As reported in Thr Guardian: Electronic cigarettes are to be classed as "medicines" under new proposals to tighten up the regulation of nicotine-containing products.
Manufacturers are to face tough new tests before they can sell their e-cigarettes as licensed products, the Medicines and Healthcare Products Regulatory Agency (MHRA) has said.
The move will also mean that licensed e-cigarettes can be prescribed by doctors to help smokers cut down or quit.
It is estimated that 1.3 million people across the UK use battery-powered e-cigarettes, which can look like real cigarettes but users inhale a mist of nicotine instead of smoke.
When the user sucks on the e-cigarette, liquid nicotine is vapourised and absorbed through the mouth. When they breathe out, a plume of what appears to be smoke is emitted but it is actually largely water vapour.
In the past, experts have said that if all smokers were to use e-cigarettes instead of normal cigarettes, millions of lives could be saved, because they do not contain harmful tar like real cigarettes.
But others have raised concerns about the safety and regulation of the products.
Experts said users could not be certain of the purity of the nicotine contained in the products. Indeed, MHRA research found that nicotine levels can be "considerably different" from the level stated on the label.
Furthermore, the amount of nicotine per product was found to differ from batch to batch – which casts doubt on how useful the products are to people who want to cut down or stop smoking, a spokesman said.
But now the MHRA will regulate the products so that there is a consistent standard across all licensed products sold over the counter.
While the regulator is not planning to recall unlicensed e-cigarettes – saying that the benefit does not outweigh the risk of users turning to real cigarettes – it is hoped that in the long term all products will be licensed.
"Reducing the harms of smoking to smokers and those around them is a key government health priority," said the MHRA's group manager of vigilance and risk management of medicines, Jeremy Mean.
"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 NCPs (nicotine-containing products) are already licensed 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.
"The decision announced today provides a framework that will enable good quality products to be widely available. 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 government's chief medical officer, Dame Sally Davies, added: "Smokers are harmed by the deadly tar and toxins in tobacco smoke, not the nicotine.
"While it's best to quit completely, I realise that not every smoker can and it is much better to get nicotine from safer sources such as nicotine replacement therapy.
"More and more people are using e-cigarettes, so it's only right these products are properly regulated to be safe and work effectively."
Deborah Arnott, chief executive of health charity Action on Smoking and Health (Ash), said: "Regulation will ensure that e-cigarettes meet the same standards for quality, safety and efficacy as medicines while remaining as readily available to smokers as they are today.
"Crucially it will also ensure marketing of e-cigarettes and other such products is controlled to prevent their promotion to children and non-smokers."
Clare Gerada, chairwoman of the Royal College of General Practitioners, said: "Rates of smoking in the poorest in our communities remain high, and as a GP in a deprived area of London I see at first hand the deaths and disease this causes.
"The RCGP supports MHRA regulation of novel nicotine products such as e-cigarettes as this will ensure that they are of good quality and reliability, and are effective in helping smokers who want to use them to cut down and quit."
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