A number of Australian, global, and overseas health agencies have issued position statements on e-cigarettes. Excerpts from some of these are included below; readers should refer to the original position statements for further detail. The statements reflect each agency or group’s assessment of the weight of the evidence at that particular point in time, and where multiple statements have been issued by the same organisation, we have included summaries of each. For an overview of the current state of evidence on vaping, see our sections on prevalence, health effects, effects on smoking, and population-level benefits and harms. Regulation of e-cigarettes in Australia is described in Section 18.13 and regulation in other countries is discussed in Section 18.14.
The Australian Government has taken a precautionary approach to e-cigarettes focussing on the overall potential impact of e-cigarettes on population health. In its June 2020 response to a report by the Parliament’s Standing Committee on Health, Aged Care and Sport on the use and marketing of e-cigarettes and personal vaporisers in Australia, the Government noted evidence linking e-cigarettes to tobacco use and nicotine addiction, and the risks of e-cigarette use leading to future smoking in the young adult population. The response concluded:
The Government will continue to monitor the impact of e-cigarettes on smoking cessation. However, at a population level, there is currently insufficient evidence to promote the use of e-cigarettes for smoking cessation. The Government will also continue to monitor emerging evidence regarding the direct harms e-cigarettes pose to human health, their impacts on smoking initiation, uptake among youth and dual use with conventional tobacco products. Finally, the Government’s current approach to e-cigarettes is premised on ensuring flexibility to change in light of new evidence. 1
Previous statements by various Government agencies are described in Section 18.15.1 below.
18.15.1 Australian Government agencies
Several Government agencies have released individual position statements on e-cigarettes, as summarised below.
The Therapeutic Goods Administration
The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health, and is responsible for regulating therapeutic goods, including prescription medicines. This includes regulating supply, import, manufacturing and advertising of therapeutic goods; and ensuring that therapeutic goods meet required standards of safety, quality and efficacy. 2
In 2015, the TGA noted that: 3
Unlike Nicotine Replacement Therapy (NRT) products, which have been rigorously assessed for efficacy and safety and, therefore, approved by the Therapeutic Goods Administration for use as aids in withdrawal from smoking, no assessment of electronic cigarettes has been undertaken and, therefore, the quality and safety of electronic cigarettes is not known.
The Australian Government is concerned about the use of electronic cigarettes in Australia. The impact of wide-scale use of these devices on tobacco use is not known, and the outcome in the community could be harmful.
During 2020, the TGA undertook a review of the scheduling of nicotine vaping products. After two rounds of public consultation and consideration of submissions to a Senate Select committee that held hearings in November 2020 and released a report in December 2020, 4 a senior medical officer of the TGA decided that Schedule 4 to the Australian Poisons Standard would be amended to clarify the status of all nicotine vaping products as prescription-only medicines. 5 A major review of legislation pertaining to vapes was undertaken during 2023 and new legislation came into place in stages on 1 January, 1 March and 1 July 2024—see Section 18.13 for details.
In September 2021 the TGA also released a Therapeutic Good Order (TGO-110) setting out minimum safety and quality requirements for nicotine vaping products that are not registered by the Australian Register of Therapeutic Goods (ARTG) but are imported into, supplied in or exported from Australia. This was updated in January 2024 and will be updated again in December 2024—refer Section 18.13 for further details.
The Australian Government Department of Health and Aged Care
In September 2019, Australia’s Chief Medical Officer and the State and Territory Chief Health Officers presented a joint statement about the emerging link between e-cigarette use and lung disease.
The statement reported that:
All Australian governments are united in maintaining a precautionary approach to the marketing and use of e-cigarettes. There is growing evidence implicating e-cigarettes in a range of harms to individual and population health. E-cigarettes are relatively new products and the long-term safety and health effects associated with their use and exposure to second-hand vapour are unknown.
At a population level, there continues to be insufficient evidence to promote the use of e-cigarettes for smoking cessation. 6
A similar statement was made in December 2019 in a meeting of the Ministerial Drug and Alcohol Forum (MDAF). It noted there was growing evidence for “the direct harms e-cigarettes pose to human health, their impact on smoking initiation and cessation, uptake among youth and dual use with conventional tobacco products.” The ministers agreed to continue monitoring developing evidence. 1
The MDAF statement received support from Cancer Council Australia, Lung Foundation Australia, the Public Health Association of Australia and the Thoracic Society of Australia and New Zealand in a joint statement which commended the ministers “for standing firm on evidence-based health policy and ignoring recent lobbying from commercial interests.” 7
In May 2020, the Australian Health Protection Principal Committee (AHPPC) issued a statement on tobacco use, e-cigarette use and COVID-19, noting that:
There is currently no direct evidence available examining the impacts of e-cigarette use on COVID-19 disease susceptibility and/or progression. However, there is increasing evidence that e-cigarette use poses a range of harms to the heart and lungs.
Clinicians should use the opportunity to intervene with patients who are smokers or users of e-cigarettes and discuss options for quitting. 8
The Department of Health’s submission to the Senate Select Committee on Tobacco Harm Reduction Inquiry in November 2020, stated:
The Australian Government is taking a precautionary approach to e-cigarettes, due to current evidence that raises concerns about direct health harms associated with e-cigarette use, concurrent use of e-cigarettes with tobacco products, and the potential for e-cigarette use to lead to nicotine addiction and tobacco use, particularly among youth.
It is important that e-cigarette regulation takes a comprehensive, evidence-based and proportionate approach that can be adapted as new evidence emerges. There is also a need to closely monitor and eliminate marketing strategies employed by the tobacco and e-cigarette industries to circumvent tobacco control efforts. Regulation should aim to protect the Australian community from the potential harms of e-cigarette use and ensure that e-cigarette use does not undermine Australia’s achievements in tobacco control and public health. 9
On 1 September 2023, health ministers from state, territory, and national governments released a joint communique expressing their commitment to enhancing the regulation of e-cigarettes. 10
In March 2024, the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024 was referred to the Senate Standing Committee on Community Affairs for inquiry and report. 11 The Department of Health and Aged Care lodged a submission to the Inquiry explaining the rationale behind the proposed reforms, stating:
The Australian Government has committed to strengthening the regulation of vapes as part of a comprehensive approach to reduce tobacco and e-cigarette use. The Government’s approach acknowledges the current evidence regarding the direct health risks that vapes may pose to human health, and the impact that vaping may have on population-wide tobacco use.
The Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024 (the Bill) would amend the Therapeutic Goods Act 1989 (the TG Act) to restrict the importation, domestic manufacture, supply, commercial possession and advertisement of non-therapeutic and disposable single use vapes while at the same time preserving legitimate patient access to therapeutic vapes for smoking cessation and the management of nicotine dependence. The Bill builds on the Government’s reforms to the regulation of vaping goods, which commenced from 1 January 2024.
Strengthening the regulation of all vapes across all stages of the supply chain, banning all disposable single use vapes and ending sales outside of pharmacy settings will make it easier to identify and disrupt the illicit supply of vapes and take enforcement action against commercial operators. 12
On 19 April 2024, Australian health ministers released a joint statement declaring their support for the Bill. 13 The AHPPC also issued a statement in May 2024 14 and again in June 2024 15 supporting the introduction of the Bill’s reforms.
The Australian Competition & Consumer Commission (Product Safety Australia)
The Australian Competition & Consumer Commission (ACCC) has a role in ensuring products are marketed in a way that is truthful and, to identify and address the risk of serious injury and death from safety hazards in consumer products. In 2019 it stated:
No assessment of the safety and quality of electronic cigarettes has been undertaken… The quality and safety of electronic cigarettes is not known. 16
The ACCC’s submission to the Senate Select Committee on Tobacco Harm Reduction Inquiry in November 2020, stated:
The ACCC supports the efforts of the TGA to regulate e-cigarettes and novel nicotine delivery systems. This includes the TGA’s interim decision on the proposed amendment to re-schedule nicotine for human use from Schedule 7 to Schedule 4 of the Poisons Standard (other than nicotine in tobacco prepared and packed for smoking or smoking cessation aids), so that nicotine in products such as e-cigarettes, e-liquid, chewing tobacco, heat-not-burn tobacco products, and snuff, can only be supplied with a doctor’s prescription. 17
National Health and Medical Research Council
Among other roles, the National Health and Medical Research Council (NHMRC) has responsibility for disseminating evidence-based health advice to the Australian community, via health professionals and government. The CEO of the NHMRC first released a statement on e-cigarettes in 2015. 18 The CEO statement was updated in 2017, and concluded:
there is currently insufficient evidence to support claims that e-cigarettes are safe and further research is needed to enable the long-term safety, quality and efficacy of e-cigarettes to be assessed. 19
From 2020 to 2022, the NHMRC established the Electronic Cigarettes Working Committee and commissioned several evidence reviews on the topics of e-cigarette use and smoking behaviour (uptake and cessation), the effects of e-cigarette advertising, promotion and sponsorship, and e-cigarette use and health outcomes, and undertook a scoping review on the toxicology of e-cigarettes. The reviews were independently reviewed for quality and evidence was synthesised and subsequently reviewed by independent experts and the federal, state and territory Chief Health Officers/Chief Medical Officers. 20 Based on this review, the NHMRC released an updated CEO statement on E-cigarettes in 2022, noting that:
- E-cigarettes heat liquid containing chemicals to an aerosol that users breathe in. Using an e-cigarette is also known as vaping.
- E-cigarettes can be harmful. All e-cigarette users are exposed to chemicals and toxins that have the potential to cause adverse health effects.
- E-cigarette-related poisonings have substantially increased over the past 5 years. E-cigarette related calls to Australian Poisons Information Centres have more than doubled between 2020 and 2021. Most poisonings are occurring in toddlers and adults.
- People who have never smoked may be more likely to take up tobacco smoking if they use e-cigarettes.
- Teenagers exposed to e-cigarette content on social media are more likely to try e-cigarettes. The World Health Organization recommends that e-cigarettes are treated in the same way as tobacco products, including use of bans and restrictions on advertising, promotion and sponsorship.
- There are other proven safe and effective options to help smokers quit. E-cigarettes are not proven safe and effective smoking cessation aids. For some smokers, using nicotine e-cigarettes may assist them to quit smoking. However, more research is needed to confirm the harms and benefits of using them for this purpose.
- There are no health benefits of using e-cigarettes for people who do not currently smoke. Short-term e-cigarette use may benefit current smokers if they are able to quit smoking and have been previously unsuccessful with other smoking cessation aids.
- People seeking additional assistance to quit tobacco smoking or quit e-cigarettes should seek further information from reliable sources, such as their healthcare practitioner or quit services.
- Further research is needed in many areas and NHMRC is currently funding a number of studies investigating e-cigarettes. 21
CSIRO (Commonwealth Scientific and Industrial Research Organisation)
In 2018, the CSIRO released a major review of the evidence on e-cigarettes, smoking and health. Regarding the impacts of the use of e-cigarettes, personal vaporisers and nicotine on individual and population health, it concluded:
The evidence available suggests that regular use of e-cigarettes is likely to have adverse health consequences. There is a lack of clarity about the magnitude of adverse health effects, and the quantity of e-cigarette use required to trigger adverse health effects. 22
Australian Industrial Chemicals Introduction Scheme
In 2019, the Australian Industrial Chemicals Introduction Scheme (previously the National Industrial Chemicals Notifications and Assessment Scheme) published a report based on i a study of the chemistry of liquids used in e-cigarette devices in Australia, which concluded the following about potential health concerns and health effects:
- “Many flavours of e-cigarette liquids are available and the specific e-cigarette liquid used is a major determinant of the chemical exposure from e-cigarette use.
- A number of flavouring chemicals used as ingredients in e-cigarette liquids are of concern to human health. Of particular concern are diketone flavourings, which have been linked to irreversible lung damage known as bronchiolitis obliterans or ‘popcorn lung’.
- Emissions from e-cigarette devices contain carbonyl compounds formed as reaction products of the e-cigarette liquid used, and these compounds may pose a risk to human health. Although it is uncertain as to whether some concentrations of carbonyl compounds measured in laboratory studies accurately reflect normal e-cigarette use, e-cigarette devices are capable of producing carbonyl compounds at levels that may be of concern to human health.
- E-cigarette emissions also contain contaminants mostly derived from the e-cigarette liquid but also from the device. The contaminants identified are metals, volatile organic compounds (VOC), phthalates, pesticides and tobacco-specific nitrosamines. At a sufficient concentration and exposure, the contaminants identified in e-cigarette emissions may have the potential to adversely affect human health.
- The particulate characteristics of e-cigarette emissions and modelling of their lung distribution indicate there is significant deposition of these emissions in the alveoli.
- E-cigarette use can cause acute (short-term) adverse health effects (to which nicotine may be a contributing factor), although the chronic (long-term) effects of e-cigarette use on health are unknown.” 23
18.15.2 Australian non-government agencies
Cancer Council Australia, Heart Foundation and Quit
These agencies issued a joint position statement in 2015. 24 In their overview, the agencies state that:
based on past experience in tobacco control and early research on electronic cigarettes, there is sufficient information to act on three particular regulatory gaps in order to prevent uptake and use of electronic cigarettes by young people and other risks to public health. Areas in need of priority attention for this purpose include the proper regulation of: (a) non-nicotine electronic cigarettes; (b) use in smoke-free environments; and (c) advertising.
The agencies make the following recommendations:
- Ban the retail sale of non-nicotine electronic cigarettes (unless the product has been approved by the TGA). It is currently unlawful to sell electronic cigarettes that contain nicotine in any form. This is because nicotine is a scheduled poison and can only be lawfully sold in the form of legal tobacco products (a historical anomaly) and approved nicotine replacement products. This position could change in the future for individual nicotine electronic cigarette products that receive approval from the TGA. Similar restrictions should also apply to non-nicotine electronic cigarettes, which come in a variety of fruit, confectionery and other flavours that appeal to children. Laws in South Australia, Western Australia and Queensland prohibit the sale of products that resemble tobacco products. There are no such laws in other states and territories, meaning that non-nicotine electronic cigarettes (when marketed without therapeutic claims) can be lawfully sold, including to young people.
- Ensuring smoke-free laws in each state and territory cover electronic cigarette use. The purchase, possession or use of electronic cigarettes containing nicotine is currently unlawful under state and territory poisons and public health laws. However, these laws are complicated and difficult to enforce. Prohibiting use of all electronic cigarettes under smoke-free laws would make the law clear for the community and ensure that both nicotine and non-nicotine electronic cigarettes are not used in places where smoking tobacco is prohibited.
- Prohibiting advertising and promotion of electronic cigarettes, consistent with tobacco advertising prohibitions. Electronic cigarettes are being aggressively promoted, with young people and children clearly identified as a target market. Electronic cigarette advertising should be subject to similar restrictions as tobacco products.
In 2018, Cancer Council Australia, the National Heart Foundation of Australia, the Australian Medical Association, Cancer Australia, and the Thoracic Society of Australia and New Zealand released a joint statement, 25 concluding:
Based on current evidence, the potential benefit of e-cigarettes on smoking cessation is not established, and there is increasing evidence of health harms. Accordingly, the undersigned health and medical organisations support a precautionary approach to the promotion and availability of e-cigarettes in Australia. This is in line with recommendations from the World Health Organization and the World Federation of Public Health Associations.
The Heart Foundation and Quit issued a joint statement in September 2021, following the implementation of new prescription requirements to access nicotine containing e-cigarette products. The statement notes that: ‘cessation of nicotine and/or non-nicotine vaping should be strongly encouraged as there are inherent health risks in repeatedly inhaling the aerosol (with and without nicotine).’ 26
In 2023, the Heart Foundation in response to a TGA consultation on Potential reforms to the regulation of nicotine vaping products (NVPs),recommended: introduction of import controls on all vaping products, registration requirements of nicotine vaping products (NVPs), improvement of minimum quality and safety standards for NVPs, clarification on the status of NVPs as therapeutic goods, regulation or ban of non-NVPs, and a whole-of-government approach to control the importation and supply of NVPs. 27
In April 2024, Cancer Council Australia noted its support for the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024 to the Senate inquiry into the Bill. It expressed strong endorsement of the Bill's intent and proposed three amendments:
- More specifically define the term ‘commercial quantity’ in the Bill.
- Require reporting of criminal prosecutions and civil proceedings to the Illicit Tobacco and E-cigarette Commissioner
- Safeguard against tobacco and vaping advertising and promotion to Health Practitioners. 28
Cancer Council Australia’s submission and amendments were supported by the Cancer Council Federation, 29-35 Quit 36 and the Australian Council on Smoking and Health (ACOSH) 37 . The Heart Foundation also made a submission supporting the passage of the Bill. 38 In June 2024, Quit and Cancer Council Victoria, 39 and the Heart Foundation 40 issued media releases welcoming the Senate’s decision to pass an amended version of the Bill.
Australian Medical Association
The Australian Medical Association (AMA) released Tobacco smoking and e-cigarettes in December 2015. 41 The statement notes that ‘the AMA has significant concerns about e-cigarettes. E-cigarettes and the related products should only be available to those people aged 18 years and over and the marketing and advertising of e-cigarettes should be subject to the same restrictions as cigarettes. E-cigarettes must not be marketed as cessation aids as such claims are not supported by evidence at this time.’ Elsewhere in the document, it states that:
The evidence supporting the role of e-cigarettes in cessation is mixed and low level, and e-cigarettes are not currently recognised as cessation aids by the National Health and Medical Research Council, the Therapeutic Goods Administration or the World Health Organisation. In fact, using an e-cigarette may significantly delay the decision to quit smoking. In addition, there is uncertainty about the longer term health implications of inhaling the vapours produced by the illegally imported (and unregulated) solutions.
There are legitimate concerns that e-cigarettes normalise the act of smoking. This has the potential to undermine the significant efforts that have been dedicated to reducing the appeal of cigarettes to children, young people and the wider population. These concerns are supported by research findings that young people using e-cigarettes progress to tobacco smoking. Currently there is no medical reason to start using an e-cigarette.
The AMA also issued a statement of support for the Australian Government’s decision in 2020 to ban the importation of nicotine containing e-cigarettes, unless prescribed by a doctor. 42
In 2022, the AMA called for stronger regulatory measures to curb the uptake of recreational vaping. Their recommendations included federal action to prevent illegal advertising of vaping products particularly online, enforcement of existing regulations, packaging regulations, nicotine concentration limits a ban on personal importation, the inclusion of nicotine vaping products (NVPs) in the Real Time Prescription Monitoring program, and amending Medicare Benefits Schedule (MBS) items to ensure only a patient's regular doctor can prescribe NVPs. 43 , 44
In April 2024, the AMA‘s submission to the Senate inquiry into the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024. endorsed the proposed legislation, particularly the proposed change to the prescription pathway allowing all GPs to prescribe therapeutic vapes for smoking cessation or nicotine dependence management. 45 The AMA also welcomed the Senate’s decision to pass an amended version of the Bill in June 2024. 46
Public Health Association Australia
The Public Health Association of Australia (PHAA) stated in 2018: 47
Based on current evidence, and in line with recommendations from the WHO, the World Federation of Public Health Associations, the Cancer Council, Heart Foundation, Cancer Australia and other leading evidence-based organisations, the PHAA strongly supports a precautionary approach to the use, promotion and availability of e-cigarettes in Australia.
In April 2024, the PHAA submitted to the Senate inquiry into the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024, noting its strong support for the Bill. 48 The PHAA also welcomed the Senate’s decision to pass an amended version of the Bill on 26 th June 2024. 49
Lung Foundation Australia
In 2017, the Lung Foundation Australia released a joint submission with the Thoracic Society of Australia and New Zealand to the government inquiry into the use of electronic cigarettes and personal vaporisers in Australia. Its summary stated that:
There is no good public health claim for an unregulated approach to e-cigarettes and personal vaporisers. There is a strong case for a total ban on these products as they are currently available. 50
In 2024, the Lung Foundation Australia made a submission to the Senate inquiry into the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024. It expressed support for the bill and emphasised the need to clearly define 'personal possession' versus 'commercial possession' to prevent the criminalisation of individuals for personal use of e-cigarettes. 51
Royal Australasian College of Physicians
The Royal Australasian College of Physicians’ (RACP) May 2018 policy on e-cigarettes stated:
The RACP is concerned there remains a lack of clear and robust evidence to inform policy makers, clinicians and the public about e-cigarettes. While there is some evidence that e-cigarettes may reduce the number of tobacco cigarettes smokers consume and that they are likely to be less harmful than tobacco cigarettes (due to lower level of potentially toxic substances in e-cigarettes compared with tobacco cigarettes), the evidence on their efficacy as aids in smoking cessation and their long-term health effects is either mixed or limited. There is also evidence indicating that their use affects the likelihood of youth initiating use of tobacco cigarettes. Based on the current evidence, at this point in time the net public health effect of e-cigarettes cannot be clarified with any degree of confidence. 52
In March 2020 the RACP’s submission to the New Zealand Health Select Committee regarding the Smokefree Environments and Regulated Products (Vaping) Amendment Bill stated its position on e-cigarettes:
For those who do not smoke, the RACP believes that e-cigarettes present no health benefits and only potential harm, and their use should be discouraged. For those who do smoke, the RACP believes that vaping has potential as a smoking cessation tool. For all groups, our Policy emphasises that e-cigarettes which employ nicotine containing e-liquid are addictive, and should be treated with caution. 53
In April 2020 the RACP issued a media release clarifying that:
“The RACP advises that not smoking tobacco or using e-cigarettes remain the safest options for the community. The long-term implications of using vaping devices are not yet known. The RACP advocates for the proven and registered smoking cessation technologies, including pharmacotherapies, ahead of vaping.” 54
Australian Council on Smoking and Health
In March 2019, Australian Council on Smoking and Health (ACOSH) provided a statement to the Select Committee on Personal Choice and Community Safety, Legislative Council, Parliament of Western Australia. It concluded:
There is insufficient evidence to recommend e-cigarettes as a safe and efficacious method to give up smoking. It is also important to note that we are now seeing increasing evidence of harms attributable to their use. It is also important to emphasise that there is now also convincing evidence that the use of e-cigarettes by children and young people is an on-ramp for the use of traditional cigarettes. In recent months, the US Surgeon General, Secretary for Health and Commissioner of the Food and Drug Administration have sounded an alarm about the “epidemic” of vaping there by adolescents. 55
In January 2023, ACOSH made a statement to the TGA consultation on Potential reforms to the regulation of nicotine vaping products (NVPs). It supported the Australian Government’s precautionary approach to e-cigarettes and advocated for several measures, including banning the importation of all vaping products, limiting flavours to tobacco only, implementing plain packaging, reducing the maximum nicotine concentration, and eliminating access to disposable NVPs . 56
In April 2024, ACOSH submitted to the inquiry into the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024 expressing strong support for the Bill and endorsing the amendments proposed by the Cancer Council Australia. 37 In June 2024, ACOSH strongly urged the Senate to pass the Bill, publishing an open letter and an advertisement endorsed by 63 organisations and 14 leading researchers and clinicians. 57 It also welcomed passage of the Bill. 58
VicHealth
VicHealth, in a 2017 submission to the Standing Committee on Health, Aged Care and Sport, recommended:
- E-cigarettes and personal vaporisers (ECPVs) should only be made available as a smoking cessation aid if they are approved by the Therapeutic Goods Administration (TGA).
- ECPV use should be subject to the same restrictions as tobacco smoking, and therefore should not be permitted in existing smoke-free areas.
- ECPVs should only be marketed as a therapeutic good if approved by the TGA. 59
In April 2024, VicHealth made a submission in support of the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024 to the inquiry into the Bill. 60 In June 2024, VicHealth issued a statement welcoming the Senate’s decision to pass an amended version of the Bill. 61
Australian Dental Association
In January 2022, the Australian Dental Association published a factsheet stating:
“The use of e-cigarettes or personal vaporisers (vaping) is not encouraged as a replacement for tobacco smoking or as a method of quitting tobacco smoking. There is currently insufficient evidence to demonstrate that e-cigarettes are effective in helping people to quit smoking.” 62
Pharmaceutical Society of Australia
The Pharmaceutical Society of Australia (PSA) issued a statement in June 2024 regarding the proposed amendments to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024. The PSA stated it was not supportive of the amendments (which reclassified e-cigarettes as a Pharmacist Only Medicine (Schedule 3)), citing an inadequate transition of nicotine vaping products from retail to healthcare professional management. In a statement, the PSA president said:
“Further, PSA continues to strongly support the government’s intent to limit the supply of vaping and removing vapes from retail settings. However, the amendment proposed undermines the role of pharmacists as health care professionals. The amendment – if it was to pass the Senate in its current form – asks pharmacists to prescribe unapproved, unregulated, untested vaping products to the public. This would not represent a health model. Pharmacist Only Medicines are pharmacist-prescribed medicines, which include a consultation with patients to establish therapeutic need. Not having patient information recorded in the prescribing of nicotine-containing vapes is inconsistent with the normal provision of health care. We cannot and do not support positioning pharmacists as retailers rather than health professionals.” 63
Following the passing of the amended Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024 in June 2024, the PSA stated:
While the amendments to the legislation are not PSA’s preferred approach, we also recognise the need for strong action to address the vaping public health crisis, and this starts with ending retail supply of vapes. 64
Royal Australian College of General Practitioners
The Royal Australian College of General Practitioners’ (RACGP) guide on Supporting Smoking Cessation for health professionals, updated in September 2021, stated under Recommendation 15:
For people who have tried to achieve smoking cessation with first-line therapy (combination of behavioural support and TGA-approved pharmacotherapy) but failed and are still motivated to quit smoking, NVPs may be a reasonable intervention to recommend along with behavioural support. However, this needs to be preceded by an evidence-informed shared-decision making process, whereby the patient is aware of the following caveats:
- Due to the lack of available evidence, the long-term health effects of NVPs are unknown.
- NVPs are not registered therapeutic goods in Australia and therefore their safety, efficacy and quality have not been established.
- There is a lack of uniformity in vaping devices and NVPs, which increases the uncertainties associated with their use.
- To maximise possible benefit and minimise risk of harms, dual use should be avoided and long-term use should be minimised.
- It is important for the patient to return for regular review and monitoring. 65
In December 2023, the RACGP released a provisional draft guidance for stakeholder consultation on smoking and vaping cessation support, in response to changes in Australia’s vaping regulations. The RACGP Expert Advisory Group (EAG) assessed the overall magnitude of acute adverse effects of NVP use in clinical settings as minor, based on a review by the Australian National University. It also re-evaluated the certainty of evidence for recommendation 15, concerning the use of NVPs for smoking cessation, raising it to a moderate level. The guidance advises that NVPs are not recommended as a smoking cessation aid for individuals under 18 years of age or for those who are pregnant or breastfeeding. 66
In March 2024, the RACGP issued a statement supporting the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024. 67 In June 2024, the RACGP issued a statement welcoming the Senate’s decision to pass an amended version of the Bill. 68
Royal Australian and New Zealand College of Psychiatrists
In contrast to other Australian health organisations, the Royal Australian and New Zealand College of Psychiatrists (RANZCP) has stated its support for the legalisation and regulation of e-cigarettes to facilitate their use as harm reduction tools in position statements issued in 2018 69 and 2023 70 . In the 2023 statement, the RANZCP recommended:
- Nicotine vaping products become a common tool in the arsenal of all psychiatrists as a harm minimisation tool when caring for those with mental illness who are dependent on nicotine via tobacco use.
- Nicotine vaping products safety standards should continue in line with current TGA (Australia) and Vaping Regulatory Authority (Aotearoa New Zealand) requirements to reduce short- and long-term harms associated with these products.
- Nicotine vaping products should not be prescribed to or used by people not dependent on nicotine via tobacco use.
- Nicotine vaping products should not be advertised to young people and adults being prescribed should be counselled to not make nicotine vaping units available to children and adolescents.
- Nicotine vaping products are subject to further research in order to determine:
- the long-term health effects of vaping
- the effectiveness of e-cigarettes and vaporisers as a cessation tool
- the demographic patterns of use including rates of initiation by young people. 70
Thoracic Society of Australia and New Zealand
In 2020, the Thoracic Society of Australia and New Zealand (TSANZ) reviewed the literature on the health effects of e-cigarettes (EC) and issued the following position statement:
“EC have adverse lung effects and harmful effects of long-term use are unknown. EC are unsuitable consumer products for recreational use, part-substitution for smoking or long-term exclusive use by former smokers. Smokers who require support to quit smoking should be directed towards approved medication in conjunction with behavioural support as having the strongest evidence for efficacy and safety. No specific EC product can be recommended as effective and safe for smoking cessation. Smoking cessation claims in relation to EC should be assessed by established regulators.” 71
In 2024, TSANZ submitted to the Senate inquiry into the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024 in support of the reforms. 72
18.15.3 Global agencies
For the most part, position statements of global agencies have adopted a cautious stance on e-cigarettes. These agencies emphasise the need for stringent controls to mitigate potential health risks and prevent youth uptake, and advocate for prioritising proven smoking cessation methods over e-cigarettes.
The World Health Organization and the Framework Convention on Tobacco Control
In response to the increase in e-cigarette use, in 2009 the World Health Organization (WHO) Study Group on Tobacco Product Regulation reviewed the evidence and recommended that ENDS should be ‘regulated as combination drugs and medical devices and not as tobacco products.’ 73
At the Fifth Session of the Conference of the Parties to the WHO Framework Convention on Tobacco Control (FCTC) in November 2012, the WHO was invited to report on the ‘control and prevention of smokeless tobacco products and electronic nicotine delivery systems, including electronic cigarettes’, 74 and to present this report to the Sixth Session of the Conference of Parties, to be held in 2014.
In the lead-up to the release of this report, Dr Margaret Chan, Director-General of the WHO, was sent a letter signed by 53 ‘specialists in nicotine science and public health policy,’ urging the WHO to consider the potential for tobacco harm reduction products to reduce the burden of smoking-related disease. 75 In the following weeks a second letter signed by 129 ‘public health and medical authorities from 31 countries’ was sent to Dr Chan, countering the arguments put forward in the first letter and encouraging the WHO to maintain its evidence-based approach to shaping an appropriate regulatory framework for ENDS. 76
In October 2014, the WHO presented its report Electronic nicotine delivery systems to Sixth Session of the FCTC Conference of the Parties in Moscow. 77 The report included the following clauses:
General considerations (clauses 33–38)
33. Smokers will obtain the maximum health benefit if they completely quit both tobacco and nicotine use. In fact, Article 5.2(b) of the Convention commits Parties not only to preventing and reducing tobacco consumption and exposure to tobacco smoke but also to preventing and reducing nicotine addiction independently from its source. Therefore, while medicinal use of nicotine is a public health option under the treaty, recreational use is not.
34. The rapid growth of ENDS use globally can neither be dismissed nor accepted without efforts to appropriately regulate these products, so as to minimize consequences that may contribute to the tobacco epidemic and to optimize the potential benefits to public health. Thus it is important to identify public health concerns and to consider these concerns when undertaking regulation and surveillance.
35. Regulation of ENDS is a necessary precondition for establishing a scientific basis on which to judge the effects of their use, and for ensuring that adequate research is conducted, that the public has current, reliable information as to the potential risks and benefits of ENDS, and that the health of the public is protected. Public health authorities need to prioritize research and invest adequately to elucidate evidentiary uncertainties as soon as possible. However, the greater responsibility to prove claims about ENDS scientifically should remain with the industry.
36. When designing a regulatory strategy for ENDS, governments should bear in mind the following general regulatory objectives:
(a) impede ENDS promotion to and uptake by non-smokers, pregnant women and youth;
(b) minimize potential health risks to ENDS users and non-users;
(c) prohibit unproven health claims from being made about ENDS; and
(d) protect existing tobacco-control efforts from commercial and other vested interests of the tobacco industry.
37. Because the product, the market and the associated scientific evidence surrounding ENDS are all evolving rapidly, all legislation and regulations related to ENDS should be adaptable in response to new scientific evidence, including evaluation of different models for ENDS regulation, as evidence accumulates.
38. 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 ENDS will not significantly decrease smoking-attributable disease and mortality even if the full theoretical risk reduction potential of ENDS were to be realized.
The Conference of the Parties accepted the WHO report and requested that the WHO be further invited to prepare ‘an expert report, with independent scientists and concerned regulators… with an update on the evidence of the health impacts of ENDS/ENNDS, potential role in quitting tobacco usage, impact on tobacco control efforts, and to subsequently assess policy options’ for the prevention and control of ENDS. 78
The updated report was presented to the Seventh Session of the Conference of the Parties, which took place in India in November 2016. 79 As to the potential role of e-cigarettes in tobacco control, it concludes that:
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. This would only be the case if the recruitment of minors and non-smokers into the nicotine-dependent population is no higher than it is for smoking, and eventually decreases to zero. Whether ENDS/ENNDS can do this job is still a subject of debate between those who want their use to be swiftly encouraged and endorsed on the basis of available evidence, and others who urge caution given the existing scientific uncertainties as well as the performance variability of products and the diversity of user behaviour. 80
The decision following the report:
Invites Parties to consider applying regulatory measures such as those referred to in document FCTC/COP/7/11 to prohibit or restrict the manufacture, importation, distribution, presentation, sale and use of ENDS/ENNDS, as appropriate to their national laws and public health objectives. 81
At the Eighth Session of the Conference of the Parties that took place in Switzerland in 2018 the decision was made to formally recognise heated tobacco products as tobacco products and therefore were made subject to the provisions of the WHO FCTC and domestic legislation. Parties were also reminded to prioritise protecting tobacco-control policies and activities from the commercial interests of novel and emerging tobacco product industries, in accordance with Article 5.3 of the WHO FCTC. In addition to applying measures in Article 13 of the WHO FCTC to the advertising, promotion and sponsorship of novel and emerging tobacco products. 82
In 2019, the WHO Report on the Global Tobacco Epidemic 2019 included the following statement:
The scientific evidence on e-cigarettes as cessation aids is inconclusive and there is a lack of clarity as to whether these products have any role to play in smoking cessation. There are also real concerns about the risk they pose to non-smokers who start to use them, especially young people. Unlike the tried and tested nicotine and non-nicotine pharmacotherapies that are known to help people quit tobacco use, WHO does not endorse e-cigarettes as cessation aids.
As ENDS are increasingly introduced to the market, careful monitoring of cessation rates is vital. The possibility of tobacco industry interference in tobacco cessation efforts through misinformation about the potential benefits of these products – which are presented as alternatives but in most cases are complementary to the use of conventional tobacco products – is a present and real threat. 83
In May 2021, the WHO Study Group on Tobacco Product Regulation issued an updated Report on the Scientific Basis of Tobacco Product Regulation. The key recommendations for policy makers included:
- to require tobacco manufacturers to disclose all product information – including product design, chemical profile, total nicotine content, nicotine forms, toxicity, other findings of product testing and testing methods – to appropriate regulatory agencies at least once a year; any modifications to products should require updating of the report;
- to ban all commercial marketing of electronic nicotine delivery systems, electronic non-nicotine delivery systems and heated tobacco products, including in social media and through organizations funded by and associated with the tobacco industry;
- to prohibit the sale of electronic nicotine delivery systems and electronic non-nicotine delivery systems in which the user can control device features and liquid ingredients (that is, open systems);
- to prohibit the sale of electronic nicotine delivery systems with a higher abuse liability than conventional cigarettes, for example by restricting the emission rate or flux of nicotine; and
- to prohibit the addition of pharmacologically active substances such as cannabis and tetrahydrocannabinol (in jurisdictions where they are legal), other than nicotine in electronic nicotine delivery systems, to electronic nicotine delivery systems and electronic non-nicotine delivery systems. 84
In July 2021, the updated WHO Report on the Global tobacco epidemic 2021: addressing new and emerging products, recommended the following actions:
- Ensure continued focus on comprehensive evidence-based tobacco control measures to reduce nicotine addiction and tobacco use through all provisions of the WHO FCTC and full implementation of MPOWER.
- Where manufacture, sale and distribution of ENDS is not prohibited, adopt appropriate regulatory options to achieve the key objectives of protecting the population from potential health risks; preventing unproven claims being made about ENDS; and protecting tobacco control activities from commercial interests.
- Consider prohibiting the sale of ENDS that the user can modify (either its features or e-liquid ingredients)
- Where a ban on manufacture, sale and distribution of ENDS is the preferred regulatory approach to protect the health of a country’s population … countries should strictly implement the ban without any interference from the industry to ensure a high degree of protection for children and adolescents.
- Monitor the use of ENDS and ensure that data are disaggregated by age and sex.
- All these recommendations should also be applied to ENNDS. 85
In December 2023, the WHO released a ‘Call to action’ on e-cigarettes stating that ‘urgent measures are necessary to prevent uptake of e-cigarettes and counter nicotine addiction alongside a comprehensive approach to tobacco control’. The statement recommends:
- Where countries ban the sale of e-cigarettes, they should strengthen implementation of the ban and continue monitoring and surveillance to support public health interventions and ensure strong enforcement.
- Where countries permit commercialization (sale, importation, distribution and manufacture) of e-cigarettes as consumer products, they should ensure strong regulations to reduce their appeal and their harm to the population, including by banning all flavours, limiting the concentration and quality of nicotine, and taxing them.
- Irrespective of whether countries ban sale of e-cigarettes or permit commercialization as consumer products, these actions should be taken in conjunction with measures to motivate and assist existing users of tobacco products to quit tobacco use using proven methods, including advice from healthcare workers, toll-free quit lines, mobile and digital cessation services, and approved therapies.
- Countries do not pursue a smoking cessation strategy that permits commercialization of e-cigarettes as consumer products. Any cessation objective utilizing these products should carefully weigh national circumstances and the risk of uptake, and exhaust other proven cessation strategies. The conditions under which the products are accessed for cessation should be controlled to ensure appropriate clinical conditions, and the products should be regulated as medicines, rather than their sale being permitted as consumer products. 86
Detailed information on the evidence underpinning the WHO guidance are provided in a Technical note on the call to action on electronic cigarettes. 87
World Federation of Public Health Associations
The World Federation of Public Health Associations (WFPHA) issued a position statement in s support for the recommendations provided by the WHO in its 2014 report, Electronic nicotine delivery systems 77 and encouraging governments to apply a precautionary principle to e-cigarettes. 88 WFPHA also issued a resolution in 2016 on Appropriate controls of manufacture, distribution and marketing of e-cigarettes, concluding that:
all governments should apply the precautionary principle and should implement an appropriate regulatory regime for e-cigarettes as products that have the potential to cause considerable harm to the public’s health. 89
Forum of International Respiratory Societies
The Forum of International Respiratory Societies (FIRS) is composed of professional organisations and experts in respiratory disease. FIRS’ 2014 position on electronic nicotine delivery devices includes the following statements: 90
- There is concern that the use of electronic cigarettes is growing rapidly, especially among young people and women. Their acceptance may be attributed in part to the perception created by marketing and the popular press that they are safe.
- The health risk of electronic cigarettes has not been adequately studied.
- The addictive power of nicotine and its untoward effects should not be underestimated.
- The potential benefits of electronic nicotine delivery devices, including harm reduction and enhancing smoking cessation, have not been adequately studied.
- Potential benefits to an individual smoker should be weighed against harm to the population of increased social acceptability of smoking and use of nicotine.
- Health and safety claims regarding electronic nicotine delivery devices should be subject to evidentiary review.
- Adverse health effects for third parties exposed to the emissions of electronic cigarettes cannot be excluded.
- Parties to World Health Organization Framework Convention on Tobacco Control should consider whether allowing use of electronic cigarettes is consistent with the requirements of the treaty.
- Electronic nicotine delivery devices should be restricted or banned, at least until more information about their safety is available.
The FIRS released a further position statement in 2018, 91 specifically addressing e-cigarette use in youth. It concludes:
There can be no argument for harm reduction in children. To protect this vulnerable population from electronic cigarettes and other nicotine delivery devices, we recommend that electronic cigarettes be regulated as tobacco products and included in smoke-free policies. Sale of electronic cigarettes should be barred to youths worldwide. Flavouring should be prohibited in electronic cigarettes, and advertising accessible by youths and young adults be banned. Finally, we recommend greater research on the health effects of electronic cigarettes and surveillance of use across different countries.
World Medical Association
The World Medical Association (WMA) is an independent federation of 111 national medical associations, including the Australian Medical Association. 92 In its statement Electronic cigarettes and other electronic nicotine delivery systems, revised in 2023, the WMA recommend:
- That e-cigarettes and ENDS be subject to the WHO Framework Convention on Tobacco Control, and to jurisdictional smoke-free laws and regulations.
- That the manufacture and sale of e-cigarettes and ENDS be subject to national regulatory bodies as either a new form of tobacco product or as a drug delivery device. At a minimum, regulations should address maximum strength of nicotine fluids, tank size on vaping devices, product labeling, and child-resistant packaging. This recommendation also applies to devices using synthetic nicotine.
- That clinical testing, large population studies and full analyses of e-cigarette ingredients and manufacturing processes be conducted to determine their level of risk, viability, and efficacy as tools for tobacco cessation.
- That e-cigarettes and other ENDS should never be marketed as a valid or efficacious method for smoking cessation without validated clinical research that is assessed by appropriate regulatory bodies. In all other instances, plain package marketing should be required, in accordance with the WMA Resolution on Plain Packaging of Cigarettes, e-Cigarettes and Other Smoking Product.
- That the sale, marketing, distribution, and accessibility of e-cigarettes and other tobacco products to children and adolescents be prohibited.
- That the production, distribution and sale of flavored e-cigarette cartridges and candy products that depict or resemble tobacco products be prohibited.
- That the sale of e-cigarettes and ENDS via the internet be prohibited in order to prevent access to these products by minors.
- That physicians, pediatric practitioners and dentists inform their patients of the potential risks of using e-cigarettes and ENDS, e.g., addiction, cardiovascular disease, lung disease, impact on brain development due to nicotine, physical injuries, etc., even if regulatory authorities have not taken a position on the efficacy and safety of these products.
- That the WMA and its members support further research on the harmful effects of e-cigarettes and ENDS, especially in children, adolescents and young adults. 93
World Heart Federation
The World Heart Federation (WHF) represents around 200 heart foundations, scientific societies and patient organisations. In 2021, WHF issued a policy brief on e-cigarettes, which included the following recommendations for governments, policymakers and other stakeholders:
- Prohibit the sale and distribution of e-cigarettes to minors, as well as the use of flavouring agents.
- Prohibit the use of e-cigarettes anywhere tobacco cigarettes have been banned.
- Prohibit marketing, advertising, and misleading claims regarding e-cigarettes.
- Apply excise taxes on e-cigarettes.
- Conduct more research regarding the long-term effects of e-cigarettes on cardiovascular health.
- Countries that have banned the commercialization of e-cigarettes should maintain these measures. 94
18.15.4 Overseas agencies
Many agencies in other countries have issued position statements.
Compared to Australian health agencies, the use of e-cigarettes as a device for harm reduction is more widely supported in the UK and New Zealand (see also Section 18.14 International regulatory overview).
For example, the Manatū Hauora (NZ Ministry of Health), along with other New Zealand health organisations, had stated:
- Vaping is not for children and young people.
- Vaping is not for non-smokers.
- Vaping can help some people quit smoking.
- Vaping is not harmless but it is less harmful than smoking for smokers.
- The best thing you can do for your health is to be smokefree and vapefree. 124
Similarly, the UK Government's Office for Health Improvement and Disparities, in its commissioned 2022 Evidence Update, concludes that in the short and medium term, vaping poses a small fraction of the risks of smoking. However, it also notes vaping is not risk-free, particularly for people who have never smoked. 95
Compared to position statements and recommendations from Australian organisations, New Zealand and UK agencies’ statements about e-cigarettes have been less negative about safety concerns and more positive about evidence of efficacy. They have been less likely to express concern about the addictive potential of nicotine in e-cigarettes as a gateway to smoking for young people and potential undermining of progress made in tobacco control. 96
Agencies in other countries that have issues position statements on e-cigarettes include:
- American Academy of Family Physicians 97
- American Academy of Pediatrics 98
- American Association for Cancer Research and the American Society of Clinical Oncology 99
- American Cancer Society 100
- American College of Cardiology 101
- American College of Obstetricians and Gynecologists 102
- American College of Physicians 103
- American College of Preventive Medicine 104
- American Heart Association 105
- American Lung Association 106
- American Medical Association 107
- American Public Health Association 108
- American Society of Addiction Medicine 109
- British Medical Association 110 (Position under review) 111
- Canadian Cancer Society 112
- Cancer Society New Zealand 113
- Council of Chief Medical Officers of Health (Canada) 114
- European Academy of Paediatrics 115
- European Association of Preventative Cardiology 116
- European Commission 117
- European Public Health Association 118
- European Respiratory Society 119-121
- House of Commons (UK) 122
- Medicines and Healthcare Products Regulatory Agency (UK) 121
- National Academies of Science, Engineering and Medicine (US) 123
- National Alliance for Hispanic Health 124
- National Institute for Health and Care Excellence (UK) 125
- New Zealand Ministry of Health 126 , 127
- Public Health England 128 , 129 (Disbanded in 2020)
- Royal College of Midwives (UK) 130 , 131
- Royal College of Physicians (UK) 132
- Royal College of Physicians (UK) and 10 other UK health agencies writing in support of Public Health England’s position 133
- Royal College of Psychiatrists (UK) 134
- Society for Adolescent Health and Medicine 135
- Truth Initiative (US) 136
- UK Government, Office for Health Improvement and Disparities 95
- US Department of Health and Human Services 137 , 138
- US Food and Drug Administration 139
- US National Institute on Drug Abuse 140
- US Preventive Services Task Force 141
- US Surgeon General 137 , 142
A 2018 review of international position statements found five major recommendation types:
- Statements encouraging the use of e-cigarettes as cessation aids or alternatives for smokers;
- Statements supporting individuals who use e-cigarettes for cessation;
- Statements recommending avoiding e-cigarettes until further information is available;
- Statements advising access to e-cigarettes be restricted;
- Statements advising e-cigarette use be prohibited. 143
Relevant news and research
For recent news items and research on this topic, click here. ( Last updated November 2024)
References
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27. No authors listed. Heart Foundation recommendations to TGA consultation on proposed reforms to the regulation of nicotine vaping products, in Heart Foundation2023. Available from: https://www.heartfoundation.org.au/blog/response-to-tga-consultation-paper-vaping.
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43. No authors listed. AMA calls for stronger nicotine vaping product regulation, in AMA2022. Available from: https://www.ama.com.au/ama-rounds/26-august-2022/articles/ama-calls-stronger-nicotine-vaping-product-regulation.
44. No authors listed. AMA calls for greater regulation on vaping products, in AMA2022. Available from: https://www.ama.com.au/ama-rounds/16-december-2022/articles/ama-calls-greater-regulation-vaping-products.
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56. No authors listed. ACOSH calls for maximum protection for young people in submission to TGA consultation, in ACOSH2023. Available from: https://www.acosh.org/acosh-submission-tga-consultation/.
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