Six European consumer organisations have filed a complaint with the European Ombudsman, arguing that the Commission’s consultation on future tobacco and nicotine legislation is methodologically incapable of producing reliable evidence. The complaint also strongly criticises DG SANTE’s language and its response to the concerns raised.
ACVODA, Anesvap, Heated Community Hub, ACPAN, EU4Snus and AIDUCE have challenged the European Commission’s public consultation on the revision of the Tobacco Products Directive and Tobacco Advertising Directive.
The complaint does not dispute the Commission’s right to regulate tobacco and nicotine products. Its central argument is that the questionnaire is designed in a way that prevents respondents from expressing meaningful distinctions between children and adults, or between cigarettes and smoke free nicotine products.
According to the organisations, the resulting data may therefore create an appearance of public support for broad restrictions without reliably measuring what respondents actually believe.
Children and adults placed in the same category
One of the clearest examples concerns the consultation’s use of the term “young people”.
The questionnaire groups together everyone between the ages of 10 and 24. This means that children, teenagers below the legal purchasing age and adults aged 18 to 24 are treated as one analytical category.
That is a serious problem in nicotine policy. Use by a 13 year old is a question of underage access. Use by a 23 year old may involve a lawful adult smoker switching to a less harmful product.
The consultation data cannot distinguish between these situations.
DG SANTE defended the wording by referring to World Health Organization terminology. The complainants reject that explanation, noting that demographic definitions do not remove the legal distinction between minors and adults.
Once the answers have been collected, it will be impossible to determine whether respondents were expressing concern about children, older teenagers or adult consumers.
Cigarettes and smoke free products merged
The second major criticism concerns the grouping of products with very different risk profiles.
Cigarettes, heated tobacco, electronic cigarettes, nicotine free vaping products and nicotine pouches are repeatedly included in the same questions about restrictions, bans and product controls.
A respondent may support a particular measure for cigarettes but oppose the same measure for nicotine pouches. In many parts of the questionnaire, there is no clear way to express that position.
DG SANTE stated in its response that the questionnaire is not intended to rank products according to relative risk or distinguish between different levels of harm at this stage.
That statement is central to the complaint.
The organisations argue that a consultation intended to inform future regulation cannot produce useful evidence if it deliberately avoids collecting views on the differences between the products being regulated.
Those distinctions cannot be introduced later during the analysis because the necessary information was never collected.
Questions that contain their own conclusions
The complaint also focuses on the use of agree or disagree questions based on contested assumptions.
Respondents are asked whether measures such as flavour bans, nicotine limits and other restrictions would be effective. However, the questionnaire often provides no structured way to identify possible negative consequences.
A respondent may believe that a flavour ban could reduce interest among some minors while also reducing adult switching, increasing illicit trade or pushing users back towards cigarettes.
A simple agreement scale cannot properly capture that position.
The same problem applies to nicotine limits. The effects of reducing nicotine concentration depend on the type of product, how it delivers nicotine and how consumers respond. Treating cigarettes, vaping products and nicotine pouches as if they raise the same regulatory question produces little meaningful information.
The supporting analysis also notes that the consultation offers many options for extending regulation but few opportunities to question existing restrictions or support a more risk based approach.
Strong criticism of the Commission’s language
The organisations do not limit their criticism to technical survey design.
They also object strongly to the way DG SANTE describes the questionnaire and responds to criticism.
The Commission states that the consultation strictly follows the principle of neutrality. The complainants argue that this claim is unsupported by evidence of independent testing, pilot studies or serious engagement with the methodological objections raised.
They also criticise the Commission’s suggestion that respondents can correct any limitations by uploading additional documents.
Closed questions can easily be converted into percentages, charts and political messages. Uploaded documents are treated as qualitative contributions and cannot repair a flawed underlying dataset.
The supporting ETHRA analysis uses particularly strong language, arguing that the consultation risks producing support for a policy direction already favored by the Commission rather than genuinely testing public opinion.
What happens if the complaint is considered relevant?
The European Ombudsman cannot annul the consultation or issue a binding court judgment. However, a formal inquiry could still have important consequences.
The Ombudsman could ask the Commission to explain its methodology, disclose internal material and justify whether the questionnaire complies with the Commission’s own Better Regulation standards.
The most immediate outcome could be pressure for a supplementary consultation that separates minors from adults and distinguishes between product categories.
The Commission could also be asked to publish clear warnings about the limits of the data, avoid drawing product specific conclusions from aggregated answers and release anonymised results for independent analysis.
Even if the Ombudsman acts after the consultation has closed, the complaint may still affect the impact assessment and any future legislative proposal.
A formal finding that the questionnaire was biased or methodologically unreliable would make it much harder for DG SANTE to present the consultation figures as objective evidence of support for uniform restrictions.
The complaint is unlikely to stop the revision of EU tobacco legislation. But it could significantly weaken any attempt to use flawed consultation data as proof that Europeans support treating cigarettes, nicotine pouches and other smoke free products in the same way.