FDA To Rush Nicotine Pouch Approvals For Philip Morris, Altria And Turning Point After Trump Pressure

The U.S. Food and Drug Administration (FDA) will launch a pilot program on Monday to fast-track reviews of nicotine pouches from four major tobacco companies, aiming to complete assessments by December under pressure from the Trump administration to speed approvals.

The program will cover products from Philip Morris International, Altria, Reynolds American, part of British American Tobacco, and Turning Point Brands. Among them 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, Reuters reported, citing FDA meeting transcripts.

Nicotine pouch approvals have historically 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 pilot is expected to streamline reviews by focusing only on core product characterization, manufacturing, stability, and abuse-liability data, while increasing communication with companies.

Nicotine pouches, placed under the lip, are the fastest-growing U.S. tobacco category, marketed as a lower-risk smoking alternative since they don't involve inhalation or tobacco. Campaigners warn of youth appeal, while FDA officials say current data does not show significant youth uptake.

PMI dominates the market with Zyn, which has posted 40% to 80% U.S. shipment growth every quarter since January 2023. Altria called the FDA's new approach encouraging for harm reduction, while Turning Point Brands said it reflects a commitment to efficiency. 

An FDA official said the agency had been pressed by leadership, including the White House, to move faster. Tobacco firms have lobbied President Donald Trump for changes, with BAT's Reynolds donating $10 million to a pro-Trump super PAC.

Yolonda Richardson, CEO of the Campaign for Tobacco-Free Kids, said rigorous review remains essential:“There should be no shortcuts when it comes to our kids' health.”

On Stocktwits, retail sentiment was 'neutral' for Philip Morris and Turning Point Brands amid 'normal' message volume, while Altria saw 'bearish' sentiment with 'low' activity.

So far this year, Philip Morris shares are up 36.4%, Altria has gained 31.8%, and Turning Point Brands has jumped 68.3%.

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