U.S. FDA to fast-track nicotine pouch reviews amid White House pressure

Nicotine pouches are seen in this image from Shutterstock.com

The U.S. Food and Drug Administration plans to fast-track reviews of four tobacco firms’ nicotine pouches in a pilot program launching on Monday, amid pressure from U.S. President Donald Trump’s administration to speed up approvals, according to meeting transcripts seen by Reuters.

The FDA aims to finish reviewing the pouches from Philip Morris International, Altria, Reynolds American - part of British American Tobacco - and Turning Point Brands by December, according to one transcript of an agency meeting held on Friday.

Tobacco companies have previously had to wait years for their products to be cleared. The agency authorized its first group of pouches, 20 of PMI’s pouch products under its successful label Zyn, in January, over five years after the company first submitted its application.

Some of the products selected for the pilot, such as an updated version of PMI’s pouches, Zyn Ultra, are not yet on the market as producers wait for the FDA’s greenlight. Rivals have gained market share with more competitive products in the meantime.

The pilot could provide a route to a far quicker legal launch for those selected to participate. For other products already on the market without permission, FDA authorization would remove questions over their legality and the threat of potential enforcement from the agency.

An FDA official told staff last month that the agency had been pressured by leadership, including at the White House, to review nicotine pouches more efficiently, according to a transcript of a second meeting.

The Department of Health and Human Services, which oversees the FDA, and the White House did not immediately respond to requests for comment.

Tobacco companies have been lobbying Trump and other key officials this year for changes they favor, including a faster, clearer FDA authorization process.

BAT’s Reynolds American donated US$10 million to Trump-aligned super PAC Make America Great Again Inc, Federal Election Commission filings show.

Nicotine pouches, which users insert under the lip to get a kick, are the fastest-growing category of tobacco products in the United States, the world’s largest market for smoking alternatives.

Pouches are generally seen as among the lowest-risk smoking alternatives given they do not involve inhalation and do not contain tobacco. Campaigners say that nicotine pouches still pose risks, such as appealing to new users, especially youth.

Yolonda Richardson, chief executive officer of the Campaign for Tobacco-Free Kids, said rigorous FDA review of new product applications is critical to protecting kids and public health.

“There should be no shortcuts when it comes to our kids’ health,” Richardson said.

Current evidence, however, does not show a significant uptake of these products among young people, an FDA official said during Friday’s meeting.

PMI leads the U.S. market with its pouch label Zyn, whose explosive growth has seen rivals BAT and Altria scramble to catch up. The brand has delivered U.S. shipment growth of between 40 per cent and 80 per cent every quarter since January 2023, and has rapidly become one of its most important products.

PMI said a project to speed up the review process could be a step in the right direction, although the company was not aware of such an effort.

As well as PMI’s Zyn Ultra, Altria’s on! and on! Plus, Reynolds’ Velo mini, and Turning Point Brands’ Fre and Alp - co-owned by former Fox News presenter Tucker Carlson - are also included.

Altria called the FDA’s approach encouraging and a positive step for harm reduction. Turning Point Brands said the streamlined path shows the administration’s continued commitment to efficiency, effectiveness and transparency.

Reynolds declined to comment.

The FDA said in Friday’s meeting that the products will be subject to an application process featuring streamlined and reduced reviews, more frequent communication between FDA staff and applicants, and expedited clearance.

Reviewers will focus only on information essential to start the scientific review of nicotine pouches, core product characterization, manufacturing consistency and stability, and abuse-liability data, according to the transcript.

(Reporting by Patrick Wingrove in New York and Emma Rumney in London; Editing by Caroline Humer, Tom Hogue and Mark Porter)