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Real-World Data Shows Tobacco Harm Reduction Potential as Scepticism Persists Among Regulators

Quick summary: Real world data from countries like Sweden and New Zealand demonstrates that promoting next generation nicotine alternatives can reduce daily smoking rates by over 50% by providing an effective exit route for adult smokers. Despite widespread misconceptions regarding nicotine and fears of youth uptake, comprehensive market evidence indicates that the transition away from traditional cigarettes significantly outweighs any potential gateway effects. These insights carry profound implications for public policy and healthcare practice, suggesting that adopting risk differentiated regulation rather than outright prohibitions is essential to support tobacco harm reduction and improve population well being.




Real-world evidence is increasingly demonstrating tobacco harm reduction in action, but many public health bodies and regulators remain sceptical. Joe Thompson, Group Science and Regulatory Affairs Director at Imperial Brands, builds on his panel contribution at the World Nicotine Congress to examine the arguments.

Longitudinal, observational research such as actual use studies are now complementing traditional emissions testing and clinical trials, providing a closer-to-real-world picture of how individuals who smoke use next-generation products (NGPs) including vapes and nicotine pouches, and whether these product help them transition away from cigarettes.

Persistent misconceptions

Despite mounting evidence, tobacco harm reduction is not universally endorsed. Concerns include from misconceptions about the absolute risk of NGPs and nicotine, to the absence of long-term epidemiological data on health impacts. Industry-funded studies are frequently dismissed out of hand, while fears persist that NGPs serve as an on-ramp to regular nicotine use and future cigarette smoking among youth.

These concerns are understandable and worthy of debate, but they must be weighed against the growing body of scientific evidence. On nicotine, expert health organisations have concluded that it has not been established to cause cancer, yet this myth persists. On the gateway concern, in-market data from the NHS 2024, NYTS, and OFDT 2025 consistently shows that the off-ramp from cigarettes to NGPs among adult smokers is significantly larger than any on-ramp among never-smokers, including youth. Panels at the World Nicotine Congress broadly agreed that banning NGPs on gateway grounds would be an own goal for public health.

Country-level evidence

The most compelling data comes from nations that have embraced harm reduction strategies in their tobacco regulation.

Sweden is on the cusp of becoming the world’s first smoke-free country, driven by decades of access to potentially reduced-harm, smoke-free alternatives such as snus and, more recently, tobacco-free nicotine pouches. According to a report by Dr David Sundén, the number of daily smokers in Sweden is roughly one-third of the EU average.

In New Zealand, the daily smoking rate has fallen by around 58% since 2011–2012, following the promotion of vaping and heated tobacco as cigarette alternatives, according to the New Zealand Health Survey 2022–2023.

The case for risk-differentiated regulation

Nobody argues that NGPs are risk-free, which is why responsible manufacturers market them towards adult smokers only. However, dismissing them outright, or regulating them as harshly as cigarettes, ignores the growing weight of scientific and real-world evidence. It also risks pushing former smokers back to cigarettes or into illicit markets, as is reportedly occurring in the Netherlands according to the Brussels Times.

With major regulatory milestones approaching, including the latest revision of the EU Tobacco Products Directive, policymakers must recognise the continuum of risk and regulate accordingly. Ignoring or cherry-picking scientific data when making tobacco control decisions is potentially damaging to future public health outcomes.

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