Federal Highlights

The American Lung Association has identified five key actions for the Trump administration and Congress to take in 2025 that will reduce the death and disease caused by tobacco use:

1. Congress must at least maintain current funding for the Centers for Disease Control and Prevention (CDC)’s Office on Smoking and Health to ensure dissemination of the “Tips from Former Smokers” campaign and resources for states and territories to prevent youth tobacco use;

2. Congress must protect both standard Medicaid and Medicaid expansion to ensure that people with the highest smoking rates can access quit tobacco treatments;
3. The U.S. Food and Drug Administration (FDA), the U.S. Department of Justice (DOJ), and other members of the multi-agency task force must act to remove all illegal tobacco products from the marketplace. To support these efforts, Congress must pass legislation requiring e-cigarette manufacturers to pay user fees, providing the FDA with the resources needed for stronger oversight and enforcement;
4. The FDA must propose and finalize regulations to implement “track and trace” technology on all tobacco products to prevent an illicit market, counterfeit and smuggling activities; and
5. The FDA must improve and expand options for tobacco cessation medications and help all people, including youth, in the U.S. end their addiction to tobacco products.

Key highlights from 2024 include:

• In January and April, President Biden delayed finalizing the long-awaited menthol cigarette and flavored cigar rules that were projected to save hundreds of thousands of lives. This decision came after significant tobacco industry pressure, including a meeting with high level tobacco industry representatives. The rules are now delayed indefinitely to protect FDA’s ability to continue working on this issue in the future. This delay will result in continued tobacco-related health disparities, death and disease.

• In March, Congress passed fiscal year 2024 funding bills that upheld FDA’s full authority over commercial tobacco products with no limitations and maintained funding for CDC’s Office on Smoking and Health.
• In July, the House Committee on Appropriations added a legislative provision to FDA’s proposed fiscal year 2025 funding bill aimed at preventing FDA from issuing rules to remove menthol cigarettes and flavored cigars from the market and reducing nicotine levels in cigarettes. The Senate Committee on Appropriations’ bill also included a rider to FDA’s funding bill that would limit funding for FDA until the agency takes certain actions related to illegal e-cigarettes. In August, the House Appropriations Committee’s funding bill proposed to eliminate the CDC’s Office on Smoking and Health. These bills remain to be resolved and reconciled in 2025.
• In April, June and October, FDA and other federal agencies took several significant enforcement actions that resulted in multiple seizures ranging from $700,000 to $76 million worth of unauthorized e-cigarettes. The FDA also took additional enforcement actions throughout the year, such as issuing warning letters and civil monetary penalties.
• In June, DOJ and FDA announced the creation of a federal multi-agency task force to combat the illegal distribution and sale of e-cigarettes. This initiative has already led to coordinated enforcement efforts and substantial seizures of illegal products.
• In November, the Surgeon General released a landmark report titled Eliminating Tobacco-Related Disease and Death: Addressing Disparities. The report highlights the tobacco industry’s predatory practices targeting vulnerable populations and emphasizes the importance of equitable access to tobacco cessation resources and prevention policies.
• In November, the U.S. Supreme Court declined to hear a tobacco industry challenge to the FDA’s 2020 rule requiring graphic warning labels on cigarette packs and advertisements. This decision upholds a March ruling by the U.S. Court of Appeals for the Fifth Circuit, which affirmed that the FDA’s warnings comply with the First Amendment. This marks a major step forward in implementing graphic cigarette warnings in the U.S.

The Lung Association is carefully watching a number of legal challenges to important tobacco control efforts that will be considered by the U.S. Supreme Court in the 2024-2025 term:

• The Braidwood lawsuit could result in the elimination of the Affordable Care Act requirement that preventive services, including tobacco cessation coverage, be provided to most people without cost-sharing. The Lung Association has weighed in via amicus briefs opposing the reversal of this critical provision.
• Triton Distribution v. FDA, a lawsuit that could significantly undermine FDA’s efforts to protect youth from the health harms of flavored e-cigarette products. The Lung Association has weighed in via amicus brief in support of FDA’s decision to put forward marketing denial orders against the products.
• R.J. Reynolds Vapor Company v. FDA involves whether filing a challenge to an FDA marketing denial order for e-cigarettes in a specific circuit court in possible violation of requirements in the Tobacco Control Act is legal.