Background
Assessment
Proposed legislation
Comment
In 2021, the Swedish government received a report on the potential legislation of tobacco-free nicotine products. While these products have so far existed in a legal void, the report proposes new legislation with rules similar to those for tobacco products and electronic cigarettes, as well as the rules for alcohol. The government has provided its comments and submitted them to the Council on Legislation. A governmental bill is expected on 22 March 2022 and it is suggested that new legislation will enter into force between 1 August 2022 and 1 February 2024.
For details of the potential issues that could arise, as well as possible resolutions to such issues, following the implementation of new legislation regarding tobacco-free nicotine pouches, see "New legislation on tobacco-free nicotine pouches expected".
In short, "snus" – a tobacco product that contains nicotine (often in a pouch) and is placed under the upper lip – is heavily regulated (albeit legal in Sweden, in contrast with other EU member states). In recent years, so-called "tobacco-free nicotine products" (most commonly administered in pouches, similar to snus) have become very popular. However, such nicotine products have so far existed in a legal void in comparison with tobacco and similar products (eg, snus and cigarettes, as well as electronic cigarettes). They have been solely self-regulated with regard to issues such as advertising, age restrictions and labelling.
In late March 2021, the government received a report that thoroughly examined the current legislation which covers nicotine products, as well as the potential need for new legislation.
First, the report confirmed that, apart from more general frameworks, such as the rules regarding product safety and marketing law, tobacco-free nicotine products do not fall under any of the legal frameworks for medicinal products, food, tobacco products, chemical products or other similar products. The report then expressed a need for new legislation, among other things, since:
- the use of nicotine products in pouches has increased in people between the ages of 14 and 18;
- nicotine may have an impact on brain development, birth defects and lungs; and
- nicotine's addictiveness can affect consumers' purchase patterns.
Nicotine products were therefore found to be associated with different types of risk compared with other products. The government agreed with the view provided in the report.
It is proposed that the new legislation will enter into force on 1 July 2022. The proposed legislation contains the following provisions:
- The packaging of tobacco-free nicotine products shall contain a declaration of their contents.
- The packaging and advertising of tobacco-free nicotine products shall include health warnings that inform the consumers of the harmful effects of nicotine.
- The labelling on the packaging of tobacco-free nicotine products may not indicate that such products are less harmful than other products.
- The labelling of tobacco-free nicotine products cannot be similar to that of food stuffs or cosmetic products.
- The marketing and advertising of tobacco-free nicotine products shall be "particularly moderate" and may not be directed towards people younger than 25 years old.
- No advertising of tobacco-free nicotine products shall be allowed on commercial television, radio or pay-per-view services.
- Tobacco-free nicotine products may not be used to sponsor a business or public event.
- Tobacco-free nicotine products may not be sold to anyone younger than 18 years old.
It is also proposed that manufacturers and importers shall have a duty to report volumes of sales, as well as information on their customers' preferences, to the Public Health Agency. Further, it is proposed that retailers shall be obliged to report that they are selling tobacco-free nicotine products.
It is also proposed that the Swedish Chemicals Agency shall provide a limit on how much nicotine each product may contain.
The government confirmed the need of said legislation as well as the contents of it. However, while the initial report suggested that the legislation should enter into force 1 July 2022, the government suggests that most of the provisions shall enter into force 1 August 2022 but that provisions on product requirements and labelling shall enter into force 1 January 2023, The duty to report shall enter into force 1 July 2023.
Tobacco-free nicotine products are currently self-regulated in respect of, for example, health warnings and age restrictions, although no real effective remedies under law exist should a retailer breach such self-regulation.
While a governmental bill has not yet been presented to Parliament – this is expected to take place on 22 March this year – it is likely that the essence of the proposed legislation will enter into force, in at least similar wording. Until then, tobacco-free nicotine products will continue to be unregulated (apart from general rules regarding product safety and marketing).
One possibly major issue that may cause problems for the bill in Parliament is if it does not clearly differentiate between the potential harm caused by different types of tobacco and nicotine products. The government report explicitly treats all types of products containing nicotine in a similar fashion, where the aim of the new legislation is cessation. The government's new strategy against alcohol, narcotics, doping, tobacco and gambling was voted down in Parliament in June last year, due to the fact that it did not make such a product harm differentiation, among other things.
In light of the above, it is expected that the proposed rules regarding the marketing of tobacco-free nicotine products will be more similar to those for alcohol than those for tobacco products. The main rule for tobacco products is that advertising is not allowed, but that certain exemptions exist. With regard to alcohol, as well as nicotine products (according to the government report) advertising is, as a general rule, allowed, but it shall be "particularly moderate". This essentially means that the marketing shall only convey that which is necessary in order to provide the consumer with relevant information about the product.
It remains to be seen whether Sweden will switch from nicotine use cessation to harm reduction as a general policy. A government election will be held in September, which may affect the outcome of this question.
The new legislation will likely not entail any changes with regard to the line between nicotine products as stimulants and their use as medicinal products. The report is clear that tobacco-free nicotine products sold with health claims (eg, smoking cessation or harm reduction) can still be classified as medicinal products, and thus fall under legislation concerning medicinal products when it comes to, for example, marketing and advertising. However, the vast majority of the nicotine products on the Swedish market will fall under the legislation proposed to enter into force on 1 August 2022.
For further information on this topic please contact Jonas Löfgren or Måns Ullman at Westerberg & Partners Advokatbyrå Ab by telephone (+46 8 5784 03 00) or email ([email protected] or [email protected]). The Westerberg & Partners Advokatbyrå Ab website can be accessed at www.westerberg.com.