Innate Healthcare Institute – FDA Warning Letter, Aug 26, 2025

The FDA issued a warning letter to Innate Healthcare Institute, located at 4835 East Cactus Road, Suite 140, Scottsdale, AZ, on August 15, 2023. The letter followed a review of the company"s website, which markets "umbilical cord mesenchymal stem cells (UC-MSCs)" for allogeneic use. The FDA identified several violations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Public Health Service Act (PHS Act).

Key violations include the misbranding of UC-MSCs, which are marketed for the diagnosis, cure, mitigation, treatment, or prevention of diseases, classifying them as drugs and biological products. The product does not meet the criteria for minimal manipulation and homologous use as per 21 CFR 1271.10(a), and lacks an approved Biologics License Application (BLA), making it unlawfully marketed.

Additionally, the product is misbranded under section 502(f)(1) of the FD&C Act due to inadequate directions for use, as it requires supervision by a licensed practitioner. The FDA also raised concerns about the marketing of exosomes, which are similarly regulated and have been associated with serious adverse events.

The FDA requires Innate Healthcare Institute to respond within 15 working days, detailing corrective actions taken or planned to address these violations. Failure to comply may result in enforcement actions, including seizure or injunction. The company is responsible for ensuring compliance with all applicable laws and regulations.