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  1. Products, Guidance & Regulations

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?

Modified Risk Tobacco Product Applications: Applications for ZYN Nicotine Pouch Products Submitted by Swedish Match USA, Inc. 
Docket No: FDA-2025-N-0835
Date: Currently no deadline for public comments
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.

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Modified Risk Tobacco Product Renewal Applications: Applications for IQOS Products submitted by Philip Morris Products S.A. 
Docket No: FDA-2021-N-0408 (IQOS 3.0 System Holder and Charger)
Docket No: FDA-2017-D-3001 (IQOS 2.4 System Holder and Charger and Marlboro HeatSticks products)
Date: December 8, 2025
Summary: FDA established the closing date of December 8, 2025, for the public comment period, 30 days from the date of notice, on the modified risk tobacco product (MRTP) renewal applications submitted by Philip Morris Products S.A. for the following products: 

  • IQOS 2.4 System Holder and Charger
  • IQOS 3.0 System Holder and Charger
  • Marlboro Amber HeatSticks (formerly named Marlboro HeatSticks)
  • Marlboro Green Menthol HeatSticks (formerly named Marlboro Smooth Menthol HeatSticks) 
  • Marlboro Blue Menthol HeatSticks (formerly named Marlboro Fresh Menthol HeatSticks)

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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