Next Generation Products
Over the past few years, the possibilities of enjoying tobacco or nicotine have expanded. Novel products provide smokers with the opportunity to switch to (potentially reduced-risk) alternatives without giving up nicotine consumption. There are heat-not-burn as well as tobacco-free products. Here are some important products from the portfolios of our member companies:
E-cigarettes allow nicotine consumption without containing or burning tobacco. Although e-cigarettes have different designs, they all have a similar basic structure. With the help of a battery-operated device, a liquid is heated and evaporated. This liquid usually consists of the carrier substances propylene glycol and glycerol as well as flavours and possibly nicotine.
There are basically two different types of e-cigarettes:
- Closed systems: the cartridge with the pre-filled liquid also contains the vaporiser, which together form a closed ready-to-use system (“pod”). When the liquid is finished, the pod is exchanged and a new one can be inserted. These are small and powerful devices, easy and discreet in use; previous experience is not required.
- Open systems: The components of the device are individually assembled. The performance can be adjusted to a certain extent and the tank is refillable. These are high-performance, versatile devices with a technically sophisticated and individualistic handling, for connoisseurs
Since 2014, e-cigarettes have been regulated as a “related product” of tobacco products. The European Tobacco Products Directive 2014/40 / EU established regulations for the production and marketing of nicotine-containing e-cigarettes and their refill cartridges.
Legal regulations for electronic cigarettes:
- In Germany, the use of flavours is subject to strict regulations and the producers report all substances used to the authorities (MORE ...).
- Since 2016, a health warning is printed on the packages of e-cigarettes and refill cartridges as well as on cigarette packages.
- Nicotine-free products will be subject to the same regulations as e-cigarettes that contain nicotine with regard to Ingredients and Advertising.
These novel products enable the enjoyment of tobacco without burning it. A battery-operated device heats the tobacco stick or capsule up to a temperature of 300-400 °C.
Modern Oral Products
Modern oral products offer another innovative (and potentially lower-risk) alternative to enjoy tobacco or nicotine. These products offer adult smokers and nicotine users a convenient and discreet way of consuming nicotine.
The pouch is activated by chewing it briefly and then placing it under the upper lip. The nicotine is absorbed through the oral mucosa. After use, the product is removed from the mouth and discarded.
Tobacco-free nicotine pouches
These are white, tobacco-free nicotine products for oral use. They are available in different nicotine contents and flavours. They mainly contain starch, plant fibres, flavours and nicotine.
Since these novel products do not contain tobacco, they are not subject to legislation on tobacco products and related products.
The member companies of the BVTE agreed on voluntary minimum standards for quality and marketing to ensure a high level of consumer protection.
These are essentially the modern version of chewing tobacco. They are offered with different nicotine contents and flavours - often in white. They mainly consist of starch, plant fibres, favours as well as tobacco that naturally contains nicotine.
These products contain tobacco and are marketed as chewing tobacco. They are subject to European and German regulations for tobacco products and related products.
Tobacco Harm Reduction
Dutch RIVM and German BfR agree on risk assessment: Nicotine pouches are a potentially less harmful alternative to tobacco consumption
Nicotine pouches are a novel alternative to traditional cigarette and tobacco products. They are small porous sachets that mainly contain starch, plant fibres, flavours and purified nicotine. Pouches are used by placing them under the upper lip. The nicotine is absorbed through the oral mucosa. Similar to chewing tobacco and other smokeless tobacco products there are no carcinogenic and harmful combustion products. By now, pouches are available in many member states of the European Union, both in stores or online.
Tobacco-free nicotine pouches are new generation products that require adequate legal regulation because they are used to consume the - addictive - substance nicotine. The BVTE takes a clear position on these products: 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. That is why it would not be appropriate to base the health assessment of nicotine pouches on the standards of unintentional nicotine intake. Tobacco and nicotine products significantly are consumed for their nicotine effects, whereas the risks of the various forms of intake and product categories differ considerably. Therefore, they required a differentiated and comparative assessment of product-related risks.
Two important scientific institutions of the European Union, the Dutch RIVM and - in a preliminary assessment - the German Federal Institute for Risk Assessment (BfR) have drawn the same conclusions for pouches: Compared to the consumption of tobacco, nicotine pouches are potentially less harmful.
The report “Nicotine products without tobacco for recreational use” published by RIVM is a well-founded assessment of nicotine pouches1. It recommends the regulation of these products within the legal framework for tobacco products because they are tobacco-like or tobacco-related products intended for nicotine intake. RIVM rates nicotine pouches as “likely to be a less harmful alternative to tobacco consumption” and agrees on both points with the BfR’s preliminary health assessment2.
RIVM focussed specifically on the cardiovascular effects of nicotine, including a moderate and temporarily increased heart rate as the most sensitive effect3. The cardiovascular risks of tobacco smoking are widely known. Comparatively few data is available for tobacco-free nicotine consumption, and a specific assessment of nicotine is therefore more difficult. However, the major components of tobacco smoke (nitrogen oxides, acrolein and other carbonyl compounds, carbon monoxide and other components) that damage blood vessels and contribute to the high cardiovascular risks of smoking are not relevant to nicotine pouch consumption. According to the BVTE, the cardiovascular risks are potential therefore much lower than for tobacco smoking. Increased risks for lung cancer and other tobacco-related diseases are also not expected for professionally manufactured nicotine pouches.
RIVM excludes serious or fatal poisoning when for pouches containing up to 32.5 mg of nicotine when they are used properly and as intended. However, there are poisoning risks for children. To limit health risks and to protect children, pregnant women and vulnerable groups, RIVM and the BfR recommend health warnings, child-resistant packaging and a ceiling for nicotine. In Germany, the sale of nicotine products to minors has already been banned.
The report also discusses the addiction potential of nicotine. RIVM considers pouches a potential cessation aid. These products were not, however, developed, registered or approved for therapeutic use – but, according to the BVTE, are intended to be a stimulant for tobacco consumers seeking a potentially less harmful option to nicotine consumption.
RIVM is concerned that nicotine pouches may particularly appeal to children and adolescents. The arguments, however, 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 potential benefits to cigarette smokers. Potentially reduced-risk products must be more attractive than conventional tobacco if they are to provide health benefits in terms of harm reduction. But there is no evidence that nicotine pouches would be more attractive to non-smokers or adolescents. In the Netherlands, only 0.3% of adolescents (13 - 17 years) and 1.3% of young adults (18 - 24 years) have ever used a nicotine pouch. The percentage of current and regular users is likely to be much lower. In the RIVM study, a total of only 0.06% of all respondents were using nicotine pouches at the time of the survey.
The recommendations of RIVM and the BfR to regulate nicotine pouches under tobacco law were also substantiated by analogy with e-cigarettes, which do not contain tobacco but are regulated by the European Tobacco Products Directive. Adapting the provisions of this directive would mean numerous legal and procedural obstacles and could take several years. As a start, it would be also possible to include nicotine pouches into the resprective national tobacco law of the member states. This approach is also in line with the call of the Conference of the Ministers of Consumer Protection of the German Federal States (VSMK) of 07 May 20214 for an amendment to 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 needed, legal certainty, consumer protection and a nationally uniform administration throughout Germany. As with e-cigarettes, the use of pouches should be the production, presentation and sale of pouches should in principle be permitted and regulated on a product-specific basis. Nicotine pouches offer smokers great potential for harm reduction. Smokers should have the opportunity to use this potential!
1 National Institute for Public Health and the Environment (RIVM): Nicotine products without tobacco for recreational use. RIVM Report 2020-0152 C.G.G.M. Pauwels et al., 2020. (https://www.rivm.nl/en/bibcite/reference/339001)
2 Bundesinstitut für Risikobewertung (BfR): “Vorläufige gesundheitliche Bewertung von Nikotinbeutelchen (Nikotinpouches)”, Az: 20-0203-03/002-11497361 of 30 March 2021
3 EFSA: Potential risks for public health due to the presence of nicotine in wild mushrooms. The EFSA Journal RN-286, 1-47, 2009. (https://www.efsa.europa.eu/de/efsajournal/pub/rn-286)