The use of electronic cigarettes in the UK continues to grow, posing complex challenges for regulators and public health policymakers alike. Current debates represent a struggle over whether e-cigs will ultimately be viewed as a trusted medicine, an everyday consumer product or a problematic recreational drug, writes Dr Catriona Rooke.
In June the UK medicines regulator (MHRA) announced that ‘nicotine-containing products’ including electronic or ‘e-cigarettes’ would be regulated as medicines to ensure that standards of quality, safety and efficacy are met. It stated that this would be achieved through support of the European Commission’s draft Tobacco Products Directive.
But just a few months later, members of the European Parliament voted on revisions to the directive, which controls the manufacture, presentation and sale of tobacco products, and rejected the Commission’s proposal to regulate all e-cigarettes as medicinal products at the European level.
This vote, hailed as both a ‘victory for common sense’ and a disappointment, reflects e-cigarettes’ ambiguous position in regulatory frameworks and public health debates.
E-cigarettes are battery-operated devices that produce a vapour which the user inhales – this usually, although not always, contains nicotine. Although nicotine is addictive, it is the toxic chemicals in tobacco smoke that are harmful; while evidence is lacking on the long-term effects of e-cigarette use, the scientific consensus is that they are likely to be much safer than smoking tobacco.
In the UK e-cigarettes have, thus far, been regulated under consumer protection regulations. This has raised concerns over manufacturing and safety standards as well as marketing and advertising practices. Usage among smokers more than doubled between 2010 and 2012, and the e-cigarette market is expected to continue to grow rapidly.
E-cigarettes have been the cause of significant debate in the public health community and, more recently, in the media.
Some academics, particularly many experts on nicotine addiction, feel strongly that e-cigarettes have great potential as less harmful alternatives to smoking tobacco – either to help people quit smoking or as a replacement for tobacco cigarettes. Online ‘vaper’ (user) communities have also been vocal in their enthusiasm for e-cigarettes.
But concerns have been raised about a range of issues including lack of regulation, continued addiction to nicotine, the possibility of them acting as a ‘gateway drug’ into smoking and their impact on social norms around smoking.
Current debates about the appropriate use and regulation of e-cigarettes provide a fascinating window onto the processes involved in shaping the identities of a technology and its users – as well as the role of law, the media, and academic, policy and user communities in this process.
Although they were developed in China in 2004 and introduced to the UK in 2006, it is over the last three years that e-cigarettes have gained visibility in public and policy spheres. Initially an unfamiliar and slightly odd gadget, they have shifted to being very visible, through advertising, their sale in a range of outlets and greater use, and are increasingly at the centre of media, policy and academic debates.
E-cigarettes trouble some key boundaries in tobacco control, and this is central to debates surrounding them and efforts to shape their trajectory. Prior to the development of e-cigarettes, products containing nicotine were placed into either the category of an accepted medicine or a risky tobacco product.
Nicotine replacement therapies such as nicotine gums and patches were developed within the pharmaceutical industry in the 1980s and consciously designed to be medicinal and not too attractive. They have been regulated as medicines in the UK since they were introduced.
Whilst use of these medicines for ‘harm reduction’ purposes – such as to aid in cutting down before quitting smoking or smoking less – has been legitimated in the UK, they remain firmly in a medical framework focussed on their use as a treatment in stopping smoking.
E-cigarettes imitate many of the visual elements of smoking – they involve the user inhaling and exhaling a vapour and are commonly designed to resemble cigarettes, sometimes including a tip that lights up when the user inhales – and are marketed as a glamorous and healthier alternative to smoking. But they are difficult to categorise as either medicinal or tobacco.
Current debates represent a struggle over whether e-cigarettes will be shaped into a trusted medicine, an everyday consumer product or a problematic recreational drug, and whether their users are responsibly undertaking a treatment or engaging in a pleasurable but dubious activity.
In the public health community, the pharmaceutical industry has, generally, been positioned as a legitimate and valued partner, producing as it does treatments for smokers. Conversely, a great deal of work has gone into highlighting the tobacco industry’s activities in delaying public health policies and misleading the public, thereby positioning it as a ‘pariah’ industry.
Initially e-cigarettes were sold in the UK by small companies, usually online. All the major tobacco multinationals have now moved into the e-cigarette market: for example, British American Tobacco (BAT) recently launched an e-cigarette called ‘Vype’ in the UK, and Nicoventures, a company within the BAT Group, is working to bring a nicotine inhaler product to market as a licensed medicine.
These shifts significantly muddy the waters around public health engagement with industry: Article 5.3 of the WHO Framework Convention on Tobacco Control underlines the importance of protecting public health policies from “commercial and vested interests of the tobacco industry”, but what happens if a tobacco company is producing a medical product?
The increasing influence of tobacco companies in the e-cigarette market, and the potential for this to shape take-up of e-cigarettes in a way that increases population harm (e.g. promotion to teens as a step towards smoking and use of e-cigarettes alongside smoking), is a valid cause for concern, especially bearing in mind the tobacco industry’s past tactics.
As such, there is a need for broad public debate over how e-cigarettes ought to be controlled to ensure that important social and ethical concerns are addressed. It is important to consider whether addiction to a substance should be condoned if it isn’t especially harmful to the user and others.
How should likely health benefits for individuals be balanced against possible harm to the population? And how should commercial vested interests, such as those of the tobacco and pharmaceutical industries, be engaged within public health policy-making?
It is crucial that these and other questions are not lost as debate over regulation progresses. Benefits to individuals must be weighed appropriately against the costs to the population as a whole, and a critical dimension to our view on the commercialisation of technologies with addictive properties must be retained.
”In the public health community, the pharmaceutical industry has, generally, been positioned as a legitimate and valued partner, producing as it does treatments for smokers”
The pharmaceutical industry who spend more on lobbying governments than the tobacco industry? The pharmaceutical industry that fund Cancer Research UK and the MHRA? The Pharmaceutical industry that have been hauled in front of numerous international courts and found guilty of widespread corruption, bribery and putting profit before health? The pharmaceutical industry whose ‘smoking treatments’ fail 95% of the time? Legitimate? Pull the other one.
If your research is an open-minded effort to explore this category of products and the harm reduction concept, then it will serve a useful purpose. But to that end, can I suggest a few points for you to consider:
1. The use of the passive voice should be avoided, as in “concerns have been raised” and “This has raised concerns over manufacturing and safety standards as well as marketing and advertising practices.” I’m not mentioning this as a matter of grammar or style, but because there is a clear oppositional faction that raises these concerns, and they form part of the politics of e-cigarettes. In fact a very small number of professionally engaged people hold these concerns – including Cancer Research UK, your funder. The people raising these concerns have incentives, biases, professional interests and established positions. They may also have an underlying model of tobacco control, based on various forms of control, coercion and prohibition that is under challenge. Many come with instinctive anti-corporate biases, which they have honed in their opposition to Big Tobacco. It is just possible that they are somewhat affronted by the rise of e-cigarettes as a purely private sector, consumer-led, innovation-driven, positive public health development with no involvement of them and the techniques they favour.
2. The fact that something is “troubling the boundaries of tobacco control” may say more about where tobacco control finds its boundaries comfortable and grounded in its past. The problem may be with that especially insular community, rather than with e-cigarettes or harm reduction. The tobacco control community is very poorly engaged with those it is supposedly trying to help, and its policies in this area owe nothing to user insight or engagement. The principle of ‘nothing about me, without me’ is a good one in public health, pioneered in HIV/AIDS, but it has been egregiously violated by the tobacco control community and medicines regulatory establishment when it comes to e-cigarettes.
3. Academics with speciality in nicotine addition might be worth listening to. They do not simply “feel strongly” about this issue, as if it is an emotional response. They have experience of the drug and the users in question. The users of these products – the people who should be worried – show little sign of any of the concerns raised by the tobacco control community. Most simply want better products (and by better they do not mean ‘safety, quality and efficacy’ in the medicinal sense) and to tell the world about what many see as breakthrough.
4. The ‘concerns’ in question have several characteristics: there is no evidence linking them to any material harm; they are hypothetical (ie. gateway effects); the risks are usually greatly exaggerated in media commentary and press releases; and the people who raise them rarely weigh the risks against the benefits. I have never seen any of the opponents of e-cigarettes discuss, for example, the potential benefits of teenagers using these products instead of starting to smoke. Also, these ‘population’ concerns are hard to reject conclusively without the products first being used and studied for many years – so they are used to create doubt and obfuscation and form a barrier to innovation and uptake. However, it might well be worth placing these concerns in a historical context and looking at what happened to harm reduction opportunities last time: the health and medical establishment went in to overdrive to have a form of smokeless tobacco (snus) banned. There was much asserting of many of the same concerns… gateway effects, reduced quitting, dual use etc. In fact, the experience of Sweden and Norway in Europe (where these products are not banned) show these products have been immensely successful for health at individual and population level. No serious health organisation can dispute this and few now try. However, despite the evidence of a strong beneficial effect recognised by many experts, the main European health and medical organisations continue to support a ban on the product. So were the concerns genuine or just tactics to progress an underlying, but indefensible, prohibitionist position?
5. Some of the things that the health lobby want (medicalization of e-cigarettes) and some they dislike or class as problematic (eg. imitating smoking, buzz and cool) show they have only a superficial grasp of harm reduction. The low risk products will have a major positive health impact precisely because they appeal to smokers. The big health gain does not come from creating a perfectly safe, dull, weak e-cigarette that no-one want to use – we already know that from the experience of NRT. It will come from creating powerful competitors to cigarettes that all smokers want to switch to. As long as the risks are about 99% lower than smoking, it doesn’t matter that they aren’t 99.9% lower or that the odd non-smoker has a go – they would be free to choose to smoke, and it is the disease and death we should focus on.
6. Avoid assumptions about the tobacco industry unless you can objectively verify them. To varying degrees these companies recognise the value of harm reduction in public health terms and see the opportunity commercially to move this agenda along aligned with public health goals. They have the customer knowledge, distribution channels, production engineering and R&D to do it – with potentially transformative effects on their business model, and in a good way. Sweeping generalisations about these companies and their approach to e-cigarettes should really be avoided. I think Article 5.3 of the FCTC is a satisfactory and quite proportionate safeguard, but the subsequent guidelines include the following principle: “There is a fundamental and irreconcilable conflict between the tobacco industry’s interests and public health policy interests”. In the context of e-cigarettes and harm reduction, I don’t think it is obvious that principle holds – and you correctly hint at this. I think that’s a fault with the guidelines rather than the tobacco industry. It is an excessively broad and backward-looking statement leaving no room for developments in harm reduction. Nor is it justified by Article 5.3 itself.
7. Watch out for implicit ethical or value judgements. You rightly pose the question: “How should likely health benefits for individuals be balanced against possible harm to the population?” It’s far from clear what this balancing would involve since the effects in question largely arise from what people do once they have bought the product. But more importantly, the prior ethical question is: “SHOULD likely health benefits for individuals be balanced against possible harm to the population?”. Consider what it means to make this balance – it may mean that a smoker who wants to use products in a way a regulator approves of, with possible life-saving consequences, may be denied or face barriers to access because someone else might use it in a way a regulator disapproves of. The likes of CR-UK have been active in ensuring that no-one in the UK has access to snus but curiously unwilling to accept responsibility for any people who are now smoking, would otherwise have turned to snus. Even if that is only one person, they have been denied access to a product much safer than the market leader using the force of law because of theoretical worries about population effects.
8. Don’t assume that this issue is really difficult and complex. It isn’t really. Look at where the supposed complexity arises and judge if this is real and material or just a distraction designed to make a simple issue complicated in order create doubt and hinder progress. What has happened so far is all good: an entrenched industry and widely used product that causes a great deal of harm to people is facing competition from a very low risk alternative that seems to satisfy the consumers and is growing rapidly without any state intervention or public spending. The pace of innovation is rapid, the products improving and user insight is developing and spreading like wild fire through social media, peer learning and word of mouth. As far as we can tell side effects are negligible, accidents rare and faults quite unusual – and all can be managed under normal product regulation. There just isn’t actually a real problem or great complexity, except the problems contrived by a remote and squeamish public health community that has lost its direction and sense of mission.
I wish you well with your research and would welcome the opportunity to discuss it with you if that would be useful.
The implicit assumption that e-cigarettes ‘ought to be controlled’ highlights the hypocrisy of commercial and public health vested interests. Were it truthfully a question of health issues arising from the ‘commercialisation of technologies with addictive properties’ then such an ethic would be applied to many current products on the market and perhaps bleed into products that support habitual use from users, too. It doesn’t… but then the tobacco and pharmaceutical conglomerates have little commercial stake in coffee, sugar and wine products, for example.
‘Control’ is often determined by ideology, puritanism and value-judgement that may appear to be benign and altruistic but which are frequently motivated by obfusticated vested interest. Over the past five decades, the shift from acting to save lives on the population level (from smallpox, polio etc) to influencing the ‘unhealthy’ habits of individuals (alcohol consumption, tobacco smoking etc) has been accompanied by the global corporatisation and monetisation of the ‘health industry’ both in terms of influential advocacy groups and government bodies (often funded or populated by the pharmaceutical industry) and the direct involvement of pharma companies themselves in public health initiatives via the NHS, for example.
This is illuminating in respect to current ‘concerns’ regarding e-cigarettes.
Should medical regulations be applied to e-cigarettes it is clear to see who would benefit. And why. As a vaper, it is clear to see that I would not benefit.
Whose voice is being sidelined in the ‘broad public debate’?
As with anything there needs to be on going research, but as it stands it clearly appears to be the better alternative. The research is already in on traditional cigarette smoking.