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FDA Issues Warning to Evolutionary Biologics Over Unapproved Drug and Biologics Sales
The U.S. FDA has warned Evolutionary Biologics for marketing unapproved drugs and unlicensed biological products, including EXO RNA™, EVO JEL™, and EVO HYBRID™. These products, derived from exosomes and human tissues such as umbilical cord and placental material, are promoted with health claims suggesting treatment for joint disease, neurodegenerative conditions, and inflammation—classifying them as drugs and biological products under U.S. law. None are approved or licensed.
The FDA also flagged violations of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) regulations, citing non-homologous uses and minimal manipulation. One exosome-based product was of special concern due to past safety warnings.
The agency ordered the company to cease distribution and respond within 15 business days. Legal action may follow if corrective measures are not taken. The FDA is also reviewing other similar products listed on the company’s websites. Full details are available in the official Warning Letter.
04-04-2025