The U.S. FDA uses class I drug recalls to remove dietary supplements adulterated with pharmaceutical ingredients that can cause potential health risks. However, researchers recently analyzed 27 recalled dietary supplements and found that one or more pharmaceutical adulterants was identified in approximately 66 percent of these products that were still available for purchase at least six months after initial recall, according to a study conducted by Pieter A. Cohen, MD, of Harvard Medical School, Boston, and colleagues.
Banned substances identified in the recalled supplements included sibutramine, sibutramine analogs, sildenafil, fluoxetine, phenolphthalein, aromatase inhibitor, and various anabolic steroids. The adulterants had all been banned for various dangers they posed to human health, including possibility of heart attacks and strokes.
The authors of the study are urging FDA to crack down on manufacturers continuing to sell adulterated dietary supplements.
“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,” the authors advise.
The Natural Products Association (NPA), the trade association representing the entire natural products industry, agrees.
“Selling drugs masquerading as supplements is a crime, and tarnishes the solid reputation of our members who follow the rules,” said Daniel Fabricant, PhD, NPA’s CEO, in a statement. “We also inform our members immediately of FDA actions so products can be taken off the shelf or out of the e-marketplace as soon as possible. While it is not the obligation of the retailer to do so, it is the right thing to do and we are always putting consumer safety first.”
The most common adulterated offenders were found to be sports enhancement supplements followed by weight loss supplements. NPA advises consumers to stay away from any products that promise results sounding too good to be true.