Recalled, drug-tainted supplements still available for purchase
(Reuters Health) – Long after the Food and Drug Administration (FDA) issued recalls for dietary supplements tainted with banned drugs, more than half of the tainted supplements were still available for purchase, a new study found.
“There’s no question that these supplements that contain pharmaceuticals are not allowed to be sold, there are clear cut laws,” lead author Dr. Pieter A. Cohen told Reuters Health by phone.
The FDA does have some loose regulatory power over supplements, which are categorized like a food, Cohen said.
If a food manufacturer’s product were tainted with salmonella, the tainted food would be recalled, the factory cleaned, and then manufacturing would continue, Cohen said. In the case of supplements, the FDA issues recalls for products tainted with dangerous pharmaceuticals, but without proper enforcement the tainted products remain on the market and some companies continue to produce more, he said.
The FDA has identified more than 400 supplement brands tainted with pharmaceuticals, and issued a recall for 70 percent of the products.
Cohen and his coauthors studied 27 of the 274 supplements the FDA recalled between 2009 and 2012, two-thirds of which were American-made. They bought the supplements from manufacturer websites at least eight months and up to four years after their FDA recall, then tested their chemical makeup.
The researchers found that 18 of the 27 supplements they purchased still contained a pharmaceutical adulterant, according to results in JAMA.
The supplements were marketed for sports enhancement, weight loss and sexual enhancement, among other things.
Among the banned substances in the products were sibutramine, a weight loss drug linked to heart attack and stroke, and phenolphthalein, a laxative being removed from many markets due to a potential link to cancer.
“Dietary supplement manufacturers and distributors are legally responsible for marketing a safe product that is not adulterated, and that complies with FDA’s good manufacturing practice regulations for dietary supplements,” the FDA told Reuters Health in a statement.
But, the FDA warned, “The supply chain for these products is extremely fragmented; one product manufactured by an unknown company overseas may be sold by dozens of different distributors in the United States. The
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Recalled, drug-tainted supplements still available for purchase – Reuters
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