said on Thursday that it had also written to 20 clinics that offer unapproved stem cell treatments, warning them that such products are generally regulated by the agency and encouraging the clinics to contact federal regulators before November 2020, when enforcement will tighten. “We’re going to be going in and inspecting more stem cell operators this year,” Dr. Scott Gottlieb, the agency’s commissioner, said in an email. “We’re focused on outfits that may be engaging in unsafe practices and haven’t been working with F.D.A. Unfortunately, there are too many firms that fit this description.”Hundreds of clinics have sprung up around the country, offering treatments supposedly containing stem cells, to treat a wide variety of ailments, including arthritis, eye disorders, Parkinson’s disease and lung problems. The treatments are marketed as having curative or healing properties, but there is no proof that they work or are safe.
Source: New York Times December 20, 2018 23:14 UTC