The EU's evaluation of the Tobacco Products Directive is being heavily criticised internally. Experts are questioning both the methodology and the sample - and now critics are warning that access to smoke-free alternatives such as e-cigarettes and nicotine pouches could be jeopardised when the rules are revised.
The European Commission commissioned activist groups from the anti-nicotine movement to evaluate the tobacco control framework (TPD) ahead of an upcoming revision of the EU-wide rules. This is according to a review by Clearing the Air magazine. The result is a report that is now being heavily criticised - not least by the EU's own Scrutiny Board.
“The report argues that the current framework has had effects that reduce smoking - without referring to relevant analyses,” the Council notes.
Says its own evaluation
In spring, the European Commission presented an impact assessment of the current tobacco control framework, better known as TPD2 (Tobacco Products Directive, version 2). The aim was to evaluate how effective the framework has been, whether it has contributed to reducing smoking and how it should be developed in the future.
According to the analysis, the framework has been successful.
“Smoking has decreased from 28 to 24 per cent during the years the framework has been in place,” the investigators write.
But the report was quickly met with criticism from both consumer organisations and researchers in the nicotine field. However, the most extensive criticism came from the Commission's own Review Board, which argues that there is a lack of analyses that actually link the regulatory framework to smoking reduction.
“The evaluation lacks the analyses needed to substantiate claims about impact and effectiveness, as well as comparisons with developments in other countries that have applied their own measures,” the Council writes.
The criticism was noted by TobaccoIntelligence, an independent organisation that analyses the nicotine market from a business perspective.
”What you are asking in practice is: What happened to Sweden? How can an investigator miss the fact that smoking has fallen much faster there than in other countries, even though the TPD has been implemented to the same extent? You don't say it outright, but that's what you imply,” says Peter Becket, editor-in-chief of Clearing The Air, a magazine that monitors nicotine legislation in the EU and recently scrutinised the upcoming revision of the Tobacco Products Directive.
Want to regulate smoke-free more strictly
As previously reported by Vejpkollen, the EU framework for the regulation of nicotine products is expected to be revised shortly. According to reports, a legislative proposal could be presented as early as late autumn 2026. It is not yet clear what will be included, but the investigators propose, among other things, to include nicotine pouches in the regulatory framework and to introduce further restrictions on smokeless nicotine products.
“We interpret the report as meaning that the authors want to equate smokeless nicotine use with cigarette smoking. This could mean a flavour ban and, by extension, a ban on everything from vapes to nicotine pouches. This is not surprising - it's a line that some Commissioners have been pushing for a long time,” says Peter Beckett, editor-in-chief of Clearing the Air.
Criticism of selection and linkages
The issue of nicotine regulation is complex and characterised by a long-standing conflict between interest groups, consumer representatives, industry and scientists. The issue of smokeless nicotine products is particularly contentious.
The European Commission has in recent years adopted a restrictive stance to what are called “novel nicotine products”, in practice e-cigarettes and nicotine pouches. When working on a new the revision of the Tobacco Products Directive was launched the contract was awarded to a small consultancy firm in Spain. But according to Clearing the Air the latter in turn used organisations with clear links to the anti-tobacco movement.
“Several of them, such as Vital Strategies and the European Network for Smoking Prevention are directly funded by a private actor - Bloomberg Philanthropies - which openly advocates for severe restrictions - or outright bans - on all smokeless nicotine except pharmaceuticals,” says Peter Beckett.
The review also shows that very few experts in the field of harm reduction have been consulted, and instead a limited number of consumer organisations have been approached to provide an “alternative perspective”.
“When the European Parliament's Ombudsman scrutinised the process, it found that there was a clear risk of bias. Having these organisations investigate the legislation is like having Elon Musk investigate the regulation of digital services,” said Beckett.
Countries leading the way
Also the consumer organisation European Tobacco Harm Reduction Advocates (ETHRA) strongly criticises the report, in particular for the lack of comparisons between different countries' strategies.
“It claims that the TPD has been instrumental in reducing smoking in the EU, but shows no causality and avoids comparisons between member states. It comes across as bureaucratic back-slapping with no basis in reality,” writes ETHRA in an open letter to the European Commission.
The organisation highlights countries such as Sweden, Greece and the Czech Republic as examples where national policies - including the availability of smoke-free alternatives - have had a clear impact on smoking.
“The Commission seems neither to understand nor to want to understand why consumers are switching from cigarettes to safer alternatives, despite the fact that 89 per cent of responses to the public consultation came from individuals - 72 per cent of whom were users of such products,” writes ETHRA.
Unusual step - passed on
Despite the criticism, the European Commission's evaluation is still the basis for the upcoming legislative proposal. Meanwhile, the report has been forwarded to the Scientific Council for further scrutiny - something that Mr Beckett says is unusual.
“Normally, reports like this stay within the responsible policy area. The fact that it is now being scrutinised further suggests that the internal criticism has had an effect,” he says.
According to Mr Beckett, there is now an opportunity for more perspectives to be included in further work.
“Hopefully, the experience of Sweden, for example, where the availability of alternative nicotine products has played a major role in reducing smoking, will be taken into account. The same applies to developments in Greece and the Czech Republic, where harm reduction is used as a strategy.”
