Marketing restrictions, age requirements and health warnings? – Proposed new regulations for tobacco-free nicotine products

Recently there has been rapid development of tobacco-free nicotine products for consumption. The marketing of these new products is extensive; we see them in ads, in sponsored posts on social media as well as in influencer collaborations. This has given rise to discussions regarding the regulatory aspects of these products. Consequently, the Swedish government has now proposed new regulations for tobacco-free nicotine products and a ban on flavoured liquids intended for consumption through e-cigarettes. In this article, we highlight some of the proposed changes that will require significant changes from the industry, and further provide some guidance.

A new industry
The tobacco market is undergoing significant changes with new products such as tobacco-free nicotine products and e-cigarettes complementing traditional tobacco products. Despite the product development and the intensive marketing carried out by the industry, the legal position of the relevant products has long remained unclear. As of today, the marketing of tobacco products is mainly regulated in the Act on Tobacco and Similar Products (2018:2088). The Act prohibits most forms of advertising of the products in question, including indirect advertisement such as product placement of tobacco and sponsorships. The rules are strict.

However, the existing tobacco legislation does not cover tobacco-free nicotine products. Moreover, current EU legislation only applies to products containing tobacco, e-cigarettes and refill containers. Snus-like products have previously been classified as food products by the Swedish Food Agency (Livsmedelsverket) and have therefore, as a general rule, been regulated by relevant food legislation. That said, in February 2019, the Swedish Food Agency concluded that snus-like products are not food products. In light of the above, the Swedish government decided in 2020 to appoint a Commission of Inquiry tasked with analysing whether there is a need for a tighter legal framework concerning new nicotine products and e-cigarettes. The Commission of Inquiry’s final report was recently presented in SOU 2021:22.

A new act on tobacco-free nicotine products
The Commission of Inquiry proposes a new act on tobacco-free nicotine products. Any tobacco-free nicotine product that contains nicotine intended for consumption will be covered by the proposed regulations. However, products that are classified as medicinal products, medical devices, narcotics or other substances harmful to health will not be covered. Additionally, no products that are governed by the Act on Tobacco and Similar Products, such as e-cigarettes and refill containers, will fall within the scope of the new Act. The proposed legislation has been drafted with the aim of covering all tobacco-free nicotine products that may be developed in the future, and further, the provisions set forth therein are in many respects similar to the regulations on e-cigarettes and refill containers in the Act on Tobacco and Similar Products.

It should be mentioned that pouches free of both tobacco and nicotine will not be covered by the proposed new act on tobacco-free nicotine products. However, such products will be equated with food in the Food Act and thus be subject to food safety legislation (i.e. similarly to snus according to the current legislation). Furthermore, what distinguishes the proposed new Act from previous legislation is the particular moderation in the marketing of the products following the freedom of press and expression, rather than the inclusion of various marketing bans.

Marketing prohibitions and health warnings
As stated above, the Commission of Inquiry proposes a requirement of moderation in the marketing of tobacco-free nicotine products. This moderation is based on the notion of prohibiting the advertisement of tobacco-free nicotine products in an intrusive or proactive manner. Thus, the proposed Act includes prohibitions on referring to the taste of the product in any way or in such a way that cannot be justified by a consumer’s need for product information. Additionally, the products should not be allowed to contain any additives that give the impression that the products entail a health advantage, such as vitamins. Nor should the products be allowed to contain stimulants that are often associated with vitality and energy, such as caffeine or taurine. Furthermore, the package should display a declaration of ingredients. Any marking on the product to suggest that the product is less harmful than other similar products is not permitted. Nor can the products be presented in a way that makes them resemble makeup or food products.

In addition, the proposed Act states that the marketing of tobacco-free nicotine products must include a clearly visible health warning of the addictive effect of nicotine. This warning will be required in commercial printed advertisements, in line with the Freedom of the Press Act (1949:105). The health warning must also be printed on the product package itself. Further proposed prohibitions include advertisements for the products in radio or television broadcasts, sponsorship and product placements where the regulations on tobacco products and e-cigarettes would be applied.

Advertising to minors
The selling and marketing of tobacco-free nicotine products is suggested to be subject to age restrictions. The minimum age for buying such products is proposed to be 18 years. Further, where there is a suspicion that the product will be distributed to a minor, the product must not be sold. Information on the required age for purchase should be clearly visible to customers in each sales point, this also applies to online sales. The Commission of Inquiry further advocates that the product must be supplied in a particular manner in which it is possible to ensure that the age requirement is fulfilled, and that the Public Health Agency of Sweden (Folkhälsomyndigheten) has the right to issue regulations concerning the vendor’s obligation to check the buyer’s age. The Act would also prohibit any marketing that specifically targets or depicts children or young people who have not attained 25 years of age.

Notification requirement
In order to ensure the appropriate control of tobacco-free nicotine products, the Commission of Inquiry proposes that producers and importers of such products should be obliged to notify the Public Health Agency of Sweden of any relevant product they intend to make available to the public. This would also have to be done when there has been a material change in the product or when the product has been removed from the market. In order for the Public Health Agency of Sweden to follow the development of new or changed products, the Commission of Inquiry argues for the introduction of an obligation for vendors to submit statistics on the sales volumes and preferences of consumer groups, in particular of young consumers, and further that the Public Health Agency of Sweden should be able to issue regulations concerning compliance with the obligation to notify. Vendors with registered offices or domicile in Sweden must notify relevant municipalities of any intended sale of tobacco-free nicotine products.

Ban on flavoured e-liquids
In an effort to reduce the incidence of young people using flavoured e-liquid nicotine products, the Commission of Inquiry proposes a ban on such e-liquids intended for consumption. This ban would apply to all liquids consumed through e-cigarettes, regardless of whether they contain nicotine. The ban is proposed to be entered in the Act on Tobacco and Similar Products together with new rules about particular moderation in the marketing of e-cigarettes and refill containers at physical sales points.

Criminal responsibility
Any advertisements for products that are not compliant with existing regulations constitute a breach of the Marketing Act (2008:486). Additionally, advertising methods considered to be misleading, aggressive or otherwise harmful are prohibited. However, the Commission of Inquiry further proposes that it be possible to sentence a person who makes available tobacco-free nicotine products to consumers if the products do not fulfil the marketing requirements with regard to health warnings and ingredient declarations, if done intentionally, to a fine or imprisonment for up to six months.

Planning ahead
The proposed new regulations are strict and will bring significant change to the industry of tobacco-free nicotine products. If adopted, the new Act will enter into force on 1 July 2022 forcing companies within the industry to review their business. However, provided that the products in question do not constitute a serious health risk, tobacco-free nicotine products manufactured before this point in time will be allowed. That said, businesses should make sure to start preparing for the new regulations as soon as possible, as they will affect not only the marketing of the products nor to whom the products may be advertised, but also what they may contain. Furthermore, businesses may have to change the packaging of the products, making sure that they display the health warnings and the ingredient declarations required. Finally, businesses must additionally review existing marketing plans as well as planned influencer collaborations to ensure that they are in line with the proposed regulations.

We would be happy to provide further guidance should you need any assistance.