A California-based owner of a pharmaceutical owner pleads guilty to an illicit scheme involving Injectable Stem Cell products.
John W. Kosolcharoen was hauled in on charges that his dodgy drugs breached the Federal Food, Drug, and Cosmetic Act and also caused multiple hospitalizations.
“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.
According to the FDA breach, the Orange County resident is already in custody, serving “a sentence for a separate, unconnected conviction.”
Illicit injectable Stem Cell products cause illness and breach FDA act
From 2016, it is alleged that Kosolcharoen masterminded the inception of Liveyon LLC and Genetech Inc.
They were devised to manufacture and distribute injectable stem cell products derived from “human umbilical cord blood.” Liveyon marketed the products under different brand names, including “ReGen.”
In his guilty plea, Kosolcharoen admitted that he and others lied about the application of ReGen. They wrongly said that the injectable could treat lung and heart diseases, autoimmune disorders, Alzheimer’s disease, Parkinson’s disease, and others.
Liveyon lied about the effectiveness, origins, and safety of these drugs but would continue to advertise the products until 2019. A full three-plus years that those injecting the drug went without knowing the dire and illegal consequences of the drug.
Reports from the FDA of bacterial infections and other results
As part of the plea, Kosolcharoen revealed that he had been plying to the FDA about the drug’s application and origins. According to the statement, he told the FDA that the drug was for “research purposes only.” It was also revealed that 2018 the FDA and the Centers for Disease Control and Prevention (CDC) received multiple reports of bacterial infections and other drug-related results from hospital admissions.
“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 suffered adverse events,” said a Special Agent in Charge Robert Iwanicki of FDA Office of Criminal Investigations Los Angeles Field Office.
Image: Pixlr.
