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Allovate Therapeutics, LLC was cited for marketing Allerdent, an allergenic toothpaste product, as an unapproved new drug and unlicensed biological product without required FDA approval under sections 505(a) of the FD&C Act and 351(a)(1) of the PHS Act. The company promoted the product directly to consumers through marketing materials claiming it could deliver oral mucosal immunotherapy for allergy treatment while brushing teeth daily, without obtaining the necessary Biologics License Application (BLA) approval from the Center for Biologics Evaluation and Research (CBER). The product was being distributed into interstate commerce in violation of section 301(d) of the FD&C Act.