FDA Reiterates Consumer Warning Regarding Unapproved Regenerative Medicine Products

June 07, 2021

The Food and Drug Administration published new communications this week cautioning consumers about the broad marketing of unapproved regenerative medicine therapy products and noting that the agency has received reports of blindness, tumor formation, infections and more following the use of such unapproved products. The agency is also aware that patients and consumers are being referred to clinicaltrials.gov as a way to suggest that the products being offered are in compliance with FDA laws and regulations.

FDA reiterated that regenerative medicine products require FDA licensure and approval to be marketed to consumers. The agency also reemphasized that FDA oversight in a clinical trial is required before approval. Consumers who are being charged for these products or offered these products outside of a clinical trial are likely being offered a product illegally, the agency stated. 

The agency asked that consumers who are offered any of these products outside of a clinical trial for which the agency has oversight to contact FDA. FDA also encouraged patients who were hurt or who had side effects following treatment with a regenerative medicine product to report it to the FDA’s MedWatch Adverse Event Reporting program.