Risk Reduction

Dutch RIVM and German BfR agree on risk assessment:
Nicotine pouches are potentially less harmful alternative to tobacco use

The RIVM report was published on 05.07.2021, the first preliminary BfR opinion on nicotine pouches on 30.03.2021. Both reports came to similar conclusions.

Nicotine pouches are a new tobacco-free alternative to conventional cigarettes and tobacco products. They consist of porous sachets containing mainly starch, plant fibres, flavourings and purified nicotine. Pouches are placed in the mouth under the upper lips for use. The nicotine is absorbed through the mucous membranes of the mouth. Similar to chewing tobacco and other smokeless tobacco products, there are no carcinogenic or harmful combustion products. Pouches are now available in shops or on the internet in many member states of the European Union.

Tobacco-free nicotine pouches are novel products that require appropriate legal regulation because they are used to consume the - addictive - substance nicotine. The BVTE has a clear position on this: pouches should be regulated by special legislation in the future. This could be done, for example, by including them in the Tobacco Products Act, which also regulates other non-tobacco nicotine products (e-cigarettes).

The consumption of nicotine takes place intentionally in pouches and is associated with health risks. Therefore, it would not be appropriate to base the health assessment of nicotine pouches on the standards of unintentional nicotine intake. Tobacco and nicotine products are consumed primarily because of the nicotine effects, whereby the risks of the various forms of intake and product categories differ greatly. Therefore, a differentiated and comparative assessment of product-related risks is needed. Two important scientific institutions in the European Union, the Dutch RIVM and - in a preliminary assessment - the German Federal Institute for Risk Assessment (BfR), came to the same conclusion for pouches: compared to tobacco consumption, the consumption of nicotine pouches is potentially less harmful.

The RIVM published a well-founded evaluation of nicotine pouches in its report "Nicotine products without tobacco for recreational use". The report recommends a regulation within the framework of tobacco law because they are tobacco-like or tobacco-related products that are intended for nicotine ingestion. The RIVM assesses nicotine pouches as a "probably less harmful alternative to tobacco consumption" and agrees with the preliminary health assessment of the BfR on both points².

The RIVM looked in detail at the cardiovascular effects of nicotine, including a moderate and temporary increase in heart rate as the most sensitive effect³.  The cardiovascular risks of tobacco smoking are well known. Comparatively few data are available for non-tobacco nicotine use and a specific assessment of nicotine is therefore more difficult. However, the most important components of tobacco smoke (nitrogen oxides, acrolein and other carbonyl compounds, carbon monoxide, etc.), which damage the vessels and contribute to the high cardiovascular risks of smoking, are not relevant when using nicotine pouches. According to the BVTE's assessment, the cardiovascular risks are therefore potentially much lower than with tobacco smoking. Increased risks for lung cancer and other tobacco-related diseases are also not to be expected for professionally produced nicotine pouches.

The RIVM rules out severe or fatal poisoning when used as intended for pouches containing up to 32.5 mg nicotine. However, high risks of poisoning exist for children. In order to limit the health risks and to protect children, pregnant women and particularly vulnerable groups, the RIVM and the BfR recommend warnings, child-resistant packaging and a maximum nicotine level. In Germany, the distribution of nicotine products to minors is already prohibited.

The report also discusses the addictive potential of nicotine. The RIVM considers a suitability of pouches as a cessation aid to be potentially possible. However, these products have not been developed, registered or approved as therapeutic applications- but are intended to be a stimulant for tobacco users seeking a potentially less harmful option for nicotine consumption, according to the BVTE.

The RIVM is concerned that nicotine pouches may particularly appeal to children and young people. The arguments for this remain largely speculative. For example, it is argued that the reduced harmfulness alone could make pouches more attractive. However, this possibility should be part of an overall assessment that includes the potential benefits for cigarette smokers. Potentially risk-reduced products must be more attractive than conventional tobacco if they are to have a health benefit in terms of harm reduction. However, there is no evidence that nicotine pouches would be of particular interest to non-smokers or young people. In the Netherlands, only 0.3 % of adolescents (13 to 17 years) and 1.3 % of young adults (18 to 24 years) have ever used a nicotine pouch. The proportion of current and regular users is likely to be much lower still. In the RIVM study, a total of only 0.06% of all respondents were using nicotine pouches at the time of data collection.

The recommendations of the RIVM and the BfR to regulate nicotine pouches in tobacco law were also justified with the analogy to e-cigarettes, which do not contain tobacco but are regulated by the European Tobacco Products Directive. The adaptation of this directive would be associated with numerous legal and procedural obstacles and could take several years. An integration of nicotine pouches into the respective national tobacco laws would initially also be possible in the member states. This approach is also in line with the demand of the Conference of Consumer Protection Ministers of the Länder (VSMK) of 07 May 20214 for an amendment of the Tobacco Products Act in order to create a legal basis for tobacco-free nicotine products.

The BVTE considers a prompt specific legal regulation to be urgently required in the interest of legal certainty, consumer protection and a nationwide uniform handling. Similar to e-cigarettes, the production, presentation and sale of pouches should be permitted in principle and regulated on a product-specific basis.

Conventional and novel tobacco and nicotine products pose different levels of risk to human health. Tobacco heaters and e-cigarettes avoid combustion processes so that fewer pollutants are released overall and the levels are significantly lower than in cigarette smoke. Consumers and bystanders are exposed to significantly fewer harmful substances, potentially reducing health risks. Properly manufactured oral nicotine products are the least harmful option for nicotine consumption and pose no risk to bystanders.

Every adult smoker has a unique relationship with smoking and there are a variety of reasons why people smoke tobacco. For many smokers who want to reduce their health risks, complete abstinence is not a realistic alternative. Novel products may provide a suitable alternative for adult smokers who continue to use nicotine but want to abstain from smoking tobacco products.

To be an acceptable alternative for adult smokers, novel products offer satisfying nicotine enjoyment because they can simultaneously serve sensory, social and behavioural aspects of smoking as a ritual - unlike medical nicotine replacement products (e.g. nicotine patches or gum).

Risk reduction through Tobacco Harm Reduction should first be considered as an individual option to avoid secondary smoking diseases. At the same time, the level of the entire population (public health aspect) must also be taken into account. Novel products must therefore fulfil three key criteria in the context of potential risk reduction:

• They must produce significantly fewer or lower amounts of harmful substances.
• They must be a satisfactory substitute for adult smokers.
• They must be unattractive to non-smokers as well as children and adolescents in order to avoid possible gateway effects, i.e. the initiation of later smoking. This requires both appropriate regulation and responsible distribution, especially not aimed at children and adolescents.

An dieser Stelle verlinken wir eigene Artikel und Beiträge und empfehlen interessante Literatur zum Thema:

• Gastartikel zu Tobacco Harm Reduction von Dr. Frank Henkler-Stephani, BVTE, in Heino Stöver (Hrsg.) Tobacco Harm Reduction, Fachschulverlag Frankfurt/M. S. 89-114, ISBN ist 978-3-947273-52-2
  PDF Gastartikel Dr. Frank Henkler-Stephani, BVTE

• Karl Olof Fagerström, 2021, Harm Reduction in Sweden – the case of snus in Tobacco Harm Reduction, Fachschulverlag Frankfurt/M. S. 197-206, ISBN 978-3-947273-52-2
  PDF Karl Olof Fagerström englisch | PDF Karl Olof Fagerström deutsch

The basis for regulation of novel tobacco and nicotine products should be a robust and comprehensive scientific assessment. Data should demonstrate that a product is significantly less harmful than conventional tobacco products.