Fuente: Tobacco Reporter Lugar: FDA A fast-track review program at the U.S. Food and Drug Administration aimed at accelerating authorizations for nicotine pouch products has stalled, as agency scientists weigh concerns about youth uptake and risks to non-users against potential harm-reduction benefits for smokers, according to sources cited by Reuters. Reuters said applications tied to pouch brands from Philip Morris International (Zyn) and British American Tobacco (Velo) remain under review despite expectations that decisions would be made by the end of 2025 under the pilot scheme. The FDA has already authorized six products under Altria Group’s on! brand, but reviewers are said to be taking a more cautious stance on other applications where evidence of net public-health benefit is viewed as less clear-cut.



While FDA data shows pouch use among middle- and high-school students remains relatively low, it has been rising, prompting heightened scrutiny. Tobacco companies argue the pilot program is critical for restoring legal market competition amid a surge of unregulated products, while public-health advocates warn that rapid authorizations could fuel new addiction trends. The FDA said decisions continue to be guided by science and statutory standards rather than external pressure.The post FDA’s Pouch Fast-Track Scheme Stalling Over Youth Worries first appeared on Tobacco Reporter.