Statement:
1.This article was submitted to 2Firsts by the authors. The views expressed in this piece are solely those of the authors and do not represent the views or positions of 2Firsts. 2Firsts publishes this content to encourage diversity of perspectives and informed dialogue within the industry.
2.The news headline, summary, and key points were prepared by 2Firsts for reader clarity, while the original title supplied by the authors has been retained for the main text.
The author puts forward the following key arguments and recommendations in this article:
Regulatory logic: The EU’s current assumptions about novel nicotine and tobacco products may become a self-fulfilling prophecy: by narrowing the space for alternatives, regulation could unintentionally reinforce the position of combustible cigarettes.
Evidence gap: The author argues that the European Commission attributes too much of the decline in smoking to its existing framework, while insufficiently examining the role that alternative products may have played in reducing cigarette consumption.
Policy signals: The real value of the evaluation lies not only in what it explicitly says, but in the signals it sends about stricter and more harmonised future regulation, especially on flavours, labelling, track and trace, nicotine pouches and digital marketing.
Business risks: Companies should be alert to the possibility that “simplification” may translate into more direct bans, stricter standardisation or higher administrative costs, while both EU-level and national-level rules continue to tighten.
Business response: Companies should plan against realistic timelines, closely monitor both EU and Member State developments, and reassess product portfolios, ingredient strategies, labelling, system interoperability and compliance costs in advance.
2Firsts Guest Contribution
April 22, 2026
EU Tobacco Framework Evaluation: Is the Commission’s Assumption Becoming a Self-Fulfilling Prophecy?
Reading between the lines of the Commission’s assessment to distill implications for the industry
Date: April 2026
Author: Carlos Cabrera- Founder & Managing Director CabLab Law & Advocacy*
The European Commission has recently published its evaluation of the EU tobacco control framework, centred on the Tobacco Products Directive, the Tobacco Advertising Directive and related tobacco control measures across the European Union. The evaluation is part of the broader policy process that will inform the next phase of EU tobacco regulation and a future revision of the current framework. For readers outside Europe, this is not yet the new Directive itself, but it is one of the clearest official signals of the Commission’s current diagnosis, priorities and likely direction of travel.
Reading the European Commission’s recent evaluation of the EU tobacco control framework, it is hard not to think about that old idea, somewhere between mythology, sociology and psychology, that reality has a curious tendency to bend under the weight of belief.
In Greek mythology, Pygmalion fell in love with a statue he had carved himself. His conviction was so intense that, according to the myth, the statue, Galatea, eventually came to life. Centuries later, Robert K. Merton gave this phenomenon a name: the self-fulfilling prophecy. When a situation is defined as real, it becomes real in its consequences.
For years, the same assumption has been repeated with notable persistence: novel nicotine products act as a gateway to traditional smoking. The evidence behind that claim, at least in the Commission’s own material, remains far from conclusive. Still, the assumption holds.
The problem is not just theoretical.
If regulation is built around that premise, and progressively removes what differentiates alternative products, the framework itself may start shaping behaviour in a way that confirms the original assumption. Not because it was right, but because it was made inevitable.
A framework that works… or one that takes credit?
The Commission concludes that its framework has limited advertising, increased awareness, reduced the appeal of tobacco products and influenced young people’s attitudes towards smoking. It goes further and links this to the decline in smoking prevalence and sales between 2012 and 2023.
That is a strong statement.
One might reasonably ask whether the Commission is not being somewhat generous in attributing these outcomes mainly to its own policies. The causal link between specific measures and behavioural change is suggested, but not really demonstrated.
At the same time, the same evaluation expresses concern about the rapid growth of novel nicotine products.The link between both trends is barely explored. It sounds like someone is not wanting to connect the dots.
Is it not at least plausible that the availability of alternatives has played a role in the decline of traditional tobacco consumption? That behaviour has been influenced less by larger warnings, track and trace or ingredient reporting, and more by the simple existence of substitutes?
The timeline would suggest so.
As cigarette consumption declined, e-cigarettes, heated tobacco products and nicotine pouches expanded. In markets where harm reduction has been more openly considered, such as Sweden or the Czech Republic, that correlation is even harder to ignore. Yet the evaluation seems reluctant to follow that line of reasoning too far.
The real imbalance: where is the “emergency”?
There is another imbalance worth noting.The Commission repeatedly refers to the “emergence” and rapid growth of novel products as a concern. At the same time, it acknowledges that smoking prevalence in the EU remains high, particularly among young people, and still struggles to fall below 20 percent.
That creates an odd contrast. Products with still-evolving evidence are treated as an urgent issue. Products whose risks have been well known for decades continue to show stubbornly high levels of use.
One would expect the sense of urgency to be distributed differently.
What actually changes behaviour?
At the core of this debate there is a simple question. What really drives behaviour?
Is it regulation on its own, or the availability of credible alternatives? It might be both.
If regulation moves towards treating different product categories in a similar way, through packaging, flavour restrictions, nicotine thresholds and marketing limitations, the signal to consumers becomes quite clear: these products are essentially the same.
And if they are the same, behaviour tends to fall back on what is familiar. For many nicotine users, that means combustibles.
In that sense, the regulatory approach itself can start producing the outcome it is trying to avoid. It is a dynamic well described in classic self-fulfilling prophecy cases, where attempts to prevent something end up bringing it about.
When assumptions start shaping outcomes
This is where the parallel becomes difficult to ignore.But there is also a key difference.
In the myth, belief turns fiction into reality. In public policy, that should not be enough. Outcomes need to be grounded in evidence, and assumptions should remain open to challenge as per EU Better Regulation standards.
At times, the Commission’s scepticism towards novel products seems almost matched by its confidence in its own framework.
One could say, not without some irony, that the distrust of new categories is only exceeded by the trust in existing policy tools.
However, unlike Pygmalion and Galatea, regulation does not become true just because it is believed in. The persistence of high smoking rates suggests that reality is more stubborn than that.
Closing the circle
Self-fulfilling prophecies are fascinating in literature and sociology. They should not guide public policy though.
Because when they do, the risk is not just analytical. It becomes practical. A framework designed to reduce harm may end up reinforcing it.
In this case, the paradox is clear. By narrowing the space for alternatives, regulation may unintentionally strengthen the position of the very products it seeks to displace.
That would be the real tragedy. Not a mythical one, but a very real missed opportunity to move towards a smokeless Europe.And perhaps, in the end, a policy outcome shaped less by evidence than by the persistence of its own assumptions.
Like Pygmalion, not discovering reality, but shaping it. The difference is that, this time, what comes to life may not be what was intended.
Appendix
Reading between the lines: what should the industry really watch (“So what?”)
Much of this discussion will feel familiar across the industry. The debate around proportionality, harm reduction and evidence is not new and will continue.
But there is another layer that deserves attention.Beyond the policy debate, the real value of this evaluation lies in what it signals.Not so much in what it says explicitly, but in what can be inferred from it.Several points stand out.
The Commission itself acknowledges that certain mechanisms are “complex, inefficient and ineffective”, particularly in relation to characterising flavours, the EU Track and Trace system and the EU-CEG reporting framework.
This might look like an opportunity for simplification. In practice, it may not be that straightforward.
Simplification does not necessarily mean flexibility. When talking about ingredients or flavours, it can also mean more direct bans or stricter standardisation, sometimes inspired by jurisdictions where entire categories of ingredients or additives are simply prohibited regardless their use might not imply a characterizing flavor. Cigarette Manufacturers present in APAC markets such as Thailand, Hong Kong or Taiwan are on the way to experience these rules already.
For manufacturers, this raises immediate questions around product composition, portfolio resilience and consumer acceptance. And for e-cigarettes, heated and pouches, the concerns on how standards applied to traditional cigarettes will be applied then to these categories.
Track and trace presents a different type of challenge. As global supply chains evolve, the coexistence of different systems may start creating friction. Any adjustment at EU level could add complexity, especially when multiple regulatory systems need to be reflected/ co-live in the same product. We can think for example about co-existence between China QR-Code and EU T&T requirements and the interoperability between them and how any change to each might impact production and economic feasibility.
There is also the cost dimension. If certain systems are considered resource-intensive, the solution may not be simplification but redistribution of costs. Higher fees or additional administrative burdens cannot be ruled out, imposing higher burdens for SMEs sized companies.
More broadly, the repeated reference to inconsistencies across Member States points towards further harmonisation.
That could affect flavours, disposables, packaging rules and the treatment of categories such as nicotine pouches or cigars and cigarillos (traditionally benefiting from relevant labelling exemptions).In that process, existing differentiated approaches may come under pressure.
For heated tobacco products, the lack of clarity around combustion and the resulting variation in labelling is unlikely to remain as it is. A move towards stricter and more uniform labelling requirements seems likely.
Nicotine pouches may be drawn more fully into the regulatory framework, including limits on nicotine levels and broader marketing restrictions.
Digital promotion, particularly through social media and influencers, is clearly on the radar. Further restrictions here should be expected, possibly including tighter control of sales channels.
From a practical standpoint, wrapping up, the following areas should be closely monitored:
Flavour regulation and ingredient restrictions
Potential shift from complex assessment procedures to more direct prohibitions or standardised limits, with material impact on product portfolios.
EU Track and Trace and system interoperability
Risk of increased operational complexity due to coexistence with other international traceability systems and potential adjustments at EU level.
Regulatory cost reallocation (EU-CEG, Track and Trace and other compliance systems)
Possibility that “inefficiencies” are addressed through higher fees or additional administrative burdens rather than simplification.
Harmonisation across Member States
Likely push towards alignment on flavours, disposables, packaging and nicotine pouches, reducing current regulatory flexibility.
Heated tobacco product classification and labelling
Expected move towards stricter and more uniform requirements, potentially aligned with cigarettes frameworks.
Nicotine pouches integration into the regulatory framework
Increased likelihood of EU-level nicotine limits and extension of marketing, packaging and distribution restrictions.
Digital marketing and distribution channels
Heightened scrutiny on social media promotion, influencer activity and cross-border sales, with potential tightening of permitted sales channels, potentially impacting on-line sales.
Timing matters more than noise (“So when?”)
For all the intensity of the debate, timing is important.
Following the evaluation, the next step will be an impact assessment, likely running into early 2027. A legislative proposal could follow, with adoption somewhere between 2027 and 2028.
Operational impact would realistically be felt between 2028 and 2030. In a most realistic scenario, we would not bet for a manufacturing/import deadline before 2029 and a market clearance before 2030.
This is worth keeping in mind. The policy debate may accelerate, but business decisions should remain anchored in realistic assumptions of timeline complemented with continuous monitoring.
In the meantime, the real action continues at national level, where regulatory developments are already moving.
Author Bio
*Carlos Cabrera is Founder & Managing Director of CabLab Law & Advocacy. Carlos is a qualified Spanish lawyer with studies in Law and Public Affairs Management and brings over 13 years of international experience in highly regulated sectors and multinational environments, with a strong specialization in FMCG. His career spans Legal, Regulatory and Corporate Affairs roles with global scope, leading projects in Europe, Asia Pacific and Middle East markets. （The author bio was provided by the author.）
