Researchers found unapproved and sometimes dangerous drugs in 746 dietary supplements, almost all of them marketed for sexual enhancement, weight loss or muscle growth, according to an analysis published on Friday.
The review of a Food and Drug Administration database of contaminated supplements for the years 2007 to 2016 most commonly turned up sildenafil — the drug sold as Viagra — and other erectile dysfunction drugs in sex enhancement products; sibutramine and the laxative phenolphthalein, both banned by the FDA, in weight loss supplements; and steroids or their analogues in muscle-building products.
About 80 percent of the supplements were contaminated by one pharmaceutical that should not have been in the product. Twenty percent contained at least two such drugs, and two of the supplements contained six unapproved drugs. One product contained a drug that raises blood pressure and another drug that lowers it. Despite these contaminants, fewer than half the products were recalled.
The presence of unknown drugs in supplements “poses a serious public health risk,” the researchers wrote. More than 50 percent of the U.S. population consumes dietary supplements, and many consumers mistakenly believe the products are carefully regulated and accurately labeled.
The drugs found in the supplements have “the potential to cause serious adverse health effects owing to accidental misuse, overuse or interaction with other medications, underlying health conditions or other pharmaceuticals,” the researchers wrote.
Controversy over adulterated supplements stretches back decades. Under a 1994 law, the Dietary Supplement Health and Education Act, the products are regulated as food and are therefore not subject to safety and effectiveness testing imposed on pharmaceuticals. The $35 billion supplement market includes multivitamins, minerals, botanicals and other products.
The new paper, written by a team from the California Department of Public Health, was published online on Friday in JAMA Network Open.
In an interview, Daniel Fabricant, president of the Natural Products Association, a supplement industry trade group, said it is unfair to consider sexual enhancement, weight loss and muscle building products in the same category as traditional dietary supplements such as vitamins. He said these are fringe products, often made by fly-by-night manufacturers and sold on the internet or in convenience stores.
“We’re completely on the FDA’s side here,” said Fabricant, who worked at the federal agency regulating supplements earlier this decade. “This is someone spiking the product. They’re saying it’s a supplement. It’s not a supplement in any way, shape or form.”
Fabricant said his organization fully supports the FDA using its authority to bring misdemeanor charges against companies that adulterate supplements with drugs.
But Pieter Cohen, who wrote an editorial that accompanied the new study, said many tainted supplements actually come from well-known manufacturers based in the United States. He cited a 2014 study that he and others conducted that found 20 of 27 supplements were still adulterated with drugs and available for purchase between eight and 52 months after they were recalled by the FDA.