Will nicotine pouches be banned in the European Union?
05th Oct 2021
Short answer: maybe.
Long answer: see below.
Nicotine pouches are a less harmful alternative to smoking. Switching from cigarettes to nicotine pouches could save hundreds of thousands of European lives every year.
But how should these products be regulated? Will the EU ban nicotine pouches as is the case for Swedish snus?
This depends on the outcome of the third Tobacco Product Directive, TPD3. In this article we will do our best to explain the most important parts of the the current legislation and foreseeable changes and explain how it may affect you as a nicotine pouch user.
WHAT IS TPD?
TPD stands for the Tobacco Product Directive. It is a legislative act from the European Union which has to be transposed into national legislation in all member states of the European Union. The countries that are part of the European Free Trade Association (EFTA), which includes Iceland, Liechtenstein, Norway and Switzerland, must also implement the directive.
The TPD sets out minimum requirements that all national legislation must include and regulates how tobacco products or substitutes of tobacco, such as nicotine containing e-cigarettes and complementary products, are sold. This includes for example ingredients, labeling, security features, marketing, market entries and reporting.
WHY IS THERE A TOBACCO PRODUCT DIRECTIVE?
The objective of the TPD2 is to give the member states a similar regulation and practices in order to;
”facilitate the smooth functioning of the internal market for tobacco and related products. Taking as a base a high level of protection of human health, especially for young people – and to meet the obligations of the Union under the WHO Framework Convention for Tobacco Control (’FCTC’).”
PRODUCTS COVERED BY TPD:
- Cigarettes
- Roll your own tobacco
- Pipe tobacco
- Cigars & cigarillos
- Smokeless tobacco – such as chewing tobacco and nasal tobacco
- Electronic cigarettes
- Herbal products for smoking
- Novel tobacco products – vague and open-ended to cover all types of tobacco not falling into another category, (placed on the market before 19 May 2014, when TPD2 entered into force).
ABOUT TPD #1 AND #2
The first Tobacco Product Directive (TPD1) was adopted by the European Union in 2001. After an extensive review, the European Commission presented a proposal for an updated legislation to the European Council and the European Parliament, the so called TPD2, which was adopted in 2014.
The European Commission must review the implementation and impact of the TPD2. A report was presented by the European Commission on 20 May 2021 regarding the application of the TPD2. In the report, market developments that may require new legislation is highlighted. In its report, the European Commission mentions the entry of nicotine pouches and the fact that they are not regulated on EU level and only in very few member states.
Current TPD2: https://ec.europa.eu/health/sites/default/files/tobacco/docs/dir_201440_en.pdf
Key changes with TPD2: https://ec.europa.eu/commission/presscorner/detail/en/IP_16_1762
WHAT IS COMING IN TPD3?
In the coming review of the TPD2, further restrictions for smoking and practices for the tobacco industry are expected. Introduction of legislation for new categories of nicotine products such as nicotine pouches can also be expected.
Several topics must be included in a revision and subsequent proposals for adjustment if the European Commission, such as:
- Experiences of graphical health warnings from TPD2
- Market developments concerning novel tobacco products
- Feasibility, benefits and possible impact of the EU wide regulation and database for ingredients and emissions of tobacco products
- Market developments concerning electronic cigarettes and refill containers, as well as waterpipe tobacco
In the European Commission’s report, cross-border sales such as through websites are discussed and it is noted that more controls, especially on age verification, is necessary.
It can also be expected that the question on plain packaging, which is already a reality in some countries like France, Ireland and Norway, will be discussed as well as larger health warning and a more neutral branding style. Also the possibility to show or market products for sales in stores, called display and/or visual ban, is a likely to be discussed.
The review report also addresses the issues with EU regulation not being applicable to new tobacco/nicotine products, for example heated tobacco products, so called ”heat-not-burn technology”, as well as nicotine pouches which are found to be similar to the banned oral tobacco snus.
The Commission’s report from May 2021 is available here in local language versions.
WHAT IS THE RISK OR OPPORTUNITY OF TPD3?
The main risks and opportunities relating to nicotine pouches are if they would be prohibited, as Swedish snus is today, and if the EU does not recognise harm reduction products as a tool for better public health.
A prohibition and no harm reduction perspective will not help people to make better choices and only segment the focus on smoking.
If a harm reduction perspective is included, meaning that products which can be proven to have a lower risk of negative health related consequences and death, such products could be made more available and not regulated as strictly as other more harmful products, typically cigarettes. With such a perspective, the review also provides an opportunity for a sound and harmonised approach for regulation to enable the introduction and sales of newer categories, such as the nicotine pouch (which did not exist in the EU market when TPD2 was adopted).
Currently there is a lack of national regulations and as the local regulations adjust faster to market developments than on EU level, it threatens the European single market. The EU needs to lead the regulatory developments and not follow, especially as there are great risks for bad or insufficient regulations in national legislation.
At the same time, the revision exposes an adherent risk for negative and harmful legislation where the nicotine pouch, as an oral nicotine product, could face the same EU wide ban as the Swedish oral tobacco product snus.
WHEN COULD TPD3 BE REAL?
It is unlikely that a legislative proposal is adopted during the current term of the current college of Commissioners (2019-2024). More likely is that the new Commission adopts a legislative proposal in the beginning of the new term in 2025. The new legislation could then be adopted in 2026 by the European Parliament and European Council to subsequently be implemented and entered into force in the different EU member states earliest in 2027/2028.
The transposition period for TPD2 was two years, giving the national parliaments and authorities an implementation period of two years.
WHICH STAGES WOULD THE PROPOSALS FOR TPD3 PASS?
The Commission’s review report was published in May 2021 and prepared for the European Parliament, the Council, the European Economic and Social Committee, and the Committee of the Regions.
The Commission has indicated needed revisions as well as opened for comments from the recipients. It is assumed that the Commission during 2021/2022 will formally decide to start the legislative work on the new TPD-TPD3.
The workstream for the Commission would thereafter be:
- Drafts and publish initial impact assessment
- Conducts public consultations, stakeholder meetings, external and internal studies etc.
- Prepares impact assessment
- Intern-service consultation
- Commission adopts legislative proposal
When adopting TPD2 this process for the Commission took about four years. To be adopted during the current term these stages should need to be completed 2022/2023.
After the Commission’s workstream the ordinary legislative procedure of the European Parliament begins with:
- Opinions and comments on the Commission’s proposal
- Discussions and adjustments from committees and plenary sessions as well as common approach for the council
- Trialogue between the Parliament, Council and Commission – discuss and agree on a position
- Adoption by the Parliament and the Council
When adopting TPD2 this part of the process took about one year. Hence the process needs to be initiated latest in spring 2023 to be finalised during current term.
WHY CARE ABOUT NICOTINE POUCHES IN THE EU?
According to the European Commission itself, tobacco consumption is the single largest avoidable health risk, and the most significant cause of premature death in the EU. It is responsible for nearly 700,000 deaths every year. Around 50% of smokers die prematurely (on average 14 years earlier).
There has been progress in terms of lowering the number of smokers in the EU, yet it is still at a high level with 26% of the overall population who smoke. Among the younger Europeans aged 15-24, it is as high as 29% who smoke tobacco.
For those adult smokers who are unwilling or cannot quit their smoking habits, there is a need for less harmful alternatives to traditional tobacco smoking. Nicotine pouches are found to be a consumer-friendly alternative with a high level of conversion of former smokers, and thereby has an enormous health benefit potential.
