FDA Issues Guidance on Cigarette Health Warnings Rule on Packaging and Advertising

The agency won’t enforce the ruling until December 2025.

September 13, 2024

The U.S. Food and Drug Administration announced that it is providing guidance on its enforcement policy for the “Tobacco Products; Required Warnings for Cigarette Packages and Advertisements” final rule, which established new required health warnings for cigarette packages and advertisements.

FDA stated that the agency intends to exercise enforcement discretion and generally not enforce requirements of the final rule for a timeframe of 15 months, or until December 12, 2025.

Additionally, with products manufactured before December 12, 2025, the FDA also intends to exercise enforcement discretion and generally not enforce the rule’s requirements for these products for an additional 30-day period, or until January 12, 2026.

The final rule requires the industry to submit a plan and obtain FDA approval for the random and equal display and distribution of required warnings on cigarette packages, as well as the quarterly rotation of required warnings in cigarette advertisements. The agency’s guidance recommends that entities that do not already have approved cigarette health warning plans submit such plans as soon as possible, but in any event within five months, or by February 10, 2025. Entities that previously submitted cigarette plans to the FDA do not need to resubmit their plans unless they wish to make changes.

The public can provide comment on the guidance in the docket at regulations.gov.

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