Hundreds of dietary products tainted
Study discovers illicit ingredients in supplements
Nearly 800 dietary supplements sold in the United States were found to be contaminated with unapproved ingredients — in some cases, drugs that have been banned by the Food and Drug Administration — in an industry analysis by California public health scientists.
Most of the tainted supplements were marketed for sexual enhancement, muscle building or weight loss, and the ingredients found in them were often pharmaceutical drugs — such as steroids or the active ingredient in Viagra — that consumers normally need a prescription to take.
The tainted products were listed in a public database maintained by the Food and Drug Administration, but in most cases the agency issued no other public notice and only rarely were the manufacturers or distributors subjected to warning letters or other penalties. The FDA issued recalls on less than half of the supplements that were found to be contaminated.
The study, published online Friday, is one of the largest and most comprehensive of an industry whose products have long been known to sometimes contain ingredients that put the public at risk. The findings are likely just “the tip of the iceberg,” said Dr. John Swartzberg, director of the UC Berkeley Wellness Letter who has studied the supplement industry, but was not part of the new research.
“You’ve got an FDA that’s underfunded and not given the adequate resources to look at these products,” Swartzberg said. “What we’ve created is an industry that many have described as the Wild West, with very poor controls.”
FDA officials said in a statement Friday that they were aware of the study and were reviewing the findings. But officials noted that there are multiple barriers to regulating the industry, including manufacturers and distributors that actively try to evade enforcement.
Once a supplement is found to contain an unapproved substance, the FDA focuses on informing the public about potential health risks and removing the product from the market “as soon as possible,” according to the statement.
More than half of Americans take supplements, which include everything from vitamins and minerals like iron, to herbal or other so-called natural remedies. Supplements are regulated as a food, not as a drug, which means the FDA has no authority to test the efficacy or safety of the products before they’re sold to consumers.
The risk to people who use supplements isn’t entirely clear. Manufacturers are supposed to report any complications — including side effects resulting in hospitalization or death — caused by their products, but it’s unlikely that every adverse event is recorded. One study estimated that supplements cause as many as 23,000 emergency room visits a year.
Daniel Fabricant, president of the industry group Natural Products Association, said the large majority of products found to be contaminated in the new analysis are not representative of the supplement market. And he supports the FDA taking aggressive actions against producers of drugtainted products: “The FDA has the ax. They should swing it,” he said.
“These (producers) are not people who are part of the reputable (supplement) industry,” Fabricant said. “These come from dark corners of the internet. They’re not what you get at your health food store.”
The paper identified 776 supplements listed in the FDA database of contaminated products from 2007 through 2016. The database is not a complete list of all adulterated products that may be on the market — it includes only supplements that were tested by the FDA. Nearly 75 percent of the supplements were sold online or through international mail orders.
Among the ingredients found in contaminated products were ephedrine, a stimulant once popular for weight loss that was banned by the FDA in 2004 after thousands of adverse events were reported, mostly related to heart problems. Several other ingredients found in weight-loss supplements had been denied FDA approval over safety concerns.
The most common unapproved substance was sildenafil, the active ingredient in Viagra, which is used to treat erectile dysfunction. More than 80 percent of the 353 contaminated sexual enhancement supplements the study looked at included sildenafil.
Nearly 90 percent of the tainted supplements for body building contained steroids or steroid-like ingredients.
When the pharmaceutical drugs used in these products are properly prescribed, they come with labels to warn consumers about possible side effects or drug interactions. Sildenafil, for example, can interfere with drugs to treat diabetes, high blood pressure or high cholesterol. But if consumers don’t know the drug is in a supplement that they think is safe, they won’t know to take proper precautions.
In general, consumers should be wary of using products in the three main categories cited by the study — sexual enhancement, muscle building and weight loss — but problems in manufacturing can occur across the industry, said Cathi Dennehy, a health sciences clinical professor at the UCSF School of Pharmacy who has studied supplements for two decades.
She believes some supplements can be healthful. “I worry about throwing the baby out with the bathwater” and dismissing all supplements based on an analysis of those containing unapproved ingredients, she said. But it’s often up to consumers to determine whether something is safe — or at least likely so.
They can start by looking at the FDA database, though that can be difficult to sort through. The website ConsumerLab.com tests and recommends supplements and other products. Supplements with the NSF — for National Sanitation Foundation — stamp on their label are probably safe bets, said Raymond Palko, a registered dietitian with Stanford Health Care.
“This study shouldn’t make everybody empty out every supplement they have in their cabinet and never step foot in the supplement aisle of the again,” Palko said. “But it should make them have a moment of reflection about what they get out of their supplement and where they get it.”
Fabricant had one other tip for consumers: “Does it sound too good to be true? It probably is.”
“If the company is saying it works like Viagra or you’re going to gain muscle like you’re on steroids — that’s not a supplement. That’s a drug,” Fabricant said. “Dietary supplements are meant to maintain health, not to take 30 minutes before sex.”
“This study ... should make them have a moment of reflection about what they get out of their supplement and where they get it.” Raymond Palko, registered dietitian, Stanford Health Care
Nearly 800 dietary supplements sold in the U.S. were found to be contaminated with unapproved ingredients, including banned drugs, in a study by California public health scientists.