SCOTUS Declines Stem Cell Case, Upholding FDA Oversight of Cell Therapies

The Supreme Court of the United States declined to hear an appeal from a pair of California stem cell clinics in a case challenging the Food and Drug Administration’s authority to regulate certain stem cell procedures as drugs under the Federal Food, Drug, and Cosmetic Act (FDCA). By declining to hear the appeal, the Court leaves in place a September 2024 ruling from the Ninth Circuit Court of Appeals affirming FDA’s regulatory oversight of these therapies.

The case involved physicians at two California clinics who created and administered a stem cell mixture known as stromal vascular fraction (SVF), which FDA alleged violated the FDCA through improper manufacturing and labeling. The Ninth Circuit rejected the clinics’ argument that their same-day SVF treatments qualify for the same surgical procedure (SSP) exemption, which allows establishments to remove and reimplant human cells, tissues, or cellular and tissue-based products (HCT/Ps) into the same patient during a single procedure without FDA regulation.

In the SVF procedure, fat tissue is removed and processed to isolate SVF cells, which are then reimplanted. Because the removed tissue (fat) and reimplanted material (SVF) differ, the Ninth Circuit ruled that SVF is more than "minimally manipulated." As a result, the court found the procedure does not qualify for the SSP exemption and remains subject to FDA regulation.