The European Commission presents its evaluation of the tobacco control framework as a comprehensive and evidence-based exercise. Yet a closer reading reveals a structural contradiction at the heart of the process.
The Commission itself states: “The majority of the responses (89%) came from EU and non-EU citizens” In other words, the consultation is overwhelmingly driven by ordinary people. Not institutions. Not regulators. Not advocacy groups. Citizens.
This matters. Because if a consultation is meant to capture real world experience, then this is precisely the group that carries it. Yet the same document makes clear that these responses are not treated on equal footing.
Campaign driven or simply engaged citizens?
In the annex analysis, the Commission introduces a crucial qualifier. It highlights the presence of what it describes as campaign driven responses and overrepresentation among certain groups of users. This framing has consequences. It provides the basis for discounting the largest body of input in the entire exercise. But there is an obvious question that follows. How are ordinary citizens supposed to participate in a consultation if they do not know it exists?
Public consultations are not neutral spaces where a random cross section of the population happens to appear. Participation requires awareness. Awareness typically comes through engagement. Often through consumer groups, online communities or advocacy networks. In practice this means that the people most likely to respond are those with direct experience. Those who have used these products. Those who have changed their behavior. Calling this overrepresentation might be technically correct. But it is also unavoidable. And more importantly, it is informative. It reflects where real world change is happening.
What consumers are actually saying
The same evaluation acknowledges patterns in consumer behavior that are difficult to ignore. Across the document, there are repeated references to declining smoking prevalence: “the prevalence of smoking among citizens also decreased from 28% in 2012 to 24% in 2023.”
At the same time, nicotine pouches have emerged and expanded rapidly: “nicotine pouches saw a marked increase in use by 2023, particularly among young people.”
We are all concerned about young people’s health and underage people should not use any nicotine product, so far, we agree. But when presented without any related data nor any reflection on relative risk they are likely to be interpreted in a skewed and unrepresentative manner. These trends are not abstract. They reflect behavior. They reflect substitution. They reflect people moving away from combustible tobacco.
Yet when consumers describe these transitions in their own words, their input is reframed as biased or campaign driven. This creates a disconnect between observed outcomes and accepted evidence.
A process that excludes by design
There seem to be two types of citizen for the European Commission. Those that never hear about the consultation and therefore never respond and those who can be dismissed as non-representative because they do hear about it, often through networks of users or consumer communities. This is not a neutral system. It is a filter.
It selects for engagement, then questions the legitimacy of that engagement. The result is predictable. Real world experience becomes structurally marginalized.
The consequences for policy
When the largest dataset is discounted, other forms of reasoning fill the gap. The evaluation places strong emphasis on risks associated with nicotine. It highlights specific groups such as pregnant women and individuals with cardiovascular conditions. It notes that nicotine can increase heart rate and blood pressure and stresses uncertainty around long term effects.
These statements are factually grounded within their scope, but they are presented in isolation and framed in a way that exaggerates their relevance for the general population. The evaluation highlights specific risk groups such as pregnant women and individuals with cardiovascular conditions, yet this type of reasoning is not applied consistently across other everyday exposures. By the same logic, activities such as climbing stairs or engaging in moderate exercise could be restricted due to transient cardiovascular strain. The issue is not whether these risks exist, but whether they are meaningful at a population level. In this case, the document fails to distinguish between targeted medical caution and general public health relevance, leading to conclusions that do not reflect real world risk distribution.
At the same time, the document acknowledges a key distinction: “nicotine pouches contain fewer toxicants and expose users to fewer harmful constituents than traditional tobacco products.”
This is the point where a discussion of relative risk would naturally follow. It does not.
Instead, products with very different risk profiles are grouped together. Outcomes are inferred from worst case scenarios. And behavioral evidence from millions of consumers is treated as secondary. This is not a balanced assessment. It is selective and intentionally misrepresentative.
The commission then double down on the cherry picking and the report states: “Nicotine pouches are not proven tools for smoking cessation, and it is unknown how their availability will affect overall smoking cessation rates“. To arrive at this conclusion, one has to ignore a consistent empirical pattern: Member States with a tradition of oral nicotine use all show significantly lower smoking prevalence, regardless of the level or intensity of conventional tobacco control measures. Sweden applies the same tobacco control measures as other EU countries. What is different is that smokers have access to viable alternatives. That is the only factor that consistently aligns with its uniquely low smoking prevalence.
Ignoring substitution while warning about transition
The evaluation repeatedly raises concerns about transitions into smoking. At the same time, it documents a sustained decline in smoking prevalence and a rise in the use of alternatives. These two observations sit uneasily together. If alternatives were primarily a gateway into smoking, the expected trend would be an increase in smoking rates. The opposite is observed. The obvious question is “where are all the smokers from the gateway?”
This tension is never resolved in the document. It is managed by shifting the weight of evidence away from consumer experience and statistics towards hypothetical risk pathways.
Who is this evaluation for?
The stated purpose of the framework is clear: “ensuring a high level of human health protection” If that is the objective, then the most relevant question is simple. What works in practice. The consultation provided a large-scale answer from the people directly affected. 89 percent of respondents. Yet their input is systematically reframed. This raises a fundamental question. Is the evaluation designed to understand behavior or to confirm a predetermined narrative?
The stakes
The Commission has a powerful tool at its disposal. It can continue allowing consumers to move away from the most harmful forms of nicotine use. It can recognize substitution where it occurs. It can differentiate based on product characteristics, including reduced risk, or it can treat all nicotine use as a problem in itself, independent of context or carrier. The current evaluation leans towards the latter.
The danger is not theoretical. It is practical. When policy ignores real world behavior, it does not eliminate it. It distorts it. It pushes it into less visible channels. It undermines trust. And ultimately, it risks slowing down the very progress it seeks to achieve.
A consultation where 89 percent of responses come from citizens is not a flaw. It is a signal. A system that discounts that signal is not cautious. It is rigged.
If this approach continues, the gap between policy and reality will widen and when that happens, the cost is not measured in documents or consultations.
It is measured in outcomes.
Brussels policymaking works best when it is rigorous, transparent, and fair — especially on files as politically charged as tobacco and nicotine regulation. We need to be clear on this: credibility requires balance, and balance requires that different products are assessed differently, that citizen voices are not sidelined, and that enforcement and unintended consequences are treated as core realities — not afterthoughts.
If the Impact Assessment does that work properly, Europe can move toward smarter regulation: youth protection that is enforceable, internal market rules that are coherent, and policymaking that meets the Commission’s own Better Regulation standards.