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Functional Foods: What are They? How are They Regulated? What Claims Can Be Made?

Published online by Cambridge University Press:  06 January 2021

Martin Hahn
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Extract

Scientific studies continue to establish a strong relationship between constituents in foods and dietary supplements and certain diseases. The general population is inundated on a seemingly daily basis by media reports of new studies showing that a food or dietary supplement is useful in treating particular diseases or reducing the likelihood that a consumer will develop particular diseases. With increasing frequency, consumers are looking for foods and supplements to help manage and prevent the onset of disease.

Not surprisingly, the food and dietary supplement industries are responding by developing new products and repositioning old products efforts to help consumers manage their health. For example, yogurt used to be positioned only as a delicious component of a meal but now is also promoted for use in weight loss programs after a study showed that the calcium in dairy products is effective in weight loss.

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Article
Information
American Journal of Law & Medicine , Volume 31 , Issue 2-3 , June 2005 , pp. 305 - 340
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2005

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References

1 See, e.g., Avocados rich in vitamin E could block Parkinson’s, THE NEWS TRIBUNE.COM, May 20, 2005, at http://www.thenewstribune.com/news/nationworld/story/4880575p-4475867c.html (reporting a study which suggests that foods rich in vitamin E may “prevent the onset of Parkinson's disease”).

2 U.S. GENERAL ACCOUNTING OFFICE, GAO/RCED-00-156, FOOD SAFETY: IMPROVEMENTS NEEDED IN OVERSEEING THE SAFETY OF DIETARY SUPPLEMENTS AND “FUNCTIONAL FOODS” 4 (2000), available at http://www.gao.gov/archive/2000/rc00156.pdf [hereinafter GAO Report].

3 Zemel, M.B. et al., Dairy Augmentation of Total and Central Fat Loss in Obese Subjects, 29 Int’L J. Obesity, 391, 391-97 (2005)CrossRefGoogle Scholar.

4 Giovannucci, Edward et al., A Prospective Study of Tomato Products, Lycopene, and Prostate Cancer Risk, 94 J. Nat’L Cancer Inst., 391, 391-97 (2002)CrossRefGoogle Scholar; Giovannucci, Edward et al., Intake of Carotenoids and Retinol in Relation to Risk of Prostate Cancer, 87 J. Nat’L Cancer Inst. 1767, 1767-76 (1995)CrossRefGoogle ScholarPubMed; Mills, P.K. et al., Cohort Study of Diet, Lifestyle, and Prostate Cancer in Adventist Men, 64 Cancer 598, 598–604 (1989)3.0.CO;2-6>CrossRefGoogle Scholar.

5 Yves Reginster, Jean et al., Long-Term Effects of Glucosamine Sulphate on Osteoarthritis Progression: A Randomised, Placebo-Controlled Clinical Trial, 357 Lancet 251 (2001)CrossRefGoogle Scholar.

6 See generally Ringel Heller, Ilene, Functional Foods: Regulatory and Marketing Developments, 56 Food Drug L.J. 197, 197 (2001)Google Scholar (explaining that the definition of functional foods includes “foods that inherently may contain an ingredient that has become associated with a particular health benefit (e.g., lycopene products made from tomatoes)”); Leslie T. Krasny, Is It Safe? Ingredients Found in Foods Are Held to a Different Legal Standard in Supplements; Wellness Foods: Regulatory Issues, FOOD PROCESSING, May 1, 2003, at S12 (“Many of the conventional/functional foods currently marketed include botanicals and other novel ingredients typically found in dietary supplements, including …glucosamine); Zemel, supra note 3 (finding that isocaloric substitution of yogurt for other foods augments fat loss).

7 Heller, supra note 6.

8 FOOD AND NUTRITION BOARD, INSTITUTE OF MEDICINE, OPPORTUNITIES IN THE NUTRITION AND FOOD SCIENCES: RESEARCH CHALLENGES AND THE NEXT GENERATION OF INVESTIGATORS 109 (1994).

9 GAO Report, supra note 2.

10 Heller, supra note 6.

11 GAO Report, supra note 2.

12 See infra note 18 and accompanying text.

13 Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301-397 (2000).

14 Federal Meat Inspection Act, 21 U.S.C. §§ 601-695 (2000); Poultry Products Inspection Act, 21 U.S.C. §§ 451-471 (2000).

15 Federal Food, Drug, and Cosmetic Act, Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. §§ 301-397 (2005)).

16 21 U.S.C. §§ 301-397.

17 Compare 21 U.S.C. §§ 351-360 (“Subchapter V: Drugs and Devices”) with 21 U.S.C. §§ 341-350 (“Subchapter IV: Food”).

18 Heller, supra note 6, at 198.

19 Betz, supra note 12.

20 21 U.S.C. § 321(g).

21 21 U.S.C. § 321(p).

22 21 U.S.C. § 321(p).

23 21 U.S.C. § 355(a).

24 See 21 U.S.C. § 355(d).

25 Cataxinos, Edgar R., Regulation of Herbal Medications in the United States: Germany Provides a Model for Reform, 1995 Utah L. Rev. 561, 574 (1995)Google Scholar (stating in a 1995 journal article that “NDA approval costs an average of $50 to $100 million per product”).

26 See generally Merrill, Richard A., The Architecture of Government Regulation of Medical Products, 82 Va. L. Rev. 1753, 1776 (1996)CrossRefGoogle Scholar.

27 21 U.S.C. § 321(f).

28 Nutrilab, Inc. v. Schweiker, 713 F.2d 335, 338 (7th Cir. 1983) (emphasis added).

29 Id. at 335.

30 Id. at 339.

31 Id at 338-39.

32 See 21 C.F.R. § 101.14(a)(3) (2005).

33 21 C.F.R. § 101.14(a)(3).

34 Food Labeling: Health Claims; Plant Sterol/Stanol Esters and Coronary Heart Disease 65 Fed. Reg. 54,685, 54,688 (Sept. 8, 2000) (codified at 21 C.F.R. pt. 101).

35 65 Fed. Reg. 54,685, 54,688 (Sept. 8, 2000).

36 65 Fed. Reg. 54,685, 54,688 (Sept. 8, 2000) (“The scientific evidence suggests that the cholesterol-lowering effect of plant sterol esters is achieved through an effect on the digestive process.”).

37 See Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body, 65 Fed. Reg. 1000, 1027 (Jan. 6, 2000) (codified at 21 C.F.R. pt. 101).

38 21 U.S.C § 343(r)(6).

39 21 U.S.C. § 321(g)(1)(C).

40 21 U.S.C. § 321(g)(1)(C).

41 21 C.F.R. § 10.85(d)(1) (2005).

42 21 U.S.C. § 321(s).

43 21 U.S.C. § 321(s).

44 21 U.S.C. § 342(a)(2)(c)(i).

45 FDA, Center for Food Safety and Applied Nutrition (CFSAN), Office of Nutritional Products, Labeling, and Dietary Supplements, Food Additives (Oct. 31, 2000), available at http://www.cfsan.fda.gov/∼lrd/foodaddi.html.

46 Id.

47 See Dana Ziker, Regulating Functional Foods: Pre- and Post-Market Strategy, DUKE L. & TECH. REV., Nov. 25, 2002, at 12.

48 21 U.S.C. § 321(s).

49 21 U.S.C. § 321(s).

50 21 C.F.R. § 170.30(c)(1) (2004).

51 U.S. FOOD AND DRUG ADMINISTRATION, supra note 45.

52 21 C.F.R. § 170.30(b) (2004); see also Degnan, Frederick H., Rethinking the Applicability and Usefulness of the GRAS Concept, 46 Food Drug Cosm L.J. 553, 571 (1991)Google Scholar.

53 21 C.F.R. § 170.30(b).

54 21 C.F.R. § 170.30(b); Degnan, supra note 52, at 557.

55 21 U.S.C. § 342(a)(2)(C)(providing that a food is deemed adulterated if it contains any food additive that is unsafe within the meaning of section 409 (21 U.S.C. section 348)); see also Noah, Lars, Starting from Scratch?: Reinventing the Food Additive Approval Process, 78 B.U.L. Rev. 329, 363 (1998)Google Scholar.

56 21 C.F.R. pts. 182 & 184 (2004).

57 21 C.F.R. § 170.35; see also Heckman, Jerome H. & Ziffer, Deborah W., Fathoming Food Packaging Regulation, 56 Food Drug L.J. 179, 183-84 (2001)Google ScholarPubMed.

58 Enzyme Preparation from Animal and Plant Sources: Affirmation of GRAS Status as Direct Food Ingredients, 60 Fed. Reg., 32, 904 (June 26, 1995) (GRAS regulation for bromelain, issued 22 years after FDA received the petition in 1973); see also Goldman Herman, Karen, Issues in the Regulation of Bioengineered Food, 7 High Tech L.J. 107, 124 (1992)Google Scholar.

59 GRAS Notification Program, 62 Fed. Reg. 18,938 (proposed April 17, 1997) (to be codified at 21 C.F.R. pt. 170).

60 FDA, CSFAN, Office of Nutritional Products, Labeling, and Dietary Supplements, Frequently Asked Questions about GRAS (Dec. 2004), available at http://www.cfsan.fda.gov/∼dms/grasguid.html#Q11 (stating that the FDA's goal is to respond to notices within 180 days).

61 FDA, CSFAN, Office of Nutritional Products, Labeling, and Dietary Supplements, GRAS Notification Program (Apr. 2005), available at http://vm.cfsan.fda.gov/∼rdb/opa-gras.html.

62 COMMISSION ON DIETARY SUPPLEMENT LABELS, Background on Dietary Supplements, http://www.health.gov/dietsupp/ch2.htm (last visited May 9, 2005).

63 Id.

64 21 U.S.C. § 343(j) (2000).

65 S. Rep. No. 493–73, at 12 (1934).

66 21 U.S.C. § 350(c)(1).

67 21 C.F.R. § 105.3(a)(1) (2005).

68 21 C.F.R. § 105.3(a)(1).

69 The Orphan Drug Act of 1983, Pub. L. No. 97-414, 96 Stat. 2049 (codified as amended at 21 U.S.C. § 360ee(b)3 (2000)).

70 The Dietary Supplement Health and Education Act of 1994, Pub. L. No. 103-417, 108 Stat. 4325-26 (codified as amended at 21 U.S.C. § 321(ff) (2000)).

71 Drug Efficacy Study Implementation, 37 Fed. Reg. 18,229, 18,230 (Sept. 8, 1972).

72 Regulation of Medical Foods, 61 Fed. Reg. 60,661, 60,662 (proposed Nov. 29, 1996).

73 61 Fed. Reg. at 60,662.

74 Regulations for the Enforcement of the Federal Food, Drug, and Cosmetic Act and the Fair Packaging Labeling Act, 38 Fed. Reg. 2124, 2126 (proposed Jan. 19, 1973).

75 See Orphan Drug Regulations, 56 Fed. Reg. 3338, 3338 (proposed Jan. 29, 1991) (to be codified at 21 C.F.R. pt. 316).

76 21 U.S.C. § 360ee(b)3. Enteral nutrition is nutrition provided through the gastrointestinal tract, taken by mouth or provided through a tube or catheter that delivers nutrients beyond the oral cavity. Regulation of Medical Foods, 61 Fed. Reg. at 60,664.

77 See 21 U.S.C. §§ 321(s); Regulation of Medical Foods, 61 Fed. Reg. at 60,662 (stating that “the agency [has] exempt[ed] medical foods from many of the requirements that apply to conventional foods”).

78 Regulations for the Enforcement of the Federal Food, Drug, and Cosmetic Act and the Fair Packaging Labeling Act, 38 Fed. Reg. at 2126.

79 21 C.F.R. § 101.9(j)(8) (2005).

80 Regulation of Medical Foods, 61 Fed. Reg. at 60,661. Although FDA has since withdrawn the ANPR, the agency noted that the ANPR continues to represent the agency's views on the proper regulation of medical foods. See Withdrawal of Certain Proposed Rules and Other Proposed Actions, 69 Fed. Reg. 68,831, 68,832 (Nov. 26, 2004).

81 61 Fed. Reg. at 60,663.

82 61 Fed. Reg. at 60,667.

83 61 Fed. Reg. at 60,669.

84 61 Fed. Reg. at 60,669-70.

85 61 Fed. Reg. at 60,669-70.

86 61 Fed. Reg. at 60,670.

87 61 Fed. Reg. at 60,664.

88 61 Fed. Reg. at 60,664.

89 Mandatory Status of Nutrition Labeling and Nutrient Content Revision, 56 Fed. Reg. 60,366, 60,377-8 (proposed Nov. 27, 1991). The FFDCA establishes different statutory and regulatory frameworks for drugs, dietary supplements, medical foods, and conventional foods. The FFDCA defines drugs as including articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals and articles (other than food) intended to affect the structure or any function of the body of man or other animals. 21 U.S.C. § 321(g). This language is broad and, generally, has been interpreted expansively by both FDA and the courts. FDA has relied upon it in the past to regulate as drugs many substances promoted as dietary supplements.

90 The Dietary Supplement Health and Education Act of 1994, §§ 4-9, Pub. L. No. 103-417, 108 Stat. 4325-26 (codified as amended at 21 U.S.C. § 321(ff) (2000)) [hereinafter DSHEA].

91 DSHEA §§ 3,5.

92 21 U.S.C. § 321(ff).

93 21 U.S.C. § 321(ff)(1).

94 21 U.S.C. § 321(ff)(1).

95 21 U.S.C. § 321(ff)(2)(C).

96 21 U.S.C. § 321(ff)(2)(A)(i).

97 21 U.S.C. § 321(ff)(2); see also Food Labeling; Requirements for Nutrient Content Claims, Health Claims, and Statements of Nutritional Support for Dietary Supplements, 62 Fed. Reg. 49,859, 49,862 (Sept. 23, 1997).

98 21 U.S.C. § 321(ff)(3)(A).

99 21 U.S.C. § 321(ff)(3)(B).

100 21 U.S.C. § 350b(c).

101 21 U.S.C. § 321(s)(6).

102 21 U.S.C. § 350b(a).

103 21 U.S.C. § 350b(a)(1).

104 21 U.S.C. § 350b(a)(2).

105 21 U.S.C. § 350b(a)(2).

106 See Nutrition Labeling and Education Act of 1990, Pub. L. No. 101-535, 104 Stat. 2352, 2353 (codified as amended at 21 U.S.C. § 343 (2005)).

107 21 U.S.C. § 343(r)(1)(A).

108 See 21 C.F.R. § 101.54 (2005).

109 21 C.F.R. § 101.54.

110 21 C.F.R. §§ 101.60-101.67.

111 21 C.F.R. § 101.54.

112 21 C.F.R. § 101.60.

113 21 C.F.R. § 101.61.

114 21 C.F.R. § 101.62.

115 21 C.F.R. § 101.65.

116 21 C.F.R. §§ 101.54(a)-101.65(a).

117 21 C.F.R. § 101.13(i)(3).

118 21 C.F.R. § 101.14(a)(1); see also Clement Pappas, Dimitri, Maintaining a Level Playing Field: The Need for a Uniform Standard to Evaluate Health Claims for Foods and Dietary Supplements, 57 Food Drug L.J. 25, 27 (2002)Google ScholarPubMed.

119 21 C.F.R. § 101.14(a)(1).

120 21 U.S.C. § 343(r)(3)(A)(i).

121 21 U.S.C. § 343(r)(3)(B)(i).

122 21 U.S.C. § 343(r)(3)(B)(ii).

123 21 C.F.R. § 101.72.

124 21 C.F.R. § 101.73.

125 21 C.F.R. § 101.74.

126 21 C.F.R. § 101.75.

127 21 C.F.R. § 101.76.

128 21 C.F.R. § 101.77.

129 21 C.F.R. § 101.78.

130 21 C.F.R. § 101.79.

131 21 C.F.R. § 101.80.

132 21 C.F.R. § 101.81.

133 21 C.F.R. § 101.82.

134 21 C.F.R. § 101.83.

135 58 Fed. Reg. 2478, 2479-80 (Jan. 6, 1993).

136 58 Fed. Reg. at 2479-80.

137 58 Fed. Reg. at 2479-80.

138 21 C.F.R. § 101.14(a)(5).

139 58 Fed. Reg. 2478, at 2479-80.

140 FDA, CSFAN, Office of Nutritional Products, Labeling, and Dietary Supplements, Dietary Guidance about Fruits and Vegetables, (July 29, 2003), available at http://www.cfsan.fda.gov/∼dms/lab-dg.html.

141 Id.

142 21 U.S.C. § 343(r)(3)(B)(i).

143 21 U.S.C. § 343(r)(3)(B).

144 21 C.F.R. § 101.14.

145 21 C.F.R. § 101.14.

146 21 C.F.R. § 101.75.

147 See General Requirements for Health Claims for Food, 58 Fed. Reg. 2478, 2505 (Jan. 6, 1993).

148 See 21 C.F.R. § 101.14.

149 21 C.F.R. § 101.14(a)(4).

150 See, e.g., Whitaker v. Thompson, 353 F.3d 947 (D.C. Cir. 2004).

151 Id.

152 Id. at 951.

153 Id.

154 Id.

155 Id. at 961-62.

156 Id. at 952-53.

157 Id. at 953.

158 See, e.g., Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999).

159 See, e.g., Pearson v. Shalala, 130 F. Supp. 2d 105 (D.D.C. 2001) [hereinafter Pearson II]; Whitaker, 353 F.3d at 952-53.

160 Pearson, 164 F.3d at 650.

161 Id. at 651-52.

162 Id. at 653.

163 The case was subsequently remanded back to the FDA on April 20, 1999. Pearson II, 130 F. Supp. 2d at 110. On September 8, 1999, the FDA published a notice requesting scientific data relating to the four health claims at issue. See Food Labeling; Health Claims and Label Statements; Request for Scientific Data and Information, 65 Fed. Reg. 59,855 (Oct. 6, 2000). On March 31, 2000, the Pearson plaintiffs unsuccessfully sought a court order forcing the FDA to move forward with compliance with the Pearson ruling. See Pearson v. Shalala, No. Civ.A. 95-1865(GK), 2000 WL 767584 (D.D.C. May 24, 2000). At that time, the district court ruled that the filing was premature because FDA had not exhausted its 540-day period in which it must make a final determination on the health claims. See id.

164 Pearson, 164 F.3d at 655, 660. FDA subsequently issued a lengthy guidance document identifying how it would evaluate scientific evidence pursuant to the significant scientific agreement standard. See FOOD & DRUG ADMIN., GUIDANCE FOR THE INDUSTRY: SIGNIFICANT SCIENTIFIC AGREEMENT IN THE REVIEW OF HEALTH CLAIMS FOR CONVENTIONAL FOODS AND DIETARY SUPPLEMENTS (1999). The guidance document advised: “Significant scientific agreement meant that the validity of the relationship is not likely to be reversed by new and evolving science, although the exact nature of the relationship may need to be refined.’” Id. at 2.

165 See Food Labeling: Health Claims and Labeling Statements; Dietary Fiber and Cancer; Antioxidant Vitamins and Cancer; Omega-3 Fatty Acids and Coronary Heart Disease; Folate and Neural Tube Defects; Revocation, 65 Fed. Reg. 58,917 (Oct. 3, 2000) (revoking denial of four claims pending further review); Food Labeling; Health Claims and Label Statements for Dietary Supplements; Update to Strategy for Implementation of Pearson Court Decision, 65 Fed. Reg. 59,855 (Oct. 6, 2000) (setting forth interim policy for evaluating basis for qualified health claim if scientific agreement is lacking).

166 65 Fed. Reg. at 59,855.

167 See Pearson II, 130 F. Supp. 2d at 105.

168 Id. at 118.

169 Id. at 119.

170 Id. at 112.

171 See Letter from FDA to Jonathan W. Emord, Esq., Emord & Associates, P.C., regarding Petition for Health Claim: Antioxidants and Cancer (Docket No. 91N-0101) (May 4, 2001) [hereinafter Letter from FDA].

172 Id.

173 Id.

174 Id. In its letter, FDA stated that antioxidant health claims are “inherently misleading and cannot be made non-misleading with a disclaimer or other qualifying language.” Id. at 58.

175 See generally Whitaker, 353 F.3d at 947.

176 FDA, CSFAN, Office of Nutritional Products, Labeling, and Dietary Supplements, Consumer Health Information for Better Nutrition Initiative Task Force Final Report, Guidance: Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements (July 10, 2003), available at http://www.cfsan.fda.gov/∼dms/nuttfe.html.

177 Pearson v. Shalala, 164 F.3d 650, 661 (D.C. Cir. 1999).

178 Id.

179 FDA, CFSAN, Office of Nutritional Products, Labeling, and Dietary Supplements, supra note 176.

180 Id.

181 FDA, CSFAN, Office of Nutritional Products, Labeling, and Dietary Supplements, Letter Regarding Dietary Supplement Health Claim for Antioxidant Vitamins and Risk of Certain Cancers (Apr. 1, 2003), available at http://www.cfsan.fda.gov/∼dms/ds-ltr34.html.

182 See Termini, Roseann B., Pharmanex, Inc. v. Shalala: A Wake Up Call for Congress and a Not So Bitter Pill for the FDA, 26 Ohio N.U.L. Rev. 269, 269-70 (2000)Google Scholar.

183 Id. at 269-70.

184 21 U.S.C. § 343(r)(6)(A).

185 21 U.S.C. § 343(r)(6).

186 21 U.S.C. § 343(r)(6).

187 21 U.S.C. § 321(g)(1)(C).

188 21 U.S.C. § 321(g)(1)(C).

189 21 U.S.C. § 321(g)(1)(C); see also Termini, supra note 182, at 269-70.

190 21 U.S.C. § 343(r)(6).

191 65 Fed. Reg. 1000, 1034 (Jan. 6, 2000) (to be codified at 21 C.F.R. pt. 101).

192 65 Fed. Reg. at 1034.

193 21 C.F.R. § 101.93(g)(1).

194 21 C.F.R. § 101.93(g)(1). This definition is identical to FDA's definition of “disease or health-related condition” set forth in the current health claim regulations. 21 C.F.R. § 101.14.

195 21 C.F.R. § 101.93(g)(2).

196 21 C.F.R. § 101.93(g)(2).

197 21 C.F.R. § 101.93(g)(2).

198 See 65 Fed. Reg. 1000, 1018 (Jan. 6, 2000) (to be codified at 21 C.F.R. pt. 101).

199 65 Fed. Reg. at 1018.

200 65 Fed. Reg. at 1034.

201 65 Fed. Reg. at 1034.

202 65 Fed. Reg. at 1033.

203 62 Fed. Reg. at 99,863.

204 21 C.F.R. § 101.93(b)(c).

205 Paula Frank, Regulating Functional Foods, Perspectives (Mar. 2001), at http://www.foodproductdesign.com/archive/2001/0301fo_p.html.

206 Food Safety: Improvements Needed in Overseeing the Safety of Dietary Supplements and “Functional Foods,” GAO/RCED-00-156 (July 2000).

207 Id.

208 See CSPI Reports: International, Functional Foods: Public Health Boon or 21st Century Quackery?, at http://www.cspinet.org/reports/functional_foods/index.html (1999).

209 Food and Drug Administration Modernization Act of 1997, § 303-304, Pub. L. 105-115, 111 Stat. 2296 (1997).

210 Food and Drug Administration Modernization Act § 303.

211 H.R. Rep. No. 105-399, at 98 (1997).

212 21 U.S.C. § 343(r)(3)(C).

213 21 U.S.C. § 343(r)(3)(C).

214 21 U.S.C. § 343(r)(2)(G).

215 FDA, CSFAN, Office of Nutritional Products, Labeling, and Dietary Supplements, Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body (June 11, 1998), available at http://www.cfsan.fda.gov/∼dms/hclmguid.html.

216 Id.

217 21 U.S.C. § 343(r)(3)(C).

218 See 63 Fed. Reg. 34,101, 34,102 (June 22, 1998) (to be codified at 21 C.F.R. pt. 101).

219 63 Fed. Reg. at 34,084.

220 FDA, CSFAN, Office of Nutritional Products, Labeling, and Dietary Supplements, Nutrient Content Claims Notification for Choline Containing Foods (Aug. 30, 2005), available at http://www.cfsan.fda.gov/∼dms/flcholin.html.

221 FDA, CSFAN, Office of Nutritional Products, Labeling, and Dietary Supplements, Health Claim Notification for Potassium Containing Foods (Oct. 31, 2000), available at http://www.cfsan.fda.gov/∼dms/hclm-k.html.

222 FDA, CSFAN, Office of Nutritional Products, Labeling, and Dietary Supplements, Health Claim Notification for Whole Grain Foods with Moderate Fat Content (Dec. 9, 2003), available at http://www.cfsan.fda.gov/∼dms/flgrain2.html; FDA, CSFAN, Office of Nutritional Products, Labeling, and Dietary Supplements, Health Claim Notification for Whole Grain Foods (July 1999), available at http://www.cfsan.fda.gov/∼dms/flgrains.html.

223 21 C.F.R. § 101.14(a)(1).

224 21 C.F.R. § 101.83(c)(2)(B)(iii).

225 21 U.S.C. § 321(g)(2)(A)-(B).

226 21 U.S.C. § 343(r)(6); 21 U.S.C. § 343(a).

227 21 U.S.C. § 343(r)(6).

228 21 U.S.C. § 343(r)(6).

229 21 U.S.C. § 321(g)(1)(A)-(B).

230 21 U.S.C. § 343; 21 U.S.C. § 331(d).

231 21 U.S.C. § 331(d).

232 FDA, CSFAN, Office of Nutritional Products, Labeling, and Dietary Supplements, Claims That Can Be Made for Conventional Foods and Dietary Supplements (Sept. 2003), available at http://www.cfsan.fda.gov/∼dms/hclaims.html.

233 21 U.S.C. § 321.

234 21 U.S.C. § 321(ff).

235 FDA, CSFAN, Office of Nutritional Products, Labeling, and Dietary Supplements, Letter to Manufacturers Regarding Botanicals and Other Novel Ingredients in Conventional Foods (Jan. 30, 2001), available at http://vm.cfsan.fda.gov/∼dms/ds-ltr15.html.

236 21 U.S.C. § 321(m). The same definition of “labeling” applies for all categories of FDAregulated products.

237 See, e.g., Kordel v. United States, 335 U.S. 345 (1948) (holding that the phrase “accompanying such article” is not restricted to materials that are physically on or in an article or package and reasoning that it is the textual relationship between a material and a product, not physical attachment, that is dispositive to a finding that the material is “labeling”).

238 21 U.S.C. § 343(r)(6)(c).

239 21 U.S.C. § 321(ff).

240 21 U.S.C. § 321(ff).

241 21 U.S.C. § 321(ff)(2).

242 21 U.S.C. § 321(ff)(2).

243 62 Fed. Reg. 49,859, 49,862 (Sept. 23, 1997).

244 62 Fed. Reg. at 49,862.

245 62 Fed. Reg. at 49,862.

246 62 Fed. Reg. at 49,862.

247 62 Fed. Reg. at 49,862.

248 62 Fed. Reg. at 49,862.

249 Letter from Joseph A. Levitt, Director, Center for Food Safety and Applied Nutrition, to Brian Perkins, President, McNeil Consumer Products Company (Dec. 23, 1998) (on file with author); Letter from Joseph A. Levitt, Director, Center for Food Safety and Applied Nutrition, to Richard A. Goldstein, Chairman and Chief Executive Officer, Lipton (Dec. 23, 1998) (on file with author).

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

251 See, e.g., Letter from Joseph A. Levitt, Director, Center for Food Safety and Applied Nutrition, to Brian Perkins, President, McNeil Consumer Products Company (Oct. 28, 1998) (on file with author).

252 Food Labeling; Requirements for Nutrient Content Claims, Health Claims, and Statements of Nutritional Support for Dietary Supplements, 62 Fed. Reg. 49,859, 49,862 (Sept. 23, 1997).

253 21 U.S.C. § 350b(a).

254 21 U.S.C. § 350b(c).

255 21 U.S.C. § 350b.

256 21 U.S.C. § 350b(c).

257 21 U.S.C. § 350b(a)(1).

258 21 U.S.C. § 342(f)(1).

259 21 U.S.C. § 348.

260 21 U.S.C. § 342(f)(1).

261 69 Fed. Reg. 6787 (Feb. 11, 2004).

262 See, e.g., Fontanarosa, Phil B. et al., The Need for Regulation of Dietary Supplements- Lessons from Ephedra, 289 JAMA 1568 (2003)CrossRefGoogle ScholarPubMed.

263 21 U.S.C. § 343(r)(6).

264 21 U.S.C. § 343(r)(6)(c).

265 21 U.S.C. § 343(r)(6)(c).

266 FDA, CFSAN, Dietary Supplement Strategy, Letter from the Director (Jan. 2000), available at http://vm.cfsan.fda.gov/∼dms/ds-strat.html#Plan.

267 21 U.S.C. § 343(r)(6)(c).

268 Foods for Special Dietary Use, 21 C.F.R. § 105.3(a)(1) (2004).

269 21 C.F.R. § 105.3(a)(1)(i).

270 21 C.F.R. § 105.3 (a)(2).

271 21 C.F.R. § 105.3(a)(1)(i).

272 21 U.S.C. § 343(j).

273 21 C.F.R. § 105.62, 105.65, 105.66; see also Heller, supra note 6, at 204.

274 58 Fed. Reg. 2427, 2428 (Jan. 6, 1993) (“[T]he agency does not consider claims made solely to portray the usefulness of a food for supplying a particular dietary need that exists by reason of a physical, pathological, or other conditions, as described in part 105, to be a nutrient content claim subject to § 101.13.”); 58 Fed. Reg. at 2482 (“FDA advises that any statement that appears on the label or in the labeling of a food intended for “special dietary use” that is consistent with provisions of the regulations promulgated under section 403(j) of the act will not be regulated as a health claim by the agency.”).

275 See, e.g., Letter from William K. Hubbard, Associate Commissioner for Policy and Planning, Food and Drug Administration, to Martin J. Hahn, Hogan & Hartson regarding “Health claim petition that crystalline glucosamine sulfate reduces the risk of osteoarthritis joint deterioration and joint pain and limitation of function (Docket No. 2004P-0060) (Oct. 7, 2004).

276 21 U.S.C. § 343(j).

277 21 U.S.C. § 343(j).

278 21 C.F.R. § 101.9(j)(8).

279 Regulation of Medical Foods, 61 Fed. Reg. 60,661, 60,664 (Nov. 29, 1996).

280 See Silverglade, Bruce A. & Ringel Heller, Ilene, Are Functional Foods the Solution to Dysfunctional Diets? A Review of U.S. Regulatory Requirements and Lessons from Abroad, 52 Food Drug L.J. 313, 314 (1997)Google Scholar.

281 21 U.S.C. § 343(q)(5)(A)(iv) (exempting medical foods from the nutrition labeling requirements); 21 U.S.C. § 343(r)(5)(A) (exempting medical foods from the nutrient content and health claim requirements).

282 See 61 Fed. Reg. at 60,664-65.

283 Id. at 60,667; see also 56 Fed. Reg. 60,366, 60,377 (Nov. 27, 1991).

284 21 C.F.R. § 101.9(j)(8)(i).

285 56 Fed. Reg. at 60,377.

286 56 Fed. Reg. at 60,377.

287 56 Fed. Reg. at 60,377.

288 21 C.F.R. § 101.9(j)(8)(i).

289 21 C.F.R. § 101.9(j)(8)(ii).

290 56 Fed. Reg. at 60,377.

291 21 C.F.R. § 101.9(j)(8)(ii).

292 21 C.F.R. § 101.9(j)(8)(iii).

293 21 C.F.R. § 101.9(j)(8)(ii).

294 21 C.F.R. § 101.9(j)(8)(iii).

295 56 Fed. Reg. at 60,377.

296 56 Fed. Reg. at 60,377.

297 56 Fed. Reg. at 60,377.

298 56 Fed. Reg. at 60,377.

299 21 C.F.R. §§ 101.9(j)(8)(iv), (v).

300 21 C.F.R. §§ 101.9(j)(8)(iv), (v).

301 21 C.F.R. §§ 101.9(j)(8)(iv), (v).

302 21 U.S.C. § 360ee(b)(3).

303 Primus Pharmaceutical's LIMBREL, a capsule containing 250 mg of flavocoxid, reportedly is being marketed in the United States as a medical food for the dietary management of mild to moderate osteoarthritis. Information about LIMBREL can be found on the website at http://www.mcramerican.com/limbrel.htm (last visited Feb. 17, 2005).

304 Letter from Daniel E. Troy, Chief Counsel, Food and Drug Administration to Jeffrey N. Gibbs, Esq., Hyman, Phelps & McNamara (Oct. 17, 2002) (foreseeable use does not establish intended use—the intended use should be determined by the claims of the manufacturer) (on file with the author).