By Hogan Lovells –
The U.S. Court of Appeals for the Ninth Circuit on Friday reversed the district court’s judgment in United States v. California Stem Cell Treatment Center, siding with the U.S. Food and Drug Administration (FDA) in finding that a stem cell clinic’s stromal vascular fraction (SVF) products may be regulated by the agency as new drugs. This ruling has significant implications for stem cell product manufacturers and distributors, as it aligns the Ninth Circuit with two others in agreement that SVF products require prior FDA approval before they may be sold commercially.
