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Public Health England, E-cigarettes: an evidence update, August 2015:
Many people think the risks of e-cigarettes are the same as smoking tobacco and this report clarifies the truth of this.
In a nutshell, best estimates show e-cigarettes are 95% less harmful to your health than normal cigarettes.
Smokers who have tried other methods of quitting without success could be encouraged to try EC to stop smoking and stop smoking services should support smokers using EC to quit by offering them behavioural support.
Much of England’s strategy of tobacco harm reduction is predicated on the availability of medicinally licensed products that smokers want to use. Licensed ECs are yet to appear. A review of the MHRA EC licensing process therefore seems appropriate, including manufacturers’ costs, and potential impact. This could include a requirement for MHRA to adapt the processes and their costs to enable smaller manufacturers to apply, and to speed up the licensing process.
The absence of a licensed product, five years after the MHRA’s consultation took place, suggests that this route to market is not commercially attractive. The fact that the only product at the application stage is a BAT product suggests that the process is very resource intensive.
The appeal of EC may rest in the fact that they are not medicines.
The licensing process has been described by the MHRA. This regulation was described initially as ‘light touch’ recognising a product that delivered nicotine could be effectively used for harm reduction or cessation purposes, thus implying a relatively speedy route to licensing. This was subsequently changed to ‘right touch’ as it was apparent that the process was more lengthy and costly than originally envisaged. We understand that the MHRA estimated costs for a one-off application of between £252K and £390K with an annually recurring cost of between £65K and £249K, for each product. This does not include the costs of making manufacturing facilities and products MHRA compliant –estimated at several million pounds
Youth uptake and gateway effect
Regular use of EC among youth is rare with around 2% using at least monthly and 0.5% weekly. A minority of British youth report having tried EC (national estimates suggest around 12%). Whilst there was some experimentation with EC among never smokers, nearly all those using EC regularly were cigarette smokers.
We strongly suggest that use of the gateway terminology be abandoned until it is clear how the theory can be tested in this field. Nevertheless, the use of EC and smoking requires careful surveillance in young people. The preferred option is that young people do not use EC but it would be preferable for a young person to use an EC instead of smoking, given the known relative risks of the EC and smoking cigarettes.
(The emphasis in both the above quotes is PHE’s.)
Overall, the adult and youth data suggest that, despite some experimentation with EC among never smokers, EC are attracting few people who have never smoked into regular use.
Vapers feel they are less dependent on EC than they were on cigarettes; and non-smokers experimenting with EC do not find them attractive and almost none progress to daily vaping. This contrasts with the fact that about half of adolescents who experiment with cigarettes progress to daily smoking.
EC should not routinely be treated in the same way as smoking. It is not appropriate to prohibit EC use in health trusts and prisons as part of smokefree policies unless there is a strong rationale to do so.
Reasons for starting, and stopping, using an e-cig
Curiosity appears to play a major role in experimentation. Most trial of EC does not lead to regular use and while there is less evidence on why trial does not become regular use, it appears that trial due to curiosity is less likely to lead to regular use than trial for reasons such as stopping smoking or reducing harm.
Of concern is that data suggest that some smokers may not continue to use EC instead of smoking because of a misguided belief that EC would be harmful to their health. In the ASH Smokers’ survey 2014, the second most frequently endorsed disadvantage was “They might not be safe enough as a product” (35%) among smokers who had tried an EC but were not using one anymore.
Other reasons for use include reducing the harm from smoking and such efforts should be supported but with a long-term goal of stopping smoking completely.
Perceptions of risk
Since 2013 perceptions of the relative harmfulness of EC have become less accurate. Significantly larger proportions perceived EC to be at least as harmful as cigarettes in 2014 than in 2013 both in the Internet Cohort GB surveys and in the ASH youth surveys. In the Internet Cohort GB survey, there was no significant change from 2012 to 2013, but from 2013 to 2014 the proportion thinking that EC were less harmful decreased in favour of equally or more harmful (p<0.001).
Although the majority of adults and youth still correctly perceive EC to be less harmful than tobacco cigarettes, there has been an overall shift towards the inaccurate perception of EC being at least as harmful as cigarettes over the last year
Clear and accurate information on relative harm of nicotine, EC and tobacco cigarettes is needed urgently
There is a need to publicise the current best estimate that using EC is around 95% safer than smoking.
Poorly labelled e-liquid and e-cartridges mostly contained less nicotine than declared and so posed no risk to users. The accuracy of product labelling currently raises no major concerns.
Consistent delivery of nicotine
Translating these findings into regulatory recommendations, it would seem that regulation to enforce standard nicotine delivery may not be needed because nicotine delivery is influenced by a host of factors, including user puffing preferences, and because consumer preferences differ.
Aldehydes in vapour
There is no indication that EC users are exposed to dangerous levels of aldehydes
Exposures to poisonous liquid among children are of concern; however they should be taken in context. The same report from the NPIS recorded 208 exposures to liquid in reed diffusers, 1,168 exposures to pesticides and more than 600 to paracetamol. E-liquids seem to contribute towards domestic poisoning incidents but regulations, such as child safety caps, could limit this risk.
The clinical outcomes of exposures to e-liquids, as detailed in the NPIS report, were predominantly either ‘no toxicity’ or ‘mild toxicity’. There were two reported cases of ‘moderate toxicity’ and one ‘severe’ case that required treatment in an intensive care unit. Toxicity symptoms included conjunctivitis, irritation of the oral cavity, anxiety, vomiting, hyperventilation and changes in heart rate.
The liquid however should be in ‘childproof’ packaging to prevent small children, who may find the flavouring appealing, from drinking it. This seems to have been widely accepted by the EC industry. All e-liquids we have seen so far in the UK and globally were sold in child-resistant packaging.
It seems likely that the risk of fire and electrical fault is similar to other domestic electrical products, indicating that EC should be subject to the same guidelines and safety mechanisms.
Impact of the TPD
The TPD certainly raises the barrier for bringing EC products to market or continuing to market existing products, and will undoubtedly constrain the EC market.
…the cap on nicotine concentrations introduced by the TPD will take high nicotine EC and refill liquids off the market, potentially affecting heavier smokers seeking higher nicotine delivery products.
An assessment of the impact of the TPD regulations on the UK EC market will be integral to its implementation. This should include the degree to which the availability of safe and effective products might be restricted.
As detailed elsewhere in the report, the information we present does not indicate widespread problems as a result of EC. Hence, the current regulatory structure appears broadly to have worked well although protecting non-smoking children and ensuring the products on the market are as safe and effective as possible are clearly important goals.
McNeill, A., Brose, L.S., Calder, R., and Hitchman, S.C., (August 2015), Public Health England, E-cigarettes: an evidence update, Report commissioned by Public Health England
Professor David Sweanor, Adjunct Professor of Law, University of Ottawa, quoted from an interview with an electronic cigarette company, May 2015:
Some part of the opposition to nicotine products comes from the same moral absolutism that we see in other abstinence-only efforts on issues concerning such things as alcohol and sexual activity. Actually, on a very wide range of issues there is a tension between those on a moralist/absolutist quest (usually tied to ideas on the perfectibility of mankind) and those on a pragmatic public health mission. It would wrong to characterize those on a moral quest as being public health advocates, and this is true whether looking at abstinence-only campaigns on sex, on alcohol, on illicit drugs or on nicotine. Campaigns based on making better people rather than making people better are driven by moral concerns rather than public health concerns.
Everything has risks, so simply pointing out that something is ‘not safe’ shows a person to be either ignorant or disingenuous. The key issue in looking at safety is that it is a relative concept; we need to look at safety of any activity compared to some alternative. Rather than the unattainable standard of ‘safe’ we should be thinking in terms of ‘safer’. Despite the risks associated with soccer, I would, for instance, prefer my children play soccer rather than play with live hand grenades.
E-cigarette Direct, (21 May 2015), E-Cigarette Interview with David Sweanor, E-Cigarette Direct
Professor Ann McNeill, professor of tobacco addiction and the Institute of Psychiatry, Psychology & Neuroscience at King’s College London, quoted in Reuters, May 2015:
'We need to de-demonize nicotine,’ said Ann McNeill, [....]
She wants people to understand the risks are nuanced – that potential harms lie on a curve with smoking at one end, and nicotine at the other. People who don’t see that may hesitate to seek help stopping smoking, or try to restrain their intake of nicotine replacement therapy (NRT). That can make it harder to quit.
Professor Marcus Munafo, professor of Biological Psychology at Bristol University, is also quoted in this Reuters article:
Should we really be that bothered about addiction in and of itself, if it doesn’t come with any other substantial harms? It’s at least a discussion we need to have.
Kelland, K., (May 19 2015), Reuters, Is nicotine all bad?, Reuters
Professor Robert West and Dr Jamie Brown, in an editorial in the British Journal of General Practice in September 2014, said:
Given that smokers smoke primarily for the nicotine but die primarily from the tar, one might imagine that e-cigarettes would be welcomed as a means to prevent much of the death and suffering caused by cigarettes. For every million smokers who switched to an e-cigarette we could expect a reduction of more than 6000 premature deaths in the UK each year, even in the event that e-cigarette use carries a significant risk of fatal diseases, and users were to continue to use them indefinitely.
West, R., and Brown, J., (1 September 2014), British Journal of General Practice, Electronic cigarettes: fact and faction, Royal College of General Practitioners
Professor Ann McNeill (and others) in Addiction in May 2014, said:
One of the main concerns about e-cigarettes is that they or the marketing concerning them could be attractive to children who will try e-cigarettes and then move from them to become dependent upon ordinary tobacco cigarettes (the ‘gateway’ hypothesis). This was also a concern about low nitrosamine smokeless tobacco products, but the evidence was highly contestable then and is similarly contestable for e-cigarettes.
Hitchman, S.C., McNeill, A., and Brose, L.S., (5 May 2015), Addiction, Electronic cigarettes: time for an accurate and evidence-based debate, Wiley
Professor Robert West, professor of health psychology and director of tobacco studies at University College London’s department of epidemiology and public health, interviewed by the BBC, 6 July 2013:
If those young people are people who would have smoked but instead they’re using e-cigarettes, then that’s a huge public health gain. If they’re people who would never have smoked but they’ve taken up e-cigarettes, frankly in public health terms it’s not really an issue – it’s like drinking coffee or something, there’s no real risk associated with it.
As for the idea that e-cigarettes undo the work to de-glamorise tobacco smoking, West, who has done consultancy work for nicotine cessation medication, says the public health opportunity provided by e-cigarettes lies in their remaining trendy. ‘The opportunity here is for something that’s seen in a different light,’ he says.
‘We never got communities of people really enthusing about nicotine patches or nicotine gum. You didn’t get a sort of nicotine gum users’ group, in which they’d rave about the gum and sort of say: ‘This sort of gum’s so much better, and I make my own gum,’ and stuff like that.’
Ninety per cent of e-cigarette users are also smoking, he says, indicating that the devices are being used as a quitting aid. Countries that have banned them are, in his view, ‘nuts’.
Kremer, W., (6 July 2013), BBC News, E-cigarettes: Is a smoking alternative being choked by regulation?, BBC World Service
Professor Lynn Kozlowski, Dean, School of Public Health and Health Professions, University at Buffalo, State University of New York, article in the Huffington Post on 24 June 2013:
Smokers should try e-cigs to completely replace cigarettes. Given the variety of e-cigs, one should ask around and explore Web forums and videos for advice on brands. The goal is to stop smoking forever and use e-cigs as long as needed.
E-cigs are much safer than cigarettes. We don’t need clinical trials to know that a large rock falling on a person is much more dangerous than a small rock falling on someone. Compared to cigarettes, reduced risks of e-cigs are obvious. The number and level of toxins are much lower in e-cigs. It is easy to be less dangerous than fire-causing, carcinogenic, smoke-generating cigarettes.
Safer does not mean safe. Many popular products are unsafe — bicycles, alcohol, aspirin, acetaminophen, off-label prescription drugs, and on-label prescription drugs, as examples. Consumers and regulators need information on comparative risks, not just on whether a product is safe or not safe.
Premature death and disability from cigarettes justified public efforts to reduce smoking. Personal distaste, disapproval, or disgust of smokers or vapors may spur some, but major harm to health should be the bedrock of public health efforts.
Kozlowski, L.T., (24 June 2013), Huffpost Healthy Living, 9 Things to Think About When Thinking About E-Cigarettes, Huffington Post
Professor Robert West, professor of health psychology and director of tobacco studies at University College London’s department of epidemiology and public health, quoted in The Guardian, 4 June 2013:
We have such a massive opportunity here. It would be a shame to let it slip away by being overly cautious. E-cigarettes are about as safe as you can get. We know about the health risks of nicotine from studies in Sweden into the use of “Snus”, a smokeless tobacco. Nicotine is not what kills you when you smoke tobacco. E-cigarettes are probably about as safe as drinking coffee. All they contain is water vapour, nicotine and propylene glycol [which is used to help vaporise the liquid nicotine].
Professor West also raises his concerns about “clever marketing”:
This is a danger. Regulators should monitor this. Their sale should be restricted to 18-year-olds and over. However, the use of e-cigarettes by children and non-smokers is basically nil at the moment. Fear of normalisation shouldn’t stop us transforming the health of smokers.
Hickman, L., (4 June 2013), The Guardian, E-cigarettes: health revolution or fresh pack of trouble?, The Guardian
Professors Ann McNeill and John Britton, in a commentary in The Lancet, 1st June 2013:
Most of the 10 million people in the UK, and 1 billion worldwide, who smoke tobacco do so because they are addicted to nicotine. However it is the many other constituents of tobacco smoke, rather than nicotine, that kill half of all smokers. Conventional approaches to smoking cessation have at their core the idea that stopping smoking involves stopping nicotine use, which many smokers feel unable, or unwilling, to do. Harm reduction provides an option for these smokers to substitute cigarettes, preferably completely, with a less hazardous nicotine source. Proof of concept is provided from Sweden, where snus, a form of smokeless tobacco, has provided a socially acceptable and widely available lower-risk option to cigarettes and contributed to exceptionally low smoking prevalence and lung cancer mortality
Britton, J., and McNeill, A., (June 2013), The Lancet, Nicotine regulation and tobacco harm reduction in the UK, The Lancet
Professor Jean-François Etter, Head of the tobacco group at Institute of Social and Preventative medicine, University of Geneva, interviewed on Smoke Without Fire video, May 2013:
It would be a mistake I think to regulate these products as medications, and if they were regulated as medications this would limit access to the product too much and cause many deaths. …
Astonishingly, the most vocal opponents of e-cigarettes are people from the public health community, who perhaps don’t understand what is at stake, and just don’t like the product because it looks too much like a cigarette. …
If regulators could let the market evolve without regulating it too much and without regulating it unjustly… because currently people who are addicted to cigarettes are condemned to use tobacco, these laws arguably kill millions of people. They are absurd because they block every competitor to cigarette makers. So there’s a need to let competitors to enter the nicotine market so more people will switch from smoking to e-cigarettes and this will save many lives.
SWOF, (May 26, 2013), SWOF: Prof. Etter with FACTS about e-cigs, YouTube
Dr David Halpern, Head of the Prime Minister’s Behavioural Insights Team (“The Nudge Unit”), reported in the Daily Telegraph in February 2013:
Then there are, as Halpern puts it, the ‘quirky’ subjects. Smokeless cigarettes, for example. While many countries, unsure about their health risks, have moved to ban them, Halpern’s team thinks that’s a mistake. It’s far better, they argue, to ask smokers to adopt a similar behaviour that, while possibly not risk-free, is less dangerous than smoking proper, than to ask them to quit completely.
‘If you give someone a decent alternative, it’s a lot easier,’ says Halpern. ‘There are 10 or 12 million smokers in Britain, of which roughly half die from their habit. So even with a 20 per cent substitution, you’re talking about a million lives.’
Bell, C., (11 Feb 2013), The Telegraph, Inside the Coalition’s contoversial ‘Nudge Unit’, The Telegraph
Professor John Britton, Chair Tobacco Advisory Group Royal College of Physicians, reported by the BBC in February 2013:
‘Nicotine itself is not a particularly hazardous drug,’ says Professor John Britton, who leads the tobacco advisory group for the Royal College of Physicians. ‘It’s something on a par with the effects you get from caffeine.
‘If all the smokers in Britain stopped smoking cigarettes and started smoking e-cigarettes we would save 5 million deaths in people who are alive today. It’s a massive potential public health prize.’
Satchell, G., (11 February 2013), BBC News, Electronic cigarettes – miracle or menace, BBC News
Professor Peter Hajek, professor of clinical psychology, and director of the Wolfson Institute of Preventive Medicine’s Tobacco Dependence Research Unit at Queen Mary University, London, in a letter to The Times, Friday 25th January, 2013:
Sir, Hugo Rifkind (Jan 21) feels ambivalent about using electronic cigarettes and believes that there is no information available on whether they damage health. Several studies have analysed e-cigarettes. The most dangerous toxins present in conventional cigarettes are absent altogether, and the levels of suspect chemicals e-cigarettes do contain are an order of magnitude lower. Nicotine itself is probably safer than caffeine (smokers are killed by other chemicals they inhale with the smoke).
E-cigarettes are not a very good competitor to the conventional cigarettes yet, but if left to develop, they are likely to replace them within a few years and end the tobacco epidemic. Alarmingly, there is an effort under way to stop it. The UK wants to regulate e-cigarettes as a medicinal device. Medicinal licensing is an expensive process likely to be accessible only to big tobacco and pharmaceutical companies, and it is likely to fossilise e-cigarettes in their current “not-yet-very-good” state for two reasons: any changes to the product would trigger expensive licensing renewals, and neither the tobacco nor pharmaceutical industry will have much interest in allowing e-cigarettes to push conventional cigarettes and stop-smoking medications off the market. The case for regulating e-cigarettes as a pharmaceutical product is on a par with regulating coffee. It is even more absurd given that conventional cigarettes face no such hurdle. Legislation which cripples e-cigarettes will protect the market monopoly of the deadly conventional cigarettes and represent a serious disservice to public health.
Professor Peter Hajek
Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry
Hajek, P., (January 25, 2013), The Times, Letters to the Editor, E-smoking, Times Newspapers
Bonnie Herzog, Wells Fargo Securities (quoted in Time magazine in January 2013):
Consumption of e-cigs may overtake traditional cigarettes in the next decade... and they’ll only evolve and improve as time goes forward – at far less risk. The technology portion of it is sort of like Apple. This is just Version 1.
Sanburn, J., (Jan 8, 2013), Time, Economics, Can Electronic Cigarettes Challenge Big Tobacco?, Time Magazine
Professor Jean-François Etter, Head of the tobacco group at Institute of Social and Preventative medicine, University of Geneva, in The electronic cigarette: an alternative to tobacco (January 2013):
The risk-averse regulation of nicotine causes thousands of deaths annually, because it artificially strengthens the position of tobacco, blocks safer products and innovations, obstructs the marketing of nicotine medications, builds high barriers of entry in the nicotine market, and otherwise distorts the market economy. The current legislation benefits mainly the tobacco and pharmaceutical industries, by eliminating competitors for nicotine supply.
and, on the Tobacco Products Directive:
In the European Union, a proposal to change the Directive regulating tobacco product was announced in December 2012. In this proposal, cartridges that contain more than 2 mg nicotine, e-liquids that contain more than 4 mg nicotine per ml, or e-cigarettes that result in blood nicotine concentrations of more than 4 ng/ml (nanograms per milliliter, a very low level, similar to level observed in non-smokers exposed to light levels of passive smoking) will need to be approved as medicinal products. If implemented in this form, this directive would essentially kill the e-cigarette market, and therefore have seriously adverse effects on public health.
It has been suggested that e-cigarettes should be authorized only after all the necessary safety and effectiveness studies are published, but this will result in a de facto prohibition of e-cigarettes for many years.
Etter, J.F., (January 2013), Amazon, The Electronic Cigarette: an Alternative to Tobacco?, Paperback – 4 Feb 2013, CreateSpace independent Publishing Platform
Lionel Shriver, cultural commentator and author of We Need to Talk About Kevin, wrote in The Guardian in January 2013:
If electronic cigarettes became a socially acceptable norm, lung cancer and emphysema rates would plummet. The trouble is that smokers have been demonised medically and morally: not merely bad for public health, but bad, full stop. E-cigs neatly separate the rational, research-backed concern for the health consequences of tobacco from a purely cultural revulsion for a “filthy” habit marking you as evil.
You want real evil? What’s truly evil is attempting to deny people addicted to a profoundly damaging substance the opportunity to transfer that addiction to a product most medical professionals rate as 99% harmless. The gathering European opposition to electronic cigarettes is the result of kneejerk cultural prejudice, puritanical vindictiveness, corporate collusion, and the unconscionable greed of tax authorities that won’t be able to heap the same punitive, confiscatory, opportunistic duties on a product that doesn’t hurt anyone.
Shriver, L., (5 January 2013), The Guardian, E-cigarettes: no smoke without ire, Guardian Newspapers
Professor Peter Hajek, professor of clinical psychology, and director of the Wolfson Institute of Preventive Medicine’s Tobacco Dependence Research Unit at Queen Mary University, London, commenting on Clive Bates’s blog, The Counterfactual, in November, 2012:
E-cigarettes should be left to evolve into an alternative to smoking as a consumer product. Overzealous regulation (let alone bans) will protect the market monopoly of the deadly conventional cigarettes. Public health strategists should view the growing interest in e-cigarettes among smokers as a grass-root harm reduction movement and a potential end-game of the tobacco epidemic.
Bates, C., (November 12th, 2012), The Counterfactual, Open letter to delegates to the WHO Framework Convention on Tobacco Control COP-5, Comments, The Counterfactual
Professor Ann McNeill, professor of tobacco addiction and the Institute of Psychiatry, Psychology & Neuroscience at King’s College London, writing in the Royal College of Physicians report Fifty years since smoking and health, said:
… despite the controversy, harm reduction offers a potentially important alternative approach in tobacco control that should be explored and exploited rather than dismissed. For harm-reduction strategies to succeed and become mainstream, we need to see a radical change in policy from government and regulators, that will: encourage innovation in alternative nicotine products; regulate them permissively to guarantee purity and acceptable safety standards without stifling innovation; impose more proportionate regulation and controls on smoked tobacco products to further discourage their continued use; inform health professionals and the public about this new strategy; and monitor performance and effectiveness when in place.
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
Behavioural Insights Team, Annual Update 2010-2011:
exploring new products for people addicted to nicotine – products that deliver nicotine quickly in a fine vapour instead of as harmful smoke could prove an effective substitute for ‘conventional smoking’. It will be important to get the regulatory framework for these products right, to encourage new products, which smokers can use as safer nicotine alternatives, to be made available in the UK. A tenet of behaviour change is that it is much easier to substitute a similar behaviour than to extinguish an entrenched habit (an example was the rapid switch from leaded to unleaded fuel). If more alternative and safe nicotine products can be developed which are attractive enough to substitute people away from traditional cigarettes, they could have the potential to save tens of thousands of lives a year;
Halpern, D., et al, (2011), Behavioural Insights Team, Behavioural Insights Team Annual update 2010-11, Cabinet Office Behavioural Insights Team
Professor Michael Russell:
It is argued here that it is not so much the efficacy of new nicotine delivery systems as temporary aids to cessation, but their potential as long-term alternatives to tobacco that makes the virtual elimination of tobacco a realistic future target. Their relative safety compared with tobacco is discussed. A case is advanced for selected nicotine replacement products to be made as palatable and acceptable as possible and actively promoted on the open market to enable them to compete with tobacco products. They will also need health authority endorsement, tax advantages and support from the anti-smoking movement if tobacco use is to be gradually phased out altogether.
By and large it is the impurities in tobacco and its smoke which kill, while nicotine provides most of the pleasure, stimulation, and relief from stress. Conventional tobacco products will in future be regarded as archaic as the use of unrefined alkaloids in folk medicine appears now in comparison with the modem products of the pharmaceutical industry.
It will be assumed throughout that our main concern is to reduce tobacco-related diseases and that moral objections to the recreational and even addictive use of a drug can be discounted provided it is not physically, psychologically or socially harmful to the user or to others.
Russell, M.A.H., (24 Jan 2006), British Journal of Addiction, The future of nicotine replacement, Wiley
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