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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Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems; Draft Guidance for Industry
Docket No.: FDA-2015-D-2496-0001
Dates: Submit comments by July 11, 2016
Summary: The FDA is announcing the availability of a draft guidance for industry entitled “Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems.” Given the relatively new presence of electronic nicotine delivery systems (ENDS) on the U.S. market and FDA's final rule deeming these products to be subject to the tobacco product authorities in the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA expects to receive premarket tobacco product application (PMTA) submissions from manufacturers of ENDS. This draft guidance is intended to assist persons with their PMTA submissions for ENDS products.

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: 05/12/2016
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