Founder and Chief Executive Officer of Injectable Stem Cell Product Manufacturer Pleads Guilty to Felony Distribution of Unapproved Drug

The founder and chief executive officer of a California-based company that marketed stem cell-based products linked to multiple hospitalizations pleaded guilty today to a felony violation of the Federal Food, Drug and Cosmetic Act.

John W. Kosolcharoen, 53, most recently of Orange County, California, pleaded guilty to introducing an unapproved new drug into interstate commerce with the intent to defraud and mislead. Kosolcharoen is currently in custody serving a sentence for a separate, unconnected conviction. U.S. District Judge Otis D. Wright II for the Central District of California presided over the hearing pursuant to a plea agreement with the government. The court set Kosolcharoen’s sentencing for Sept. 23.

According to court documents, beginning in 2016, 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.” In pleading guilty, 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.

In recent years, 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. Stem cell products are regulated by FDA, and generally they must have FDA approval before being introduced into interstate commerce.

As part of the plea agreement, Kosolcharoen admitted that to mislead FDA about Liveyon’s activities, 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 admitted that he and others fraudulently induced customers into purchasing stem cell-derived Liveyon products by, among other things, misleading the public about the cause and severity of adverse events suffered by Liveyon patients, and falsely reporting and concealing material facts regarding the outcome of an FDA inspection of Genetech. According to FDA records, that inspection documented evidence of significant deviations from good manufacturing and tissue practices.

“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,” said Principal Deputy Assistant Attorney General Brian Boynton, head of the Justice Department’s Civil Division. “The Department of Justice 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.”

“This defendant recklessly put people’s lives in danger, giving false hope to patients with serious illnesses,” said U.S. Attorney Martin Estrada for the Central District of California. “Today’s guilty plea shows that we will hold accountable corporate executives and healthcare professionals who put profits over patients.”

“We are grateful for the work by the Department of Justice to hold accountable establishments that prey upon vulnerable populations by marketing potentially dangerous stem cell products with false and misleading claims about their safety and effectiveness,” said Director Peter Marks, M.D., Ph.D. of FDA’s Center for Biologics Evaluation and Research.

“When unscrupulous providers offer umbilical cord blood stem cell products and treatments that are both unapproved and unproven, they put consumers’ health at risk, and multiple users of this firm’s products in fact suffered adverse events,” said Special Agent in Charge Robert Iwanicki of FDA Office of Criminal Investigations Los Angeles Field Office. “FDA will continue to investigate and bring to justice those who endanger the public’s health for material gain.”

“This investigation was a joint effort between multiple federal agencies and state and local health departments to quickly put a stop to the distribution of unsafe, contaminated products,” said Director Michael Bell, M.D. of CDC’s Division of Healthcare Quality Promotion. “The rapid response by our public health system identified products marketed as stem cell treatments to be the source of serious infections in dozens of patients. Our message to all consumers and providers is to heed the warning against the use of unapproved products like these with unproven claims of effectiveness for conditions like joint disease, chronic pain, or COVID-19. Please don’t let products like these put you or your patients’ health at risk.”

FDA’s Office of Criminal Investigations, FBI, Amtrak Office of Inspector General, Defense Criminal Investigative Service, Department of Health and Human Services Office of Inspector General, Department of Labor Employment Benefits Security Administration and California Department of Health Care Services investigated the case.

Assistant U.S. Attorneys Mark Aveis and David Chao for the Central District of California, Assistant Director Ross S. Goldstein and Trial Attorneys Meredith B. Healy, Kathryn A. Schmidt and Peter J. Leininger of the Justice Department’s Consumer Protection Branch are prosecuting the case.

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

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Source: Justice.gov