FDA Seeks Feedback on Scary Cigarette Pack Warnings
Published Date: 12/19/2025
Notice
Summary
The FDA wants your thoughts on how they collect info about cigarette warning labels on packs and ads. This affects tobacco companies who must follow these rules and helps keep smokers informed. You’ve got until February 17, 2026, to share your comments—no cost to you, just your voice!
Analyzed Economic Effects
5 provisions identified: 2 benefits, 3 costs, 0 mixed.
Pre‑Approval Cigarette Plan Requirement
If you are a tobacco product manufacturer, you must submit a cigarette plan to FDA and get FDA approval before displaying or distributing cigarette packages or advertisements. Plans must show how required warnings will be randomly and equally displayed on packaging and rotated quarterly in advertising.
Time Burden for Plan Submissions
FDA estimates up to 17 entities will submit initial cigarette plans each year, taking an average of 150 hours per initial plan, and about 8 supplements per year at 75 hours each. FDA estimates total annual reporting hours of 3,150 and a total annual burden (reporting + recordkeeping) of 3,981 hours.
Recordkeeping and 4‑Year Retention Rule
Manufacturers must keep a copy of the FDA‑approved cigarette plan while it is in effect and for at least 4 years after it was last in effect, and that copy must be available for FDA inspection and copying. FDA estimates 51 recordkeepers will keep about 77 records at 3 hours per record for 231 hours annually.
Public Comment Opportunity Deadline
You can submit electronic or written comments on this FDA information‑collection notice to docket FDA‑2025‑N‑6076 by February 17, 2026, using https://www.regulations.gov or by mail; there is no fee to comment. Comments received by that date will be placed in the public docket.
Mandatory Warnings on Packs and Ads
Cigarette packages and advertisements must bear one of 11 textual warning statements accompanied by color graphics depicting the negative health consequences of smoking; the final rule implementing this was published March 18, 2020, with an effective date of June 18, 2021. These warnings are required under the Federal Cigarette Labeling and Advertising Act and FDA's implementing regulation.
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Key Dates
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