The United States Justice Department rendered an 11-count indictment against supplement maker USPlabs LLC, and has also filed five civil suits against other supplement makers. The lawsuits are part of a nationwide sweep of more than 100 supplement makers conducted by DOJ and its federal partners.The indictment alleges that by using false certificates of analysis and false labeling and lying about the source of its ingredients, USPlabs engaged in conspiracy. It also alleges that the company sold some of their products without determining if they would be safe to use and with the knowledge that studies had linked the products to liver toxicity.Six executives with USPlabs and S.K. Laboratories, which actually manufactured the supplements for USPlabs, face criminal charges. Four were arrested on Tuesday and two were expected to surrender, the Justice Department said.
Supplements are regulated by the U.S. Food and Drug Administration (FDA). Unlike drugs, they do not require pre-market approval. However, the makers must ensure that their products are safe. Many supplements contain undeclared ingredients hazardous to those with certain medical conditions and interfere with prescription medications. Others have banned drugs.
In 2014, the agency issued seven recalls and more than 30 public notifications about these products.
The DOJ’s actions are the result of a year-long effort that began in November 2014. Criminal and civil enforcement actions have been brought against 117 individuals and entities. USPlabs, which makes Jack3d and OxyElite Pro, and several of its corporate officers face criminal charges.
Jeffrey Newman represents whistleblowers