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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?

Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments
Docket No: FDA-2024-N-3654
Comment Period Open Date: September 20, 2024
Comment Period End Date: December 4, 2024
Summary: The Food and Drug Administration (FDA, Agency, we) is issuing a direct final rule amending the Scope section of our regulation that provides for a regulatory hearing before the Agency in order to clarify when such hearings are available. We are revising the list of statutory provisions enumerated in the Scope section of the regulation by adding one statutory reference and removing a different statutory reference.

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Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Certain Tobacco Products
Docket No: FDA-2024-N-1111
Comment Period Open Date: August 16, 2024
Comment Period End Date: October 15, 2024
Summary: The Food and Drug Administration (FDA), with the Department of the Treasury’s concurrence, proposes amending its regulations to require that the Submission Tracking Number (STN) for Electronic Nicotine Delivery System (ENDS) tobacco products that are being imported or offered for import be submitted in the Automated Commercial Environment (ACE) or any other electronic data interchange system authorized by U.S. Customs and Border Protection, at the time of entry.

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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: Currently no deadline for public comments
Summary: FDA is announcing the availability for public comment of 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 will post the application materials on a rolling basis as they are redacted in accordance with applicable laws.

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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