Tainted supplements sold after recalls, study says
Tainted dietary supplements often continue to be spiked with hidden and potentially dangerous drugs months and even years after being the subjects of product recalls, according to research published Tuesday in the Journal of the American Medical Association.
Researchers identified 27 supplements available for purchase online in the summer of 2013 that were among 274 recalled during 2009-2012. Tests conducted by the team found one or more pharmaceuticals in nearly 67% of the supplements available for purchase, including chemicals similar to the erectile dysfunction drug Viagra or the diet drug Meridia, which was pulled from the market because of heart attack and stroke risks.
Among sports enhancement or bodybuilding supplements, 85% of those purchased by the researchers remained adulterated with dangerous compounds, including anabolic steroids, the study found.
"Consumers need to avoid the categories of supplements that these drugs are found in: weight-loss, sports supplements and sexual enhancement supplements," said Pieter Cohen, an assistant professor at Harvard Medical School and one of the authors of the study. The regulatory approach to supplements provides little assurance to consumers that products in these categories — which are often the subject of recalls and FDA health alerts — are truly all-natural and don't contain potentially dangerous pharmaceuticals, he said.
Among the recalled products Cohen and the research team found for sale that their tests showed contained adulterants:
•Novedex XT: This bodybuilding supplement, sold by Gaspari Nutrition, was recalled in 2010 because it contained an anti-estrogen compound. Researchers purchased the product in July 2013, and tests showed it contained an anabolic steroid and an anti-estrogen compound. Gaspari officials said in an e-mail they had no comment.
•Massdrol: This bodybuilding supplement, sold by Kilo Sports, was the subject of a recall in 2009 because it contained a steroid or steroid-like compound. Researchers purchased the product in August 2013, and their tests showed it contained an anabolic steroid. Kilo Sports did not respond to interview requests.
•Slim Xtreme Herbal Slimming Capsule: This weight-loss supplement was recalled by Globe All Wellness in 2011 after products sold by an unauthorized seller was found to contain sibutramine, the active ingredient in the weight-loss drug Meridia. Ron Hamami, a company manager, said the tainted products — then and now — are counterfeits that have put his firm's name on their bottles. He says Globe All Wellness hasn't sold the capsules in two years because of the counterfeiting problem.
•M-Drol: This bodybuilding supplement, sold by Competitive Edge Labs, was recalled in 2009 because it contained a steroid or steroid-like compound. Researchers purchased M-Drol in August 2013, and tests found it contained an anabolic steroid. Steve Wood, the company's president, said the product purchased last year by the researchers is probably counterfeit because the bottle didn't have an expiration date. "We haven't made pro-hormones in years," Wood said. He said he's seen many counterfeits of his firm's former product available for sale online.
The research paper calls for more aggressive enforcement by the U.S. Food and Drug Administration, as well as increases in the agency's powers, to prevent supposedly all-natural dietary supplements spiked with pharmaceuticals from being marketed to consumers. The research is the latest to raise questions about the adequacy of FDA oversight of the $30 billion supplement industry, which has been featured in USA TODAY's ongoing "Supplement Shell Game" series.
Supplement industry officials said Tuesday that tougher FDA enforcement is needed. However, Steve Mister, president of the Council for Responsible Nutrition, said the new journal article "grossly misrepresents the extent of the situation and understates the success of FDA's efforts." Mister and Daniel Fabricant, executive director of the Natural Products Association, noted the researchers were able to buy only 27 of the recalled supplements, and the tests didn't find pharmaceuticals in nine of them, indicating they had been reformulated.
"Do I think stronger enforcement is needed? Oh, yes," said Fabricant, who was the FDA's top supplement regulator until this year. Fabricant said that although the FDA does take action against companies that sell tainted supplements, it too often takes a long time to build felony cases against bad actors.
Fabricant said the FDA needs to use its authority to bring faster misdemeanor cases against firms selling adulterated supplements. "I don't think the issue is with the law, I think it's with the willpower to bring these cases," he said.
In a statement, the FDA said it "faces the challenge of providing effective deterrents to prevent unscrupulous firms from fraudulently marketing and importing these products." The industry is "extremely fragmented" and often involves products made overseas and packaged and sold by many small distributors, some of them difficult to identify and locate, the FDA said.
To report an adverse event involving a dietary supplement to the FDA, call 800-332-1088.
To read USA TODAY's investigative coverage of dietary supplements, go to: supplements.usatoday.com
Follow reporter Alison Young on Twitter: @alisonannyoung