Center for Biologics Evaluation and Research, U.S. Food and Drug Administration

Poster Authors
Rachael F. Anatol, PhD; Melissa J. Mendoza, JD

Summary
The U.S. Food and Drug Administration regulates regenerative medicine therapies, including stem cells, amniotic fluid, Wharton’s jelly, and other product types. In recent years, there has been a proliferation of unapproved and unlawfully marketed regenerative therapies to treat or cure a wide range of diseases or medical conditions. Regenerative therapies have not been approved for the treatment or prevention of COVID-19, orthopedic conditions, neurological disorders, autism, macular degeneration, or these other marketed indications. FDA is calling the public’s attention to these products, which pose potentially significant safety concerns including blindness, formation and bacterial infections, among other risks. FDA urges health care providers and consumers to look out for red flags, suggests they contact FDA with any questions, and provides insight on what to do when encountering regenerative medicine therapies.

Contact
Rachael Anatol, PhD
Deputy Director, Office of Tissues and Advanced Therapies (OTAT), CBER,FDA
Email: Rachael.strong@fda.hhs.gov
Phone: 301-325-9452

Additional Information
Important Patient and Consumer Information About Regenerative Medicine Therapies

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