FDA’s Tobacco Director Testifies Before House Subcommittee, Addressing Concerns on Regulation and Enforcement

Dr. Brian King, Director of the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP), testified before the U.S. House Energy & Commerce Health Subcommittee on September 10th, fielding questions on the FDA’s handling of tobacco regulations, including the agency’s approach to new tobacco products and enforcement actions. The hearing, titled “Evaluating FDA Human Foods and Tobacco Programs,” also featured testimony from Jim Jones, Deputy Commissioner for Human Foods.

Though premium cigars were not a focal point of the hearing, several key issues emerged that have broad implications for the tobacco industry. Dr. King revealed that the FDA plans to ask Congress to increase user fees on all deemed tobacco products, a move that could directly impact manufacturers. He also indicated the agency’s commitment to advancing rules aimed at reducing nicotine levels in tobacco products and finalizing updated manufacturing standards.

Members of the subcommittee, representing both parties, expressed frustration over the slow and opaque handling of Premarket Tobacco Product Applications (PMTAs). Of particular concern was the FDA’s limited authorization of products intended to reduce harm, such as nicotine pouches. To date, the agency has authorized only 34 vapor products out of more than 26 million submitted PMTA applications. Lawmakers pointed to the FDA’s failure to meet the statutory 180-day review period for these applications, despite a doubling of CTP staff and an increase in funding.

Further concerns were raised about the proliferation of unsafe, illicit vapor products from China, with subcommittee members criticizing the FDA’s perceived lack of enforcement to remove these products from U.S. store shelves. Representatives also called for clearer guidance for retailers on which products are subject to enforcement.

In response, Dr. King highlighted the progress the CTP has made, stating that over 25 million PMTA applications have already been reviewed, with roughly 500,000 still under consideration. He defended the agency’s rigorous standards for product authorizations, emphasizing that PMTAs must demonstrate a clear benefit to public health in order to be approved.

Dr. King also noted the creation of a joint task force between the FDA and the Department of Justice, aimed at ramping up enforcement across the supply chain. This collaboration has already resulted in what King described as “first-of-its-kind” enforcement actions targeting illicit products. He called on Congress to implement user fees for vapor manufacturers to further support enforcement efforts, bolster the PMTA review process, and fund public health campaigns.

On the issue of tobacco harm reduction, Dr. King acknowledged that no tobacco product is entirely safe but suggested that alternatives like vapor products and nicotine pouches could offer less harmful options compared to traditional cigarettes. He cited data from the 2024 National Youth Tobacco Survey, which showed a decline in youth usage of vapor products and a continued low prevalence of nicotine pouch use among young people.

Lastly, Dr. King reaffirmed the FDA’s commitment to finalizing proposed rules that would ban menthol cigarettes and flavored cigars. These rules are currently under review at the White House and, if implemented, could mark a significant shift in U.S. tobacco policy.

As the FDA continues to face scrutiny over its regulatory approach, the Center for Tobacco Products remains at the center of a complex debate over the future of tobacco regulation in America.