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  1. Products, Guidance & Regulations

Submit Comments on Tobacco Products

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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.

We solicit 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.

Submit Comments

Request for Nominations for Voting Members on the Tobacco Products Scientific Advisory Committee  
Docket No: FDA-2018-N-3263
Submit Nominations By: December 16, 2019
Summary: The Food and Drug Administration is requesting nominations for members to serve on the Tobacco Products Scientific Advisory Committee, in the Center for Tobacco Products. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.

Request for Nominations of a Nonvoting Representative of the Interest of the Tobacco Manufacturing Industry on the Tobacco Products Scientific Advisory Committee
Docket No: FDA-2018-N-3263
Submit Nominations By: November 18, 2019
Summary: The Food and Drug Administration is requesting nominations for a nonvoting representative of the interests of the tobacco manufacturing industry to serve on the Tobacco Products Scientific Advisory Committee, in the Center for Tobacco Products.  FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore encourages nominations of appropriately qualified candidates from these groups.  A nominee may either be self-nominated or nominated by an organization.

Premarket Tobacco Product Applications and Recordkeeping Requirements
Docket No: FDA-2019-N-2854
Comment Period End Date: November 25, 2019
Summary: The Food and Drug Administration (FDA) is issuing a proposed rule that would set forth requirements for premarket tobacco product applications (PMTAs) and would require manufacturers to maintain records establishing that their tobacco products are legally marketed. The proposed rule would help to ensure that PMTAs contain sufficient information for FDA to determine whether a marketing order should be issued for a new tobacco product, including detailed information regarding the physical aspects of a tobacco product, as well as full reports of information to demonstrate the scope of, and details regarding, investigations that may show the potential health risks of the product. The proposed rule would codify the general procedures FDA would follow when evaluating PMTAs, including application acceptance, application filing, and inspections, and would also create postmarket reporting requirements for applicants that receive marketing orders. The proposed rule would allow for the submission of PMTAs in alternative formats in certain instances to reduce the burden of submitting a PMTA for modifications to a product that previously received a PMTA marketing order or resubmitting a PMTA to address deficiencies specified in a no marketing order. The proposed rule would also require tobacco product manufacturers to keep records regarding the legal marketing of certain tobacco products without a PMTA, such as documents showing that a tobacco product is not required to undergo premarket review or has received premarket authorization.

Modified Risk Tobacco Product Applications for VLN™ King, VLN™ Menthol King, Combusted, Filtered Cigarettes, Submitted by 22nd Century Group Inc.
Docket No: FDA-2019-N-0994
Comment Period End Date: Currently no deadline for public comments
Summary: The FDA is announcing the availability for public comment of modified risk tobacco product applications for VLNTM King and VLNTM Menthol King, combusted, filtered cigarettes, submitted by 22nd Century Group Inc. FDA will post the application materials on a rolling basis as they are redacted in accordance with applicable laws. 

Modified Risk Tobacco Product Applications: Application for Copenhagen Snuff Fine Cut submitted by U.S. Smokeless Tobacco Company; Availability
Docket No: FDA‐2018‐N-3261
Comment Period End Date: Currently no deadline for public comments
Summary: The FDA is announcing the availability for public comment of a modified risk tobacco product (MRTP) application for Copenhagen Snuff Fine Cut, a loose moist snuff tobacco product submitted by U.S. Smokeless Tobacco Co. LLC. FDA will post the application materials on a rolling basis as they are redacted in accordance with applicable laws.


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
  • Read more tips for submitting effective comments on the regulations.gov website.

Your role in shaping tobacco regulation

Our regulatory process generally follows these steps:

  1. Rule/Regulation Proposed
    We publish a proposed rule in the Federal Register.
  2. Public Comments Considered
    Our proposals generally have a 60-90 day review period.
  3. Final Rule Issued
    After considering all comments, we issue a final rule.
  4. Compliance with New Rule Enforced
    We must ensure that retailers and businesses comply with the regulation.

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