Regulated tobacco products for non payment of user fee

Why FDA issued it

Note: The revision of this Import Alert (IA) dated 12/1/2023 updates the guidance section including agency contacts. Changes to the import alert are bracketed by asterisks (***). Section 919(a) of the FD&C Act requires FDA to, in accordance with section 919, "assess user fees on, and collect such fees from, each manufacturer and importer of tobacco products subject to" Chapter IX of the FD&C Act. Under section 902(4) of the FD&C Act, a tobacco product is deemed adulterated if the manufacturer or the importer of the tobacco product fails to pay a user fee assessed to such manufacturer or importer pursuant to section 919 by the date specified in section 919 or by the 30th day after final agency action on a resolution of any dispute as to the amount of such fee. A tobacco product that is, or appears to be, adulterated is subject to refusal of admission under Section 801(a)(3) of the FD&C Ac

Quoted from the “Reason for Alert” section of the FDA page for 98-05, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.