The Commission’s answer to a parliamentary question on the French nicotine pouch ban should worry anyone who still believes that the internal market is meant to mean something. It is obvious that maintaining a disproven dogmatic position on the dangers of nicotine pouches is more important than the fundamental internal market principle of mutual recognition. If nicotine pouches can be banned in markets where 24% of the population smokes on the basis of public health concerns it would be possible to ban anything anywhere.
The starting point in EU law is not prohibition. It is free movement. Under the principle of mutual recognition, a product lawfully sold in one Member State should generally be allowed to be sold in another, even where EU harmonisation is incomplete or absent. The Commission’s own explanation of mutual recognition says precisely this: goods not fully harmonised at EU level should enjoy market access unless very specific conditions are met, including health, safety or environmental grounds.
That principle is rooted in Articles 34 to 36 TFEU and the logic of Cassis de Dijon. Article 34 prohibits quantitative restrictions and measures having equivalent effect. Article 36 allows exceptions for public health, but those exceptions are not magic words. They must be interpreted narrowly, must be based on evidence, and must be proportionate. The European Parliament’s own summary of free movement rules notes that Article 36 exceptions cannot become arbitrary discrimination or disguised restrictions on trade, and must directly serve the public interest in a proportionate way.
This is where the Commission’s response fails.
The French measure is not a labelling rule, a product standard or a targeted youth-protection measure. It is a ban and criminalization of oral nicotine products, including nicotine pouches, while cigarettes remain legal and widely available. France notified the measure under TRIS as a proposal to prohibit products for oral use containing nicotine. The same notification shows that seven Member States, Romania, Greece, Hungary, Slovakia, Sweden, Czechia and Italy, issued detailed opinions on the proposal.
Yet the Commission now says it has not identified “sufficient elements” indicating that the French legislation would be unjustified or disproportionate.
That is not a neutral position. It is a decision to look away.
Article 36 is not a shortcut around evidence
Of course Member States have discretion to choose their level of public-health protection. No one disputes that youth protection matters. No one disputes that nicotine is not risk-free. Nicotine can cause dependence, and products containing nicotine should be regulated.
But Article 36 does not allow a Member State to prohibit a substantially lower-risk product simply by invoking “health” while ignoring the product it is replacing. In public health, the relevant question is not whether nicotine pouches are completely harmless. The relevant question is whether banning them is a proportionate response in a country where cigarettes remain available and where adult smokers are denied access to a non-combustible alternative.
That is where the French approach collapses. The measure treats nicotine pouches as if they are a higher risk to public health than cigarettes. They are not. The rule is imposed in a Member State where around 24 percent of adults still smoke, according to the Commission’s own 2026 evaluation communication.
A public-health assessment that ignores cigarettes is not public-health analysis. It is category blindness.
“Serious health risks” is not an argument
Commissioner Várhelyi’s answer repeats the claim that novel tobacco and nicotine products, including nicotine pouches, pose “serious health risks” and represent a “significant public health concern.”
Used in this way, the statement is unsupported and misleading.
Nicotine pouches are not cigarettes. They are not burned. They do not produce smoke. They do not expose users to combustion products, tar or carbon monoxide. The health risks of smoking are driven overwhelmingly by combustion and inhalation of toxic smoke. Nicotine contributes to dependence and habit formation, but it is not the main driver of smoking-related cancer, COPD or cardiovascular mortality.
The FDA has just demonstrated what a serious evidence-based assessment can look like. In June 2026, it authorised 20 nicotine pouch products to be marketed with a specific modified-risk claim: that using these products instead of cigarettes lowers the risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis. The FDA stressed that the decision followed extensive scientific review.
This means that according to the FDA the risk difference is real, material and scientifically defensible.
The FDA had already authorised the same products for marketing in January 2025, finding that they contained substantially lower amounts of harmful constituents than cigarettes and most smokeless tobacco products.
That is the comparison the Commission refuses to make. In fact they refuse to even consider the relative risk at all and make claims that are unsupported or even goes against the scientific consensus. There is no feasibility in the statement that nicotine pouches are equally dangerous as cigarettes, even if one would include extremely long chains of causality i.e. that they would somehow contribute to increase smoking etc. More on the gateway myth later.
The Commission knows how to do better
The Commission’s own mutual-recognition guidance shows what should happen when a Member State restricts access to a non-harmonised product. National decisions restricting market access should set out the technical or scientific evidence considered and include evidence that the decision is appropriate and proportionate. The Commission has itself criticised national decisions where that scientific and proportionality reasoning was insufficient.
That standard should apply here.
Instead, the Commission appears willing to accept a French ban on the basis of broad assertions about nicotine, youth and public health, while disregarding the risk gradient between cigarettes and non-combustible nicotine products.
There are better European examples. When the EU regulated e-cigarettes under the Tobacco Products Directive, it did not simply ban them as a category. It introduced product requirements, nicotine concentration limits, specific packaging, notification obligations and safety rules. The Commission itself explains that the Directive sets a maximum nicotine concentration and volume for cartridges, tanks and nicotine liquid containers, requires child-resistant and tamper-evident products, and imposes purity and delivery requirements.
That is regulation. If it is a good one I leave to other to comment on. But a blanket prohibition of nicotine pouches, while significantly more problematic products remain on the shelves, is something else.
Sweden shows why the gateway theory cannot carry a ban
The French and Commission logic relies heavily on youth and gateway concerns. Again, youth use must be addressed. But gateway claims must be tested against real-world evidence.
Sweden is the obvious place to look. Daily smoking among Swedes aged 16 to 84 was 5.4 percent in 2024. More recent studies indicate figures below 5%. Among those aged 16 to 29, daily smoking was only 2,3 percent. At the same time, nicotine pouch use has increased and tobacco related disease is a fraction of that of other member states.
This is not what a smoking gateway looks like.
If nicotine pouches were pulling people into smoking at population level, Sweden should be one of the first places where that effect appears. Instead, Sweden has some of Europe’s lowest daily smoking rates. The burden should be on those claiming a gateway to show where the smokers who supposedly entered through that gateway are.
Better Regulation is not optional
The deeper problem is not only this answer. It is the pattern.
The Commission’s own Regulatory Scrutiny Board issued a negative opinion on the tobacco-control evaluation. The official evaluation document confirms that the draft Staff Working Document was reviewed by the RSB and that the Board issued a negative opinion on 12 December 2025.
The Commission then proceeded anyway.
Stakeholders have also criticised the consultation process as risk-blind and poorly suited to distinguishing between products with very different risk profiles. ETHRA described the 2026 consultation as “impossible to answer” in a meaningful way because it lumps tobacco and nicotine products together instead of properly reflecting relative risk. MEPs made similar statements criticizing the consultation and questioning if it had any value.
This matters because the Commission is supposed to be the institution that prepares legislation independently, proportionately and on the basis of evidence. If it selectively invokes the internal market when it wants harmonisation, but looks away when a Member State criminalises access to lower-risk products, confidence in that role is damaged.
The Commission cannot simultaneously claim to defend Better Regulation, scientific integrity and the internal market while accepting risk-blind prohibitionist measures that treat nicotine pouches as if they were cigarettes.
Time for a reset
The French ban should not be treated as a harmless national experiment. It is a direct challenge to mutual recognition, proportionality and evidence-based policy.
A proportionate approach is available: age limits, strict enforcement, sanctions for proxy sales, responsible retailing, product standards, nicotine limits, marketing rules and risk-based taxation. These tools address legitimate concerns without denying adult smokers access to a non-combustible alternative.
The Commission’s answer does the opposite. It elevates vague claims about “serious health risks” over the scientific consensus that non-combustible nicotine products are substantially less harmful than cigarettes. It ignores the Swedish experience. It treats Article 36 as a convenient escape route from the internal market and a reason not to deal with France. And it does so at the very moment when its own evidence base for future tobacco and nicotine legislation has been criticised by its own scrutiny system.
It is time for the Commission to take a serious step back.
Europe does not need legislation built on dogma, selective evidence and preconceived assumptions. It needs a regulatory framework that recognises risk differences, protects minors, preserves adult access to lower-risk alternatives and treats the internal market as a principle rather than an inconvenience.
Right now, the Commission is failing that test.