The U.S. Justice Department unsealed an indictment on Tuesday against USPlabs, which made the workout supplement Jack3D, with criminal charges.
The department said it also filed charges against six company officials, four of whom were arrested on Tuesday.
The Justice Department said the indictment and arrests were part of a larger sweep by multiple agencies aimed at stemming the sale of unproven nutritional supplements.
The FDA released a statement on its website that said that USPlabs is a Dallas, Texas company that formerly manufactured highly popular workout and weight loss supplements.
The indictment charges USPlabs, S.K. Laboratories Inc. and their operators with a variety of charges related to the sale of those products.
The defendants were arrested/surrendered to the U.S. Marshal’s Service today.
Along with the arrests, FDA and IRS special agents seized assets in dozens of investment accounts, real estate in Texas, and a number of luxury and sports cars.
The indictment also said there were a rash of liver injuries associated with the product OxyElite Pro Advanced Formula in late 2013, and several users needed liver transplants.
USPlabs, when told of this, informed the U.S. Food and Drug Administration that it would stop marketing the supplement but instead tried to sell off inventories as quickly as possible even as executives ordered that two offending substances be removed from the formula, the indictment said.
The indictment alleges that USPlabs engaged in a conspiracy to import ingredients from China using false certificates of analysis and false labeling and then lied about the source and nature of those ingredients after it put them in its products.
According to the indictment, USPlabs told some of its retailers and wholesalers that it used natural plant extracts in products called Jack3d and OxyElite Pro, when in fact it was using a synthetic stimulant manufactured in a Chinese chemical factory.
The indictment also alleges that the defendants sold some of their products without determining whether they would be safe to use. To the contrary, as the indictment notes, the defendants knew of studies that linked the products to liver toxicity.
What is Jack3D?
Jack3d (pronounced “jacked”) is a pre-workout supplement sold by USPLabs, which also sells OxyElite Pro. Jack3d contains a drug known as DMAA (aka1,3-dimethylamylamine, methylhexanamine or geranium extract, DMAA is an ingredient found illegally in some dietary supplements and often touted as a “natural” stimulant).
DMAA was recently found in the bloodstream of two U.S.Army soldiers who died of heart attacks during physical training. The US Department of Defense has since banned the on-base sale of DMAA products, including Jack3d.
In 2010 two South African Springbok rugby players also tested positive for methylhexaneamine. At the time Ron Read, trade manager at Bolus, which distributed the supplement Jack 3d locally, said they warned professional athletes not to use the product as it contained methylhexaneamine.
Though the products remain legal to use and buy, there is growing concern that they may actually have serious, life-threatening side effects such as cardiovascular disorders, heart attack, central nervous system disorders, psychiatric disorders, and death,
Others also indicted
The US Government department also said it filed civil cases against five companies in the past week, alleging the improper sale of a range of supplements.
The companies included Clifford Woods, which sold Taheebo Life Tea and Life Glow Plus; Viruxo, which sold a product of the same name to treat herpes; and Optimum Health, which sold DMSO Cream for a variety of conditions.
The Federal Trade Commission filed lawsuits against Sunrise Nutraceuticals LLC, Health Nutrition Products and NPB Advertising Inc, alleging that they sold or advertised deceptive or unproven workout or weight loss supplements.