There are still more unknowns than knowns about the shape of future European regulation for novel nicotine products.
By Barnaby Page
Europe’s relationship with novel nicotine products has always been a mixed one. On the one hand, the more extreme forms of hysteria about youth vaping or supposed health risks have been relatively absent from the European scene; the U.K. in particular has been regarded as perhaps the most pro-vaping major economy in the world. And regulation—in most countries, heavily shaped by the European Union’s Tobacco Products Directive (TPD)—is in some respects light-touch.
Most notably, rather than following the U.S. model, which in theory requires marketing authorization by the Food and Drug Administration before products can be sold, the EU has eschewed the premarket approval approach and simply asks for products and businesses to be compliant with the TPD’s requirements.
But if Europe (which for the rest of this article mostly means the EU and its member states) has been looser in its regulatory approach than the U.S. in some ways, many of the requirements that it does make are quite onerous: the 20 mg per milliliter limit on nicotine strength, for example. It is also well known that the TPD as originally conceived was going to be far more restrictive and was only scaled back after pressure.
And there have been distinct signs lately of Europe becoming more cautious. Most flavors were banned EU-wide in heated-tobacco products; several countries have enacted, or will enact, disposable e-cigarette bans; the Netherlands, usually famed for its tolerance, is an example of a country that has started showing a lot of skepticism toward novel nicotine products; even in the U.K.—no longer an EU member—government support for tobacco harm reduction seems to be ebbing away a little, though it certainly hasn’t turned into outright opposition yet.
Set against this background, there is concern that the next version of the TPD may make major changes to the EU’s regulatory framework for novel tobacco products, reflecting conservative positions.
So far, nothing is known for sure about the actual content of the next TPD or about any updates to the lesser-known Tobacco Advertising Directive and Tobacco Excise Directive—though a European Commission spokesperson did confirm to Tamarind Intelligence, late last year, that vaping would be a focus of the TPD. The commission’s job with the TPD is essentially to formulate the legislation, which representatives from all the EU member states, in the European Parliament and the Council of the European Union, then vote on.
However, looking at what is already happening across Europe gives some indicators of what’s possible—action against disposable vapes in France and Belgium, for example, or against flavored products in Finland and Hungary. Though it’s true that EU policy certainly does not derive directly from localized policy in member states, there are trends visible that are bound to be reflected in Brussels. It’s also worth noting that the much-anticipated swing to the populist right in the most recent European elections failed to fully materialize, which may well mean that the EU will continue to favor tight, precise regulation and not care too much whether it is seen as “business-friendly.”
First, disposable bans: There have been debates or even legislation in most major European countries over banning disposables, partly because of youth usage but also because of environmental impacts. Even if not all of these come to pass, the fact that an outright prohibition on disposable vapes is so widely seen as a reasonable, proportionate regulatory response—not an unrealistic or extremist one—must make an EU-wide ban a possibility.
Second, flavors: There is a precedent for some kind of vape flavor ban in the existing EU ban on flavors in heated tobacco, and a number of EU health ministers have given such a measure their support. This would be a greater blow to the industry than a disposables ban, though a crucial question would be exactly what is outlawed and what is permitted.
The most draconian position would be a reduction of the market to tobacco and perhaps menthol/mint flavors. There could, however, be a middle ground with some other flavors allowed that still removed the more outre and (supposedly) youth-tempting ones from the market; there have also been suggestions that a ban on extreme flavor descriptions, rather than the actual flavors, could achieve the same end. So there are quite a lot of options on the table when it comes to regulation of flavors, and this is perhaps the area to watch most closely.
Other major areas likely to come under consideration include taxation, and an extension of the existing EU ban on snus (from which only Sweden is exempt) to tobacco-free nicotine pouches.
An equally big question, however, is when any of this will happen. The process of revising the TPD has been underway for more than two years now, suffering several delays and changes in its schedule.
For example, the European Commission’s Directorate-General for Health and Food Safety (DG Sante) had originally promised to finalize its evaluation report on tobacco policy last year, but when the commission published its work program for 2024, it made no mention of revising tobacco policy. Therefore, it seems unlikely that there will be major announcements on the TPD or other Europe-wide tobacco regulation in 2024.
When it eventually does happen, it will be the culmination of a process that started more than two years ago, when the commission launched a call for evidence, which ran from May 2022 to June 2022. This was then followed by a public consultation from February 2023 to May 2023. Eventually, the results of these consultations should be taken into account by the commission when it drafts a directive to be discussed by the Parliament, but so far … nothing.
So it’s been a long period of near silence even though many expected action—and debate—much sooner. The delays may be partly down to divergence in member states’ positions on tobacco control—it’s going to be hard to come up with Europe-wide policies that at least partially satisfy enough member states and enough competing principles.
Although the European Commission will be the one to propose the new policies, it is the legislators in the Parliament (and the Council of the European Union, the other “house” of the European legislature) who ultimately vote for or against it. So, while the commission may well be likely to maintain a conservative or even quasi-prohibitionist stance, it’s very possible that Members of Parliament (MEPs) may disagree. Some MEPs who spoke with ECigIntelligence said that they were prepared to fight conservative approaches to novel nicotine products that may be counterproductive for harm reduction, and the influx of new MEPs after this year’s election adds a further level of uncertainty.
Moreover, positions on novel nicotine products cannot easily be predicted from political affiliation. Generally, the more right-wing a party is, the more easygoing toward novel nicotine products it tends to be (and this would in theory make the broadly rightward trend in politics a positive one for harm reduction’s proponents), but this is far from consistent and there are many exceptions (as indeed there are to that rightward trend).
For example, arguments prioritizing consumer education and freedom of choice over strict policies, historically usually attributed to right-wing parties, are often also shared by left-wing parties. The national origin of a politician may be just as significant as their nominal position on the left-right spectrum—a left-winger from a country with very strict regulation of tobacco products is often likely, we find, to be more sympathetic to that kind of legal regime than a left-winger from a country with a much lighter touch.
So there are plenty of unknowns, and of course the unusual position of the U.K.—the biggest market for novel nicotine products in Europe—is another one. When the last TPD appeared, the U.K. was still a member of the EU, and so it adopted the TPD’s measures into its own domestic legislation (as all EU member states must do with European directives). But it has since left the union, via Brexit. The current British government certainly seems to have a hardline attitude on disposables, but there are also indications that it remains supportive of harm reduction, so how aligned the U.K. will remain with the rest of the EU in the future is very much an open question. One distinct possibility is that even if Britain starts to tighten regulation on some aspects of novel nicotine products, it remains more liberal than an EU that gets even tougher.
