A case for e-cigarettes
Professor Gerry Stimson takes a closer look at electronic cigarettes and asks – 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 – 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 – 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 medium-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 – for many public health experts – 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’s 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.
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.
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’s 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’s behavioural insights team – the so-called ‘nudge unit’ – 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 – currently going through the European legislative process – proposes that all e-cigarettes should be regulated under medicines legislation.
‘Smoking cessation’ or ‘smoking sensation’?

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 ‘de-normalise’ 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 – 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 – these are not ‘smoking cessation products’, they are ‘smoking sensation products’.
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.
Prof Gerry Stimson is visiting professor, London School of Hygiene and Tropical Medicine and director of Knowledge-Action-Change.
Soapbox
Get them young
It’s time to overcome our paralysis on tackling young people’s drug use, says Kate Iorpenda of the International HIV/AIDS Alliance.
Article 3 of the UN Convention on the Rights of the Child declares that in all actions concerning children, whether undertaken by public or private social welfare institutions, courts of law, administrative authorities or legislative bodies, the best interests of the child shall be a primary consideration. With this in mind, the issue of drug use among children – and in particular injecting drug use – is one that raises a number of ethical dilemmas and consequent heated debate among practitioners.
Perhaps it’s because we find the reality of children and adolescents using drugs too difficult to face. Or perhaps it’s because supporting young people to use drugs more safely seems irresponsible and contrary to the values of protecting children. Whatever the reason, the comprehensive services that are available to young people in some countries are not currently translating into service provision in poorer countries. In such contexts we need to be asking ourselves: have we consulted with young people to find out what they want and are we well enough informed about the types of drugs they take and their patterns of use? Otherwise we run the risk of being paralysed by the ethical dilemmas and conflicting values about what it might mean to be providing teenagers with clean needles.
Injecting drug use is a key driver of HIV epidemics in regions like Eastern Europe and Central and South East Asia, and the little available data we have indicates that in some countries children start injecting at a very young age. The lack of funding and attention to the needs of young people who use drugs has resulted in a situation where we lack concrete data on the extent of their drug use. However we do know that children with histories of abuse, mental health problems, and drug dependence in the family are among those at higher risk.
Adults have rights and choices about services and can be helped to seek other support – counselling, debt advice, housing – but with children there is a duty of care, and so service providers need to think both about safeguarding that duty of care and about how far it extends, given the complex and multiple needs of many young people who inject drugs.
Children and young people are often hidden within harm reduction services due to age restrictions and fears around asking and documenting age. In some countries, legal systems criminalise children as young as eight for drug use but deny them access to harm reduction services until they are 18. Additionally, service providers are often poorly prepared to work with young people, running programmes that don’t meet their needs and which have been designed without their input.
What kind of system punishes a child for drug use by incarcerating them in an adult prison? So many rights are being denied while we make up our minds on such issues. We need to know so much more about young people and their drug use and to recognise the diversity involved: different ages, different contexts, different genders, different drugs. We have to find ways within existing legal frameworks, good or bad, to ensure that we listen and respond. We need to collectively challenge the systems that continue to deny young people access to evidence-based interventions because of their age, but we also need to go beyond global policies.
Instead we must face the problems head on and listen to young people, find the missing data, face the unpalatable truth about the extent of their drug use and the systems that violate their rights. We need to confront uncomfortable choices to ensure that young people have access to information and services that they need and respect, and to support and protect their ability to make decisions. Easy to say and so much harder to do, but we are going nowhere unless we get over our paralysis.
Kate Iorpenda is senior advisor on children and impact mitigation at the International HIV/AIDS Alliance, www.aidsalliance.org
The International HIV/AIDS Alliance is supporting the Support. Don’t Punish campaign (supportdontpunish.org) which calls on governments to bring an end to the criminalisation and punishment of people who use drugs.