In his guilty plea, Kosolcharoen acknowledged that he and his associates falsely claimed ReGen was effective for treating numerous ailments, including lung and heart diseases, autoimmune disorders, Alzheimer’s, Parkinson’s, and more.
The founder and CEO of a California company that sold stem cell-based products, which were associated with numerous hospitalizations, admitted guilt yesterday to a felony charge under the Federal Food, Drug, and Cosmetic Act.
John W. Kosolcharoen, 53, who most recently resided in Orange County, California, confessed to the unlawful introduction of an unapproved new drug into interstate commerce with the aim to deceive and mislead. He is currently incarcerated, serving time for an unrelated conviction. The hearing was overseen by U.S. District Judge Otis D. Wright II in the Central District of California, following a plea agreement with federal authorities. Kosolcharoen's sentencing is scheduled for September 23.
“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.”
Court records reveal that starting in 2016, Kosolcharoen established two companies, Liveyon LLC and Genetech Inc., aimed at producing and distributing injectable stem cell products derived from human umbilical cord blood. Liveyon promoted these products under various brand names, including “ReGen.”
In his guilty plea, Kosolcharoen acknowledged that he and his associates falsely claimed ReGen was effective for treating numerous ailments, including lung and heart diseases, autoimmune disorders, Alzheimer’s, Parkinson’s, and more. Liveyon continued to market these products across the United States until approximately April 2019, utilizing promotional materials filled with numerous deceptive and misleading claims regarding their 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.
Anyone considering the use of anything purported to be a regenerative medicine product, including stem cell products, exosome products, or other widely promoted products such as products derived from adipose tissue (this product is also known as stromal vascular fraction), human umbilical cord blood, Wharton’s Jelly, or amniotic fluid should know:
None of these products have been approved for the treatment of any orthopedic condition, such as osteoarthritis, tendonitis, disc disease, tennis elbow, back pain, hip pain, knee pain, neck pain, or shoulder pain.
None of these products have been approved to treat any neurological disorder, such as multiple sclerosis, amyotrophic lateral sclerosis (ALS; Lou Gehrig’s disease), Alzheimer’s disease, Parkinson’s disease, epilepsy, or stroke.
None of these products have been approved for the treatment of any cardiovascular or pulmonary (lung) diseases, such as heart disease, emphysema, or chronic obstructive pulmonary disease (COPD).
None of these products have been approved to treat autism, macular degeneration, blindness, chronic pain, or fatigue.
“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.”
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.
In 2019, the U.S. Food and Drug Administration issued a warning to Liveyon Labs Inc. and Liveyon LLC, based in Yorba Linda, California, along with their leaders, Roya Panah and John W. Kosolcharoen. The warning was due to the processing and distribution of unapproved products made from umbilical cord blood.
The FDA highlighted serious violations of current good tissue practice (CGTP) and current good manufacturing practice (CGMP) standards, which included inadequate donor eligibility checks, poor aseptic techniques to avoid contamination, and insufficient environmental monitoring. These issues raise significant safety concerns that could endanger patients. The unapproved products in question are known as PURE and PURE PRO.
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