A quiet internal move in the European Commission is sending unusually loud signals across Brussels. The Tobacco Products Directive, one of the EU’s most sensitive health files, has been reassigned after a negative scrutiny opinion. Behind the technical language lies a more fundamental problem: the evidence base is under question. At the same time, political pressure is building around the figures shaping the file. Taken together, this is no longer just about process. It is about credibility.
The European Commission has quietly but significantly reshuffled responsibility for the Tobacco Products Directive dossier inside DG Santé. According to reporting by TobaccoIntelligence, the file has been moved from the Disease Prevention Unit to the Scientific Advice and Reporting Unit following a negative opinion from the Regulatory Scrutiny Board. This is not a routine adjustment. It signals that something has gone wrong at a more fundamental level.
The Commission’s own evaluation appears to rest on incomplete submissions from most member states, forcing reliance on extrapolation across the EU27. The available data is described as limited, scattered and inconsistent. This is not a technical detail. It goes to the credibility of the entire exercise. If the evidence is weak, the conclusions cannot be strong. Moving the file to a unit focused on scientific analysis is therefore both corrective and revealing.
For DG Santé, this is a clear setback. A central health file has triggered a negative opinion from the Commission’s own scrutiny mechanism. At the same time, it shows that the system still functions. The RSB exists to stop weak analysis from underpinning legislation, and in this case, it appears to have done so.
The implication is straightforward. Any revised TPD will require a positive opinion from the RSB. Without it, the process cannot move forward. Formally, the Board does not assess political choices. It assesses whether the analysis is robust. Yet when the underlying data is contested, that distinction becomes harder to sustain.
This inevitably brings Olivér Várhelyi into focus. Already a controversial figure, his public statements on nicotine products have been heavily criticized by researchers in the field, including in an open letter to Ursula von der Leyen. The issue is not politics but accuracy. Blurring the risk differences between product categories undermines confidence in the policy process itself.
There is also an adjacent discussion regarding certain practices within the Hungarian permanent representation under Várhelyi, and even if no formal conclusions have been drawn, the political climate has most definitely shifted. It is unclear if this could lead to formal sanctions, but according to sources in the Commission, the erosion of trust is starting to lead to isolation and marginalization.
All of this feeds back into the TPD. The Commission now faces a choice. It can proceed on an incomplete and contested evidence base, or it can reset and restore confidence in how the commission handles this file. A credible reset requires a transparent dataset, clear differentiation based on risk and analysis that withstands scrutiny.
Even if the position of Pouchforum is very clear, this particular discussion is about more than taking a position for or against nicotine pouches. Legislators are entitled to regulate, restrict or even ban products if measures are grounded in robust scientific evidence and are necessary and proportionate. However, that requires credible data and conclusions that reflect real risk profiles. At present, there is no evidence base that even remotely supports treating non combustion products as comparable to smoking.
In practice, legislators cannot, or at least should not, take far-reaching decisions if the Commission does not provide an assessment anchored in reality and science. Without that, proportionate and sound policymaking is not possible.
If a product is orders of magnitude less harmful than smoking, that must be reflected in the analysis. If policymakers act regardless in contravention of the evidence, they should explain why, using real data. Claims that all nicotine products carry the same risk do not meet that standard. Nor do gateway arguments that contradict empirical trends in countries where alternative products are widely used and smoking rates are low.
The reshuffle within DG Santé is therefore more than procedural. It signals a process under strain, but also an opportunity to correct course. Whether the Commission restores confidence or deepens the credibility gap will depend on what happens next.