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Smoking cessation

Stop demonising a potentially useful product for smokers

Compulsory regulation of electronic cigarettes could spoil a safe substitute for smoking.

Illustration of e-cigarette

Source: christophkadur / Shutterstock.com

Electronic cigarettes are becoming more popular but are not licensed as medicines

The market for electronic cigarettes is rapidly growing and no proof of serious health risks associated with their use has so far emerged. Much of the media coverage has focused on the risks and potential downsides of these products. We must take a step back from these unfounded fears and consider e-cigarettes in a different light.

E-cigarettes offer a powerful response to the grotesque burden of disease caused by smoking, something that should excite anyone interested in public health. They provide a satisfactory alternative to smoking because the user is still consuming nicotine, the active agent in tobacco. But when people inhale vapour from an e-cigarette, they are not breathing in the harmful products of combustion in cigarette smoke.

There are 10 million smokers in the UK (approximately 20% of adults) and around 1.3 billion worldwide — the current annual premature death toll attributed to smoking is 100,000 and six million, respectively. The World Health Organization (WHO) estimates one billion premature deaths from smoking in the 21st century on current trends.

The public health proposition is that e-cigarettes can substitute for cigarette use and provide a satisfactory alternative to smoking, with e-cigarette use expected to be at least 20 times safer than smoking tobacco cigarettes[1].

A survey published by Action on Smoking and Health in July 2014[2] showed that 2.1 million people in Great Britain are using e-cigarettes and around one third are now ex-smokers. To affect the immediate welfare and long-term health outlook of 700,000 people is an achievement, requiring no NHS resources or public spending. One Wall Street analyst, Bonnie Herzog of Wells Fargo Securities, projects that vaping will surpass smoking within a decade[3]. Other analysts are less bullish, but many see great potential. If anything close to this scale of change does occur, it will be one of the most remarkable public health phenomena in history.

Risks and concerns

No one could claim that vaping is entirely benign but it does not need to be to make large inroads into the burden of smoking-related disease. Studies of liquids and vapour chemistry reveal traces of contaminants and thermal breakdown products that are potentially harmful, but at low levels unlikely to pose a material threat.

The most comprehensive review of e-cigarettes so far was conducted by Igor Burstyn of Drexel University, Philadelphia[4].

“The current state of knowledge about chemistry of liquids and aerosols associated with electronic cigarettes indicates there is no evidence that vaping produces inhalable exposures to contaminants of the aerosol that would warrant health concerns by the standards that are used to ensure safety of workplaces,” he concluded. “Exposures of bystanders are likely to be orders of magnitude less, and thus pose no apparent concern.”

We cannot rule out unexpected effects in the future but, for now, we know enough from the basic chemistry involved, toxicology of liquids and vapours, trials of the products and surveys of users to be confident that e-cigarettes can have a positive impact on the health of those who switch from smoking.

Opponents of e-cigarettes now concentrate on ‘population’ arguments. This is the idea that, although vaping is considerably less hazardous than smoking, at population level it could be more dangerous because it changes the way people smoke. For example: e-cigarettes might serve as a ‘gateway’ to smoking for adolescents; they might dissuade people from quitting smoking; and they might ‘renormalise’ smoking in society.

In fact, none of these hypothetical effects have so far materialised. As expected, e-cigarettes are displacing smoking, as one of the UK’s foremost experts in smoking cessation, Robert West of University College London, points out.

“Evidence conflicts with the view that electronic cigarettes are undermining tobacco control or ‘renormalising’ smoking, and they may be contributing to a reduction in smoking prevalence through increased success at quitting smoking,” he says.

Scare stories

Anyone hoping to gain an insight into the safety of e-cigarettes by reading newspapers should tread carefully. There is something of a propaganda war raging and many spurious claims are published uncritically. For example, the fact that particle size of the e-cigarette vapour aerosol is similar to that of tobacco smoke led Metro to write an article on 30 July 2014 with the headline “E-cigarettes ‘may also cause lung cancer’”[5]. Of course, the chemistry of tobacco smoke does the damage, and that is completely different to e-cigarette vapour.

Professionals looking for guidance on the evolving science should consult literature reviews in the formal academic press. The most recent and authoritative is by Peter Hajek and colleagues, published in the journal Addiction[6]. The authors conclude: “Health professionals may consider advising smokers unable or unwilling to quit through other routes to switch to [electronic cigarettes] as a safer alternative to smoking and a possible pathway to complete cessation of nicotine use.”

A further source of concern to critics is the role of the tobacco industry in the e-cigarette market. In practice, it is hard to see how this could be negative: the tobacco industry is threatened by e-cigarettes and has entered the market by buying firms to catch up. To survive, each company will need to produce high quality alternatives or risk losing market share to other tobacco companies or non-tobacco e-cigarette companies. Competition will force them to make better products and, as a result, they will become a driver of the wholesale switch from smoking to vaping.

The risk of regulation

The development most likely to put the e-cigarette market at risk is not the tobacco industry but excessive regulation. It might seem like a paradox, but at the heart of the regulatory challenge there is a ‘double negative’: being tough on e-cigarettes is being tough on the competitive alternative to cigarettes — and that may lead to more smoking and more ill-health than it prevents.

In a report on electronic nicotine delivery systems (ENDS) published in August 2014, the World Health Organization (WHO) called for tougher regulation on e-cigarettes. It issued a series of recommendations, including a ban on indoor use until there is evidence that exhaled vapour is not harmful, stopping sales to children and putting health warnings about nicotine on products. It also recommended that manufacturers, and others, should be prevented from describing the products as smoking cessation aids, until there is scientific proof of their effectiveness.

However, the science base behind the WHO report was strongly criticised within a week of publication by UK and European experts[7] and the Department of Health was quick to reject WHO’s proposal for a legal ban on vaping in public places[8]. Policy analysts warn that excessive tough regulation of e-cigarettes give cigarettes and smoking an easy ride and effectively protects cigarette sales and causes more disease and death. The battle over the right balance of regulation and commercial freedom is sure to rage on.

At the moment, e-cigarettes are regulated as general consumer products but since 2010, the Medicines and Healthcare products Regulatory Agency (MHRA) has encouraged companies to submit medicine licence applications voluntarily for e-cigarettes to be approved as medicines.

The European Union has produced e-cigarette regulation in the revised Tobacco Products Directive that will come into effect from May 2016 for e-cigarettes containing up to 20mg/ml of nicotine. It includes a ban on advertising that will protect cigarettes from competition; limits on liquid container sizes; and bold warnings covering 30% of the pack. The measures were negotiated behind closed doors with no credible scientific or legal basis. E-cigarettes with stronger concentrations of nicotine, used by more dependent smokers, will require authorisation by MHRA as over-the-counter medicines in the UK.

The system of medicine regulation is not well suited to regulating recreational products because the products are not medicines, either in law or common sense. It applies heavy costs, burdens, restrictions and unnecessary technical demands that would limit the range of products and number of suppliers, while acting as a barrier to innovation. It is likely that only tobacco companies entering the business would be able to comply.

What should happen next?

The future plans for tougher regulation could damage the market for e-cigarettes. A rethink is needed — either through a policy change or the European Court of Justice. There is little wrong and much that is positive with the market as it functions today. It would benefit from some genuine light touch regulation that builds consumer confidence but the proposals in place could destroy perfectly good firms and greatly limit the diversity of products.

Some changes would be useful, such as purity and safety standards for liquids, some design constraints for vaping devices, tamper-proof liquid containers, proportionate health messages that encourage smokers to switch and restrictions on marketing similar to those in place for alcohol. Regulation in moderation could assist, but this is a market-based revolution that should be led by consumers, innovative producers and engaged retailers. If regulators intervene too strongly, they will end up doing far more harm than good.

Clive Bates worked with 53 specialists in nicotine science and public health to co-ordinate and deliver a letter to Margaret Chan, the director general of the World Health Organization, arguing against excessive regulation of e-cigarettes and urging caution in the handling of safer alternatives to smoking when WHO hosts the sixth conference of the parties to its Framework Convention on Tobacco Control, due to be held in Moscow on 13 October to 18 October 2014.

Citation: The Pharmaceutical Journal URI: 20066415

Readers' comments (6)

  • I think social attitudes towards smoking have changed; it's no longer acceptable to smoke in a restaurant. As a result I think that vaping is seen in much the same way.

    The main problem I have with ecigarettes is the lack of assurance of quality. To me, it's the same as supplying an unlicensed medicine when there are perfectly acceptable licensed alternatives available.

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  • Clive Bates does not appear to have read in the Tobacco Directive 2014/40/EU that it envisages three categories of e-cigarette, i.e. consumer e-cigarettes, e-cigarettes marketed as medical devices, and e-cigarettes marketed as medicinal products. Directive 2014/40/EU applies ONLY to consumer e-cigarettes. The relevant wording in the Directive reads as follows:

    "Electronic cigarettes and refill containers should be regulated by this Directive, unless they are – due to their presentation or function – subject to Directive 2001/83/EC [...] or to [...] Directive 93/42/EEC."

    Directive 2001/83/EC is the Medicinal Products Directive; Directive 93/42/EEC is the Medical Devices Directive.

    This seems to me to be an entirely rational approach. If a manufacturer wants to market an e-cigarette for use as a smoking cessation aid to compete with existing nicotine replacement products, then he has to negotiate the same regulatory hurdles as have to be negotiated by the manufacturers of these existing products for exactly the same quality and safety reasons ... the origins of which can be traced back directly to the consumer protection measures that were put in place following the thalidomide tragedy.

    And, it is also reasonable to expect consumer e-cigarettes to meet the specified quality and safety standards laid down in the Tobacco Directive 2014/40/EU. If they were not subject to the requirements of the Tobacco Directive 2014/40/EU, they would still be subject to the requirements of the Dangerous Substances Directive 2001/59/EC and the General Product Safety Directive 2001/95/EC.

    There is a big difference between the tobacco in a cigarette and the e-liquid cartridge of an e-cigarette. The latter contains nicotine, a dangerous neurotoxin, in a form that can quickly be absorbed on skin contact or following ingestion to cause serious poisoning. Older gardeners will remember the days no so long ago when a 40% nicotine solution could readily be bought from garden centres for use as an insecticide. That was dangerous material in the hands of the unwary.

    And nicotine, if not rigorously purified, can contain anabasine. This is a known teratogen that has been linked to oral clefting in newborns following maternal tobacco use. So, it comes as no surprise to me that the Tobacco Directive 2014/40/EU requires that "only ingredients of high purity are used in the manufacture of the nicotine-containing liquid", allowing only "trace levels" of impurities that "are technically unavoidable during manufacture".

    So, irrespective of whether Clive Bates has "worked with 53 specialists in nicotine science and public health", I can't understand the basis upon which he makes his assertion that "The measures [in the new Tobacco Directive] were negotiated behind closed doors with no credible scientific or legal basis."

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  • @Richard Schmidt 12 Sep

    To take these points one at a time:
    1. Closed doors? It is a matter of record that the terms of Article 20 of the Tobacco Products Directive were negotiated behind closed doors: firstly, as a hastily contrived amendment hammered out in closed political group meetings in the week before before the 8 Oct 2013 plenary. Secondly in a closed 'trilogue' process that ran from October to December 2013, with most of the agreement on e-cigarette happening late in December, with all relevant documents classified Limité. The proposals that now make up Article 20 of the directive have not been subject to rigorous justification, options appraisal or consultation - and the normal processes of national parliament scrutiny were bypassed.

    2. Scientific basis? A group of Europe's most credible experts in these subjects wrote to the Commission to protest that the science based used was completely flawed. Their letter: Scientific errors in the Tobacco Products Directive is well worth a read, and has never received an adequate response (17 January 2014)
    http://www.ecigarette-research.com/web/index.php/2013-04-07-09-50-07/149-tpd-errors

    3. Legal basis. In EU law the science and law are linked. The directive is supposed to be justified as enabling free movement of goods, subject to high levels of health protection. So a justification is required to show that any impediment of free movement of good is justified with reference to health protection. At the same time the measures have to be 'proportionate', 'non-discriminatory' and have adequate legal base. In addition the EU legislature is required to consult etc on new legislation - something it didn't do. Many of the measures in the TPD fail these tests. However, no definitive judgement can be made on that until the ECJ hears a judicial review. This is likely - one company has mounted challenge and it is likely that the high court will refer the case to the ECJ on 6 October. If you want an idea of where the legal vulnerabilities lie, please look here: Flawed science, irregular procedure, unlawful measures - http://www.clivebates.com/?p=1846

    4. It is not that everything in the TPD is wrong - and it is quite right to insist on pharmaceutical grade nicotine, excipients and purity standards. It is fine to classify them as medicines when they are sold with a medical therapeutic claim, though this hardly ever happens.

    5. Most products are not bought or sold as medicines and manufacturers generally don't make claims about treating or preventing disease that would bring these products into the classification of 'medicines by presentation'.

    6. Much PR effort goes into demonising nicotine - but although it is the addictive agent in e-cigarettes its risks are quite low at the concentrations and exposures typical of e-cigarette use. There is an extensive literature on this, and of course nicotine is sold in licensed NRT products, with relative light warnings and contraindications. It will always be better to use nicotine from an e-cigarette than to smoke.

    7. It would be better not to classify and regulate these products as either tobacco or medical. They are neither. Consumer protection legislation (some of which is mentioned in the comment) would provide most safeguards necessary - and specific standards could be applied to require, inter alia, pharma grade ingredients, child resistant containers, purity standards etc. Marketing restrictions similar to those applied to alcohol would be more appropriate than the total ban applied to tobacco.

    The reality is that the EU has, through a wholly inadequate process, contrived regulation that it arbitrary, counter-productive, and discriminatory. Some how they have made it easier to put cigarettes on the market. Through unjustified restrictions that provide no health benefits they weakened a competitor to smoking, even though all informed opinion is considers the risk 95-100% lower than smoking.

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  • Clive Bates argues that electronic cigarettes should not be classified and regulated as either tobacco products or medical products because, or so he asserts, they are neither. In which case, I would suppose that he would agree that the General Product Safety Directive 2001/95/EC would apply by default? The General Product Safety Directive is a so-called horizontal Directive the purpose of which is to "cover lacunae" where specific consumer safety legislation for a particular type of consumer product does not otherwise exist. The primary objective of the General Product Safety Directive is "to ensure that products placed on the market are safe [...] under normal or reasonably foreseeable conditions of use including duration [...] ".

    Clive Bates goes on to argue that nicotine is not as toxic or dangerous as the literature would suggest. Having read the article by Mayer (2014) [http://dx.doi.org/10.1007/s00204-013-1127-0], I would not dispute this point. But there is more than just the acute toxicity of nicotine that needs to be considered. Individuals who are exposed to nicotine acquire a tolerance to it. This is a confounding factor when trying to determine a value for what might be described as the "LD50" in man. Consumer safety laws have to provide protection for those who have never previously been exposed to nicotine, in whom the "LD50" will be much lower. Moreover, electronic cigarettes are not simply delivering nicotine. They are delivering nicotine that has been co-vaporised with a glycol-containing solvent. It is normal from a toxicological perspective to assume, until otherwise proven, that something unexpected might happen chemically during this co-vaporisation process, to produce a new toxic entity.

    So, whilst I would not disagree that "vaping" is probably safer that "smoking", I would drawn attention to my use of the word "probably". The fact remains that, scientifically, neither I nor Clive Bates nor anyone else can be sure that vaping is safer than smoking. So it is not so much the [possibly arbitrarily selected] 20mg/ml limit for the nicotine in consumer e-cigarettes that is the issue, but whether an unexpected toxin is produced by the co-vaporisation of nicotine with its glycol-based flavour-containing solvent. So, how can the e-cigarette manufacturer (or importer) assure the consumer that their e-cigarettes are safe to use in the longer term? I'm not sure they can yet.

    This is why I believe that the way in which the issue has been addressed in the Tobacco Directive 2014/40/EU is a sensible compromise. The 20mg/ml nicotine concentration limit applies only to consumer e-cigarettes. Manufacturers who want to put higher strength products on the market are free to do so (or so I understand from the wording in the Tobacco Products Directive), so long as they comply instead with the requirements of the Medical Devices Directive 93/42/EEC or the Medicinal Products Directive 2001/83/EC. And what is the difference between the three options? Perhaps only the paperwork burden as regards the size of the dossier of evidence needed to demonstrate the safety of the product. But in each case, there is an unavoidable requirement for the manufacturer / importer to satisfy the appropriate government competent authority of the safety of the product, and to accept full legal responsibility for quality and safety. Would Clive Bates want anything less, I wonder?

    I'm not sure that a judicial review challenging the alleged procedural "behind closed doors" issues will serve any purpose. I do not know how the judicial review process works at the European level, but if it mirrors the process at the national level, then all that might be achieved is that the regulators will be asked to revisit the decision-making process. It does not follow that the decision they originally made will necessarily have to change.

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  • There isn't serious dispute that vapour products are much less risky than cigarettes. There is no need for 'probably'. The physics and chemistry of vapour and cigarette smoke are are sufficient to know that. Expert attention is focussed on where in the range 95-100% the risk reduction lies. By suggesting a doubt, you would be misleading people into believing they could be indifferent to risk between smoking and e-cigarette use. I hope no-one in a pharmacy gives out that sort of advice. There is a disreputable history of antagonists to harm reduction approaches using residual uncertainties to exaggerate what is unknown - hoping to scare people into complete abstinence. That is deeply unethical.

    Nicotine is not harmful in the doses experienced as either a smoker or a vaper - though it is the addicting agent. I can't say much more than that. If there are hazards in vapour, it will be thermal breakdown products of excipients or flavourings. So far these have not been found at levels that give any material concern. I cited Igor (2014) above on this - it's worth a read.

    The General Product Safety Directive would apply as you say, but the framework of consumer protection law allows for products specific standards to be set. Alternatively, a directive could itself establish standards without resorting to classifying products as tobacco or medicines when they are neither - for example, there is regulation specific to cosmetics. If Article 20 of the directive is struck down in court, then the opportunity to do this arises again. I support mandatory standards: e.g. use of pharmaceutical grade nicotine and excipients, banning known respiratory sensitisers, electrical safety, child resistant proof containers, sensible labelling - and the products should be and do as they are described (another principle of standard consumer protection law)

    There's nothing good or clever about the Tobacco Products Directive. It's main features are pointless or counterproductive, and it doesn't actually do useful things that should be done.

    The TPD limit of 20mg/ml for e-liquid strength is arbitrary and counter-productive and most vapour products are not medicinal and should not forced to be classified that way. These stronger liquids are used mostly by people first converting to vapour products, and most vulnerable to relapse, and by more dependent smokers. 25-30% of users make use of products above the threshold at present - with no problems. These are the people who most need readily available products in a wide variety of options. Deny them that by making the stronger liquids require medicine marketing authorisation and there will be fewer, less appealing and more expensive products - and possibly none. The result would be more smokers who don't switch and more relapse from vaping - a supposedly safer regime causing more harm. It wouldn't stop there - there would be a rise in DIY, home mixing and black market activity - all with higher risks than the status quo.

    The limit on container size serves no purpose but makes the products more annoying to use and so less attractive. Again we tilt the odds towards smoking. We don't generally control hazardous substances in the home by limiting bottle sizes to safe doses - imagine if that was done for bleach?

    The TPD ban on vapour product advertising is disproportionate. Most tobacco advertising is banned in the EU because tobacco kills 700,000 per year. Vapour products likely kill no-one and have a highly beneficial effect as an alternative to smoking. But bans on advertising protect incumbents (cigarettes) and favour those with extensive distribution channels (tobacco companies), while making it hard for new innovative products to capture users' attention. Again, good news for cigarette sales, not so good for health (or pharmacies).

    The TPD imposes a form of regulation and testing regime that will likely only the big companies to participate in the market. I say likely because the Commission is still working on the detail. It's very well suited to confining the products to commoditised high volume low diversity products, and very aversive to the products that are growing in popularity with the users.

    So if you want to shape the market to create an oligopoly for Big Tobacco and a few pharma companies willing to dip their toes in the water, then the TPD is a very well designed instrument for your purposes.

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  • I really hope that trends continue as they are going. We have made so much improvement since the 50's in regards to our views on smoking. Most people who smoke have tried to quit at least once and more and more are succeeding. The technologies that are available to us are a blessing for improving the health of millions. Some solutions, like electronic cigarettes, may not be meant for the long-term, but they can certainly help overcome immediate struggles.
    Helen | Vapoligy

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