The Food and Drug Administration has released guidance on the agency’s graphic cigarette health warning rule. The agency said it will not enforce the final rule until Dec. 12, 2025.
The “Tobacco Products; Required Warnings for Cigarette Packages and Advertisements” final rule requires cigarette manufacturers to rotate 11 health warnings on cigarette packs, which consist of textual statements and color graphics depicting the negative health consequences of cigarette smoking. Manufacturers, wholesalers and retailers that create or produce their own cigarette advertising were required to submit a cigarette health warning rotational plan to the FDA.
The final rule was issued in March 2020, but it has been challenged several times. The U.S. District Court of the Eastern District of Texas struck down the rule in December 2022. The government appealed the decision though, and in May of 2024 the U.S. Court of Appeals for the Fifth Circuit reversed the district court’s decision. This reinstated the final rule, the FDA said, causing the rule to now be in effect.
The plaintiffs’ petition for Supreme Court review is pending, the FDA said.
The new guidance provides the industry with the FDA’s enforcement policy, which states that the FDA intends to exercise enforcement discretion and “generally not enforce requirements of the final rule for a timeframe of 15 months, or until Dec. 12, 2025,” the agency said.
For products manufactured before Dec. 12, 2025, the FDA said it intends to exercise enforcement discretion and “generally not enforce the rule’s requirements for these products for an additional 30-day period, or until Jan. 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,” it said.
The final rule also requires manufacturers, wholesalers and retailers that create or produce their own cigarette advertising to submit a plan to the FDA on the quarterly rotation of required warnings in cigarette advertisements. Plans should be submitted as soon as possible, “but in any event within five months, or by Feb. 10, 2025,” the agency said.
The public can comment on the guidance at regulations.gov.
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