# 2025-23851: FDA Roundtable: E-Cigs Get Bureaucratic Ear

2025-23851, Roundtable on Premarket Tobacco Application Submissions for Electronic Nicotine Delivery Systems Products; Notice of Meeting; Establishment of a Public Docket; Request for Comments, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2025-12-29, effective 2026-02-10 (as of 2026-06-08).

- Canonical: https://policyrisk.com/federal-register/2025-23851
- As of: 2026-06-08
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-23851
- Title: Roundtable on Premarket Tobacco Application Submissions for Electronic Nicotine Delivery Systems Products; Notice of Meeting; Establishment of a Public Docket; Request for Comments
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 60715
- Published: 2025-12-29
- Effective: 2026-02-10
- Comments close: 2025-12-29
- Significant: no
- Touches household money: no
- Regulation identifier numbers: none
- Last updated: 2026-06-08

## In one line

FDA Roundtable: E-Cigs Get Bureaucratic Ear

## Summary

The FDA is hosting a roundtable on February 10, 2026, to hear from small makers of electronic nicotine delivery systems (like e-cigarettes) about their experiences with the premarket approval process. They want to improve how these products are reviewed, focusing on safety, manufacturing, and health effects. If you’re involved in making or selling these products, now’s the time to share your thoughts and help shape future rules!

## 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.

## Effects PRIA read

- FDA Roundtable for Small ENDS Makers: benefit, medium. The FDA is holding a roundtable on February 10, 2026 to hear from small electronic nicotine delivery systems (ENDS) manufacturers about PMTA (premarket tobacco product application) submissions. Topics include product characterization, manufacturing controls, pharmacological profile (e.g., pharmacok…
- Limited Panel Slots and Eligibility Rules: cost, low. Registration to participate as a panelist is open to "small tobacco product manufacturers" (those with fewer than 350 employees) and is limited to 30 participants representing companies that have previously submitted an ENDS PMTA, including pending PMTAs. Registration is free and panelist registrat…
- Public Docket, Comment Deadlines, and Remote Access: benefit, low. FDA established a public docket (Docket No. FDA-2025-N-7022) beginning December 29, 2025 for comments on the roundtable topics; electronic comments to be considered for the roundtable must be submitted by February 3, 2026, and all other electronic comments must be submitted by March 12, 2026 (regul…

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## Sources
- [2025-23851 on federalregister.gov](https://www.federalregister.gov/documents/2025/12/29/2025-23851/roundtable-on-premarket-tobacco-application-submissions-for-electronic-nicotine-delivery-systems)
- [2025-23851 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-12-29/pdf/2025-23851.pdf)

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Source: PRIA, https://policyrisk.com/federal-register/2025-23851 (as of 2026-06-08).