The Lacuna Project

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Exhibit 1300

Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications: Considerations Related to Youth Risk (draft guidance)

Exhibit 1300 ยท Agency guidance

Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications: Considerations Related to Youth Risk (draft guidance)

Where the totality of evidence demonstrates comparatively lower youth initiation risk, FDA may consider a correspondingly lower magnitude of incremental adult benefit necessary to support an APPH determination relative to flavors with higher youth appeal.

Draft guidance, nonbinding, for comment. Sets a graduated, risk-proportionate evaluation of flavored ENDS applications and records that FDA has issued marketing granted orders for menthol-flavored ENDS.

Source
U.S. Food and Drug Administration, Center for Tobacco Products
Date
March 2026
Quoted from
p. 14, section III
Grade
Primary record
Document
https://www.fda.gov/media/191455/download
Accessed
2026-11-10
Cited by
Findings citing this exhibit
Note
sha256 151e01579dd66a0a8cb66e6a2dcc71ce8ec08e9da85e95e95f5b8f90eaa6a10d. Federal Register notice and docket not retrieved.

Cited by

Finding MED-6.10
Primary record FDA authorized four Glas e-cigarette pods on 5 May 2026, which it described as its first authorizations of non-tobacco, non-menthol e-cigarettes. A March 2026 draft guidance on flavored e-cigarette applications states that where the evidence shows comparatively lower youth initiation risk, FDA may consider a correspondingly lower magnitude of adult benefit necessary to support authorization.