The founder and CEO of a stem cell therapy company has confessed to peddling an unapproved drug with potentially grave implications for consumers. John Warrington Kosolcharoen, the brains behind the California-based Liveyon LLC and Genetech Inc., has admitted to flouting federal regulations by selling an injectable stem cell product that wasn't greenlit by the FDA, as per a statement released by the Justice Department.
Serving an unrelated sentence, the executive, aged 53, from Rancho Santa Margarita, owned up to one count of introducing a non-sanctioned new drug into interstate commerce under deceiving pretenses. His actions have been characterized as a direct threat to patients desperately seeking cures for severe illnesses. United States Attorney Martin Estrada articulated the government's stance when he shared, "This defendant recklessly put people’s lives in danger, giving false hope to patients with serious illnesses." Estrada emphasized the importance of corporate integrity, especially when patient welfare is concerned.
According to the court documents, dating back to 2016, Kosolcharoen's companies marketed the stem cell concoction ReGen, which was touted as a treatment for a gamut of conditions—ranging from cardiac and pulmonary diseases to neurodegenerative disorders liked Alzheimer's and Parkinson's disease. However, his admission unveils a different story; that the marketing materials were littered with unfounded assertions about ReGen's safety and efficacy. In the face of such claims, the FDA has continuously cautioned consumers about unverified stem cell products that have not been proven safe or effective, potentially exposing patients to unknown risks.
In misleading the FDA, Kosolcharoen had craftily labeled his products as for research purposes only. The FDA and CDC were inundated with reports of hospitalizations due to bacterial infections in 2018, all traced back to Liveyon's stem cell products. The Justice Department has not minced words, thoroughly condemning the exploitation of patients under the guise of treatment. Principal Deputy Assistant Attorney General Brian Boynton affirmed, "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." FDA's commitment to safeguard the public was further echoed by special agents promising relentless pursuit of those who gamble with public health for profit.
The extensive investigative web leading to Kosolcharoen's courtroom confession was cast by a coalition of federal agencies, including the FBI and FDA's Office of Criminal Investigations, and spearheaded by Assistant United States Attorneys Mark Aveis and David H. Chao, as well as Justice Department's Consumer Protection Branch officials. The case leads us to a sentencing hearing dated September 23, where Kosolcharoen might receive a maximum of three years in federal prison on the books. The guilty plea and its details can be found in the Justice Department's announcement.
