Unapproved Ingredients in Over-the-Counter Supplements

JAMA Network Open


Media advisory: To contact corresponding study author Madhur Kumar, M.S., Ph.D., email Corey Egel at cdphpress@cdph.ca.gov. The full study is available on the For The Media website.

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About JAMA Network Open: JAMA Network Open is the new online-only open access general medical journal from the JAMA Network. Every Friday, the journal publishes peer-reviewed clinical research and commentary in more than 40 medical and health subject areas. Every article is free online from the day of publication.


Bottom Line: Potentially harmful and undeclared pharmaceuticals were identified in more than 700 over-the-counter dietary supplements in an analysis of U.S. Food and Drug Administration warnings from 2007 through 2016.

Why The Research Is Interesting: More than half of adults in the United States report using dietary supplements, and the FDA has warned about unapproved pharmaceutical ingredients in some of these supplements. This study analyzed data from a tainted supplements database maintained by the FDA for trends in adulterated dietary supplements associated with a warning by the FDA.

What and When: Data from the FDA’s Center for Drug Evaluation and Research, Tainted Products Marketed as Dietary Supplements_CDER database from 2007 through 2016; date, product name, company, hidden ingredients, product category, source of sample and warning type (i.e. voluntary recall, public notification, news release, consumer update or warning letter) for each warning were recorded

How (Study Design): This was a quality improvement study.

Authors: Madhur Kumar, M.S., Ph.D., California Department of Public Health, Sacramento, and coauthors

Results: Unapproved pharmaceutical ingredients were identified in 776 dietary supplements, most of them marketed for sexual enhancement, weight loss or muscle building; 20 percent of the products had more than one unapproved ingredient; and 28 products were named in two or three warnings.

Study Limitations: Analysis was independent of FDA involvement; total number and variety of products tested by the FDA each year are unknown; and findings are limited to drugs for which the FDA tested.

Study Conclusions:





Related Material: The invited commentary, “The FDA and Adulterated Supplements — Dereliction of Duty,” by Pieter A. Cohen, M.D., Somerville Hospital Primary Care, Somerville, Massachusetts, also is available on the For The Media website.


Visual Abstract:



To Learn More: The full study is available on the For The Media website.


Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

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