Dietary supplements and bulk dietary ingredients that are or contain new dietary ingredients

Why FDA issued it

Note: The revision of this Import Alert (IA) dated 09/08/2023 updates the guidance section including the contact information and PAC. Changes to the import alert are bracketed by asterisks (***). This Import Alert (IA) has been developed for bulk dietary ingredients and dietary supplements that have been imported or offered for import into the United States that are or contain ingredients that FDA has determined to be adulterated under section 402(f)(1)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. � 342(f)(1)(B)]. A "new dietary ingredient" (NDI) is defined as a dietary ingredient that was not marketed in the United States before October 15, 1994, (Section 413(d) of the FD&C Act [21 U.S.C. � 350b(d)]). Under section 402(f)(1)(B) of the FD&C Act [21 U.S.C. � 342(f)(1)(B)], a food shall be deemed to be adulterated if it is a dietary supplement or contains a dietary

Quoted from the “Reason for Alert” section of the FDA page for 54-18, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.