As smoking rates remain stubbornly high in many regions, nicotine pouches are gaining attention as a practical, smoke-free alternative for adults who would otherwise continue using combustible tobacco. Yet while evidence of their harm reduction potential grows, some policymakers are moving toward heavy restrictions or bans. For tobacco harm reduction experts, the central questions to be asked are simple: do nicotine pouches help adults move away from cigarettes, and are they safer than the latter? And the answer to both these questions is a resounding yes.
The proof is in the pudding
A recent U.S. observational study published in Cureus tracked 346 adult ZYN users across 11 western states over 10 weeks, monitoring daily use of cigarettes, vaping products and smokeless tobacco. Rather than testing a formal intervention, researchers observed real-world behavior patterns and the findings showed meaningful shifts.
Smoking prevalence fell from 15.9 percent to 8.1 percent over 10 weeks, with average daily cigarette use dropping from 0.56 to 0.34. Weekly moist snuff use halved from 15 percent to 7.5 percent. Exclusive nicotine pouch use rose from just over half to nearly two-thirds of participants, while dual use declined and one in four combined users switched to pouches only.
Participants maintained strong intentions to quit smoking, primarily using pouches to cut down or stop, alongside benefits like convenience and discreet use. Although limited by self-reporting, high dropout rates and a narrow sample, the findings indicate nicotine pouches may support short-term harm reduction and merit further long-term study.
U.S. regulatory review supports “reduced-risk” claim
In the United States, regulators have at least begun formally assessing the reduced-risk profile of nicotine pouches. At a recent public hearing, the FDA’s Tobacco Products Scientific Advisory Committee (TPSAC) reviewed Swedish Match USA’s application to market 20 ZYN varieties with modified risk language. The company seeks permission to state that switching completely from cigarettes to ZYN lowers the risk of major smoking-related diseases, including lung cancer, heart disease and chronic bronchitis.
TPSAC concluded that the proposed reduced-risk claim was “scientifically accurate,” despite acknowledging the absence of decades-long epidemiological data specific to pouch users. The committee also determined that youth pouch use in the U.S. is “relatively low” and that viewing the proposed claim did not increase young adults’ intention to use the product.
This review follows the FDA’s earlier pre-market authorization of ZYN and its 2019 modified risk designation for General snus. The agency’s approach reflects a framework that evaluates products based on relative risk rather than treating all nicotine products as equivalent to cigarettes. A final FDA decision on the ZYN Modified Risk Tobacco Product (MRTP) application is expected after the public comment period closes in March 2026.
EU member states pushback against sweeping restrictions
Meanwhile, regulatory trends in parts of Europe have moved in the opposite direction. Spain’s proposal to impose sweeping restrictions on nicotine pouches and other smoke-free products, has prompted formal objections from several EU member states, including Sweden, Romania, Hungary, Czechia, Greece and Italy.
Under the EU’s Technical Regulation Information System (TRIS), these Detailed Opinions require Spain to pause its legislative process and respond to concerns. Objecting governments argue that disproportionate restrictions risk undermining harm reduction strategies and distorting the internal market by limiting access to lower-risk alternatives for adult smokers. Sweden’s experience is frequently cited in this debate. The country is close to achieving smoke-free status, with low smoking prevalence coinciding with widespread use of smokeless nicotine products.
In the Asia-Pacific region, the Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA) is calling for structured regulations for the products, rather than bans. The group advocates creating a distinct legal classification for nicotine pouches, alongside clear product standards, accurate labeling requirements and credible testing systems. It supports licensed retail sales with strict age verification, robust advertising controls to minimize youth appeal, and regular inspections backed by enforceable penalties. According to CAPHRA, such regulated frameworks give governments the tools to monitor compliance effectively, protect young people and maintain controlled access for adults.
The persistent youth question
While youth uptake remains a central concern in such regulatory debates, unregulated oral stimulant products, such as caffeine pouches, are expanding rapidly in some markets, often with fewer age restrictions and minimal regulatory scrutiny. The contrast highlights the importance of proportionate regulation based on product risk and usage patterns.
Nicotine pouches may not be risk-free, but they eliminate combustion—by far the primary source of smoking-related disease. For adult smokers unable or unwilling to quit nicotine entirely, non-combustible alternatives may represent a lower-risk pathway.
What the data mean for public health
Short-term behavioral data, toxicological assessments and regulatory reviews suggest that nicotine pouches can contribute to reductions in cigarette and smokeless tobacco use among adults. While more long-term research is needed, current evidence does not support treating these products as equivalent to cigarettes.
For policymakers, the debate centers on regulatory design. Structured, evidence-based oversight can combine youth protections with adult access. Sweeping prohibitions limit that balance. As governments consider their next steps, the central public health objective remains unchanged: reducing the disease burden caused by smoking. Whether nicotine pouches are allowed to play a role in that effort will depend on whether regulation follows comparative risk, or exagerated precaution going against emerging evidence.
