A measure signed into law 3 October in the state of California, U.S., requires clinics to inform patients if they are using stem cell interventions that have not been approved by the Food and Drug Administration (FDA). Senate Bill 512 mandates that clinics post a notice in their offices, and provide a handout to each patient stating that the procedure has not been approved by the FDA.
“By signing this bill, the Governor has taken an important step to help patients in California know they are taking a risk when they purchase unproven stem cell treatments that have not been approved by the Food and Drug Administration,” said Hans Clevers, ISSCR president. “Many clinics have been selling unproven cell therapies, which often have little basis in science or medicine,” he said. “At least by requiring that clinics acknowledge when treatments have not been proven to be safe or effective, Californians will be able to make more informed decisions about their healthcare."
The ISSCR has a history of policy efforts to address the marketing and sale of unproven stem cell therapies, and stem cell tourism.