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General Enforcement Discretion Re: Sept. 9 Premarket Tobacco Applications

Submissions of applications for marketing orders were required by Sept. 9, 2020 for new deemed tobacco products on the market as after Aug. 8, 2016. As the FDA has been developing a public list of premarket tobacco product applications (PMTA) received by the Sept. 9, 2020 deadline, they have learned about the confusion regarding the one-year review period. The FDA generally defers enforcement of premarket requirements for certain deemed new tobacco products, typically those not subject to FDA’s enforcement priorities as described in Agency guidance, on the market as of Aug. 8, 2016 for which applications were submitted by the Sept. 9 deadline for up to one year. During the year review period, if the FDA takes a negative action on an application, the product(s) must be removed from the market or risk FDA enforcement.

FDA is prioritizing enforcement against any electronic nicotine delivery system (ENDS) product that lacks a product application after Sept. 9, 2020, in addition to those described as priorities in the Apr. 2020 guidance. FDA will also make enforcement decisions on a cases-by-case basis for other deemed tobacco products that do not have premarket authorization, other than premium cigars. FDA intends to prioritize enforcement based on, among other things, the likelihood of youth use or initiation to make the most efficient use of its resources.

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