Tobacco Directive in the new EU Commission: the future for Snus and Nicotine Pouches

Could tobacco Snus be legalized throughout the EU? Or will tobacco-free Nicotine Pouches even be banned in the future? As much as these two questions span the arc of current discussions, opinions differ widely. After the European elections at the latest, the topic could provide fuel for heated debates in the new EU Commission, as the current Tobacco Directive is to be reinterpreted then. And what is being advocated here for the legalization of Snus and against a ban on Nicotine Pouches can be found in the following article.

EU Tobacco Directive to be reinterpreted

Elections will be held in June, after which the issue of tobacco is to be revisited at EU level - at least that is the current state of affairs. Comprehensive decisions by the EU Commission on an EU-wide tobacco control policy were made some time ago - specifically the Delegated Directive (EU) 2022/2100 in 2022. The starting point for this was the European Tobacco Products Directive (2014/40/EU), which had come into force on May 19, 2014 and was incorporated into law in the member states by May 20, 2016. From the manufacture and presentation to the sale of tobacco products, there have been various changes and tightenings.

However, a lot has happened since then and the term "novel tobacco product" in particular seemed to have reached its limits. In addition, there was also a lively discussion about the term "novel nicotine product". After all, those products that had not been covered yet by the Tobacco Products Directive at that time with novel tobacco products, because they only emerged later, could ultimately manage without tobacco and could then be regulated in the future in the sense of an extension to novel nicotine products, spread extremely quickly on the EU internal market. In particular, we are talking about Nicotine Pouches - they are now (literally) on everyone's lips.

Currently not yet legally defined in the Tobacco Products Directive (2014/40/EU), the White Pouches and their rapid spread are not only causing a stir among some international players, but are also attracting criticism at national level. Whether this is justified remains to be seen for the time being. In any case, a possible implementation of such products in a revised EU directive for tobacco products currently seems likely.

No legal framework for Nicotine Pouches at EU level

As mentioned, the current EU Tobacco Products Directive does not cover novel nicotine products such as Nicotine Pouches for oral use. This is a reason why individual member states have been able to introduce different restrictions for this - if they have explicitly done so at all.

Sales restrictions for Nicotine Pouches in individual EU member states

There are explicit restrictions on the regional trade with Nicotine Pouches in Belgium, the Netherlands and also in individual federal states or districts of Germany, for example. In Hamburg e.g. there was already a decision by the administrative court in March 2021 in which the trade with such white Snus was prohibited until further notice. Such restrictions primarily affect local retailers and points of sale, but not online purchases from companies based outside Germany. So you can still buy white Snus online if the online store is based outside Germany.

In order to be able to assess Nicotine Pouches expertly, the authorities must first clarify how they are to be legally classified, according to various legal issues in Germany. Whether as a foodstuff, medical device or medicinal product could not be clearly determined, according to some committees and courts following the introduction of Nicotine Pouches on the market. Although there are now tendencies and court opinions that declare such products to be foodstuffs - the justification and validity of this remains to be seen - nothing is kept at bay yet. And a decision by the Hamburg Administrative Court that is valid "until further notice" draws its force from this.

Just as these sales restrictions are seen by some as a hope for legal establishment, for many they seem to have been plucked out of thin air - precisely because these new types of nicotine products cannot be classified clearly or even without contradiction in existing regulations. The need for an EU-wide set of regulations is now being heard from both sides. And this is precisely where the (new) EU Commission could remedy the situation by revising its current tobacco control policy.

>> Read more on the topic here: Snus in Germany

Evaluation of the EU legal framework on tobacco control

The European Commission is currently conducting a comprehensive evaluation of the EU legal framework of the Tobacco Products Directive (2014/40/EU). A possible revision will then depend on the results of the evaluation, the public consultation and an in-depth impact assessment, according to EU spokesperson Stefan de Keersmaecker. The exact wording is still being finalized:

„Die politischen Entscheidungen in dieser Hinsicht werden von der nächsten Kommission im Lichte der oben genannten vorbereitenden Schritte getroffen werden.“

Probably aware of international differences in the regulation of such tobacco-free novel nicotine products for oral use, the Commission is all too likely to address this issue as well. How exactly and what the consequences will be is currently difficult to predict. In line with the basic tenor of tobacco control and the primary objective of reducing cigarette consumption, such nicotine products would in any case represent a cigarette alternative  which could be skillfully used as an opportunity.

Basic tenor of the Tobacco Products Directive

The European Union has an EU-wide plan to combat cancer, which aims to achieve a "tobacco-free generation" by 2040. The Tobacco Products Directive offers a set of instruments with various levers for this - after all, it can be used to get such a project on track and set any important course.

As the EU has often communicated in the past, tobacco-free and, in particular, smoke-free policies are the linchpin in the fight against cancer - after all, 27 percent of all cancers can be attributed to tobacco consumption.

In essence, it is therefore about reducing the prevalence of cancers that can be attributed to tobacco consumption - this is the agenda and the basic tenor behind the regulations.

Now the questions are pressing: Is nicotine itself carcinogenic and are Nicotine Pouches therefore? Are Snus carcinogenic? And which form of tobacco consumption is the most harmful?

Are Nicotine Pouches carcinogenic?

With regard to the aforementioned legal uncertainty in Germany and an expert assessment of Nicotine Pouches, the Federal Institute for Risk Assessment published a health assessment report in 2022 - based on existing studies and data. The assessment of carcinogenicity - i.e. the ability to cause cancer - plays a key role in this report.*

The exact wording is based on the findings of the RIVM (Netherlands Institute for Public Health and the Environment):

„Das RIVM fand in seiner Monographie zu Nikotinbeuteln keine Hinweise für karzinogene Eigenschaften von Nikotin [5]. Die Übersichtsarbeit von Sanner & Grimsrud, 2015 kommt zu dem Ergebnis, dass keine Schlussfolgerungen über mögliche tumorauslösende Effekte einer Langzeitbehandlung mit Nikotin gezogen werden können [33]. [..]“

Clearly, nicotine is therefore not harmless - an addictive potential and possible risk of cardiovascular disease is not ruled out by "no evidence of carcinogenic properties of nicotine". - But these results at least suggest that the nicotine contained in Nicotine Pouches has no carcinogenic potential.

The report also mentions so-called tobacco-specific nitrosamines (TSNA) - these would be considered carcinogenic. Thus, at least in some of the examined Pouches these substances are still present in traces. If nicotine pouches contain TSNA in small quantities, this could pose a cancer risk.

But firstly, not all types of Nicotine Pouches contain such substances. Namely, there are differences in the quality standards, the type of production and the nicotine form processed in them or even whether they contain synthetically produced nicotine or nicotine extracted from the tobacco plant. And the former cannot even contain such substances in its pure form, while purification processes can reduce the proportion of the latter to a barely measurable value.

Secondly, one could conclude: If they contain it, then only in traces, i.e. small quantities. If the amount of TSNA determines the level of the resulting cancer risk, then these products pose a lower cancer risk than other tobacco products with a higher TSNA content.

For Snus, which contain tobacco and therefore also have higher levels of TSNA, such a conclusion clearly cannot be applied - but a look at Sweden, where they are consumed by a majority, could also suggest a lower risk here than thought and in any case a lower risk than with cigarettes.

*See also: https://www.bfr.bund.de/cm/343/gesundheitliche-bewertung-von-nikotinbeuteln-nikotinpouches.pdf

Swedish example: Does Snus reduce the cancer rate?

Sweden is smoke-free, but not nicotine-free; and there is a low incidence of cancer in Sweden, which is linked to tobacco consumption - this could roughly summarize the statements made by some supporters of Sweden's tobacco control policy.

Extending this to the mortality (death rate) that can be attributed to tobacco consumption, Karl Olov Fagerström - a Swedish psychologist working in the field of addiction research - writes in his article "Harm reduction in Sweden - the case of Snus“*:

„Nach Schätzungen der schwedischen Snus-Kommission sterben in der EU jedes Jahr 561 000 Männer an Krankheiten, die auf Tabakkonsum zurückzuführen sind. Hätten die Männer in der gesamten EU die gleichen Tabakkonsumgewohnheiten wie in Schweden, läge diese Zahl bei 205 000.“

That Snus could have a positive effect on reducing cancer rates and tobacco-related mortality is also suggested by the Swedish Lakeville Study of 2022.*1 And figures don't lie, many would say - but are they meaningful and representative? This is where some critics see the reason for skepticism.

For Heino Stöver, Director of the Institute for Addiction Research Frankfurt (ISFF), such "Swedish figures on the low prevalence of cancer appear to be the central parameters" to advocate for a EU-wide Snus legalization.

Although the EU is showing restraint for the time being, the "Swedish example" is unlikely to be completely ignored in the upcoming Commission debates on tobacco control policy. According to Eurostat, the known lowest smoking rate in the member states, currently less than 5 percent, draws attention in this direction. Especially if the most harmful of all forms of consumption, namely cigarette smoking, is to be minimized as a first step.

*See also: https://www.bvte.de/files/content/themen/risikoreduktion/23045702_Harm%20Reduction%20in%20Sweden_DE.pdf

*1 See also: https://hayppgroup.com/app/uploads/2022/08/Fighting-smoking-with-alternative-nicotine-products.pdf

What advocates a legalization of Snus and stays against a ban on Nicotine Pouches

In current discussions on this topic, one hears and reads a lot about so-called harm reduction or a strategy of harm minimization. The core idea behind such approaches is the EU's aim to be tobacco-free by 2040, the more harmful effects of tobacco cigarettes compared to oral consumption alternatives, a look at Sweden, the unproven carcinogenic effects of nicotine, etc. The arguments for the legalization of Snus and against a ban on Nicotine Pouches are in focus that way.

One person who puts this into a compact words is David Eberhard, for example, a psychiatrist specializing in addictions. And he says, although there are people who are addicted to Snus, cause nicotine is a drug with addictive potential.

„Aber wenn man eine Droge, die wirklich schädlich für einen ist, in etwas umwandeln kann, das nicht auf die gleiche Weise schädlich ist, dann erreichen wir eine Schadensbegrenzung.“

That means, to get a a highly harmful drug in a form, wich is not harmful the same way - means a damage limitation. In short: with Snus and Nicotine Pouches, smoking rates could be reduced, thus limiting the most harmful of all forms of consumption. And Sweden shows that this can work. As Patrick Strömer, Secretary General of the Swedish Snus-manufacturers' association, recently explained, the Snus-case today is a "live experiment" compared to 30 years ago, and now showes how Sweden could become European champion after 3 decades with a low "smoking prevalence".

It seems clearer now, what would be useful in terms of Nicotine Pouches and Snus in the case of EU-wide regulation. If one takes the basic tenor of a long-term fight against cancer in the sense of the European Union, the opponents of a release of such less harmful cigarette alternatives may seem somewhat invalidated, if we look to Sweden and the functional aspects of Snus or Nicotine Pouches there. The fact that a European solution would be helpful for the latter can be seen in national legal issues and their problems anyway. In any case, a European solution should not thwart the EU plan, by squandering opportunities. And primarily focus now should be stop cigarrette smoking.