Clarification on General Enforcement Discretion Related to Sept. 9 Premarket Tobacco Applications



Per a court’s order, for new deemed tobacco products on the market as of Aug. 8, 2016, submissions of applications for marketing orders were required by Sept. 9, 2020. As part of FDA’s outreach to companies to develop a public list of premarket tobacco product applications (PMTA) received by the Sept. 9, 2020 deadline, we have learned that there may be some confusion about the one-year review period and FDA’s exercise of enforcement discretion for certain tobacco products that are the subject of a pending application. To clarify, per the court order, FDA may (and generally intends to) defer enforcement of premarket requirements for certain deemed new tobacco products (i.e., 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, or until Sept. 9, 2021. If a negative action is taken by the FDA on an application during that year, the product(s) must be removed from the market or risk FDA enforcement.

While processing PMTA submissions received by the Sept. 9, 2020 deadline, FDA continues to enforce the law. As previously stated, 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. Additionally, for other deemed tobacco products that do not have premarket authorization, other than premium cigars, FDA will make enforcement decisions on a case-by-case basis and 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.