FDA Plans to Overhaul Tobacco Product Review Process to Speed Vape and Nicotine Pouch Approvals

The U.S. Food and Drug Administration is expected to announce in the coming days that it will revisit a 2021 rule governing new tobacco product applications, according to people familiar with the matter cited by the Wall Street Journal. The agency is weighing options including simplifying scientific study requirements and shortening review timelines, with the changes mattering most for vapes and nicotine pouches, which are not eligible for the expedited path to market that older products such as cigarettes can use.

Congress mandated that these reviews be completed in roughly six months, but in practice they have often stretched for years, creating a bottleneck that companies say has stunted growth in the fastest-expanding segments of the nicotine market. Altria's NJOY unit and other manufacturers and retailers sued the FDA over the review system earlier in September, and Philip Morris International recently received authorization for 11 Zyn nicotine-pouch products under the existing framework.

The planned changes land against a politically charged backdrop. Lawmakers from both parties have objected to recent FDA approvals of flavored products including blueberry and mango varieties. An HHS spokeswoman said the administration is committed to keeping nicotine away from minors while providing safer alternatives for adults trying to quit cigarettes. Dr. Heidi Overton, President Trump's nominee to lead the FDA, was scheduled to face her Senate confirmation hearing Thursday, adding further urgency to the agency's positioning on tobacco policy. Plans could still change before any formal announcement, the sources said.