E-cigarette classification as medicines plan angers industry

Health officials want to give electronic products same status as gums, patches and mouthsprays that contain nicotine

Electronic cigarettes are to be classed as medicines under proposals to tighten up the regulation of products containing nicotine – but their manufacturers say they will not co-operate unless forced to do so by EU law.

Invitations to put their products forward voluntarily to be classed as medicines by UK authorities provoked fury in the industry, which may be worth £250m in Britain by next year. The products are used by an estimated 1.3 million people.

Health chiefs want to put e-cigarettes on the same legal basis as gums, patches and mouthsprays designed to help wean smokers off their habit, but the trade association for the industry, Ecita, claimed this would force alternatives to tobacco out of the market.

The Medicines and Healthcare products Regulatory Authority (MHRA) said the government wanted to regulate all nicotine-containing products - some such as gums, patches and mouth-sprays already are - because it could not at the moment guarantee their safety and efficacy. The move will also mean that licensed e-cigarettes could be prescribed to help smokers cut down or quit.

The UK is pressing for an EU-wide position in new legislation to be introduced next year and take force in 2016. It believes countries such as France, Germany and Denmark are likely to take a similar path. Meanwhile the MHRA encouraged e-cigaratte companies to apply for a medicines licence in advance of any law.

Jeremy Mean, responsible for vigilance and risk management at the MHRA, said the decision that 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."

There is no sign of any part of the UK following France in considering a ban on using e-cigarettes in public places. The chief medical officer, Dame Sally Davies, said: "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."

The decision was backed Action on Smoking and Health and Labour, although its public health spokeswoman Diane Abbott warned that "increasing regulation on e-cigarettes while kicking standard packaging for cigarettes into the long grass is a sign the government has caved into the bullying tactics of Big Tobacco and risks sending out the wrong message that e-cigarretes pose a greater threat than smoking."

Ecita said: "Nicotine containing products can only be considered a medicine when they claim to help users quit smoking. Electronic cigarettes do not do this: they simply allow users to satisfy their desire for recreational nicotine – a perfectly legal drug – without the thousands of harmful chemicals produced by burning tobacco.Courts around Europe have already ruled that electronic cigarettes marketed without such claims cannot be reclassified as medicines, because this would lead to the absurd situation of tobacco cigarettes becoming medicines.

Katherine Devlin, Ecita's president, said: "What the MHRA proposes – forcing all e-cigarette users to use licensed products that cannot replicate the smoking experience in the same way – is bad news for public health. Yet the MHRA proposes to do exactly that, while toxic tobacco products which cause far more harm are left on the market."

Damien Scott, commercial manager of manufacturers SKYCIG, said his company would wait to see how the law played out in ther EU. "We don't think this is necessary. We self-regulate, and restriction on products long-term will make them ineffective."