Compulsory regulation of electronic cigarettes could spoil a safe substitute for smoking.
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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 journalAddiction[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 Dr 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 JournalURI: 20066415
