4. EU Guidelines
Related Links:
ECigarette Direct Response to MHRA Proposal to Regulate Electronic Cigarettes as Medicines
The EU directive 2001/83/EC states "Electronic cigarettes may fall under the definition of a medicinal product if the product is presented as a remedy against nicotine addiction or if it is qualified as restoring correcting or modifying physiological functions" (emphasis added).
If the electronic cigarette or the nicotine cartridge are not classified as either medicinal product or medical device, Directive 2001/95/EC on general product safety applies by default. This Directive provides for restrictive or preventive measures to be taken if the product is found to be dangerous to the health and safety of consumers. 8
The NJOY electronic cigarette is not marketed as a smoking cessation device. It is an alternative method of nicotine delivery, without the attendant harms of tar, tobacco and hot smoke found in traditional nicotine delivery systems, and without the concommittent dangers of combustion and fire damage and death. It does not purport to be a nicotine replacement therapy. The component parts comply with EU and UK regulations, and the labelling is as required by Trading Standards officers in Keighley, where the company is based.
8 Answer given by Mr Dalli on behalf of the EU Commission.
E Cigarette Direct is the UK based online retailer of the NJOY electronic cigarette. E Cigarette Direct has a strong interest in promoting research into the electronic cigarette and tobacco harm reduction, and you can find interviews with doctors and scientists on its website as well as summaries of recent research.