United States: FDA slows down accelerated review of nicotine pouches

In the United States, the process implemented by the Food and Drug Administration (FDA) for reviewing applications for the authorization of nicotine pouches is experiencing a slowdown. According to several consistent reports, including Reuters, some cases involving widely distributed products have not been finalized within the initially envisaged deadlines due to persistent uncertainties regarding the strength of available scientific data and potential effects in terms of nicotine initiation, especially among young people and non-users. This development comes at a time of significant growth in the nicotine pouch market in the United States and increased debates about their regulatory oversight.

A rigorous procedure facing public health requirements

In September 2025, the FDA launched a pilot program to expedite the review of certain authorization requests while maintaining the scientific requirements of the post-market tobacco product review procedure. A first set of decisions was made in December 2025, authorizing six products presented as originating from this review system.

However, several cases processed under this framework did not reach expected conclusions. The information provided by manufacturers is deemed insufficient at this stage to establish a net benefit for public health. Questions particularly focus on the appeal of these products to young people and their potential for initiation among non-nicotine users. In accordance with U.S. legal framework, the FDA bases its decisions on an overall product evaluation that must be “appropriate for public health protection.” This approach involves balancing potential benefits for smokers against the risks of expanding usage to new audiences. The agency emphasizes the highly addictive nature of nicotine and its effects on young people’s brain development in this regard.

A rapidly expanding market under regulatory scrutiny

This slowdown occurs amidst a pronounced rise in nicotine pouches in the United States, now identified as the fastest-growing segment among nicotine products. The non-combustible tobacco alternatives market is estimated at around $22 billion with rapidly increasing sales volumes. For example, nearly 794 million boxes of ZYN were sold in the U.S. in 2025, more than double the sales recorded in 2023. This trend assigns strategic importance to these products for manufacturers, as swift market access is a major competitiveness and profit issue. It also raises pressure on regulatory authorities. Some changes in the pilot program, such as using general data rather than specific studies for each product, have faced criticism regarding their ability to address differences in composition, dosage, or flavors that could influence usage behavior.

The risk of youth initiation at the forefront of concerns

The proliferation of nicotine pouches among young people poses a central point of concern. Data from the National Youth Tobacco Survey shows that the current use of these products among American students increased from 1.5% in 2023 to 1.8% in 2024, indicating nearly half a million young users. More than one in five of them report daily usage, largely favoring certain brands. While these levels remain below those observed for other products, their growth combined with aggressive marketing strategies fuels public health worries. Some experts underscore during the review process that anticipated benefits for smokers are insufficiently supported given the risk of initiation, including among young adults.

This analysis prompts the FDA to adopt a cautious approach, emphasizing that potential risk reduction gains require complete tobacco smoking replacement, not concurrent use or spreading among non-nicotine users. Beyond the sole risk reduction criterion compared to cigarettes, evaluation considers these products’ overall impact on consumption behavior and public health as a whole. The observed hesitations reflect a growing concern: preventing products marketed by manufacturers as tobacco alternatives from contributing to the emergence of new forms of nicotine addiction.

“Smoke-Free Generation”

Sources: [1] Emma Rumney, Patrick Wingrove, Exclusive: US nicotine pouch fast-track scheme slowed by worries over youth, new users, Reuters, published on April 1, 2026, accessed on the same day

National Committee Against Smoking