Last week's post looked at the options available to Canada's federal health minister to address the recent marketing of Zonnic nicotine pouches. (TLDR?: They should be sold as prescription medications until Canada's tobacco laws include these new products).
This post reports on a variety of recent actions taken to regulate nicotine pouches in European countries. Of these, the experience in Finland may have the greatest relevance for Canada. There, as here, pouches were only available as licensed medicines. Recognizing that this therapeutic designation was not consistent with how the pouches were being sold or used it decided to regulate them as part of the tobacco and vaping product market.
Oral tobacco products, like traditional chewing tobacco or snus, are banned in all but one EU countries by a European Union directive. Nicotine pouches, however, do not meet the definition of tobacco products under EU law, and so this prohibition does not apply to them.
The EU is in the process of revising its rules for tobacco, and there are rumours that a ban on non-tobacco nicotine pouches are under consideration. In the meantime, in the absence of a region-wide directive, countries are left on their own to decide how to control this market.
Within the European region, oral tobacco use (snus) is established and commonplace in the Scandinavian countries. Tobacco-based snus is legal in Sweden because it received an exemption from the EU ban on oral tobacco when it joined the EU and is legal in Norway, which is not a member of the European Union. Although sales of oral tobacco are banned in Finland and Denmark, they are easily imported into these countries and usage is increasing.
Non-tobacco nicotine pouches were first marketed in 2014 in Sweden. As shown in the table provided by Tobacco Tactics, sales of these products have increased substantially in the past few years, especially in the United States and Western Europe.
Sales of nicotine pouches in million units, by region, 2019-2022.
(Source Euromonitor International)
The regulatory response in European countries to nicotine pouches
Belgium
Belgium is the first European country to ban nicotine pouches. The ban came into force at the retail level in October 2023, seven months after it was proclaimed in a Royal Decree (Arrêté royal relatif à l'interdiction de mise sur le marché de certains produits similaires, March 2023).
The stated objective of the order was "to prevent known and potential harmful health effects from the use of these new products, to discourage their use by young people and to avoid possible negative consequences on efforts to combat the smoking."
British American Tobacco launched a legal challenge to the regulation.
Czechia
In May 2023, Czechia passed a decree imposing requirements on the manufacture of nicotine pouches. These included required elements for labelling, restrictions on the additives that could be put in them, minimum packaging of 20 pouches, maximum nicotine of 12 mg per pouch, restrictions on promotional packaging. English and French-language versions of the regulation and background information can be accessed on the EU TRIS site.
Denmark
In Denmark, tobacco-free nicotine pouches became regulated under the Tobacco Act as a tobacco surrogate/substitute in 2020. The rules which apply to them include health warnings, restrictions on sales to young people and other labelling and packaging restrictions.
Estonia
Estonia included smokeless tobacco products during its 2020 revisions to its Tobacco Act. These extend some of the restrictions on combustible products to nicotine pouches, and provide for a specific health warning. ("This tobacco product damages your health and is addictive").
Finland
The Finnish government is currently transferring the regulation of nicotine pouches from medicinal products to tobacco products in an attempt to control the illicit market. Legislation to accomplish this is expected to be presented to the Finnish legislature within a few weeks.
In preparation for this change, the Finnish ministry of health prepared both an explanatory Draft Text with the changes, as well as an Impact Assessment . These were provided to the European Commission TRIS portal as a routine part of the EU's management of technical barriers to trade.
The de-medicalization of pouches is being managed in two steps. A stop-gap measure was put in place in June 2023 with an order under the Finnish Chemicals Act and increased enforcement activity. The longer-term approach involves amendments to their tobacco law -- scheduled for introduction in February. These would regulate nicotine pouches largely as tobacco and vaping liquids currently are and would establish a maximum nicotine limit of 20 mg and restrictions on flavourings. (The exact flavours to be restricted would be established by regulation).
Germany
The report noted that German state authorities currently regulate nicotine pouches as a novel food, rendering the sale of pouches illegal in some states, but not illegal to use by those who privately import them. Germany's national tobacco law (Tabakerzeugnisgesetz) does not include specific rules for nicotine pouches.
In 2022, the German Federal Institute for Risk Assessment (Bundesinstitut für Risikobewertung) provided its Health risk assessment of nicotine pouches. Although the agency concluded that pouches were less harmful than cigarette smoking, it noted that they can expose users to tobacco-specific nitrosamines (TSNAs).
Their assessment found that nicotine pouches could delivery much more nicotine than smoking a cigarette: "at least half of the nicotine in the pouch can be absorbed. Relevant
nicotine blood levels were achieved, i.e. levels were within a range that is comparable with
conventional cigarettes. Use of high-dose products led to significantly higher nicotine levels
than cigarette consumption."
Hungary
Outside of Scandinavia, Hungary is a country with higher involvement with nicotine pouches. British American Tobacco opened a large nicotine pouch manufacturing plan in Hungary in 2020. Over the past year, however, the government has raised concerns about the unregulated market and this summer proposed restrictions on nicotine levels (17 mg per pouch) and other limitations on "nicotine containing smoking substitutes" similar to those in place for tobacco products.
Iceland
Iceland revised its law in 2022 to address nicotine pouches. Restrictions include a ban on advertising, an age limit of 18 years, and prohibitions on using in places where children and young people are present. Although the law permits a ban on flavourings, none are yet in place. Maximum nicotine levels are 20 mg per pouch.
Latvia
Latvia's legislature, the Saeima, is finalizing its review of amendments to its tobacco law. Among the proposed changes are restrictions on tobacco substitutes, a category which includes nicotine pouches. As described in an impact assessment submitted to the EU, these measures include "specific composition requirements for tobacco substitute products to be placed on the Latvian market, including the maximum admissible nicotine concentration of 4 mg per g, restrictions on additives, including a restriction on the added flavourings, with the exception of flavours which produce the odour or taste of tobacco. The draft law also foresees a prohibition of sales to minors, including sales by means of distance communication, including distance contracts, restrictions on advertising and sponsorship, including restrictions on visible placement of tobacco products in retail stores. The draft law also requires placement of a mandatory health warnings on tobacco substitute products. "
Lithuania
Lithuania is reported to be responding to an increase in illegal sales of nicotine pouches by developing a law to regulate their sale.
Netherlands
In November 2021, the Netherlands health minister informed the legislature that he would propose legislation to address nicotine pouches and other new nicotine products, but would use food regulations temporarily to block the sale of pouches. The following spring, a declaration that nicotine pouches containing more th an 0.035 mg of nicotine were unsafe and therefore not legal for sale was formally published. This maximum nicotine level was calculated by the government's public health agencies by applying the food standard Acute Reference Dose for nicotine as set by the European Food Safety Authority.
In September 2023, the Netherlands legislature was provided with draft amendments to the tobacco law which would expand the law to include non-tobacco nicotine products (and impose similar restrictions to these products as were applied to tobacco products) and which would ban nicotine pouches.
Following an election in November 2023, there was a change of government in the Netherlands. The new government has not formally been set, and so the impact of this change on tobacco policy is unknown.
Norway
Norway is not a member of the European Union, and oral tobacco (snus) is commonly used by adults and young people.
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In Norway, Zyn contains a small
amount of tobacco
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Norwegian law, similar to Canada's, bans the marketing of nicotine pouches, other than those specifically authorized as a medical device. To skirt this regulation, nicotine pouches in Norway are sold with small amounts of tobacco in them. As tobacco products, they must be sold in plain packaging.
For example, the PMI product Zyn is sold in Norway with some tobacco included. ("The all-white appearance of the snus is made possible thanks to a composition of plant fiber and a small proportion of light tobacco. The mixture and the portion provide a soft fit and a long-lasting taste experience." translation from www.snuslageret.no/zyn/)
Sweden
In 2022, Sweden responded to a court ruling which required it to remove e-cigarettes from medicinal regulation. It created a specific law for tobacco-free nicotine products (Act 2022:1257). The law will be fully in force in 2024. The regulations include health warnings, labelling requirements, reporting obligations, and premarket notification. Sweden's permissive approach to oral nicotine products is reflected in its expressions of concern about other EU countries banning them.
United Kingdom
The United Kingdom is no longer a member of the EU, but has to date maintained EU-consistent tobacco laws.
In the UK and Scotland, nicotine pouches are not regulated under the same laws that cover tobacco and vaping products, but under consumer product safety rules. As a result, restrictions on advertising, labelling and minimum age do not apply. Despite concerns raised about the marketing of these products, and a call for government action, the UK government did not include reference to this in its recent announcements regarding tobacco law reforms.
