USPlabs charged in money laundering, wire fraud case
A company known for its popular workout and weight-loss treatments has been charged with 11 counts related to the unlawful sale of dietary supplements, according to a federal indictment made public Tuesday.
The charges against Dallas-based USPlabs come after a year long sweep of 117 individuals and companies that were selling products that potentially harmed consumers.
USPLabs was one of the companies included in a 2013 USA TODAY investigation into questionable dietary supplements and the companies who provide them.
An indictment filed in a U.S. District Court in Dallas alleges that company executives committed wire fraud, mail fraud and conspiracy in connection with the scheme.
Benjamin C. Mizer, Principal Deputy Assistant Attorney General for the Department of Justice’s civil division, said that USPlabs misled consumers about their products including the marketing of synthetic Chinese ingredients with falsified certificates of analysis as natural additives.
In fact, the USPlabs products were “100% synthetic,” Mizer said, adding that USPlabs’ “deception put lives at risk … defendants sometimes tested the products on themselves and sold the ones that made them feel good.”
USPlabs has a history of run-ins with federal regulators. It has previously come under scrutiny after federal health investigators announced that the company’s workout supplement OxyElite Pro appears to be connected to dozens of serious incidents of liver injury, including one death and several cases that required liver transplants.
The FDA has long been scrutinized for a lack of urgency toward the illegal activity in the supplement industry.
Howard Sklamberg, FDA’s Deputy Commissioner for Global Regulatory Operations and Policy, said the agency’s enforcement has been “vigorous,” having sent hundreds of warning letters to supplement companies over the past year.
But until now, Pieter Cohen, an assistant professor at Harvard Medical School who published a report on the supplement industry in late October, said these warning letters are all the FDA has done.
The recent criminal indictment against USPlabs comes as a joint effort from six federal agencies, including the FDA, Department of Defense and U.S. Anti-Doping Agency.
“Would the FDA have done anything about this on their own? Without these outside organizations, I don’t think the FDA would even have acted,” Cohen said.
The FDA has been aware of the use of synthetic materials in dietary supplements for some time, Cohen said, noting past small cases.
However, USPlabs is a mainstream player in the industry with products at major retailers, Cohen said.
“The mainstream supplement industry has done nothing and finally the FDA is saying enough is enough … there are going to be criminal charges,” Cohen said.
Because these dietary supplements are not legally considered drugs, companies do not have to report new products to the FDA, Sklamberg said the supplement industry is “one of the most challenging areas that FDA regulates.” A previously flagged company could change the name of a product and put the FDA back at “square one” with regulation, Sklamberg said.
Sklamberg said this recent development should be a reminder to supplement companies that federal agencies are watching.
“Today’s joint agency effort is a testament to our commitment to protecting consumers from potentially unsafe dietary supplements,” Sklamberg said. “The criminal charges against USPlab should serve as notice to industry that if your products are found to be severely harming public health the FDA will exercise it’s full authority under the law to bring you to justice and protect consumers.”