What lies ahead for new nicotine products? [Advocacy Lab Content]

March was a tough month for the vaping sector. An avalanche of political decisions cascaded through public discourse against the background of the European Commission’s evaluation of the EU framework for tobacco control. So, what lies ahead for nicotine products?

On 6 March, Euractiv held a public event, under Chatham House rules, to address this question.

The ongoing discussion is taking place in a blizzard of bad press for the vaping industry. According to The Times, a new University College London study reports that: “People who vape suffer similar changes to their DNA as smokers who develop cancer.” Researchers found that samples of cheek cells from both vape users and cigarette smokers had similar DNA cell changes in their mouths. The UCL team found that: “These changes were, in turn, linked to the future development of lung cancer in smokers.”

Published in the journal Cancer Research, the study did not prove e-cigarettes cause cancer but indicates that vapes are likely not harmless, and the industry does not claim e-cigarettes to be harmless, but is of the position that vapes are potentially reduced-risk alternatives to continued smoking.

Europe is fuming

Euractiv recently reported that the French parliament reached an agreement to ban so-called ‘puffs’, single-use electronic cigarettes, probably by the end of September, pending approval by the European Commission – French teen use of electronic cigarettes tripled between 2017 and 2022. While in Poland, Euractiv reported that: “ (…) almost all consumers of flavoured disposable e-cigarettes in Poland are underaged (…) Warsaw is drafting legislation to ban their use.”

And in Belgium, 19 March, the European Commission published a decision announcing its approved of a Belgian bill to ban the sale of disposable electronic cigarettes likely from 1 January 2025. The Belgian aim is to reduce the number of smokers aged 15-24 to 6% or less by 2028.

Chatham House rules

Speakers at the Euractiv event included Johan Nissinen MEP, Member SANT Committee, European Parliament; Judy Gibson Membership Director, INNCO; Dr. Konstantinos Farsalinos, External Research Associate, University of Patras; and Sean Roberts, Chief Legal and Corporate Affairs Officer, Imperial Brands. Under the Chatham House format, we can report what was said, but not attribute it to the speaker.

 Tobacco Products Directive evaluation

The tobacco control evaluation is anticipated to conclude in late 2024 and has been driven mainly by the emergence of new nicotine products and the rapid innovation of the nicotine sector. This led the Commission to question if the Tobacco Products Directive (TPD) needs to be revised, or remains fit for purpose: which means ensuring the smooth functioning of the internal market while taking a high level of public health protection into account, especially among youth.

While acknowledging the risks associated with potentially reduced-risk products, some stakeholders from academia, the industry and EU citizen groups underline the harm reduction potential of these alternatives, emphasising the importance of scientific substantiation and evidence-based regulatory decisions.

Proposing that electronic cigarettes be subject to excise taxes, allowing Member States to better monitor and control their distribution while maintaining a meaningful price difference between electronic cigarettes and traditional cigarettes to facilitate adult smokers’ transition. Implementing retail licensing and strengthening national-level enforcement of age restrictions for the sale of new nicotine products, along with penalties for retailers who sell to minors.

Follow science, not emotion

“We have to follow the science, not emotions,” said one speaker, setting the tone of discussion. They argued that the possible TPD revision is an opportunity to realise the full potential of reduced-risk products. Accepting a clear problem with underage vapers, it was remarked that a critical aspect of the regulatory framework was largely ineffective – enforcement.

Youth access, they said, was too easy. There is, they explained, a lack of enforcement of the current rules, and a failure to properly consider additional proportionate rules to stop “irresponsible products” coming onto the market. By banning what they called “responsible flavours and descriptors”, they argued that there is a loss of public utility in helping adult smokers come off combustibles.

It was also remarked that an overly broad interpretation of WHO FCTC Article 5.3, to the point of attempting to regulate public discussions on tobacco and new nicotine products: “manifests injustice not to include all parties in the debate and the need for more balance,” – given that the industry is largely excluded from the policy discussion.

Swedish success in shifting to a low number of smokers was, said one speaker, thanks to Sweden’s policy on harm reduction. The Swedes applied lower taxes on snus and higher taxes on cigarettes, with one panellist arguing that the EU should allow oral tobacco products, and regulate nicotine pouches, within the single market.

TPDII to TPDIII

The European Commission’s ongoing evaluation of the Tobacco Products Directive (TPDII) (adopted in 2014 and effective since 2016) deals with the scope of manufacturing regulation, presentation, and sale of nicotine products in the EU, including traditional cigarettes, and fine-cut tobacco, as well as new nicotine products, such as e-cigarettes, heated tobacco.

The evaluation timeline expects a conclusion in Q3-Q4 2024, and the earliest the TPDIII proposal could come would be around Q1-Q2 2026.

Speakers expressed concern that the TPD3 proposal may be so onerous and restrictive that the public health potential of harm reduction may be cancelled by introducing unreasonable barriers to adult consumers of new nicotine products, despite tobacco harm reduction (THR) success in reducing smoking rates in some Member States.

Discussing possible new restrictions under TPDIII, the panel listed a ban on flavours in new nicotine products; a ban on nicotine pouches; stricter packaging and labelling requirements for all products; and altogether, no longer a reduced risk distinction between combustible products and new nicotine products.

Responding to Euractiv’s questioning on the validity of THR measures in the context of new underage users, panelists remarked that they support EU proposals to ban youth-appealing product designs and flavour descriptors, without limiting the variety of flavours available.

The flavour controversy

Flavours in e-cigarettes, they said, play a crucial role in helping adult smokers transition away from smoking. Most adult smokers, they argued, who have transitioned to e-cigarettes, have used flavoured products.

There was further discussion about the validity of “real-world evidence” shows that disposable e-cigarettes provide a more accessible entry point for adult smokers switching to new nicotine products, compared to refillable electronic cigarettes. Panellists argued that a ban would be “disastrous for the transition to potentially reduced-risk products and, worse, may push adult smokers towards unregulated and unsafe illicit disposables.”

[By Brian Maguire | Euractiv’s Advocacy Lab ]

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