Over the last decade, smoking has fallen across most high-income countries, but not at the same pace. In some jurisdictions, the decline has been steep; in others, more gradual and persistent. This variation is not solely explained by cultural or economic factors. It reflects differences in regulatory design and how policymakers approach nicotine use.
This Insight examines four contrasting models: the European Union’s precaution-oriented Tobacco Products Directive, the more market-driven substitution dynamics observed in the United States, the Nordic experience with long-established oral alternatives, and New Zealand’s structured integration of harm reduction into public health policy.
Across these cases, a central question emerges: should regulation primarily seek to control all nicotine use, or should it also enable transitions away from combustion?
Diverging trajectories in smoking decline
Smoking prevalence has declined on both sides of the Atlantic, but at different rates. In the European Union, rates fell from approximately 28% in 2012 to around 24% in 2023. Over a similar period, the United States saw a sharper decline, from roughly 18% to near 11–12%.
These differences do not imply a single causal explanation, but they do suggest that regulatory environments, particularly those influencing access to alternatives, may play a role in shaping the pace of change.
The EU model: precaution and standardisation
The EU’s Tobacco Products Directive (TPD), introduced in 2014, established a comprehensive regulatory framework covering both combustible tobacco and emerging nicotine products. It imposed limits on nicotine concentrations, restrictions on advertising, and standardisation of product formats and packaging.
This approach reflects a precaution-first philosophy. It seeks to minimise risks associated with both smoking and the uptake of new products, particularly among young people. At the same time, the framework emphasises consistency across Member States and regulatory control over product design and distribution.
Smoking prevalence has continued to decline under this model, although the pace has been comparatively gradual.
The US model: substitution through market dynamics
In contrast, the United States experienced a period of rapid smoking decline during which alternative nicotine products became widely available before full regulatory consolidation.
Successive product waves, pod-based systems, disposable devices, and oral nicotine formats, created multiple pathways for smokers to move away from combustible tobacco. Much of this transition was driven by consumer behaviour, with many individuals substituting rather than exiting nicotine entirely.
This environment was further shaped by rising cigarette prices, which increased the relative attractiveness of non-combustible alternatives.
Nordic countries: long-term substitution patterns
The Nordic experience provides a longer-term example of substitution dynamics. Sweden has reduced smoking prevalence to among the lowest levels in Europe, with Norway also achieving substantial declines.
These outcomes have been associated with the sustained use of non-combustible oral products, particularly snus. These products have been available for decades under regulated conditions and are embedded in consumer behaviour as alternatives to cigarettes.
Rather than a recent shift, the Nordic model reflects a long-standing pattern in which substitution away from combustion contributes to reduced exposure to smoke-related toxicants.
New Zealand: integrating harm reduction into policy
New Zealand represents a more structured model in which harm reduction has been explicitly incorporated into tobacco control strategy.
Strong regulatory oversight is combined with legal access to non-combustible alternatives and clear public health communication. Smoking has declined rapidly within this framework, suggesting that regulated access to alternatives can coexist with robust safeguards.
This model demonstrates how substitution can be guided within a defined policy structure rather than emerging primarily through market forces.
Interpreting the differences
These four cases illustrate two broad regulatory orientations. One emphasises precaution, standardisation, and control, aiming to limit risks across all nicotine products. The other allows greater scope for substitution, enabling alternative products to play a role in accelerating transitions away from cigarettes.
The faster declines observed in the United States, Nordic countries, and New Zealand suggest that access to alternatives may influence the speed of smoking reduction. At the same time, these environments also face distinct challenges, including youth uptake concerns, product variability, and enforcement complexity.
Conversely, more restrictive frameworks may maintain stronger control and consistency but may not generate the same pace of behavioural transition.
Evidence, evaluation, and policy design
These differences also highlight the importance of how evidence is incorporated into regulatory decision-making.
As noted in recent policy discussions, questions have been raised regarding the scope and balance of evidence considered in EU-level evaluations, particularly in relation to emerging nicotine products and comparative risk assessment.
From a regulatory perspective, the key issue is not the presence of oversight, but the extent to which evaluation processes are transparent, inclusive, and reflective of real-world behavioural patterns. Policy outcomes are shaped not only by rules themselves, but by how evidence is interpreted and translated into legislative frameworks.
Maintaining analytical depth and incorporating a broad range of inputs, including scientific evidence, consumer behaviour, and market dynamics, remains central to effective policy development.
Finding a workable balance
The comparison does not point to a single optimal model. Instead, it underscores the need to balance competing public health priorities.
Regulatory systems must simultaneously:
reduce smoking prevalence,
protect youth and non-users,
ensure product safety and quality,
and maintain clarity and enforceability.
The challenge lies in designing frameworks that address these objectives without undermining progress in reducing smoking-related harm.
Conclusion
Smoking is declining globally, but under very different regulatory conditions. The EU’s precaution-oriented framework, the United States’ market-driven transition, the Nordic substitution model, and New Zealand’s structured harm reduction approach each reflect distinct policy choices.
The evidence suggests that regulatory design plays a meaningful role in shaping outcomes, particularly in relation to the availability and use of alternatives to combustible tobacco.
For policymakers, the central task is not to choose between precaution and substitution as mutually exclusive approaches, but to determine how elements of both can be combined to support sustained improvements in public health.

