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Submit Comments on Tobacco Regulatory Activities

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Submit comments on Tobacco Products

Make your voice heard and be part of our ongoing effort to improve public health in the United States.

FDA gathers information and comments, announced in the Federal Register and posted in dockets on Regulations.gov, from concerned citizens, industry, and organizations on a wide range of issues related to implementation of the Tobacco Control Act.

What Topics Are Currently Open for Comments?

Roundtable on Premarket Tobacco Application Submissions for Electronic Nicotine Delivery Systems Products; Notice of Meeting; Establishment of a Public Docket; Request for Comments 
Docket No: FDA-2025-N-7022
Date: February 3, 2026 (for consideration in the meeting); March. 12 (for any comment) 
Note: The comment period opens Dec. 29, 2025.
Summary: 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.

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Modified Risk Tobacco Product Applications: Applications for ZYN Nicotine Pouch Products Submitted by Swedish Match USA, Inc. 
Docket No: FDA-2025-N-0835-0001
Date: March 4, 2026
Summary: FDA is announcing an opportunity to provide public comment on modified risk tobacco product applications (MRTPAs) submitted by Swedish Match USA, Inc. for ZYN nicotine pouch products containing nicotine derived from tobacco.

FDA posted the application materials on a rolling basis as they were redacted in accordance with applicable laws. All of the materials are currently available on FDA’s website. 

Did You Know?

You can comment on any Guidance document at any time. However, to ensure that the agency considers a comment on a draft version of a guidance before it begins work to finalize it, submit comments through Regulations.gov or in writing to the agency by the draft’s closing date.

What Makes an Effective and Useful Comment?

Our decisions are based on science and law. We look for logic, good science, and other evidence in the comments we evaluate.

  • Provide a clear statement of whether you support or oppose the proposed rule or guidance.
  • Include any of the following that support your position:
    • Data
    • Research
    • Analysis
  • Tips for submitting effective comments are on the regulations.gov website.

Information on Planned Upcoming Regulations

The FDA's Planned Regulations on the President’s Unified Agenda provides federal agencies with the opportunity to update the American public on our government’s regulatory priorities.

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