December 17, 2015
Unsafe Supplements Likely Still for Sale
FDA’s recent indictment of 100+ supplement makers for tainted products underscores weak regulation
The U.S. Department of Justice recently charged more than 100 supplement makers with fraud and arrested three executives of USPlabs, a major supplement manufacturer, for allegedly lacing their bodybuilding product OxyElite Pro with the banned drug dimethylamylamine (DMAA). In response, the health-food chain GNC announced it was pulling all USPlabs products from its shelves. That’s good news, according to Pieter Cohen, M.D., a dietary supplements expert at Harvard Medical School. “But you shouldn’t assume that means other supplements on the market are safe,” he says. “This is only the tip of the iceberg,” notes Cohen. “There are likely many other dietary supplements still on store shelves that contain drugs.”
While prosecuting sellers of tainted supplements is a step in the right direction, “it does not address the overarching problem that the Food and Drug Administration should not be letting these dangerous products on the market in the first place,” says Chuck Bell, who focuses on the regulation of the supplement industry for Consumers Union, the policy and advocacy arm of Consumer Reports. “Unfortunately, for now the FDA is hamstrung by the law so there’s not much it can do to protect consumers from dangerous, ineffective supplements.”
Serious government actions like this one are rare. The law regulating dietary supplements, the Dietary Supplement Health and Education Act (DSHEA), only allows the FDA and Federal Trade Commission to take action after supplements are already on the market and if the agencies can prove that the products are causing harm. Unlike over-the-counter and prescription drugs, the FDA does not evaluate the safety and effectiveness ofsupplements before they are available to the public. “The current law requires that manufacturers ensure the safety of their own products without government oversight,” says Cohen, who has published studies of numerous dietary supplements found to contain illegal drugs. “Today, we see that this law is completely inadequate to ensure consumer safety,” Cohen says. The Council for Responsible Nutrition, a trade group representing the supplement industry, has long argued that the existing laws are sufficient to protect consumers and that the majority of supplement companies take appropriate steps to ensure the safety of their products before they go to market. In a statement released after the indictments, the organization thanked the Justice Department, saying that it had earlier warned that “companies engaging in blatant criminal activity were presenting a serious public health risk and hijacking the credibility of the reputable industry.” In a statement released after the indictment, USPlabs said it “stands firmly behind the safety and integrity of its products,” and denied that it “sold any unsafe products, or engaged in any wrongdoing.”
History of Selling Dangerous Supplements
In the fall of 2013, USPlabs agreed to halt sales of one of its weight-loss and bodybuilding supplements. But according to the Justice Department’s current indictment, the company instead “took a surreptitious, all-hands-on-deck effort to sell as much OxyElite Pro as it could as quickly as possible.” And this most recent action isn’t the first time that the FDA has flagged USPlabs. Fo example, in 2012 the agency issued warning letters after finding DMAA in USPlabs products. “This shows how absurdly supplements are regulated in the U.S. We wait until consumers are exposed to dangerous, often spiked products before the government does anything about it,” Cohen says. “Until there’s a paradigm shift in the regulation of supplements, consumers will continue to be exposed to supplements that place their health at risk,” he says.
What can be done?
Consumers Union has long advocated for significant amendments to DSHEA. “The passage of the Dietary Supplement Health and Education Act in 1994 opened the floodgates to uncountable entrepreneurs to sell their health nostrums without proper FDA review and with no regard to efficacy or safety,” says Marvin M. Lipman, M.D., Consumer Reports’ chief medical adviser. Each year, an estimated 23,000 people visit the emergency room as a result of taking dietary supplements, and 2,100 of them are hospitalized, according to a recent analysis by researchers with the Centers for Disease Control and Prevention and FDA. “The health of the nation would be much improved if DSHEA was repealed,” Lipman says. For now, consumers should avoid taking any supplements for weight loss, bodybuilding, or erectile dysfunction. Those supplements are among the type most frequently found to contain banned, experimental, or prescription drugs that can harm your health. http://www.consumerreports.org/vitamins-supplements/feds-endict-usplabs-for-tainted-supplements?EXTKEY=NS0N01512&utm_source=acxiom&utm_medium=email&utm_campaign=20151216_nsltr_safetyalertdec2015