9th Cir. Says FDA May Regulate Stem Cell Treatment Under FDCA

SAN FRANCISCO – The 9th Circuit U.S. Court of Appeals has ruled that the FDA may regulate stem cell treatments, used for conditions such as osteoarthritis, because the mixture, known as stromal vascular fraction (SVF), is a “drug” under the Food, Drug and Cosmetic Act.

In a Sept. 27 opinion, the appellate panel reversed a California federal court’s judgment in favor of the defendants - doctors who create and administer SVF in clinics – whom the FDA accuses of violating the FDCA by improperly manufacturing and labeling the SVF product.

The panel further ruled that the FDA is authorized …