Sacramento, CA—More than one-half of adults in the United States report using dietary supplements. What they probably don’t realize is how many of those products could include potentially harmful and/or undeclared pharmaceuticals.

That is according to a study in JAMA Network Open in which California public-health researchers analyzed data from an FDA-maintained database of tainted supplements associated with FDA warnings.

More than 700 OTC dietary supplements analyzed by the FDA from 2007 through 2016 were found to have ingredients that were undeclared and/or possibly harmful.

The Tainted Products Marketed as Dietary Supplements file includes date, product name, company, hidden ingredients, product category, and source of sample. The file is also sorted by warning type, such as voluntary recall, public notification, news release, consumer update, or warning letter.

Products for sexual enhancement, weight loss, or muscle building were most likely to include questionable substances, the report notes. 

Of the products with warnings for undisclosed or potentially dangerous ingredients:
• 45.5% were for sexual enhancement
• 40.9% were for weight loss
• 11.9% were for muscle building

The most common adulterants were sildenafil for sexual-enhancement supplements (166 of 353 [47.0%]), sibutramine for weight-loss supplements (269 of 317 [84.9%]), and synthetic steroids or steroidlike ingredients for muscle-building supplements (82 of 92 [89.1%]). 

Furthermore, 157 products (20.2%) contained more than one unapproved ingredient, according to the study, which notes that 28 products were named in two or three warnings more than 6 months apart. Most of the 28 were reported to contain new unapproved ingredients in the second or third warning.

“Active pharmaceuticals continue to be identified in dietary supplements, especially those marketed for sexual enhancement or weight loss, even after FDA warnings,” study authors caution. “The drug ingredients in these dietary supplements have the potential to cause serious adverse health effects owing to accidental misuse, overuse, or interaction with other medications, underlying health conditions, or other pharmaceuticals within the supplement.”

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