1. Home
  2. Tobacco Products
  3. Products, Guidance & Regulations
  4. Submit Comments on Tobacco Regulatory Activities
  1. Products, Guidance & Regulations

Submit Comments on Tobacco Regulatory Activities

On this page:

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?

Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk
Docket No: FDA-2026-D-1817
Date: May 11, 2026
Summary: This guidance is intended to assist persons submitting premarket tobacco product applications (PMTAs) for electronic nicotine delivery systems (ENDS) under section 910 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 387j). This guidance communicates FDA’s current thinking on these applications to improve the efficiency of application submission and review; however, the recommendations in this guidance are non-binding. When FDA reviews PMTAs for ENDS, it will base decisions on the obligations that arise from the FD&C Act and its implementing regulations. FDA anticipates that the experience gained through the implementation of this guidance, if finalized, and review of PMTAs may contribute to future rulemaking and guidance.

 

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.

Back to Top