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Talk to a SpecialistTalk to a SpecialistNew Life Medical Services, LLC was cited for selling unapproved biological products including umbilical cord-derived products (Restor+1, Regain, Renyte), an amniotic fluid product (ReCyte/Cytosomes), and an exosome product (Rexo) without required FDA approval, violating Section 505(a) of the FD&C Act and Section 351(a)(1) of the PHS Act. The company marketed these products for therapeutic use—including diagnosis, treatment, mitigation, or prevention of disease—through their website and social media without obtaining either a Biologics License Application (BLA) approval or an approved new drug application. FDA's May 2024 inspection documented that the products were being distributed into interstate commerce without the legally required regulatory authorizations.