FDA to Delay Enforcement of Required Warnings on Cigarette Packages
The FDA is delaying enforcement of its final rule requiring warnings for cigarette packages and advertisements for tobacco products so that companies have time to implement the rule's requirements after the rule had previously been on hold due to litigation, it said in a Federal Register notice.
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The FDA does not expect to enforce the requirements of the final rule for the next 455 days, which translates to sometime around Dec. 12, 2025. The agency also will not enforce the requirements for products manufactured before the December 2025 date until around Jan. 12, 2026, or 18 months from now.
The FDA also recommends that entities submit cigarette plans as soon as possible but by around March 12, 2025, or five months from now.
"FDA recognizes that some manufacturers, distributors, and retailers already may have begun to prepare to implement the rule’s requirements. For instance, some manufacturers, distributors, and retailers already have submitted and obtained approval of cigarette plans," the agency said in the notice. "Even so, FDA recognizes that entities may need time to implement the rule’s requirements." In the guidance, FDA sets out its enforcement policy for the final rule.
The FDA also is offering guidance in “Enforcement Policy for Required Warnings for Cigarette Packages and Advertisements,” setting out the enforcement policy for the final rule, which establishes new required cigarette health warnings for cigarette packages and advertisements.