New Tobacco Products, Other Than ENDS, Without Required Marketing Authorization

Why FDA issued it

Note: The revision of this Import Alert (IA) dated 12/20/2024 updates the guidance section and agency contacts. Changes to the import alert are bracketed by asterisks (***). The Federal Food, Drug, and Cosmetic Act (FD&C Act) generally requires premarket review for any "new tobacco product," which means any tobacco product that was not commercially marketed in the United States as of February 15, 2007, or any modification of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007 (section 910(a) of the FD&C Act; 21 U.S.C. 387j(a)). A marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. 387j(c)(1)(A)(i)) is required for a new tobacco product unless (1) FDA issues an order finding the product substantially equivalent to a predicate tobacco product (section 910(a)(2)(A) of the FD&C Act) or (2) FDA

Quoted from the “Reason for Alert” section of the FDA page for 98-06, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.