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Daniel Donauer
Due to numerous new forms of consumption, the tobacco market has changed in recent years. New products such as electronic cigarettes (e-cigarettes), disposable vapes and other nicotine-containing products for oral use are now available to consumers as alternatives to conventional (nicotine-containing) cigarettes and are one of the reasons why the number of cigarette packs sold in Switzerland is declining. These alternative products are becoming increasingly popular.
According to the Federal Office of Public Health (FOPH), 3% of the Swiss population used e-cigarettes at least once a month in 2022. Among young people between the ages of 15 and 24, the proportion is even higher at 5.7% – and the numbers are rising.
E-cigarettes, whether containing nicotine or not, are offered in different sizes, shapes, colours, and flavours. What they have in common is that – in contrast to a conventional cigarette – no classic combustion process takes place when the product is used. Among other things, e-cigarettes use a battery-operated, electric vaporiser. This ensures that the liquid contained in a cartridge is heated and ultimately vaporised. The consumer can start this process, similar to a cigarette, by pulling on the mouthpiece and inhale the vapour produced by the e-cigarette.
The strong emergence of alternative “stimulant products” such as e-cigarettes over the past ten years has further tightened the already existing regulatory gaps in Swiss tobacco law and product regulation. As a result, the legislator has reacted to this circumstance and passed the new Tobacco Products Act (TobPA), which is now expected to enter into force in 2024. The TobPA – as the successor to the Swiss Tobacco Ordinance (TobO) – is the first independent (i.e., stand-alone) tobacco act in Switzerland and will in future also explicitly cover alternative products such as e-cigarettes as separate product categories.
Until the TobPA enters into force, e-cigarettes (as well as other alternative stimulant products) will continue to be covered “merely” by the currently applicable product regulations (outside of traditional tobacco law) under Swiss food and commodities law.
1. Current legal situation for Electronic Cigarettes
According to current Swiss product law, e-cigarettes fall within the scope of the Swiss Federal Act on Foodstuffs and Utility Articles (FSA). Based on art. 5 lit. b FSA, e-cigarettes are qualified as so-called commodities for human contact. In contrast to traditional tobacco products, which are regulated separately as traditional stimulants under the TobO, which is still in force today, the regulatory assessment of e-cigarettes (as well as comparable alternative products) is currently governed only by the provisions on commodities under the FSA and associated ordinance law.
This product-regulatory assumption is based on the fact that a legal basis for alternative (novel) products such as e-cigarettes has been lacking up to now – i.e., until the TobPA enters into force. The TobO, for example, which contains regulations on the product characteristics of tobacco-based products, does not apply to alternative products without tobacco. The Federal Administrative Court justified this in a ruling by stating that in the case of e-cigarettes there is no combustion process (as is required for smoking products). The legal qualification of e-cigarettes as an article of daily use for human contact has various consequences, the most important of which are the absence of an age limit for persons of legal age only or the absence of obligatory warnings and/or pictorial warnings.
Despite this (objectionable) legal situation, which has been constant for years, it must be pointed out at this point that Swiss legislation on foodstuffs and consumer goods fundamentally prohibits the marketing of e-cigarettes containing nicotine. According to art. 61 para. 2 of the Swiss Federal Ordinance on Foodstuffs and Utility Articles (FSO), it is explicitly stated for utility articles for human contact that the addition of substances that impart pharmacological effects to the products, such as nicotine, is prohibited. However, this prohibition norm, which at first glance appears to be unambiguous, is at the same time eliminated or derogated by special regulations on the elimination of technical barriers to trade. As a result, there are already numerous different e-cigarettes containing nicotine and similar products containing nicotine on the Swiss market today – i.e., before the explicit legalisation under the new TobPA – which can be legally purchased by consumers (see below).
Switzerland has introduced the Cassis de Dijon principle developed by the European Court of Justice within the framework of autonomous enforcement and anchored it in the Federal Act on Technical Barriers to Trade (TBA) in art. 16a et seq. TBA. The Cassis de Dijon principle goes back to a ruling of the European Court of Justice in 1979. The principle developed in this ruling stipulates that products that can be lawfully marketed in an EU member state can in principle – unless exceptions justify a restriction – also be marketed in all other member states, since the product regulations of the member states are to be regarded as equivalent. Today, the principle is enshrined in Swiss law as follows: Products that are already legally marketed in an EC (EU) or EEA member state may also be marketed in Switzerland if they comply with the technical regulations of the EC (EU) and, in the case of incomplete or missing harmonisation in the EC (EU), with the technical regulations of a member state of the EC (EU) or the EEA.
In EU Directive 2014/40/EU of 3 April 2014, the EU harmonised the manufacture, presentation and sale of tobacco products and related products as well as the regulations on the placing on the market and labelling of e-cigarettes containing nicotine. If the requirements of this directive are met and the products have already been lawfully placed on the market in an EU or EEA member state, then the products are considered safe and can therefore also be distributed in Switzerland.
In order to ensure that Swiss producers who produce exclusively for the domestic market do not suffer any disadvantage as a result of this regulation, art. 16b TBA was introduced as a measure to prevent discrimination against domestic producers. This provides that manufacturers who produce exclusively for the domestic market may manufacture their products in accordance with the same regulations of the EC (EU) or an EC (EU)/EEA member state and distribute them accordingly in Switzerland.
It can thus be stated that e-cigarettes qualify as articles of daily use for human contact according to art. 5 lit. b FSA and may in principle only be sold or imported free of nicotine or for personal use according to art. 61 para. 2 FSO. However, since the Cassis de Dijon principle established in the EU is explicitly anchored in the TBA, which takes precedence over the provisions of food and consumer goods law, the distribution of e-cigarettes containing nicotine is already legally possible in Switzerland under the above-mentioned conditions of the TBA.
For the time being, there will be no change in the legal classification of e-cigarettes under art. 5 lit. b FSA until the TobPA enters into force – with corresponding consequences for manufacturers and distributors. For example, the Federal Ordinance on Protection against Dangerous Substances and Preparations (ChemO) does not provide for any exceptions to its scope for articles intended for human contact. Consequently, the provisions of the ChemO for placing e-cigarettes on the market must be observed in parallel with food and consumer goods law (in particular in connection with labelling provisions under chemical law).
2. Legal classification of e-cigarettes under the TobPA in the future (from 2024)
The entry into force of the new TobPA in 2024 will change the legal classification of e-cigarettes. In future, the scope of the TobPA will explicitly include e-cigarettes as a separate product category and define them as devices that are used without tobacco and with which the emissions of a liquid heated by means of added energy can be inhaled with or without nicotine. The TobPA is binding for all tobacco products and all other comparable products such as e-cigarettes as of its entry into force. As a result, the legal classification of e-cigarettes as articles for human contact under the FSA will be superseded and rendered obsolete by the entry into force of the TobPA.
Due to the new subordination of e-cigarettes to Swiss tobacco law, stricter regulations will also come into force for e-cigarettes. For example, e-cigarettes may not (or no longer) be sold to minors and advertising for e-cigarettes on posters, in cinemas, on sports grounds, in and on public buildings and in and on public transport will be prohibited. Regarding the product requirements, the TobPA largely adopts the existing regulation of the current TobO. The change from positive lists and maximum quantities of permissible substances to a negative list can be seen as a positive innovation. This change makes time-consuming authorisation procedures for new substances obsolete and could accelerate the market entry of new products.
The new legislative direction of the legislator then clearly shows that e-cigarettes containing nicotine are to be recognised and legalised as a separate category in Switzerland in the future and that the legal diversions via the qualification as an article of daily use for contact with tobacco and subsequently via the TBA will be abolished.
As far as can be seen, the treatment of health protection-related regulations under the TobPA in the context of the TBA, which without special regulations within the TobPA or the associated ordinance law, would in principle also take precedence over the TobPA in the future, still seems unclear. In other words, if the Federal Council does not decide on an exception to the Cassis de Dijon principle for e-cigarettes (and similar products) within the scope of its powers under ordinance law, the technical regulations newly introduced under the TobPA would also be able to be derogated from in future (to a certain extent) via the TBA.
An example should clarify this area of tension: The TobPA – if there are no more significant changes until 2024, especially in the ordinance law to be drafted – now provides in an Annex 2 for maximum amounts of emissions and substances that may be contained in the products. Thus, a maximum amount of nicotine of 20mg/ml is provided for the liquids contained in the e-cigarettes. Although the EU Directive 2014/40/EU of 3 April 2014 also provides for a maximum nicotine content of 20 mg/ml, this standard has not yet been established in all EU or EEA member states, so that final harmonisation has not (yet) been completed. In certain countries, e-cigarettes with a higher concentration of nicotine are in circulation, so that at the moment the distribution of such products could also be possible in Switzerland on the basis of art. 16a and 16b TBA. Analogous examples can be found on the maximum filling quantity of liquids that may be offered to consumers. It therefore remains to be seen which concrete specifications the legislator or the Federal Council will implement regarding the TobPA/TBA ratio regulation until the new tobacco law enters into force.
3. Final remarks
The entry into force of the TobPA will undoubtedly change the regulatory classification of e-cigarettes. The current classification as a human contact article will be replaced by the new TobPA and e-cigarettes will be included in the TobPA as a separate product category. This provides a legal framework through which the regulatory gaps can be partially closed and gives manufacturers and producers a certain degree of legal certainty – which is very welcome. However, the situation is unclear in that the relationship between the new TobPA and the TBA does not (yet) seem to be sufficiently regulated. For products which are legally distributed in Switzerland via the Cassis de Dijon principle or via art. 16a and 16b TBA, but which do not fulfil the requirements and conditions of the new TobPA in the future, the legal situation thus remains rather unclear.
