Tobacco Products

Comment Opportunities

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

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We solicit information and comments, announced in the Federal Register and posted in dockets on, from concerned citizens, industry, and organizations on a wide range of issues related to implementation of the Tobacco Control Act.

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Submission of Warning Plans for Cigars

Docket No.: FDA-2016-D-2495
Dates: Submit comments by September 29, 2016
Summary: The FDA is announcing the availability of a draft guidance for industry entitled “Submission of Warning Plans for Cigars.” The draft guidance, when finalized, will help those involved in the manufacture, distribution, and sale of cigars in the United States understand the new cigar warning plan requirements under FDA's final rule deeming these products to be subject to the tobacco product authorities in FD&C Act. The draft guidance reiterates the required health warning statements and the requirements for random display and distribution that should be provided in cigar warning plans, and, when finalized, will help persons determine who should submit a warning plan, when a plan must be submitted, and what information should be included when submitting a plan.

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 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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Page Last Updated: 09/07/2016
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