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The Food and Drug Administration (FDA) plans to fast-track reviews of four tobacco firms’ nicotine pouches in a pilot program, amid pressure from the Trump administration to speed up approvals.
The details: FDA aims to review pouches from Philip Morris International (Zyn Ultra), Altria (on! and on! Plus), Reynolds American (Velo mini), and Turning Point Brands (Fre and Alp) by December.
- FDA said the products will be subject to an application process featuring streamlined and reduced reviews, more frequent communication between FDA staff and applicants, and expedited clearance. Reviewers will focus only on information essential to start the scientific review of nicotine pouches, core product characterization, manufacturing consistency and stability, and abuse-liability data.
Reminder: FDA authorized its first group of nicotine pouches, 20 Zyn products, in January, over 5 years after Philip Morris submitted the application.
The bigger picture: Tobacco companies have previously had to wait years for their products to be cleared. The companies have been lobbying the Trump administration, and FDA was pressured by leadership, including at the White House, to review nicotine pouches more efficiently.
- But: The acting director of FDA’s Center for Tobacco Products said the agency was not facing any pressure to lower its scientific standard or compromise its commitment to protecting public health.
Read more: Exclusive: US FDA to fast-track nicotine pouch reviews amid White House pressure
Published
September 2025