FDA WARNING_LETTER - Supreme Rejuvenation, LLC - May 20, 2025

The FDA issued a Warning Letter to Aracely Cabrera of Supreme Rejuvenation on May 5, 2025, following a review of their websites, www.supremerejuvenation.com and www.instagram.com/supremeexosomes. The company 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.

The FDA determined these products are unapproved new drugs, violating section 505(a) of the FD&C Act, and unlicensed biological products, violating section 351(a)(1) of the PHS Act. The products are marketed with claims for treating various conditions, including hair growth, wound care, Traumatic Brain Injury, joint/ligament repair, Botox alternatives, IV infusions, scar rejuvenation, fibromyalgia, and reducing dependency on insulin injections for diabetic patients. They also claim to improve skin texture, reduce wrinkles, stimulate hair growth, have neuro-protective effects, promote nerve regeneration, improve symptoms in COVID-19 long-haulers and dementia, reduce inflammation, and promote cartilage regeneration for arthritis.

The FDA states that a valid biologics license or an approved new drug application is required for these products, neither of which Supreme Rejuvenation possesses. While