Regulation of electronic cigarettes
BMJ 2014; 349 doi: https://doi.org/10.1136/bmj.g5484 (Published 05 September 2014) Cite this as: BMJ 2014;349:g5484
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Arnott claims that
"In England we have a very clear philosophical basis for the public health legislation that prohibits smoking in enclosed public places. This is based on John Stuart Mill’s harm principle which holds that the actions of individuals should only be limited to prevent harm to other individuals."
This is not true. The smoking ban in, more accurately, non residential buildings and secure mental hospitals, prohibits private smoking clubs, even those staffed on a volunteer basis by their own (smoking) members. Countries which adhere to Mill's philosophy permit smoking in bars staffed only by the bar owner. Currently, at least, the Netherlands is one such country. It should be remembered that the stated purpose of the UK indoor smoking ban is to protect employees - not to protect customers, who may choose to go elsewhere.
Regarding electronic cigarettes: all the debates now taking place are academic, as the UK Government is obliged, in 2016, to adopt into UK law, the EU Tobacco Products Directive. The most important of many restrictions placed on ecigs by the TPD are
1. Liquid strength restricted to 2% nicotine
Around 25% of current vapers - these who smoked 20 a day or more,choose stronger liquid.
2. Refillable devices only permitted where there is no possibility of leakage.
This is impossible to achieve and so all refillable devices currently on sale will be banned.
The inevitable consequence of the TPD is that only disposable cartridge "cig-a-like" devices will be available. For the ex 20 a day smoker, these cost about around £50 a week to run, compared with £8 for refillable devices using ready mixed liquid, or £3 using liquid home-mixed from 7.2% nicotine concentrate.
In view of the TPD, the Tobacco Control Industry can choose to be as generous, or vindictive, as it wishes towards vapers. The outcome will be the same.
Competing interests: No competing interests
It may not always be apparent but there is a lot more that unites than divides the public health community with respect to electronic cigarettes and harm reduction. There is general agreement that the best outcome for smokers is to stop using nicotine altogether; (1) that the tobacco industry is not to be trusted; and that electronic cigarettes must be appropriately regulated to maximise potential benefits to public health while minimising the risks. The devil is in the detail.
Professor Ashton says that critics of the WHO statement on electronic cigarettes like ASH are ‘challenging the presumption of “at least do no harm”’’. This is based on an over-simplistic analysis which ignores the fact, accepted by the MHRA, that nicotine is not a novel drug and that the appropriate comparator is smoking, the most deadly vehicle for nicotine delivery.
It is not that we are, as Ashton suggests, “unable to decide whether e-cigarettes are a short-term medical aid to quitting smoking or a consumer good, to be used in the long-term”. ASH believes, in line with the MHRA and NICE, that alternative nicotine sources like e-cigarettes can be both a quitting aid and a long-term alternative to smoking.(1,2)
ASH takes its lead from Richard Peto, who says that “helping large numbers of young people not to become smokers could avoid hundreds of millions of tobacco-related deaths in the middle and second half of the twenty-first century, but not before. In contrast, widely practicable ways of helping large numbers of adult smokers to quit… might avoid one or two hundred million tobacco-related deaths in the first half of this century.” (3) Evidence from population surveys shows that electronic cigarettes as currently regulated are proving to be more successful in helping smokers quit than NRT bought over the counter, as well as providing a long-term alternative to smoking (4,5) thereby helping achieve Peto’s primary goal.
We share Ashton’s concern about nicotine initiation in youth. That’s why we support an age of sale for e-cigarettes of 18 with appropriate enforcement. We also support regulation to prevent marketing promoting smoking and encouraging uptake by non-smokers and young people. But when youth trends are carefully examined, it becomes clear that regular use is almost entirely confined to smokers and ex-smokers and smoking prevalence amongst young people continues to decline.(6) The evidence shows that e-cigarettes are being used by millions of smokers primarily to help them quit.(7)
Ashton is also concerned that ASH doesn’t support a ban on e-cigarette use indoors.
In England we have a very clear philosophical basis for the public health legislation that prohibits smoking in enclosed public places. This is based on John Stuart Mill’s harm principle which holds that the actions of individuals should only be limited to prevent harm to other individuals. (8) On this basis there is insufficient justification to extend our smokefree laws to include e-cigarettes, given that, to quote McNeill et al “exposure of bystanders to chemicals in e-cigarette vapour is not at levels that would be expected to cause health problems” (9). ASH believes, therefore, that rather than using legislation it should be for organisations and individuals to decide for themselves whether they want to allow e-cigarette use in their premises.
ASH wants to see appropriate regulation to ensure that e-cigarettes are safe, reliable and effective and that their marketing is controlled. That’s why we support medicines regulation and are pleased to see the MHRA has given a licence to the first nicotine inhaler.(10) In Europe we have an evolving twin track regulatory approach which will be in force by 2016/17 which will require novel nicotine delivery devices to be regulated under the Tobacco Products Directive or to have a medicines licence. There are those concerned that such regulation is already too stringent and may undermine the growing market for alternative nicotine products. Our view is that since this is the regulatory framework that is about to be put in place we need to do all we can to ensure that it works to the benefit of smokers and of public health, in line with the evidence base.
In Britain an evidence-based comprehensive tobacco control strategy (11) has been highly effective, accompanied by falls in smoking prevalence that have been faster amongst children (6) than adults. (12) If our strategy is to remain effective it needs to continue to be based on the evidence.
ASH has certainly not suspended ‘disbelief about the tobacco industry’s goodwill’. But the tobacco industry continues to profit primarily from the sale of tobacco products, not safer alternatives, and is only moving into e-cigarettes because they are becoming serious competitors to smoked tobacco. It is crucial that we do not play into the hands of the tobacco industry by implementing regulation which inhibits the development of a market for safer alternatives for smokers who are unable to quit because of their nicotine addiction. That would indeed be to the detriment of population health and tobacco control.
(1)NICE Guidelines [PH45]. Tobacco: harm-reduction approaches to smoking. NICE, June 2013
(2)Drug Safety Update Article. Nicotine Replacement Therapy and Harm Reduction. MHRA, January 2010.
(3)Peto, R. Future worldwide health effects of current smoking patterns. In: IARC Monographs on the Carcinogenic risk to humans. Vol 83: Tobacco smoke and involuntary smoking. IARC, 2002
(4)Brown J, West R, Beard E, Michie S, Shahab L, McNeill A. Prevalence and characteristics of e-cigarette users in Great Britain: Findings from a general population survey of smokers. Addictive Behaviours 2014; 39:1120-5. doi: 10.1016/j.addbeh.2014.03.009. Epub 2014 Mar 12
(5)Brown J, Beard E, Kotz D, Michie S & West R. Real-world effectiveness of e-cigarettes when used to aid smoking cessation: a cross-sectional population study. Addiction May 2014. DOI: 10.1111/add.12623
6) Smoking, drinking and drug use among young people in England in 2013, Health and Social Care Information Centre (HSCIC), 2014.
(7) Use of electronic cigarettes in Great Britain: ASH Fact Sheet, July 2014
(8) John Stuart Mill. On Liberty. Oxford University. pp. 21–22. 1859.
(9)McNeill A, Etter JF, Farsalinos K, Hajek P, le Houezec J, McRobbie H. A critique of a WHO-commissioned report and associated article on electronic cigarettes. Addiction.
doi: 10.1111/add.12730
(10) First Regulatory Authorisation for Voke® Nicotine Inhaler. Marketing Authorisation Announcement. Kind Consumer, 12th September 2014.
(11) Tobacco Control Plan for England, HM Government, March 2011.
(12) The 2011 General Lifestyle Survey Office for National Statistics, March 2013.
Competing interests: I have read and understood BMJ policy on declaration of interests. I am a member of the CHM working group on nicotine containing products and was a member of the NICE PDG on tobacco harm reduction. I have no relevant commercial interests.
Dr Crawshaw refers to some of the issues around inequality and smoking, data from the Addictive Behaviours paper showing e-cigarette use is associated with higher socio-economic status, and goes on to say that early indications suggest that the benefits of e-cigarettes potentially being useful aids to smoking cessation “are not being observed in those social class groups who are already more likely to use tobacco [and] are the least likely to quit”.
It’s obvious that alternative smoking cessation measures, such as nicotine-replacement products and stop-smoking services, have also not been successful at ensuring maximum social justice, given that smoking rates are still higher in less-advantaged socio-economic groups. But it is not the case that e-cigarettes are not used by these groups at all. Professor Ann McNeill, one of the authors of the paper to which Dr Crawshaw refers, gave a presentation at a Public Health England seminar in May this year (https://www.phe-events.org.uk/HPA/media/uploaded/EVHPA/event_344/ecig%20...) providing data which breaks down e-cigarette use in England by social class, showing that all such classes use e-cigarettes (page 18). Given that e-cigarette prevalence overall has been increasing (http://www.ash.org.uk/files/documents/ASH_891.pdf), use amongst less-advantaged socio-economic groups must also have been growing. Professor McNeill’s presentation concludes that “E-cigarettes have potential to reduce smoking, reduce inequalities and improve public health”.
In arguing that e-cigarettes might be a market solution to a social problem I would also point out that that doesn’t obviate the role of other measures which might enhance their role in addressing the inequalities to which Dr Crawshaw refers (nor the need for sensible regulation of advertising, product standards, youth access etc). For instance, the National Centre for Smoking Cessation Services, which supports the NHS and local authorities, has published a briefing on e-cigarettes (http://www.ncsct.co.uk/usr/pub/e-cigarette_briefing.pdf), recommending that practitioners “be open to electronic cigarette use in people keen to try them” and that “multi-session behavioural support . . . is likely to improve the efficacy of electronic cigarettes in the same way such support markedly increases the efficacy of NRT”. There may be a debate to be had on whether e-cigarettes should eventually be available on NHS prescription (http://www.theguardian.com/theobserver/2014/may/24/debate-should-nhs-pre...).
Professor Watson and Dr Forshaw point out the important potential risks of the re-normalisation of smoking and the possibility that young people and non-smokers might take up e-cigarettes. The NEJM paper which they reference discusses re-normalisation risk but provides little evidence of its effects occurring. Professor John Britton and Dr Ilze Bogdanovica wrote in the May 2014 Public Health England report (https://www.gov.uk/government/uploads/system/uploads/attachment_data/fil...) that “. . . use of electronic cigarettes in smoke free places is more likely to lead to normalisation of nicotine devices than to smoking, and hence potential benefit as a support to existing smoke-free policies”.
Last week’s paper in Addiction (http://onlinelibrary.wiley.com/doi/10.1111/add.12730/abstract) provided arguments and evidence that “current use of e-cigarettes in non-smoking youth is very low and there is currently virtually no regular use in children who have never smoked or never used tobacco”, and that “the advent of e-cigarettes on the market has been accompanied by a continued reduction in youth smoking prevalence”.
Competing interests: I am an investor. I do not currently own any tobacco stocks but have done in the past and may do so in future.
We agree with some of the concerns raised by Professor Ashton particularly in relation to the potential effect of e-cigarettes on population health and tobacco control.(1) It is crucial that we do not lose sight of the fact that tobacco smoking is still the largest single preventable cause of ill health and death in the UK. However, the reduction in smoking rates should be seen as a public health success story.(2) But, safeguards are needed to ensure that rates do not increase.
E-cigarettes are increasingly popular, and in the UK we have already seen the establishment of high-street vendors of such products, thus potentially contributing to the perceived normalisation of this activity. The widespread use of e-cigarettes might also help to normalise smoking in public once more, and could act as a gateway to traditional cigarettes.(3)
For existing smokers, they might be a temporary aid toward cessation efforts, however they are not without their own drawbacks. Nicotine is a highly addictive compound, and is therefore not harmless when tar and other substances are not present. There is also the possibility that e-cigarettes will develop a market of their own, and could appeal to young people and non-smokers, leading to a new drug habit that replaces smoking in the future. Research into such possibilities is not currently well developed.
The widespread use of such devices has not been demonstrated to be conducive to health and as such we are not in favour of e-cigarettes being widely advertised or promoted. We support any move to restrict their use and sale only to circumstances where there is evidence for their effectiveness.
We conclude by making five key recommendations.
1. E-cigarettes should be seen as a part of the armoury of devices intended to wean smokers away from cigarettes, and nothing more.
2. E-cigarettes should not be promoted to non-tobacco users.
3. More research is needed into the efficacy of e-cigarettes.
4. There needs to be further debate about the use of e-cigarettes in public places (including workplaces).
5. Careful monitoring of the promotion and use of e-cigarettes is needed.
References
1) Ashton J. BMJ 2014;349:g5484
2) Royal College of Physicians. Fifty years since Smoking and health. Progress, lessons and priorities for a smoke-free UK. Report of conference proceedings. London: RCP, 2012.
3) Fairchild AL, Bayer R, Colgrove J. "The Renormalization of Smoking? E-Cigarettes and the Tobacco “Endgame”." N Engl J Med 2014, 370; 293-95
Competing interests: No competing interests
Thank you Prof. Ashton for an insightful editorial on an issue that, I have no doubt, will become a paradigm for the perennial tensions that have defined public health policy since the epidemiological transition of the mid twentieth century. There is much to discuss in what Prof. Ashton writes, but the most important area for me as a social scientitst relates to the observation that 'The psychology of substance use is firmly grounded in individual and social rituals.' This is the crux of the issue. As over 30 years of research and interventions in tobacco use have demonstrated, smoking (in whatever form it takes) is a profoundly social practice. The best evidence for this sweeping statement lies in the myriad demographic data that has consistently shown that quit rates and long term cessation remain most stubbornly low in social class groups with the least resources (broadly conceived of course). The real issue therefore becomes, as it has been throughout the history of public health, one of addressing inequality and ensuring greater social justice.
The emergence of e-cigarettes is simply another episode in this perennial saga. A study in Addictive Behaviours in June this year (see http://www.ncbi.nlm.nih.gov/pubmed/24679611) describes how 1 in 5 current smokers in a sample of nearly 4k use e-cigarettes, with nearly a one third having used them at some time. 70 percent of the total sample believed them to be less harmful than conventional cigarettes. Most significantly, their use was associated with higher socio-economic status. As every public health practitioner knows, this reflects wider trends in smoking cessation.
If, and, as Prof. Ashton notes, it remains a big 'if', e-cigarettes are a useful aid to smoking cessation, early indications suggest that those benefits are not being observed in those social class groups who are already more likely to use tobacco, are the least likely to quit and who, for a host of other reasons, experience the poorest health. This raises important questions, as, if Mr. Fell is correct in his response to Prof. Ashton, that e-cigarettes might constitute a market response to a social problem, it is clear that, as ever, the market does not operate in a way capable of ensuring maximum social justice.
Competing interests: No competing interests
As one who was successful in stopping smoking after more than 40 years, by using an e-cigarette, I want to add my voice to those who urge sensible and regulated approval of these devices.
Any harm that the vapour may provide is surely less than that of tobacco smoke, and there is a place for these as a cessation aid.
Competing interests: No competing interests
I found Professor Ashton’s editorial intriguing, and not just for the poetic reference or talk of the “primitive roots of oral gratification” (a new element to the gateway theory?).
I’m particularly interested in the lines: “Many, seemingly well informed, people appear willing to suspend disbelief about the tobacco industry’s goodwill. This issue is much about commercial politics as science. Let us get the science right by making sure all vested interests are in the open . . .”
This might be read as attempting three sleights of hand at once: firstly, suggesting that the tobacco industry is effectively behind all commercial efforts in e-cigarettes; secondly, identifying all e-cigarette and vaping advocates with commercial interests (knowingly, or as dupes); and, thirdly, implying that the mere identification of a business interest behind a given position in itself disposes of that argument.
But some harm reduction advocates feel that e-cigarettes are a case in which public health and commercial interests can coincide – a market solution to a problem. The tobacco industry’s interest (or any other corporate interest) in e-cigarettes doesn’t have to be entirely altruistic in order to contribute to potentially substantial health benefits for the population if there is a large-scale switch away from conventional cigarettes.
Wouldn’t it be equally relevant to ensure that all other ideological interests were in the open, and that anyone whose views opposing more liberal e-cigarette policies were, at least in part, informed by a political viewpoint (say, an instinctive antipathy to business, born of left-wing politics, or an objection to the role of private companies in healthcare) made that clear too?
Yours sincerely,
Jonathan Fell
Competing interests: I am an investor. I do not currently own any tobacco stocks but have done in the past and may do so in future.
Re: Regulation of electronic cigarettes
E-cigarettes are also known as e-vaping devices and are a recent development in tobacco harm reduction. Studies have revealed that there is tremendous growth in the e-cigarette market and millions of people currently using them. E-cigarettes have become the fashion statement among young tobacco users.
It has the potential to kill as inhaling nicotine could be dangerous. It is also very harmful for passive smokers. A major concern is that e-cigarettes could perpetuate nicotine addiction in smokers or lead to nicotine addiction among youth. The most common side effects from e-cigarette use are sore throat, dry cough, and headache due to inhalation of PG/VG and/or nicotine. E-cigarettes are the subject of a public health dispute because of safety issues. There are health risks to users, non-users and bystanders. Appropriate legislative and regulatory measures to prevent the use of e-cigarettes are necessary. It is premature, however, to conclude that e-cigarettes are safe to use, in part because no long-term studies have been conducted.
E-cigarettes are set to be banned in India soon. The decision to ban E-cigarettes was initiated by India. The Union health ministry has decided to ban these “nicotine inhalers” through proper legislation soon. E-cigarette smoking is declared illegal in Punjab, India’s first state to do so (health department’s Chief Secretary, Vini Mahajan in a Smoke-free workshop organised by Union of South East Asia). 18 districts of Punjab have already been declared no smoking districts.
Competing interests: No competing interests