Supreme Rejuvenation, LLC, Houston, TX, received a Warning Letter from the US Food and Drug Administration. The FDA reviewed the company’s websites, including www.supremerejuvenation.com and www.instagram.com/supremeexosomes. The site indicates that Supreme Rejuvenation sells “100 Billion Exosomes: Human Umbilical Cord Mesenchymal Stem Cell Derived Exosomes,” “15 ml 100 Billion Exosomes: Stem Cell Exosome Gel,” and “30 ml 200 Billion Exosomes: Stem Cell Exosome Gel” for allogeneic use.”

FDA said the products are unapproved new drugs in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Products are also unlicensed biological products in violation of section 351(a)(1) of the Public Health Service Act (PHS Act), 42 U.S.C. § 262(a)(1). 

Based on information reviewed by FDA, including Supreme Rejuvenation websites, www.supremerejuvenation.com and www.instagram.com/supremeexosomes, the products are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease or conditions in humans and/or are intended to affect the structure or function of the body.