�Detention Without Physical Examination of Unlicensed Biological Products Promoted in the U.S.�

Why FDA issued it

Unlicensed biological products present public health and safety risks because they have not been reviewed by FDA for safety, purity, and potency. Without FDA review, there is no way to determine if these biological products are safe, pure, and potent, and whether these biological products are manufactured, processed, packed, or held in a way that assures that the products continue to be safe, pure and potent. Unlicensed biological products have resulted in patient harm, and the agency works to protect patients from the safety risks posed by these products. Section 351(i) of Public Health Service Act (PHS Act), U.S.C. 262(i), defines �biological product� as a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein, or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compo

Quoted from the “Reason for Alert” section of the FDA page for 57-22, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.