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E-cigarettes: Is smoking about to come back into fashion?

This New Year, thousands of people pledged to stop smoking once and for all. Some 95 per cent of them will make the same pledge again next year. One product may stop this frustrating tradition.

The World Health Organisation (WHO) doesn't like smoking. It calls tobacco use a global epidemic that, if unchecked, will claim over a billion lives during the 21st century, with 80 per cent of those deaths in low- and middle-income countries.

Figures from the UN agency show that nearly 100,000 children start smoking every day, and almost 80 per cent of teenagers in Europe suffer second-hand smoke at home. In short, the WHO damns tobacco use as the leading cause of preventable deaths worldwide.

So why is the WHO criticising electronic cigarettes – novel devices that deliver the buzz of nicotine without proven health risks? Why did the US government seize shipments of these devices at its borders while continuing to trade over 100 billion deadly cigarettes annually?

How e-cigarettes work

E-cigarettes are simple to understand. A plastic tube houses a heating element, battery, control electronics and a cartridge of liquid containing nicotine. When the user inhales at one end, a dose of liquid is vaporised and the user (or 'vaper' as many have come to be known) receives a nicotine hit.

Since the introduction of e-cigarettes to the UK in 2005, ex-smokers and doctors have lauded them as one of the most effective ways to quit, or, at least, to quit inhaling the tar, benzene, formaldehyde, arsenic, cyanide, radioactive polonium and over 50 other known carcinogens that accompany the intended nicotine hit.

Ranged against the devices, however, is a host of governments and scientists doing their best to ensure that the unregulated, untested and potentially unsafe e-cigarettes are kept out of smokers' hands. E-cigarettes are currently illegal in Australia, Canada, Thailand, Singapore and Brazil. Meanwhile, multinational tobacco and pharmaceutical companies watch from the sidelines, unsure whether e-cigarettes represent a threat or an opportunity for their multi-billion pound global businesses.

Is nicotine harmful?

E-cigarettes are the latest in an array of products that aim to satisfy nicotine cravings without the harmful effects of smoking tobacco. Patches, chewing gum, lozenges and even inhalers are now common, and constitute a healthy '250m market for British pharmaceutical companies. The logic behind them is simple: while smoking tobacco massively increases your risk of suffering lung and coronary heart disease, strokes and cancer, nicotine itself is relatively benign.

Nicotine is both a stimulant and a relaxant; it suppresses appetite and raises the metabolism. It has been linked to increased levels of birth defects and can certainly raise blood pressure, but there is little evidence that nicotine alone is carcinogenic. It is, however, very addictive – possibly even as habit-forming as cocaine.

'At the end of the day, nicotine is an addictive drug and we'd much rather people didn't use it at all,' says Amanda Sandford of anti-smoking campaign group ASH. 'But we have to live in the real world and some people do choose to use a variety of substances, nicotine among them.' The lure of e-cigarettes is that they promise a safe, effective way to deliver that nicotine, in a way that's both familiar and socially acceptable.

'Using an e-cigarette is the same as smoking a cigarette: you get a hit within seven seconds,' says Birju Pujara, sales and marketing manager for e-cigarette brand Nicocigs. 'Compare that to a nicotine patch where it takes five to ten minutes to get a hit. It's a very different experience. E-cigarettes are completely safe and also combat psychological issues, such as the hand-to-mouth movement.'

E-cigarettes generate a convincing stream of 'smoke' (actually water vapour and propylene glycol) and most have an LED that glows red when 'vapers' inhale. Unlike tobacco cigarettes, e-cigarettes can be used legally almost anywhere: restaurants; cinemas; aeroplanes; even hospitals.

In a survey of users by the University of Geneva, nearly 80 per cent of respondents said that e-cigarettes had helped them quit smoking. Many users claimed that e-cigarettes had improved their breathing and reduced coughing and sore throats.

Popularity meets reality

While there are no hard figures for the size of the e-cigarette market, the products do seem to be finding a growing audience. Almost one in six convenience stores in the US now stock e-cigarettes, one brand (Intellicig) can be found in more than 10,000 UK newsagents and Ruyan, the largest e-cigarette manufacturer, has annual global sales of over £33m.

E-cigarettes are also finding favour with some doctors. The American Association of Public Health Physicians believes that e-cigarettes could save the lives of half the adult smokers who would otherwise die a tobacco-related death over the next 20 years.

However, governments and scientists aren't buying it. They're not convinced that e-cigarettes are effective at replacing tobacco or helping people to quit smoking, and they're not even sure that the products are safe.

'Frankly, nobody knows anything about e-cigarettes,' says Dr Holly Morrell of the Centre for Tobacco Control Research and Education at the University of San Francisco. 'In terms of their health profile, the information is really limited. E-cigarette company Ruyan is funding research on their own products through legitimate-seeming universities and front groups, and the two papers that have come out so far have, of course, shown that their e-cigarettes are safe. But I always question the validity of research when the company that's going to profit from positive results is funding it.'

Another industry-funded report, carried out by LPD Laboratory Services in Blackburn in 2009, found that Gamucci e-cigarettes contained the correct amount of nicotine, propylene glycol and only very low levels of potentially harmful flavourings.

Publicly-funded tests

Some publicly-funded research came to a different conclusion. The US Federal Drug Administration's Centre for Drug Evaluation and Research tested two different brands of e-cigarette in 2009 and found tobacco-specific nitrosoamine carcinogens in the vapour, albeit at very low levels. It also contained diethylene glycol, a toxic organic solvent.

Thomas Eissenberg of the Institute for Drug and Alcohol Studies at Virginia Commonwealth University has concerns about the propylene glycol found in most e-cigarette liquids. This is generally considered safe as a food additive, but it's also used as a vehicle for intravenous drugs in hospitals where high or prolonged doses can lead to lactic acidosis.

'The question then is: is propylene glycol when inhaled into the lungs as safe as when it is eaten? Or is it as dangerous as when you inject it intravenously?' says Eissenberg. 'I don't think anyone knows the answer to that question.'

Another safety issue is the quality and reliability of e-cigarette manufacturing. The University of Geneva study captured many anecdotal reports of e-cigarettes leaking liquid, failing frequently and generally being of poor construction.

'Some e-cigarette liquids are being made in very small operations by people who may or may not be following the safety standards for, say, inhaled medications,' says Eissenberg. 'It could become a health threat if the individual mixing it happens to have a cold or pneumonia. I'm very worried about people inhaling that product into their lungs, which is exactly where a cold virus or the pneumonia bacteria would like to be.'

Variability concerns also apply to the prime ingredient – nicotine itself. Eissenberg tested the bloodstream of people using e-cigarettes under laboratory conditions – and was unable to detect any significant quantity of nicotine in their blood plasma at all. In contrast, the FDA's Centre for Drug Evaluation and Research found that three identical liquids delivered significantly different amounts of nicotine per puff – and that a supposedly nicotine-free cartridge did in fact contain small quantities of the drug.

You might think that e-cigarettes delivering little or no nicotine would be completely ineffective at satisfying smokers' urges to light up. Strangely, this was not the case. Eissenberg's e-cigarette users experienced fewer withdrawal symptoms than smokers sucking on unlit cigarettes, and these findings were backed up by a (Ruyan-funded) university study in New Zealand.

Social effects

However, just as the effectiveness of e-cigarettes cannot be measured in terms of nicotine alone, some people think that their dangers transcend pharmacology. Dr Matthew McKenna, director of the office of smoking and health at the Center for Disease Control in the US, is one of them.

'E-cigarettes could counter the impact from smoke-free laws that have decreased the social acceptability of smoking behaviour,' he says. 'They stand to reintroduce the appearance of smoking in otherwise smoke-free environments like shops, restaurants and even nurseries.'

The Trading Standards Institute in the UK envisages 'confusion and upset' from bystanders who believe they're being exposed to tobacco smoke – and public order offences by e-smokers being asked to stop.

More critically, says Eissenberg: 'People might sometimes use the e-cigarettes but sometimes use a tobacco cigarette. If that's the case, it's unlikely that we'll see any health benefits or decreased fatality.'

There is another aspect to e-cigarettes that worries some public health professionals. With their reassuring safety claims, celebrity endorsements and liquid flavours that include bubble gum, strawberry or chocolate, some officials fear that e-cigarettes could become a gateway product to tobacco for children.

'Tobacco industry research has demonstrated that fruit and sweet flavours increase the social acceptance of cigarettes, their excitement factor and curiosity,' says Dr Jonathan Winickoff, chair of the American Academy of Pediatrics Tobacco Consortium. 'E-cigarettes are being marketed as an entry-level product for children and young adults who are nicotine-naive. Once a youth has decided to try an e-cigarette, there's nothing that protects him from getting addicted to nicotine and later using regular cigarettes.'

Sandford adds: 'We haven't seen many cases of children getting hold of e-cigarettes and there doesn't seem to be any clear evidence that they are a gateway drug. However, it does highlight the need for regulation, so that products are sold with a clear health warning and that they're only sold to adults.'

Licensing and regulation

In the UK, the body responsible for overseeing therapeutic products, like nicotine patches and gum, is the Medicines and Healthcare products Regulatory Agency (MHRA). Before such products can go on sale, they have to be granted a 'marketing authorisation' to ensure that they meet rigorous standards of safety, quality and efficacy.

The licensing process usually includes scientific tests and trials and often results in health warning labels on packaging or bans on sales to minors. Simply applying for MHRA marketing authorisation can cost over £100,000, and the cost of large-scale clinical trials can run well into the millions.

At the moment, however, any nicotine-containing product (NCP) that doesn't claim or imply it can help you to quit smoking can be sold freely as a 'smoking substitute', without having to be licensed, evaluated or restricted to adults. Naturally, e-cigarette makers go out of their way to say that their products are not smoking cessation aids.

For the past seven months, the MHRA has been considering submissions to a public consultation on whether to bring all NCPs (with the exception of cigarettes, cigars and tobacco itself) within the medicines licensing regime.

Three options are on the table. The first is for the MHRA to treat all NCPs as medicinal products by function – because nicotine is a drug – and to remove any unlicensed products from the market within 21 days. As no e-cigarettes currently have a marketing authorisation or are in the process of being issued one, this amounts to an immediate de facto ban.

'Should this be the outcome, our business would be financially burdened,' says Emma Christou, operations director at Liberro, a UK e-cigarette company. 'Many businesses within the sector would inevitably cease trading if that were the case.'

The second option is similar but will give manufacturers a generous grace period, say a year, to acquire their marketing authorisation. The third, and least likely, option is for the MHRA to do nothing at all and to allow unregulated NCPs to remain on the market.

Big tobacco is all for anything that keeps potential rivals down. Philip Morris, maker of Marlboro and Benson & Hedges cigarettes, says: 'It is not tenable to permit products that deliver nicotine – whether marketed with or without claims – to be sold without any regulatory oversight.'

Perhaps surprisingly, some e-cigarette makers are also in favour of licensing. 'It should be a regulated market,' says Pujara of Nicocigs. 'However, we don't believe that it should be classed as a medicine. There's a stigma there. It's not going to appeal to the huge market sector of people who don't want to give up smoking. We call ourselves a safe alternative: you don't have to give up smoking, but here's a healthier option that you can use indoors and that's cheaper.'

Tobacco scientists tend to be quite hard-nosed about commercial realities. 'Those of us in the research communities have long been asking for a product that could deliver pharmacologically pure nicotine to the lungs as effectively as cigarettes,' says Eissenberg. 'If we could get that product, we'd be well on our way to helping a lot more people get off tobacco cigarettes. We don't have that product yet and it has to be demonstrated to be safe and effective before we can champion it. I don't think that not having the money to do a safety assessment is a good reason not to do a safety assessment.'

If e-cigarettes suddenly disappeared from the market, however, there's a real chance that tens of thousands of 'vapers' would return to smoking tobacco. The American Association of Public Health Physicians (AAPHP) is suggesting a different tactic: reclassifying e-cigarettes as tobacco products in a programme of harm reduction.

Harm reduction is the policy of replacing something known to be very harmful with something less dangerous, but not necessarily without its own risks. This has involved substituting methadone for heroin, for example, or smokeless tobacco for cigarettes (even the worst smokeless tobaccos carry a 95 per cent lower cancer risk than cigarettes).

The AAPHP believes that, while further research is necessary on e-cigarettes, current products promise a 99 per cent eventual reduction in tobacco-related illnesses and death. Treating them as cigarettes would allow them to be sold alongside tobacco, to carry health warnings – and even to be taxed, according to ASH's Sandford.

'The most common way of taking nicotine is through ordinary cigarettes, which also cause the most harm. Taxing e-cigarettes would be a sensible way of raising revenue for the government. The duty needs to be put on par with cigarettes or possibly cheaper, so there's an incentive for smokers to quit.'

E-lephants in the room

All of which brings us to the two very large and very quiet elephants in the room. If government regulation classifies e-cigarettes as medicines, as seems likely in Britain, the only companies with both the experience of making therapeutic nicotine products and deep enough pockets to finance marketing authorisation are likely to be pharmaceutical multinationals. Johnson and Johnson, maker of market-leading Nicorette smoking cessation products, declined to comment for this article 'for proprietary reasons'.

However, if e-cigarettes are treated as tobacco products, as a recent Federal court ruling suggests will happen in the US, it is the tobacco firms that are likely to move in. With global sales of well over £30bn a year, any of the big tobacco companies could inhale the entire e-cigarette industry in a single puff. Philip Morris International is already reported to have had talks to acquire Chinese e-cigarette manufacturer Ruyan.

As long as legal and regulatory environments remain uncertain and enforcement remains patchy, the market for e-cigarettes will remain tiny, run by small companies that, at best, cannot prove their devices safe or effective and, at worst, may be selling unreliable or unsafe products.

And next New Year's Day, just like every other day this year and every single day for years to come, another 14,000 people will die from tobacco-related diseases.

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