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Draft Guidance for Industry Applications for Premarket Review of New Tobacco Products
This draft guidance is intended to assist persons submitting applications for new tobacco products under section 910 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act; 21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 This draft guidance explains, among other things: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