.
59. 2003 WL 21283814, at *1 (Cal. Superior (2003)).
60. Id.
61. Id. at*l, *13.
62. Id.
63. Id. at * 14.
64. Id. at *15.
65. Id. at *13.
66. Id. at* 16.
67. Id. at *17.
68. Id. at *16-17.
69. See 2008 U.S. Dist. LEXIS 44145, at *4-5, *8 (N.D. Ga. (2008)).
70. Id. at *4-5.
71. Id. at *47-76.
72. Id. at *53-65.
73. Id.
74. Defs.' Resp. to PL's Mot. for Summ. J., at 2.
75. Id. at 9-10.
76. See 2008 U.S. Dist. LEXIS, at *55.
77. Id. at *58-59.
78. Id at *64 n.l7.
79. See id. at *65-76.
80. Id. at *74 n.l9.
81. See 164 F.3d 650, 651-652 (D.C. Cir. (1999)).
82. Id. The Nutrition Labeling and Education Act of 1990 (NLEA) created a "safe harbor" for foods and dietary supplements to bear FDA-approved health claims. Id. at 653. Prior to the NLEA, a health claim, which advertises a benefit for a disease or health-related condition, would render a food or a supplement an unapproved drug. Id. The N LEA provided a "significant scientific agreement" standard for FDA to assess health claims for foods, but left the FDA to develop a standard for approving dietary supplement health claims. Id. at 653-654. The FDA subsequently adopted the same "significant scientific agreement" standard for dietary supplement health claims/and rejected the four claims at issue under this framework. Id.
83. Id. at 655.
84. See id. at 659-660.
85. See Pearson II, 130 F. Supp. 2d at 114.
86. Whitaker v. Thompson, 248 F. Supp. 2d 1, 10-11 (D.D.C. (2002)).
87. See 130 F. Supp. 2d at 114-119.
88. See 77 F. Supp. 2d at 1269-1270.
89. See id. at 1270-1272, 1274.
90. Id. at 1266.
91. See id. at 1267.
92. 2008 U.S. Dist. LEXIS 44145, at *6-7, * 100-105.
93. Id. at* 100-105.
94. PL's Mem. of Law in Resp. to Defs.' Mot. for Summ. J., at 25-26 (internal citations omitted).
95. See 2008 U.S. Dist. LEXIS 44145, at *13 n.9.
96. When FDA approves a health claim, it provides specific requirements for the particular claim. Industry members who choose to use the claim must follow these specific requirements, as well as general requirements provided in 21 C.F.R.§ 101.14(d).
97. See 21 C.F.R. §§ 101.14(e)(2), 101.70-101.83. Five of the health claims currently approved involve the benefits of particular ingredients.
98. See 21 C.F.R. §§ 101.14(d), 101.70-101.83. Neither the general requirements, nor the specific requirements for these five claims, require final product testing to ensure efficacy of the particular ingredients when consumed as part of the whole food or dietary supplement.
99. See http://www.fda.gov/cder/about/smallbiz/Presentations/4.ppt#20 (stating that clinical studies are not required in order to market monograph OTC drugs); http://www.fda.gov/cder/offices/ otc/reg-mechanisms.htm ("An OTC drug product containing ingredients that comply with standards established in an applicable monograph is considered to be 'generally recognized as safe and effective' (GRASE) and does not require specific FDA approval before marketing").
100. See http://www.wrigley.com/brands/eclipse.do (explaining that testing on the key ingredient, magnolia bark extract, supports efficacy); http://www.pepto-bismol.com/ (no discussions of clinical trials); http://www.tropicana.com/#ourproducts (noting the FDA-approved qualified claim for Omega-3 and providing no discussions of clinical trials). Benecol employs an FDA-approved health claim for plant sterols as well as additional claims. See http://www.benecol.com/home2.jhtml. A question and answer segment explains as follows: Q: Have any clinical studies been done to support the efficacy of BENECOL Smart Chews? A: Over 25 published clinical studies support the safety and efficacy of plant stanol esters, the cholesterol lowering ingredient contained in BENECOL Smart Chews. Based on the totality of this scientific evidence on the cholesterol-lowering efficacy of plant stanol esters, the [FDA] allows its use in various foods and supplement products including Benecol Smart Chews.
101. See Press Release, NAD, Daimler Trucks, Navistar Participate in NAD Forum (Sept. 18, 2008), http://www.nadreview.org/News Room.aspx.
102. Id.
103. http://www.nadreview.org/AboutNAD.aspx.
104. See, e.g., Irwin Naturals, NAD Case No. 4725, at 1, 5 (Sept. 13,2007); NMD Marketing, NAD Case No. 4187, at 1, 4 (May 20, 2004).
105. See Indigene Pharmaceutical, Inc., NAD Case Rep. 4756, at 12 (Nov. 27, 2007).
106. See also Patent HEALTH, LLC, NAD Case No. 4335, at 17 (May 27, 2005); Nutramax Laboratories, NAD Case No. 3899, at 15 (Apr. 29, 2002) ("Although not mandated, unless an advertiser is making establishment claims, specific product or brand testing is the gold standard for claim substantiation because dosage is controlled and such testing accounts for variations in extraction and manufacturing processes that may result in differences in the quality and performance of the end product. Simple logic dictates that it is the most direct and affirmative means by which to assess the performance of a specific product") (internal citation omitted); Chattem Inc., NAD Case No. 3497, at 6-7 (Oct. 1, 1998).
107. See Pub. Law No. 103-417.
108. Id. at § 2.
109. Id.
110. See, e.g., Nutrition 21, Inc., NAD Case No. 4927, at 5-7 (Nov. 5, 2008) (rejecting, in the absence of full product testing, unqualified performance claims such as, "Improve Memory and Recall" and "Improve Focus and Vitality"); Green Willow Tree, LLC, NAD Case No. 4824, at 9 (Apr. 8, 2008) (recommending, in the absence of whole product testing, that "the advertiser limit any claims to ingredient type claims, such as, contains ingredients that provide 'Superb Thyroid Support'"); Bodyhealth.com, Inc., NAD Case No. 4748 (Nov. 5, 2007). The only minor exception to this rule on product claims has been where the product "is essentially just the key ingredient" that was subject to tests.
111. See Idea Village Products Corp., NAD Case No. 4894, at 13-14 (Aug. 5, 2008);
112. see also Nutrition 21, NAD Case No. 4547, at 4-5 (Aug. 24, 2006).
113. Sera-Pharma Labs, Inc., NAD Case No. 4731, at 1 (Sept. 21, 2007).
114. Id. at 4.
115. Id.
116. Id. (emphasis in original).
117. See, eg., New Age Opt-In, Inc., NAD Case No. 4329, at 3-5 (May 11, 2005) (citing potential ingredient interaction among reasons that the advertiser should discontinue "strong health and performance claims" for the product); Natrol, Inc., NAD Case No. 4158, at 10 (Mar. 19, 2004).
118. See also South Beach Beverage Co., Inc., NAD Case No. 3819, at 2 (Aug. 1, 2001) (rejecting claims for SoBe drinks where the advertiser, inter alia, failed to "provide evidence that the Sobe Lean product as a whole, as formulated" provided the same benefits shown for one ingredient contained in the product).
119. See, e.g., Vital Pharmaceuticals, Inc., NAD Case No. 4868, at 15 (July 9, 2008);
120. Irwin Naturals, NAD Case No. 4725, at 9-10; Health and Nutrition Sys. Int'l, NAD Case No. 4212, at 1, 5 (July 9, 2004) (rejecting claims based on "variable" dosages;
121. also noting variation in ingredient form, leaf versus extract);
122. Barmensen Labs, LLC, NAD Case No. 4401, at 8 (Nov. 1, 2005) ("As in the case of the other challenged claims, the advertiser did not provide any testing of its product but merely extrapolated from general studies examining different ingredients, different dosages of the ingredients in the advertiser's product, and different mechanisms of action");
123. Vital Basics, Inc., NAD Case No. 3878, at 5-6 (Feb. 14, 2002); Knight-McDowell Labs, NAD Case No. 3862, at 2-3 (Jan. 7, 2002);
124. but see Nutrition 21, Inc., NAD Case No. 4927, at 11-12 (accepting the claim "maintains brain fluidity and may help in the maintenance of cognitive function," based on Docosahexaenoic acid (DHA) studies, even though "there is no evidence of a particular amount of DHA that is optimal to include in a dietary supplement").
125. See, e.g., Calpis USA, NAD Case No. 4891, at 3, 9-10 (July 30, 2008) (accepting claims based on substantiating trials that tested ingredients "in amounts equal to or less than" the amounts in the advertised product; rejecting as substantiation trials testing amounts higher than the ingredient amounts present in the advertised product);
126. Vital Pharmaceuticals, Inc., NAD Case No. 4868, at 15 (accepting claims based on caffeine where the amount of caffeine present in the advertised product falls within an effective range provided in an FDA monograph);
127. Irwin Naturals, NAD Case No. 4725, at 9-10 (accepting claims based on studies testing the same dosage of key ingredients as present in the advertised product);
128. Primal Nutrition, Inc., NAD Case No. 4676, at 5 (May 21, 2007) (accepting claims based on ingredient studies where the advertised product "contains the ingredients in the same (or in some cases higher) dosages as were employed in the various studies").
129. Sera-Pharma Labs, Inc., NAD Case No. 4731, at 3.
130. See also, e.g., Vital Pharmaceuticals, Inc., NAD Case No. 4868, at 12-18, 20; Bodyhealth.com, Inc., NAD Case No. 4748, at 5-6;
131. Renaissance Health Publishing, LLC, NAD Case No. 4677, at 1, 7 (May 22, 2007) ("NAD determined that, as would be the case with any broad spectrum antioxidant, such as Revatrol, the advertiser can discuss the proven benefits of each of the individual antioxidant ingredients in the product as long as it is not conveying a message about the product itself").
132. See, e.g., Biotech Corp. Int'l, NAD Case No. 4821, at 18 (Apr. 1, 2008)
133. See Beneficial Corp. v. FTC, 542 F.2d 611, 617 (3d Cir. (1976)); Dietary Supplements: An Advertising Guide for Industry, at 3 ("When identifying claims, advertisers should not focus just on individual phrases or statements,
134. but rather should consider the advertisement as a whole, assessing the 'net impression' conveyed by all elements of the ad, including the text, product name, and depictions") (emphasis in original).
135. The National Advertising Review Board (NARB) reviewed Rexall Sundown, Inc. on other grounds. See NARB Panel No. 146 (Jan. 31 2008).
136. Primal Nutrition, Inc., NAD Case No. 4674, at 5.
137. Kashi Co., NAD Case No. 4447, at 2-3 (Jan. 26, 2006) (internal citations omitted).
138. Id.
139. Id.
140. Bayer Healthcare LLC, NAD Case No. 4736, at 7 (Oct. 5, 2007).