FDA To Expedite Nicotine Pouch Reviews In Pilot Program Under Trump Pressure: Report

North America
Source: Benzinga.comPublished: 09/08/2025, 05:38:02 EDT
FDA
Tobacco Industry
Nicotine Pouches
Regulatory Policy
Philip Morris International
Altria
FDA To Expedite Nicotine Pouch Reviews In Pilot Program Under Trump Pressure: Report

News Summary

The U.S. Food and Drug Administration (FDA) is reportedly launching a pilot program to fast-track the review of nicotine pouches from four major tobacco companies, including Philip Morris International, Altria, Reynolds American (part of British American Tobacco), and Turning Point Brands. This initiative comes amid increasing pressure from the Trump administration, with the FDA aiming to complete reviews by December, a process that historically has taken several years. Earlier this year, the FDA authorized the first batch of nicotine pouches, including 20 of Philip Morris's Zyn products, more than five years after their initial application. The new pilot program could significantly accelerate legal product launches for the selected companies. An FDA official indicated pressure from the White House to improve review efficiency, aligning with tobacco companies' lobbying efforts for a faster and clearer authorization process. Federal Election Commission filings show BAT's Reynolds American contributed $10 million to a Trump-backed super PAC.

Background

Tobacco companies are navigating declining traditional cigarette sales by pivoting aggressively towards the "smoke-free" product market, with nicotine pouches representing the fastest-growing segment in the U.S. These products are positioned as lower-risk alternatives to smoking but have raised concerns about potential youth attraction and usage. The FDA's product review process has historically been criticized for its length, exemplified by the over five-year wait for Philip Morris's Zyn products. The Trump administration has expressed a desire to streamline regulatory processes, and tobacco companies have actively engaged in lobbying and political contributions to push for faster approvals. This expedited review comes as companies like Philip Morris are strategically shifting their focus towards smoke-free products, even considering divesting non-core assets to support this transition.

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