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Review
. 2025 Dec;22(1):2534128.
doi: 10.1080/15502783.2025.2534128. Epub 2025 Jul 15.

"Common questions and misconceptions about dietary supplements and the industry - What does science and the law really say?"

Affiliations
Review

"Common questions and misconceptions about dietary supplements and the industry - What does science and the law really say?"

Jose Antonio et al. J Int Soc Sports Nutr. 2025 Dec.

Abstract

Dietary supplement use is popular among fitness enthusiasts as well as competitive athletes. There is, however, confusion regarding the regulatory framework as well as the basic science regarding the use of supplements. Although there is an extensive body of scientific and legal writings on dietary supplements, several misconceptions persist vis-à-vis this category. Thus, the following questions will be addressed in this review. 1) Are dietary supplements regulated by the Food and Drug Administration? 2) Are foods and supplements regulated similarly? 3) What is the role of the Federal Trade Commission? 4) Besides federal regulations for dietary supplements, do state laws also regulate the category? 5) If a supplement company funds a study, does that automatically call into question the results? 6) Can diet alone provide everything you need without using supplements? 7) Is it necessary to conduct randomized controlled trials (RCTs) on dietary supplements? 8) How safe are supplements compared to OTC drugs? 9) Where can consumers find accurate information about supplements? 10) Why does the NIH fund dietary supplement research related to disease, yet findings cannot be marketed by supplement companies? 11) What is the size of the dietary supplement industry compared to the pharmaceutical industry? 12) How can I know if a dietary supplement is safe and free of banned substances? Similar to our prior papers, a team of legal and science scholars evaluated the evidence on these salient questions.

Keywords: FDA; Social media; nutrition; regulation; safety.

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Conflict of interest statement

JA is the CEO and co-founder of the International Society of Sports Nutrition (ISSN), an academic nonprofit (501c3) that has been sponsored by companies that manufacture, market, and sell dietary supplements. He is also a scientific advisor to brands including Bear Balanced®, Create®, Enhanced Games®, and Liquid Youth®.

BD is a partner at Amin Wasserman Gurnani, helping health and wellness companies navigate their most intricate regulatory challenges. He is a former Acting Director and Deputy Director of the Office of Dietary Supplement Programs (ODSP) in the FDA’s Center for Food Safety and Applied Nutrition (CFSAN).

CL is the Vice President of Scientific Affairs at Woodbolt Distribution LLC (dba Nutrabolt; Austin, TX) and is the lead inventor of several patented and patent-pending ingredients and formulae wholly owned by, or to be licensed to companies that market consumer packaged goods domestically and internationally.

DGC has conducted industry-sponsored research involving creatine, protein, caffeine, and energy drink supplementation. In addition, DGC has received travel support for presentations involving creatine supplementation at scientific conferences. In addition, D.G.C. serves on the Scientific Advisory Board for Alzchem and Create (companies that manufacture creatine products) and as an expert witness/consultant in legal cases involving creatine supplementation.

DK declares that in his career, he has worked for Contract Research Organizations and research sites that have executed studies for the US government (i.e. DoD/NIH) pharmaceutical, medical devices, foods, beverages, and dietary supplement industries. DK co-founded the consultancy Substantiation Sciences, serving clients in the legal (Expert Witness) pharmaceutical, medical device, foods, beverages, and dietary supplement industries. He is a co-founder of The ISSN and currently serves as a volunteer on the Scientific Advisory Board of Alzchem. He has no other conflicts to report.

EB is an advisor and investor in Electrolyte Boost and has an affiliate link with Thorne.

RC is a founding member of Collins Gann McCloskey & Barry. His law firm represents numerous companies in the natural products and dietary supplements industries on civil, criminal, and regulatory matters. He has contributed chapters to several textbooks on sports nutrition and serves as legal counsel to the International Society of Sports Nutrition.

JRS has received grants and contracts to research dietary supplements, served as a paid consultant for industry, and received honoraria for speaking at conferences and writing lay articles about sports nutrition ingredients and topics.

References

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    1. Federal Food, Drug, and Cosmetic Act (FD&C Act) . Available from: https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-foo...
    1. Dietary Su pplement Health and Education Act of 1994 . Available from: https://www.congress.gov/bill/103rd-congress/senate-bill/784?utm_source=...
    1. Wallace TC, Koturbash I. DSHEA 1994–celebrating 30 years of dietary su pplement regulation in the United States. J Diet Suppl. 2025;22(1):1–8. doi: 10.1080/19390211.2024.2419434 - DOI - PubMed

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