FDA Guidance: Flavored ENDS Premarket Applications

FDA Guidance Documents

Published March 9th, 2026

Detected March 10th, 2026

Summary

The FDA has issued guidance to assist with premarket tobacco product applications (PMTAs) for flavored electronic nicotine delivery systems (ENDS). This guidance, intended to improve submission and review efficiency, focuses on considerations related to youth risk. The document is non-binding and aims to inform potential future rulemaking.

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What changed

The FDA's Center for Tobacco Products has released a non-binding guidance document (Docket Number: FDA-2026-D-1817) to assist manufacturers in submitting premarket tobacco product applications (PMTAs) for flavored electronic nicotine delivery systems (ENDS). The guidance focuses on considerations related to youth risk and aims to streamline the application submission and review process. While non-binding, the FDA states that experience gained from this guidance and PMTA reviews may inform future rulemaking.

Regulated entities, specifically manufacturers of ENDS, should review this guidance to understand the FDA's current thinking on PMTA submissions for flavored products. Although the guidance is non-binding, adherence to its recommendations may facilitate a smoother review process. Comments on the guidance can be submitted at any time via the regulations.gov portal or by mail, referencing the docket number. No specific compliance deadline is provided, as the guidance is intended to inform current and future submissions.

What to do next

Review FDA guidance on flavored ENDS PMTAs for youth risk considerations.
Incorporate recommendations into current or future PMTA submissions for flavored ENDS.
Submit comments to Docket Number FDA-2026-D-1817 if desired.

Source document (simplified)

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Guidance Documents

Docket Number: FDA-2026-D-1817 Issued by: Guidance Issuing Office Center for Tobacco Products 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 implementation of this guidance, if finalized, and review of PMTAs may contribute to future rulemaking and guidance.