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Dietary Supplements are Not all Safe and Not all Food: How the Low Cost of Dietary Supplements Preys on the Consumer

Published online by Cambridge University Press:  06 January 2021

Joanna K. Sax*
Affiliation:
Institute of Health Law Studies, California Western School of Law, University of Pennsylvania
*

Abstract

Dietary supplements are regulated as food, even though the safety and efficacy of some supplements are unknown. These products are often promoted as ‘natural.’ This leads many consumers to fail to question the supplements' safety, and some consumers even equate ‘natural’ with safe. But, ‘natural’ does not mean safe. For example, many wild berries and mushrooms are dangerous although they are natural. Another example is tobacco—a key ingredient in cigarettes: it is natural, but overwhelming studies have established the harm of cigarette smoke. The Food and Drug Administration (FDA) requires safety and efficacy testing prior to market entry for drugs. In contrast, the FDA only has limited ability to regulate the entry of new dietary supplements into the marketplace because supplements are treated as food.

Two main arguments support the current regulatory structure of dietary supplements: (1) cost and (2) access. But lower cost and increased access to dietary supplements do not necessary have any relationship to safety and efficacy. Manufacturers' marketing techniques tout the health benefits of their supplements. Meanwhile, consumers are ingesting supplements without scientific studies indicating whether or not they are harmful.

The FDA Food Safety and Modernization Act, signed into law on January 4, 2011, did not address the safety concerns regarding dietary supplements. This article discusses the regulatory deficiencies concerning dietary supplements and proposes novel solutions to address this specific sector of the food supply. This article advocates for the use of scientific data to support a multi-tiered classification system to ensure that dietary supplements on the market are safe.

Type
Articles
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2015

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References

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2 See U.S. Food & Drug Admin., FSMA Facts: Background on the FDA Food Safety Modernization Act (FSMA) 1 (2011), available at http://www.fda.gov/downloads/Food/GuidanceRegulation/UCM263773.pdf.

3 Id. at 1-2.

4 21 U.S.C. § 321(ff) (2012).

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6 FDA Food Safety Modernization Act § 101(a)(4), 21 U.S.C. § 350c(a)(2).

7 FDA Food Safety Modernization Act § 103(g), 21 U.S.C. § 350g.

8 FDA Food Safety Modernization Act § 113, 21 U.S.C. § 350b.

9 21 U.S.C. § 350b(c)(1).

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13 21 U.S.C. § 321(ff) (2012); Questions and Answers on Dietary Supplements, U.S. Food & Drug Admin., http://www.fda.gov/Food/DietarySupplements/QADietarySupplements/default.htm (last updated Apr. 28, 2015).

14 See Dietary Supplement Health and Education Act of 1994, Pub. L. No. 103-417, 108 Stat. 4325 (codified as amended in scattered sections of 21 U.S.C.).

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17 See infra Part II.

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27 Id. at 795.

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35 Id. at 224.

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40 Id. at B2.

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42 Id. at 1524-25.

43 Id.

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49 Id.

50 See 21 U.S.C. § 355 (2012).

51 FAQ, supra note 48.

52 Id.

53 Id.

54 Cf. Gurley, Bill J. et al., Content Versus Label Claims in Ephedra-Containing Dietary Supplements, 57 Am. J. Health-Sys. Pharmacy 963, 963 (2000)CrossRefGoogle ScholarPubMed.

55 Cf. id.

56 Id. 968-69 (collecting examples).

57 Id. at 964.

58 Id.

59 Id.

60 Id.

61 Id. at 963-64.

62 Id. at 965-66.

63 Id. at 966.

64 Id.

65 Id. at 967.

66 Id.

67 Id.

68 See id. at 968.

69 Id.

70 Singer & Lattman, supra note 5, at B1.

71 Id.

72 Id.

73 Id. at B2.

74 Warning Letter from Michael W. Roosevelt, Acting Dir., Office of Compliance, Food & Drug Admin. Ctr. for Food Safety & Applied Nutrition, to USP Labs, LLC (Apr. 24, 2012) (on file with Food & Drug Admin.), available at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm302167.htm.

75 See, e.g., Singer & Lattman, supra note 5, at B2.

76 See Yetley, Elizabeth A., Multivitamin and Multimineral Dietary Supplements: Definitions, Characterization, Bioavailability, and Drug Interactions, 85 Am. J. Clinical Nutrition (Supplement) 269s (2007)CrossRefGoogle ScholarPubMed.

77 Id. at 270s-71s.

78 Cf. id. at 272s.

79 NPA GMP Certification Program, Nat. Products Ass'n, http://www.npainfo.org/NPA/EducationCertification/NPAGMPCertificationProgram.aspx (last visited May 13, 2015).

80 Monika Samtani et al., Remarks During a Satellite Broadcast on Current Good Manufacturing Practices for Dietary Supplements (Oct. 24, 2007) (transcript available on the U.S. Food & Drug Admin. website), available at http://www.fda.gov/Food/GuidanceRegulation/CGMP/ucm173996.htm; see generally 21 C.F.R. § 111 (2014).

81 Moyer, supra note 30, at 462.

82 Mursu et al., supra note 44, at 1631.

83 Henderson, L. et al., St John's Wort (Hypericum Perforatum): Drug Interactions and Clinical Outcomes, 54 Brit. J. Clinical Pharmacology 349, 349 (2002)CrossRefGoogle ScholarPubMed.

84 Id. at 349.

85 Id.

86 See id.

87 Dietary Supplement Fact Sheets, Nat'l Inst. Health, http://ods.od.nih.gov/factsheets/list-all/ (last visited May 13, 2015) [hereinafter Supplement Fact Sheet].

88 Calcium: Fact Sheet for Consumers, Nat'l Inst. Health, http://ods.od.nih.gov/factsheets/Calcium-Consumer/ (last reviewed Mar. 19, 2013) [hereinafter Calcium Fact Sheet].

89 Id.

90 See Lindsey Duncan, So, What's So Good About Acai? A Whole Lot., Dr. Oz Show (May 24, 2011), http://www.doctoroz.com/blog/lindsey-duncan-nd-cn/so-whats-so-good-about-acai-whole-lot.

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93 Id.

94 See id.

95 Cohen, supra note 28, at 1524.

96 Id.

97 Id. at 1523.

98 Id.

99 Id. at 1524.

100 Id.

101 Id.

102 Id.

103 See U.S. Preventative Servs. Task Force, Folic Acid for the Prevention of Neural Tube Defects: U.S. Preventive Services Task Force Recommendation Statement, 150 Annals Internal Med. 626, 626, 631 (2009)Google Scholar.

104 Annals of Internal Med., Summary for Patients — Folic Acid for the Prevention of Infant Neural Tube Defects: U.S. Preventive Services Task Force Recommendation, at I-50 (2009) [hereinafter Summary for Patients]; Folic Acid, Medline Plus, http://www.nlm.nih.gov/medlineplus/folicacid.html#cat2 (last updated May 12, 2015) [hereinafter Folic Acid].

105 Summary for Patients, supra note 104, at I-50; Folic Acid, supra note 104.

106 Cohen, supra note 28, at 1523-24.

107 Id.

108 Id. at 1524.

109 See 21 U.S.C. § 342(a)(1) (2012).

110 Dietary Supplement Health and Education Act of 1994, Pub. L. No. 103-417, § 2, 108 Stat. 4325, 4325-26 (codified as amended in scattered sections of 21 U.S.C.).

111 Dietary Supplement Health and Education Act § 2(2).

112 Moyer, supra note 30, at 462.

113 See Mursu et al., supra note 44, at 1625.

114 Dietary Supplement Health and Education Act § 2(4).

115 Diabetes Guide, Web MD, http://www.webmd.boots.com/diabetes/guide/risk-factors-for-diabetes (last visited May 13, 2015) (“Diabetes has long been linked to obesity and being overweight. Research at the Harvard School of Public Health in the U.S. showed that the single best predictor of type 2 diabetes is being obese or overweight.”).

116 Dietary Supplement Health and Education Act § 2(8).

117 Id.

118 See supra Part II.

119 See, e.g., Calcium Fact Sheet, supra note 88.

120 Dietary Supplement Health and Education Act § 2(12)(A).

121 David Lariviere, Nutritional Supplements Flexing Muscles As Growth Industry, Forbes (Apr. 18, 2013, 7:09 PM), http://www.forbes.com/sites/davidlariviere/2013/04/18/nutritional-supplements-flexing-their-muscles-as-growth-industry/.

122 See, e.g., Eric Lipton, Support Is Mutual for Senator and Utah Industry, N.Y. Times (June 20, 2011), http://www.nytimes.com/2011/06/21/us/politics/21hatch.html?pagewanted=all&_r=0.

123 Economic Facts About U.S. Tobacco Production and Use, CDC, http://www.cdc.gov/tobacco/data_statistics/fact_sheets/economics/econ_facts/index.htm#sales (last updated Apr. 16, 2014).

124 Dietary Supplement Health and Education Act § 2(14).

125 See, e.g., Singer & Lattman, supra note 5, at B1-B2.

126 See, e.g., Thomas, Alessa, Note, Making Sense of Supplements: Suggestions for Improving the Regulation of Dietary Supplements in the United States, 2010 Mich. St. L. Rev. 203, 233-34Google Scholar (discussing the benefits of a number of dietary supplements, including multivitamins, such as One-a-Day Women's, folic acid, and calcium supplements).

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129 See 21 U.S.C. § 342(f) (2012).

130 21 U.S.C. § 350b(a).

131 See Gurley et al., supra note 54, at 967-68.

132 Id. at 965-67.

133 21 U.S.C § 342(g); 21 C.F.R. § 111 (2014); Samtani et al., supra note 80.

134 21 C.F.R. §§ 111.55-.95.

135 21 C.F.R. § 111.55.

136 21 C.F.R. § 111.70(b)(2).

137 21 C.F.R. § 111.75(c)(1).

138 21 C.F.R. § 111.75(c)(3).

139 21 C.F.R. §§ 111.77, 111.80, 111.83, 111.90, 111.95.

140 21 C.F.R. § 111.105.

141 21 C.F.R. § 111.130.

142 21 C.F.R. § 111.205.

143 21 C.F.R. §§ 111.553, 111.560.

144 21 C.F.R. § 111.205.

145 21 C.F.R. § 111.70(a)(2).

146 Gurley et al., supra note 54, at 964.

147 Id. at 967-68.

148 See 21 C.F.R. §§ 111.503, 111.510, 111.530.

149 Dietary Supplements, U.S. Food & Drug Admin., http://www.fda.gov/Food/DietarySupplements/ (last updated Apr. 28, 2015).

150 Press Release, U.S. Food & Drug Admin., U.S. Marshals Seize Drug Products Distributed by a Florida Company (Feb. 14, 2013) (on file with author), available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm339887.htm.

151 Id.

152 Id.

153 Id.

154 Id.

155 Id.

156 U.S. Food & Drug Admin., Hidden Risks of Erectile Dysfunction “Treatments” Sold Online 1 (2009), available at http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM143726.pdf.

157 Id.

158 Id.

159 See, e.g., Questions and Answers: FDA alerts companies to stop the illegal sale of products claiming to treat diabetes, U.S. Food & Drug Admin., http://www.fda.gov/ForConsumers/ProtectYourself/HealthFraud/ucm359553.htm (last updated July 23, 2013).

160 See Letter from Margaret A. Hamburg, Comm'r, U.S. Food & Drug Admin., to Dietary Supplement Mfrs. (Dec. 15, 2010) (on file with the U.S. Food & Drug Admin.) [hereinafter Letter from Hamburg], available at http://www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/UCM236985.pdf.

161 Id.

162 Id.

163 Cohen, supra note 28, at 1524.

164 Letter from Hamburg, supra note 160.

165 21 U.S.C § 321(ff) (2012).

166 Supplement Fact Sheet, supra 87.

167 See, e.g., Gurley et al., supra note 54, at 964.

168 Id.

169 Id.

170 See, e.g., Pitkin, Roy M., Folate and Neural Tube Defects, 85 Am. J. Clinical Nutrition (Supplement) 285S (2007)CrossRefGoogle ScholarPubMed.

171 See, e.g., Holick, Michael F., Vitamin D Deficiency, 357 New Eng. J. Med. 266, 270 (2007)CrossRefGoogle ScholarPubMed.

172 Pillitteri et al., supra note 24, at 795; Zeratsky, supra note 32; Vitamin E Fact Sheet for Consumers, Nat'l Inst. Health, http://ods.od.nih.gov/factsheets/VitaminE-Consumer/#h8 (last reviewed Oct. 11, 2011) (“In supplement form, high doses of vitamin E might increase the risk of bleeding (by reducing the blood's ability to form clots after a cut or injury) and of serious bleeding in the brain (known as hemorrhagic stroke).”).

173 See, e.g., Ashley Oerman, The Pre-Workout Drink That Can Help You Burn More Calories, Women's Health (July 10, 2014), http://www.womenshealthmag.com/weight-loss/caffeine-pre-workout.

174 Dietary Supplement Health and Education Act of 1994, Pub. L. No. 103-417, § 2, 108 Stat. 4325, 4325-26.

175 See 21 U.S.C. §§ 331(a)-(c), 332-333, 342(a)(1) (2012).