Doctors leaders have described the move to regulate all nicotine-containing products as medicines as ‘good news’.
The government decision means that e-cigarettes will be regulated as a medicinal rather than a consumer product as has been the case so far.
The MHRA (Medicines and Healthcare products Regulatory Agency), which will take on the regulation, said the move will make the products safer and more effective to reduce the harms of smoking.
BMA director of professional activities Vivienne Nathanson said: ‘It is very good news that the MHRA has decided to regulate all nicotine-containing products, including e-cigarettes.
‘We can now build on this and press for good research which looks at the efficacy and health implications of e-cigarettes. It’s really important that we find out if the hand-to-mouth use of e-cigarettes either breaks or reinforces smoking behaviours. We need to know if e-cigarettes actually help smokers quit.
‘Smoking remains the biggest cause of avoidable death in England so we need to do all we can to help smokers give up but it is also essential that aids to quit smoking are safe.’
Nicotine-containing products, such as gums, patches or mouth sprays, are considered useful in helping people cut down or stop smoking. But doctors and patients need to have confidence that the products are safe, of the right quality and that they work. Licensing a product will provide these assurances, the MHRA believes. The change will come into effect in 2016.
Safety is key
MHRA group manager of vigilance and risk management of medicines Jeremy Mean said: ‘Reducing the harms of smoking to smokers and those around them is a key government health priority. Our research has shown that existing electronic cigarettes and other nicotine-containing products on the market are not good enough to meet this public health priority.
‘Some products are already licensed [as medicines] and the government’s decision to work towards medicines licensing for all these products is designed to deliver quality products that will support smokers to cut down and to quit.
‘It’s not about banning products that some people find useful, it’s about making sure that smokers have an effective alternative that they can rely on to meet their needs.’
The BMA had been concerned about the rapid rise in e-cigarette sales as there was a lack of peer-reviewed evidence on their value in helping smokers cut down or stop.
The government will also press the EU to come to a Europe-wide consensus on nicotine-containing products through the revision of the Tobacco Products Directive.
The MHRA estimates 1.3 million people use e-cigarettes.