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The European Union’s new ban on flavours in heated tobacco applies from today throughout the 27 EU member states, amid criticism from harm reduction advocates, tobacco companies and some European politicians who believe that it could discourage smoking cessation.
Discussed internally by EU policy-makers as long ago as December 2021, and then adopted in June 2022 by the European Commission (EC), Commission Delegated Directive (EU) 2022/2100 technically entered into force on 23rd November last year. But that date merely represented legal recognition of the directive’s existence, and it is only this week that it becomes enforceable.
It is likely to have a considerable impact on the European heated tobacco market, as outlined in our market report. But although most EU member states supported the introduction of the ban (with only Bulgaria, Cyprus, Greece and Italy opposing it), its implementation across the member states – which must incorporate it into their own domestic law, a process known as “transposition” – remains patchy.
Indeed, in late September the European Commission took action against 17 member states that had missed a 23rd July deadline for notifying the EC that they had transposed the directive. (Some had in fact completed transposition, but simply failed to report it.) In theory, although it happens rarely, such letters of formal notice can eventually lead to the EC bringing non-compliant member states to the Court of Justice of the European Union (CJEU).
As of today, the ban has actually become national law in only 14 – just over half – of the member states. Of the remainder, most are in the process of considering it, although a few have not yet taken any action.
Heated tobacco flavours therefore remain, in practice, legal across much of the EU, and of course the prohibition does not affect Europe’s non-EU states – although the members of the European Economic Area will eventually follow the EU’s lead and implement their own bans.
Concerns have led to actions that hit dead ends
The controversy that has surrounded the flavour ban since its first discussions in the EC’s Group of Experts on Tobacco Policy has been extensively covered by TobaccoIntelligence, and includes legal concerns as well as public health considerations.
From a legal perspective, one major criticism has been the way that the Commission introduced the new category of heated tobacco products through a delegated act – an executive action, rather than one voted on by legislators. This has been repeatedly brought up as a reason to declare the flavour ban void, by member states, members of the European Parliament (MEPs) and industry insiders.
But none of these concerns led anywhere close to a revocation of the flavour ban, and for a while its opponents’ hopes seemed to rest upon an action for annulment of the ban brought before the CJEU by Nicoventures Trading and others (Case T-706/22).
However, this avenue for overturning the flavour ban was also closed off in September, when the CJEU declared the action for annulment inadmissible because the applicants lacked the right to challenge the delegated directive. This was a procedural issue – the court didn’t rule on the substance of the plea, namely whether the delegated directive is in fact contrary to EU law – but it was enough to end the case.
One possible road out through the CJEU
One final option remains. As outlined in our regulatory report, the only available approach now to a judicial challenge of the delegated directive is the preliminary reference procedure.
In such a case, a complainant needs to challenge the national measure that implements the delegated directive, before the court of an individual member state. The national court can then refer it to the CJEU, if it considers that CJEU involvement is “necessary to enable it to give judgement in the national proceedings”.
This has already happened in Ireland, where a case brought before the High Court by British American Tobacco subsidiaries Nicoventures and PJ Carroll has reportedly been referred to the CJEU for a preliminary ruling.
The CJEU may therefore finally examine the validity of the flavour ban itself, a stage it never reached in the other Nicoventures case. And if it finds that the EC exceeded its powers when it adopted the directive setting out the flavour ban, the Court would declare the directive invalid and the ban would be revoked.
Can education reach further than prohibition?
If the ban remains in force, many of its opponents are worried about its impact.
Czech MEP Radka Maxová, who serves with the Progressive Alliance of Socialists and Democrats (S&D), told TobaccoIntelligence she was concerned that a ban on flavours could push users of a less harmful alternative back to combustible tobacco smoking.
She believes the measure was principally aimed at making these products less appealing to young users, but worries that a ban may not be the best way to achieve it.
“I advocate a harm reduction approach, focusing on reducing the risks associated with tobacco, rather than an outright ban,” she said, suggesting that education can reach further than prohibition.
“The fight against addiction should include education and awareness from a young age, highlighting the harmful effects of tobacco addiction while emphasising the importance of a healthy lifestyle and the risks of smoking.”
Companies that make heated tobacco products are, naturally, anxious too.
Luca Lodato, a spokesperson for Iqos maker Philip Morris International (PMI), agreed with Maxová that the ban could be counterproductive for harm reduction.
“The characterising flavour ban in heated tobacco products risks undermining the role of these products in reducing smoking rates in Europe, as flavours are relevant to adult smokers’ switch to alternative non-combustible products,” Lodato said.
“Heated tobacco products are, as demonstrated by a growing body of scientific evidence and regulatory decisions, much better for their users than continued smoking,” he added.
He also argued that Europe’s Beating Cancer Plan – adopted last year by the European Parliament – acknowledged heated tobacco’s potential in harm reduction by calling for “a scientific assessment” of its risks compared with those of traditional tobacco smoking.
“Many public health experts and consumers’ associations are concerned that banning the use of characterising flavours in non-combustible alternatives such as heated tobacco products may undermine their role in accelerating the decline of smoking rates in Europe by discouraging switching to better alternatives by those adults who would otherwise continue to smoke,” Lodato said.
‘An ideological objection and an unrealistic goal’
Not everyone agrees with that interpretation of the Beating Cancer Plan’s position on heated tobacco.
Indeed, the plan was also referred to by Stella Kyriakides, the EU commissioner for health and food safety, when she announced the Commission’s intention to move forward with the flavour ban in June last year.
“By removing flavoured heated tobacco from the market we are taking yet another step towards realising our vision under Europe’s Beating Cancer Plan to create a tobacco-free generation with less than 5% of the population using tobacco by 2040,” the commissioner said.
But her statement was harshly criticised by harm reduction activists across Europe.
The European Tobacco Harm Reduction Advocates (Ethra) group told TobaccoIntelligence it believed that the EC’s move was not based on healthcare concerns.
An Ethra spokesperson said: “The clear and obvious problem with [Kyriakides’s] statement is that we know that harms from smoking are due to combustion, not simply the use of a tobacco product, and to conflate the two is highly misleading.”
According to Ethra, the directive was instead based on what the lobbying group describes as “a substantial change of circumstances”.
“When we look closer at the reasons for the proposal, we can see that it’s far from being a health-based decision,” the spokesperson said. “To put this plainly, large numbers of smokers have improved their health by switching to a low-risk alternative, and the Commission has had a knee-jerk reaction which is based on nothing more than an ideological objection to the use of a nicotine product and an unrealistic goal of being tobacco-free by 2040.”
– Tiziana Cauli and Sergi Riudalbàs Clemente TobaccoIntelligence staff
Photo: Antoine Schibler
