FDA Halts Packaging Enforcement for 15 Months

The U.S. Food and Drug Administration has provided guidance on the “Tobacco Products; Required Warnings for Cigarette Packages and Advertisements” final rule that established new required health warnings for cigarette packages and advertisements.

Specifically, the FDA has issued guidance to the tobacco industry that describes the agency’s enforcement policy for the final rule. The final rule was issued in March 2020 and was challenged in the U.S. District Court for the Eastern District of Texas. In December 2022, the District Court struck down the rule.

The government appealed the decision and in May of 2024, the U.S. Court of Appeals for the 5th Circuit reversed the District Court’s decision. This reinstated the final rule, causing the rule to now be in effect. The plaintiffs’ petition for a review by the Supreme Court review is pending.

“The new guidance for the agency’s enforcement policy states that the FDA intends to exercise enforcement discretion and generally not enforce requirements of the final rule for 15 months, or until December 12, 2025,” an FDA release states. “With respect to 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 FDA chose 15 months to provide an orderly transition period; this aligns with the 15-month compliance period originally contemplated by the Family Smoking Prevention and Tobacco Control Act, before that timing was disrupted by litigation.

The final rule also 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 and 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.