Dietary supplement marker USPlabs LLC is seeking to fight claims made by the U.S. Department of Justice (DOJ) that weight loss product OxyElite Pro is dangerous to consumers by introducing experts to testify that the product was safe under the conditions of recommended use listed on its label.
The judge overseeing the case will decide whether to hold a hearing to determine whether experts can testify on behalf of the defense regarding the safey of OxyElite Pro when the case goes to trial.
The indictment unsealed last November alleges USPlabs made hundreds of millions of dollars through a criminal conspiracy involving the distribution of marketing materials that concealed the ingredients in its dietary supplements OxyElite Pro and Jack3d. Both were found to contain the amphetamine-like appetite suppressant dimethylamylamine, or DMAA, an ingredient the Food and Drug Administration (FDA) has labeled dangerous. DMAA can cause a dangerous increase in blood pressure leading to problems ranging from shortness of breath to heart attacks.
The indictment also referenced a 2013 outbreak of liver injuries including jaundice and the need for liver transplants in consumers who had consumed OxyElite Pro. At least one person died in the outbreak. A wrongful death lawsuit against USPlabs was dismissed earlier this year with prejudice
The company’s contract manufacturer, S.K. Laboratories, and executives from both companies were also charged in the indictment. The case is currently pending in the U.S. District Court for the Northern District of Texas, Dallas Division.