Last updated: August 26, 2024
Regulatory Framework
Are e-cigarettes partly or entirely regulated under tobacco control laws?
E-cigarettes are regulated by both Scottish and UK law. E-cigarettes are primarily regulated under the Tobacco and Primary Medical Services (Scotland) Act 2010; Health (Tobacco, Nicotine etc. and Care) (Scotland) Act; and the Sale of Nicotine Vapour Products (Vending Machines) (Scotland) Regulations 2017.
E-cigarettes are also regulated under the UK-wide Tobacco and Related Products Regulations 2016 (S.I. 2016 No. 507). Amendments were made to these regulations under the Tobacco Products and Nicotine Inhaling Products (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019 No. 41) and the Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020 after the withdrawal from the European Union.
Are e-cigarettes partly or entirely regulated under medicine or pharmaceutical laws?
Manufacturers can apply to register e-cigarettes as medicines under either Regulation 51 or 52 of the Human Medicines Regulation (as amended). The government has issued guidance on how to license e-cigarettes and other inhaled nicotine-containing products as medicines. E-cigarettes regulated as medicines may contain higher nicotine levels (more than 20 mg/ml) and e-liquid volume (more than 2 ml for single-use cartridges/disposables, and more than 10 ml for refills).
