November 1, 2014

Many Recalled Dietary Supplements Remain Unchanged

From recent studies, it appears that many dietary supplement manufacturers that have recalls made because of contaminated products, thumb their nose at the FDA and continue to sell the product. How bad is it? A study published in the October 22/29 issue of JAMA found that about two-thirds of FDA recalled dietary supplements analyzed, still contained banned drugs 6 months after being recalled. It is sad that this study has to be behind a pay wall.

The U.S. Food and Drug Administration (FDA) initiates class I drug recalls when products have the possibility of causing serious adverse health consequences or death. The FDA has used class I drug recalls in an effort to remove dietary supplements adulterated with pharmaceutical ingredients from U.S. markets. Research has found that even after FDA recalls, dietary supplements remain available on store shelves. However, it has not been known if the supplements on sale after FDA recalls are free of the adulterants, according to background information in the article.

Pieter A. Cohen, M.D., of Harvard Medical School, Boston, and colleagues conducted a study to determine if banned drugs were still present in dietary supplements purchased at least six months after a recall. Twenty-seven of the 274 FDA recalled supplements (9.9 percent) met inclusion criteria for the study. These supplements were analyzed using the same methods at the FDA’s laboratories (e.g., gas chromatography/mass spectrometry). Supplements were purchased an average of 34.3 months (range 8-52 months) after the FDA recall. Seventy-four percent of supplements (20 of the 27) were produced by U.S. manufacturers.

The researchers found that one or more pharmaceutical adulterant was identified in 66.7 percent of recalled supplements still available for purchase (18 of the 27). Supplements remained adulterated in 85 percent (11 of 13) of those for sports enhancement, 67 percent (6 of 9) for weight loss, and 20 percent (1 of 5) for sexual enhancement. Of the subset of supplements produced by U.S. manufacturers, 65 percent (13 of the 20) remained adulterated with banned ingredients.

Sixty-three percent of analyzed supplements contained the same adulterant identified by the FDA. Six (22.2 percent) 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.

To our knowledge, this is the first study to determine if adulterants remain in supplements sold after FDA recalls,” the authors write. “Action by the FDA has not been completely effective in eliminating all potentially dangerous adulterated supplements from the U.S. marketplace. 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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