A federal court in Texas has sentenced two former OxyElite Pro dietary supplement executives to prison and ordered two companies to pay $10.7 million in criminal forfeiture for fraudulently selfing popular workout supplements called Jack3d and OxyElite Pro, according to the United States Department of Justice. U.S. District Judge Sam A. Lindsay presided.
Former USPlabs CEO Jacobo Geissler was sentenced to 60 months, and former USPLabs president Jonathan Doyle was sentenced to 24 months. All of the defendants were charged in a 2015 indictment returned by a federal grand jury in the Northern District of Texas.
U.S. Attorney for the Northern District of Texas, Erin Nealy Cox, said in a statement, “Dietary supplement companies cannot be allowed to deceive their consumers and hide the fact that they are including untested ingredients in their products. We are committed to holding people who harm consumers accountable for their unconscionable behavior.”
“Consumers of dietary supplements do not expect the products they purchase to put their health at risk, said Judy McMeekin, Pharm.D., Associate Commissioner for Regulatory Affairs for the U.S. Food and Drug Administration. “Distributing supplements that jeopardize consumer health by being falsely or misleadingly labeled will not be tolerated. The FDA will continue to investigate and bring to justice those who endanger the public’s health and violate the law.”
The defendants allegedly developed, manufactured, or marketed the popular workout and weight loss supplements known as Jack3d and OxyElite Pro. Both men admitted they imported substances with false and misleading labeling to avoid regulatory attention. And the indictment alleged that the defendants “sold some of their products without determining whether they would be safe to use.”
In 2013, there were several FDA recalls issued for OxyElite Pro dietary supplements for links to liver illnesses and death. The FDA used its recall authority on this product under the 2011 Food Safety Modernization Act. In that recall notice, the government stated, “The Hawaii Department of Health reviewed 46 medical reports and forwarded them to the FDA. They found that 27 patients, or 58%, had taken OxyElite Pro before becoming ill. Seventeen of the 27 patients (63%) reported that OxyElite Pro was the only dietary supplement they were taking. One person has died among this group. One person had a liver transplant; others are waiting for liver transplants.”
The indictment also alleged that the defendants imported dietary supplement ingredients from China, including the stimulant DMAA, using false certificates of analysis and false labeling. DMAA is an amphetamine derivative that is illegal to use in dietary supplements. Risks associated with this compound include high blood pressure, severe acute hepatitis, bleeding in the brain, and stroke. The defendants allegedly told some of their retailers that the products contained natural plant extracts, when they actually contained a synthetic stimulant made in a Chinese chemical factory.
