A Dallas company that had been ordered to recall a dietary supplement pill because of links to liver damage has been indicted along with several of its executives on charges that they intentionally misbranded their products, the Justice Department announced Tuesday.
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The allegations cover the company’s past troubles with the Food and Drug Administration, which in 2013 directed the firm to cease production of a weight loss and muscle-building supplement after the product was linked to liver damage and several users needed liver transplants to save their lives.
In a statement, GNC said that lawsuit was “without merit”.
USPlabs, which is based in Dallas, did not respond to requests for comment.
The DOJ is partnering with multiple other agencies, including the Federal Trade Commission and the U.S. Food and Drug Agency, in an ongoing review of dietary supplements to rat out the items-and the manufacturers-using unlawful and fraudulent ingredients.
GNC in March reached an agreement with New York’s attorney general on testing standards for its herbal supplements.
Shares of dietary supplement makers GNC Holdings (GNC) were down 24 percent in afternoon trading, while those of Vitamin Shoppe (VSI) fell almost 8 percent and Herbalife (HLF) 2.5 percent.
To remove a supplement from the market, the FDA first has to prove that it’s not safe – which is what happened in the case of OxyElite Pro. (WMT), after a study failed to detect identifiable genetic material for the plants depicted on the labels in most of the four retailers’ herbal supplement products. The actions follow a year-long effort to cleanse the profitable industry of products that threaten public health, the department said.
Two companies in particular, USPlabs and S.K. Laboratories, face criminal charges for allegedly lying about the ingredients in their products. They didn’t. Instead, they undertook a surreptitious, all-hands-on-deck effort to sell as much of the product as they could.
Benjamin Mizer, the head of the Justice Department’s civil division, said the deception put lives at risk.
Howard Sklamberg, FDA’s deputy commissioner for global regulatory operations and policy, said in a statement: “The criminal charges against USPlabs should serve as notice to industry that if products are a threat to public health, the FDA will exercise its full authority under the law to protect Americans and bring justice”.
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NPR has previously reported on banned drugs turning up in weight loss supplements. A complaint filed in U.S. District Court for the Central District of California alleges that dietary supplements sold by the defendants are adulterated because they are not manufactured in accordance with the FDA’s current good manufacturing practice regulations.
