The year 2016 will ring in significant changes in the way electronic cigarettes are regulated and marketed in Britain. Products containing nicotine including electronic cigarettes will be regulated by the country’s top regulator, The Medicines and Healthcare products Regulatory Agency (MHRA), as medicines. A statement to this effect was made by the MHRA on Wednesday. The country also aims to pursue similar legislation to regulate electronic cigarettes as medicines in all of Europe.
According to the MHRA, the classification of e-cigarettes as medicines would go a long way in ensuring that the product meets the minimum standards of quality and safety, making users of the product more confident about their use.
Till the regulation commences, the regulator does not recommend the use of the product, while at the same time, it feels a ban would be inappropriate.
Electronic cigarettes are devices designed to deliver nicotine to users in the form of a vapour. It uses the power from a battery to convert a nicotine laced liquid into a vapour which can be inhaled by the user. E-cigarettes are crafted to resemble tobacco cigarettes and have a mouth piece at one end and a LED, which glows at each drag, at the other.
With over two years left for the regulation to kick in, manufacturers of e-cigarettes are left with ample time to tweak their products to comply with the norms set by the regulators. E-cigarettes will be available as over-the-counter medical products once the regulation commences.
Sally Davies, chief medical officer in Britain states that the best option is for smokers to quit entirely but recognises that this can be a difficult task for most smokers. In such circumstances, it is preferable to get nicotine from alternative sources like replacement therapy. Regulation is a step in the right direction to make the products safer and ensure that they work effectively.
The regulator, in a statement last week, recommended the use of nicotine delivery products such as patches and gums to help smokers who could not face the withdrawal symptoms of suddenly quitting smoking. Notably, e-cigarettes were excluded from this recommendation only because they are not subject to any regulation. Experts concur on the fact that it is the tar and harmful chemicals and not the nicotine in tobacco cigarettes that put users at risk.
Over 80,000 people die in Britain annually from causes directly attributable to their use of tobacco cigarettes, a product which is not regulated in the country.
Some producers of electronic cigarettes expressed worry over the categorisation of the product as medicines. Commercial manager of SKYCIG, Damien Scott pointed out that manufacturers have been regulating themselves to ensure that the products were able to match the highest standards which consumers have come to expect. He felt that regulation of the product as medicines was unjustified and would affect the free availability of a electronic cigarettes which are, by nature, a lifestyle product.
So when is the electronic cigarette UK ban going to take place? Following a court ruling, the US FDA was unable to regulate electronic cigarettes under the tough rules for drug-delivery devices used for medical purposes. A 2011 announcement by the FDA stated that the product would be regulated as tobacco products. Even if the product is used as an aid to quit smoking, it could be included under the regulatory category of drugs/ drug-delivery devices. Whichever the category, the FDA desires to bring the product under its regulatory framework very soon.