A BITTER PILL TO SWALLOW: AMERICA’S UNREGULATED SUPPLEMENT INDUSTRY AND THE COST TO CONSUMERS

A Note by Jessica Bury

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In 2021, the global dietary supplement market was worth USD 149 billion, and was projected to grow to USD 240 billion by 2028.[1] The U.S. alone was responsible for approximately thirty-two percent of the market.[2] This growth is attributable to a variety of societal changes including increased concerns over healthcare costs, skin health, shifts in lifestyle choices, celebrity endorsements, fears about immune system health resulting from COVID-19, greater self-care awareness, and sports and fitness trends.[3] Although supplement use within American society is rampant, with 57.6% of adults aged twenty and over consuming at least one dietary supplement within the past month, few people understand how they are produced, manufactured, and regulated.[4] A 2019 survey indicated that a majority of Americans overestimate the FDA’s role in regulating supplements, assuming that the FDA tests supplements before sale or that supplement manufacturers must prove to the FDA that their products are safe or effective.[5] The law requires that every supplement bottle contains a label notifying consumers that “[t]his statement has not been evaluated by the Food and Drug Administration.  This product is not intended to diagnose, treat, cure, or prevent any disease.”[6] This does little to clarify misinformation or counter consumer’s assumptions.[7] As every single supplement label states, supplements are not evaluated by the Food and Drug Administration (FDA), but that does not mean they lack oversight altogether.[8]


[1] Sagar Kumar, Global Dietary Supplements Market Size In 2022: Growth Opportunities and Future Outlook 2028, Linkedin (Sep. 14, 2023), https://www.linkedin.com/pulse/global-dietary-supplements-market-size-2022-growth-future-sagar-kumar/.

[2] Grand View Research, U.S. Dietary Supplements Market Size, Share & Trends Analysis Report By Type (OTC, Prescribed), By Ingredient, By Form, By Application, By End-user, By Distribution Channel, And Segment Forecasts, 2023 – 2030, https://www.grandviewresearch.com/industry-analysis/us-dietary-supplements-market-report (last visited Apr. 4, 2023).

[3] Bone and Joint Health Supplements Global Market Report 2024 – Product Innovations and Strategic Acquisitions Fueling Market Dynamics, PR Newswire (Feb. 7, 2024), https://www.prnewswire.com/news-releases/bone-and-joint-health-supplements-global-market-report-2024—product-innovations-and-strategic-acquisitions-fueling-market-dynamics-302056576.html; Immune Health Supplements Market Pioneers Next-Gen Wellness Solutions, More than $14 Billion Opportunities in the Next 6 Years – Arizton, PR Newswire (Jan. 31, 2024), https://www.prnewswire.com/news-releases/immune-health-supplements-market-pioneers-next-gen-wellness-solutions-more-than-14-billion-opportunities-in-the-next-6-years–arizton-302049387.html.

[4] Suruchi Mishra, et al., Dietary Supplement Use Among Adults: United States, 2017–2018, Nat’l Ctr. of Health Statistics Data Brief (Feb. 2021), https://doi.org/10.15620/cdc:101131.

[5] Americans Support Requiring Supplement Makers to Tell FDA About Their Products, The Pew Charitable Trusts (Dec. 18, 2019), https://www.pewtrusts.org/en/research-and-analysis/fact-sheets/2019/12/americans-support-requiring-supplement-makers-to-tell-fda-about-their-products.

[6] 21 C.F.R. § 101.93(a)(3)(c).

[7] See id.

[8] 21 U.S.C. § 343(r)(6).