Today, Dr. Brian King, Director of the U.S. Food & Drug Administration’s (FDA) Center for Tobacco Products (CTP), testified before the U.S. House Energy & Commerce Health Subcommittee during a hearing titled, “Evaluating FDA Human Foods and Tobacco Programs.” He was joined by Jim Jones, Deputy Commissioner for Human Foods, to address a range of concerns surrounding tobacco regulations.

While premium cigars were not specifically raised in Dr. King’s testimony, there were several items of importance to our industry under discussion. Among other items, Dr. King indicated that FDA intends to request that Congress should act to increase user fees on all Deemed tobacco products. He also emphasized that the Agency will press forward with a limit on nicotine levels in tobacco products and a final rule on manufacturing practices.

During the hearing, Committee members voiced bipartisan concerns about the FDA’s slow and unclear handling of Premarket Tobacco Product Applications (PMTAs) and called for more proactive engagement with stakeholders. Lawmakers also highlighted the lack of approvals for products that could support tobacco harm reduction, including nicotine pouches, with only 34 vapor products authorized out of over 26 million submitted applications. They also expressed frustration over the FDA’s failure to meet the 180-day statutory review period for PMTAs despite increased staffing and funding at the CTP. Additionally, concerns were raised about the proliferation of unsafe, illicit vapor products from China and the lack of enforcement to remove these products from the U.S. market. Representatives also emphasized the need for clearer guidance for retailers regarding which products are subject to enforcement and sought updates on the status of the FDA’s proposed bans on menthol cigarettes and flavored cigars.

In response to the concerns raised, Dr. Brian King emphasized that the Center for Tobacco Products (CTP) has already reviewed over 25 million of the 26 million PMTA applications received and is working diligently to complete the review of the remaining 500,000 applications. He noted that PMTA authorizations require substantial scientific evidence to meet the standard of being “appropriate for the protection of public health.”

Dr. King also highlighted the recent creation of a joint FDA-Department of Justice multi-agency task force, which has ramped up enforcement efforts across the supply chain, leading to “first-of-its-kind” enforcement actions against illicit products. He urged Congress to implement “user fees” on vapor manufacturers to increase funding for enforcement, PMTA reviews, and public health campaigns.

Acknowledging tobacco harm reduction, Dr. King stated that while no tobacco product is entirely safe, less risky alternatives such as vapor and nicotine pouches are generally safer than cigarette smoking. He also cited the 2024 National Youth Tobacco Survey (NYTS), showing a decrease in youth use of vapor products and continued low usage of nicotine pouches.

Lastly, Dr. King reaffirmed the FDA’s commitment to finalizing the proposed rules banning menthol cigarettes and flavored cigars, which are currently under review at the White House.

CRA will continue to monitor important events like this involving FDA and Director King and share any relevant updates