Imperial Brands Science responds to the Tobacco Products Directive Evaluation Report

Five Years On, the EU Commission Still Won’t Acknowledge the Public Health Potential of Alternative Nicotine Products

In 2021, the scientific committee of the EU Commission, SCHEER, published a review of electronic cigarettes to provide updated scientific evidence on the health effects of vaping.

Imperial Brands’ response at the time was clear: we argued the Commission was struggling to acknowledge the growing body of scientific and real-world evidence supporting vaping as a compelling tool to help facilitate tobacco harm reduction (THR) and contribute to better public health outcomes.

The SCHEER report’s oversights were glaring; it focused narrowly on absolute risk, ignored real-world behavioural data, and overlooked the lived experience of millions of adults who smoke who had transitioned to potentially harm reduced vapes.

Fast-forward to this April, and the Directorate-General for Health & Food Safety has released its long-awaited TPD Evaluation Report, alongside a Joint Research Centre’s (JRC) publication on health outcomes for e-cigarettes, heated tobacco, and nicotine pouches.

Our science team analysed the Report and concluded that, despite the explosion of peer-reviewed research around next generation products (NGP) including vapes, heated systems, and oral nicotine pouches since the SCHEER opinion, the Commission is still ignoring the overwhelming weight of scientific and real-world evidence.

Scientific and Real-World Evidence – Cherry Picked

When we published our SCHEER response in 2020, we noted the committee had limited its review to studies published up to 2019. In 2026, the evidence base is not simply exponentially larger; it is dramatically clearer.

Adult smokers deserve access to next generation products – and to know the scientific facts about their potential risk reduction profiles.

Independent reviews from the UK, New Zealand, Canada, and the US[i] – plus advocacy from Sweden, Greece, and Czechia – continue to conclude that vaping and other NGP expose users to significantly fewer and far lower levels of toxicants than cigarettes.

Furthermore, clinical studies repeatedly demonstrate that adult smokers who transition to substantial reductions in biomarkers of exposure, often approaching the levels seen in those who quit entirely[ii].

Unfortunately, in several instances, the TPD Evaluation Report selectively cites, misinterprets – or even entirely omits – findings from these reputable sources.

The Report creates the false impression that NGP somehow exist in a vacuum, evaluated on absolute risk alone – rather than relative risk compared to cigarettes.

This, unfortunately, is the same fundamental flaw that undermined the SCHEER opinion.

Nicotine Misunderstood – Myths Perpetuated

Many expert health organisations have concluded that nicotine is not a carcinogen and is not – by itself – the cause of smoking related disease. In fact, the highest risks from smoking are from burning tobacco and inhaling the smoke, not nicotine.

Yet there are several instances within the Evaluation Report where the effects of nicotine itself are incorrectly conflated with product-specific effects. This apparent lack of understanding, and misinterpretation of the scientific evidence, is concerning.

Sweden: The World’s Most Successful THR Case Study – Ignored

Sweden is a public health success story when it comes to smoking-related disease – and this should be celebrated.

Perhaps the most striking omission in the Report is Sweden; by far the most compelling real-world demonstration of THR success anywhere in the world.

Sweden is on the brink of becoming the first country to reach “smokefree” status, defined as adult smoking rates below 5%[iii]. Regulators have achieved this not through prohibition, abstinence-only messaging, or punitive taxation – but through proportionate regulation of alternative nicotine products like snus and, more recently, tobacco-free nicotine pouches.

Sweden’s lung cancer rates, oral cancer rates, and smoking related mortality are dramatically lower than comparable European countries[iv].

Yet, across hundreds of pages of EU and JRC analysis, Sweden’s experience is essentially invisible.

A public health success story of this magnitude should surely be front-and-centre of any serious evaluation of tobacco and nicotine policy – but it isn’t.

Flawed Methodologies, Misrepresented Findings, and Missing Contextualisation

Our science team concluded the evidence base within the Evaluation Report relies heavily on non-peer reviewed, outdated, and – in some cases – inaccessible sources, which limits the reliability of the conclusions. Additionally, several statements extend beyond, or misrepresent, what is supported by the evidence cited, and omit critical scientific context.

For instance, the JRC report acknowledges that NGP differ from cigarettes in toxicant profile and exposure but crucially stop short of articulating what this potentially means for public health.

Instead, they default to the same narrative that dominated the SCHEER opinion: theoretical gateways for never-smokers (disregarding a substantial body of scientific evidence that goes against this hypothesis[v], backed up by the falling youth smoking rates in most countries), absolute risk from NGP, and continued uncertainty about long-term effects.

We agree the evidence base is still incomplete, but the  positive real-world evidence keeps on accumulating.

For instance, as of today, there is no evidence of fatalities from regulated nicotine vaping products in the EU.

Any regulatory framework that refuses to consider relative risk is missing the entire point of NGP, which were conceived and designed to offer adult smokers a potentially less harmful alternative to cigarettes.

A Public Health Opportunity – Overlooked

Five years on from SCHEER, the TPD Evaluation Report concludes that a precautionary approach remains the only scientifically defensible position regarding NGP.

High quality, scientifically substantiated NGP can help drive tobacco harm reduction.

The reality is that millions of adult smokers across Europe have already switched to NGP. Tens of millions more could also embrace the opportunity – but only if regulators base rules on science rather than ideology, and don’t reduce adult access to high quality, responsibly marketed NGP.

Instead, the Commission continues to send the opposite message: that all nicotine products, including combustible tobacco, are essentially the same, and that the only acceptable path is complete abstinence – despite the science clearly suggesting otherwise.

Five years ago, we criticised this ‘quit or die’-style mindset and raised concerns that, far from driving falls in smoking rates, prohibition-style approaches could result in unintended consequences – including a surge in illicit NGP.

Indeed, these concerns have materialised: today nearly 50% of e-cigarettes in the EU are sold through irregular channels.

Five Years Later, the Commission Still Lags Behind the Science

In 2020, we wrote that the SCHEER opinion “appeared out of touch with the current scientific consensus on vaping.” In 2026, the very same criticism unfortunately applies to the latest reports – this time encompassing not just vapes, but all NGP.

The truth is that between 2020-26 the science has evolved. Millions of adult smokers have transitioned. Countries including Sweden, the UK, the Czech Republic, and Greece are demonstrating that public health wins through falling smoking rates are possible through pragmatically regulating NGP.

Unfortunately, the TPD2 Evaluation Report fails to provide a sufficiently robust and balanced scientific foundation to support future regulatory decisions affecting every country in Europe – with significant public health implications for tens of millions of nicotine consumers across the EU.

Through our future consultation responses Imperial Brands will continue to engage on the behalf of adult nicotine consumers to advocate that regulation is informed and driven by substantiated research, real-world data, and genuine scientific consensus.

[i] Nicotine Vaping in England: 2022 Evidence Update: https://www.gov.uk/government/publications/nicotine-vaping-in-england-2022-evidence-update; Hammond et al., 2025 – Cancer Epidemiology, Biomarkers & Prevention: https://pubmed.ncbi.nlm.nih.gov/39992176/; Hammond et al., 2024 – JAMA Network Open: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2831325; New Zealand Ministry of Health – Vaping and Health: Evidence Update (2021): https://www.health.govt.nz/publication/vaping-and-health-evidence-update

[ii] Goniewicz et al., 2017: https://pubmed.ncbi.nlm.nih.gov/28166548; McNeill et al., 2018: https://www.gov.uk/government/publications/e-cigarettes-and-heated-tobacco-products-evidence-review

[iii] https://v3-media-se.haypp.com/sehaypp/files/2025_Lakeville_-_The_race_towards_a_smoke-free_society.pdf

[iv] https://imperialbrandsscience.com/geo-block-us/snus-and-the-eu-a-golden-public-health-opportunity/

[v] UK ref: NHS 2024. “In 2023, 11% (confidence interval 10-13%) of 11-15 year old pupils had ever smoked which is the lowest level ever recorded by this survey. ” “In 2023, 3% (confidence interval 3-4%) of pupils were classified as current smokers which is the same as in 2021.

US ref: NYTS data. Cigarette smoking reached the lowest level ever recorded by the survey, with only 1.4% of students reporting current use in 2024.

French ref: OFDT, 2025. Observatoire français des drogues et des tendances addictives. (2025). Drogues et addictions, chiffres clés 2025 [Key data on drugs and addictions 2025]. OFDT.

Beard et al., (2022) “Association of quarterly prevalence of e-cigarette use with ever regular smoking among young adults in England: a time-series analysis between 2007 and 2018.”  [link] Reported no association between increased vape use by adolescents and young adults in England and changes in smoking prevalence.

Fearon et al., (2023), “Curiosity and intentions to use myblu e-cigarettes and an examination of the ‘gateway’ theory: Data from cross-sectional nationally representative surveys” Funded by IMB. [link] Concluded: “There was minimal evidence to suggest the existence of a ‘gateway’ effect to established cigarette smoking among never-smoking myblu users.”

Hajat et al., (2022) “Analysis of common methodological flaws in the highest cited e-cigarette epidemiology research.”  [link] This commentary reported that many studies claiming a ‘gateway’ effect from vaping to smoking fail to properly account for confounding factors.

Sun and Hall., (2022) “Using survey data to test the hypothesis that e-cigarettes are a gateway to cigarette smoking in youth.”  [link]. Reported no association between increased vape use by adolescents and young adults in England and changes in smoking prevalence.

Wamba et al., (2023) “Impact of e-cigarette experimentation and use on smoking behaviour among adolescents aged 15-16 years in the Loire department, France.” [link]  Reported little evidence of a ‘gateway effect’.

[vi] UK: https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/healthandlifeexpectancies/bulletins/adultsmokinghabitsingreatbritain/2024; Czechia: Czech Statistical Office. (2023). Health Status of the Population (Zdravotní stav obyvatelstva) https://www.czso.cz/; Greece: Eurobarometer, Attitudes of Europeans towards tobacco and related products. European Commission, 2021; Statista, Health Indicators Greece report, 2024

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