The emergence of electronic cigarettes (E-cigarettes) in the past decade has required governments around the world to grapple with how to regulate this product.
The scale of the challenge facing governments can be seen in the growing number of E‑cigarette users in the United States of America (USA) and in the United Kingdom of Great Britain (UK), which are already in the millions. Currently, the E‑cigarette industry is estimated to be worth more than $US 6 billion globally per annum.
In addition, the regulatory decisions facing governments are made more difficult by the lack of certainty regarding the health impacts of E‑cigarettes. 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.
In Australia there has, to date, been a precautionary approach taken to the regulation of E‑cigarettes containing nicotine. The sale of nicotine E‑cigarettes is prohibited unless approved as an aid to help people quit smoking and, so far, no E‑cigarette has been approved for this purpose.
Internationally, the regulatory response to the emergence of E‑cigarettes has been varied. In some countries there has been a similar approach taken to that of Australia, and the sale of some, or all, types of E‑cigarettes is prohibited. In contrast, other countries including the USA and the UK have opted to make E‑cigarettes legally available.
About the Inquiry
Objectives and Scope
On 25 May 2017, the Minister for Health, the Hon Greg Hunt MP, referred the Inquiry into the Use and Marketing of Electronic Cigarettes and Personal Vaporisers in Australia (the inquiry) to the Standing Committee on Health, Aged Care and Sport (the Committee).
As part of the inquiry, the Committee examined whether:
E‑cigarettes are effective in helping people to quit smoking;
Greater availability of E‑cigarettes is likely to result in more young people taking up tobacco smoking; and
E‑cigarettes should be regulated as a therapeutic good or as a consumer good.
The inquiry focussed on E-cigarettes and Personal Vaporisers, which are devices that heat a flavoured liquid (which may or may not include nicotine) to create a vapour which is inhaled by the user. These devices are referred to in this report as E‑cigarettes, and the liquid they heat is referred to as an E‑liquid. The process of using an E‑cigarette is, following colloquial use, referred to as ‘vaping’.
Heated tobacco products electrically heat tobacco to create a vapour, without burning the tobacco, to create smoke. While referred to occasionally during the inquiry, heated tobacco products are not generally considered a form of E‑cigarette and were not a major focus of the inquiry.
On 26 May 2017, the Committee issued a media release that announced the commencement of the inquiry and called for submissions to be received by 6 July 2017. The Committee also invited submissions from: government agencies, public health organisations, business organisations, universities and research organisations.
The inquiry received 352 submissions and 45 exhibits, which are listed at Appendix A and B respectively.
In addition, the Committee received three different form letters, which were letters provided by multiple participants with the same, or substantially similar, content. The first form letter was received from two participants, the second form letter was received from 1695 participants, and the third form letter was received from seven participants.
The Committee subsequently held three public hearings. In addition, the Committee held three private briefings with witnesses from the UK and later published the transcripts of these briefings.
Table 1.1: Public Hearings Held
12 July 2017
8 September 2017
5 October 2017
New Zealand Delegation
In addition to hearing from UK witnesses, the Committee undertook a delegation to New Zealand from 18 December to 20 December 2017.
The purpose of the delegation was for the Committee to gain an understanding of the issues encountered in New Zealand moving towards the legalisation of E‑cigarettes.
During its visit to New Zealand the Committee met with:
The Hon Jenny Salesa, Associate Minister of Health;
New Zealand Parliament Select Health Committee;
The Acting High Commissioner to New Zealand;
Ministry of Health, New Zealand;
The Technical Experts Advisory Group on Electronic Cigarettes;
New Zealand Cancer Society;
Action on Smoking and Health, New Zealand; and
Dr Natalie Walker and Dr Marjolein Verbiest from Auckland University.
Issues raised and discussed included:
Proposed legislative changes to legalise nicotine E‑cigarettes in New Zealand;
Regulations relating to the sale and marketing of E‑cigarettes, and the use of E‑cigarettes in public places;
E‑cigarette use among specific demographics with high rates of tobacco smoking;
Public health perspectives on the proposed legalisation of nicotine E‑cigarettes; and
The possible health impacts of E‑cigarettes.
The policy context in New Zealand is discussed in more detail in Chapter 5. As delegation meetings were not transcribed, the delegation’s findings are discussed in a general manner without attributing statements to individuals.
Figure 1.1: New Zealand Delegation
Mr Trent Zimmerman MP (Chair), Mr Steve Georganas MP (Deputy Chair) and Mr Tim Brennan (Inquiry Secretary) on the steps of the New Zealand Parliament in Wellington on 19 December 2017.
World Health Organization Guidelines
Several inquiry participants expressed concern at the appearance of tobacco industry representatives at public hearings during the inquiry. The Australian Medical Association (AMA) stated that:
… the AMA note and object in the strongest terms [to] the involvement of the tobacco industry in these proceedings … The AMA, as a matter of policy, does not meet with or engage in discussions with the tobacco industry. The primary purpose of the tobacco industry is to make profit for shareholders through the sale of tobacco products. That they are diversifying into E-cigarettes does not exclude their commercial conflict of interest in these proceedings.
Some inquiry participants were concerned that the appearance of tobacco industry representatives could be in breach of Australia’s obligations under Article 5.3 of the World Health Organization’s Framework Convention on Tobacco Control. The guidelines for implementing Article 5.3 (the Guidelines) state that Parties to the Convention ‘need to be alert to any efforts by the tobacco industry to undermine or subvert tobacco control efforts’.
The Guidelines also state that Parties should ‘establish measures to limit interactions with the tobacco industry and ensure the transparency of those interactions that occur.’ Where interactions with the tobacco industry are necessary, Parties should ensure they are conducted transparently and that ‘whenever possible, interactions should be conducted in public, for example through public hearings, public notice of interactions [and] disclosure of records of such interactions to the public.’
The Committee undertook the inquiry following established parliamentary practices and procedures and so sought the views of a wide range of organisations and individuals including government agencies, public health organisations, peak associations, and business organisations.
Representatives of the tobacco industry lodged submissions to the inquiry which were published on the inquiry webpage. In addition, representatives of the tobacco industry appeared at public hearings in Sydney and Melbourne. These hearings were accessible to members of the public, an audio stream of the hearings was available on the internet, and the transcripts of the hearings are available on the inquiry webpage.
Previous Inquiries and Reports
Health Committee Inquiry into the Plain Packaging Bill
On 22 August 2011, the Committee’s predecessor, the House Standing Committee on Health and Ageing tabled its advisory report on the Inquiry into Tobacco Plain Packaging. The report recommended that the House of Representatives pass the Tobacco Plain Packaging Bill 2011 and the Trade Marks Amendment (Tobacco Plain Packaging) Bill 2011.
The Tobacco Plain Packaging Bill 2011 was designed to prevent tobacco advertising and promotion on the packaging of tobacco products in order to reduce the appeal of tobacco products to consumers and increase the effectiveness of mandated health warnings. The House Standing Committee on Health and Ageing stated that Australia was a world leader in tobacco control and that ‘packaging plays a significant role in the marketing of tobacco products’. The House Standing Committee on Health and Ageing also stated that the tobacco industry has resisted tobacco control measures such as plain packaging but that ‘research has shown that over time many of these tobacco control measures have been effective in reducing the smoking rate’.
The two bills received royal assent on 1 December 2011.
Senate Inquiry into Vaporised Nicotine Products Bill
On 22 June 2017, the Senate referred the Vaporised Nicotine Products Bill 2017 to the Senate Community Affairs Legislation Committee for inquiry.
On 14 September 2017, the Senate Community Affairs Legislation Committee presented to the Senate its report which recommended that the ‘Senate does not pass the Bill until further scientific evaluation of the efficacy and safety of E‑cigarettes and related products has been undertaken’.
The Vaporised Nicotine Products Bill 2017 seeks to ‘exclude E‑cigarettes from regulation by the Therapeutic Goods Administration in order to legalise E‑cigarettes in Australia.’
The Senate Community Affairs Legislation Committee found that:
Given the lack of a strong evidentiary basis surrounding E‑cigarettes, the Committee supports the [Department of Health’s] precautionary approach, which is based on the need to consider the overall impact that E‑cigarettes may have on population health, including smokers and non-smokers.
The Senate Community Affairs Legislation Committee also stated that it anticipates that the Inquiry into the Use and Marketing of Electronic Cigarettes and Personal Vaporisers in Australia:
… may assist in identifying an appropriate framework for the regulation of E‑cigarettes. The Committee considers that any decisions regarding the regulatory framework for E‑cigarettes should take into account the findings of that inquiry.
South Australia Committee on E-cigarettes
On 17 June 2015, the South Australian House of Assembly passed a resolution to appoint a select committee to inquire into the appropriate legislative and regulatory controls on the sale, use, and advertising of E‑cigarettes.
In February 2016, the select committee released its final report and made 20 recommendations. The committee recommended setting restrictions on the sale, advertising, and public use of E‑cigarettes that would bring E‑cigarette regulation in line with tobacco regulation. In addition, the Committee’s recommendations included: prohibiting the sale of products that may specifically appeal to children; packaging and labelling requirements; further research into the health impacts of E‑cigarettes; and appealing to the Federal Government to more stringently enforce nicotine regulations.
In January 2017, the South Australian Government responded to the recommendations of the inquiry. The South Australian Government accepted the recommendations that could be implemented through the Tobacco Products Regulation Act 1997 (SA). The South Australian Government also stated that recommendations dealing with prohibiting the sale of products that may appeal to children, packaging and labelling requirements, and the need for further research should be addressed through a national response.
Therapeutic Goods Administration Rulings
On 23 March 2017, the Therapeutic Goods Administration (TGA) ruled on a proposal to exempt nicotine for use in E‑cigarettes from Schedule 7 of the Poisons Standard. The proposed amendment included allowing a maximum nicotine concentration of 3.6 per cent, a maximum container size of 900 milligrams, and requiring safety and labelling standards for packaging.
The TGA ruled that the current scheduling of nicotine, which restricts access to the substance under the Poisons Standard, was appropriate. The TGA’s reasons for choosing not to exempt nicotine from Schedule 7 of the Poisons Standard included:
The possibility of E‑cigarettes leading to nicotine dependence and a greater uptake of smoking among young people;
The lack of evidence regarding the safety of long term nicotine use;
The risk of nicotine poisoning, especially for children, and the increased rate of nicotine poisoning seen overseas following the growth in usage of E‑cigarettes;
Uncertainties around the effectiveness of E‑cigarettes as an aid for quitting smoking;
Risks of inappropriate marketing of E‑cigarettes and inadequate protections against the sale of E-cigarettes to people under 18 years of age; and
Under existing regulation it is already possible for an E-cigarette product to be approved by the TGA if it is proven to be effective as a smoking cessation aid.
In June 2016, the Australian Competition and Consumer Commission (ACCC) commenced enforcement activity against three online 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 commissioned independent testing which identified the presence of formaldehyde, acetaldehyde and acrolein. The ACCC stated that it was concerned consumers could be misled into ‘believing that the use of those products would not expose them to harmful chemicals, cancer-causing chemicals or carcinogens like those contained in conventional tobacco cigarette smoke.’
Following admissions by the three companies involved, the Federal Court of Australia ordered these companies to pay pecuniary penalties. The ACCC has since written to over 30 E‑cigarette suppliers reminding them of their responsibilities under Australian Consumer Law.
National Health and Medical Research Council Statement
On 3 April 2017, the National Health and Medical Research Council (NHMRC) released a CEO Statement on Electronic Cigarettes (the Statement). The Statement considered the potential health risks of E‑cigarettes, the effectiveness of E‑cigarettes as an aid to smoking cessation, the role of E‑cigarettes in tobacco control policies, and the manufacturing quality of E‑cigarettes.
The Statement’s key findings included that:
‘E-cigarettes may expose users to fewer toxic chemicals than conventional tobacco cigarettes; however the extent to which this reduces harm to the user has not been determined;’
E-cigarettes may expose users to toxins, heavy metals, and particulates at potentially unsafe levels;
There is insufficient evidence to determine whether E‑cigarettes are effective in helping people quit smoking;
There is some evidence that E‑cigarettes are associated with the uptake of smoking; and
Policy makers should act to minimise harm to users, bystanders, and vulnerable groups until ‘evidence of safety, quality and efficacy can be produced.’
National Academy of Sciences Review
In May 2016, the USA Food and Drug Administration (US FDA) issued a rule providing it with the authority to regulate the manufacturing, distribution, and marketing of tobacco products, including E‑cigarettes. In order to support the regulatory work of the US FDA, the National Academy of Sciences (NAS) undertook a comprehensive review of the science relating to the public health risks and benefits of E‑cigarettes.
The NAS Review identified more than 800 peer reviewed studies relating to the health impacts of E‑cigarettes. The NAS Review considered health issues related to E‑cigarettes including:
The short and long-term health risks from regular E‑cigarette use;
The effectiveness of E‑cigarettes in assisting people to quit smoking; and
Whether E‑cigarettes increase the likelihood of young people taking up smoking.
On 23 January 2018, the NAS released its report entitled Public Health Consequences of E‑cigarettes. The key findings of the report included that:
E‑cigarettes emit toxic substances but (in the most part) at lower levels than tobacco cigarettes;
There are health impacts from E‑cigarette use but the long‑term effect on mortality and morbidity is unknown;
E‑cigarettes are likely to pose less risk to individuals than tobacco cigarettes;
E‑cigarettes are likely to be effective in helping people to quit smoking;
E‑cigarettes are likely to increase the likelihood of young people taking up smoking; and
E‑cigarettes are likely to result in a net public health benefit in the short‑term but in the long‑term (for example 50 years into the future) may have a negative public health impact.
Summary of Current Policy
In Australia, nicotine for use in E‑cigarettes is classified as a poison and, therefore, nicotine E‑cigarettes cannot be legally sold in Australia. Despite this, if an E‑cigarette product (regardless of whether it contains nicotine) can prove that it is a safe and effective aid to help people quit smoking it could be approved for sale as a therapeutic good. To date, however, no E‑cigarette product has been approved for this purpose.
Non-nicotine E‑cigarettes are regulated by the states and territories. The regulations relating to the sale, marketing, and use of E‑cigarettes vary between states and territories. In most jurisdictions, non-nicotine E‑cigarettes can be legally sold but the sale of these products is prohibited in Western Australia.
There is significant divergence in the approach to regulating E‑cigarettes internationally; from complete prohibition, to prohibiting only nicotine E‑cigarettes, to allowing the sale of all types of E‑cigarette. Notably, nicotine E‑cigarettes can be legally bought and sold in the USA, the European Union, and the UK. Both New Zealand and Canada have also indicated that they intend to make legislative changes to legalise the sale of nicotine E‑cigarettes.
Chapter 2 provides background and context to the issues discussed throughout the report. Issues discussed in Chapter 2 include: the development of E‑cigarettes; types of E‑cigarettes available; the prevalence of tobacco smoking and E‑cigarette use in Australia and overseas; regulatory principles such as the precautionary principle and harm reduction; tobacco control policy in Australia; and E‑cigarette regulations in Australia and internationally.
Chapter 3 discusses the health considerations relating to E‑cigarettes, including: research on the effectiveness of E‑cigarettes as a smoking cessation aid; the use of E‑cigarettes as a substitute for smoking or in conjunction with smoking; the possibility that E‑cigarettes could increase the likelihood of young people taking up smoking; the health impacts of long term E‑cigarette use; and other potential risks such as battery explosions and nicotine poisoning.
Chapter 4 outlines personal accounts of E‑cigarette use and discusses issues raised, such as the use of E‑cigarettes as an aid to quit smoking and the health effects of switching from tobacco smoking to E‑cigarette use.
Chapter 5 discusses the approaches taken to regulate E‑cigarettes in Australia and overseas. In particular, Chapter 5 details: E‑cigarette regulations in Australian states and territories; regulating E‑cigarettes as a therapeutic good; the potential to regulate E‑cigarettes as a consumer good; regulatory issues relating to the use of E‑cigarettes in public places; labelling, packaging, marketing, and product safety regulations; taxation issues; the regulatory approaches to E‑cigarettes internationally; and the proposed changes to E‑cigarette regulation in New Zealand.