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# FDA Stem Cell Therapy Regulation at Risk: Attorneys
- URL: https://www.fdaweb.com/fda-stem-cell-therapy-regulation-at-risk-attorneys/
- Published: 2022-12-15T12:00:00.000Z
- Updated: 2026-09-14T18:09:57.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5153408

Three Ropes & Gray attorneys say a potential split between the 9th and 11th Circuit Courts of Appeals over stem cell therapy regulation could “fundamentally alter FDA’s ability to regulate stem cell therapies.” [Writing](https://www.ropesgray.com/en/newsroom/alerts/2022/december/ninth-circuit-appeal-in-stem-cell-clinic-case-likely-to-have-significant-impact-on-fdas-authority?ref=fdaweb.com) in an online *Alert*, the attorneys outline the two cases that are setting up the potential conflict.

The federal government on 10/27 appealed to the 9th Circuit what the attorneys call a “rare defeat in an injunction case” brought under the Federal Food, Drug, and Cosmetic Act (FFDCA). The appeal followed the denial of an injunction by a California federal court that ruled that stem cell products produced at the California Stem Cell Treatment Center were not subject to regulation as drugs under the FFDCA and that one of the medical procedures through which the products were administered met the criteria for the “same surgical procedure exception (SSP Exception)” that exempts procedures from FDA regulation.

The attorneys write that the California decision conflicts with recent precedents, including a Florida federal court decision involving the U.S. Stem Cell Clinic that was affirmed by the 11th Circuit that held that the SSP Exception did not apply to a very similar set of facts and that the stem cell products at issue were drugs.

The attorneys say that if the 9th Circuit upholds the lower court decision, it would create a circuit split regarding the applicability of the SSP Exception and could affect the legal interpretation of what constitutes a drug in the context of human cells, tissues, and cellular and tissue-based products. They say stem cell clinics and other healthcare providers who perform procedures with a patient’s cells and tissues will be watching the 9th Circuit deliberations in the case very closely in 2023.

“If the 9th Circuit were to affirm the district court’s holding,” the attorneys conclude, “the resulting split could undermine FDA’s authority to regulate clinics like U.S. Stem Cell Clinic and California Stem Cell Treatment Center. The case could make its way to the Supreme Court, where deference to an agency’s interpretation of its own ambiguous regulations is far from assured.”