FDA Releases Guidance on Tobacco Product Warning Labels and Ads

On September 12th, the U.S. Food and Drug Administration (FDA) website announced that they are providing guidance on the final rule regarding "Tobacco Products; Required Warnings for Cigarette Packages and Advertisements." The rule aims to promote greater public understanding of the negative health effects of smoking by adding new health warnings to cigarette packaging and advertisements.

The final rule was published in March 2020 and faced a challenge in the Eastern District Court of Texas. In December 2022, the district court overturned the rule. However, the government appealed this decision, and in May 2024, the United States Fifth Circuit Court of Appeals overturned the district court's ruling, reinstating the final rule, which is now officially in effect. The plaintiffs are now waiting for review by the Supreme Court.

In the newly released guidance document, the FDA plans to exercise enforcement discretion for 15 months or until December 12, 2025, generally not enforcing the requirements of final rules. For products manufactured before December 12, 2025, the FDA will also provide an additional 30-day grace period, or until January 12, 2026. The FDA has chosen a 15-month orderly transition period, consistent with the initially envisioned 15-month compliance period of the Family Smoking Prevention and Tobacco Control Act, but impacted by litigation proceedings.

The final rule also requires the industry to submit plans and obtain FDA approval to ensure that warning labels on cigarette packaging are displayed and distributed randomly and evenly, while rotating warning labels on cigarette advertisements quarterly. Therefore, entities with cigarette health warning plans that have not yet been approved are advised to submit such plans as soon as possible, but must do so within five months or by February 10, 2025. Entities that had previously submitted cigarette plans to the FDA do not need to resubmit their plans unless they wish to make changes.