18B.10 Key Australian and international position statements on e-cigarettes, health, and options for regulation

Last updated: March 2022 

Suggested citation: Greenhalgh, EM, Jenkins, S. & Scollo, M. InDepth 18B: Electronic cigarettes (e-cigarettes). In Greenhalgh, EM, Scollo, MM and Winstanley, MH [editors]. Tobacco in Australia: Facts and issues. Melbourne: Cancer Council Victoria; 2022. Available from: http://www.tobaccoinaustralia.org.au/chapter-18-harm-reduction/indepth-18b-e-cigarettes

 

The Australian Government is taking a precautionary approach to e-cigarettes and is considering 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 18B10.1 below. In addition, a number of well-respected Australian and global health agencies have issued position statements on e-cigarettes. Excerpts from some of these are included in Sections 18B10.2 and 18B10.3 below; it’s impracticable to provide an exhaustive list, or to reproduce them in full. Readers should refer to the original position statements for further detail.

Some overseas organisations have published position statements, and a selection of these, with web links, is listed in Section 18B.10.4.  The majority of these statements come from agencies based in the UK or the US, where usage of the products is more widespread. Regulation of e-cigarettes in other countries is discussed in Chapter 18B.9.

18B.10.1 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 capture all nicotine vaping products as prescription-only medicines.5

In September 2021 the TGA 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.

TGO 110 aims to:

  • help health practitioners and consumers access accurate information about the chemical constituents of the unregistered nicotine vaping product
  • prohibit substances with known, demonstrable health risks associated with inhalation, and active ingredients not required for smoking cessation, from being added as ingredients in these products, and
  • minimise the risks of accidental exposure to and/or ingestion of nicotine vaping products, particularly by children, which can be fatal.

Further details of regulation of e-cigarettes in Australia are provided in Section 18B.9.

Note in TGO-110 the following statement that reflects the TGO’s assessment of the risks and benefits of e-cigarettes:

The TGA does not assess the safety, quality and efficacy of ‘unapproved’ nicotine vaping products nor of Export Only products listed on the ARTG (together, unregistered nicotine vaping products). The long-term health risks of nicotine vaping products are still unclear and evidence of their potential efficacy for smoking cessation is currently mixed, with more reliable, large-scale studies required (Hartmann-Boyce et al. 2021, Patnode et al. 2021, Pound et al. 2021, SCHEER 2021, Wang et al. 2021, Zhang et al. 2021).6

The Australian Government Department of Health

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 (see Section 18B.5.5).

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.7

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.”8

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.9

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.10

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.11

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.12

National Health and Medical Research Council

Among other roles, the National Health and Medical Research Council (NHMRC)  has responsibility for developing health advice for the Australian community, health professionals and government.13 The CEO of the NHMRC released a statement on e-cigarettes in 2017,14 noting 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 chemicals and toxins such as formaldehyde, heavy metals, particulate matter and flavouring chemicals, at levels that have the potential to cause adverse health effects.
  • There is currently insufficient evidence to conclude whether e-cigarettes can assist smokers to quit. Smokers wishing to quit should consult the Quitline or their general practitioner.
  • There is some evidence from longitudinal studies to suggest that e-cigarette use in non-smokers is associated with future uptake of tobacco cigarette smoking.
  • Health authorities and policy-makers should act to minimise harm to users and bystanders, and to protect vulnerable groups such as young people, until evidence of safety, quality and efficacy can be produced.
  • NHMRC is currently funding a number of studies into the safety and efficacy of e-cigarettes.
  • Consumers should seek further information about e-cigarettes from reliable sources, such as the relevant State or Territory Health Department or quit smoking services.

The NHRMC is currently undertaking a review of the evidence on e-cigarettes with a view to updating its CEO statement.15

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.16

Australian Industrial Chemicals Introduction Scheme

Based on it study of the chemistry of liquids used in e-cigarette devices in Australia, the Australian Industrial Chemicals Introduction Scheme (previously the National Industrial Chemicals Notifications and Assessment Scheme) has 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.”17

18B.10.2 Australian non-government agencies

In 2018, the Australian Medical Association, Cancer Australia, Cancer Council Australia, National Heart Foundation of Australia, and the Thoracic Society of Australia and New Zealand released a joint statement,18 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.

Cancer Council Australia, Heart Foundation and Quit

These agencies issued a joint position statement in 2015.19 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:

  1. 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.
  2. 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.
  3. 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.

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 (see Section 18B.8). 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).’20

Australian Medical Association

The Australian Medical Association (AMA) released Tobacco smoking and e-cigarettes in December 2015.21  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.22

Public Health Association Australia

The Public Health Association of Australia stated in 2018:23

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.

Lung Foundation Australia

In 2017, 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.24

Royal Australasian College of Physicians

The Royal Australasian College of Physicians’ (RACP) May 2018 policy on e-cigarettes states:

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.25

In March 2020 the RACP made a submission to the New Zealand Health Select Committee regarding the Smokefree Environments and Regulated Products (Vaping) Amendment Bill.  In the background information RACP state its current 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.26

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.”27

Australian Council on Smoking and Health (ACOSH)

In its March 2019 statement to the Select Committee on Personal Choice and Community Safety, Legislative Council, Parliament of Western Australia, ACOSH summates that:

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.28

VicHealth

VicHealth, in its 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.29

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.”30

Royal Australian College of General Practitioners

In the Royal Australian College of General Practitioners’ (RACGP) updated guide on Supporting Smoking Cessation for health professionals it states 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.31

Royal Australian and New Zealand College of Psychiatrists

In contrast to the above organisations, in its October 2018 position statement,32 the Royal Australian and New Zealand College of Psychiatrists (RANZCP) stated its support for the legalisation and regulation of nicotine-containing e-cigarettes and other vaporised nicotine products to facilitate their use as harm reduction tools. It recommends:

  • exemption of nicotine-containing e-cigarettes and vaporisers from the restrictions imposed under the Poisons Standard so that they may be subject to stringent and suitable regulations as consumer products
  • lower rates of taxation for e-cigarettes and vaporisers compared to smokable tobacco products to ensure affordability for low-income smokers, and to provide a financial incentive to switch
  • further research into:
    • the long-term health effects of vaping
    • the effectiveness of e-cigarettes and vaporisers as a cessation tool
    • monitoring of demographic patterns of use including rates of initiation by young people.

Thoracic Society of Australia and New Zealand

In 2020, the Thoracic Society of Australia and New Zealand (TSANZ) finished a review of 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 exclusivee 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.”33

18B.10.3 Global agencies

For the most part, position statements of global agencies express caution about e-cigarettes, generally acknowledging that while they could have the potential to benefit public health, there is currently insufficient evidence to be sure that e-cigarettes assist smokers in quitting, do not cause some level of physical harm, and will not serve to undermine long-standing and effective tobacco control measures. 

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 to date, and recommended that ENDS should be ‘regulated as combination drugs and medical devices and not as tobacco products.’34

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’,35 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.36 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.37

In October 2014, the WHO presented its report Electronic nicotine delivery systems to Sixth Session of the FCTC Conference of the Parties in Moscow.38 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.39

The updated report was presented to the Seventh Session of the Conference of the Parties, which took place in India in November 2016.40 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.41

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.42

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.43

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.44

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.45

 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.46

World Federation of Public Health Associations

The World Federation of Public Health Associations (WFPHA) has announced its support for the recommendations provided by the WHO in its 2014 report, Electronic nicotine delivery systems.38  In its position statement, the WFPHA:47

  • Endorses WHO’s call for caution and seeks the application of the precautionary principle by governments
  • Calls for further evidence and research
  • Emphasizes that ENDS/e-cigarettes should not be used as a means of bypassing Article 5.3 of the FCTC or re-normalizing smoking behaviour.

In support of the WHO approach, the WFPHA calls for regulations to:

  • Ban all forms of advertising and promotion for ENDS to ensure both that children, young people and non-smokers are not exposed to ENDS promotions and that any commentary about ENDS is made by governments and health authorities, not by those with a commercial interest in these products and tobacco promotion
  • Ensure strict emission and control measures for e-cigarettes
  • Prohibit unproven health claims about e-cigarettes
  • Ensure that smoke-free measures are applied to ENDS products in all situations where they apply to smoking
  • Protect existing tobacco control efforts from commercial and other vested interests of the tobacco industry by ensuring that Article 5.3 of the FCTC is fully applied to those involved in production and promotion of ENDS
  • Ensure that any claims on the health benefits of ENDS or their efficacy as a cessation aid are rigorously reviewed by independent authorities and subject to appropriate governmental controls
  • Take all possible steps to minimize potential health risks to e-cigarette users and nonusers; this should include applying smoke-free measures to ENDS products
  • Ensure that there is maximum continuing action as recommended by WHO to reduce smoking, without distraction from discussions on ENDS.

Forum of International Respiratory Societies

The Forum of International Respiratory Societies (FIRS) is composed of professional organisations and experts in respiratory disease. Member societies include Asociacio´n Latinoamericana del To´rax, the American College of Chest Physicians, the American Thoracic Society, the Asian Pacific Society of Respirology, the European Respiratory Society, the International Union Against Tuberculosis and Lung Disease and the Pan African Thoracic Society.  FIRS’ 2014 position on electronic nicotine delivery devices includes the following statements:48

  • 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 2018,49 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.50 In its 2012 statement Electronic cigarettes and other electronic nicotine delivery systems,51 the WMA recommended:

  • That the manufacture and sale of e-cigarettes and other electronic nicotine delivery systems be subject to national regulatory bodies prior approval based on testing and research as either a new form of tobacco product or as a drug delivery device.
  • That the marketing of e-cigarettes and other electronic nicotine delivery systems as a valid method for smoking cessation must be based on evidence and must be approved by appropriate regulatory bodies based on safety and efficacy data.
  • That e-cigarettes and other electronic nicotine delivery systems be included in smoke free laws.
  • Physicians should inform their patients of the risks of using e-cigarettes even if regulatory authorities have not taken a position on the efficacy and safety of these products.

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:52

  • 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.

 

18B.10.4  Overseas agencies

Many overseas agencies have issued position statements.  Some of these include:

American Academy of Family Physicians53

American Academy of Pediatrics54

American Association for Cancer Research and the American Society of Clinical Oncology55

American Cancer Society56

American College of Cardiology57

American College of Obstetricians and Gynecologists58

American College of Physicians59

American College of Preventive Medicine60

American Heart Association61

American Lung Association62

American Medical Association63

American Public Health Association64

American Society of Addiction Medicine65

British Medical Association66

California Department of Public Health67

Canadian Cancer Society68

Cancer Society New Zealand69

Council of Chief Medical Officers of Health (Canada)70

European Academy of Paediatrics71

European Association of Preventative Cardiology72

European Commission73

European Public Health Association74

European Respiratory Society75, 76

House of Commons (UK)77

Medicines and Healthcare Products Regulatory Agency (UK)78

National Academies of Science, Engineering and Medicine79

National Alliance for Hispanic Health80

National Institute for Health and Care Excellence (UK)81

New Zealand Ministry of Health82

Public Health England83, 84 (Disbanded in 2020)

Royal College of Midwives (UK)85

Royal College of Physicians (UK)86

Royal College of Physicians (UK) and 10 other UK health agencies writing in support of Public Health England’s position87

Royal College of Psychiatrists (UK)88

Society for Adolescent Health and Medicine89

Truth Initiative (US)90

US Department of Health and Human Services91, 92

US Food and Drug Administration93

US National Institute on Drug Abuse94

US Preventive Services Task Force95

US Surgeon General91, 96

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.97

Overall, 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 18B.9). The recommendations from Australian organisations express greater concern about e-cigarettes and the current lack of safety and efficacy evidence. In particular, 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.98

 

Relevant news and research

For recent news items and research on this topic, click here (Last updated August 2022)

 

References

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