FDA Regulation of Stem Cell Therapies: Using a Stem Cell Fraud Strike Force to Separate Fact from Fiction

Mary Ann Chirba


In recent years, growth in the U.S. stem cell industry has surged through online marketing of unproven cell therapies to treat everything from multiple sclerosis and dementia to autism. This Article focuses most closely on adipose (fat) derived stem cell therapies because of their prevalence in the market and the U.S. Food and Drug Administration’s (FDA’s) problems in regulating them. The discussion explains why FDA has stumbled to date and faces even greater problems going forward, and offers a more effective and efficient strategy of using an Federal Trade Commission (FTC)-led inter-agency collaboration to target clinics for false advertising rather than arguing about the intricacies of stem cell biology.