The Food and Drug Administration’s criminal division is conducting a mail fraud investigation of USPlabs over misleading statements about its sports supplements, which are popular among fitness buffs and body builders, according to federal search warrants.
FDA agents raided the business late last year and seized more than $1 million from its bank account. No charges have been filed. FDA officials and the U.S. attorney’s office in Dallas declined to comment on the pending inquiry.
USPlabs marketed and sold its products nationwide without first seeking FDA approval for ingredients found to have sickened and harmed consumers, according to a federal affidavit attached to the search warrants. USPlabs continued to sell products with a dangerous and illegal stimulant, dimethylamylamine, known as DMAA, in 2013 after being warned about it a year before by the FDA, the affidavit said.
The federal agency banned DMAA in 2012 and ordered several companies to remove it from their products.
The drug, an amphetamine derivative that’s banned in other countries, can lead to high blood pressure, seizures, neurological and psychological problems, heart attacks and other cardiovascular problems, according to the FDA.
Last year, USPlabs agreed to destroy its remaining stock of OxyElite Pro and Jack3d containing DMAA despite insisting they were safe.
Lawyer’s response
Peter Barton Hutt, a lawyer for USPlabs and a former FDA chief counsel, said the company’s products are safe.
“Based on extensive animal testing and human clinical studies, USPlabs demonstrated that DMAA presented no more risk to humans than two or three cups of coffee,” he said.
USPlabs sold more than $50 million worth of OxyElite Pro in 2012 and 2013, court records show. The company’s supplements are marketed to boost athletic performance, improve concentration and lead to weight loss, according to court records.
The FDA began inspecting USPlabs’ facilities in 2010 after reports that its supplements had sickened some who took them. The agency has said it cited USPlabs several times for various violations.
The company has been sued more than two dozen times in federal court since 2011, records show. At least half of those cases, filed in Texas and other states, are still pending.
In one of the pending lawsuits, filed last year in the Western District of Texas, a woman claimed her daughter took one of USPlabs’ supplements and developed liver failure and other health complications before she died about a month later in late 2011.
Sylvia Ogbonna of Mississippi blames the death of Demekia Cola on DMAA in the supplement she took, court records show. Ogbonna also sued the company’s chief executive officer, Jacob Geissler, and its president, Jonathan Doyle, who both live in Dallas, in an attempt to hold them personally liable.
A federal judge, however, ruled recently that the men could not be held legally responsible for Cola’s death.
USPlabs denies the allegations and claims that Cola, an Army sergeant who was based in Fort Bliss, died from unrelated pre-existing conditions.
Cola was one of three young Fort Bliss soldiers who died after taking USPlabs’ supplements with DMAA. One of them, a 22-year-old Army private, collapsed in 2011 after a 10-minute run. His family is also suing USPlabs in federal court.
Geissler, 38, who has a degree in nutrition from Texas A&M University, started the company in 2006, records show. At the time, Geissler was on probation for possessing about 3,000 pills containing anabolic steroids, court records show. He was indicted for it in 2003 in Bexar County.
He was sentenced to 10 years’ probation the following year. But after serving half of that time, a judge released him early from probation and the felony case was dismissed, records show.
Different ingredient
After taking its products with DMAA off the market, USPlabs ran into more trouble with the FDA over supplements containing a different ingredient called aegeline, a synthetic version of a natural substance.
Dozens of people who used a new OxyElite Pro product and other supplements with aegeline developed liver failure, most of them in Hawaii, the FDA has said.
The FDA said USPlabs failed to notify them that it was using aegeline in its supplements or to submit documentation that it was safe, the federal affidavit said.
“FDA was not able to assess the dangers posed by this new dietary ingredient on consumers prior to the nationwide distribution of the product,” the affidavit said.
Hutt said the company “strongly believes” the exact cause of the Hawaii liver failure cases has not yet been identified.
“As with DMAA, the company marketed aegeline only after animal and human testing demonstrated that it was safe,” Hutt said.
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