Last updated: December 15, 2020
Are e-cigarettes partly or entirely regulated under tobacco control laws?
Nicotine-containing e-cigarettes and refill containers are regulated by the European Union (Manufacture, Presentation and Sale of Tobacco and Related Products) Regulations 2016 (S.I. No. 271 of 2016), which transposed the European Union Tobacco Products Directive 2014/40/EU.
Are e-cigarettes partly or entirely regulated under medicine or pharmaceutical laws?
E-cigarettes and refill containers that make medicinal claims (i.e., that they can be used in or assist in smoking cessation) are subject to medicines regulation. This is confirmed by the Health Products Regulatory Authority’s “Guide to Definition of a Human Medicine.” As such, these products require a marketing authorization from HPRA prior to being placed on the market. Further, the European Union (Manufacture, Presentation and Sale of Tobacco and Related Products) Regulations 2016 specifically state that the regulations do not apply to e-cigarettes and refill containers that are subject to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, or the requirements under Directive 93/42/EEC of 14 June 1993 concerning medical devices.
Are e-cigarettes partly or entirely regulated under any other laws?
Within the EU, e-cigarettes are also regulated under the following legal acts, which have been transposed into national law:
- European Communities (General Product Safety) Regulations 2004
- European Union (Restriction of Certain Hazardous Substances in Electrical and Electronic Equipment) (Amendment) (No. 2) Regulations 2012
- European Union (Batteries and Accumulators) Regulations 2014, amended by the European Union (Batteries and Accumulators) (Amendment) Regulations 2014
- European Union (Low Voltage Electrical Equipment) Regulations 2016
- European Communities (Electromagnetic Compatibility) Regulations 2017