Many Recalled Supplements Remain on the Market Months Later

Many dietary supplements remain on the retail market months after they were recalled by the US Food and Drug Administration (FDA) because they contained banned pharmaceutical ingredients, according to a research letter published in the October 22/29 issue of JAMA.

To determine the effect of FDA recalls, Peter A. Cohen, MD, from Harvard Medical School, Boston, Massachusetts, and colleagues conducted an analysis of dietary supplements recalled between January 1, 2009, and December 31, 2012.

In July and August 2013, they purchased previously recalled supplements either from supplement manufacturers' websites or in retail stores. They made the purchases 8 to 52 months (mean, 34.3 months) after the related recall was issued. After confirming that the supplement name, manufacturer, and distributor were identical to the FDA recall information, the researchers prepared samples for testing using the marketing claim on the label, but none of the other information.

The researchers included 27 supplements in their analysis, of 274 dietary supplements the FDA recalled during the study period. Twenty of the 27 tested samples were from US manufacturers.

Coauthor James Neal-Kababick, BS, analyzed the contents of the samples at a laboratory, using multiple modes of mass spectrometry — the same methods used in the FDA's field laboratories to screen supplements.

The researchers found one or more adulterant in 66.7% (18/27) of the supplements tested and still available for purchase. When broken down by marketing area, they found that:

85% (11/13) of sports enhancement supplements remained adulterated,
67% (6/9) of weight loss supplements remained adulterated, and
20% (1.5) of sexual enhancement supplements remained adulterated.

Moreover, the majority (63%; 17/27) of the supplements analyzed contained the same adulterant listed in the FDA recall, and 22.2% (6/27) contained one or more additional banned ingredients not identified in FDA recalls. Banned substances included sibutramine, sildenafil, fluoxetine, and anabolic steroids.

"To our knowledge, this is the first study to determine if adulterants remain in supplements sold after FDA recalls," the researchers write. "We found that 66.7% of recalled supplements still available for purchase at least 6 months after FDA recalls remained adulterated with banned ingredients."

They conclude that more aggressive enforcement, changes in law to give the FDA stronger enforcement capability, or both will be required to prevent sales of these products.

This research was supported by a grant from Consumers Union. One coauthor has reported receiving fees from SSP Nutrition outside of this work. Neal-Kababick has reported serving on a US Pharmacopeia expert panel, being co-owner of the testing laboratory for this study, and serving as an expert witness on dietary supplement quality. The remaining authors have disclosed no relevant financial relationships.

JAMA. 2014;321:1691-1693. Extract

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