Rewriting the Rules
Will the next EU Tobacco Products Directive embrace harm reduction?
By Stefanie Rossel
Things may take a bit longer in Brussels. The European Commission (EC) started preparations in 2021 to revise its Tobacco Products Directive (TPD), but the process remains in its evaluation phase, with an impact assessment expected in 2025.
The commission’s draft proposal is anticipated in late 2025. By 2027 or 2028, member states are expected to implement the new legislation. Shaping the new policy will be the job of the next commission. In June 2024, the common market elected a new European Parliament for the next five years.
The TPD currently under evaluation was issued in 2014. While already covering vape and heated-tobacco products in addition to traditional cigarettes, it does not include products that emerged after the legislation was adopted, such as nicotine pouches. How these and other novel nicotine products will be regulated in TPD3 remains the subject of speculation.
“We know only that the evaluation phase should have long been concluded,” says Jan Muecke, managing director of the German Association of the Tobacco Industry and New Products. One reason for the delay, he suggests, could be the EU ombudsman’s investigation of the commissioning of the European Network for Smoking and Tobacco Prevention (ENSP), which advises the EU Commission in the evaluation process. As a network of anti-tobacco nongovernmental organizations, the ENSP can’t be objective, according to Muecke.
Muecke expects the new commission, which will take up its official duties this autumn, to close the evaluation and push for far-reaching changes to the directive. The question, he says, is whether these changes will include a recognition of tobacco harm reduction (THR). While proponents claim novel nicotine products are significantly less harmful than combustible cigarettes and should therefore be treated differently, the EU, which has ratified the World Health Organization Framework Convention on Tobacco Control, insists that “less harmful” means “still harmful” and worries about yet-unknown long-term health effects and the protection of youth.
Missing Its Target
However, critics contend that continuing the existing approach or adopting an even more hostile stance toward novel nicotine products may prevent the EU from achieving its goal of a “‘tobacco-free generation” (defined as a smoking prevalence of less than 5 percent) by 2040.
According to the most recent Eurobarometer survey, the EU smoking rate decreased by only 1 percent between 2020 and 2023. At 24 percent, nearly a quarter of EU adults still smoke cigarettes. Since the TPD took force in 2016, EU smoking prevalence has fallen 3 percent. At this pace, the advocacy group Clearing the Air calculated, the EU will reach its tobacco-free goal 70 years after the target date.
“So far, EU tobacco policy has been focusing on paternalism against consumers, manufacturers and retailers,” says Muecke. “As this approach has not led to any relevant results, a real strategy change is needed. Instead of plain packaging and high taxes, politics should actively promote smokers’ switching to less hazardous products such as vapes, THPs [tobacco-heating products] or pouches. By having chosen such an approach, Sweden will soon have reached the status of a smoke-free nation. For such a reorientation of politics, however, a lot of persuasive efforts in Brussels will be required. But recently, there were very few signals from the EC that it might dare turn away from its regulatory approach of ‘quit or die.’ The civil servants in Brussels still consider e-cigarettes and the likes as a problem and not as part of the solution.”
“The big takeaway point from Eurobarometer is that there isn’t a hope of the EU achieving its smoke-free or tobacco-free targets, particularly when they continue to demonize safer nicotine products, which actually help people quit smoking,” echoes Damian Sweeney, a partner in the European Tobacco Harm Reduction Advocates (ETHRA), a consumer advocacy group. “It’s important to keep in mind that policymakers may not be aware of the detail in reports like Eurobarometer and certainly not success stories like Sweden and the U.K. This is why advocacy is so vital to educate policymakers and make them aware of what can and does work in reducing the burden on health from smoking.”
Nevertheless, Sweeney is cautiously optimistic about TPD3 as there seems to be a growing number of Members of Parliament (MEPs) that understand the concept of tobacco harm reduction. In a February 2022 report, for example, the European Parliament’s Special Committee on Beating Cancer (BECA) acknowledged the concept of harm reduction.
“Of course, the BECA report and the more recent report from the subcommittee on noncommunicable diseases, which adopted the same language as BECA in relation to safer nicotine products, is a positive in that respect,” says Sweeney. “Both reports are useful tools that advocates can utilize when speaking to MEPs about the role of SNPs in reducing smoking. It is important to note that we do not see these positive signs replicated in the European Commission.”
At this pace, the advocacy group Clearing the Air calculated, the EU will reach its tobacco-free goal 70 years after the target date.
More Stringent Rules Anticipated
If common sense does not prevail, the EC’s draft proposal will likely contain considerably stricter regulations for all product categories, according to Muecke. “Brussels could try to introduce standardized rules that completely ignore product-specific characteristics,” he says. “The regulation of nicotine products according to their harm potential, as it was partly introduced for e-cigarettes in the current TPD, is also likely to be put to the test. Furthermore, the EC will try to anticipate the development of new products in their regulations. Tobacco-free nicotine pouches don’t fall into the scope of the TPD, which is why many member states in recent years felt obliged to pass their own regulations. The EC will try to prevent such a development for future innovations. This is something we must pay particular attention to because innovation should always be possible.”
With vape flavors increasingly under scrutiny, Sweeney thinks it’s possible that the commission will propose a flavor ban. “This is where advocacy and building relationships with members of the European Parliament will be key, as proposals will have to be debated and voted on in committee and in the European Parliament as a whole,” he says.
In June, EU health ministers discussed proposals by Latvia and Denmark to restrict flavors in vapes and nicotine pouches. The current TPD allows member states to set their own rules for flavors. Denmark, Estonia, Finland, Hungary, Lithuania, the Netherlands and Slovenia already ban vape flavors. Spain recently completed a public consultation on the topic; Latvia reportedly is in the process of introducing flavor restrictions.
“It’s very concerning that member states would attempt to pressurize the commission to bypass the ongoing review of the TPD, but I don’t expect to see any actions at an EU level before the TPD,” says Sweeney. “Ahead of the June meeting, ETHRA wrote to all EU health ministers to highlight the serious unintended consequences of banning flavors: increase in smoking through reduced adult switching and increased relapse from vaping to smoking, a growing black market for flavored products, and potentially dangerous consumer workarounds, such as DIY [do-it-yourself] mixing, which can carry some risks.”
“Tobacco harm reduction shouldn’t be a right/left issue—it’s a people issue.”
Pouches in Peril
According to a commission spokesperson, snus will be part of the directive’s evaluation, but neither Muecke nor Sweeney expect the EU to legalize the product, which has been banned throughout the EU, except in Sweden, since 1992. “Sweden is on the verge of becoming smoke-free, 16 years ahead of the EU’s target, and snus has played a key role in that,” says Sweeney. “This success story could be emulated across the EU if the ban on snus was lifted; unfortunately, I can’t see that happening, and there’s a possibility the ban could be extended to nicotine pouches.”
Prohibiting the latter would be difficult, however, according to Muecke, as nicotine pouches are already available in 16 member states.
Despite increasing calls to ban disposable vapes, Sweeney expects single-use e-cigarettes to remain legal in the next TPD. However, the products are likely to disappear from the market anyway due to the EU Battery Directive, which will ban single-use batteries. “Manufacturers are already adapting and moving toward disposable-style devices that are rechargeable.”
Whether the recent EU election, in which the center-right European People’s Party (EPP) gained seats, will impact TPD3 remains to be seen. “As far as tobacco harm reduction and the availability of safer nicotine products is concerned, this is a positive move as the EPP have been supportive of THR,” says Sweeney. “But I think it’s important to remember that THR isn’t and shouldn’t be a right/left issue—it’s a people issue. As advocates, we need to bring as many people as possible on board—no matter what their political leanings are.”
