By Emma Rumney and Patrick Wingrove
LONDON/NEW YORK, April 1 (Reuters) - Popular nicotine pouch products have yet to be cleared for sale in the United States despite a fast-track Food and Drug Administration scheme, as agency scientists hesitate to authorise them due to potential risks to new users, including children, three sources told Reuters.
New tobacco products like pouches, which users insert under their lip to get a nicotine buzz, must be authorised by the FDA in order to be legally sold in the U.S.,
the world's largest market for smoking alternatives worth some $22 billion.
When granting licences, the agency weighs whether a product can help smokers switch to a less harmful form of nicotine use while not driving risks too high for non-tobacco users and children.
The concerns behind the hold-ups, previously unreported, are a blow to tobacco firms like Philip Morris International, which has pending applications for newer versions of its top-selling label Zyn, as well as British American Tobacco with rival label Velo.
Pouches are the fastest-growing nicotine product in the U.S., with millions of users. PMI alone sold 794 million cans of its current version of Zyn in the country in 2025, more than double its 2023 sales.
EVIDENCE NOT CLEAR-CUT, SOURCES SAY
The FDA planned to fast-track the outstanding applications in a pilot programme first reported by Reuters last year, with decisions expected by the end of 2025.
Six pouches under one label, Altria's on! PLUS, were granted licences in December.
But applications related to three other pouch brands are still pending due to a cautious approach by agency reviewers, three sources familiar with the FDA's process said, adding that the scientific evidence for speeding them through was not as clear-cut as expected.
Two of those sources said specific concerns related to risks to youth or other non-users, such as driving addiction in adults who do not already smoke.
The FDA said in a response to questions from Reuters that the applications in the pilot are on track for faster decisions than most others. It declined to comment on whether its reviewers had concerns related to risks to youth or new users.
BAT said in a statement that its applications warrant the agency's authorisation given robust scientific support, and it continues to engage constructively with the FDA. PMI did not address Reuters questions around the delay to its applications.
FDA UNDER PRESSURE
The FDA says nicotine products are highly addictive and are not risk-free even for adults, while nicotine can harm developing brains.
Pouches, however, are generally less harmful than cigarettes, and when smokers switch completely scientific data indicates they can lower health risks, the FDA said in a statement to Reuters.
The agency is weighing evidence on how effective each pouch product is at getting smokers to switch against information on risks, including its own survey data on how popular pouches are among middle- and high-schoolers and which brands they use.
This annual FDA survey shows that nicotine pouch use remains low among these groups but it has risen in recent years.
The FDA's pilot programme was developed as tobacco lobbyists and the White House pushed the agency to authorise more brands for sale.
Some manufacturers have had licence applications languishing for years, leaving them unable to sell any products legally or only outdated versions. Meanwhile, sales of unregulated nicotine products have boomed.
Asked whether it was under pressure to grant more licences under the pilot, the FDA said it makes its decisions based on science and law.
PMI and BAT said in statements to Reuters that the FDA's pilot programme could help support public health and also restore fair competition in the U.S. nicotine market.
WORRIES OVER NEW ADDICTION
One of the sources said the remaining applications were more complicated than expected and "in a holding pattern", with a lot of concerns around risks to youth and children.
Anti-tobacco campaigners like the Campaign for Tobacco-Free Kids worry pouches' surging popularity and more liberal marketing strategies could lead to higher youth use in future.
Another source said there has already been a sizeable uptick in pouch use among young adults, and it was "not as clear" that the benefits of pending products outweighed the risks.
"I wouldn't count on slam dunk of (authorisations) for all of those brands," the person said.
(Reporting by Emma Rumney; Editing by Caroline Humer and Kirsten Donovan)
