Dietary supplement products from firms that have not met dietary supplement gmp

Why FDA issued it

Note: The revision of this Import Alert (IA) dated 10/26/2023 updates the IA name, reason for alert, guidance section including agency contacts, charge code language, and product description section. Changes to the import alert are bracketed by asterisks (***). Section 402(g)(2) of the Federal Food, Drug, and Cosmetic Act provides, in part, that the Secretary of Health and Human Services may, by regulation, prescribe good manufacturing practices (GMP) for dietary supplements. On June 25, 2007, FDA published a final rule setting out the GMP requirements for dietary supplements in the Federal Register ***[72 FR 34752].*** The final rule created Title 21, part 111 (21 CFR Part 111), which established the minimum current GMPs necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement. Per the regulati

Quoted from the “Reason for Alert” section of the FDA page for 54-14, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.