In United States v. California Stem Cell Treatment Center, Inc.[1], the FDA brought a lawsuit against doctors who create and administer a stem cell mixture called stromal vascular fraction (SVF), alleging violations of the Food, Drug, and Cosmetic Act (FDCA). The district court ruled in favor of the doctors, but the Ninth Circuit Court of Appeals court reversed that decision.
SVF as a “Drug
The Ninth Circuit Court of Appeals held that SVF constitutes a “drug” under the FDCA based on the plain text of the statute. SVF is administered to treat diseases and affect body structures, fitting the definition of a drug. The court rejected arguments that this interpretation improperly intrudes on medical practice or raises major questions about FDA authority.
Same Surgical Procedure Exception
The court rejected the doctors’ argument that their same-day SVF treatment is exempt from FDA regulation under the “same surgical procedure” exception. This exception applies when an establishment removes and implants the same HCT/Ps (human cells, tissues, or cellular/tissue-based products) during one surgical procedure. The court held that for the SVF procedure, the removed HCT/P is fat tissue, not the cells targeted for implantation. Since fat tissue is removed but SVF is implanted, the procedure does not qualify for the exception.
Concurring Opinion
Judge Friedland agreed that the SVF treatment does not fall under the exception, but for different reasons. She found the exception’s language ambiguous after examining its text, structure, purpose and history. However, she concluded the FDA’s interpretation deserves deference as it reflects the agency’s authoritative position, implicates its expertise, and represents fair judgment without unfair surprise.
Conclusion
The appeals court reversed the district court’s judgment in favor of the doctors and remanded the case for further proceedings. The court’s decision means the FDA can regulate SVF treatments as drugs under the FDCA, requiring premarket approval to demonstrate safety and efficacy.
[1] No. 22-56014 D.C. No.5:18-cv-01005-JGB-KK (2024)
