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Evolutionary Biologics Inc. was cited for selling three unapproved biologic products—EXO RNA™ (exosome product), EVO JEL™ (umbilical cord-derived product), and EVO HYBRID™ (multi-tissue cellular product)—without FDA approval or licensure. The company's website made explicit disease claims for these products, including statements that EVO JEL™ could repair and regenerate tissue, reduce inflammation, and serve as a non-surgical orthopedic treatment option, thereby establishing them as drugs and unlicensed biologics under FDA jurisdiction. The FDA determined that marketing and distributing these products in interstate commerce violated the Federal Food, Drug, and Cosmetic Act by introducing unapproved new drugs and unlicensed biological products into U.S. commerce.