Dr. Bret Koplow, acting director of the FDA’s Center for Tobacco Products (CTP), sat down for a fireside chat to kick off the second day of the American Tobacco and Nicotine Forum (ATNF) in Leesburg, Va. Christopher Greer, president and CEO of the Nicotine Resource Consortium, led the discussion on behalf of industry leaders eager to hear more about the inner workings of the regulatory agency.
Koplow said the agency has made significant progress in reducing its backlog of premarket tobacco applications, cutting it by roughly 70% over the past year and eliminating the acceptance queue. He noted that while the FDA has reviewed approximately 27 million applications, only a small number have been authorized, largely because most submissions lacked the scientific data required to demonstrate public health benefits.
Koplow said the agency is working to improve transparency and guidance for applicants, including plans to share lessons learned from the review process to help companies better meet regulatory standards. He also pointed to efforts to streamline evaluations in certain product categories, such as nicotine pouches, where a pilot program enabled faster authorizations and is expected to inform broader regulatory approaches.
On enforcement, Koplow highlighted increased action against illicit products, including major seizures of unauthorized e-cigarettes in coordination with federal agencies, with most originating from China. He acknowledged ongoing challenges in balancing harm reduction for adult smokers with youth protection, noting declines in youth vaping but continued concerns about public understanding of nicotine risks and the need for stronger evidence on comparative benefits of alternative products.