FDA GUIDANCE · DRAFTMarch 11, 2026

Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk: Draft Guidance for Industry

What this record is not

Guidance details are published by the U.S. FDA; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA. The authoritative text is on fda.gov.

Status

Draft

Issue date

March 11, 2026

This is a draft guidance — issued for comment and not for implementation. It signals FDA’s current thinking and the direction of a requirement, but the final document may change. Track the comment window on the FDA page.

CHECKING ACCESS

Checking your access…

READ THE FULL GUIDANCE

The complete guidance document — every recommendation and its scope — is published by the FDA. SPEQ surfaces and indexes it for reference; the authoritative text lives on fda.gov.

View on fda.gov →

PUT THIS GUIDANCE TO WORK

Decode the standardsThe requirements this guidance interprets →Assess your quality systemBaseline against 12 GxP domains in 10 minutes →All FDA guidanceBrowse the live guidance feed →