International status of regulations on nicotine pouches

The study of the regulatory status of nicotine pouches in 67 countries reveals that half of them already have a legal framework that can include these products. One regulatory path, also applicable to other nicotine products, would be to develop a regulatory framework that specifically addresses the issue of nicotine.

Nicotine pouches (" pouches ") contain in particular a nicotine-based powder, whether derived from tobacco or synthetic. These sachets, which are placed between the lip and the gum, are confused by many media with snus, which are bags containing a tobacco preparation. Highlighted in December 2022 around the Football World Cup, nicotine bags have already been present on all continents for several years.

This market is growing very rapidly, with global sales increasing from 292 million units in 2018 to 6.8 billion units in 2021, a growth of more than 2,000 %. Tobacco multinationals have all developed one or more brands in this market segment, sometimes by acquiring other manufacturers. Nicotine concentrations may vary. from 1.79 mg to 47.5 mg per bag[1], more than smoked tobacco or other nicotine products provide, the impact of these products on health raises the question of their regulation. A study today takes stock of the regulations concerning nicotine pouches according to the countries[2].

Significant variations depending on existing regulations

Covering 67 countries, the study indicates that 34 of them have already enacted regulations that could include nicotine pouches, of which 23 also take into account the issue of synthetic nicotine, while 27 countries had no regulations on the matter.

Of the 34 countries where the subject is regulated, 20 had already seen nicotine pouches appear on their market, 16 have regulated nicotine pouches as tobacco products, 10 have regulated only tobacco-derived nicotine pouches as tobacco products, and 8 have adopted legislation specifically concerning synthetic nicotine pouches. Of the 14 countries with legislation covering nicotine pouches before they reached the market, 6 have banned them (Australia, New Zealand, Brunei, Iran, Mauritius and Singapore), 3 require a medical prescription (Canada, Malaysia, and synthetic nicotine pouches in Australia), and 1 requires a marketing authorisation (Spain).

The authors note different regulatory strategies adopted, most of which remain focused on tobacco products and their derivatives. Some countries, notably the United States, have adapted their definition of tobacco products to encompass all products containing nicotine, including synthetic nicotine. Other countries have preferred to legislate on new categories of products or to classify nicotine pouches as medicines. By classifying nicotine pouches as a substitution treatment, Uruguay has so far managed to avoid their interference in its market, which puts into perspective the manufacturers' discourse on risk reduction.

Synthetic nicotine, source of legal loopholes

Because they are not derived from tobacco, synthetic nicotine pouches pose specific legislative challenges. Some countries, such as Norway and New Zealand, have adopted regulations that focus on nicotine rather than the tobacco plant, which may provide a model for other countries. Legislating on this topic would in particular help to anticipate legal loopholes that may arise with other products using synthetic nicotine, for example in the form of e-cigarettes.

The results of this study are only partial, with European countries being over-represented (27/67), while low-income countries are poorly represented (5/67). The study also only takes into account national regulations, as local arrangements may exist. It nevertheless constitutes a first attempt at an international comparison between different legislations on this subject. The recent requests to ban sachets in Belgium and in Luxembourg[3] suggest that it is prudent to ask the regulatory question before these products enter the market.

To learn more about nicotine pouches, check out our decryption.

Keywords: nicotine pouches, pouches, synthetic nicotine, regulation

M.F.

[1] Mallock N, Schulz T, Malke S, et al. Levels of nicotine and tobacco-specific nitrosamines in oral nicotine pouches. Tob Control 2022. Epub ahead of print 05 Aug 2022. 10.1136/tc-2022-057280

[2] Duren M, Atella L, Welding K, Kennedy RD. Nicotine pouches: a summary of regulatory approaches across 67 countries. Tob Control 2023;0:1–9. Epub ahead of print: 08 Feb 2023. doi:10.1136/tc-2022-057734

[3] Jacquemot P, Not so harmless, these little nicotine sachets that are such a hit, Les Frontaliers, published on February 6, 2023, consulted on February 8, 2023.