The US Food and Drug Administration has stalled fast-track approval for new nicotine pouches after concerns from agency researchers about potential risks to non-users, including children, according to three sources familiar with the matter.
New tobacco products must be cleared by the FDA before being legally sold in the US. The agency weighs the potential risk to non-tobacco users against the products' ability to help smokers switch to less harmful nicotine sources.
The delay is unwelcome news for Philip Morris International, which is awaiting approval for newer versions of its Zyn pouches, and British American Tobacco, which has a similar application for its Velo product. Zyn is the fastest-growing nicotine product in the US, with PMI selling nearly 795 million cans last year.
The FDA had planned to fast-track approvals, with a decision expected by end of 2025. While Altria’s on! PLUS pouches were granted licences in December, decisions on four other brands are now in a “holding pattern” pending further review, a source told Reuters.
An FDA spokesperson confirmed the products were scheduled for speedy approval but did not comment on reports of concerns. The agency maintains that nicotine is highly addictive and not risk-free, especially for developing brains.
Anti-tobacco groups, including the Campaign for Tobacco-Free Kids, oppose the approvals, citing increased youth nicotine use. A source noted a “notable increase” in youth pouch use, questioning whether cessation benefits outweigh risks.
