This guidance is intended to assist persons submitting premarket tobacco product applications (PMTAs) for electronic nicotine delivery systems (ENDS) under section 910 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 387j). This guidance communicates FDA’s current thinking on these applications to improve the efficiency of application submission and review; however, the recommendations in this guidance are non-binding. When FDA reviews PMTAs for ENDS, it will base decisions on the obligations that arise from the FD&C Act and its implementing regulations. FDA anticipates that the experience gained through the publication of this guidance and review of PMTAs may contribute to future rulemaking and guidances.
The guidance explains, among other things:
- Products to which this guidance applies;
- When a PMTA is required under the statute and regulations;
- General procedures for review of an ENDS PMTA;
- What information the FD&C Act requires you to submit in a PMTA; and
- What information FDA recommends you submit in an ENDS PMTA to show that permitting your new tobacco product to be marketed would be appropriate for the protection of the public health (APPH).
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:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.