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Saturday, October 24, 2020
Prison for Natural Supplement Makers Behind Wave of Liver Damage, Death in Hawaii
By News Release @ 2:09 AM :: 947 Views :: Health Care, Law Enforcement

Execs of once-thriving supplements brand USPlabs sentenced to prison

From Natural Products Insider, Oct 22, 2020 (excerpt)

…On Oct. 13, U.S. District Judge Sam A. Lindsay sentenced the 44-year-old Geissler to five years of prison. Doyle, age 41, was sentenced to two years behind bars. USPlabs was previously sentenced to pay $4.7 million in criminal forfeiture, while SK Laboratories was ordered to forfeit $6 million.

“It’s sad that it has to come to this where people are … fined and imprisoned, but it’s even sadder that people had to suffer and die from these supplements,” said Linda Wong, a liver transplant surgeon at The Queen’s Medical Center in Honolulu, in an interview.

Wong was working at the same facility—the only transplant and liver center in Hawaii—when she and her colleagues noticed a pattern of cases of liver failure among patients who had taken OxyElite Pro. The outbreak in September 2013 fueled an investigation by state and federal authorities, including the Hawaii Department of Health, Centers for Disease Control and Prevention (CDC) and FDA.

The Hawaii Department of Health declined to comment for this article.

CDC identified 97 people with acute non-viral hepatitis in an outbreak that began in Hawaii—72 of whom reported exposure to an OxyElite Pro branded product, FDA stated in an annual report to Congress submitted in February 2015.

A 42-year-old female who took OxyElite Pro and fell ill could not have a liver transplant because an “emergent liver transplantation work-up” disclosed she had an early form of breast cancer, according to a 2015 article published in the scientific journal, Drug Testing and Analysis.

“Despite aggressive care,” she died on Oct. 4, 2013 after suffering swelling of the brain, researchers wrote.

Another patient died due to complications from a liver transplant and other factors, Wong shared. A third patient who took OxyElite Pro and received a liver transplant remains alive, “but she’s on chronic medications for the rest of her life,” the surgeon added….

read … Execs of once-thriving supplements brand USPlabs sentenced to prison

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Two Individuals And Two Companies Sentenced In Scheme To Fraudulently Sell Popular Dietary Supplements

News Release from US DoJ, Oct 15, 2020

A federal court in Texas sentenced two former dietary supplement company executives to prison and ordered two companies to pay a combined $10.7 million in criminal forfeiture for their roles in fraudulently selling popular workout supplements, the Justice Department announced today.

On Oct. 13, 2020, U.S. District Judge Sam A. Lindsay sentenced former USPlabs CEO Jacobo Geissler, 44, of University Park, Texas, to 60 months’ imprisonment. On October 15, Judge Lindsay sentenced former USPLabs president Jonathan Doyle, 41, of Dallas, to 24 months’ imprisonment. In addition, the Court ordered each defendant to pay a criminal fine of $250,000. The Court previously sentenced USPlabs to pay $4.7 million in criminal forfeiture, and sentenced another company, SK Laboratories Inc., to forfeit $6 million in connection with the case. All of the defendants were charged in a 2015 indictment returned by a federal grand jury in the Northern District of Texas.

 “Consumers rely on dietary supplement manufacturers to accurately represent the ingredients in their products and ensure that they are safe to consume,” said Acting Assistant Attorney General Jeffrey Bossert Clark of the Justice Department’s Civil Division.  “We will tirelessly investigate and prosecute individuals and companies that place profits before the safety of consumers.”

“Dietary supplement companies cannot be allowed to deceive their consumers and hide the fact that they are including untested ingredients in their products,” said U.S. Attorney for the Northern District of Texas Erin Nealy Cox. “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. 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,” said Judy McMeekin, Pharm.D., Associate Commissioner for Regulatory Affairs, U.S. Food and Drug Administration.

“The defendants in this case thought they could profit off the boom in dietary supplements, while blatantly concealing the true nature of the products they were peddling,” said Assistant Special Agent in Charge Kevin Caramucci, Dallas Field Office. “IRS-CI is proud to stand with our federal partners in investigating financial crimes that bilk millions of dollars from our honest taxpayers, especially when products such as those distributed by Mr. Geissler and Mr. Doyle caused so much harm.”

The defendants each played roles in developing, manufacturing, or marketing the popular workout and weight loss supplements known as Jack3d and OxyElite Pro, which were distributed by USPlabs. In pleading guilty last year to conspiracy to introduce misbranded food into interstate commerce, Doyle and Geissler admitted that they imported substances with false and misleading labeling to avoid law enforcement and regulatory agency attention. SK Laboratories pleaded guilty to introduction of misbranded food into interstate commerce, and USPlabs pleaded guilty to conspiracy to introduce misbranded food into interstate commerce. The misbranding charges relate in part to OxyElite Pro, which was recalled in 2013 in the wake of an investigation by the Food and Drug Administration into whether the supplement caused liver injuries in consumers. The indictment alleged that the defendants sold some of their products without determining whether they would be safe to use.

Three other individuals also pleaded guilty and are expected to be sentenced in the coming months. Cyril Willson, 39, of Ralston, Nebraska, and Matthew Hebert, 42, of Dallas, pleaded guilty to introducing misbranded food into interstate commerce with the intent to defraud or mislead. Sitesh Patel, 37, of Irvine, California, the vice president of S.K. Laboratories, a California dietary supplement manufacturer, pleaded guilty to conspiracy to introduce misbranded food into interstate commerce and to the introduction of misbranded food into interstate commerce.

According to the indictment, sales of USPlabs products related to the conspiracy brought the company hundreds of millions of dollars in revenue. The indictment alleged that the defendants participated in a conspiracy to import dietary supplement ingredients from China, including the stimulant known as “DMAA,” using false certificates of analysis and false labeling, and then lied about the source and nature of those ingredients. According to the indictment, the defendants told some of their retailers and wholesalers that USPlabs products contained natural plant extracts, when in fact they contained a synthetic stimulant manufactured in a Chinese chemical factory.

The case was investigated by Special Agent Chad Medaris and former Special Agent Liam Gimon of FDA’s Office of Criminal Investigations and Special Agent Larissa Wilson of the Internal Revenue Service. The case is being prosecuted by Trial Attorneys David Sullivan, Patrick Runkle, and Raquel Toledo with the Consumer Protection Branch of the Department of Justice’s Civil Division, and Assistant United States Attorneys Errin Martin and John DelaGarza of the U.S. Attorney’s Office for the Northern District of Texas.

Additional information about the Consumer Protection Branch and its enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch.

For more information about the U.S. Attorney’s Office for the Northern District of Texas, visit its website at https://www.justice.gov/usao-ndtx.

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2013:  "Oxyelite Pro" Dietary Supplement Linked to Death, Liver Failure

2013:  Liver Let Die

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