By Edvard Pettersson – Courthouse News Service –
The FDA asked the Ninth Circuit to follow their colleagues on the 11th Circuit and find that novel stem cell procedures are not exempt from the agency’s oversight.
PASADENA, Calif. (CN) — The U.S. Food and Drug Administration told a Ninth Circuit panel on Wednesday it has the authority to regulate a California provider of stem cell treatments that has been likened to “liquid magic.”
The FDA is appealing the decision by a federal judge who concluded that the California Stem Cell Treatment Center’s procedure, which involves extracting body fat from a patient, isolating stomal vascular fraction, or SVF, cells from the tissue and injecting these back into the patient, doesn’t amount to creating a drug and falls under the so-called same surgical procedure exemption to FDA oversight.