A case for e-cigarettes Professor Gerry Stimson \u00a0takes a closer look at electronic cigarettes and asks \u2013 if e-cigarettes can save lives, why are we jeopardising this public health breakthrough? Until recently, an end to cigarette smoking looked like a long and slow business. Year on year only small reductions have been made in reducing smoking prevalence in developed countries. The arrival of electronic cigarettes (e-cigarettes) and other new nicotine delivery devices changes that. These new devices are a disruptive technology, just as the invention of the cigarette-making machine was in the 1880s. There are now real prospects of helping smokers shift from smoking tobacco to using nicotine by less harmful routes. The Medicines and Healthcare Products Regulatory Agency (MHRA) and the European Commission (EC) now want to regulate e-cigarettes as medicines. Will this advance the sale of e-cigarettes, or push back the progress that has been made? First introduced to the UK in 2006, uptake of e-cigarettes has been a relatively quiet consumer-led revolution. There has been no public health input or encouragement, and no spending of NHS resources \u2013 no taxpayers have been harmed in this process. There has been little expenditure on marketing. The growth in popularity has come about by word of mouth and internet advertising. Unlike many public health measures, there is a population ready and eager to change \u2013 most smokers want to stop smoking. Until e-cigarettes there was no viable option but to quit smoking altogether or to use nicotine replacement therapy (NRT). The MHRA estimates that 1.3m people are using e-cigarettes in 2013. The proportion of smokers using them rose from 3 per cent in 2010 to 11 per cent in 2013. The European market is estimated at around EUR 400-500m, and sales of e-cigarettes now equal those of NRT. The market has been dominated by mainly small and\u00a0medium-sized distributors, but this will change as most major tobacco companies are already selling or investing in the development of new nicotine delivery devices. Most anti-smoking organisations aim for an end of the tobacco industry. Ironically \u2013 for many public health experts \u2013 an end to tobacco smoking may be hastened not through the end of the tobacco industry but through its transformation. In the next couple of decades, tobacco companies, under pressure from anti-tobacco legislation, will move towards becoming nicotine companies. Wells Fargo stock analysts predict that revenue from e-cigarettes will overtake ordinary cigarettes by 2021. E-cigarettes v smoking tobacco E-cigarettes have major advantages over smoking tobacco. More than 4,000 chemical compounds are found in tobacco smoke, and it\u2019s the products of the burnt organic material that are so harmful to health. Around 80,000 people in England die every year from smoking-related disease. Smoking is the single most common cause of preventable illness and death. As Mike Russell noted long ago, people smoke cigarettes for the nicotine but die from the tars. \u00a0 E-cigarettes contain nicotine, propylene glycol (a carrier that creates the vapour when heated) and flavourings. They deliver nicotine but without the dangerous toxins found when tobacco is burnt. They are used by people who want to stop smoking but who do not want to or cannot stop using nicotine.\u00a0 A visit to e-cigarettes and vaping websites indicates extraordinary testimony of their successful use by long-term smokers. E-cigarettes contain some potentially harmful constituents but at traces very much lower than found in regular cigarettes, within the safe limits for consumer products, and indeed at similar levels to potentially harmful constituents found in NRT. And their attraction for many users is precisely that they are not medicines. Where to with tobacco policy? Harm reduction is central to current tobacco policy in England. This will be welcome news to those in the drugs field who feel rather beleaguered and browbeaten by the drugs recovery agenda. The history of tobacco harm reduction is tied in with the development of NRT. In 1990 there were only three NRT products, all prescription-only. Pharmacy sales started in 1991, expanded to all products by 2000, and since 2009 all NRT products have been on general sale. Initially NRT was only indicated for abrupt quitting, and later extended for people who wanted to cut down more gradually before stopping. But in 2009\/2010 the MHRA agreed it could be used for harm reduction, including temporary abstinence and a reduction in smoking with no intention to quit. The Department of Health\u2019s 2011 tobacco control plan committed to encouraging tobacco users who cannot quit to switch to safer sources of nicotine and to encourage manufacturers of safer sources of nicotine to develop new types of nicotine products. In 2012 the Cabinet Office\u2019s behavioural insights team \u2013 the so-called \u2018nudge unit\u2019 \u2013 urged the use of e-cigarettes. The most recent piece of the story is the work of the National Institute for Health and Clinical Excellence (NICE) which gives a strong endorsement for tobacco harm reduction for people who do not wish to quit smoking altogether, and for people who want to quit smoking but are unable or unwilling to quit using nicotine. The NICE group concluded that nicotine does not pose a significant health risk. Enter MHRA and the European Tobacco Products Directive. The MHRA has decided to regulate all electronic cigarettes as medicinal products by 2016, and the European Tobacco Products Directive \u2013 currently going through the European legislative process \u2013 proposes that all e-cigarettes should be regulated under medicines legislation. \u2018Smoking cessation\u2019 or \u2018smoking sensation\u2019?\u00a0 Those in favour of medical regulation argue that electronic cigarettes are currently unregulated products, that they are accessible to children, that there is no control over advertising, that they contain potentially dangerous constituents, and that the devices themselves, including the batteries, pose a threat to user safety. Medicines regulation, they argue, will improve safety, quality and efficacy, and make them work better as a smoking cessation product. There is another thread going through the political argument however, which is that electronic cigarettes are just another way to feed addiction to nicotine, and that they send the wrong message and undermine attempts to drive down tobacco use. Some claim that electronic cigarettes are contrary to efforts to \u2018de-normalise\u2019 smoking. There are already scaremongering stories about schoolchildren using them. Certainly they might be a short-term fad amongst some children who wish to challenge authority, but the e-cigarettes market is made up of long-term smokers and surveys by Action on Smoking and Health (ASH) show minimal use by non-smokers and by young people. Consumers do not want medical regulation. There has been extensive comment on the proposals on social media sites, Twitter, and letters to members of the European Parliament \u2013 current users insist that these are consumer products, a safe way of enjoying nicotine, rather than a therapy. These products are popular precisely because they are not medicines. As one user put it \u2013 these are not \u2018smoking cessation products\u2019, they are \u2018smoking sensation products\u2019. Getting the balance right The problem is the trade-off between making the product safe enough, but also sufficiently attractive to achieve widespread uptake. On balance more weight should be given to attractiveness, given their relatively low risks and the huge consequences of continued smoking. The argument that these products are currently unregulated is false. The Electronic Cigarette Industry Trade Association has shown that they are covered by the General Product Safety Directive and various other EC directives covering electrical safety, chemical safety, weights and measures, packaging and labelling, commercial selling practice and data protection. Applications to MHRA are costly, including the licence fee and the required studies, analyses, documentation. There are fears that few companies will be able to afford this, that the process will favour big players and drive many products off the market. There are further problems with medical regulation in that e-cigarettes include a big range of products and product combinations. Not all of them are simple pre-packaged cigarette lookalikes, but many are customisable, where the user can vary the delivery device and the nicotine strength and flavourings. It is likely that medical regulation will prematurely limit the range of products and stifle innovation. Even the announcement of future medical regulation has created uncertainty among retailers, current and potential e-cigarettes users. How this will play out is uncertain. Given that MHRA has put the deadline as 2016, by then there will be a much larger market and it will be harder to limit and control products. Already there have been four successful legal challenges against classing these products as medical products (two in Germany, and one each in Estonia and the Netherlands). At the end of the day the potential public health gains from e-cigarettes will be determined by the decisions about how to regulate these devices. There is right thinking about tobacco harm reduction, but a risk of making significant mistakes in the way this is played out in regulatory frameworks. The danger is a classic regulatory trap: making safer products harder to obtain than their unsafe counterparts. The regulatory proposals are tougher on e-cigarettes than on tobacco cigarettes. The framing of electronic cigarettes within a regulatory context misses the point that the public health drive must be to promote, endorse and facilitate their use.\u00a0 Prof Gerry Stimson is visiting professor, London School of Hygiene and Tropical Medicine and director of Knowledge-Action-Change.