Dietary supplements still contain banned ingredients

SIBUTRAMINE, sibutramine analogs, sildenafil, fluoxetine, phenolphthalein, aromatase inhibitor, and anabolic steroids – these are banned substances still being used in many recalled dietary supplements at least six months after being recalled. Pieter A. Cohen, M.D., of Harvard Medical School, Boston, and colleagues revealed this information based on a study they conducted to find out if such banned ingredients will still be found in recalled products long after these have been ordered off the shelves.

Until this research came out, authorities have not been aware of such practice in the US. For its part, the U.S. Food and Drug Administration (FDA) initiates class I drug recalls when products have the reasonable possibility of being lethal or causing serious adverse health consequences. The FDA has used class I drug recalls to remove dietary supplements adulterated with pharmaceutical ingredients from U.S. markets. But even after FDA recalls, dietary supplements remain available on store shelves. What was not clear is if these dietary supplements back on sale after FDA has recalled them, have been reformulated to exclude the adulterants. The investigation made by Dr Cohen and his team reveals many supplements are the same products.

They said one or more pharmaceutical adulterant was identified in 66.7% of recalled supplements still available for purchase (18/27). 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 U.S. manufacturers, 65% (13/20) were adulterated with banned ingredients.

Furthermore, 63% of analysed supplements contained the same adulterant identified by the FDA. Six (22.2%) supplements contained one 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 said in their report which appears in the October 22/29 issue of JAMA. “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.” (Photo © Scowill | Dreamstime.com)