US FDA re-imposes new health warning rules on cigarette packaging, with compliance deadline until 2025

US FDA re-imposes new health warning rules on cigarette packaging, with compliance deadline until 2025

The U.S. FDA has issued guidance on the health warning rule for cigarette packaging and advertising, and provided the industry with a 15-month transition period, requiring companies to submit a document plan by February 2025.

On September 12, the U.S. Food and Drug Administration (FDA) official website announced that it was providing guidance on the final rule of "Tobacco Products; Warnings Required for Cigarette Packaging and Advertising", which aims to promote better public understanding of the negative health effects of smoking by adding new health warnings to cigarette packaging and advertising.

The final rule was issued in March 2020 and faced a challenge in the U.S. District Court for the Eastern District of Texas. In December 2022, the district court overturned the rule. But the government appealed the decision, and in May 2024, the U.S. Court of Appeals for the Fifth Circuit overturned the district court's ruling, which brought the final rule back into effect, and the rule is now officially in effect. The plaintiffs are awaiting review by the Supreme Court.

The newly released guidance document shows that the FDA plans to exercise enforcement discretion for 15 months or until December 12, 2025, and generally does not enforce the requirements of the final rule. FDA will also grant an additional 30-day grace period, or until January 12, 2026, for products manufactured before December 12, 2025. FDA's selection of 15 months for an orderly transition period is consistent with the 15-month compliance period originally envisioned by the Family Smoking Prevention and Tobacco Control Act, which was impacted only by the interruption of the litigation process.

The final rule also requires industry to submit and obtain FDA approval for plans to ensure that warning labels on cigarette packages are displayed and distributed evenly and at random, while rotating warning labels in cigarette advertising on a quarterly basis. Therefore, the agency's guidance recommends that entities that do not yet have an approved cigarette health warning plan submit such a plan as soon as possible, but in any event within five months or by February 10, 2025. Entities that have previously submitted plans to FDA for cigarettes do not need to resubmit their plans unless they wish to make changes.