The FDA recently filed complaints in federal court seeking “permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval and for significant deviations from current good manufacturing practice requirements.”1
The action on May 9, 2018, was taken against U.S. Stem Cell Clinic of Sunrise, FL, which the FDA alleges was using manufacturing practices that “could impact sterility” to create products that were not approved by the FDA.
“The FDA is taking this action because U.S. Stem Cell Clinic did not address the violations outlined in a warning letter to the clinic and failed to come into compliance with the law,” the agency said in a statement.1
The FDA also moved against the California Stem Cell Treatment Center in Beverly Hills and Cell Surgical Network in Rancho Mirage. These affiliated firms have some 100 for-profit stem cell clinics.
Last year, the FDA issued warning letters to a number of stem cell clinics after highly publicized issues of patient harms and bizarre treatments that included the use of the vaccine for smallpox, a pathogen that has been eradicated in the wild. (For more information, see the October 2017 issue of IRB Advisor.)
“Cell-based regenerative medicine holds significant medical opportunity, but we’ve also seen some bad actors leverage the scientific promise of this field to peddle unapproved treatments that put patients’ health at risk,” FDA Commissioner Scott Gottlieb, MD, said in a statement on the most recent action. “In some instances, patients have suffered serious and permanent harm after receiving these unapproved products. In the two cases filed today, the clinics and their leadership have continued to disregard the law and, more importantly, patient safety.”
1. U.S. Food and Drug Administration. FDA seeks permanent injunctions against two stem cell clinics. May 9. 2018. Available at: https://bit.ly/2jKs0YC.