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Herrera onCIGAR LAWTMSince 2001

Topic

FDA & Premium Cigars

The deeming rule, the premium cigar definition, user fees, registration and premarket review.

On the tracker Full tracker

Premium cigar exemption from the deeming rule
In effect by court order
Cigars meeting all eight elements of the court-approved definition are outside the 2016 deeming rule. Definition confirmed on remand April 15, 2026.
Premium cigar user fee refunds
Litigation pending
Refund suits in the Court of Federal Claims. FDA's stated position is that it will not refund quarters before the 2023 order.
Registration and listing proposed rule (21 CFR Part 1108)
Proposed; comments closed Sept. 14, 2026
Would extend registration and listing to foreign establishments. Redesigned Form FDA 3741 announced Sept. 29, 2026.
Flavored cigar product standard
Withdrawn 2025
Proposed 2022, pulled from OMB review in January 2025 and listed as withdrawn in the Unified Agenda. Never finalized.
S. 3922, statutory exemption for traditional and premium cigars
In committee
Introduced Feb. 25, 2026 and referred to the Senate HELP Committee.

The briefing

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