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Submit Comments on Tobacco Products

Submit Comments on Tobacco Products

Make your voice heard and be part of our ongoing effort to improve public health in the United States.

Young woman looking forward

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

Public Scientific Workshop and Request for Comment Youth Tobacco Cessation: Science and Treatment Strategies
Docket No:
Date:  May 31, 2019
Summary: FDA is announcing the following public scientific workshop entitled “Youth Tobacco Cessation: Science and Treatment Strategies.”  The purpose of the workshop is to discuss the unique challenges associated with youth tobacco addiction and cessation, and the current science regarding youth tobacco use and addiction as well as treatment strategies to support youth tobacco cessation.  

Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports; Proposed Rule
Docket No:
Date: June 17, 2019
Summary: The Food and Drug Administration (FDA) is issuing a proposed rule to establish requirements for the content and format of reports intended to establish the substantial equivalence of a tobacco product (SE Reports). The proposed rule would establish the information an SE Report must include so that FDA may make a substantial equivalence determination. In addition, the proposed rule would establish the general procedures FDA intends to follow when evaluating SE Reports, including procedures that would address communications with the applicant and the confidentiality of data in an SE Report. The proposed rule is intended to provide more clarity to applicants and support efficient and predictable reviews of SE Reports.

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
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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