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Dietary Supplements for Weight Loss: Legal Basis for Excise Tax and Other Government Action to Protect Consumers from a Public Health Menace
Published online by Cambridge University Press: 11 July 2022
Abstract
Dietary supplements sold for weight loss pose a risk to public health due to deceptive claims and unscrupulous manufacturing practices in the context of weak federal regulation. Efforts to strengthen U.S. federal oversight have not been successful, thus action at the state and local levels should be explored. This study investigates proposed action to impose excise taxes on weight-loss supplements.
We reviewed U.S. federal law on taxation at federal, state, and local levels and precedent for taxation of harmful consumer products to promote public health. We assessed the rationale, legal viability, and potential effectiveness of proposed excise taxes on weight loss supplements.
Taxation of tobacco and sweetened beverages is effective in reducing consumer use. Imposition of excise taxes on weight-loss supplements is within the authority of federal, state, and local governments, though is least politically feasible at the federal level. State or local taxation of these products has clear rationale, legal viability, and likelihood of effectiveness in reducing the public health burden posed by these products.
Excise taxation is an effective policy intervention to reduce consumer use, particularly among youth, and is a promising public health strategy to decrease consumer exposure to noxious weight-loss supplements.
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Footnotes
Katrina Velasquez, JD, MS, is the Principal of Center Road Solutions in Washington, DC. Allison Ivie, MPP, MA, and Shanna Fegely, JD, are also with Center Road Solutions. Amanda Raffoul, PhD, is a Research Scholar with the Strategic Training Initiative for the Prevention of Eating Disorders (STRIPED) based in the Division of Adolescent and Young Adult Medicine at Boston Children’s Hospital in Boston, MA. Julia A. Vitagliano, BA, is also with STRIPED. Christina A. Roberto, PhD, is Associate Professor of Medical Ethics & Health Policy at the Perelman School of Medicine at the University of Pennsylvania in Philadelphia, PA. S. Bryn Austin, ScD, Director of STRIPED and Professor in the Department of Social and Behavioral Sciences at the Harvard T.H. Chan School of Public Health and in the Department of Pediatrics at Harvard Medical School and a Research Scholar in the Division of Adolescent and Young Adult Medicine at Boston Children’s Hospital in Boston, MA. The author can be contacted at [email protected]
This study was conceived of by SB Austin. K Velasquez, A Ivie, S Mason conducted the review of the legal literature and conducted legal analyses. K Velasquez, A Ivie, SR Fegely, A Raffoul, and SB Austin drafted the manuscript. All authors reviewed and revised the manuscript and provided critical input. The authors would like to thank Nancy Ortmeyer Kuhn for her contributions to the legal research for this manuscript. This research was supported by the Ellen Feldberg Gordon Fund for Eating Disorders Prevention Research. The funders were not involved in the conduct of the study. The authors do not have financial conflicts of interest with this study.
References
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8 Id. at 5.
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15 See, e.g., Press Release, Am. Psych. Ass’n, Excessive Workout Supplement Use: An Emerging Eating Disorder in Men? (2015), https://www.apa.org/news/press/releases/2015/08/eating-disorder [https://perma.cc/C9T5-YGWP] (citing research by Richard Achiro & Peter Theodore finding 40 percent of participants increased their weight loss supplement use over time and 22 percent replaced their meals with supplements).
16 Levinson et al., supra note 12, at 109.
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18 Id. (Roughly 42 percent of households with income under $40,000 have used dietary supplements, compared to 30 percent in households with income $40,000 and above); S. Bryn Austin et al., Household Expenditures on Dietary Supplements Sold for Weight Loss, Muscle Building, and Sexual Function: Disproportionate Burden by Gender and Income, 6 Preventative Med. Reps. 236, 238 (2017).
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23 Pub. L. No. 103-417, § 3(a) 108 Stat. 4325, 4327 (1994).
24 Jennifer L. Pomeranz, Grant Barbosa, Caroline Killian & S. Bryn Austin, The Dangerous Mix of Adolescents and Dietary Supplements for Weight Loss and Muscle Building, 21 J. Pub. Health Mgmt. Prac. 496, 496 (2015).
25 Federal Food, Drug, and Cosmetic Act of 1938, 21 U.S.C. § 321(g)(2) (defining “drug”).
26 21 U.S.C. § 343(r)(6)(A).
27 21 U.S.C. § 343(r)(6)(C).
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29 Id.
30 FDA Certain Types of Statements for Dietary Supplements, 21 C.F.R. § 101.93(g)(2) (2000).
31 “FDA agrees with these comments that obesity is a disease, and that obesity claims are not acceptable structure/ function claims.” 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) (to be codified at 21 C.F.R. pt. 101).
32 Id.
33 Dietary Supplements Guidance Documents & Regulatory Information, U.S. Food & Drug Admin. (Mar. 7, 2022), https://www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/dietary-supplements-guidance-documents-regulatory-information#labeling [https://perma.cc/7FGM-DCLR].
34 Fed. Trade Comm’n, Deception in Weight-Loss Advertising Workshop: Seizing Opportunities and Building Partnerships to Stop Weight-Loss Fraud 3 (2003), https://www.ftc.gov/sites/default/files/documents/reports/deception-weight-loss-advertising-workshop-seizing-opportunities-and-building-partnerships-stop/031209weightlossrpt.pdf [https://perma.cc/SGK2-D6AV].
35 List of manufacturers and warning letters available as archived content. U.S. Food & Drug Admin., Advisory Letter to Dietary Supplement Manufacturers About Unsubstantiated Weight Loss Claims (Oct. 22, 2004), http://wayback.archive-it.org/7993/20170113101236/ http://www.fda.gov/Food/ComplianceEnforcement/WarningLetters/ucm188917.html; List of Distributors and Manufacturers Receiving Warning or Advisory Letters for Unsubstantiated Weight Loss Claims, U.S. Food & Drug Admin. (Nov. 4, 2004), http://wayback.archive-it.org/7993/20170406024556/ https:/www.fda.gov/Food/ComplianceEnforcement/WarningLetters/ucm189675.htm.
36 Citizen Petition of the Am. Dietetic Assoc., Obesity Soc’y, Shaping Am.’s Health, & GlaxoSmithKline Consumer Healthcare, FDA-2008-P-0248-0001, Requesting the Food & Drug Administration to Determine that Claims that Dietary Supplements Promote, Assist, or Otherwise Help in Weight Loss are Disease Claims Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act (2008).
37 U.S. Food & Drug Admin., Opinion Letter on Citizen Petition Requesting Section 403(r)(6) Determination on Dietary Supplement Claims (Oct. 17, 2008) [hereinafter Interim Response Letter] (Letter from Barbara O. Schneeman, Off. Nutrition, Labeling, & Dietary Supplements Director, to Bruce S. Manheim, Jr., Ropes & Gray LLP) (Docket no. FDA-2008-P-0248-0857).
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39 Id. at 16-17.
40 Natasha Singer & Peter Lattman, F.D.A. Issues Warning on Workout Supplement. N.Y Times (April 12, 2013), https://www.nytimes.com/2013/04/13/business/fda-issues-warning-on-workout-booster.html [https://perma.cc/4RD5-9UCS].
41 Tucker et al., supra note 5, at 6.
42 See generally, Beverly G. Tchang et al., Pharmacologic Treatment of Overweight and Obesity in Adults (2021) in Endotext (Kenneth R. Feingold ed. 2022) (ebook), https://www.ncbi.nlm.nih.gov/books/NBK279038/ [https://perma.cc/KK39-HXCT].
43 See, e.g., U.S. Food & Drug Admin., Prescribing Information (2020) loc. 1 INDICATIONS AND USAGE (2020), https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206321s012s013s014lbl.pdf [https://perma.cc/V74K-9GYJ] (indicating Saxenda as a weight management medication for adults and pediatric patients who meet age or body weight criteria and/or have a weight-related comorbid condition).
44 The Lap-band is an FDA-approved medical device that is surgically implanted around the stomach to help patients with severe obesity lose weight. Its patient information sheet notes that “[p]atients who elect to have this surgery must make the commitment to accept significant changes in their eating habits for the rest of their lives.” Important Safety Information, Lap Band, https://www.lapband.com/safety/ [https://perma.cc/H8SQ-DLSX] (last visited Apr. 11, 2022).
45 Aaron S. Kesselheim et al., Mandatory Disclaimers on Dietary Supplements Do Not Reliably Communicate the Intended Issues, 34 Health Affs, 438, 445 (2015).
46 Marlys J. Mason et al., The Impact of Warnings, Disclaimers, and Product Experience on Consumers’ Perceptions of Dietary Supplements, 41 J. Consum Affs. 74, 94 (2007).
47 Pomeranz, Barbosa, Killian, & Austin, supra note 24, at 500.
48 Or et al., supra note 10, at 460 (After a retrospective observational study of adverse event reports of dietary supplements, the authors opined that the “[Dietary Supplement Health and Education Act], which prevents the FDA from robustly regulating the dietary supplements market, should be revised or repealed.”); Pieter A. Cohen & Scott Bass, Injecting Safety into Supplements - Modernizing the Dietary Supplement Law, 381 New Eng. J. Med. 2387, 2387–88 (2019); S. Bryn Austin, Kimberly Yu, Alvin Tran & Beth Mayer, Research-to-Policy Translation for Prevention of Disordered Weight and Shape Control Behaviors: A Case Example Targeting Dietary Supplements Sold for Weight Loss and Muscle Building, 25 Eating Behavs. 9, 11 (2017); Jennifer L. Pomeranz, Lisa M. Taylor, & S. Bryn Austin, Over-the-Counter and Out-of-Control: Legal Strategies to Protect Youths from Abusing Products for Weight Control, 103 Am. J. Pub. Health 220, 222-23 (2013); Pomeranz, Barbosa, Killian & Austin, supra note 24 at 499-500.
49 Pomeranz, Barbosa, Killian & Austin, supra note 24, at 500.
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52 See, e.g., 21 C.F.R. § 201.5(a) (2021) (“Drugs; adequate directions for use.”).
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57 MW Long et al., Comparative Cost-Effectiveness of Five Strategies for Primary and Secondary Prevention of Eating Disorders: Results of a Microsimulation Study (Under review) (on file with author).
58 U.S. Const. art. VI, cl. 2.
59 U.S. Const., art. I, § 8, cl. 1.]
60 U.S. Const., amend. X (“The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people.”).
61 Gibbons v. Ogden, 22 U.S. (9 Wheat.) 1, 189 (1824) (establishing the doctrine of the Dormant Commerce Clause).
62 U.S. Const. art. I, § 10, cl. 2.
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64 Id. See also State and Local Taxes, U.S. Dep’t of the Treasury (Dec. 5, 2010, 10:24 AM), https://www.treasury.gov/resource-center/faqs/taxes/pages/state-local.aspx [https://perma.cc/S5TF-3X2W].
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66 U.S. Dep’t of the Treasury, supra note 64.
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68 Id.
69 26 U.S.C. §§ 4041-5000C.
70 26 U.S.C. § 5000B.
71 Id.
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73 Id. (“[M]any proposed excise taxes come in the form of ‘sin’ taxes on specified activities (such as smoking or drinking or gambling), so advocates can make a case around the health benefits that result when higher prices lead to reduced consumption.”).
74 See supra note 58 and accompanying text.
75 Barry Latzer, Four Half-Truths About State Constitutional Law, 65 Temp. L. Rev. 1123, 1125 (1992).
76 McCulloch v. Maryland, 17 U.S. (4 Wheat.) 316, 425, 428 (1819).
77 Jennifer L. Pomeranz et al., The Potential for Federal Preemption of State and Local Sugar-Sweetened Beverage Taxes, 53 Am. J. Preventive Med. 740, 741-42 (2017).
78 Supplemental Nutrition Assistance Program (SNAP): What can SNAP Buy?, U.S. Dep’t of Agric. (Apr. 14, 2021), https://www.fns.usda.gov/snap/eligible-food-items [https://perma.cc/5N2A-AAVL].
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82 Id.
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86 “Since FY17, the majority of Beverage Tax revenue has gone to the General Fund, where it remains untracked and can be used for other spending purposes.” Data Release: Beverage Tax Revenue and Expenditures, Off. of the Controller, City of Phila. (Jan. 12, 2022), https://controller.phila.gov/philadelphia-audits/data-release-beverage-tax/ [https://perma.cc/V8QE-38KR].
87 Backholer et al., supra note 50, at 3080-81.
88 Jennifer Falbe, The Ethics of Excise Taxes on Sugar-Sweetened Beverages, 225 Physiology & Behav., at 2 (2020).
89 Id.
90 Pub. L. No. 111-148, § 10907(b), 124 Stat. 119, 1020-21 (2010) (codified as amended at 26 U.S.C. § 5000B).
91 Elisabeth Ryan, The ‘Tanning Tax’ Is A Public Health Success Story, Health Affs. Blog (Aug. 15, 2017), https://www.healthaffairs.org/do/10.1377/hblog20170815.061547/full/ [https://perma.cc/4HDR-WA83].
92 Chaloupka et al., supra note 53, at 193 (citing research showing no net impact on jobs due to tobacco, alcohol, or sugary beverage cessation efforts); Lisa M. Powell et al., Employment Impact of Sugar-Sweetened Beverage Taxes, 104 Am. J. Public Health 672, 675 (2014) (a macroeconomic simulation model found a net employment increase after a 20 percent tax on sugar sweetened beverages).
93 U.S. Gov’t Accountability Off., GAO-17-416, Memory Supplements: Clarifying FDA and FTC Roles Could Strengthen Oversight and Enhance Consumer Awareness 8 (2017), https://www.gao.gov/assets/690/684620.pdf [https://perma.cc/62ZP-B5FY].
94 Vig & Deshmukh, supra note 2.
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96 Austin, Yu, Tran, & Mayer, supra note 48, at 11 (The article refers to the original name of H.B. 3471, as introduced in September 2015: An Act Regulating the Sale of Dietary Supplements for Weight Loss or Muscle Building.). Rep. Kahn introduced this bill once more in 2021. H.B. 2331, 192nd Gen. Ct., Reg. Sess., (Mass. 2021), https://malegislature.gov/Bills/192/HD1309 [https://perma.cc/2YFP-SADA].
97 Lobbyist Public Search, Sec’y of the Commonwealth of Mass, https://www.sec.state.ma.us/LobbyistPublicSearch/Default.aspx [https://perma.cc/DPD7-QLZV] (last visited Apr. 14, 2022) (choose “Activity or Bill”; then select any of the years from 2017 – 2021 in the “Select registration year:” dropdown; then enter “An Act Protecting Children From Harmful Diet Pills and Muscle-Building Supplements” in the “Enter bill name or description:” field and click “search”). Click on a lobbyist’s name to view specific details about each lobbyist’s compensation from individual clients.
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