ROME, APRIL 9TH 2026
Dear Commissioner Varhelyi,
Last Thursday, we had the opportunity to read the results of the evaluation report on the review of the Tobacco Products Directive (TPD).
While we support and support the need to strengthen tobacco control policies to protect minors who are starting to smoke and non-smokers, we believe the evaluation report suffers from an imbalance in the scientific evidence and would like to highlight the following points:
• Better regulatory standards promised but not delivered
The European Commission promised an evidence-based and impartial evaluation. Instead, the process failed to meet its standards, reaching conclusions based on opinions, assumptions, and clear gaps in the evidence. The risk is that bias will cloud the data, which is the only reliable tool for making accurate, evidence-based decisions that can truly help and support the public.
• Independent science, particularly on harm reduction, has been sidelined.
The Commission fails to take science seriously. DG SANTE relies on incomplete evidence, fails to properly evaluate smoke-free products compared to cigarettes, and repeats claims widely rejected by scientists. The report characterizes vaping as a gateway to smoking, despite robust evidence showing that a record number of adult smokers have switched to vaping products, reducing the negative impact on their health or as an acceptable transition tool to quitting.
People need clear answers to make informed choices, but this assessment fails to even address the fundamental question of whether smoke-free nicotine products are less harmful than traditional smoking. By failing to address this issue, it ignores a fundamental question.
Although the Commission has committed to “gathering scientific evidence on the health risks and benefits” of tobacco and nicotine products, its assessment fails to meaningfully address the science of tobacco harm reduction and adopts the “quit or die” dichotomy, which places the burden of the health consequences on the person with tobacco use disorder, ignoring all the social and economic determinants that contribute to the development of their addiction and the resulting burden of disease.
• The Commission relies largely on the SCHEER opinion, which does not assess the comparative risks of vaping versus traditional smoking. This is precisely the comparison consumers need to make informed choices, which many smokers have already made through a process of trial and error, aware of the risks and the need to at least partially improve their consumption patterns.
• The Commission’s official statements have downplayed the risk-reduction potential of smoke-free products, contradicting international health authorities and independent researchers, and putting consumers at risk.
• Evidence demonstrating that alternative flavors and products help adult smokers switch to combustion-free products has been ignored or downplayed. Furthermore, focusing on the “risk vs. nonuse” comparison ignores the reality that many consumers will not quit nicotine completely. Different dependence profiles (strong or long-standing) exist that make smokers resistant or their receptor structure fixed.
• The Open Evidence Report used by the Commission considered only 10 Member States and was largely based on data prior to 2017. Furthermore, only 26% of the literature reviewed was based on data from EU Member States, without any significant consideration of harm reduction, a partial prevention tool already adopted in numerous branches of medicine.
• The Swedish case completely ignored
Sweden reduced smoking by 54% in the same period by ensuring that safer alternatives to nicotine—such as snus, nicotine sachets, and e-cigarettes—are acceptable, accessible, and affordable. As a result, Sweden now has the lowest smoking rates in Europe—5.3% in 2024 and currently 3.7%—and a dramatically reduced disease burden, including a 61% lower male lung cancer mortality rate than the EU average and a 34% lower overall cancer death rate. However, the only reference to Sweden in the Commission report is as a warning about the use of nicotine sachets. The information presented in this way is unbalanced and does not help citizens make informed choices.
Conclusions – As the MOHRE Observatory, which has been applying the principles of risk reduction as a partial prevention tool in the medical field for years, particularly in the fight against smoking, we believe that this evaluation represents a missed opportunity to truly advance European public health.
Harm reduction is neither a new nor controversial concept in medicine. It is the rationale that governs the treatment of opioid addiction, diabetes management, pathological gambling policies, and numerous other areas. Applying this same rationale to smoking is not a concession to industry: it is applied science, real-life experiences for people with tobacco addiction.
We therefore call for:
1. Adopting a comparative, not absolute, risk assessment approach, recognizing that the relevant comparison for public health is not between smoke-free products and no use, but between smoke-free products and combustible cigarettes, which continue to kill 700,000 Europeans every year.
2. Include in the TPD review the evidence produced by independent health authorities—including Public Health England, the US FDA, and the researchers who documented the Swedish case—rather than relying solely on selective opinions that ignore decades of peer-reviewed literature on assisted smoking cessation.
3. Recognize that the heterogeneity of addiction profiles requires a variety of therapeutic tools. Imposing a single tobacco cessation route—total and immediate cessation—is equivalent to ignoring everything that behavioral medicine and addiction neuroscience have taught us over the past thirty years.
4. Conduct a serious analysis of the Swedish experience, which constitutes the most rigorous natural experiment available in Europe on the impact of tobacco harm reduction on population health. Ignoring it is not scientific caution: it is an omission that would require explicit justification.
A review of the TPD based on filtered evidence will not only fail to achieve its public health objectives but also risks pushing adult smokers toward more harmful products due to poorly calibrated regulation. As the Scientific Board, we cannot emphasize enough that protecting health requires the courage to follow the evidence, even when it leads in politically inconvenient directions.
We remain available to contribute our scientific expertise to the review process, in the belief that a dialogue based on robust data and transparent methodologies can lead to policies that effectively protect both non-smokers and smokers seeking realistic harm reduction paths.
Respectfully,
· Johann Rossi Mason, Sociologist and Director of MOHRE Observatory
· Fabio Beatrice, MD PhD, Director of Scientific Board MOHRE Observatory
· Claudio Leonardi, MD PhD, Presidente della Società Italiana per le Malattie da Dipendenza (SIPaD) and Member of Scientific Board MOHRE Observatory
· Konstantinos Farsalinos, MD, PhD, visiting researcher at the University of Patras, Greece. Smoking Behavior Research Unit, University of Western Attica, Greece, and scientific member MOHRE Observatory Board
· Giacomo Mangiaracina, MD, Presidente ANP, Past President SITAB and Member of Scientific Board MOHRE Observatory
· Giuseppina Massaro, Psichologist and Member of Scientific Board MOHRE Observatory
· Claudio Zin, MD, PhD, specializing in Nephrology at the University of Buenos Aires Clinics Hospital (UBA), Science Journalist, Former Minister of Health of the Province of Buenos Aires, Argentina and Member of Scientific Board MOHRE Observatory
· Heino Stover, Executive Director of the Institute for Addiction Research in Frankfurt (ISFF) and Member of Scientific Board MOHRE Observatory
