Roundtable on Premarket Tobacco Application Submissions for Electronic Nicotine Delivery Systems Products; Notice of Meeting; Establishment of a Public Docket; Request for Comments

Issuing agencies

Abstract

The Food and Drug Administration (FDA, the Agency, or we) is announcing a roundtable discussion with small tobacco product manufacturers to solicit input on premarket tobacco product application (PMTA) submissions for electronic nicotine delivery systems (ENDS) products. The topics to be discussed will include certain components of PMTAs such as product characterization, manufacturing controls, pharmacological profile (e.g., pharmacokinetic studies), studies of adult benefit (e.g., longitudinal cohort/randomized controlled trial (RCT) studies), and toxicological profile (e.g., estimated lifetime cancer risk). The purpose of the roundtable is to provide manufacturers an opportunity to share their experience with, and other opinions about, the premarket application process. This notice provides information on meeting participation and selection. FDA is establishing a docket for public comments related to the roundtable meeting.