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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

Purpose

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.

Methods

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.

Results

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.

Conclusions

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.

Type
Articles
Copyright
© 2022 The Author(s)

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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 Bryn.Austin@childrens.harvard.edu

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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2 Himanshu Vig & Roshan Deshmukh, Weight Loss and Weight Management Diet Market by Product Type (Better-for-you, Meal Replacement, Weight Loss Supplement, Green Tea, and Low-calorie Sweeteners) and Sales Channel (Hypermarket/Supermarket, Specialty Stores, Pharmacies, Online Channels, and Others): Global Opportunity Analysis and Industry Forecast, 2021–2027 (2021), https://www.alliedmarketresearch.com/weight-loss-management-diet-market [https://perma.cc/D2TL-SFBY].

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7 Tucker et al., supra note 5 at 3.

8 Id. at 5.

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11 Janet M. Liechty & Meng-Jung Lee, Longitudinal Predictors of Dieting and Disordered Eating Among Young Adults in the U.S., 46 Intl J. Eating Disorders. 790, 794-95 (2013); Marita P. McCabe & Lina A. Ricciardelli, Extreme Weight Change Behaviours: Are Overweight and Normal Weight Adolescents Different, and Does this Vary Over Time?, 17 Eur. Eating Disorders Rev. 301, 310-11 (2009).

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13 Levinson et al., supra note 12, at 109-10; Hazzard et al., supra note 12, at 1290-91.

14 See, e.g., Levinson et al., supra note 12, at 109 (“[A] causal relationship may exist, as using diet pills and laxatives for weight control could serve as a ‘gateway’ behavior to escalating weight-control practices … .”).

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.

17 Janine L. Pillitteri et al., Use of Dietary Supplements for Weight Loss in the United States: Results of a National Survey, 16 Obesity 790, 792 (2008).

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).

19 Pillitteri et al., supra note 17, at 792; Karen M. Wilson et al., Use of Complementary Medicine and Dietary Supplements Among U.S. Adolescents, 38 J. Adolescent Health 385, 391 (2006).

20 Julia A. Vitagliano et al., Disproportionate use of Over-the-Counter Diet pills Among Latinx Youth and Increased use Over Time Among Latinx Females: Results of U.S. National Study, J Adolescent Health at 2-3 (Epub ahead of print 2022).

21 See supra notes 616 and accompanying text.

22 See supra notes 1013 and accompanying text.

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).

28 U.S. Food & Drug Admin., FDA-20004-D-0303, Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act (2009), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-substantiation-dietary-supplement-claims-made-under-section-403r-6-federal-food#:~:text=The%20FTC%20standard%20of%20competent,qualified%20to%20do%20so%2C%20using [https://perma.cc/UK8L-ZXXZ].

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.

34 Fed. Trade Commn, 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 Socy, 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).

38 U.S. Dept Health & Hum. Servs., Off. of Inspector Gen. Dietary Supplements: Structure/Function Claims Fail To Meet Federal Requirements (2012), https://oig.hhs.gov/oei/reports/oei-01-11-00210.pdf [https://perma.cc/LKE3-ZAB4].

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.

50 Christina A. Roberto et al., Association of a Beverage Tax on Sugar-Sweetened and Artificially Sweetened Beverages With Changes in Beverage Prices and Sales at Chain Retailers in a Large Urban Setting, 321 JAMA 1799, 1805-06 (2019); see also Kathryn Backholer et al., The Impact of a Tax on Sugar-Sweetened Beverages According to Socio-Economic Position: A Systematic Review of the Evidence, 19 Pub. Health Nutrition 3070, 3074 (2016) (finding a statistically significant reduction in sugary beverage consumption among children from low-income families following a 1% beverage tax increase); Zachary J. Ward & Steven L. Gortmaker, Sugar-Sweetened Beverage Taxes Are a Sweet Deal: Improve Health, Save Money, Reduce Disparities, and Raise Revenue, 4 JNCI Cancer Spectrum (Solicited Editorial) 1, 2 (2020); Chad Cotti et al., The Effects of Tobacco Control Policies on Tobacco Products, Tar, and Nicotine Purchases Among Adults: Evidence From Household Panel Data, 8 Am. Econ. J.: Econ. Poly 103, 113-14 (2016); M Arantxa Colchero et al., In Mexico, Evidence of Sustained Consumer Response Two Years After Implementing a Sugar-Sweetened Beverage Tax, 36 Health Affs. 564, 567 (2017); Alexander C. Wagenaar et al., Effects of Alcohol Tax and Price Policies on Morbidity and Mortality: A Systematic Review, 100 Am. J. Pub. Health 2270, 2273 (2010); Alexandra Wright, et al., Policy Lessons From Health Taxes: A Systematic Review of Empirical Studies, 17 BMC Pub. Health, June 2017, at 1, 7 (2017).

51 Eugene M. Lewit et al, Price, Public Policy, and Smoking in Young People, 6 Tobacco Control (Supplement) S17, S22 (1997).

52 See, e.g., 21 C.F.R. § 201.5(a) (2021) (“Drugs; adequate directions for use.”).

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55 Marr & Huang, supra note 53, at 2.

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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.

63 What are Government Entities and Their Federal Tax Obligations?, Internal Revenue Serv. (Mar. 29, 2022), https://www.irs.gov/government-entities/federal-state-local-governments/government-entities-and-their-federal-tax-obligations [https://perma.cc/7MEE-2UER].

64 Id. See also State and Local Taxes, U.S. Dept 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].

65 What are Government Entities and Their Federal Tax Obligations?, supra note 63.

66 U.S. Dept of the Treasury, supra note 64.

68 Id.

69 26 U.S.C. §§ 4041-5000C.

70 26 U.S.C. § 5000B.

71 Id.

72 Janelle Cammenga, How Much Does Your State Collect in Excise Taxes Per Capita?, Tax Found. (Apr. 3, 2019), https://taxfoundation.org/excise-taxes-per-capita-2019/ [https://perma.cc/5LEC-3MUS].

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. Dept of Agric. (Apr. 14, 2021), https://www.fns.usda.gov/snap/eligible-food-items [https://perma.cc/5N2A-AAVL].

79 Pomeranz et al., supra note 78, at 742.

81 Eric Crosbie et al., State Preemption to Prevent Local Taxation of Sugar-Sweetened Beverages, 179 JAMA Internal Med. 291, 291 (2019).

82 Id.

83 Liam Dillon, California bans local soda taxes, LA Times (June 28, 2018), https://www.latimes.com/politics/la-pol-ca-soda-tax-ban-20180628-story.html [https://perma.cc/W8S4-MS4F].

84 Jennifer L Pomeranz et al., State Preemption of Food and Nutrition Policies and Litigation: Undermining Government’s Role in Public Health, 56 Am J Preventative Med. 47, 54-56 (2019).

85 Wright et al., supra note 50, at 9 (citing studies in which ministerial and public support for taxes increased when funds were earmarked for public initiatives); Luc L. Hagenaars et al., Six Lessons From Introducing Sweetened Beverage Taxes in Berkeley, Cook County, and Philadelphia: A Case Study Comparison in Agenda Setting and Decision Making, 124 Health Poly 932, 935 (2020) (quoting policymakers’ and stakeholders’ views on the passage of the Philadelphia sugary beverage tax and the impact of its framing as a revenue source for statewide preschool).

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. Govt 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.

95 Nutritional & Dietary Supplements: Lobbying, OpenSecrets, https://www.opensecrets.org/industries/lobbying.php?ind=H4600 [https://perma.cc/7U4V-JDEZ] (last visited Apr. 11, 2022).

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, Secy 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.

98 Cohen & Bass, supra note 48, at 2388; Akshay Kapoor & Joshua M. Sharfstein, Breaking the Gridlock: Regulation of Dietary Supplements in the United States, 8 Drug Testing & Analysis 424, 426-72 (2016); Ranjani Starr, Should States and Local Governments Regulate Dietary Supplements?, 8 Drug Testing & Analysis 402, 402 (2016).

99 See supra notes 36-37 and accompanying text.

100 Bruce A. Brod, Health Care Reform Produces Both Heat and Light With the Indoor Tanning Tax, 91 Cutis 221, 221 (2013).

101 Dawn M. Holman et al., Prevalence of Indoor Tanning Among U.S. High School Students From 2009 to 2017, 44 J. Cmty. Health 1086, 1087 (2019).

102 Roberto et al., supra note 50, at 1805.

103 Lisa M. Powell & Julien Leider, The Impact of Seattle’s Sweetened Beverage Tax on Beverage Prices and Volume Sold, 37 Econ. Hum. Biology, May 2020 at 1, 5.

104 Lisa M. Powell et al., The Impact of a Sweetened Beverage Tax on Beverage Volume Sold in Cook County, Illinois, and its Border Area, 172 Annals Internal Med. 390, 394 (2020).