FDA to fast-track review of nicotine pouches from big tobacco firms - Reuters

Published 08/09/2025, 06:22

Investing.com-- The U.S. Food and Drug Administration is piloting a program to fast-track approval of nicotine pouches from four major tobacco companies, in a move that could reshape the booming market for smoke-free alternatives, Reuters reported on Monday, citing meeting transcripts.

The FDA plans to complete reviews of products from Philip Morris International Inc (NYSE:PM), Altria (NYSE:MO), Reynolds American -- part of British American Tobacco (LON:BATS) -- and Turning Point Brands (NYSE:TPB) by December, far quicker than the years-long process companies have faced, Reuters reported.

Earlier this year, the agency cleared 20 Philip Morris pouches under its Zyn label after a five-year wait.

Products in the pilot include an updated version of Zyn, called Zyn Ultra, as well as Altria’s on! Plus, Reynolds’ Velo mini, and Turning Point’s Fre and Alp. For items already sold without FDA clearance, approval would remove legal risks and potential enforcement, the report said.

The initiative comes amid pressure from the Trump administration to accelerate authorizations and follows heavy industry lobbying. Nicotine pouches, inserted under the lip, are the fastest-growing U.S. tobacco category, the report added.

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