Criminal charges have been filed against the company behind the best-selling workout supplement Jack3d and six of its executives, the U.S. Justice Department says.
In the indictment, Dallas-based USPlabs LLC is charged with using synthetic stimulants from China in its popular Jack3d and OxyElite Pro workout and weight loss supplements but telling retailers they contained only plant extracts.
"The Justice Department and its federal partners have joined forces to bringing to justice companies and individuals who profit from products that threaten consumer health," said Principal Deputy Assistant Attorney General Benjamin C. Mizer.
The indictment cited a number of instances of liver injury in late 2013 linked to OxyElite Pro Advanced Formula, with several users of the supplement requiring liver transplants.
When informed of this, USPlabs promised to end marketing of the supplement but instead continued to sell off inventory as quickly as possible, the indictment charges, noting that USPlabs' supplements accounted for $400 million in sales from 2008 to 2013.
Four defendants have been arrested, and two are expected to self-surrender to the U.S. Marshals Service, said a statement from the U.S. Food and Drug Administration, which, in partnership with other federal agencies, conducted a year-long investigation of the dietary supplements.
In addition to the arrests, FDA and IRS agents seized assets in numerous investment accounts, along with real estate in Texas as well as a number of sports and luxury cars, the agency said.
The indictment alleges the defendants sold their products without taking steps to determine and ensure they were safe to take, the Justice Department said.
"From California to Maine, consumers ingest pills, powders and liquids every day, not knowing whether they are wasting money or whether they may end up harming, rather than helping, themselves," Mizer said. "Unfortunately, many of these products are not what they purport to be or cannot do what the distributors claim they can do."
The year-long federal investigation by the Justice Department, the FDA, the Federal Trade Commission and the U.S. Anti-Doping Agency resulted in civil and criminal cases against more than 100 manufacturers and distributors of dietary supplements, officials said.
Experts have long argued that supplements, which have become a $35 billion industry, are subject to insufficient regulation because they are not considered either a food or a drug.
While the FDA is granted some oversight authority when it comes to dietary supplements, it is nothing like the strict regulatory control it exercises over pharmaceutical drugs.
More than half of Americans use some sort of dietary, workout or weight-loss supplement, according to the industry trade group Council for Responsible Nutrition.