In 2003, the electronic cigarette (E‑cigarette) was developed by the Chinese pharmacist Hon Lik, who was struggling to quit smoking and wanted to develop a machine that could provide nicotine in a way that would mimic the ‘look, feel and hit of smoking.’ In 2004, the first commercial release of E‑cigarettes took place in China and, by 2007, E‑cigarettes had started to appear in the United Kingdom of Great Britain (UK).
E-cigarettes use battery power to heat a liquid (known as E‑liquid) and disperse an aerosol solution which is inhaled by the user. While technically an aerosol, the solution inhaled by the user is typically referred to as a vapour and this is the basis of the established terminology of E-cigarette use as ‘vaping’, and E‑cigarette users as ‘vapers’.
E-liquids may, but do not necessarily, contain nicotine. In addition, E‑liquids typically contain food flavouring, propylene glycol, and vegetable glycerine.
The first types of E‑cigarette to become commercially available are known as cigalikes, as they physically resemble tobacco cigarettes. Cigalikes are often disposable, or alternatively they may feature a disposable E-liquid cartridge. Cigalikes deliver relatively small amounts of nicotine to the user, in part due to many of the particles in the vapour being too large to be absorbed by the lungs.
Newer models of E‑cigarettes are generally larger and do not resemble cigarettes as closely. These E‑cigarettes are rechargeable and contain a tank that is designed to be refilled, enabling the vaper to experiment with different flavoured E‑liquids. Tank system E‑cigarettes have longer lasting batteries and deliver nicotine in smaller particles that can be better absorbed by the user. Some tank systems allow the user to make adjustments to the power delivered by the battery and the temperature used to heat the E‑liquid.
As of 2016, cigalikes were the most popular style of E‑cigarette in Russia and the United States of America (USA), while tank systems were the most popular type of E‑cigarette in the UK.
Initially, tobacco companies were not major players in the E‑cigarette industry. From 2012 onwards, however, tobacco companies began purchasing existing E‑cigarette companies or creating their own E‑cigarette brands. Today all major tobacco companies have investments in the E‑cigarette industry.
For example, the tobacco company Philip Morris recently advertised in a number of UK newspapers that its ‘New Year’s Resolution’ was to ‘give up cigarettes’ and stated that it had an ‘ambition to stop selling cigarettes in the UK’.
In addition, Philip Morris has stated that it is ‘committed to a smoke-free future where electronic cigarettes and personal vaporisers will replace cigarettes’.
Some public health agencies, however, cast doubt on the intentions behind this change of direction, with the Australian Medical Association (AMA) stating that in ‘developed countries where there is increasing regulation, the business model is to move to other ways to maintain and grow nicotine addiction.’
In addition, the Public Health Association of Australia stated that tobacco companies have shown little interest in selling E‑cigarettes in the developing world. Instead, the tobacco companies have increased their sales of tobacco cigarettes in those countries where there is limited regulation and people may not ‘understand the full dangers of tobacco’.
To date, tobacco company investment has primarily been in developing the cigalike style of E‑cigarette. In the UK, the refillable tank systems, which have the major share of the market, are predominantly produced by small to medium manufacturing companies.
The peak body for Australian E‑cigarette retailers, Australian Vaping Advocacy, Trade and Research (AVATAR), advised that there are no local manufacturers of E-cigarette devices in Australia and approximately 90 per cent of E‑cigarettes are imported from Europe, the USA, and China. In contrast, the majority of E‑liquid sold by AVATAR members was produced in Australia and AVATAR described making E‑liquid as ‘an easy process.’
In the UK, where E-cigarettes are legal, the industry grew from a value of £25 million in 2011 to £459 million in 2014. In 2016, the value of sales of E‑cigarettes globally was estimated to be $US6.5 billion.
Smoking Rates in Australia
In 2016, about three million Australians, or 14.9 per cent of the population over 14 years of age, were current tobacco smokers and 2.4 million Australians (12.2 per cent) smoked daily. Smoking rates in Australia have been on a ‘long term downward trend since 1991’ with the daily smoking rate halving between 1991 and 2016. Between 2013 and 2016, however, the daily smoking rate ‘only decreased slightly’ from 12.8 per cent to 12.2 per cent.
The decline in smoking rates has been driven by fewer people taking up smoking rather than existing smokers quitting. Due to this, the smoking population is ageing. Between 2001 and 2016 the proportion of daily smokers over the age of 40 years rose from 44 per cent to 57 per cent.
The Department of Health advised that, in 2011, smoking was estimated to be responsible for the death of almost 19 000 Australians. Smoking is also estimated to account for 22 per cent of the total cancer burden in Australia.
Until recently, smoking rates in the UK and the USA were significantly higher than in Australia, but in recent years the smoking rates in both countries have declined more rapidly than in Australia. In the USA, between 2010 and 2015, smoking rates dropped from 19.4 per cent to 15.1 per cent, while in the UK the rate dropped from 20 per cent in 2012 to 15.5 per cent in 2016.
Use of E-cigarettes
In its National Drug Strategy Household Survey 2016 the Australian Institute of Health and Welfare (AIHW) stated the ‘current use of E‑cigarettes was relatively low in the general population with only 1.2 per cent of people aged 14 or older reporting that they currently use E-cigarettes’.
The AIHW also stated that 31 per cent of smokers had tried E-cigarettes in their lifetime. Younger smokers were more likely than older smokers to have tried E-cigarettes with 49 per cent of smokers aged 18 to 24 having tried E‑cigarettes compared with 18.7 per cent of smokers aged 60 to 69.
A 2015-2016 study found that three per cent of the Queensland adult population were using E‑cigarettes and that 10 per cent of the adult population had tried them during their life.
Rates of E-cigarette use are higher in the UK than in Australia. In 2015, 5.4 per cent of the population of the UK were E-cigarette users. In 2017, among E-cigarette users in the UK, 52 per cent were ex‑smokers, 45 per cent were smokers and 3 per cent had never smoked tobacco. The proportion of vapers who are ex-smokers has risen consistently since 2014. E‑cigarette use among youth in the UK is lower than in the general population with 87.7 per cent of youth having never used an E‑cigarette and 2.6 per cent using E‑cigarettes more than monthly.
Guiding Principles – Harm Reduction and Precautionary Principle
The perspectives of many inquiry participants were informed by two key public health policy principles — harm reduction and the precautionary principle. Participants advocating for a continuation of current policy towards E-cigarettes tended to emphasise the precautionary principle, while participants advocating for greater availability of E-cigarettes tended to emphasise harm reduction principles.
The Thoracic Society of Australia and New Zealand and Lung Foundation Australia defined the precautionary principle by stating that ‘if there is a suspected risk of harm and the scientific information is lacking, such that there is an absence of scientific consensus, then the burden of proof that it is not harmful falls on those wanting to progress the issue.’
Participants advocating for the use of the precautionary principle for the regulation of E‑cigarettes highlighted the lack of long term evidence on the health impacts of E‑cigarettes. Emeritus Professor Simon Chapman, Professor Mike Daube, David Bareham, and Associate Professor Matthew Peters (Emeritus Professor Chapman) highlighted the risks of flavouring chemicals used in E-cigarettes, stating ‘our knowledge of the impact of long term inhalation, many times a day over many years, of vapour arising from the heating of these chemicals is in its infancy.’
The AMA added that ‘the longitudinal research that is required to establish safety will take time, but until more definitive evidence on safety becomes available the precautionary principle should be applied to these products.’
In contrast, Associate Professor Coral Gartner and Professor Wayne Hall suggested that this approach sets the threshold of acceptable risk too high. Associate Professor Gartner and Professor Hall suggested the acceptable level of risk is context dependent. Therefore, an acceptable risk of poisoning from tap water would be very low as people presume the water they drink will be safe. In contrast, smokers are already engaged in a very high risk activity and so would accept ‘some uncertainty about the absolute risk [of E‑cigarettes] given the known risks of smoking.’
Public Health England stated that personal opinions on whether E‑cigarettes should be available:
… [comes] down to one's attitude to the precautionary principle … rather than waiting 20 years to get definitive evidence, we have to make the best decision on the evidence that's available now, and that points us towards cautious use of E-cigarettes.
The Royal College of Physicians of London (RCPL) stated that, in 2007, it adopted harm reduction as part of its tobacco control policy. The RCPL described tobacco harm reduction approaches as being:
… predicated on the principle that smokers smoke primarily because they are addicted to nicotine; that nicotine addiction, of itself, is not a major health hazard and that the harms from smoking arise primarily from the many toxins in tobacco smoke; and hence that in addition to encouraging all smokers to quit if possible, tobacco control policies should encourage those who continue to smoke to switch to a less hazardous source of nicotine.
Professor Gerry Stimson illustrated the concept of harm reduction by providing the example of driving motor vehicles. Driving is an inherently risky activity but rather than prohibiting it, governments seek to reduce the risk of harm through road rules and safety regulations. Professor Stimson also suggested Australia had experienced public health benefits from using a harm reduction approach to other drug policy issues; for instance in the use of needle and syringe exchanges, safer injecting facilities, and the prescription of methadone.
Dr Alex Wodak stated that the introduction of harm reduction strategies in Australia has generally been accompanied by ‘acrimonious debate’. Dr Wodak suggested that opposition to harm reduction strategies was often based on the risk compensation hypothesis which suggests that if you lower the risk of an activity, then more people will undertake that activity. Dr Wodak suggested that ‘we should always look for the possibility of risk compensation but it rarely happens.’
Associate Professor Colin Mendelsohn described E‑cigarettes as meeting many of the criteria for an ‘ideal tobacco harm reduction product’. Associate Professor Mendelsohn stated that E‑cigarettes were able to deliver nicotine ‘without the vast majority of harmful constituents of tobacco smoke, and provide the behavioural and sensory aspects of the smoking ritual.’
The Department of Health stated that its regulatory response to E-cigarettes as outlined in the National Tobacco Strategy 2012-2018 (NTS) was based on the principles of harm minimisation which ‘includes the three pillars of demand reduction, supply reduction and harm reduction’. The Public Health Association of Australia (PHAA) emphasised the importance of the combination of these three principles and critiqued the idea that the increased availability of E‑cigarettes would minimise harm. The PHAA stated:
… this argument is based on highly selective use of the evidence, coupled with a fundamental misunderstanding of a comprehensive harm minimisation strategy. This includes not only harm reduction but also reduction in demand and supply—two elements that are explicitly rejected by many advocates of electronic cigarettes.
The Department of Health added that the effects of E‑cigarette availability on non-smokers should also be considered in relation to the potential for E‑cigarettes to minimise harm. The Department of Health stated:
… for nearly 90 per cent of the population that are not currently smoking, it is not a harm minimiser … to open a pathway that would start exposing them to nicotine. That’s not harm minimisation; it’s quite a harm increase.
Emeritus Professor Chapman referred to products, including asbestos filters and light or low tar cigarettes, as previous examples of products that have been marketed as reducing harm but were not subsequently shown to be less harmful. Emeritus Professor Chapman stated that ‘the long history of failure [of harm reducing products] and the consequences of again promoting false hopes must give all responsible authorities strong pause for consideration.’
The Department of Health suggested that E‑cigarettes create ‘a numbers game’ where governments must balance ‘the risk of people starting smoking versus [the] hope that a number will stop smoking at the other end of their life — adults versus teenagers and young adults’. The Department of Health added that due to this need to balance these competing concerns, the World Health Organization has advised against making E‑cigarettes available in countries with low rates of smoking.
Tobacco Control Policy in Australia
The Department of Health described Australia as a ‘global leader’ in tobacco control, and Public Health England stated that it has ‘huge respect for what [Australia has achieved] in the area of tobacco control in the past—things like plain packaging.’
The Department of Health stated that the Australian Government’s approach to tobacco control has a ‘strong evidence base’ and is undertaken in partnership with non-government health organisations. Key elements of Australia’s tobacco control policy include:
Regular, staged increases in the excise for tobacco products;
Education campaigns and programs;
Plain packaging for tobacco products;
Graphic health warnings on tobacco product labels;
Prohibiting tobacco advertising and promotion;
Providing support for smokers to quit.
Australia’s approach to tobacco control is outlined in the NTS, which sets out priority areas for action and was developed with the objective of ‘reducing the prevalence of smoking and its associated health, social and economic costs, and the inequalities it causes.’ The nine priority areas for action outlined in the NTS are:
Protect public health policy, including tobacco control policies, from tobacco industry interference;
Strengthen mass media campaigns to: motivate smokers to quit and recent quitters to remain quit; discourage uptake of smoking; and reshape social norms about smoking;
Continue to reduce the affordability of tobacco products;
Bolster and build on existing programs and partnerships to reduce smoking rates among Aboriginal and Torres Strait Islander people;
Strengthen efforts to reduce smoking among populations with a high prevalence of smoking;
Eliminate remaining advertising, promotion and sponsorship of tobacco products;
Consider further regulation of the contents, product disclosure and supply of tobacco products and alternative nicotine delivery systems;
Reduce exceptions to smoke-free workplaces, public places and other settings; [and]
Provide greater access to a range of evidence-based cessation services to support smokers to quit.
Regulation of E-cigarettes in Australia
In Australia, the regulation of E‑cigarettes ‘is a shared responsibility between the Commonwealth, state and territory governments’ and different regulations apply to nicotine and non-nicotine E‑cigarettes.
Nicotine E‑cigarettes are regulated through the Poisons Standard which classifies nicotine as a poison. The Poisons Standard is a legislative instrument under the Therapeutic Goods Act 1989 (Cwlth) and is ‘given legal effect … through relevant state and territory legislation’.
States and territories are able to make their own laws to determine the availability of poisons and medicines but, in the majority of cases, classify these substances in accordance with the Poisons Standard. In the case of nicotine, ‘the commercial supply of nicotine for use in E‑cigarettes is prohibited by legislation in all states and territories.’
There are exemptions in the Poisons Standard for the use of nicotine in tobacco; for veterinary purposes; and as a therapeutic good (such as in nicotine replacement therapies).
All products that claim to be able to assist people to quit smoking are considered therapeutic goods and must be authorised for use by the Therapeutic Goods Administration (TGA). The TGA stated that it is ‘unable to confirm or deny’ whether it has received any applications for an E‑cigarette product. To date the TGA has not approved any E‑cigarette product for use as a therapeutic good.
The TGA also oversees the Personal Importation Scheme which enables the importation of nicotine for personal use. People may legally import nicotine through the Personal Importation Scheme if they have a prescription from a general practitioner, are importing no more than a three month supply, and it is lawful in their state or territory (in Queensland, for instance, this is specifically prohibited).
E‑cigarettes that do not contain nicotine and do not make therapeutic claims (such as aiding people to quit smoking) are governed by the legislation and regulation of the states and territories. Currently there is significant variation in how non-nicotine E‑cigarettes are regulated in the states and territories. The sale of non-nicotine E‑cigarettes is legal in most states and territories but is prohibited in Western Australia; other regulations relating to where E‑cigarettes can be used and how they can be marketed differ between jurisdictions. The relevant regulations in each jurisdiction are considered in more detail in Chapter 5.
International Approaches to Regulation
The World Health Organization Framework Convention on Tobacco Control (FCTC), to which Australia is a Party, commits ‘nations to implementing a range of demand and supply-side tobacco control measures’.
In 2014, a FCTC report stated that in countries with very low rates of tobacco smoking, the use of E‑cigarettes will not result in reductions in the rates of disease and mortality caused by smoking. The Department of Health also advised that the ‘FCTC has repeatedly invited Parties to the Convention to consider regulating and/or prohibiting [E‑cigarettes]’.
The Department of Health stated that ‘there is currently no international consensus on the most appropriate regulatory framework for E‑cigarettes.’ Regulatory approaches to E‑cigarettes include regulating them as ‘tobacco products, poisons, medicines (including medical devices) and consumer products.’ Nicotine E‑cigarettes cannot be sold in nine countries and the sale of all E-cigarettes is prohibited in 27 countries.
In contrast, nicotine E‑cigarettes can be legally purchased in the European Union (EU), the UK, and the USA. In the EU and the UK, E‑cigarettes are regulated through the Tobacco Products Directive (TPD). The TPD: requires manufacturers to disclose information about the content of E‑liquids; requires E‑cigarette packaging to contain health warnings; places restrictions on E‑cigarette advertising; and limits the volume and concentration of nicotine available in E‑liquid solutions.
In the USA, nicotine E‑cigarettes are regulated as a tobacco product by the Food and Drug Administration (US FDA). The US FDA regulates the ‘manufacture, import, packaging, labelling, advertising, promotion, sale, and distribution of E‑cigarettes.’
The Governments of Canada and New Zealand have proposed legislative changes to regulate the sale of E‑cigarettes as consumer products. In both countries, E‑cigarette products that make therapeutic claims, such as being able to assist people to quit smoking, will be regulated as medicines.
Australia has a strong record as a global leader in the field of tobacco control and has often been at the forefront of implementing measures designed to reduce the appeal of smoking. This strong approach to tobacco control has made an important contribution to the significant decline in the number of smokers in Australia since the 1990s. Nevertheless, with approximately three million Australians still smoking, it is clear that more may be done.
Despite being a relatively new product, electronic cigarettes (E‑cigarettes) are already being used by a significant number of people. Just over one per cent of Australians are currently using E-cigarettes and over 30 per cent of smokers have tried an E‑cigarette at least once. In the United Kingdom of Great Britain, where nicotine E‑cigarettes are legally available, rates of E-cigarette use are higher with more than five per cent of the population currently using E‑cigarettes.
During the inquiry, there was substantial discussion about the appropriate use of the precautionary principle and harm reduction approach in public health policy. Both the precautionary principle and harm reduction approach have been used in the past to underpin decisions that have resulted in positive health outcomes.