Editor's note: This was updated on July 31, 2020 to clarify when FDAs regulatory framework for regenerative medicine products takes effect. The Food and Drug Administration (FDA) has taken a series of actions in recent years to crack down on businesses marketing high-risk, unapproved regenerative medicine interventions, including unproven stem cell treatments, but more needs to be done to ensure consumers are protected. The proliferation of clinics offering these interventionsmore than 700 in the United Statesposes a significant risk to public health and has led to multiple instances of patient harm, including blindness and life-threatening infections