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The U.S. Food and Drug Administration (FDA) is set to fast-track reviews of nicotine pouches from Philip Morris International (PMI), Altria, Reynolds American (part of British American Tobacco), and Turning Point Brands in a new pilot program launching Monday. According to meeting transcripts reviewed by Reuters, the FDA aims to complete reviews by December, a sharp contrast to the years-long approval process companies previously faced.
This move follows pressure from the Trump administration and heavy lobbying by tobacco companies seeking faster, clearer authorization pathways. Federal filings show Reynolds American recently donated $10 million to a Trump-aligned super PAC, underscoring the industry’s push for regulatory changes.
Nicotine pouches, placed under the lip for nicotine delivery without smoke or tobacco, are the fastest-growing category of smoking alternatives in the U.S. PMI leads the market with its Zyn brand, which has posted 40% to 80% U.S. shipment growth each quarter since early 2023. The pilot includes products such as PMI’s Zyn Ultra, Altria’s on! and on! Plus, Reynolds’ Velo mini, and Turning Point Brands’ Fre and Alp.
The FDA plans streamlined reviews focused on essential scientific data, product stability, and abuse-liability. Officials emphasized more frequent communication with applicants to speed decisions. Industry players welcomed the move, with Altria calling it a positive step for harm reduction. Critics, however, warn against regulatory shortcuts, stressing risks of youth appeal.
Despite concerns, current evidence shows limited uptake among young people, an FDA official noted. Still, public health advocates argue rigorous oversight remains critical. If successful, the pilot could pave the way for quicker legal launches of nicotine pouches, offering companies a clearer path while addressing regulatory uncertainty.
