Tobacco Products

Applications for Premarket Review of New 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This draft guidance is intended to assist persons submitting applications for new tobacco products under section 910 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act; 21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 This draft guidance explains, among other things: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. 

 

Contact FDA

1-877-287-1373
(9am EST-4pm EST)
Tobacco

For General Inquiries:
AskCTP@fda.hhs.gov


Center for Tobacco Products
Food and Drug Administration
10903 New Hampshire Avenue
Document Control Center

Building 71, Room G335
Silver Spring, MD 20993-002


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