Exhibit 1301

FDA Expands Market Access, Authorizes New ENDS Products

Exhibit 1301 · Agency press release

FDA Expands Market Access, Authorizes New ENDS Products

FDA states it authorized four Glas ENDS pods (Classic Menthol, Fresh Menthol, Gold, Sapphire) under the premarket tobacco product pathway and describes it as its first authorization of non-tobacco and non-menthol ENDS.

Source: U.S. Food and Drug Administration
Date: 5 May 2026
Grade: Primary record
Document: https://www.fda.gov/news-events/press-announcements/fda-expands-market-access-authorizes-new-ends-products
Accessed: 2026-11-10
Cited by: Findings citing this exhibit
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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 A March 2026 draft guidance on flavored e-cigarette applications states that where the evidence shows comparatively lower youth initiation risk, FDA may consider a correspondingly lower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.