U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Applications for Premarket Review of New Tobacco Products
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Applications for Premarket Review of New Tobacco Products Draft Guidance for Industry September 2011

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2011-D-0212
Issued by:
Guidance Issuing Office
Center for Tobacco Products

This draft guidance is intended to assist persons submitting applications for new tobacco products under section 910 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act; 21 U.S.C. 301 et seq.), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Public Law 111-31). This draft guidance explains, among other things:

  • Who may submit a new tobacco product application under section 910 of the FD&C Act (21 U.S.C. 387j);
  • When to submit a new tobacco product application;
  • How to submit a new tobacco product application;
  • What information the FD&C Act requires you to submit in a new tobacco product application; and
  • What information FDA recommends you submit in a new tobacco product application.

Additional Resources

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2011-D-0212.

Questions?

Back to Top