Import Alert Name:
"Detention Without Physical Examination of New Tobacco Products Without Required Marketing Authorization"
Reason for Alert:
In June 2009, the Family Smoking Prevention and Tobacco Control Act provided FDA with authority to regulate tobacco products by recognizing it as the primary Federal regulatory authority with respect to the manufacture, marketing, and distribution of cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. The Deeming rule, which published in the Federal Register on May 10, 2016, and took effect on August 8, 2016, extended FDA's authority to deemed tobacco products such as electronic cigarettes, cigars, hookah tobacco, and pipe tobacco, as well as their components and parts, but not their accessories.
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 issues an order finding the product to be exempt from the requirements of substantial equivalence and the required submission is made under section 905(j)(1)(A)(ii) of the FD&C Act (21 U.S.C. 387e(j)(1)(A)(ii)).
Deemed products that meet the definition of a "new tobacco product" are subject to the premarket requirements in sections 910 and 905 of the FD&C Act.
New tobacco products that do not have the required FDA marketing authorization are adulterated under section 902(6)(A) of the FD&C Act, and misbranded under section 903(a)(6) of the FD&C Act because a notice or other information respecting these products was not provided as required by section 905(j) of the FD&C Act (21 U.S.C. 387e(j)).
Guidance:
Divisions may detain, without physical examination, the tobacco products identified on the Red List of this Import Alert. If the division is not sure whether a tobacco product is the same product as one identified on the Red List, the division should consult with the Center for Tobacco Products (CTP). CTP concurrence is required to add a product to the Red List. Read More→
https://www.accessdata.fda.gov/cms_ia/importalert_1163.html
