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GUIDANCE DOCUMENT

Applications for Premarket Review of New Tobacco Products June 2019

Draft

Not for implementation. Contains non-binding recommendations.

Applications for Premarket Review of New Tobacco Products

Issued by:
Guidance Issuing Office
Center for Tobacco Products
September 2011

This draft guidance is intended to assist persons submitting applications for new tobacco products under section 910 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act; 21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 This draft guidance explains, among other things: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 on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

Questions?

Contact Point
Contact CTP
Document Control Center
Center for Tobacco Products
Food and Drug Administration
10903 New Hampshire Ave WO71-G335
Silver Spring, MD 20993-002
AskCTP@fda.hhs.gov
(877) 287-1373 (9am EST-4pm EST)