FDA to Fast-Track Nicotine Pouch Reviews for Tobacco Giants
A new pilot program, reportedly driven by industry and political pressure, aims to slash review times from years to months.
The U.S. Food and Drug Administration (FDA) is launching a new pilot program to accelerate the review of nicotine pouches, a move that could significantly impact major tobacco companies pivoting towards smoke-free alternatives. The initiative will expedite reviews for products from Philip Morris International, Altria, Reynolds American (a subsidiary of British American Tobacco), and Turning Point Brands.
This accelerated timeline comes amid reports of pressure from the Trump administration and industry lobbyists. According to a Benzinga report, the , a stark contrast to the multi-year process that has been the standard. For context, the agency took over five years to authorize the first batch of Philip Morris’s popular Zyn products.
The U.S. represents the largest market for smoking alternatives, with nicotine pouches being the fastest-growing product segment. An expedited path to market is a critical objective for these companies as they navigate declining smoking rates and shift their focus. However, the move is not without controversy, as .
The push for a faster authorization process has been a key lobbying point for tobacco firms this year. Federal Election Commission filings, as , show that BAT's Reynolds American contributed $10 million to a Trump-backed super PAC. This new pilot program suggests these efforts may be influencing regulatory timelines, creating a pivotal moment for the future of the tobacco industry's fastest-growing category.