California CEO Pleads Guilty to Felony Distribution of Unapproved Drug
A California-based CEO has pleaded guilty to a felony violation of the Federal Food, Drug and Cosmetic Act, related to the distribution of unapproved stem cell products.
John W. Kosolcharoen, 53, of Orange County, California, pleaded guilty to introducing an unapproved new drug into interstate commerce with the intent to defraud and mislead.
According to court documents, Kosolcharoen created two companies, Liveyon LLC and Genetech Inc., to manufacture and distribute injectable stem cell products made from human umbilical cord blood. Liveyon marketed the products under different brand names, including ‘ReGen.’
Kosolcharoen admitted that he and others misrepresented ReGen as suitable for the treatment of a variety of conditions, such as lung and heart diseases, autoimmune disorders, Alzheimer’s disease, Parkinson’s disease, and others. Liveyon marketed the products throughout the United States until about April 2019 using advertising materials that contained multiple false and misleading statements about their purported safety and effectiveness.
The U.S. Food and Drug Administration (FDA) has warned consumers that patients seeking cures and remedies for serious diseases and conditions may be misled about unapproved stem cell products that are illegally marketed, have not been shown to be safe or effective, and, in some cases, may have significant safety issues that put patients at risk.
Kosolcharoen admitted that he directed Liveyon’s purchase orders to falsely state that the stem cell products were being sold ‘for research purposes only.’ In 2018, FDA and the Centers for Disease Control and Prevention (CDC) received reports of patients in multiple states requiring hospitalization for bacterial infections after receiving Liveyon products.
Kosolcharoen is currently in custody serving a sentence for a separate, unconnected conviction. His sentencing for the current charge is set for September 23.
Principal Deputy Assistant Attorney General Brian Boynton said, ‘Unapproved stem cell treatments not only endanger public health but also exploit the hopes of patients who seek relief from the most serious of diseases. The Justice Department is committed to safeguarding the public from these schemes and will vigorously pursue legal action to hold accountable those who unlawfully market and sell these unproven therapies.’
Key Facts
- State: California
- Category: Drug Trafficking|White Collar Crime
- Source: DOJ Press Release â†â€â€
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