Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS) Guidance for Industry March 2023

GUIDANCE DOCUMENT

• Docket Number: FDA-2015-D-2496
• Issued by: Center for Tobacco Products

The final rule “Premarket Tobacco Product Applications and Recordkeeping Requirements” (the final PMTA rule) published in the Federal Register of October 5, 2021 (86 FR 55300), and on November 4, 2021, it became effective. The final PMTA rule sets forth content and format requirements for PMTAs and requires manufacturers to maintain records establishing that their tobacco products are legally marketed. FDA intends to update this guidance to ensure the recommendations on preparing and submitting PMTAs for electronic nicotine delivery systems (ENDS) are consistent with the requirements of the final PMTA rule.

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).

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Additional Resources

• Applications for Premarket Review of New Tobacco Products

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

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Dockets Management
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All written comments should be identified with this document's docket number: FDA-2015-D-2496.

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