Keywords

1 E-cigarette Regulations in Australia

It is not legal to sell e-cigarettes that contain nicotine as consumer products in Australia because nicotine (except in the form of cigarettes) was classified within the federal Poisons Standard in 2008. The Therapeutic Goods Administration (TGA), Australia’s national poisons and medicines regulatory agency, classifies substances into various schedules of the Poisons Standard, but state and territory governments enforce this standard via their own legislation. The Poisons Standard classified nicotine as a “dangerous poison” (Schedule 7). This prevents consumer access, unless an exemption applies (Australian Therapeutic Goods Association, 2018). The only such exemptions are for “tobacco prepared and packed for smoking” and preparations intended “for human therapeutic use” (Australian Therapeutic Goods Association, 2018). The latter are classified as “prescription only medicines” (Schedule 4) except for nicotine replacement therapy, such as nicotine patch, gum and lozenges. The TGA could approve an e-cigarette containing nicotine as a therapeutic good, if evidence was available from clinical trials of its effectiveness and safety (Bullen et al., 2013; Hajek et al., 2019; Walker et al., 2020), but no company has applied to do so and no e-cigarette has been approved for medical use.

Before 2012, nicotine replacement therapy products delivered by inhalation were classified as Schedule 2 medicines which allowed their over-the-counter sale in pharmacies. In response to concerns about e-cigarette use by youth, nicotine by inhalation was deleted from Schedule 2 (Gartner & Hall, 2015). One approved nicotine inhaler was exempted on the grounds that its site of absorption was oromucosal cavity rather than the lungs. After this change, a medical prescription was required to use nicotine e-cigarettes for smoking cessation. In October 2021, a scheduling change applied the Schedule 4 classification to all nicotine products for human use. This removed nicotine-containing e-cigarettes from Schedule 7 “Dangerous Poison” classification, but it still meant that smokers required a medical prescription to access them. This regulatory change also allows pharmacies to sell nicotine vaping products if they meet a product standard (TGO 110), and if a customer has a medical prescription. No other retailers are permitted to sell e-cigarettes that contain nicotine.

1.1 Policy Variations Between States

Because Australia is a Federation of six states and two territories, the regulation of e-cigarettes is a patchwork of federal and state/territory laws that regulate drugs and poisons, therapeutic goods and tobacco use and sales. These laws, and their interpretation, have differed between jurisdictions, creating confusion for consumers (Gartner & Bromberg, 2019; Saw et al., 2019).

In most Australian jurisdictions, it is legal to sell nicotine-free e-cigarettes and refill liquids that do not contain nicotine as consumer products subject to consumer law on product safety, packaging and marketing. In most cases, similar restrictions apply as to the sale and use of tobacco cigarettes under state tobacco control laws (Douglas et al., 2015). The exception is Western Australia where it is illegal to sell any type of e-cigarette under a law which prohibits the sale of any product that “resembles” a tobacco product (Gartner & Bromberg, 2019).

These complex regulations meant that many smokers were confused about the legality of using e-cigarettes. Inconsistent advice from state health departments showed that state regulators were also confused about the law and regulations (Gartner & Bromberg, 2019; Saw et al., 2019). The TGA and medical groups strongly discouraged the public from legally accessing nicotine e-cigarettes as an unapproved therapeutic good (Erku et al., 2020; Therapeutic Goods Association, 2014). This made it difficult for smokers to find medical practitioners who were willing to prescribe nicotine e-cigarettes.

Australian policy has severely limited smokers’ access to nicotine-containing e-cigarettes. Despite this, in 2019, approximately 39% of Australian smokers had tried an e-cigarette (Australian Institute of Health and Welfare, 2020). The International Tobacco Control Policy Evaluation (ITC) Project reported that only 43% of Australians using e-cigarettes used nicotine liquid, compared with 73% in the UK (Yong et al., 2015). The TGA reported that by 2020 it had only approved 15 prescriptions for nicotine (from 12 doctors) (Select Senate Committee on Tobacco Harm Reduction, 2020). It is likely therefore that most Australian smokers who have used e-cigarettes have illegally imported them or purchased them on the local illicit market.

1.2 Governmental Reviews of Australian E-cigarette Policy

Australia’s very restrictive e-cigarette policy was developed with very little public input in 2008. State and federal officials formulated the policy on the advice of tobacco control advocates and health and medical organisations (Gartner & Bromberg, 2019). The Commonwealth Health Department commissioned reviews of the policy in 2012 and 2014, but public submissions were not invited and neither report was published (Gartner & Bromberg, 2019). The first review in 2012 was a commissioned regulatory impact assessment of e-cigarettes and smokeless tobacco products (Australian Intergovernmental Committee on Drugs, 2012). The second in 2016 was an assessment of “Options to minimize the risks associated with the marketing and use of electronic nicotine delivery systems in Australia.” This included a closed consultation process and it was conducted by a consortium that included several members who publicly advocated for increased restrictions on e-cigarettes during the consultation period (Barnes, 2016).

2 Justifications of Australia’s E-cigarette Policy 2008–2021

Detailed justifications for Australia’s e-cigarette policy have been provided in response to attempts by critics of the policy to liberalise access. These have included applications to the TGA to reconsider its classification of nicotine to allow easier access for smokers who wished to use e-cigarettes for quitting or as a smoking substitute. Later, vaper agitation and disquiet among backbench parliamentarians led to inquiries in state and federal parliaments that examined e-cigarette regulation.

2.1 Applications to Reschedule Nicotine

In 2008, an e-cigarette retailer applied to create a new exemption from Schedule 7 for nicotine “in electronic cigarettes prepared and packed as an alternative to traditional smoking.” The application was rejected by the TGA on the grounds that e-cigarettes would widen the appeal of nicotine products, provide rapid delivery of nicotine, and contained potentially harmful chemicals such as acetaldehyde (National Drugs and Poisons Scheduling Committee, 2008).

In 2017, a consumer organisation, the New Nicotine Alliance Australia (NNAA), modelled on a consumer group of the same name in the UK, asked the TGA to exempt e-cigarettes from Schedule 7. By this time, e-cigarette use had increased worldwide and there was an international debate about their regulation. The TGA received 71 submissions: 54 from consumers and e-cigarette suppliers who supported the proposed rescheduling and 17 from health organisations that all opposed it (National Drugs and Poisons Scheduling Committee, 2017). Consumers described their success in using vaping to quit smoking after many unsuccessful attempts and the health benefits they experienced from using e-cigarettes (National Drugs and Poisons Scheduling Committee, 2017). A small group of researchers supported the rescheduling, including two of the authors of this chapter (CG and WH).

Submissions in favour of a more liberal policy argued that e-cigarettes were less harmful than smoking cigarettes and were effective quitting aids. They pointed out that the sales ban on e-cigarettes had created a black market for imported nicotine of unknown quality and forced smokers to choose between breaking the law by using e-cigarettes and continuing to smoke combustible cigarettes (National Drugs and Poisons Scheduling Committee, 2017). The 17 submissions that opposed the rescheduling of nicotine liquid came from Government Health Departments, health NGOs, peak medical bodies and a university public health academic (National Drugs and Poisons Scheduling Committee, 2017). These submissions argued that: e-cigarettes were not effective quit aids and promoted dual use of e-cigarettes and combustible cigarettes instead of quitting; allowing e-cigarettes with nicotine would increase the number of persons addicted to nicotine and renormalise smoking, and second-hand e-cigarette vapour exposure was harmful (National Drugs and Poisons Scheduling Committee, 2017).

The TGA rejected the NNAA application on the grounds that there were risks that young people would use e-cigarettes and go on to smoke cigarettes. They also pointed to the risks of nicotine poisoning, the lack of evidence about the safety of long-term use of e-cigarettes and the health risks of nicotine dependence. It stated that “government policy supports the cessation of smoking rather than harm reduction” (National Drugs and Poisons Scheduling Committee, 2017).

2.2 Parliamentary Inquiries into E-cigarettes 2014–2018

Several state and federal government inquiries examined e-cigarette regulation and some invited public submissions. In 2014, the Australian Capital Territory conducted a public consultation that received 242 submissions, the majority from community members who wanted easier access to e-cigarettes. ACT Health stated that they were “committed to ensuring that any potential harms to the community associated with electronic cigarettes are minimised, while retaining access to the devices for smokers who choose to use them to help quit smoking” (ACT Health, 2015). A South Australian State Parliamentary Inquiry in 2015 received 142 submissions, with more than 70% from vapers advocating for easier access to e-cigarettes (South Australian Parliament, 2016). The report recommended that the state government “appeal to Federal Government for more stringent enforcement of regulations regarding nicotine importation, sale and possession to prevent its recreational use across Australia” (South Australian Parliament, 2016).

A libertarian Senator, David Leyonhjelm, made several unsuccessful attempts to reduce restrictions on e-cigarettes. He introduced a private members bill (Commonwealth of Australia, 2017) and chaired two Senate Committees (Senate Economics References Committee on Personal Choice and Community Impacts, 2016; Senate Red Tape Committee, 2017). In general, Australian politicians who advocate easier access to e-cigarettes have been free market advocates from the right-wing of the Liberal Party or other minor parties (Pauline Hanson’s One Nation Party) and independents (Gartner & Bromberg, 2019). The centre-left Labor Party and the Greens both support the existing sales ban.

In 2017, a Committee of the House of Representatives commissioned a comprehensive Parliamentary Inquiry into the use and marketing of electronic cigarettes (E-cigarettes) and personal vaporisers in Australia. It was asked to report on: (1) the use and marketing of e-cigarettes and personal vaporisers to assist people to quit smoking; (2) the health impacts of the use of e-cigarettes and personal vaporisers; (3) international approaches to legislating and regulating the use of e-cigarettes and personal vaporisers; and (4) the appropriate regulatory framework for e-cigarettes and personal vaporisers in Australia.

The inquiry collected evidence, invited public submissions and conducted public hearings in 2017. It received 336 written submissions, 259 from individuals and 77 from organisations, and over 1700 form letters from individuals (House of Representatives Standing Committee on Health, 2018). Most (97%) of the submissions in favour of making e-cigarettes more accessible came from e-cigarette users (House of Representatives Standing Committee on Health, 2018). A small number of vaping advocacy groups made submissions in support of greater accessibility to e-cigarettes. These included the now defunct NNAA. Another was the Australian Taxpayers Alliance, a libertarian organisation opposed to “nanny state” policies. There were also submissions from the tobacco industry, individual e-cigarettes retailers, and organisations representing e-cigarette retailers. There were very few submissions from independent manufacturers of vaping products. All submissions from the commercial or retail sector and the tobacco industry supported reduced restrictions. They argued that these products are a safer option than smoking for people who find it difficult to quit tobacco use, and that a highly restricted market would lead to black market sales and reduce income to businesses.

All State and Federal Health Department submissions supported the existing restrictions on the sale of e-cigarettes and non-government health bodies overwhelmingly opposed any relaxation of the restrictions (Erku et al., 2019). These included: the Australian Cancer Council, the Australian Medical Association, the National Heart Foundation, the Royal Australasian College of Physicians, the Thoracic Society of Australia and New Zealand, and the Australia and New Zealand Public Health Association. The only peak health body that supported greater access to e-cigarettes was the Royal Australian and New Zealand College of Psychiatrists.

The most common argument used to justify the sales ban on nicotine e-cigarettes was the claim that there was no evidence that e-cigarettes are safe or effective in helping smokers to quit (House of Representatives Standing Committee on Health, 2018). Peak health bodies and government health departments argued that there was insufficient evidence on the long-term safety of e-cigarettes so the precautionary principle required a ban on their sale (Morphett et al., 2021). The Commonwealth Department of Health defined the precautionary approach as warranting:

…action to prevent harm when there is scientific uncertainty and until a body of evidence establishes the requirement for alternative regulation. This includes the lack of conclusive evidence around the safety risks posed to users by the unknown inhalation toxicity of nicotine and other chemicals used with e-cigarettes, passive exposure to e-cigarette vapour, risks associated with child poisoning, and issues around quality control and efficacy. The precautionary approach also takes into account the broader risks that e-cigarettes may pose to population health, namely their potential to disrupt the decline in tobacco use in Australia. (Australian Government Department of Health, 2018)

The Commonwealth Department of Health suggested that “conclusive evidence” about safety was required to justify a shift in policy, but it did not specify what sort of evidence would comprise “conclusive evidence.”

The majority report of the House of Representative inquiry accepted this framing of the evidence:

As the E-cigarette is a device that has only recently come into widespread use, there is limited, and often conflicting research available in relation to the impact of E-cigarettes on smoking rates and the health implications of long term E-cigarette use. (House of Representatives Standing Committee on Health, 2018)

The majority report also represented the precautionary principle and a harm reduction approach as being in opposition to each other:

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. (House of Representatives Standing Committee on Health, 2018)

Peak health bodies and government health departments argued that because there was insufficient evidence on the long-term safety of e-cigarettes, the precautionary principle required a ban on their sale (Morphett et al., 2021). The Thoracic Society of Australia and New Zealand (TSANZ) and the Lung Foundation Australia defined the precautionary principle as follows:

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. (Thoracic Society of Australia and New Zealand and Lung Foundation Australia, 2017)

In 2018, the Committee’s majority report supported a continuation of the e-cigarette sales ban (House of Representatives Standing Committee on Health, 2018). It recommended that the National Health and Medical Research Council (NHMRC) conduct a review of evidence on the safety and efficacy of e-cigarettes. It also recommended that the Department of Health develop a national approach to regulation, including “if necessary, restricting colourings and flavourings used in electronic cigarettes” (House of Representatives Standing Committee on Health, 2018).

A dissenting minority report by three members of the Liberal Party recommended that nicotine in e-cigarettes be made exempt from Schedule 7 of the Poisons Standard so that they could be regulated as consumer products like in the European Union and include restrictions on e-cigarette colourings and flavourings (House of Representatives Standing Committee on Health, 2018). The dissenting report downplayed the claims about the health risks of nicotine and argued that the primary concern was with the health effects of additives, colourings and flavourings (House of Representatives Standing Committee on Health, 2018). They also shared the concern of the NHMRC (National Health and Medical Research Council, 2017) that flavourings and colourings could appeal to young people and be toxic when inhaled. These were also among the reasons used by the committee majority to justify sales restrictions on e-cigarettes (House of Representatives Standing Committee on Health, 2018).

2.3 A 2021 Proposal to Tighten E-cigarette Regulation

In June 2020, the Federal Health Minister, Greg Hunt, announced that he would ban the personal importation of nicotine and only allow e-cigarettes with nicotine to be obtained on prescription. Nicotine would only be able to be imported with an authorisation from the Office of Drug Control (Sutton, 2020). The proposal was prompted by several developments that had alarmed the Australian public health community.

The first was a very large increase in the use of e-cigarettes by adolescents and young adults in the US between 2015 and 2019 (National Institute on Drug Abuse, 2020). The second was an outbreak in 2019 of 2558 serious lung injuries (including 60 deaths as on 7 January 2020) (Werner et al., 2020). These injuries were given the name E-cigarette and Vaping-associated Lung Injury (EVALI) because most of the cases reported using e-cigarettes (Hall et al., 2021). Australian State and Federal Chief Health Officers were quick to invoke the EVALI outbreak in the US to justify Australia’s precautionary prohibition on the sale of nicotine e-cigarettes (Gartner et al., 2020a; Hall et al., 2021). A leading Australian tobacco control advocate described EVALI as a “canary in the coalmine” for nicotine e-cigarettes (Knott, 2019). Because most EVALI cases reported using e-cigarettes, CDC investigators initially focused on nicotine e-cigarettes as the cause of the outbreak (Hall et al., 2021). Investigations indicated that cannabis oils adulterated with vitamin E were the most likely cause of the outbreak (Centers for Disease Control and Prevention, 2020). Despite the CDC and FDA conclusions on the cause, a 2022 statement by the Chief Executive Officer of the NHMRC still identifies e-cigarettes as cause of EVALI.

The third factor that contributed to the Minister’s decision was that e-cigarette use had increased among Australian adolescents and young adults around the same time as the US “youth e-cigarette epidemic” (King et al., 2020) and EVALI outbreak. A 2019 national household survey found a substantial increase in e-cigarettes use between 2016 and 2019 among young adults (Australian Institute of Health and Welfare, 2020). The fact that the largest increase occurred among young adults who were already cigarette smokers was overshadowed by claims that e-cigarette use had greatly increased among the minority of adolescents who had not previously smoked cigarettes.

2.4 Senate Inquiry into Tobacco Harm Reduction 2020

Because of objections from backbench coalition members of parliament, the implementation of the Minister’s proposed new regulations was delayed until after the report of a Senate Select Committee on Tobacco Harm Reduction in October 2020 (that had been established in to examine criticisms of the proposed policy). The Select Committee received over 900 public and name withheld submissions, over 30 confidential submissions and 8324 form letters. The contents of the submissions largely reprised the evidence that had been presented to the 2018 House of Representatives Inquiry. The majority of medical and public health groups strongly supported Australia’s “precautionary approach,” arguing that: there was an absence of evidence that e-cigarettes were safe and effective, and that allowing Australian smokers to have ready access to e-cigarettes would promote uptake among Australian youth and expose smokers to the unknown long-term harms of e-cigarette use. In another echo of the House of Representatives inquiry, the Chair and a committee member (both from the centre-right governing party) dissented from the majority report because they claimed that its findings did not accurately reflect the evidence that had been presented.

The majority report accepted the findings of evidence reviews on the effectiveness of e-cigarettes for cessation and gateway effects commissioned by the Health Minister (Banks, 2020). The TGA spokesperson defended the proposal to tighten rules on importation of nicotine e-cigarettes by increasing penalties for importing nicotine without a prescription up to $222,000. The Committee’s findings were framed as if the policy choice was between having no regulation of e-cigarettes and adopting a precautionary approach. The committee majority unsurprisingly supported continuing policies that restricted access to e-cigarettes.

3 The 2021 Rescheduling of Nicotine

At the Health Minister’s request, the Commonwealth Department of Health developed a streamlined process to allow smokers to access nicotine e-cigarettes using the TGA’s Special Access Scheme (SAS) or Authorised Prescribers (AP) programme. These programmes are intended to allow patients to have access to unapproved therapeutic goods on prescription. In the case of e-cigarettes, the programmes allow medical practitioners to apply for approval from the TGA to prescribe and arrange the supply of NVPs to Australian smokers who want to quit smoking and who have unsuccessfully used an approved cessation medicine (Therapeutic Goods Administration, 2021a). A prescription can be written by any medical practitioner for a named patient and, in the case of prescribers approved by the TGA, to a broad class of patients (e.g. tobacco smokers who want to quit and have failed to do so using approved methods) (Gartner et al., 2020b).

The regulation allows nicotine-containing e-cigarettes to be sold in Australian pharmacies, if they meet a product standard (TGO 110) that sets minimum quality, and packaging and labelling requirements, and imposes some restrictions on the content of these products (maximum nicotine content, prohibited ingredients) (Therapeutic Goods Administration, 2021b). Heat not burn and smokeless tobacco products were excluded from the TGO 110 standard after the TGA rejected an application from Philip Morris to allow the sale of a heat not burn tobacco product in August 2020 (Therapeutic Goods Administration, 2020). If they are purchasing an e-cigarette in Australia, patients with a prescription can only obtain the specific product listed on the prescription from a pharmacist. E-cigarettes can also be imported for personal use if the individual importing the nicotine product holds a prescription from any Australian medical practitioner. Some TGO 110 requirements, such as ingredient requirements, also apply to imported products. The TGA recommends that the imported product is shipped with a copy of the prescription enclosed so that customs can confirm the item has been legally imported.

In principle, the proposed TGA processes will increase Australian smokers’ access to nicotine e-cigarettes. In practice, their impact may be more limited because medical and public health spokespersons discourage patients from using them and doctors from prescribing them. The Australian Medical Association (AMA), for example, supports GPs prescribing “nicotine solutions to patients where appropriate” (Australian Medical Association, 2020), but a prominent former AMA president has said that he would never prescribe nicotine e-cigarettes for his patients because they “actually get young people into smoking, rather than helping them get off it” and the current president has argued that doctors should focus on getting smokers “off nicotine completely” (McCauley, 2020). Pharmacy professional bodies’ support for dispensing unapproved nicotine e-cigarettes is unclear (Haggan, 2020; Pharmaceutical Society of Australia, 2020; Retail Pharmacy, 2020). It is also uncertain how many manufacturers or importers will supply nicotine e-cigarettes that can be dispensed and it remains to be seen how many Australian vapers will use this pathway to access them.

The TGA has cautiously supported the use of nicotine e-cigarettes for patients who have unsuccessfully tried to cease smoking using approved cessation aids such as NRT and pharmaceutical drugs. Its website now encourages medical practitioners, pharmacists and consumers to use the approved pathways and provides advice on how to do so. It also provides a list of medical practitioners who are authorised to prescribe nicotine e-cigarettes, who have consented to being publicly listed and who are prepared to prescribe via telehealth consultations.

4 Explaining How Australia’s E-cigarette Policy Came About

As noted above, Australia’s policy was initially formulated by federal and state health regulators acting on the advice of tobacco control and public health advocates who favoured policies to reduce demand for tobacco, such as increased tobacco taxes, and who were opposed to tobacco harm reduction approaches. This was in large part because of the past failure of “light” and “low-tar” cigarettes to reduce harm, while convincing smokers that they were smoking less harmful products (King et al., 2003). The failure of “low-tar” cigarettes produced an understandable mistrust of tobacco harm reduction as Simon Chapman, a leading tobacco control advocate in Australia, has written:

… most in the public health community have bitter memories of being hoodwinked by the industry. We were kept in the dark about its internal knowledge of compensatory smoking that made a mockery of machine-measured yields …. This has engendered immense mistrust of any next generation harm reduction claims. (Chapman, 2007)

4.1 Key Public Health Policy Advisors

After the election of a federal Labour government in 2007, the new Health Minister, the Hon. Nicola Roxon, established a National Preventative Health Taskforce in April 2008. Tobacco policy was given priority and she explained that she was determined to toughen up tobacco control policy motivated by her father dying from a smoking-related oesophageal cancer. She appointed a Tobacco Working Group chaired by Mike Daube, former director of Action on Smoking and Health (ASH) in the UK, a former Director General of the Health Department in Western Australia, a past president of the Public Health Association of Australia and Professor of Health Policy at Curtin University. The working group’s report (National Preventative Health Taskforce, 2009) recommended that e-cigarettes should only be marketed as smoking cessation aids, and then only if they were listed on the Australian Register of Therapeutic Goods (National Preventative Health Taskforce, 2009):

If e-cigarettes are marketed as an aid in withdrawal from smoking they will be considered a therapeutic good, and would have to be listed on the Australian Register of Therapeutic Goods before they could be imported and retailed in Australia. It seems unlikely that they would meet standards for safety and efficacy. If, on the other hand, e-cigarettes are marketed exclusively as recreational devices, they may not meet the definition of therapeutic use. The Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) currently categorises all nicotine products that are not tobacco products or are used for NRT as falling under Schedule 7, which covers Dangerous Poisons. Therefore, at present, such products (not being clearly a tobacco product or NRT) would probably not satisfy the stated exceptions, and could not be retailed under state and territory legislation. (National Preventative Health Taskforce, 2009)

Nicola Roxon supported this approach, describing e-cigarettes as an “insidious, manipulative attempt to hook people on smoking” (Cauchi, 2009). In 2011, Nicola Roxon announced a campaign to introduce tobacco plain packaging in Australia, describing this “as the next great step we could take in limiting the glamour and appeal of tobacco” (Australian Council on Smoking and Health, 2017). Plain packaging legislation came into force on 12 December 2011.

4.2 Tobacco Harm Reduction: Advocates and Opponents

Advocates of policies that would increase smokers’ access to e-cigarettes justified it as a harm reduction approach to tobacco. They included researchers (such as two authors, Coral Gartner and Wayne Hall), e-cigarette advocacy groups and clinicians. A general practitioner and founder of the Australian Tobacco Harm Reduction Association, Dr. Colin Mendelsohn, argued that e-cigarettes were “an ideal tobacco harm reduction product,” because they provided nicotine without most of the harmful constituents of tobacco smoke and involved the hand-to-mouth action that smokers are accustomed to (Mendelsohn, 2017). The Royal Australian and New Zealand College of Psychiatrists also emphasised the value of e-cigarettes in tobacco harm reduction for persons with serious mental illness (Royal Australian and New Zealand College of Psychiatrists, 2017).

Nigel Gray, an Australian tobacco control pioneer, had earlier advocated for the regulation of cigarettes to reduce harm to smokers. He proposed a comprehensive nicotine policy that would combine the progressive reduction in the nicotine content of combustible cigarettes with increasing smokers’ access to clean forms of nicotine, such as pharmaceutical preparations (Gray et al., 2005). After e-cigarettes were introduced and taken up by smokers in the US, he recognised their potential value as cleaner nicotine products (Gray, 2014). Professor Ron Borland, a leading tobacco control researcher at Cancer Council Victoria from 1986 to 2019, has also been a proponent of tobacco harm reduction policies within a comprehensive tobacco control strategy (Borland, 2016).

The overwhelming majority of Australian healthcare and public health organisations, however, have opposed tobacco harm reduction policies. Michael Moore, CEO of the Public Health Association of Australia, argued that Australia had very successfully reduced the prevalence of smoking so there was no need for tobacco harm reduction (Public Hearing of the Parliamentary Inquiry into the Use and Marketing of Electronic Cigarettes and Personal Vaporisers in Australia, 5 October 2017). Opponents of e-cigarettes also argued that their introduction would reverse the gains Australia had made in tobacco control over the last few decades and increase the population harms arising from the use of nicotine (Studdert, 2017).

Increasing hostility to the concept of tobacco harm reduction was reflected in changes made in successive Australian National Tobacco Strategies. These form sub-strategies of the National Drug Strategy (NDS) that adopts a harm minimisation approach to alcohol, tobacco and illicit drugs in which the “three pillars” of demand reduction, supply reduction and harm reduction are “equally important” and “applied together in a balanced way” (Ministerial Council on Drug Strategy, 2010).

Tobacco harm reduction was a prominent part of the National Tobacco Strategy of 2004–2009. Among its four primary objectives was “where feasible, to reduce harm associated with continuing use of, and dependence on, tobacco and nicotine” (Ministerial Council on Drug Strategy, 2004). An associated outcome indicator was “a reduction in the exposure of remaining users of tobacco (or tobacco substitutes) to dangerous smoke constituents” … “by replacing some or all tobacco products with medicinal nicotine or other nicotine products” (Ministerial Council on Drug Strategy, 2004). The strategy noted the lack of a comprehensive plan to regulate nicotine products with the statement that “we have no mechanism at all for regulating some classes of products” (Ministerial Council on Drug Strategy, 2004).

The strategy noted that “The absence of measures that reduce harm from continuing smoking results in greatest harm among socially disadvantaged smokers” (Ministerial Council on Drug Strategy, 2004). A document was developed: “More efficiently regulating tobacco: Ideas and resources” by an unnamed consultant “with advice from the former National Expert Advisory Committee on Tobacco and support by the Intergovernmental Committee on Drugs” (Unknown Author, 2004). It provided options to regulate tobacco and nicotine products to “reduce overall population harm.” These included:

  1. 1.

    “Forcing the pace of innovation towards less harmful and, if feasible (and if deemed desirable), less addictive tobacco products.

  2. 2.

    Controlling the price and the accessibility of tobacco products and products that would replace tobacco products with inherent harmfulness.

  3. 3.

    Creating incentives to market tobacco products that would replace tobacco products in ways that minimise overall population harm” (Unknown Author, 2004).

These suggestions were not implemented and a proposed report commissioned by the Victorian Department of Health to investigate nicotine and tobacco product regulation (Ministerial Council on Drug Strategy, 2004) was never released.

In the 2010–2015 National Drug Strategy, by contrast, the only tobacco harm reduction strategy mentioned was smoke-free policies to reduce harms to non-smokers in workplaces and public spaces. The National Tobacco Strategy 2012–2018 contained no strategies to reduce harm to smokers other than cessation. E-cigarettes were only mentioned in recommendation 6.7 to: “Consider further regulation of the contents, product disclosure and supply of tobacco products and alternative nicotine delivery systems” (Intergovernmental Committee on Drugs, 2012) in order to “determine whether there is a need to increase restrictions on their availability and use” (Intergovernmental Committee on Drugs, 2012).

4.3 Selective Citation of Evidence on the Risks and Benefits of E-cigarettes

Critics argue that policy makers and supporters of Australia’s ban on the sale of e-cigarettes as consumer products used have justified it by selectively using the evidence on the effectiveness and safety of e-cigarettes. These appraisals have discounted evidence from clinical trials that e-cigarettes assist smokers to quit and dismissed observational evidence that smoking has declined as e-cigarettes use has increased. They have also amplified equivocal evidence that e-cigarettes cause harm to smokers and exaggerated the strength of the observational evidence that e-cigarettes served as a gateway to cigarette smoking in adolescents.

4.4 Protecting Young People from the Gateway Effect

A major justification for an e-cigarette sales ban has been that e-cigarettes could addict a new generation of young people to nicotine and serve as a gateway to cigarette smoking (National Heart Foundation, 2017). The review commissioned by the Department of Health concluded that there was “strong” evidence for a gateway effect in longitudinal studies (Banks, 2021), and the TGA cited this conclusion to justify its classification of e-cigarettes. Advocates of e-cigarettes argued that these studies failed to take account of the shared liability to addiction and pointed to the UK and the US where rates of smoking had declined among young people as the use of e-cigarettes increased (House of Representatives Standing Committee on Health, 2018). Some of those who invoked the gateway effect to support Australia’s sales ban implied that policy makers had to choose between (1) banning the sale of e-cigarettes and (2) allowing e-cigarettes to be sold without regulations or restrictions on supply, advertising or age of purchase.

There are plenty of drugs that we know do harm. I take one, but it's medically administered. That's okay in that group of people, but to sell it to children who are unable to give consent and are unable to understand the issues at hand, that's just unconscionable. (Professor Thompson, Thoracic Society of Australia and New Zealand, Public Hearing for the 2018 Parliamentary Inquiry)

Alternative policy options were neglected, such as restrictions on where e-cigarettes were sold and used, were overlooked, as was the inconsistency in imposing lesser restrictions on the sale of cigarettes than those proposed for e-cigarettes.

4.5 The Adverse Health Effects of Nicotine

Nicotine replacement therapy has long been considered safe when used for smoking cessation or as long-term substitute for smoking by organisations that have strongly opposed the use of e-cigarettes (e.g. Quit Victoria, 2018). However, Australian governments and health organisations have increasingly emphasised the potential harms of nicotine, arguing that it causes acute toxicity and poisoning in children, for example, (Queensland Government, 2018), that it is an “addictive and potentially toxic substance” (Cancer Council Australia, 2016) and may be a cancer promoter (Chapman, 2016). The Commonwealth Department of Health has argued that nicotine was addictive, posed “significant health risks including adverse cardiovascular, respiratory, and reproductive effects” and was “associated with DNA damage and other pathways of carcinogenesis” (Commonwealth Government Department of Health, 2017). In its 2017 decision on rescheduling, the TGA also claimed that nicotine adversely affects the brain development of young people and foetuses, potentially causing learning and anxiety disorders (Therapeutic Goods Association, 2017).

4.6 The Role of the Tobacco Industry

The decisive fact for many in the Australian tobacco control community is that the tobacco industry has invested in e-cigarette companies and campaigned for a relaxation of the e-cigarette sales ban. They argued that the tobacco industry would use e-cigarettes to reduce quitting among smokers and promote youth smoking. The industry was also accused of using tobacco harm reduction to re-engage with public health authorities and ensure that tobacco policies better served their interests. For example, Maurice Swanson from the Australian Council on Smoking and Health stated of the tobacco industry that:

Their objective…is to provide a range of nicotine delivery devices, from traditional cigarettes to e-cigarettes through to heated tobacco products, and their reason for doing so is that they know that in many Western countries the prevalence of smoking is falling and they need to maintain profitability. If they can dress up their alternative nicotine delivery products as being safer—that's what they're promoting—then they can maintain both their share value and their profitability. (Select Senate Committee on Tobacco Harm Reduction, 2020)

Advocates for tobacco harm reduction were sometimes depicted as witting or unwitting allies of the tobacco industry (Slessor, 2018). Media articles also reported on advocates’ receipt of funding from commercial sources, particularly e-cigarette retailers (Chenoweth, 2021; Han, 2018; Workman & Hutcheon, 2021).

Witnesses who gave evidence to the Senate Committee inquiry in favour of more liberal e-cigarette policies were required to make multiple sworn statements that they had not received any funding directly or indirectly from the tobacco or e-cigarette industries.

4.7 The Misuse of the Precautionary Principle

The most popular arguments advanced against allowing Australian smokers to have greater access to nicotine e-cigarettes were that there was insufficient evidence that e-cigarettes are safe or effective in helping smokers to quit, and that they posed an unacceptable risk to youth (House of Representatives Standing Committee on Health, 2018). Peak health bodies and government health departments also argued that given the lack of evidence on the long-term safety of e-cigarettes, the precautionary principle required a ban on their sale until evidence showed that they were safe (Morphett et al., 2021). The Commonwealth Department of Health defined the precautionary approach as warranting:

…action to prevent harm when there is scientific uncertainty and until a body of evidence establishes the requirement for alternative regulation. This includes the lack of conclusive evidence around the safety risks posed to users by the unknown inhalation toxicity of nicotine and other chemicals used with e-cigarettes, passive exposure to e-cigarette vapour, risks associated with child poisoning, and issues around quality control and efficacy. The precautionary approach also takes into account the broader risks that e-cigarettes may pose to population health, namely their potential to disrupt the decline in tobacco use in Australia. (Australian Government Department of Health, 2018)

The Commonwealth Department of Health indicated that “conclusive evidence” of safety would justify a shift in policy, but it did not specify what would comprise “conclusive evidence” of safety.

The Australian Medical Association implied that evidence of zero risk would be required:

CHAIR: What would be the threshold? … The claims around less harm have ranged up to 95 per cent less harm. What is the threshold that becomes an acceptable point? If 95 per cent was accurate, would you say, 'That's a good basis, then, for legalising it'?

CHAIR: So You Would Have to Be Convinced that It Did no Harm at All?

Dr Bartone: I'm not Going to Be Tied to a Number Other Than 100 Per Cent Because—

Dr Bartone: Yes, before I would personally look at that. (Public Hearing of the Parliamentary Inquiry into the Use and Marketing of Electronic Cigarettes and Personal Vaporisers in Australia, 5 October 2017)

Most guidelines on the use of the precautionary principle reject the strong form that requires a product to be 100% safe because zero risk is impossible to achieve (Commission of the European Communities, 2000; Morphett et al., 2021; Weir et al., 2010). These guidelines usually recommend that regulations should be proportional to the risk the product poses (Commission of the European Communities, 2000; Weir et al., 2010). Two of the authors of this chapter (Wayne Hall and Coral Gartner) have argued that zero risk is not appropriate in a regulatory context when consumers are freely able to use a widely-available product that is an established cause of very serious health harms (House of Representatives Standing Committee on Health, 2018).

5 Conclusion

Drugs and poisons regulations in Australia have made it difficult to access nicotine-containing e-cigarettes since 2012. Moves to increase smokers’ access to e-cigarettes have been resisted by regulatory authorities and the public health field. This has been despite the relaxation of similar restrictions in Canada and New Zealand and evidence that using e-cigarettes is less harmful than smoking tobacco (Byrne et al., 2018; Health, 2017; McNeill et al., 2018; U.S. National Academies of Sciences Engineering and Medicine, 2018). Influential public health organisations in Australia, and all relevant government agencies, maintain that nicotine-containing e-cigarettes should only be available on prescription.

Australian e-cigarette policy comprises a complex and confusing array of state and federal laws that have been difficult for smokers to navigate (Saw et al., 2019). The regulatory challenges raised by novel nicotine products have been acknowledged in parliamentary reports and the National Tobacco Strategy 2004–2009 (Ministerial Council on Drug Strategy, 2004), but over the past decade recommendations to develop a comprehensive regulatory regime for all tobacco and nicotine products have been ignored.

The main reasons for the strong resistance to changes in e-cigarette policy in Australia are as follows:

Firstly, public officials and politicians believe that tobacco harm reduction approaches are unnecessary because demand reduction strategies (e.g. taxation, smoke-free polices and media campaigns) have successfully reduced smoking prevalence to date. They also believe that tougher demand reduction policies will further reduce smoking prevalence.

Secondly, harm reduction strategies have been framed as presenting an unacceptable risk in comparison with “tried and true” demand reduction strategies, namely because e-cigarettes may allegedly deter smokers from quitting and recruit non-smokers to nicotine dependence and cigarette smoking.

Thirdly, there is also a lack of enthusiasm for nicotine replacement in smoking cessation because of the belief among leading public health advocates that cold turkey is the best way for smokers to quit. The result is that the majority of Australian tobacco control advocates support the sales ban on nicotine-containing e-cigarettes because they believe that Australian policy should give priority to preventing smoking uptake among young people over any benefits to adults who smoke.

The history of tobacco control in Australia has been strongly influenced by key individuals and professional networks. Tobacco control has been dominated by public health professionals whose successful advocacy for demand reduction policies has substantially reduced overall smoking prevalence. These policies have been less successful in reducing social disparities in smoking prevalence (Intergovernmental Committee on Drugs, 2012), and health inequalities have not been featured strongly in policy documents or discussions about e-cigarettes.

Major health organisations and government health departments at Commonwealth and state level have justified the rejection of e-cigarettes as a harm reduction strategy by invoking a strong interpretation of a precautionary approach. According to this approach, e-cigarettes should be shown to be completely safe before they can be legally sold to consumers. This use of the principle does not compare the safety of e-cigarettes with that of smoked tobacco but instead compares their safety to that of not using nicotine. This approach is inconsistent with guidelines on the use of the precautionary principle in public policy (Morphett et al., 2021).

The fact that the tobacco industry is now involved in the e-cigarette market has been a major reason that many in the tobacco control community oppose the sale of e-cigarettes in Australia. As one reporter observed, “The shadow of Big Tobacco has darkened the e-cigarette landscape” (Powell, 2018). Concern about tobacco industry motives is understandable, given their history of manipulation and their continued interest in selling dangerous and addictive tobacco products to consumers. Nonetheless, suspicion of the tobacco industry has produced a policy that perversely protects cigarettes by restricting smokers’ access to lower risk e-cigarettes and low nitrosamine smokeless tobacco products while cigarettes remain freely accessible as consumer products in supermarkets and convenience stores.