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Eleventh Circuit grants FDA request to enjoin South Florida company from marketing stem cell treatment

On June 2, 2021, in USA v. US Stem Cell Clinic, LLC, et al, No. 19-13276, the Eleventh Circuit Court of Appeals affirmed a SDFL district court summary judgment for the FDA enjoining the defendant company from offering a procedure in which they remove fat tissue from a patient, isolate the portion containing stem cells, and inject that portion back into the patient.This procedure purportedly treats all manner of chronic conditions, from pain to Parkinson’s disease. The district court’s order enjoins the defendant from offering its procedure until it can demonstrate to the FDA that its stem cell therapy is safe and effective. The defendant argued on appeal that it is exempt from regulation because the procedure falls into either the “same surgical procedure” exception or the “361 HCT/P” exception to regulation under the Food, Drug, and Cosmetics Act codified at 21 U.S.C. §§ 301 et seq. See 21 C.F.R. § 1271.15(b); id. § 1271.10. The Eleventh Circuit disagreed, concluding that procedure does not fall within the first exception because the biological material implanted into the patient is not the same as that removed and the procedure does not fall within the second exception because the Clinic intends the stem cells to perform functions after the procedure beyond the basic functions the stem cells performed prior to the procedure.