Miracle cure for smoking or saviour of the tobacco industry, next big thing or fleeting celebrity fad - the electronic cigarette divides opinion, but its status in the UK has just become much clearer.
For the first time e-cigarettes are to be regulated as medicines – meaning they will have to meet strict safety standards or be banned.
The nicotine-containing products, which have become increasingly popular around the world with 1.3m users in the UK, will have to meet stricter Government regulations by 2016. E-cigarettes that meet standards will then be available on prescription from the NHS as an aid to quitting smoking.
The decision, announced by the Medicines and Healthcare Products Regulation Agency (MHRA), covers all nicotine-containing products currently on the market.
E-cigarettes will still be available over the counter in supermarkets and newsagents, but medicines regulation will mean that manufacturers will have to seek a licence and will be banned from advertising them to under 16s. Product labels will have to sign-post to support for quitting smoking.
The Government will also push for an EU law to regulate the products. Licensing will begin in 2016, when a new Europe-wide tobacco directive is due to come into force.
The MHRA said that none of the e-cigarettes currently on the market met safety standards required for licensing as a medicine. They are, however, much safer than tobacco.
Nicotine is the main addictive ingredient of tobacco, but not the cause of harms associated with smoking. On its own the substance is much less of a health risk, but is still extremely addictive and can cause heart problems.
Campaigners say that e-cigarettes could undermine efforts to reduce smoking but there is also increasing evidence that e-cigarettes are being used by smokers as an alternative to Tobacco.
“It is not about banning products that some people find useful,” said Jeremy Mean, group manager at the MHRA. “It is about making sure that smokers have an effective alternative that they can rely on to meet their needs.”
E-cigarettes mimic smoking behaviour by turning nicotine and other chemicals into vapour that is inhaled. They are designed to look like cigarettes, producing a smoke-like vapour, which has led to their use becoming known as “vaping”. They are subject to restrictions on sales in several countries and banned in Brazil, Norway and Singapore.
Martin Dockrell, director of policy and research at smoking charity ASH said that e-cigarettes had “enormous public health benefits potentially” but that there were also risks.
The charity estimates that just under a million British smokers and 400,000 non-smokers use the devices. Five per cent of 11 to 15-year-olds have tried it, the charity said, and nine per cent of 16 to 18-year-olds.
The MHRA said that e-cigarettes deemed to be marketed at children would be banned. Some companies sell chocolate and bubblegum-flavoured products. Mr Mean said it was unlikely such products would be licensed.
E-cigarettes are now a £100m industry and there are hundreds of manufacturers, many of them small businesses. Adrian Everett, CEO of Zandera, which makes the leading brand E-Lites, said that restricting the use or availability of the devices would be “a significant health loss.”
“What we don’t want to see is electronic cigarettes made less available than tobacco counterparts and we’d like to see assistance for smaller companies to achieve the parameters required to stay on the market,” he said.
The MHRA revealed that more than one thousand ex-smokers wrote to them during to consultation process over regulation, warning that, if e-cigarettes were banned, they would return to smoking tobacco.
Big tobacco has been making in-roads into the e-cigarette market. Reynolds American, which makes Camels and Pall Mall cigarettes has launched its first smokeless, tobacco-free device, while Marlboro-makers Altria, the biggest US manufacturer is also planning to launch its own e-cigarette.
“We have to watch the tobacco industry’s activity very closely,” Mr Dockrell said.