US FDA’s Stem Cell Clinic Enforcement Takes A Hit With Loss In California Case

01 Sep 2022

Federal judge denies government’s request to permanently enjoin California stem cell clinic from administering unapproved stromal vascular stem cell treatments, concluding they are not ‘drugs’ under the FD&CA. Ruling runs counter to decision in similar case involving a Florida stem cell clinic.

Roadblock — FDA's bid to halt a California stem cell clinic's treatments hit a roadblock in federal court. • Source: Shutterstock

The US Food and Drug Administration’s regulatory oversight of stem cell clinics took a hit on 30 August when a California federal judge ruled that defendants’ unapproved stromal vascular stem cell treatments are not “drugs” within the meaning of the Food, Drug and Cosmetic Act.

In a ruling that comes more than a year after a bench trial, US District Judge Jesus Bernal denied the...