FDA to Expedite Nicotine Pouch Reviews Under Trump Pressure: A Pilot Program to Fast-Track Product Launches for Major Tobacco Companies.

The FDA plans to expedite the review of nicotine pouches from four major tobacco companies under pressure from the Trump administration. The pilot program aims to complete the review by December, a process that typically takes several years. The move could boost market performance for companies like Philip Morris International and Altria Group by allowing quicker product launches.

The U.S. Food and Drug Administration (FDA) has announced a pilot program to fast-track the review of nicotine pouches from four major tobacco companies, aiming to complete assessments by December. This initiative, driven by pressure from the Trump administration, seeks to streamline the review process, which typically takes several years.

The pilot program will cover products from Philip Morris International (PMI), Altria, Reynolds American (part of British American Tobacco), and Turning Point Brands. Among the products included are PMI’s 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. This expedited review process focuses on core product characterization, manufacturing, stability, and abuse-liability data, while increasing communication with the companies involved [1][2].

Historically, nicotine pouch approvals have taken years. The FDA cleared its first group in January, including 20 Zyn products, more than five years after PMI first submitted its application. The new pilot program aims to provide a faster route to legal launches for selected products and remove questions over legality for those already on the market without permission [2].

The move has been praised by tobacco companies as a step towards harm reduction and increased efficiency. Altria called the FDA’s new approach encouraging, while Turning Point Brands highlighted the commitment to efficiency. However, campaigners like Yolonda Richardson, CEO of the Campaign for Tobacco-Free Kids, have expressed concerns about the potential risks to youth and the importance of rigorous review [1][2].

The pilot program is expected to have a significant impact on the market performance of companies like Philip Morris International and Altria Group. PMI’s Zyn has seen explosive growth, with U.S. shipment growth of between 40% and 80% every quarter since January 2023 [2].

As the FDA and tobacco companies work to expedite the review process, investors and financial professionals should closely monitor the developments. The success of this pilot program could set a precedent for future regulatory changes in the tobacco industry.

References:

[1] https://stocktwits.com/news-articles/markets/equity/fda-to-rush-nicotine-pouch-approvals-for-philip-morris-altria-and-turning-point-after-trump-pressure/chwWZSDRdA2

[2] https://www.reuters.com/sustainability/boards-policy-regulation/us-fda-fast-track-nicotine-pouch-reviews-amid-white-house-pressure-2025-09-08/