The emerging role of oral nicotine pouches in tobacco harm reduction.

Global smoking prevalence remains high, underscoring the need for strategies that complement conventional cessation. Tobacco harm reduction (THR) offers a pragmatic strategy by promoting substitution of combustible cigarettes with substantially less harmful alternatives. Oral nicotine pouches (ONPs) have emerged as a promising option. Modeled on the Scandinavian success of snus, ONPs deliver pharmaceutical-grade nicotine without tobacco leaf or combustion, eliminating thousands of toxicants and lowering exposure to carcinogens such as tobacco-specific nitrosamines to near-undetectable levels. Epidemiological evidence from snus users provides a strong precedent for ONPs' potential impact on population health. Preclinical, toxicological, and biomarker studies consistently demonstrate a favorable safety profile for ONPs, with minimal cytotoxic or inflammatory effects. Their discreet, odorless, and spit-free design may further promote adherence compared with traditional nicotine replacement therapies. Despite this promise, skepticism persists within public health, particularly concerning youth uptake and the potential renormalization of nicotine use. Yet current evidence indicates that ONPs are primarily adopted by adult smokers and smokeless users seeking lower-risk options. Regulatory responses are uneven: while the U.S. Food and Drug Administration has authorized their marketing, other jurisdictions have enacted prohibitions that risk perpetuating cigarette consumption. Incorporating ONPs into tobacco control frameworks, especially in low- and middle-income countries where cessation support is scarce, represents both an urgent and ethical opportunity to accelerate progress toward ending combustible tobacco use.