The fast-track approval by the U.S. Food and Drug Administration for new nicotine pouches has stalled after some agency researchers expressed concerns over the potential risk to new users, including children, according to three individuals familiar with the situation.
The sources spoke to Reuters about the delayed clearance.
When a new tobacco product is introduced to the U.S., it has to be cleared by the FDA before it can be legally sold.
When considering alternative nicotine products, the FDA weighs the potential risk for non-tobacco users against products’ potential to help smokers move to a less damaging means of using nicotine.
Reports that there are risk concerns holding up the approval of the products will be unwelcome news for Philip Morris International, which has applications for newer versions of its Zyn tobacco product awaiting approval with the agency. British American Tobacco, which offers the Velo nicotine product, is waiting for similar approval on one of its products.
Current pouch offerings — like Zyn — are the fastest-growing nicotine product in the U.S. Millions use the products. Last year PMI sold nearly 795 million cans of Zyn, doubling its sales from 2023, The Guardian reports.
The FDA reportedly planned to fast-track approval for the pouches, with a decision expected by the end of 2025. Six pouches under one label — Altria’s on! PLUS — were granted licenses in December. Now, reportedly due to concerns about the pouches’ potential risk to non-smokers and children, the FDA is hesitating on decisions over four other brands. A source speaking to Reuters said the approvals were in a “holding pattern” pending further review.
In a comment to Reuters, an FDA spokesperson confirmed the products were scheduled to receive a fairly speedy approval, but did not elaborate on reports of concerns among agency scientists.
The FDA’s official position on nicotine is that products that contain the drug are highly addictive and are not risk-free, especially for children whose brains are still developing.
A source speaking to Reuters said that there has already been a notable increase in youth tobacco pouch use and that the benefits for smoking cessation may not outweigh the possible risks.
Pouches have largely been considered less harmful than cigarette smoking, and current data suggests that smokers can benefit from fully switching to pouch use, according to the USDA.
The approvals have been opposed by anti-tobacco groups like the Campaign for Tobacco-Free Kids, which has raised concerns that the pouches’ popularity and marketing will lead to an increase in youth nicotine use.
