Overview of regulatory position regarding electronic cigarettes
E-Lites electronic cigarettes are regulated under UK law and enforcement of this regulation lies with Trading Standards, National Measurement Office and The Home Office. We at E-Lites have set the bar for Compliance and have gone beyond the requirements of law.
Our electronic cigarettes are not regulated as medicinal products but that is not to say that they are not regulated at all. We are in fact regulated under many statutes of UK law and all our products are independently tested in UK laboratories. E-Lites were in fact the first Company to obtain ECITA's (Electronic Cigarette Industry Trade Association) Industry Standard of Excellence, a mark which surpasses the requirements of UK statute.
The ECITA ISE auditing programme check every aspect of compliance with the law as it stands. The statutes we refer to are as follows:
General Product Safety Regulations 2005, as amended by CHIP4, CLP and REACH in 2009. As the legislative changes are implemented, the ISE will be updated to reflect the changes.
- Chemicals (Hazard Information and Packaging for Supply) Regulations (CHIP) 2009
- Weights & Measures (Packaged Goods) Regulations 2006
- Plugs and Socket (Safety) Regulations 1994
- The Waste Electronic and Electrical Equipment Regulations 2006 (WEEE)
- The Batteries and Accumulators (Placing on the Market) Regulations 2008
- The Waste Batteries and Accumulators Regulations 2009
- Consumer Protection (Distance Selling) Regulations 2000
- Electronic Commerce (EC Directive) Regulations 2002
- Data Protection Act 1998
- Health and Safety at Work Act 1974
- Control of Misleading Advertising Regulations (1998)
- Business Protection from Misleading Marketing Regulations (2008)
- Advertising Standards Agency Code, the Enterprise Act (2002), and the Unfair Trading Regulations (2008)
Electronic cigarette testing
All E-Lites electronic cigarette products are CE and RoHs tested and certificated. We hold a complete and up to date Compliance file.
Under UK law, as there is no medicinal claim made with our product there is no requirement for a medicinal licence and therefore medical regulation does not apply. Our electronic cigarette products are sold as a safer "smoking alternative" to tobacco cigarettes.
The liquid in E-Lites E-Tips is subject to blind testing by UK Laboratory (West Yorkshire Analytical Services) showing it is pharmaceutical grade nicotine and free from impurities.
Electronic cigarettes offer a harm reducing, pleasant alternative to traditional smoking, with massively reduced risk since there is no combustion.
Recently the UK Governments Cabinet Office Behavioural Insight Team came out in support of electronic cigarettes stating that the UK should be;
"exploring new products for people addicted to nicotine – products that deliver nicotine quickly in a fine vapour instead of as harmful smoke could prove an effective substitute for ‘conventional smoking’, to encourage new products, which smokers can use as safer nicotine alternatives, to be made available in the UK. A tenet of behaviour change is that it is much easier to substitute a similar behaviour than to extinguish an entrenched habit (an example was the rapid switch from leaded to unleaded fuel). If more alternative and safe nicotine products can be developed which are attractive enough to substitute people away from traditional cigarettes, they could have the potential to save tens of thousands of lives a year."
There has been an ongoing consultation by the MHRA regarding nicotine containing products which in 2010 threatened to remove these products from the shelves. E-Lites through ECITA have engaged with MHRA assisting and educating them about our products.
The MHRA process has been criticised for lacking objectivity and leaning towards a form of medical regulation for a product which is clearly not a medicine. The results of this consultation have been delayed and are now expected in spring 2013.
Court cases in USA, The Netherlands and Germany have clearly stated that electronic cigarettes are NOT a medicinal product.
The MHRA move towards a definition of “medicinal by function” away from ”medicinal by presentation” is totally absurd as it relies on a definition of changes in metabolic rate.
If it were to be applied to this product it would also suggest that any nicotine containing product that appreciably affects the metabolic rate is a medicinal product. By this logic tobacco cigarettes, potatoes and tomatoes would have to be considered medicinal products.
Remember to watch this space as we will be releasing a range of great blogs over the coming months. Our readers can also find our E-Lites Facebook page at http://www.facebook.com/ELitesUK. For all the latest goings on, you can keep up-to-date with E-Lites on Twitter https://twitter.com/ELitesUK. And we also have an E-Lites YouTube channel live at http://www.youtube.com/user/ElitesUK.