Tobacco Products

Comment Opportunities

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, from concerned citizens, industry, and organizations on a wide range of issues related to implementation of the Tobacco Control Act.

Submit Comments

Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”
Docket No.:
Dates: Submit comments by November 24, 2015
Summary: The Food and Drug Administration (FDA) is proposing regulations to describe the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).  This action is intended to provide direction to regulated industry and to help avoid consumer confusion.

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.

Share this page Share this page on FacebookTweet this pageEmail this page



Page Last Updated: 10/01/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.