Genesis Medical Sellng Unapproved Adipose Cellular Products: FDA

The CBER Office of Compliance and Biologics Quality says its review of a Web site, social media pages, and other online sources for Genesis Medical Center, Irvine, CA, determined that the firm markets what it describes as a “stem cell therapy” or “biological therapy” product derived from adipose tissue to treat many diseases or conditions. A 9/16 Notice of Violation says the firm also markets an exosome product to consumers to treat diseases.

The letter says the firm’s adipose-derived cellular product is regulated as a drug and as a biological product, requiring a valid BLA, which Genesis does not have.

FDA also cautions that generally exosomes for clinical use in humans are regulated as drugs and biological products and are subject to premarket review and approval requirements.

Genesis was told to respond within 30 days.