FDA Consumer Warning Regarding Stem Cell Therapy

Published 2019-09-09

On the 3rd of September, FDA issued a Consumer Warning Statement regarding Stem Cell Therapies. In the statement, FDA warns about some Stem Cell treatments which may be "illegal and potentially harmful". While FDA did not provide specific examples, it warned about Stem Cell products which do not have FDA approval or have not been evaluated under an Investigational New Drug (IND) application. FDA did point out that the warning pertains to " stem cell products that are used in unapproved ways—or when they are processed in ways that are more than minimally manipulated". This appears to imply that the consumer warning pertains to procucts which do not meet the 361 exception.