United States: FDA slows down expedited review of nicotine pouches

In the United States, the accelerated procedure implemented by the Food and Drug Administration (FDA) for reviewing applications for marketing authorization of nicotine pouches is experiencing a slowdown, according to several concurring reports, including Reuters.[1], Some applications for widely distributed products were not finalized within the initially planned timeframe due to persistent uncertainties regarding the robustness of the available scientific data and the potential effects on nicotine initiation, particularly among young people and non-users. This development occurs against a backdrop of strong growth in the US market for nicotine pouches and increased debate on the conditions for their regulatory framework.

An accelerated procedure confronted with public health requirements

In September 2025, the FDA launched a pilot program to expedite the review of certain marketing authorization applications while maintaining the scientific requirements of the pre-marketing approval process for tobacco products. The first set of decisions was issued in December 2025, authorizing six products presented as products of this review process.

However, several cases investigated within this framework have not been resolved within the expected timeframe. The information provided by manufacturers is deemed insufficient to establish, at this stage, a net benefit to public health. Questions remain, in particular, regarding the appeal of these products to young people and their potential to initiate nicotine use in adults who do not currently use nicotine.

In accordance with the U.S. legal framework, the FDA bases its decisions on a comprehensive evaluation of the product, which must be "appropriate for the protection of public health." This approach involves weighing the potential benefits for smokers against the risks of expanding use to new populations. The agency emphasizes in this regard the highly addictive nature of nicotine and its effects on the brain development of young people.

A rapidly expanding market under regulatory scrutiny

This slowdown comes amid a marked boom in nicotine pouches in the United States, now identified as the fastest-growing segment among nicotine products. The market for alternatives to smoking tobacco is estimated at approximately $22 billion, with sales volumes increasing rapidly. For example, nearly 794 million boxes of ZYN were sold in the United States in 2025, more than double the sales recorded in 2023.

This dynamic gives these products strategic importance for manufacturers, for whom rapid market access is a major factor in competitiveness and profit. It is accompanied by increased pressure on regulatory authorities. In this context, certain developments in the pilot program, particularly the use of general data rather than product-specific studies, have drawn criticism regarding their ability to capture differences in composition, dosage, or flavorings that could influence consumer behavior.

The risk of youth initiation is a key concern.

The distribution of nicotine pouches among young people is a key area of concern. Data from the National Youth Tobacco Survey indicates that current use of these products among American students is projected to increase from 1.5 million per 100,000 in 2023 to 1.8 million per 100,000 in 2024, representing nearly half a million young users. Of these, more than one in five reports daily use, with certain brands being particularly prevalent.

While these levels remain lower than those observed for other products, their increase, combined with aggressive marketing strategies, is fueling concerns among public health stakeholders. During the review of applications, some experts emphasize that the expected benefits for smokers are not sufficiently substantiated in light of the risk of initiation, including among young adults.

This analysis leads the FDA to adopt a cautious approach, noting that any potential gains in terms of risk reduction assume a complete replacement of smoked tobacco, and not concurrent use or dissemination to non-user audiences.

Beyond the sole criterion of risk reduction compared to cigarettes, the evaluation is based on the overall impact of these products on consumption patterns and public health as a whole. The observed hesitations thus reflect a growing concern: to prevent products presented by manufacturers as alternatives to tobacco from actually contributing to the emergence of new forms of nicotine addiction.

©Generation Without Tobacco

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