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

 
• By Sue Sutter

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. The ruling runs counter to a decision in a 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 US Department of Justice’s request to permanently enjoin defendants California...

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