WASHINGTON—Researchers who tested 27 dietary supplements that were subject to FDA recalls found two-thirds of them still contained pharmaceutical adulterants several months later.
Sixty three percent of the analyzed products that researchers purchased several months after a recall contained the same adulterant FDA had identified, according to the study, which was published in the peer-reviewed Journal of the American Medical Association (JAMA). Researchers found a number of banned substances in the recalled products, including sibutramine, sibutramine analogs, sildenafil, fluoxetine, phenolphthalein, aromatase inhibitor and anabolic steroids.
“To our knowledge, this is the first study to determine if adulterants remain in supplements sold after FDA recalls," the researchers wrote.
Of the supplements made by U.S. companies, 65 percent or 13 of 20 products remained tainted with banned ingredients, according to the article.
“Action by the FDA has not been completely effective in eliminating all potentially dangerous adulterated supplements from the U.S. marketplace," wrote the authors, who hail from Harvard Medical School, Cornell University and Flora Research Laboratories. “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."
Of the 27 supplements analyzed, products remained adulterated in 85 percent (11 of 13) for sports enhancement, 67 percent for weight loss (six of nine) and 20 percent (one of five) for sexual enhancement. Sexual enhancement, weight loss and muscle-building products are said to comprise more than 90 percent of the approximately 400 products that are listed in FDA's tainted supplements database.
Siobhan DeLancey, a spokeswoman for FDA, said a fragmented supply chain is among the challenges FDA faces in deterring companies from marketing and importing adulterated supplements.
“The individuals and businesses selling these products generally are difficult to locate, operate out of residential homes, and distribute via the Internet, small stores and mail," DeLancey said in an emailed statement. “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."
Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), said the findings published in JAMA were exaggerated. Of 274 products recalled over three years, just 27 percent remained on the market, he said in an emailed statement. Taking into consideration the 18 of the 27 remaining supplements that contained active pharmaceutical ingredients, Mister said FDA’s recall efforts achieved a success rate of 93 percent.
The authors acknowledged limitations of the study, including the fact that they limited testing based on certain marketing claims. The researchers also said the analyses may not have identified recently introduced drug analogs, and they could not determine if all the supplements found to contain the adulterants were manufactured after FDA had issued a recall.
Researchers tested supplements that met three criteria. The products were recalled due to the presence of pharmaceutical ingredients between Jan. 1, 2009 and Dec. 31, 2012; available for purchase in July or August 2013 directly from supplement manufacturers’ or retailers’ websites; and the supplement name, manufacturer and distributor matched the information provided in the FDA recall. Researchers including Pieter Cohen of Harvard Medical School purchased the supplements an average of 34.3 months after the FDA recall.
Daniel Fabricant, executive director and CEO of the Natural Products Association (NPA), said distributors who are not expressly subject to a recall notice may continue to sell products that are adulterated with banned substances such as anabolic steroids. He advised consumers to consult FDA’s public list of recall notices when they are in the market to purchase supplements.
“That resource of recalled products is available not for the industry, but for consumers," said Fabricant, who previously served as director of FDA’s division of dietary supplement programs. “If you are going to buy a product in the weight loss, bodybuilding, sexual enhancement area, go to that list."
A number of dietary supplement firms that sold products subject to the recalls—and that were found to contain banned substances months later—did not respond Tuesday to requests for comment on the study.
“These aren’t supplements," Fabricant said, referring to adulterated products referenced in the study. “These are drugs masquerading as supplements."
The study perhaps bolstered the case for critics such as Cohen, who argue the 20-year-old law governing dietary supplements is too weak and requires more oversight by regulators. Supplements are not subject to FDA preapproval, and the agency generally does not receive information on products labeled as dietary supplements before they are marketed.
“Once FDA becomes aware that a product contains an undeclared ingredient that poses a safety concern, FDA takes action as appropriate, including public warnings, enforcement action, and working with the firm to recall the product," DeLancey said.
The supplement industry contends the Dietary Supplement and Health Education Act of 1994 (DSHEA) doesn’t need to be changed; FDA just needs adequate resources to step up its enforcement.
“Increased resources to enforce the nation’s drug laws would more directly address the problem and help reduce the number of unrepentant products to zero," Mister said.
Cohen cited a lack of enforcement.
“There’s no consequences to the manufacturer, which is absurd," he told Reuters Health.
The leader of another trade organization said the researchers' findings don't reflect exploitation of a loophole in DSHEA.
"These are cases of criminals breaking existing law," said Michael McGuffin, president of the American Herbal Products Association (AHPA), in a statement. "Passing new laws won't make these activities any more illegal."
DeLancey said FDA has taken a number of measures over the last several years against companies that unlawfully market adulterated products, including the issuance of warning letters, working with companies to voluntarily recall and destroy products, and taking civil and criminal enforcement action. The agency also has warned consumers about adulterated products in hundreds of consumer alerts and press announcements, she said.