Nicotine pouches: a summary of regulatory approaches across 67 countries.

INTRODUCTION: Nicotine pouches are small, permeable pouches containing nicotine. The nicotine may either be derived from tobacco plants or synthetically produced. Nicotine pouches are available worldwide, but little is known as to how various countries regulate these products. This study summarises nicotine pouch regulatory policies across 67 countries. METHODS: This research summarises insights obtained through active policy surveillance work in which we requested information on the availability of nicotine pouches and applicable policies and analysed responses from representatives of 67 countries (representatives included subject matter experts in government or civil society organisations). These countries span all WHO regions. RESULTS: We found significant variation in how countries classify nicotine pouches, with many countries' current regulatory approach failing to regulate nicotine pouches that used synthetic nicotine. We found 34 countries regulate nicotine pouches with 23 of these countries' policies encompassing synthetic nicotine. Countries regulating both synthetic and tobacco-derived nicotine pouches generally (1) rely on existing policies for tobacco products and/or medicines or (2) have developed new policies or regulatory classifications that specify nicotine as the substance at issue rather than linking policies solely to tobacco. CONCLUSION: Our work offers novel insight into nicotine pouch markets and national regulatory approaches. Policy approaches vary from not regulating nicotine pouches at all to banning both forms of nicotine pouches. Policies used by countries regulating both tobacco-derived and synthetic nicotine pouches offer a roadmap for how other jurisdictions can add effective guardrails to the use of these and other non-medicinal nicotine products.