Nicotine pouches: a summary of regulatory approaches across 67 countries

Introduction:

This article provides a summary of nicotine pouch regulatory policies across 67 countries. It highlights the significant variation in how countries classify nicotine pouches and the regulatory approaches they take. A key focus of the study is the distinction between nicotine pouches that use tobacco-derived nicotine and those that use synthetic nicotine.

Key Points:

* The study identified 34 countries that regulate nicotine pouches, with 23 of these countries' policies encompassing synthetic nicotine.
* Countries regulating both synthetic and tobacco-derived nicotine pouches generally rely on existing policies for tobacco products and/or medicines or have developed new policies that specify nicotine as the substance at issue.
* Some countries have policies that specifically exclude nicotine pouches from tobacco product regulations, while others have policies that are unclear or do not explicitly address nicotine pouches.
* There is a trend towards regulating synthetic nicotine pouches as medicines or drugs, particularly in countries that have existing regulations for nicotine replacement therapies.
* The study found that 14 countries regulate nicotine pouches but do not currently sell them, with six countries banning nicotine pouches, three requiring a prescription, and one requiring premarket authorization.
* The authors suggest that countries may be able to regulate nicotine pouches using existing drug/medicine approval pathways and that an effective long-term strategy could be to broaden existing definitions of tobacco products to include nicotine or develop a regulatory framework based on nicotine rather than tobacco.

Main Message:

The study offers valuable insights into the regulatory landscape for nicotine pouches, highlighting the need for clear and consistent policies. The findings suggest that countries can regulate nicotine pouches using existing drug/medicine approval pathways or by broadening existing definitions of tobacco products to include nicotine. The study also underscores the importance of monitoring synthetic nicotine pouches, which may require a different regulatory approach than tobacco-derived nicotine pouches. Overall, the study provides a roadmap for how other jurisdictions can add effective guardrails to the use of non-medicinal nicotine products.

Duren, M., Atella, L., Welding, K., & Kennedy, R. D. (2023). Nicotine pouches: A summary of regulatory approaches across 67 countries. Tobacco Control, tc-2022-057734. https://doi.org/10.1136/tc-2022-057734