Even Mandatory FDA Recalls Can’t Make Supplement Manufacturers Stop Lying About What’s in their Products

There is ample evidence that under the current lax regulatory system in the U.S., dietary supplements are frequently mislabeled and adulterated with pharmaceuticals, toxins, and other undesirable substances. Apart from the lack of evidence to support the claims of benefits for most such products, this unreliable labeling represents a real danger to consumers. There are many examples of people injured or killed by such products.

The FDA has made some efforts to control this problem, and one tool used for this purpose is the mandatory recall. A recent short feature in the Journal of the American Medical Association (JAMA) has examined the impact of such recalls and found that, unfortunately, they do not seem to be very effective in encouraging better compliance with the law or quality control on the part of supplement manufacturers.

Cohen PA, Maller G, DeSouza R, Neal-Kababick J.  Presence of banned drugs in dietary supplements following FDA recalls. JAMA. 2014 Oct 22-29;312(16):1691-3. doi: 10.1001/jama.2014.10308.

According to this study, about half of the Class I mandatory recall in the last 10 years have been of adulterated dietary supplements. Over the four-year period from 2009-2012, the FDA recalled 274 dietary supplements. In this study, the authors tested about 10% of these recalled supplement for common banned substances. The results show how unconcerned this industry appears to be about consumer health and safety:

One or more pharmaceutical adulterant was identified in 66.7% of recalled supplements still available for purchase.

Supplements remained adulterated in 85% (11/13) of those for sports enhancement, 67%(6/9) for weight loss, and 20%(1/5) for sexual enhancement. Of the subset of supplements produced by US manufacturers, 65% (13/20) remained adulterated with banned ingredients.

Sixty-three percent of analyzed supplements (17/27) contained the same adulterant identified by the FDA. Six of the 27 (22.2%) supplements contained 1 or more additional banned ingredients not identified by the FDA… Some supplements contained both the previously identified adulterant as well as additional pharmaceutical ingredients.

It is particularly important to note that this was not simply a problem with supplements manufactured outside of the United States, since a majority of domestically produced supplements remained adulterated even after being recalled for representing a serious safety hazard. I completely agree with the authors’ conclusions:

More aggressive enforcement of the law, changes to the law to increase the FDA’s enforcement powers, or both will be required if sales of these products are to be prevented in the future.

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