Key Takeaways
- Reuters reported that several popular nicotine pouch products still do not have FDA authorisation for sale in the United States.
- Three sources said FDA reviewers are taking a cautious approach because of risks to youth and new users.
- The report said the FDA had planned to fast-track the applications under a pilot program with decisions expected by the end of 2025.
- Six on! PLUS nicotine pouch products from Altria were authorised in December 2025.
- Applications related to four other brands remain pending.
2Firsts, April 1, 2026
According to Reuters, several popular nicotine pouch products still have not been cleared for sale in the United States despite a fast-track pilot program launched by the U.S. Food and Drug Administration.
Sources said the FDA is taking a cautious approach over risks to youth and new users
Three sources told Reuters that FDA scientists have hesitated to authorise the products because of concerns about the risks they may pose to children, youth and other non-tobacco users.
The report said the United States is the world’s largest market for smoking alternatives, worth about USD 22 billion. Under U.S. rules, new tobacco products such as nicotine pouches must be authorised by the FDA before they can be legally sold.
When considering these applications, the FDA weighs whether a product can help smokers switch to a less harmful form of nicotine use while not creating excessive risks for non-tobacco users and children.
Aside from on! PLUS, applications for four other nicotine pouch brands remain pending
Sources said the FDA had expected to fast-track the outstanding applications in a pilot program, with decisions originally expected by the end of 2025. However, only six on! PLUS nicotine pouch products from Altria were authorised in December 2025, while applications related to four other brands are still pending.
Reuters said the delay is a setback for tobacco companies including Philip Morris International and British American Tobacco. Philip Morris has pending applications for newer versions of its top-selling Zyn brand, while British American Tobacco has pending applications for its rival Velo brand. Turning Point Brands also has applications related to two pouch brands under the pilot.
Reuters said Philip Morris shares fell more than 7.00% on Wednesday before recovering part of the loss, British American Tobacco shares were down 1.50%, and Turning Point Brands shares fell more than 17.00%.
Reuters said the FDA is weighing switching benefits against addiction risks
Two of the sources said one specific concern among reviewers is the risk that the products could affect youth or other non-users, including creating nicotine addiction among adults who do not already smoke.
In response to Reuters, the FDA said the applications in the pilot remain on track for faster decisions than most others, but it declined to comment on whether reviewers had concerns specifically related to youth or new users.
The report also said the FDA considers nicotine products highly addictive and not risk-free even for adults. At the same time, the agency said nicotine pouches are generally less harmful than cigarettes and that scientific data show health risks can decline when smokers switch completely.
Reuters said the FDA is weighing evidence on how effective each pouch product is at getting smokers to switch against information on risks, including annual FDA survey data on how popular nicotine pouches are among middle- and high-school students and which brands they use. Although use remains low in those groups, it has risen in recent years.
One source said the remaining applications are more complicated than expected and are now in a “holding pattern,” with many concerns centered on risks to youth and children. Another source said nicotine pouch use among young adults has already risen significantly and that it is “not as clear” whether the benefits of the pending products outweigh the risks.
Image source: Reuters
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