Unapproved pharmaceutical ingredients identified in many over-the-counter dietary supplements

Reviewed by Kate Anderton, B.Sc. (Editor)Oct 12 2018

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.​

Source: https://media.jamanetwork.com/news-item/unapproved-ingredients-in-over-the-counter-supplements/