The regulatory framework for e-cigarettes consists of a triumvirate of legislation consisting of Directive 2001/83/EC, (the Pharmaceutical Code) and UK implementing legislation the Human Medicines Regulations 2012 (HMRs), SI 2012/1916, Directive 93/42/EEC on medical devices (MDD), and the European Tobacco Products Directive 2014/40/EU (TPD). E-cigarettes classified as consumer products The TPD (implemented in the UK by the Tobacco and Related Products Regulations 2016, SI 2016/507) sets out rules for e-cigarettes (and refill containers) which set minimum standards for safety and quality, and ensure that information is provided to consumers so that they can make informed choices and protects children from starting to use these products. The European TPD also mandates maximum capacity for e-cigarettes, maximum nicotine strength, packaging and labelling requirements and bans certain ingredients including colourings, caffeine and taurine. Importantly, the TPD mandates that all e-cigarettes