Anabelle Colaco
10 Sep 2025, 06:28 GMT+10
WASHINGTON, D.C.: The U.S. Food and Drug Administration is preparing to fast-track reviews of nicotine pouches from four major tobacco companies, a move that comes amid mounting pressure from the Trump administration to accelerate approvals, according to internal meeting transcripts seen by Reuters.
The pilot program, which began on September 8, will cover products from Philip Morris International, Altria, Reynolds American (owned by British American Tobacco), and Turning Point Brands. The FDA aims to finish reviews by December, a sharp departure from the years-long process companies have faced in the past.
The agency only authorized its first set of pouches in January, when it cleared 20 versions of Philip Morris's Zyn, more than five years after the company first submitted its application. Products in the new pilot include Zyn Ultra, Altria's on! and on! Plus, Reynolds' Velo mini, and Turning Point's Fre and Alp, co-owned by former Fox News host Tucker Carlson.
For manufacturers, faster approvals could mean new products hit shelves much sooner, while those already on the market would gain legal certainty and protection from possible enforcement actions.
An FDA official acknowledged last month that leadership, including the White House, had pressed the agency to speed up nicotine pouch reviews. Both the Department of Health and Human Services and the White House declined to comment.
Industry players have been lobbying heavily for regulatory changes. BAT's Reynolds American, for example, donated US$10 million this year to a Trump-aligned super PAC, filings show.
Nicotine pouches — placed under the lip for a nicotine hit without tobacco or inhalation — are the fastest-growing category of tobacco alternatives in the U.S. While health experts say they are less risky than cigarettes, critics warn they could attract new users, especially teenagers.
"There should be no shortcuts when it comes to our kids' health," said Yolonda Richardson, CEO of the Campaign for Tobacco-Free Kids. Still, FDA staff noted in a meeting late last week that evidence so far does not suggest significant youth uptake.
Philip Morris said it welcomed any effort to accelerate reviews, though it was not aware of the new pilot. Altria called the approach "encouraging" and a positive step for harm reduction. Turning Point Brands praised the move as showing "continued commitment to efficiency, effectiveness, and transparency." Reynolds declined to comment.
Under the pilot, reviews will focus only on essential information: scientific data, product consistency and stability, and abuse-liability studies. According to transcripts, the process will also include streamlined communication between companies and FDA reviewers.
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