The classification and regulation of non-therapeutic oral nicotine products varies widely across countries. Regulations on tobacco products do not always capture nicotine products, particularly those made from synthetic nicotine (i.e., nicotine that is not derived from tobacco). Some countries use existing policies for tobacco products and/or medicines to regulate nicotine pouches, or have developed new policies or regulatory classifications that focus on nicotine rather than tobacco.1 Examples of some of these policies are presented below. For a detailed description of the regulation of oral nicotine products in Australia, see Section 18C.7.
New Zealand
In New Zealand, The Smokefree Environments and Regulated Products Act 1990 prohibits the importation, sale, and distribution of oral tobacco products and oral nicotine products (unless approved as medicines).2
North America
United States
In 2022, the United States passed a bill to redefine a tobacco product as ‘any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption’, bringing oral nicotine products under the authority of the Food and Drug Administration (FDA).1 Manufacturers are required to submit certain product information to the FDA, convey nicotine warnings, and comply with marketing restrictions.3
However, while nicotine pouches fall under the jurisdiction of FDA, one study notes that they were not included in smokeless tobacco regulation, and are therefore still allowed to advertise on radio, television, or other media.4 Attempts to circumvent regulations have also been noted by researchers, such as nicotine gummies being described as ‘supplements’(which fall outside of regulation by the FDA) 5 and pouches being marketed as ‘flavour ban approved’. 6
Canada
In Canada, oral nicotine products are regulated either as a ‘Natural Health Product’ (if they contain less than 4mg of nicotine) or as a prescription drug. In July 2023, Health Canada authorised the marketing of BAT’s Zonnic nicotine pouch as a natural health product. This allows BAT/Nicoventures to market five flavours, and to advertise these pouches as a cessation aid and for use in places where smoking is banned or discouraged. It also permits the pouches to be sold to children (although it advises people under 18 not to use it).7 A group of health organisations have called for the federal government to reclassify the nicotine pouches as a prescription product (meaning they will be sold only in pharmacies) or to suspend the sale of them until they can be regulated in a similar way to cigarettes.8
United Kingdom
In the UK, oral nicotine products are not captured by regulation of either tobacco products or e-cigarettes and are only regulated under general consumer product safety regulations. This means they can be sold to children.9
Europe and the European Union
Nicotine pouches are not covered by current tobacco product regulations, including an EU-wide ban on snus. This is subject to review in the next revision of the Tobacco Products Directive.10 However, individual member countries regulate these products in a variety of ways.
Sweden
Sweden has an exemption from the EU ban on snus; however, despite having one of the largest markets, there are currently no regulations addressing nicotine pouches.2
France
In France, nicotine pouches fall under the designation of poisonous substance and are subject to applicable regulations. Pouches can also be submitted to the French health authorities and regulated as a medicine for cessation purposes.2
Finland
The Finnish Medicines Agency (Fimea) announced in April 2023 that nicotine pouches would no longer be classified as medicinal products, allowing the sale of pouches without a separate marketing authorisation. Regulations proposed by the new government seek to include nicotine pouches in the scope of the Tobacco Act and will require retailer permits and regulate nicotine levels and flavours.11
Belgium
A ban on the sale of nicotine pouches came into effect in Belgium in October 2023. British American Tobacco (BAT) and Philip Morris International have reportedly appealed to overturn the ban.12
Netherlands
In April 2023, the Dutch government announced that it would ban the sale of nicotine pouches.13
Germany
Germany regulates nicotine pouches as a food product; under this authority, some products have been withdrawn by classifying pouches as a health hazard due to their high nicotine content.1 Some federal states have also withdrawn pouches.2
Norway
In Norway (which is not a member state of the EU) a ban on novel tobacco and nicotine products was lifted in July 2021 and replaced with a market authorisation scheme. All forms of advertising and sponsorship of nicotine pouches are banned.2
Low and middle-income countries
Some low- and middle-income countries, such as Argentina, Bangladesh, Georgia, Indonesia, and Nigeria, regulate only tobacco-derived products and not those derived from synthetic nicotine. Others including Brazil, Brunei Darussalam, India, Iran, Thailand regulate both tobacco-derived and synthetic nicotine pouches. Many countries where nicotine pouches are present in the market, including Fiji, Mexico, Pakistan, Philippines, Uganda, Ukraine, Uzbekistan, and Yemen, have no policies regulating these products.1
References
1. Duren M, Atella L, Welding K, and Kennedy RD. Nicotine pouches: a summary of regulatory approaches across 67 countries. Tobacco Control, 2023. Available from: https://www.ncbi.nlm.nih.gov/pubmed/36750358
2. Institute for Global Tobacco Control. Policy Scan: Nicotine Pouches. Available from: https://www.globaltobaccocontrol.org/en/policy-scan/nicotine-pouches.
3. Marynak KL, Wang X, Borowiecki M, Kim Y, Tynan MA, et al. Nicotine Pouch Unit Sales in the US, 2016-2020. Journal of the American Medical Association, 2021; 326(6):566-8. Available from: https://www.ncbi.nlm.nih.gov/pubmed/34374729
4. Sparrock LS, Phan L, Chen-Sankey J, Hacker K, Ajith A, et al. Nicotine Pouch: Awareness, Beliefs, Use, and Susceptibility among Current Tobacco Users in the United States, 2021. International Journal of Environmental Research and Public Health, 2023; 20(3). Available from: https://www.ncbi.nlm.nih.gov/pubmed/36767414
5. Borowiecki M, Emery SL, and Kostygina G. New recreational nicotine lozenges, tablets, gummies and gum proliferate on the US market. Tobacco Control, 2022. Available from: https://www.ncbi.nlm.nih.gov/pubmed/36319083
6. Jabba SV, Erythropel HC, Woodrow JG, Anastas PT, O'Malley S, et al. Synthetic cooling agent in oral nicotine pouch products marketed as 'Flavour-Ban Approved'. Tobacco Control, 2023. Available from: https://www.ncbi.nlm.nih.gov/pubmed/37380351
7. Callard C. BAT shoehorns its nicotine pouches onto the Canadian market. Physicians for a Smoke-Free Canada, 2023. Available from: https://smoke-free-canada.blogspot.com/2023/07/bat-shoehorns-its-nicotine-pouches-onto.html
8. Dangerfield K. What are nicotine pouches? Why health experts are sounding the alarm in Canada. Global News, 2023. Available from: https://globalnews.ca/news/10090440/nicotine-pouches-canada-kids/
9. Action on Smoking and Health. Awareness and use of nicotine pouches. 2022. Available from: https://ash.org.uk/resources/view/awareness-and-use-of-nicotine-pouches
10. Tobacco Tactics. Nicotine Pouches. 2023. Available from: https://tobaccotactics.org/article/nicotine-pouches/
11. Finnish Government. A strong and committed Finland: Programme of Prime Minister Petteri Orpo's Government. 2023. Available from: https://valtioneuvosto.fi/en/governments/government-programme#/.
12. Total ban on nicotine pouches in Belgium from 1 October. Belga Newsagency, 2023. Available from: https://www.belganewsagency.eu/total-ban-on-nicotine-pouches-in-belgium-from-1-october
13. Meijer B. Netherlands bans sale of all nicotine pouches. Reuters, 2023. Available from: https://www.reuters.com/world/europe/netherlands-bans-sale-all-nicotine-pouches-2023-04-21/