The Food and Drug Administration just put dubious stem cell clinics on notice.
The agency announced plans on Monday for new policies and enforcement efforts to stamp out what it called “unscrupulous actors” peddling unproven, potentially dangerous, and often expensive stem cell therapies—including a bizarre and troubling instance involving smallpox vaccine.
As an initial demonstration of its harder stance, the agency today posted information on two enforcement efforts. One was a warning letter to a Florida stem cell clinic that had posed as legitimate clinical research and ended up blinding three patients after injecting stem cells directly into their eyeballs. The other was a concerning announcement that the agency had seized five vials of smallpox vaccine from stem cell clinics in California.