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Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications-Considerations Related to Youth Risk; Draft Guidance for Industry; Availability
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Summary (from the Federal Register abstract)
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled "Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications--Considerations Related to Youth Risk; Draft Guidance for Industry." The draft document describes FDA's current thinking and provides recommendations regarding evidentiary considerations for premarket tobacco product applications (PMTAs) for flavored ENDS submitted under section 910 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
- Document type
- Notice
- Federal Register document number
- 2026-04732
- Published
- Mar 11, 2026
- Action
- Notice of availability; request for comment.
- Docket
- FDA-2026-D-1817
- Comments posted on Regulations.gov (at last check)
- 0
- DATES section (from the document)
- Submit either electronic or written comments on the draft guidance by May 11, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
- Topics (auto-tagged)
- Tobacco
Source: Federal Register API, document 2026-04732. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.