Posted 22 October 2014
“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 individuals and businesses selling these products generally are difficult to locate, operate out of residential homes, and distribute via internet, small stores, and mail. Products are shipped through the international mail facilities and are often misdeclared as unrelated goods to avoid detection. Even after recall and enforcement action against one major distributor, the product may continue to be widely sold.”
Many consumers don’t realize how potent these pharmaceuticals are, Cohen said.
“Responsible manufacturers and marketers of dietary supplements applaud strong enforcement measures by FDA to address illegal products that contain undisclosed, active pharmaceutical ingredients,” Steve Mister, President and CEO of the Council for Responsible Nutrition in Washington, D.C., a dietary supplement trade association, wrote in a statement. “We have zero tolerance for this problem and welcome not only recalls, but also criminal enforcement against companies that put consumers at risk.”
Although the researchers found 27 of the 274 recalled supplements still available online from manufacturers, more may be available in shops or gas stations, where an earlier study showed most people purchase supplements, said Cohen, a professor of medicine at Harvard Medical School in Boston and an internist at the Cambridge Health Alliance.
Also, a supplement manufacturer could easily rename its recalled product and start marketing it again without reformulation, and the FDA would have to go back and test the renamed product before issuing another recall, he said.
Although there is a framework in place to regulate supplements, enforcement is lacking, he said.
“There’s no consequences to the manufacturer, which is absurd,” he said.
Although they aimed to purchase supplements manufactured after the FDA recall, some may have been manufactured before it, the authors note.
Some consumers may seek these products out even though they have been recalled, but many are unaware of the recall, Cohen said.
“This is criminal activity,” said Daniel Fabricant, former Director of the Division of Dietary Supplement Programs at the FDA and current CEO of the Natural Products Association, another trade association. “There needs to be some really hardcore enforcement.”
“Consumers need to understand the risks, if they can’t get an erectile dysfunction drug and they go looking for a natural product tainted with pharmaceuticals,” he told Reuters Health by phone.
Some of the recalled products have labels in mixed languages, which is also against the law, Fabricant noted.
“Right now my recommendation is for consumers to avoid muscle building supplements, weight loss and sexual enhancement supplements,” which are most likely to contain dangerous drugs, Cohen said.
These supplements either do not work or are tainted with pharmaceuticals, he said.
Many vitamin and mineral supplements are safe, especially those sold as single ingredients, he said. Products made up of a “cocktail” of ingredients are more likely to be tainted, he said.
JAMA, October 21, 2014.