FDA Can Regulate Stem Cell Treatments as Drugs, Ninth Circuit Rules

The Food and Drug Administration can regulate certain stem cell mixtures as “drugs” under federal law, a three-judge panel of the Ninth Circuit Court of Appeals ruled Friday. The unanimous decision reversed a lower court's ruling in favor of two California stem cell clinics.

The case involved doctors who created and administered a stem cell mixture called stromal vascular fraction (SVF). FDA alleged that the clinics were violating the Food, Drug, and Cosmetic Act (FDCA) by improperly manufacturing and labeling the SVF product.

The Ninth Circuit determined that FDA has the authority to regulate SVF as a drug under the FDCA, which requires that all "drugs" be proven safe and effective. The court also affirmed FDA's regulatory authority over human cells, tissues, and cellular and tissue-based products (HCT/Ps), such as SVF, under the FDCA and the Public Health Service Act.

The court rejected the clinics' argument that their same-day SVF treatment is exempt from FDA regulation under the same surgical procedure (SSP) exemption. The exemption allows establishments to remove and reimplant HCT/Ps into the same patient during a single procedure without FDA oversight. The court clarified that the SSP exemption applies only when the removed and reimplanted materials are identical. In the SVF procedure, fat tissue is removed and processed to isolate SVF cells, which are then reimplanted. Since the removed tissue (fat) and reimplanted material (SVF) differ, the court ruled that SVF is more than "minimally manipulated." Therefore, the procedure does not qualify for the SSP exemption and is subject to FDA regulation.