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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

Tobacco Products; Required Warnings for Cigarette Packages and Advertisements
Docket No: FDA-2019-N-3065
Comment Period End Date: October 15, 2019
Summary: The Food and Drug Administration is issuing a proposed rule to establish new required cigarette health warnings for cigarette packages and advertisements. The proposed rule would implement a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) that requires FDA to issue regulations requiring color graphics depicting the negative health consequences of smoking to accompany new textual warning statements. The Tobacco Control Act amends the Federal Cigarette Labeling and Advertising Act (FCLAA) of 1965 to require each cigarette package and advertisement to bear one of the new required warnings. This proposed rule, once finalized, would specify the color graphics that must accompany the new textual warning statements. FDA is proposing to take this action to promote greater public understanding of the negative health consequences of cigarette smoking.

Harmful and Potentially Harmful Constituents in Tobacco Products; Established List; Proposed Additions; Request for Comments 
Docket No: FDA-2012-N-0143
Comment Period End Date: October 4, 2019
Summary: The Food and Drug Administration is requesting comments, including scientific and other information, concerning whether additional harmful and potentially harmful constituents (HPHCs) in tobacco products and tobacco smoke should be added to the Agency’s established list of tobacco HPHCs (the HPHC established list).  This information will assist the Agency in determining whether any or all of the 19 constituents listed in this document should be added to the HPHC established list.

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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