Overview
5.1
A variety of approaches have been used to regulate electronic cigarettes (E‑cigarettes) internationally. These include regulating E‑cigarettes as: tobacco products, a unique product type, consumer goods, therapeutic goods, or using a combination of these approaches. Nicotine availability also varies between countries. In some countries, nicotine in E‑cigarettes is widely available, while other countries have classified it as a dangerous poison.
5.2
This chapter outlines international approaches to regulation; guidance provided by the World Health Organization (WHO); and examines the regulatory frameworks of the European Union (EU), the United Kingdom of Great Britain (UK), the United States of America (USA), Canada, and New Zealand.
5.3
The current regulatory framework for E‑cigarettes in Australia is also discussed, as well as potential areas of regulatory reform.
International Approaches to E-cigarette Regulation
World Health Organization
5.4
The WHO Framework Convention on Tobacco Control (FCTC) is a global public health treaty which entered into force on 27 February 2005, to which Australia is a Party.
5.5
The Department of Health described the aim of the FCTC as:
… to advance international cooperation to protect present and future generations from the preventable and devastating health, social, environmental and economic consequences of tobacco consumption and exposure to tobacco smoke.
5.6
In 2014, a decision was adopted by Parties to the FCTC regarding E‑cigarettes. The decision was described by the WHO as one that:
… acknowledges the need for regulations along the lines of policies concerning other tobacco products, including banning or restricting promotion, advertising and sponsorship of [E‑cigarettes].
5.7
The WHO’s advice was described by the Australian Self Medication Industry as having:
… encouraged a precautionary approach to E‑cigarettes in response to the lack of evidence of safety, the potential risks to users and non-users, the lack of evidence of effectiveness in smoking cessation, the concerns about use by children and non-smokers and the potential for undermining of tobacco control efforts.
5.8
The Government of Western Australia and the Cancer Council Australia and the National Heart Foundation of Australia (CCA and NHFA) referenced a section of the WHO’s guidance on E‑cigarettes which cautioned against the introduction of E‑cigarettes in countries with low smoking rates. The passage states:
Governments should consider that if their country has already achieved a very low prevalence of smoking and that prevalence continues to decrease steadily, use of [E-cigarettes] will not significantly decrease smoking‑attributable disease and mortality even if the full theoretical risk reduction potential of [E‑cigarettes] were to be realised.
5.9
The Government of Western Australia highlighted the relevance of this section in relation to Australia ‘having among the lowest smoking rates in the world.’ Further, the Department of Health advised that ‘the Conference of the Parties to the WHO FCTC has repeatedly invited Parties to the Convention to consider regulating and/or prohibiting [nicotine and non‑nicotine E‑cigarettes].
5.10
Associate Professor Colin Mendelsohn stated that the WHO’s report on E‑cigarettes had been ‘harshly critiqued by the UK Centre for Tobacco and Alcohol Studies’, particularly for disregarding the ‘potential [for E‑cigarettes] to reduce consumption of smoked tobacco’, as well as ‘factual errors and misinterpretations’ and a lack of transparency.
5.11
British American Tobacco Australia quoted a section of the WHO’s advice which highlighted the potential for E‑cigarettes to help some people quit smoking. This section of the WHO’s advice stated:
If the great majority of tobacco smokers who are unable or unwilling to quit would switch without delay to using an alternative source of nicotine with lower health risks, and eventually stop using it, this would represent a significant contemporary public health achievement.
National and Regional Approaches
5.12
Associate Professor Mendelsohn advised that countries have classified E‑cigarettes in different ways in order to regulate them. These include:
Creating a new regulatory classification for E‑cigarettes (55 countries);
Classification as a tobacco product (42 countries);
Classification as a medicinal product (22 countries);
Classification as a poison (4 countries); and
Using multiple classification systems (16 countries).
5.13
Associate Professor Mendelsohn stated that the sale of all types of E‑cigarettes is banned in 27 countries. The Department of Health advised that this includes: Brazil, Singapore, Uruguay, Jordan, Oman and Qatar. The CCA and NHFA stated that the sale of nicotine E‑cigarettes is banned in nine countries: Australia, Canada, Costa Rica, Jamaica, Japan, Malaysia, Mexico, New Zealand and Switzerland. Associate Professor Coral Gartner and Professor Wayne Hall advised, however, that Canada is in the process of implementing regulatory changes.
European Union and the United Kingdom
5.14
In the EU, E‑cigarettes are regulated as consumer products under the Tobacco Products Directive (TPD). Public Health England outlined requirements regarding E‑cigarettes under the TPD and stated:
All [E-cigarette consumer] products must be notified to a common notification system, with a maximum nicotine concentration, leak proof/tamper proof containers, on-pack health warnings, quality standards for ingredients and the removal of products that do not comply … Each Member State is required to nominate a “competent authority” to oversee the national notification process.
5.15
The TPD also prohibits most forms of advertising for E‑cigarettes. Counterfactual Consulting stated that the TPD ‘has been extensively criticised for its arbitrary standards, bureaucratic burdens for which no clear purpose exists, and excessive restrictions on advertising and trade.’
5.16
The All‑Party Parliamentary Group for E‑cigarettes in the UK Parliament (All-Party Group) explained that the maximum nicotine concentration level for E‑liquid introduced under the TPD may be ‘insufficient to satisfy the cravings of nicotine from somebody using a high‑tar cigarette.’ The All‑Party Group further stated that this limit may encourage people who ‘want something stronger’ to purchase it from an unregulated supplier.
5.17
The UK adheres to the TPD through its Tobacco Related Products Regulations 2016. Under the UK’s system, nicotine and non-nicotine E-cigarettes can legally be bought and sold. E‑cigarettes can be classified as either consumer goods or therapeutic goods, although no E‑cigarette has been approved as a therapeutic good to date.
5.18
The UK Vaping Industry Association stated that the Westminster Government has also started to ‘actively promote vaping as a tool to stop smoking.’ The UK Department of Health’s ‘Tobacco Control Plan for England’ stated that:
The best thing a smoker can do for their health is to quit smoking. However, the evidence is increasingly clear that E-cigarettes are significantly less harmful to health than smoking tobacco. The government will seek to support consumers in stopping smoking and adopting the use of less harmful nicotine products.
5.19
Public Health England advised that it had recently highlighted E‑cigarettes as smoking cessation devices for the ‘Stoptober’ campaign, which encourages smokers to quit smoking in the month of October.
North America
5.20
In Canada, nicotine E‑cigarettes are regulated as medicines, while non‑nicotine E‑cigarettes that do not make health claims are unregulated. The Government of Canada has introduced legislative amendments that will regulate the sale of E‑cigarettes as consumer goods, and classify them as separate from tobacco products. Regulations under this proposal include prohibiting the sale of E‑cigarettes to minors and in vending machines, restrictions on advertising, and quality standards for products. Any E‑cigarette product that makes a therapeutic claim would continue to be regulated separately as a medicine.
5.21
In the USA, the Food and Drug Administration (FDA) regulates E‑cigarettes as tobacco products. The Royal Australasian College of Physicians (RACP) summarised the regulatory arrangements in the USA by stating:
… E‑cigarettes with nicotine are regulated in the same way as traditional tobacco products, including their manufacture, import, packaging, labelling, advertising, promotion, sale, and supply. All [E‑cigarettes with nicotine] have to undergo the FDA’s review and evaluation, including their ingredients, product features, health risks and their attractiveness to minors and non-users. The regulations also prohibit the sale of nicotine containing E‑cigarettes to minors in person or online, require health warnings on product packages and in advertisements, and ban their sale in vending machines.
5.22
Philip Morris advised that the FDA application process for E‑cigarette liquids and devices can range from over $100 000 to over $2 million. Philip Morris stated that ‘such an approach tends to favour products currently on the market - notably, combustible tobacco products - over disruptive technologies.’
New Zealand
5.23
From 18 to 20 December 2017, the Committee undertook a delegation to inquire into the development of E‑cigarette policy in New Zealand. The delegation met with representatives of the New Zealand Government, the New Zealand Parliament, public health bodies, and academics.
5.24
New Zealand currently has regulatory arrangements in place which are similar to that of Australia, with nicotine E‑cigarettes unable to be legally sold. New Zealand’s current legislation, however, is considered to have loopholes that make enforcement of this prohibition difficult.
5.25
In 2017, the New Zealand Government announced a decision to amend the Smoke-free Environments Act 1990 in order to legalise the sale of nicotine E‑cigarettes and E-liquids as consumer products.
5.26
The proposed changes would prohibit the sale of E‑cigarettes to people under 18 years of age and prohibit sale via vending machines. Retailers would be permitted to have marketing displays at point-of-sale locations with more extensive marketing permitted in shops restricted to people over the age of 18 years. Broader advertising in the media, on billboards, and on the internet would, however, be prohibited. Vaping would also be prohibited in all smoke-free areas.
5.27
New Zealand’s proposed regulatory framework would be likely to operate using a notification system where E‑cigarette importers inform the government of the products and ingredients imported. New Zealand’s framework would also be designed to be flexible enough so that particular ingredients could be banned if they were found to have negative health impacts.
5.28
Following the New Zealand election on 23 September 2017 there was a change of government in New Zealand. The new government is yet to announce its position on the proposal to legalise the sale of E‑cigarettes in New Zealand.
Populations with High Smoking Rates
5.29
While the smoking rate across the total New Zealand population is relatively low at 15.7 per cent, there are particularly high levels of smoking within particular demographics. Specifically, 35 per cent of Māori adults and 24 per cent of Pacific adults smoke, while adults living in socio‑economically deprived areas are three times more likely to smoke than other New Zealanders.
5.30
In New Zealand, traditional tobacco control approaches no longer appear to be reducing smoking rates among the above mentioned demographics and there is a hope that E‑cigarettes may offer a new tool to encourage these smokers to quit.
5.31
One group of particular concern is young Māori women. Currently 42.7 per cent of Māori women aged 18 to 24 smoke daily. Stakeholders suggested that many of these women valued the time spent smoking as a moment of respite from the daily pressures of life or as an opportunity to talk and bond with other women. Further, these stakeholders suggested that E‑cigarettes could offer an alternative to tobacco that allows these women to retain the psychological and social benefits they gain from the time spent smoking.
5.32
In addition, there was a perception that many quit smoking options used a medical approach that treated smokers as patients and that this was not appealing to some members of the Māori population. E‑cigarettes may offer a more self‑directed treatment option that could be more suitable.
Attitudes to E‑cigarettes in the Public Health Community
5.33
In comparison with Australia, the approach to tobacco control in New Zealand has focussed less on mass media campaigns and more heavily emphasised the use of pharmaceutical aids for smoking cessation. This may have resulted in public health groups in New Zealand being more receptive (than their Australian counterparts) to the potential use of E‑cigarettes as a smoking cessation aid or tobacco substitute.
5.34
When the proposal to legalise the sale of nicotine E‑cigarettes was first announced in New Zealand, it was broadly, but not universally, supported by the public health community. In the last few years many public health bodies and tobacco control researchers have moved from initial scepticism to a growing acceptance that there could be a role for E‑cigarettes within a tobacco control framework.
5.35
Nevertheless, many of New Zealand’s public health groups and tobacco control researchers remain cautious regarding how E‑cigarettes should be used within tobacco control. In New Zealand, E‑cigarettes are considered to offer potential benefits only for smokers who have unsuccessfully tried to quit using other methods and within populations with high smoking rates. One view was that, from an ethical perspective, health professionals should at least be able to offer E‑cigarettes as a potential cessation aid to those smokers who had been unable to quit using traditional methods.
5.36
There remains, in New Zealand, a concern about the potential for E‑cigarettes to appeal to young people. New Zealand’s public health professionals believe that if E‑cigarettes are legalised, this should be accompanied by strong messages emphasising that, while safer than tobacco smoking, E‑cigarettes are still not safe.
5.37
Another key concern for the public health community was the potential presence of the tobacco industry within a legal E‑cigarette industry. Currently, the tobacco industry is not involved in the E‑cigarette industry in New Zealand but this would most likely change if nicotine E‑cigarettes became legal. There was a concern that E‑cigarettes could be being used by the tobacco industry as a ‘stalking horse’ to make the introduction of Heat‑not‑Burn cigarettes more politically acceptable.
5.38
There is also debate in New Zealand about where E‑cigarettes should be sold. Many stakeholders were supportive of vaping stores being the primary sales outlet, as staff in these stores had the knowledge to assist customers to choose a product that would suit their needs. Concerns were raised, however, that vaping stores often sold other drug paraphernalia and that they did not have a good compliance record in regard to the sale of these products. An alternative view was that E‑cigarettes could be sold at pharmacies but there was a concern that staff would lack the necessary working knowledge to assist customers. In addition, having pharmacists selling E‑cigarettes could create the impression that E‑cigarettes are a health enhancing product. This could contradict the message that, while safer than smoking, E‑cigarettes are still not safe.
International Comparisons with Australia
5.39
The Australian Drug Law Reform Foundation (ADLRF) considered that Australia’s regulation of E‑cigarettes is out of step with many international approaches. The ADLRF stated that:
… Australia does have a much more unfriendly environment for people who want to switch to vaping than all of the countries that we like to compare ourselves with. So that is UK, New Zealand, Canada and the [USA]. More countries are moving in that direction … I think Australia is going to be more and more isolated.
5.40
The Department of Health considered that decisions of other countries do not necessarily mean Australia should go down the same path, and stated that:
While it is true that nicotine is available for use in E-cigarettes in a number of overseas jurisdictions, the department is of the view that this alone does not justify widespread access to nicotine for use in E-cigarettes in Australia, nor should this situation be seen to inhibit further substantial progress in tobacco control in Australia.
Regulatory Approaches in Australia
Current Regulatory Arrangements in Australia
5.41
In Australia, the regulation of E‑cigarettes and nicotine is a shared responsibility between the Federal Government and the states and territories. The Department of Health described the current regulatory arrangements in Australia and stated:
In Australia, the current regulatory framework draws on existing regulation of tobacco products, poisons, therapeutic goods and consumer goods, however there remains significant variation between states and territories in their regulatory approaches to E-cigarettes.
5.42
Nicotine is classified as a dangerous poison under Schedule 7 of the Poisons Standard. Schedule 7 provides an exemption for the use of nicotine in nicotine replacement therapies, tobacco smoking and for veterinary purposes. All Australian jurisdictions have implemented legislation consistent with Schedule 7, and as such the commercial supply of nicotine for use in E‑cigarettes is currently prohibited. Current regulatory state and territory frameworks for the use of E‑cigarettes and the sale and marketing of non‑nicotine E‑cigarettes appear in Table 5.1.
5.43
The Department of Health advised that, while states and territories ‘have the legislative ability to make individual variations’, it is rare for them to depart from the TGA’s federal scheduling system — although Victoria has done this in relation to medicinal cannabis. The Department of Health also advised that variations to the national scheduling would be contrary to the Council of Australian Governments agreement to adopt all scheduling decisions.
Table 5.1: State and Territory Regulation of E-cigarettes
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Qld, Vic, the ACT and Tas
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E-cigarettes are subject to similar restrictions as conventional tobacco cigarettes, including: restrictions on sales to minors, use in smoke-free areas, advertising, and sales.
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NSW
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Regulations regarding E-cigarettes include: restrictions on sales to minors, advertising and sales.
E-cigarettes can be used in smoke free areas, including indoors, unless an individual establishment or workplace chooses to ban it. The NSW Government has introduced a Bill to prohibit the use of E-cigarettes in areas which are smoke-free areas for tobacco products.
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SA
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Currently, the sale of products that resemble tobacco products is prohibited. The South Australian Parliament is currently considering legislation that proposes to treat E-cigarettes in a similar way to conventional tobacco cigarettes, including: prohibiting sale to minors and use in smoke-free areas, advertising and sales restrictions.
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WA
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The sale of products that resemble tobacco products, including E‑cigarettes, is an offence.
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NT
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E-cigarettes can be used anywhere in the NT, unless there are signs prohibiting their use. The NT Government is considering regulations about E‑cigarettes.
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5.44
The Thoracic Society of Australia and New Zealand and the Lung Foundation Australia (TSANZ and LFA) described the existing federal, state and territory regulatory arrangements as ‘confusing’ and ‘complex.’ The Australian Competition and Consumer Commission (ACCC) highlighted the risks associated with current regulatory arrangements and stated:
Cumulatively, the [E‑cigarette regulatory] framework is not consistent nationally and nor is it uniformly enforced. As a result, a number of emerging safety hazards associated with E‑cigarettes and nicotine E‑liquid may need to be addressed.
5.45
The RACP advised that a nationally consistent framework for E‑cigarettes is needed:
The RACP is of the view that developing a national E-cigarette policy framework is crucial. It will not only allow for a clear set of shared objectives to be set, but also support consistency and coherence in implementing effective policy measures across Australia for the benefits of all Australians regardless of where they live and how they travel across state borders.
5.46
The Tasmanian Government recommended the development of agreed principles to guide discussion around a national regulatory framework. The Tasmanian Government recommended the consideration of issues including: the need for evidence based policy, use of the precautionary principle, the need to protect public health gains, legal clarity for the public, and that any changes complement state laws. The Department of Health expressed similar sentiments, and stated that any national regulatory policy for E‑cigarettes should:
be precautionary in nature, as well as flexible and responsive to change in light of new evidence in relation to the potential short and long term harms associated with E-cigarettes;
be proportionate to the level of risks and potential benefits that E‑cigarettes may pose to population health;
protect the Australian community from any potential health risks associated with the short and long term use of E-cigarettes; and
not undermine Australia’s efforts to reduce smoking prevalence or impede the de-normalisation of smoking in Australia.
‘Black Market’
5.47
Many E‑cigarette users order nicotine online and import it unlawfully. In addition, it was suggested that some vaping stores in Australia sell under the counter liquid nicotine. One participant described these methods of obtaining liquid nicotine for personal use as an ‘open secret’ and that the lack of regulation of ingredients in E‑liquids was potentially dangerous.
5.48
The Peregrine Corporation called on the government to enforce existing regulations to combat the ‘illicit trade’ of nicotine for E‑cigarettes. The ACCC expressed similar sentiments and recommended that states and territories consistently enforce poisons laws, and the federal government consider any import controls that could ‘assist in the reduction of the illicit trade of nicotine E‑liquids.’
Regulating E-Cigarettes as a Therapeutic Good
5.49
In Australia, all therapeutic goods must be approved by the TGA before they can be sold. This includes products that claim to help people to quit smoking. Currently, no E‑cigarette has been approved as a therapeutic good by the TGA.
5.50
Emeritus Professor Simon Chapman, Professor Mike Daube, David Bareham, and Associate Professor Matthew Peters (Emeritus Professor Chapman) recommended that E‑cigarettes remain under the remit of the TGA because ‘a core part of the case being put forward for the benefits of [E-cigarettes] is based on a therapeutic claim (efficacy in smoking cessation)’. Emeritus Professor Chapman stated that the TGA is ‘vastly experienced in assessing therapeutic product safety.’
5.51
The TSANZ similarly stated that ‘the only potential benefit [of an E‑cigarette] in the literature, although unproven, is as a smoking cessation device, which makes it a therapeutic good.’
TGA Application Process
5.52
Counterfactual Consulting advised that the regulation of E‑cigarettes as a therapeutic good ‘functions as a de facto ban,’ as ‘no vaping products have been approved by a medicines regulator and brought to market in any country.’ Associate Professor Mendelsohn agreed and added that the TGA application process for products is ‘onerous and expensive’, which could ‘delay innovation’ and ‘be a huge barrier to entry’ for new products. Associate Professor Mendelsohn also stated that the cost associated with the therapeutic model could make E‑cigarettes more expensive for consumers.
5.53
The TSANZ agreed that the TGA process is an ‘expensive undertaking’, but that this was necessary ‘to ensure the equipment and ingredients are manufactured and sold to the standard required to protect the lungs of Australians using them.’
5.54
In contrast, the Department of Health suggested that the costs were not overly prohibitive for manufacturers. The Department of Health stated:
… a smoking cessation product could be available over the counter or … [as] a prescription medicine. If it is an over-the-counter medicine, for example, the maximum application registration fee is $27 000; the annual one is $1430 a year … it is difficult to see how that would be a major impost on some of the significant multinational companies involved in this area. Even as a prescription medicine … it's a one-off cost of about $240 000 and then I think it is $3230 [annually] — again, hardly onerous for a company that is expecting to have a major market presence.
5.55
Associate Professor Coral Gartner and Professor Wayne Hall explained that there are additional costs of a therapeutic good application and stated:
… the TGA application fee is only a small proportion of the total costs of making an application. Other costs include running clinical trials to provide data on efficacy, certification of manufacturing at [Good Manufacturing Practice] standards, pharmacovigilance monitoring and regulatory consultant fees in preparing an application. These are not costs required to market tobacco cigarettes in Australia.
Personal Importation Scheme
5.56
In some cases, nicotine for E‑cigarettes can be legally imported under the TGA’s Personal Importation Scheme. A person may be able to import nicotine for E‑cigarettes under the Personal Importation Scheme if:
they have a valid prescription from a general practitioner (GP);
no more than three months’ supply for personal use is imported at one time; and
they do not import more than 15 months’ supply within 12 months.
5.57
The Department of Health advised that states and territories may have additional requirements that prohibit the use of nicotine E-cigarettes even with a prescription. The Queensland Department of Health stated that:
Specifically, it is an offence for a person to manufacture, obtain, possess, prescribe, dispense, sell, advertise, use or destroy nicotine, unless the person is specifically authorised or holds an approval under the Health (Drugs and Poisons) Regulation 1996. This includes importing electronic cigarettes containing nicotine for personal or therapeutic use even with a prescription from a medical practitioner.
5.58
Associate Professor Mendelsohn stated that as the TGA and the National Health and Medical Research Council have not endorsed the use of E‑cigarettes for quitting smoking, GPs generally do not provide prescriptions. As such, it was estimated that the vast majority of people using liquid nicotine for E‑cigarettes do not have prescriptions and are importing it illegally.
5.59
The Royal Australian College of General Practitioners (RACGP) also commented that the paperwork GPs need to fill out to provide a prescription for nicotine is ‘quite onerous’. The RACGP further stated that this process may ‘make it extremely difficult for people who want to get access to some form of nicotine.’
5.60
The New Nicotine Alliance Australia (NNAA) stated that E-cigarettes should be ‘at least as available or more available than cigarettes.’ The NNAA therefore did not support making it necessary to have a prescription to access E‑cigarettes. The Australian Taxpayers’ Alliance (ATA) agreed, and outlined the following scenario:
… [smokers] can go to their local servo and buy a packet of cigarettes. If they're trying to quit [using E‑cigarettes on prescription], they think: 'Oh, I've run out! I need to schedule an [appointment] with my doctor, go to visit the doctor, see the doctor, pay for the doctor if they're not bulk billing, then go to the pharmacy and hope the pharmacy is … open, because it might be out of hours.' If we are trying to stop people from smoking, giving them so many hoops to go through just to buy something doesn't really work.
5.61
In addition to the Personal Importation Scheme, other avenues to access unapproved therapeutic goods include the Special Access Scheme and Authorised Prescriber Scheme. The Department of Health stated that:
Under these Schemes, medical practitioners are required to apply to access the unapproved therapeutic good on behalf of their patient(s), and they are required to formally prescribe them to the patient/s. While these schemes may be used to import unapproved therapeutic goods into Australia, they are intended … to enable access to products only in cases when suitable TGA‑approved alternatives that achieve the same therapeutic purpose are not available on the Australian market.
Other Considerations
5.62
Counterfactual Consulting considered E-cigarettes to be ‘unsuited’ to a therapeutic regulatory model, as they are ‘designed to replace an existing but much more harmful consumer nicotine product, combustible cigarettes, and fit in the same place in the market and consumer psychology.’ Using the analogy of diet cola to illustrate this point, Counterfactual Consulting advised that ‘if it was only possible to place diet cola on the market if it was approved as an anti-obesity drug, then there would be few if any diet cola options.’
5.63
Associate Professor Coral Gartner and Professor Wayne Hall highlighted the potential consequences of regulating E-cigarettes as a therapeutic good while ‘a much more harmful consumer product —tobacco cigarettes —continues to be sold without similar restrictions.’
5.64
In contrast, the Department of Health stated that ‘the current availability of conventional tobacco products, which we all know is an anomaly of history, does not provide a reasonable basis to expose the public to other harmful substances and products.’
5.65
Associate Professor Mendelsohn suggested that E‑cigarettes could be regulated as both consumer and therapeutic goods, which is currently the system in the UK. Professor Mendelsohn stated:
… there is the option of allowing a therapeutic pathway as well [as a consumer pathway] ... some countries like New Zealand and the UK mostly allocate products as consumer products, if they do not make a therapeutic claim, but they also have a therapeutic pathway. If a company like [British American Tobacco] wants to promote a product as a cessation aid, then they can go down that pathway.
Regulating E-cigarettes as Consumer Goods
5.66
Another option for the regulation of E‑cigarettes is to classify them as consumer goods. Associate Professor Mendelsohn explained that ‘the first essential step’ in developing an appropriate regulatory framework is ‘to exempt low-concentrations of nicotine from Schedule 7 [of the Poisons Standard] … so that it may be available for use with an E-cigarette for tobacco harm reduction.’ British American Tobacco Australia explained that amending the Poisons Standard in this way will mean that nicotine for E‑cigarettes will no longer be overseen by the TGA but by the ACCC under Australian Consumer Law.
5.67
In 2016, the TGA received an application from a member of the public to exempt nicotine from Schedule 7 for use in low concentrations in E‑cigarettes ‘for the purpose of tobacco harm reduction.’ In March 2017, the TGA decided that ‘the current scheduling of nicotine remains appropriate.’
5.68
The Australian Retailers Association recommended E‑cigarettes be regulated as consumer goods, and stated that the legalisation of nicotine E‑cigarettes provides ‘greater choice to consumers and allows retailers to sell a harm reduction product whilst also replacing revenue from the traditional [tobacco cigarette] product.’ The ADLRF also stated that regulating E‑cigarettes as consumer goods may encourage competition and drive innovation, as a greater diversity of products will be able to come into the market.
5.69
Counterfactual Consulting supported a consumer good framework, stating that ‘vapour technologies are consumer products rather than medicines.’ The NNAA expressed similar sentiments, stating that using a therapeutic model of regulation ‘medicalises’ E‑cigarettes, and that ‘most smokers switching to vaping do not see themselves as sick’.
5.70
Dr Neil McKeganey from the Centre for Substance Use Research agreed and stated a consumer model could be used to provide access to E‑cigarettes for smokers, while also deterring young people:
… [A] regulatory model which would provide smokers with much easier access to these devices would be to regulate them as consumer products —though subjecting them to appropriate consumer regulatory requirements in terms of manufacturing standards, chemical constituents, age verification, etc. Through existing and if necessary enhanced consumer regulation … it would be possible to maximise adult’s access to this technology whilst reducing young peoples’ access to the technology.
5.71
Conversely, the TSANZ and LFA cautioned against the regulation of E‑cigarettes as consumer products. They instead recommended E‑cigarettes be prohibited altogether, unless they are found to have therapeutic benefits and would consequently be classified as a therapeutic good.
5.72
VicHealth also advised against the regulation of E‑cigarettes as anything other than therapeutic goods (and only to be sold as therapeutic goods following TGA approval). VicHealth explained:
There are no health benefits to promoting nicotine products, including [E‑cigarettes], to non-smokers and ex‑smokers. Indeed, there is potential for harm to non-smokers and ex‑smokers by indirectly encouraging uptake of nicotine products and/or smoking.
5.73
The CCA and NHFA similarly stated:
… the lobbying from commercial interests, including tobacco companies, for mass-market E-cigarette availability in Australia and a sidestepping of established poison controls, medical research and therapeutic goods authorities, is itself another example of aggressive E-cigarette marketing to drive take-up rather than confer a health benefit.
Other Regulatory Issues
5.74
Regulatory requirements for E‑cigarettes that have been used in Australia and/or overseas include:
Restrictions on sale, such as prohibitions on the use of nicotine;
Minimum age restrictions for use;
Restrictions or prohibition of advertising, promotion and sponsorship;
Packaging requirements, such as health warnings, child safety packaging and lists of ingredients, emissions and concentration levels;
Product standards for liquid and devices, such as prohibition of certain ingredients or limits on nicotine concentration;
Reporting requirements, such as requiring e‑cigarette manufacturers to notify health authorities of their intention to bring a product to market;
Restrictions on places of use, such as in public places or in a vehicle with a minor present.
5.75
The Public Health Association of Australia (PHAA) considered that the restrictions that apply to conventional cigarettes, such as plain packaging and a ban on smoking in public places such as restaurants and pubs, should apply to E‑cigarettes. The PHAA stated that these restrictions would guard against the renormalisation of smoking.
5.76
In contrast, Philip Morris and British American Tobacco Australia stated that E‑cigarettes should have different rules to tobacco cigarettes to encourage people to switch. Philip Morris stated:
Non-combustible alternatives to cigarettes should be treated differently from combustible products, favouring the former and disfavouring the latter: different health warnings and packaging requirements; different rules for displaying the products and communicating about them with adult smokers; and different rules for where they can be used should apply to clearly distinguish them from cigarettes and encourage adult smokers to switch to them.
5.77
Japan Tobacco International advised that ‘governments and regulators should avoid excessive regulation that prevents adult consumers from choosing these products.’
5.78
The RACP recommended that ‘all states and territories that haven’t introduced laws specifically governing E‑cigarettes should be encouraged to impose some regulation to control their sale, display, advertising and promotion.’
Vaping in Public Places
5.79
Inquiry participants including VicHealth, the RACP and Emeritus Professor Chapman recommended that the use of E‑cigarettes be prohibited in smoke-free areas. The RACP stated that the prohibition of E‑cigarette use in smoke‑free areas would protect non-users from exposure to second-hand vapour. VicHealth added that it would also prevent the renormalisation of smoking. Emeritus Professor Chapman agreed and stated that the restriction would help prevent former smokers from being triggered into relapsing, and also protect bystanders from a potential explosion of an E‑cigarette device. The TSANZ and LFA recommended restrictions be put in place to discourage use among young people, such as banning the use of E‑cigarettes in cars with minors present, indoors, and places where children are likely to be (such as playgrounds).
5.80
Counterfactual Consulting stated that ‘the evidence suggests that E‑cigarettes cause no material risk to bystanders.’ As such, Counterfactual Consulting recommended that:
… the appropriate policy is to allow owners and operators to decide their policy and make informed judgements, including the welfare value to vapers and smokers and make clear whether vaping is permitted or not. The role of the government should be limited to providing guidance to assist in making such decisions, an approach that has been adopted in England.
5.81
The Royal Australian and New Zealand College of Psychiatrists (RANZCP) commented that there may be some benefits of using E‑cigarettes in some smoke-free places, such as mental health facilities. The RANZCP explained that:
… many mental health facilities are now smoke-free and there may be benefits in allowing the use of E-cigarettes and vaporisers in these settings. This may encourage patients to switch to these less harmful alternatives while reducing the conflicts which smoking bans can sometimes cause.
5.82
Philip Morris considered that people using E‑cigarettes should not be forced to use the same space as smokers. Instead, it recommended that ‘new spaces can be carved out for exclusive use of smoke-free products.’
Labelling and Packaging
5.83
The TSANZ and LFA recommended that, if E‑cigarettes are approved as therapeutic products, product labels should include detailed information about the E‑liquid content. The TSANZ and LFA recommended this information include:
All ingredients and concentrations … including specifying compounds used for flavouring, not just the common name of the flavour, (e.g. ‘apple flavouring’); and
A warning statement about the impact on health.
5.84
The TSANZ and LFA also recommended the use of ‘tamper-proof and kid-safe packaging.’
5.85
Japan Tobacco International recommended that E‑cigarette packaging include a leaflet with instructions for use, a statement as to whether the product contains nicotine, and contact details of the manufacturer or importer. Japan Tobacco International also listed elements that should not be included in the leaflet, including misleading statements about health effects and risks. Japan Tobacco International further recommended that the packaging include a list of ingredients and a warning to keep out of reach of children.
5.86
The Australian Self Medication Industry recommended the use of plain packaging (along with other restrictions) to ‘prevent the (re)glamorisation of smoking, especially among children.’ The Australian Vaping Advocacy, Trade and Research (AVATAR), in contrast, cautioned that plain packaging could lead to a ‘race to the bottom in terms of pricing’ of E‑liquid, and ‘you would just have incredibly cheap E‑liquid sold for $1.’
Regulating Marketing
5.87
Dr Becky Freeman advised that E‑cigarette advertising is currently found in Australian print media, retail outlets and online. The Australian Medical Association (AMA) observed that online marketing in particular is ‘sophisticated’ and ‘designed to entice young consumers.’ Dr Freeman added that ‘E‑cigarette ads often contain misleading information about health benefits and safety’. The AMA agreed and stated that it would ‘welcome moves to address the inappropriate advertising of E‑cigarettes as cessation aids.’
5.88
The ACCC advised that it had taken enforcement action against three E‑cigarette retailers ‘for making false and misleading representations that their products did not contain toxins and carcinogens contained in cigarettes when this was not the case.’ The ACCC further stated that these representations ‘had the potential to mislead consumers about the health effects of non-nicotine electronic cigarettes.’
5.89
The ACCC also advised that it had ‘identified low levels of compliance with the Australian Consumer Law (ACL)’ from the Australian online E‑cigarette industry. Reflecting this finding, the ACCC wrote to over 30 Australian E‑cigarette suppliers ‘reminding them of their obligations under the ACL.’ The TSANZ and LFA also expressed concern that ‘the wide and poorly regulated marketing of E-cigarettes will make smoking socially acceptable again and will undermine the smoke free legislation.’
5.90
The AMA explained how the advertising of E‑cigarettes differs from advertising for nicotine replacement therapies, such as nicotine gums, patches and inhalers:
The marketing of products such as nicotine replacement therapy is in stark contrast [to the marketing of E‑cigarettes]. These are not desirable consumer products. We do not see young people being compelled to improve their image by using nicotine replacement products.
5.91
Dr Freeman explained that research has shown that E‑cigarette advertisements may increase a person’s desire to try the products, and if advertisements show people vaping, they may also increase the urge to smoke tobacco cigarettes. The AMA and Dr Freeman both considered that advertising of E-cigarettes should be subject to the same restrictions applied to tobacco cigarettes.
5.92
The Australasian Association of Convenience Stores (AACS) explained that currently, E‑cigarettes are ‘hidden behind a cupboard door’ in shops, ‘so people do not know they are available to be sold.’ The AACS considered that E‑cigarette devices should be more easily accessible, and that information should be available in store about the positives and negatives of E‑cigarette use. The ATA agreed and stated that consumers need to be educated about the potential benefits of E‑cigarettes through advertising and other means, to encourage smokers to switch to vaping. The ATA concluded that therefore ‘advertising restrictions, hiding them with display bans and all those other things will be very counterproductive.’
5.93
In contrast, the CCA and NHFA stated that:
Arguments that vaping and its promotion should be exempted from advertising restrictions related to smoking are in our view fallacious, in light of the relationship between vaping and smoking, the involvement of the tobacco industry in seeking to maximise profits from both, and vaping as a precursor to smoking in young people.
5.94
VicHealth cautioned that E‑cigarettes should not be marketed in any way except as a therapeutic good (if approved). VicHealth stated:
There are no health benefits to promoting nicotine products, including [E‑cigarettes], to non-smokers and ex-smokers. Indeed, there is potential for harm to non-smokers and ex-smokers by indirectly encouraging uptake of nicotine products and/or smoking. If [E‑cigarettes] are approved for use as a smoking cessation aid, VicHealth strongly recommends that marketing is restricted for that purpose only.
5.95
Counterfactual Consulting advised that ‘the approach used to regulate the advertising of alcohol [in Australia] would provide a reasonable starting place’ for the regulation of E‑cigarette advertising.
5.96
Japan Tobacco International recommended Australia look to the UK Committee of Advertising Practice’s (CAP) guidance regarding the advertising of E‑cigarettes. Japan Tobacco International advised that this approach in the UK strikes ‘the right balance between allowing a responsible advertising of electronic cigarettes while preventing the targeting of minors and non‑smokers’.
5.97
The UK CAP guidance included an emphasis on socially responsible marketing; avoiding any association with tobacco; only using approved health claims; prohibition on the use of health professionals to advertise E‑cigarettes; factual information about nicotine and other ingredients; and prohibition of marketing to non‑smokers and young people.
Taxation
5.98
The RACP recommended E‑cigarettes be ‘subject to Australia’s excise tax, at a lower rate than that of tobacco cigarettes to discourage any E-cigarette users switching to tobacco cigarettes.’ Philip Morris agreed and added that taxation should also ‘encourage manufacturers to invest in research and development of smoke‑free alternatives to cigarettes.’
5.99
The RANZCP considered that any tax on E‑cigarettes should be minimal to ensure socioeconomically disadvantaged individuals, who are more likely to have a mental illness and more likely to smoke, can access E‑cigarette devices.
Sales and Product Safety
5.100
A number of inquiry participants discussed ways to enhance the safety of E‑cigarette liquids and devices. The RANZCP advised that E‑cigarette products should be subject to ‘strict regulations’ including:
Legislated maximum nicotine concentrations for E‑liquids; and
Requirements for the disclosure, testing and monitoring of E‑liquid composition.
5.101
Japan Tobacco International recommended that E‑cigarette manufacturers be required to report to authorities prior to bringing a new product to market. The reporting would include details of the manufacturer, a list of ingredients and their quantities, a list of the main constituents present in emissions, toxicological data, information on nicotine dosage and a description of product components and production processes.
5.102
Philip Morris made a similar point, and added that ‘an abbreviated process should be used where a product has already been approved by a trusted overseas regulator, an approach which has been adopted in New Zealand.’
5.103
The appropriate age limit for accessing E‑cigarettes was also discussed. Philip Morris and British American Tobacco Australia recommended that sales of E‑cigarettes be restricted to persons over 18 years of age. Associate Professor Mendelsohn stated that while this age limit was the most ‘politically acceptable’ option, two USA studies found that bans on E‑cigarette sales to adolescents in some states had led to ‘significantly increased adolescent smoking rates’. As such, Associate Professor Mendelsohn put forward the alternative of allowing ‘youth to purchase E‑cigarettes with the explicit permission of a parent, guardian or doctor.’
Concluding Comment
5.104
The Committee understands that Australia is a world leader on tobacco control and acknowledges the achievements that have been made in halving the rate of daily smokers over the last 25 years. Care should be taken to ensure this progress is not undermined.
International Regulatory Approaches
5.105
Countries around the world have taken a variety of approaches to regulating electronic cigarettes (E-cigarettes). Many of the countries Australia has close links with, such as Canada, the United Kingdom of Great Britain and the United States of America, have, or are in the process of implementing, a liberalised regulatory system for E-cigarettes.
5.106
New Zealand, like many countries, is currently in the process of developing its policy response to E-cigarettes. Many public health groups in New Zealand have adopted a different position on E-cigarettes than their Australian counterparts. These New Zealand groups support E-cigarettes having a role in tobacco control, especially as a cessation aid for people who have been unable to quit using other methods and among particular demographics with high smoking rates.
5.107
Nevertheless, the Committee agrees with the Department of Health that the actions of other countries are not a sufficient justification for Australia to legalise nicotine E-cigarettes. The Committee also acknowledges that the World Health Organization has encouraged caution in relation to E‑cigarettes, particularly for countries like Australia, which already have low smoking rates.
Regulation of E-cigarettes in Australia
5.108
The Committee notes there is an existing process for the consideration of nicotine replacement therapies through the Therapeutic Goods Administration (TGA). The Committee believes that this process is adequate for assessing any application for the sale of nicotine E-cigarettes, and the Committee does not recommended changes be made to the existing process.
5.109
State and territory regulation of non-nicotine E-cigarettes, and enforcement of these regulations, varies across Australia. The Committee heard from individuals who found it difficult to understand whether they could use E‑cigarettes in their state or territory, and what rules applied. The Committee considers that there is a need to ensure that these regulations are applied consistently across Australia.
5.110
The Committee heard evidence that the TGA’s Personal Importation Scheme enables some smokers to access nicotine E-cigarettes using a doctor’s prescription and that this could assist long term, heavy smokers to quit tobacco smoking. Despite this being an existing pathway for smokers to access nicotine E-cigarettes, it is not widely used. The Committee heard evidence that the regulatory paperwork that doctors must fill out so a patient can access this Scheme may be overly burdensome, and that rules regarding the application of this Scheme differ across states and territories.
5.111
In Chapter 3, the Committee outlined its concern that the ingredients and flavourings used in non-nicotine E-cigarettes may have negative health impacts, and that further research in this area is needed. The Committee further considers that any regulatory framework for non-nicotine E‑cigarettes should assess the ingredients used in E-cigarette liquid and their potential to cause harm.
5.112
The Committee received a large amount of evidence from a range of stakeholders as part of this inquiry. While the evidence presented was often conflicting, it was provided in good faith by people wanting to reduce the health burden created by tobacco cigarettes. Having considered this evidence, the Committee is of the view that the current regulatory arrangements for nicotine E-cigarettes remain appropriate. The Committee also considers that further research into the health impacts of E-cigarettes is needed.
5.113
The Committee recommends a national approach be taken to the regulation of non-nicotine electronic cigarettes.
5.114
The Committee recommends that the Therapeutic Goods Administration continues to oversee the classification of nicotine and relevant exemptions, and the assessment of any electronic cigarette product as a therapeutic good.
5.115
The Committee recommends that the Australian Government establish a regulatory process for assessing and, if necessary, restricting colourings and flavourings used in electronic cigarettes.
Mr Trent Zimmerman MP
Chair