Recent Legal Battles and FDA Warning to Stem Cell Companies

In 2008 Regenxxx (Des Moines, IA) was forced to stop using cultured and expanded cells in the US after a protracted legal battle with the FDA for violations of manufacturing a drug product without approval.

In 2018, the DOJ/FDA initiated a court case against US Stem Cell Clinic (Weston, FL) and US Stem Cell Inc. (Sunrise, FL), seeking permanent injunction after at least four reports of blindness following eye injections using their stem cells. In June 2019 a US District Judge ordered the company to halt eye injection procedures. A Complaint against US Stem Cell for manufacturing of stem cell products without FDA approval was also filed by the DOJ/FDA.

The DOJ/FDA have also recently sought a permanent injunction against California Stem Cell Treatment Center Inc., from marketing non-FDA approved cellular products to patients.

In 2019, a federal judge granted class action status of a lawsuit filed in 2016 against StemGenex (San Diego, CA) for wrongfully exaggerating patient satisfaction in marketing. “StemGenex claims that 100% of its prior consumers are satisfied with its service.” The FDA also states that their manufacturing process poses “potential significant safety concerns.”

In 2019, the FDA sent a warning letter to R3 Stem Cell (Scottsdale, AZ) regarding their marketing of unapproved stem cells for unapproved conditions. The FDA determined that their products are regulated as drugs and biological products under the Federal Food Drug and Cosmetic Act (FD&C) and the Public Health Service (PHS) Act. As such their products require a valid investigational new drug (IND) application and a valid biologics license application (BLA) which R3 Stem Cell did not have.

In December 2019, the FDA sent a warning letter to Liveyon Labs (Yorba Linda, CA) for marketing and selling unapproved umbilical cord derived stem cell products. After their inspection, the FDA concluded that due to not meeting specific regulatory criteria, not having a valid BLA, or an IND, and not qualifying for any regulatory exceptions for their PURE and PUREPRO products, Liveyon Labs is in violation of the FD&C Act and the PHS Act. For more information about this specific warning letter please see FDA Warning Letter to Liveyon Labs Inc.