What is ‘tobacco harm reduction’?
Tobacco harm reduction is a public health strategy that makes use of regulation, fiscal measures, communications and support services to reduce the harms associated with tobacco or nicotine use, including the secondary harms induced by tobacco or nicotine policy. In practice, this primarily means encouraging smokers or would-be smokers to adopt non-combustible nicotine products such as e-cigarettes rather than combustible, smoking products such as cigarettes. Harm reduction is widely practised in public health, for example in illicit drugs and sexual health, because ‘abstinence-only’ approaches are ineffective. Harm reduction is acknowledged as within the definition of tobacco control in the Framework Convention on Tobacco Control.
- Letter to Director-General World Health Organisation, Innovation in tobacco control: developing the FCTC to embrace tobacco harm reduction, 2018 [link][blog]
- Beaglehole R et al. Nicotine without smoke: fighting the tobacco epidemic with harm reduction, The Lancet 2019 [link][PDF]
What products are involved?
There are four broad categories of non-combustible consumer nicotine products. Vaping products, heated tobacco products, smokeless tobacco products, and oral nicotine products.
Most of this briefing will concentrate on vaping products, but we have already seen proof-of-concept in Scandinavia with snus (a form of smokeless tobacco) driving smoking down to the world’s lowest level, with clear public health benefits as a result.
Are e-cigarettes less harmful than cigarettes?
Yes. Beyond any reasonable doubt, e-cigarettes are much less harmful: one to two orders of magnitude less risky. Almost all the harm done by cigarettes arises from the smoke, inhaling the products of high-temperature combustion of dried and cured tobacco leaf. The smoke is the sticky smoke particles and hot toxic gases that are drawn into the lung. E-cigarettes do not produce smoke because there is no combustion and no burning organic material, just heated tiny droplets of nicotine-carrying liquid. Combustion is the key difference and this creates completely different physical, chemical and biological effects.
Don’t the recent US cases of severe lung injury prove that e-cigarettes are very harmful
As of February 2020, there have been nearly three thousand hospitalisations and over sixty deaths from a severe lung injury condition. This has been given the misleading name EVALI (electronic-cigarette or vaping product use–associated lung injury). Is this a serious new risk from nicotine vaping?
No, definitely not. These cases have gained worldwide publicity, but they are completely unrelated to normal nicotine e-liquids and e-cigarettes. The cases occurred in users of cannabis vaping products and were caused by the use of a particular additive used for thickening cannabis (THC) oils – Vitamin E Acetate. It is possible other additives were also involved. The additive is used to ‘cut’ (i.e. dilute) expensive THC oils for economic gain, but without losing the viscosity (thickness of the liquid) that consumers use to gauge quality of THC oils. This additive cannot be used in nicotine-based e-liquid and would, in any case, serve no purpose as nicotine liquids are inexpensive and there is no reason to dilute with anything other than PG/VG.
Reasons for doubt 1. There is no credible evidence that links nicotine vaping to these injuries. The primary source of doubt is the inherently unreliable testimony of users, who have incentives not to candidly disclose THC use because of possible legal, employment, education or parental consequences.
A total of 9 of 11 patients who reported no use of THC-containing e-cigarette products in the 90 days before the onset of illness had detectable THC or its metabolites in their BAL [lung] fluid (Blount BC et al. NEJM)
Reasons for doubt 2. As well as unreliable user testimony, a further source of doubt and confusion is that there isn’t a clear definition and diagnosis of the lung injury condition – so several cases may have been included in the diagnosis but actually be a different condition.
Since EVALI is a diagnosis of exclusion for which there is no confirmatory diagnostic test, we could not confirm case status for these three patients. The EVALI case definition is intentionally sensitive, which raises the likelihood that a patient’s illness could be misattributed to EVALI. (Blount BC et al. NEJM)
Reasons to be confident. This is why analysis should focus on the suspect supply chain. Once a cause has been identified in one supply chain (Vitamin E acetate added to illicit THC vapes), there is a vanishingly small chance that a separate independent cause would emerge at the same time and same place with the same symptoms in commercially available e-cigarettes.
The lung injury cases are a tragedy, but they are primarily caused by the illegal supply of cannabis vapes and provide no basis for changing policy on e-cigarettes. They do, however, provide a warning about creating black markets by banning products – and that would be an additional risk of bans on e-cigarettes or flavours: a black market will develop.
Though these cases have nothing to do with regular nicotine liquids or e-cigarettes. The way key US agencies like CDC and FDA handled the controversy has meant that public opinion falsely attributes the cause to the nicotine products, with over 60% blaming regular nicotine vapes. No less dangerously, only 28% attribute the cause to adulterated THC vapes.
These misperceptions are potentially deadly: vapers or dual users may revert to smoking or be put off switching. THC users may continue to use THC vaping products from a compromised supply chain that poses lethal risks. Policymakers may take excessive regulatory action against nicotine products to address risks that do not, in reality, exist. This is a major public health failure, but no-one is accountable.
- Blount BC, et al. Vitamin E Acetate in Bronchoalveolar-Lavage Fluid Associated with EVALI. N Engl J Med. 2019 Dec 20; [link]
- David Downs, Vape pen lung injury: Here’s what you need to know, Leafly January 2020 [link]
- Gartner et al. Miscommunication about the causes of the US outbreak of lung diseases in vapers by public health authorities and the media, Drug and Alcohol Review, January 2020 [link]
- Mike Siegel, Newest CDC Data Confirm that Respiratory Disease Outbreak was Caused by Vitamin E Acetate Oil in THC Vaping Cartridges, The rest of the story, December 2019 [link]
- Guy Bentley, The CDC Is to Blame For More Americans Than Ever Being Misinformed About Vaping and E-Cigarettes, Reason Foundation, January 2020 [link]
- CDC. Outbreak of Lung Injury Associated with the Use of E-Cigarette, or Vaping, Products [link]. CDC’s advice has belatedly focused on THC vapes.
- Michelle Minton, CDC Confirms Black Markets, not “Vaping,” Caused Outbreak, Competitive Enterprise Institute. January 2020. [link]
- Clive Bates. Comment to FDA on lung injury outbreak: US vaping lung injury outbreak was a public health fiasco or worse – comment to FDA [link]
What about long term effects – shouldn’t we take a precautionary approach?
It is true (and a truism) that we cannot have 50-year studies of a product that has only been in use for about 10 years, but that does not mean we have no data. We have extensive data on the toxicants in the vapour and measurements of ‘exposure biomarkers’ in the blood, urine and saliva of users – all suggest very much lower risks than smoking.
One argument is that we should impose very tough regulation by applying the ‘precautionary principle’ until we have certainty about long term risks (by which those supporting the precautionary principle usually mean ‘never’). This is based on a basic misunderstanding of the precautionary principle. This idea, which is difficult to operationalise in practice, requires an assessment of both the costs of doing nothing but also the possible harms from intervening with excessive regulation, having estimated both the what is known and what risks are less certain. We have no doubt that cigarettes are very harmful, so intervening to discourage switching to vaping on the basis of hypothetical, unknown or trivial risks is likely to be more reckless than it is precautionary.
- The ‘no long term evidence’ gambit [link] and Abusing the Precautionary Principle [link] discussed in the Ten perverse intellectual contortions: a guide to the sophistry of anti-vaping activists [link]
It took decades for the harmful effects of smoking to emerge, won’t it be the same with vaping?
No. We would know immediately today that smoking is highly harmful. We would not have to wait five decades for epidemiology to show that smoking was causing cancer, heart disease etc. This is because the discipline of systems toxicology has hugely advanced since the mid-twentieth century. We also know a lot more about the risks of particular exposures, for example to heavy metals, without needing data from e-cigarette studies. Instead, we can draw on findings from other disciplines such as occupational health and the limits that are imposed on exposure in the workplace. These limits provide benchmarks for the tolerability of risk that we can use to benchmark vapour emissions and exposures.
How much less harmful are e-cigarettes than cigarettes?
The US National Academies of Science Engineering and Mathematics said that compared to cigarettes e-cigarettes are:
“likely to be far less harmful”
The premier British medical organisation, the Royal College of Physicians, said e-cigarettes are
“Although it is not possible to precisely quantify the long-term health risks associated with e-cigarettes, the available data suggest that they are unlikely to exceed 5% of those associated with smoked tobacco products, and may well be substantially lower than this figure.
The main English government public health agency, Public Health England, said that
“…stating that vaping is at least 95% less harmful than smoking remains a good way to communicate the large difference in relative risk.
None of these bodies, or the experts advising them, has any connection to the e-cigarette or tobacco industries. In each case, the experts based their view on a comprehensive published review of the evidence.
- National Academies of Science, Engineering and Medicine NASEM (US). The Public Health Consequences of E-cigarettes. Washington DC. January 2018. [link] Launch presentation summary (slide 44) [link][link]
- Tobacco Advisory Group of the Royal College of Physicians (London), Nicotine without smoke: tobacco harm reduction. 28 April 2016 [link]
- McNeill A, Brose LS, Calder R, Bauld L & Robson D. Evidence review of e-cigarettes and heated tobacco products 2018. A report commissioned by Public Health England. London: Public Health England. 6 February 2018 [link] [Press release]
Is it fair to say e-cigarettes are likely to be at least 95% lower risk than smoking?
Yes, the statements above are reasonable expert estimates of the relative long-term risks based on what we know of the respective toxicology of cigarette smoke and vape aerosol and also what we know of the exposure to toxicants in the body as measured in blood, saliva and urine. Based on the available evidence on relative toxicity and human exposures to toxicants, independent experts making assessments for PHE in 2015 and the RCP in 2016 concluded that it is reasonable to work on the basis that e-cigarettes are likely to be at least 95% lower risk than cigarette smoking and potentially substantially lower than that. In the short to medium term, there does not appear to be any significant risks given the experience of tens of millions of users over 10 or more years.
At present, there is no new evidence that would challenge that assessment and much that would reinforce it. While it is possible that some risks will emerge it is also quite possible that long term effects will be negligible or that technology improvements or regulation will allow us to tackle any risks that do emerge. In practice, we will not be able to directly determine the actual health effect of vaping for many decades, if ever (given that most vapers have also been smokers). But knowledge of systems toxicology is far advanced from the early days of smoking and health research and we do not need to wait many decades to understand risk.
It is important to be clear what these communications are.
- These communications are designed to address a widespread problem – the misperception of relative risk among the public (see below) whereby many people believe the products are as harmful or more harmful, and if there is a difference, the risk is only a little less.
- Perceptions inform behaviours, and in this case, we expect false perceptions to be causing more cigarette smoking and dual-use than would otherwise be the case – therefore causing material physical harm.
- It is what is known as a heuristic (a rule of thumb), that aims to guide people in making good, well-informed decisions, that are less vulnerable to biases induced by the way that messages are communicated.
- Figures of this nature are widely used in health and risk communication to help the public understand what otherwise confusing and complex data really mean for them using the best judgement of experts.
- The alternative is to leave those at risk to form their views from the media based on many misleading communications from academics, activists and billionaire funders and their proxies.
- The format “likely to be at least 95% lower” is not a point estimate based on deterministic calculations, but expressed as a rough guide to where the risks are likely to come out based on expert judgement
- It is based on what is currently known, but by definition, it cannot assess ‘unknown-unknowns’ – however, after 10 years of widespread use there are no signs of surprises and it is important to assess the likelihood of something novel emerging.
Why the hostility to these claims? These basic risk communications have been the subject of sustained attacks from tobacco control activists. I do not believe this is because those involved are concerned about misleading smokers or vapers (few complain when academics mislead smokers by falsely claiming that smoking and vaping are of equivalent risk). It is more because they just do not like this approach, which is based on empowered consumers interacting with innovative businesses in a lightly regulated market. This is antithetical to the tobacco control playbook, which tends to favour punitive, coercive and stigmatising measures.
- Clive Bates. Vaping is still at least 95% lower risk than smoking – debunking a feeble and empty critique, January 2020 [link]
- Clive Bates. Public Health England says truthful realistic things about e-cigarettes, August 2015 [link]
- Clive Bates. Smears or science? The BMJ attack on Public Health England and its e-cigarettes evidence review, November 2015 [link]
Do people understand the risks of vaping?
No, most people greatly over-estimate the risks compared to smoking. The chart below from ASH (UK) is the position in Britain – only 15% accurately identify e-cigarettes as a lot less harmful than smoking. But 26% think they are more or equally harmful. Because behaviour is informed by perceptions, it means that many people may be still smoking because they do not understand the benefits of switching.
This is not confined to the UK, in fact, it is worse in the United States – only 3.6% correctly recognise e-cigarettes are much less harmful than smoking, 45% wrongly believe e-cigarettes are very harmful, 56.5% incorrectly believe that nicotine is the substance that causes most of the cancer caused by smoking, and only less one in seven (13.4%) correctly understand that smokeless tobacco is less risky than cigarettes (and ‘much less risky’ – the real answer is not an option in this survey).
- National Cancer Institute, Health Information National Trends Survey (HINTS) 2018. E-cigarettes compared to cigarettes [link]; E-cigarettes harm to health [link]; Smokeless tobacco compared to cigarettes [link]; Nicotine as a cause of cancer [link]
- Huang J, et al. Changing Perceptions of Harm of e-Cigarette vs Cigarette Use Among Adults in 2 US National Surveys From 2012 to 2017. JAMA Netw Open.March 2019[link]
Do e-cigarettes help people quit smoking?
Yes. There are now four strands of evidence that suggest e-cigarettes are effective in helping people to quit smoking:
- Evidence from randomised controlled trials, notably, Hajek et al 2019, which showed vaping to be about twice as effective as NRT; “E-cigarettes were more effective for smoking cessation than nicotine-replacement therapy, when both products were accompanied by behavioral support.“
- Observational studies (watching what happens when people use e-cigarettes) for example, Jackson et al 2019; “Use of e‐cigarettes and varenicline are associated with higher abstinence rates following a quit attempt in England.“
- Population data (unusually rapid reductions in smoking prevalence or cigarette sales visible in market data), for example, Zhu S-H et al, 2018. “The substantial increase in e-cigarette use among US adult smokers was associated with a statistically significant increase in the smoking cessation rate at the population level. These findings need to be weighed carefully in regulatory policy making regarding e-cigarettes and in planning tobacco control interventions.“
- The thousands of testimonials of users who have struggled to quit smoking using other methods. See, for example, CASAA (12,500 testimonials) and, before dismissing ‘anecdotes’ see Carl V Phillips on why Anecdotes ARE scientific data
None of these is decisive in its own right, but all four strands point towards e-cigarettes displacing smoking.
There are also several pathways by which vaping can displace smoking, not simply as a quit aid. The following mechanisms are possible:
- As an aid for someone who already wants to quit smoking – a kind of souped-up NRT.
- By encouraging people who would not otherwise try to quit to give it a try, because it continues pleasurable aspects of a habit they like. In this way, it increases the number of quit attempts.
- It may form part of a (reluctant) response to a tobacco control measure – for example, the economic pressure created by cigarette taxation
- It may never be a conscious effort to quit smoking, but become a change of behaviour by default.
- It may prevent relapse to smoking among people who have already quit smoking, but miss it or are vulnerable to relapse to smoking (e.g. due to stressful life events).
- It may displace smoking uptake in young people or be a diversion from smoking experimentation that would otherwise consolidate into a more entrenched smoking habit
We need to avoid simplistic analogies with smoking cessation treatments and see the emergence of reduced-risk products as a pervasive technology diffusion and disruption in a market dominated until now by a very dangerous product.
Further reading and viewing
- Clive Bates, Colin Mendelsohn. Do vapour products reduce or increase smoking? 19 October 2017 [link]
- Villanti AC et al. How do we determine the impact of e-cigarettes on cigarette smoking cessation or reduction? Review and recommendations for answering the research question with scientific rigor. Addiction. 2017 [link]
- Carl V Phillips, Science lesson: how vaping leads to smoking cessation, 2017 [link]
Isn’t most vaping ‘dual-use’ of e-cigs and cigarettes?
Many vapers do use both e-cigarettes and cigarettes. But this is not the bad thing that it is often made out to be. The proportion of dual users has been falling in the UK and the United States, and in the UK is now well below half. This is probably due to several factors: many dual users are in transition from smoking to vaping over a period of months or years. Also, as the technologies improve over time, it is likely that more of the users will find exclusive vaping a satisfactory alternative to smoking. Dual-use should be properly understood as part of a behavioural pathway that evolves over time, not something this is static and fixed. Vaping may start with no intention to quit smoking, but as the user becomes more familiar and finds the product they like they gradually make more use of the product in more situations.
We should remember that just about every attempt to quit smoking using established methods involves continuing to smoke, usually by serial quitting and relapse. Unless cold-turkey, smoking cessation therapies or behavioural counselling are 100% and immediately effective, people who are trying to quit will continue to smoke over the course of quitting.
It’s also worth remembering the effect that anti-vaping messages have on smokers and dual-users. If they are being told there is no benefit and that it is harmful or anti-social, why should they feel motivated to make a complete switch? Many of the same activists who are raising dual-use as a problem (it isn’t) are also doing what they can to slow down or reverse the migration from dual-use to exclusive vaping (which is a major problem).
- Clive Bates. Claim 10: Dual-use undermines the value of vaping, August 2019 [link] in Vaping risk compared to smoking: challenging a false and dangerous claim by Professor Stanton Glantz [link]
- Simonivicius et al. What factors are associated with current smokers using or stopping e-cigarette use? Drug and alcohol dependence, 2019 [link]
- Persoskie A et al. Perceived relative harm of using e‐cigarettes predicts future product switching among US adult cigarette and e‐cigarette dual users, Addiction, 2019 [link]
What is the difference between NRTs, smoking cessation pharmaceuticals and vape products?
From a public health perspective, we should support the use of whatever options we can to reduce smoking, which is the primary driver of disease. The impact of any approach to quitting smoking is a product of two things – (1) how effective it is and (2) how willing people are to use it. At least in the UK and the US, e-cigs are now the most used product by smokers trying to quit smoking, more than any of the officially-approved smoking cessation medications.
The great strength of the vaping approach is that it is effective at replacing cigarettes because it replicates many aspects of smoking but without the harm (for example, nicotine effects, sensory experience, hand-to-mouth movement, and a behavioural ritual). But it also does this in a way that appeals to smokers – it is fun and interesting and there is a sub-culture to go with it. The secret of vaping is the combination of effectiveness and appeal. There may be occasions when it makes sense for a vaper to use NRT – for example, while learning to vape, on long flights, perhaps even overnight. The consumer market is developing diverse nicotine products – for example, oral nicotine pouches – which may also help.
- Notley et al. The unique contribution of e-cigarettes for tobacco harm reduction in supporting smoking relapse prevention, 2018. [link] found that: E-cigarettes meet the needs of some ex-smokers by substituting physical, psychological, social, cultural and identity-related aspects of tobacco addiction
- Louise Ross, Pragmatism versus dogma: freeing the inner vaper in smokers – Michael Russell Oration 2020, Global Forum on Nicotine (online) [link]
Should the healthcare system cover e-cigarettes as smoking cessation aids?
Generally, no. These are consumer choices and alternatives to smoking and not medications. People who can afford to smoke can afford to vape. The healthcare system should, however, offer encouragement, advice and expertise to potential switchers and possibly partner with vape shops or chains for delivery. One of the strengths of the ‘tobacco harm reduction’ approach is that the health gains are made on the initiative of the users and at the users’ own expense.
What about people who are disadvantaged and cannot afford to vape? Should they get support?
There may be a case for support. If people can afford to smoke, they can generally afford to vape – and the tax system should aim to keep it that way. So healthcare providers should not be funding vaping long term. However, for the economically disadvantaged (very poor, homeless, etc) there are issues at the point of transition:
- There are upfront costs for a device – the user may save money in the medium term, but if they don’t have the upfront cash the savings can’t be made
- The user may worry about ending up paying for both cigarettes and vaping equipment if the latter doesn’t work for them – and this is a barrier to experimentation
- Some sort of inducement to try might be necessary and be highly cost-effective for the provider
Is vaping a gateway to smoking?
No, there is no compelling evidence for this theory. However, we do see a quite strong association between young people who vape and then subsequently smoke. They are about four times as likely to smoke if they have vaped. This has allowed some academics or activists to claim a gateway effect. But this approach is flawed – you would need to know what the person would have done in the absence of vaping, and many would have progressed straight to smoking. It is most likely that ‘common liability’ explains the associations. This means that the same factors that incline young people to smoke also incline them to vape. The factors might include genetics, family smoking history, home circumstances, mental health and personal efficacy, delinquency, educational attainment, social group etc. Statisticians can try to eliminate these ‘confounding’ factors from the association to show that what is left of the association can be attributed to trying vaping. The trouble is that they can never do this completely – they will never have enough data or accurate models for confounding, and therefore never be able to eliminate these factors completely.
- Vanyukov, et al. Common liability to addiction and “gateway hypothesis” theoretical, empirical and evolutionary perspective. Drug Alcohol Depend. 2012. [link].
- Phillips C V. Gateway Effects: Why the Cited Evidence Does Not Support Their Existence for Low-Risk Tobacco Products (and What Evidence Would). Int J Environ Res Public Health 2015;12:5439–64. [link]
- Carl V Phillips, Science Lesson: How Understanding ‘Confounding’ Can Combat Anti-Vaping Junk Science, 20 November 2017 [link]
- Lee PN et al. Considerations related to vaping as a possible gateway into cigarette smoking: an analytical review, 2019 [link]
- Chan GCK, Stjepanovic D, Lim C, Sun T, Shanmuga Anandan A, Connor JP, et al. Gateway or common liability? A systematic review and meta‐analysis of studies of adolescent e‐cigarette use and future smoking initiation. Addiction. 2020 Sep 4; [link]
Should flavours be banned to stop youth vaping?
No. E-cigarettes and e-liquids are inherently flavoured products – all products, including the tobacco flavoured products – have flavouring agents added to give them flavour. Banning all or most flavours would be like banning all or most toppings on pizzas – it would effectively prohibit all or most of the products, leaving only the unattractive base or tobacco-flavoured liquids. This would make e-cigarettes nearly useless as alternatives to smoking for adults, promote a black market and may even increase risks to young people if it encourages them to smoke or to access black markets. It may make sense to ban certain flavour descriptors (the names given to flavours), if these are designed to appeal to youth.
- Clive Bates. The US vape flavour ban: twenty things you should know. 4 November 2019 [link]
What can be done to protect young people?
Regulations to protect youth should always be targeted at youth and not indiscriminately affect adults (for example through flavour bans, nicotine limits, blanket advertising bans, or taxes). There are three main legitimate policy approaches to protect young people:
- control access by setting age limits and restricting where and how products can be purchased;
- control marketing, packaging and branding to prevent marketing targeted at adolescents;
- provide credible reality-based campaigns, information and warnings targeted at young people.
Should e-cigarettes be banned?
No, absolutely not. This would prevent smokers (of any age) accessing much less risky alternatives to cigarettes, protect the cigarette trade from disruptive competition, and cause more disease and death. It would also put legitimate suppliers out of business, create a large black market and stimulate international internet trade. If nicotine is a legal drug, like alcohol or caffeine, then policymakers should be encouraging the least risky options to use it – not banning the safer alternatives to create a monopoly for the most dangerous nicotine products, cigarettes. Bans on e-cigarettes can be explicit prohibitions (as in India), implemented through poisons regulation (as in Australia), through classification as a medicine (Japan) or can be de facto prohibitions of essential elements of the product like bans on flavours (United States) or insurmountable evidential hurdles required for authorisation (United States).
There are multiple likely negative consequences arising from prohibition or de facto prohibition. These include:
- current vapers reverting to smoking
- current smokers not switching to vaping
- a boost for the cigarette trade as it benefits from reduced competition
- the development of widespread home DIY mixing
- the development of a black market in vaping products – with issues of quality and consumer rights and loss of regulatory supervision
- the enrichment of criminals and increase in crime
- the exposure of more people to criminal suppliers who also supply illicit drugs and other illegal commodities
- …and above all… the basic infringement of the liberty and autonomy or people to control their own risks, make their own pro-health decisions and to take their own initiatives to protect their own health at their own expense. On what basis does a government or public health activist intervene to stop that?
Policymakers and activists proposing prohibitions need to show that they have assessed the consequences listed above and concluded that the benefits outweigh these costs. Not a single state that has prohibited vaping has done this.
Should e-cigarettes be regulated like cigarettes?
No. Cigarettes are far more harmful than e-cigarettes and e-cigarettes can help people quit smoking. For these two reasons alone, the policy needs to take account of difference in risk and the potentially large benefits of e-cigarettes. The aim should be to use ‘risk proportionate’ regulation to encourage switching from cigarettes to e-cigarettes while controlling safety risks and preventing youth uptake of all tobacco and nicotine products.
Should e-cigarettes be regulated as smoking cessation medicines with pharmaceutical regulation?
No, do not do that. These products are not medicines. They work as consumer products – effective competitors to cigarettes rather than medicinal therapies for tobacco dependence. They are not medicines, the people using them do not see themselves as sick and many do not want to enter a healthcare setting. They are using these products as a lifestyle consumer choice and as a better alternative to cigarettes. The fundamental problem with medicine regulation is that ‘appeal’, which is the key to the success of vaping as a consumer rival to smoking, becomes ‘abuse liability’ in the regulatory framework for medicines.
What is the right approach to regulating e-cigarettes?
Regulation of tobacco and nicotine products should be “risk-proportionate” – with more stringent controls placed on the highest risk products. This means (in brief) a regulatory agenda as follows:
Cigarettes, hand-rolling tobacco and other combustibles
Vaping, heated tobacco smokeless and oral nicotine
Relatively high taxes
Low or zero tax (sales tax only)
Track and trace (FCTC protocol)
Prohibit other than within trade
Control themes and placement
Graphic warnings depicting disease
Messages encouraging switching
Legally mandated controls
Up to the discretion of the owner
Control reward-enhancing additives
Blacklist material health hazards
Allow, subject to health hazards
Not applicable if flavours banned
Control appeal to youth/trademarks
No sales to under-21s
No sales to under-18s
Permitted with age controls
Control risks and reduce appeal
- ASH New Zealand, A surge strategy for New Zealand. 2019 [link] (discussion of ‘risk proportionate regulation’)
- Fairchild A. et al. Evidence, alarm, and the debate over e-cigarettes: Prohibitionist measures threaten public health, Science, December 2019. [link]
What are the potential unintended consequences of vaping regulation?
The danger is that excessive regulation will make vaping (or heated, smokeless or oral nicotine products) relatively less attractive to nicotine users compared to cigarettes. Poorly designed regulation has the potential to shift the calculations of users in favour of more harmful products. As the Royal College of Physicians said in its 2016 report, Nicotine without smoke: tobacco harm reduction:
However, if [a risk-averse, precautionary approach to e-cigarette regulation] also makes e-cigarettes less easily accessible, less palatable or acceptable, more expensive, less consumer friendly or pharmacologically less effective, or inhibits innovation and development of new and improved products, then it causes harm by perpetuating smoking. Getting this balance right is difficult. (Section 12.10 page 187)
But there is an important fact to consider when striking this balance, the possible unintended consequences (more smoking) are much more serious than almost all of the conceivable harms that the regulation of low-risk products is designed to prevent. This means that regulators and policymakers should be paying particularly vigilant attention to unintended consequences that would cause more smoking. The uncritical endorsement of outright prohibitions by WHO, suggests that at the highest levels this simple idea has not been grasped.
- Clive Bates, Plausible unintended consequences of excessive regulation of low-risk nicotine products. 2019 [link]
- Michael Pesko: E-cigarette Policy Evaluation Research, accessed 20 February 2020 (updated regularly) [link]. Mike Pesko’s group specialises in economically-based research, looking at behavioural responses to policy interventions.
Should regulators impose limits on the strength of nicotine in e-liquids?
No, definitely not. The danger of limiting nicotine is that it leaves cigarettes in place as the most rapid and effective way of delivering nicotine. Such limits will make e-cigarettes ineffective alternatives for heavier smokers or those struggling to convert from smoking to vaping. It also may be a block on current and future innovation (e.g. to make products safer, smaller, easier to use) and make them more dangerous by forcing users to consume more liquid for a given dose of nicotine. Limits should only be set for poison-safety reasons (for example 7.2% or approximately 72mg/ml is a poison threshold in the UK) and not to limit nicotine uptake as this would provide an advantage to cigarettes
- Clive Bates. Who cares about a few thousand dead? Defending EU limits on the strength of nicotine e-liquids. 2016 [link]
- N. Voos, et al., What is the Nicotine Delivery Profile of Electronic Cigarettes?, Expert Opinion on Drug Delivery (2019) [link]
Should there be a special tax on e-cigarettes?
No. In any country with high rates of smoking, most vapers will be using e-cigarettes to cut down or quit smoking – they are doing this on their own initiative and at their own expense to improve their own health. Policymakers should be trying to make this as economically attractive as possible by using taxes to maintain a difference in the cost of vaping and smoking. At this stage, the priority is to reduce smoking as deeply and as rapidly as possible and a tax on e-cigarettes would slow down that progress, protect the cigarette trade, and increase the burdens of disease and premature death.
The danger is that raising taxes on e-cigarettes simply changes the choice of nicotine products, with only minor deterrent effects on overall uptake. For example, Cotti et al. used data from US 35,000 retailers and showed that every 10% increase in e-cigarette prices reduced e-cigarette sales by 26%, but also increased traditional cigarette sales by 11%, concluding that e-cigarettes and traditional cigarettes are economic substitutes. So those determined to impose taxes on e-cigarettes need to account for likely increases in cigarette consumption as a result.
- Pesko M, et al. The Effects of Traditional Cigarette and E-Cigarette Taxes on Adult Tobacco Product Use. Cambridge, MA; 2019 Jun. [link]
- Cotti CD, The Effects of E-Cigarette Taxes on E-Cigarette Prices and Tobacco Product Sales: Evidence from Retail Panel Data; NBER, January 2020 [link]
- New Nicotine Alliance: To tax or not to tax? Response to EU on taxing vaping and other reduced-risk products, 2016 [link]
- Chaloupka FJ, et al. Differential Taxes for Differential Risks–Toward Reduced Harm from Nicotine-Yielding Products. New England Journal of Medicine 2015. [link]
Do e-cigarette vapours pose the same risks to bystanders and family members as second-hand smoke from cigarettes?
No, far from it. Overall: bystanders are exposed to far lower levels of toxicants and for much less time. Three things are very different and toxic exposure to bystanders depends on all three:
- The quantity emitted. Most of the inhaled vapour is absorbed by the user and only a small fraction is exhaled (15% or less, depending on the constituent). In contrast, about four times as much environmental tobacco smoke comes directly from the burning tip of the cigarette than is exhaled by the smoker. There is no equivalent of this “sidestream smoke” for vaping.
- The toxicity of the emissions. Tobacco smoke contains hundreds of toxic products of combustion that are either not present or present at very low levels in vapour aerosol. Vapour emissions do not have toxicants present at levels that pose a material risk to health. Exposure to nicotine, itself relatively benign, is unlikely to reach a level of pharmacological or clinical relevance.
- The time that the emissions remain in the atmosphere. Environmental tobacco smoke persists for far longer in the environment (about 20-40 minutes per exhalation). The vapour aerosol droplets evaporate in less than a minute and the gas phase disperses in less than 2 minutes.
Many studies have misunderstood the risks; it is not sufficient to detect agents in the indoor air to declare a risk, the risk depends on exposure. It is possible to compare exposures with second-hand tobacco smoke or by reference to an indoor air quality standard – for example, standards set in workplaces for occupational exposure.
[With thanks to Roberto Sussman]
- Avino et al. Second-hand Aerosol From Tobacco and Electronic Cigarettes: Evaluation of the Smoker Emission Rates and Doses and Lung Cancer Risk of Passive Smokers and Vapers. 2018 [link] “…excess life cancer risk (ELCR) for second-hand smokers was five orders of magnitude larger than for second-hand vapers.“
- O’Connell G et al. An Assessment of Indoor Air Quality before, during and after Unrestricted Use of E-Cigarettes in a Small Room, setting Int. J. Environ. Res. Public Health 2015. [link] “In this study, the data suggest that any additional chemicals present in indoor air from the exhaled e-cigarette aerosol, are unlikely to present an air quality issue to bystanders at the levels measured when compared to the regulatory standards that are used for workplaces or general indoor air quality.” [note: tobacco industry study].
- Fernández E et al. Particulate Matter from Electronic Cigarettes and Conventional Cigarettes: a Systematic Review and Observational Study, Current Environmental Health Reports., 2015. [link] “We have found similar concentrations of PM2.5 in the smoke-free homes and in the e-cigarette user homes, both under 10 μg/m3, which is the threshold concentration for long-term exposures established in the Air Quality Guidelines of the World Health Organization . This is in contrast to the PM2.5 concentrations in the conventional cigarette user’s home, which were 58 times higher than in the e-cigarette user home.” Despite these encouraging findings, the authors tried to put a negative spin on the paper. They were called out by Mike Siegel: New Article Demonstrates Severe Bias by Anti-Tobacco Researchers in the Communication of Scientific Results about E-Cigarettes
Should vaping be banned by law in public places and workplaces?
No. There is a (contested) case to ban indoor smoking as there is science showing that second-hand cigarette smoke exposure is harmful to bystanders. However, e-cigarette vapour is quite different chemically and physically. The evidence suggests vaping creates exposures far below thresholds that would be allowed for occupational health limits, for example. The force of law should be reserved for protecting people from material harm caused by others. Vaping may still be disagreeable to some people, but it is primarily a matter of etiquette and respect for the preferences of others. E-cigarette policy should be decided, therefore, by the owners and managers of premises (hotels, bars, restaurants, shops, transportation, offices, public buildings etc). The hospitality industry may be more open to vaping and to welcome vapers, but public buildings will be most likely to prohibit it. The point is that owners and managers should be able to make the decisions that are right for them and their clientele.
Should e-cigarettes be available only through pharmacies or on prescription or over-the-counter everywhere?
No. They should be available everywhere cigarettes are – convenience stores, petrol stations, supermarkets – and more besides. The alternatives to smoking need to be just as easy to access as the harmful incumbent product, cigarettes. It is important not to place barriers in the way of easy access: if people cannot access them easily there is less chance they will try and more chance they will fail and relapse back to smoking. Vape shops are especially important as they combined diverse personalised product options with expert advice – offering what amounts to a smoking cessation service. Vaping products are now available in some hospital shops in England – this is to encourage patients, visitors and staff to try a permanent switch from smoking.
Should vaping products be available on-line?
Yes. Particularly in areas of sparse population, specialist vape shops selling diverse products would not be viable (the inventory costs would be too high) and many people also like the convenience and wide choice of online shopping and bargain hunting. Again, this is an area where vaping can and should outcompete smoking. Online sales present barriers to youth access through the requirement to make card payments and stronger systems of age verification are possible in some jurisdictions.
Are e-cigarettes a tobacco industry ploy to keep people smoking?
No. Modern e-cigarettes were not invented by the tobacco industry and there are thousands of suppliers who are not part of the tobacco industry. The tobacco industry has realised that its customers want to switch to these products and has entered the market. The industry deserves to be treated with great scepticism and should always be handled with caution. However, it is positive that the industry is marketing low-risk alternatives to its core product, the cigarette – there is no reason to want the industry to remain exclusively focussed on selling cigarettes. A long-term transition of the industry from selling combustible products to non-combustible is in the interests of public health and is the most likely and rapid way to end the worldwide epidemic of smoking-related disease.