Regulation of e-cigarettes
Produced in partnership with Jaspreet Takhar of Baker McKenzie
Regulation of e-cigarettes

The following Life Sciences practice note Produced in partnership with Jaspreet Takhar of Baker McKenzie provides comprehensive and up to date legal information covering:

  • Regulation of e-cigarettes
  • What are e-cigarettes?
  • Overview of regulatory framework
  • E-cigarettes as consumer products
  • Requirements of e-cigarettes
  • Obligations for producers, suppliers and retailers
  • Notification process
  • Content of notification
  • Fees for notifications in the UK
  • Annual reporting
  • More...

What are e-cigarettes?

Electronic cigarettes (commonly known as ‘e-cigarettes’, ‘vapourisers’ or ‘vapes’) are products that can be used to consume nicotine-containing vapour via a mouth piece. For the purposes of the legislation discussed in this Practice Note, e-cigarettes also include any component of such product (including a cartridge, tank and the product excluding a cartridge or tank).

E-cigarettes work by heating a solution (e-liquid) that typically contains nicotine, propylene glycol and/or vegetable glycerine, and flavourings. E-cigarettes do not contain tobacco (ie leaves and other natural processed or unprocessed parts of tobacco plants), and do not burn or produce carbon monoxide, tar or smoke.

E-cigarettes are therefore distinct from tobacco products and herbal products for smoking. The latter includes products based on plants, herbs or fruits, and does not contain tobacco.

The distinction between ‘e-cigarettes’, ‘tobacco products’ and ‘herbal products for smoking’ is crucial, as they are regulated separately under EU and UK legislation. This Practice Note discusses the regulation of e-cigarettes only.

Overview of regulatory framework

At a high level, there are three regulatory regimes which may apply to e-cigarettes:

  1. Directive 2014/40/EU, the Tobacco Products Directive (TPD) which regulates tobacco and related products

  2. Directive 2001/83/EC (consolidated version 16.11.2012), the Pharmaceutical Code which regulates medicinal products for human use

  3. Directive 93/42/EEC (consolidated version 11.10.2007), the Medical Devices Directive (MDD) which regulates medical devices

Most e-cigarettes are regulated as tobacco-related products or consumer

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