FDA Opens Criminal Investigation into Maker of OxyElite Pro

January 16, 2015 — A federal criminal investigation has been opened into USPLabs, the Dallas-based manufacturer of OxyElite Pro, after the diet pill was linked to several hospitalizations, deaths, and an outbreak of liver damage.

According to the Dallas Morning News:

“The Food and Drug Administration’s criminal division is conducting a mail fraud investigation of USPlabs over misleading statements about its sports supplements.”

No charges have been filed by the U.S. Attorney’s Office in Texas. However, it is not unusual for the government to take years to initiate criminal prosecutions.

Last year, the FDA raided the business and seized more than $1 million in a bank account. Court documents show that USPLabs sold more than $50 million worth of OxyElite Pro in 2012 and 2013.

The CEO of USPLabs, Jacob Geissler, founded the company in 2006. As the time, he was on probation for possession of thousands of pills containing anabolic steroids. He was given 10 years probation, but released after serving half the sentence. Felony charges were dismissed.

In 2010, the FDA cited USPLabs for failing to comply with good manufacturing requirements. Two years later, OxyElite Pro was linked to a 21 year-old’s death from cardiac arrest. The FDA inspected USPLabs again and issued a warning letter about methylhexanamine (DMAA), an illegal stimulant in OxyElite Pro.

In 2013, after fighting with the FDA over the legality of DMAA for a year, USPLabs re-formulated OxyElite Pro with aegeline, another unapproved ingredient. OxyElite Pro was rapidly linked to about 100 cases of liver damage, including one death. About two dozen lawsuits are now pending against the company.

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