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

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Last updated: December 2016  Suggested citation: Greenhalgh, EM, & Scollo, MM. InDepth 18B: Electronic cigarettes (e-cigarettes). In Scollo, MM and Winstanley, MH [editors]. Tobacco in Australia: Facts and issues. Melbourne: Cancer Council Victoria; 2016. Available from: http://www.tobaccoinaustralia.org.au/chapter-18-harm-reduction/indepth-18b-e-cigarettes

A number of authoritative Australian and global health agencies have issued position statements on e-cigarettes. Excerpts from some of these are included below: it is not practicable 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 also published position statements, and a selection of these, with web links, is listed in Section 18B.10.3, below.  The preponderance of these statements have been issued by agencies based in the UK or the USA, where usage of the products is comparatively widespread and the market largely unregulated compared with Australia. Regulation of e-cigarettes in other countries is discussed in Section 18B.9.

For the most part, position statements 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.  

18B.10.1  Australian agencies

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.¹

The TGA notes that:²

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.

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.³

The NHMRC reviewed the evidence about the risks and benefits of personal vapourisers in early 2015, and concluded that:⁴

There is currently insufficient evidence to conclude whether e-cigarettes can benefit smokers in quitting, or about the extent of their potential harms. It is recommended that health authorities act to minimise harm until evidence of safety, quality and efficacy can be produced. NHMRC is currently funding research into the safety and efficacy of e-cigarettes for smoking cessation.

Public Health Association Australia 

The Public Health Association of Australia has endorsed⁵ the position adopted by the World Federation of Public Health Associations,⁶ which supports the World Health Organization’s ‘call for caution and seeks the application of the precautionary principle by governments’ in relation to ENDS. Statements from the World Federation of Public Health Associations and the World Health Organization are included in Section 18B.10.2 – Global agencies, below.

Cancer Council Australia and Heart Foundation

These agencies issued a joint position statement in 2015.⁷ 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.

Australian Medical Association

The Australian Medical Association (AMA) released Tobacco smoking and e-cigarettes in December 2015.⁸ 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, they state 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.

Lung Foundation Australia

In its statement of June 2014, Lung Foundation Australia declared that:⁹

There is currently not enough evidence to suggest the use of e-cigarettes as an effective smoking cessation tool over current recommended strategies including pharmacotherapy and clinical counselling. This could change as more research is published on this subject. 

While the number of toxins in an e-cigarette is fewer than those in traditional cigarettes, there are no long-term studies on the safety of e-cigarettes and concern has been expressed about the small particles inhaled when “vaping” and their health impact, particularly on youth.

Lung Foundation Australia strongly urges relevant government agencies to further regulate access to e-cigarette devices and components, nicotine-filled cartridges, and non-nicotine cartridges.

18B.10.2 Global agencies

The World Health Organization and the Framework Convention on Tobacco Control

In response to the increase in e-cig use, in 2009 the 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.’¹⁰   

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’,¹¹ 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.¹² 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.¹³

In October 2014, the WHO presented its report Electronic nicotine delivery systems to Sixth Session of the FCTC Conference of the Parties in Moscow.¹⁴ 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.15 The updated report is to be presented to the Seventh Session of the Conference of the Parties,15 due to take place in Noida, India, in November 2016.16

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 their 2014 report, Electronic nicotine delivery systems.¹⁴ In their position statement, the WFPHA:⁶

• 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.

International Union Against Tuberculosis and Lung Disease 

The International Union Against Tuberculosis and Lung Disease (the Union) recognises tobacco use as a global public health challenge. The Union issued a position statement on ECs/ENDS in 2013,¹⁷ and an update in October 2014.¹⁸

Key messages of the updated statement include that:

• The safety of electronic cigarettes (ECs) or electronic nicotine delivery systems (ENDS) has not been scientifically demonstrated. 
• Adverse health effects for third parties exposed (second-hand exposure) cannot be excluded because the use of ECs leads to the emission of fine and ultrafine inhalable liquid particles, nicotine and cancer-causing substances into indoor air.
• The benefits of ECs have not been scientifically proven. To date, few studies have assessed ECs/ENDS as a harm reduction and cessation aid; those that do exist have conflicting findings. 
• Marketing, awareness and use of ECs or ENDS are growing rapidly.
• The tobacco transnationals have increasingly entered the EC/ENDS marketplace with a strong presence. 
• A range of current and proposed legislative and regulatory options exists; some countries (such as Brazil, Norway, Indonesia and Singapore) have banned ECs/ENDS completely. Other countries are considering banning them. 
• ENDS could undermine the implementation of the WHO Framework Convention on Tobacco Control (FCTC) Article 12 (de-normalisation of tobacco use); use of ENDS could also hamper the implementation of Article 8 (protection from exposure to tobacco smoke), as ENDS users in public places may claim that their electronic cigarette does not contain tobacco and/or does not produce second-hand tobacco smoke. 
• The Union strongly supports regulating the manufacturing, marketing and sale of ECs or ENDS, preferably as medicines.

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’ position on electronic nicotine delivery devices includes the following statements:¹⁹   

• 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.

World Medical Association

The World Medical Association (WMA) is an independent federation of 111 national medical associations, including the Australian Medical Association.²⁰ In their 2012 statement Electronic cigarettes and other electronic nicotine delivery systems,²¹ 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. 

18B.10.3  Overseas agencies

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

• American Association for Cancer Research and the American Society of Clinical Oncology²²  
• American Heart Association²³  
• British Medical Association²⁴
• Canadian Cancer Society²⁵
• Cancer Society New Zealand²⁶
• Public Health England²⁷
• Royal College of Physicians (UK) and 10 other UK health agencies writing in support of Public Health England’s position²⁸
• US Department of Health and Human Services²⁹
• US Food and Drug Administration³⁰
• US National Institute on Drug Abuse³¹
• US Preventive Services Task Force³²

Use of e-cigarettes as a device for harm reduction is more widely supported by health agencies in the UK than in most other countries (see also Section 18B.9).

Recent news and research

For recent news items and research on this topic, click here (Last updated March 2018)  

 

References

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3. National Health and Medical Research Council, NHMRC home page. Canberra: NHMRC; 2015. Available from: https://www.nhmrc.gov.au/ .

4. National Health and Medical Research Council, NHMRC CEO statement: Electronic cigarettes (e-cigarettes). Canberra: NHMRC; 2015. Available from: https://www.nhmrc.gov.au/guidelines-publications/ds13 .

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11. Conference of the Parties to the WHO Framework Convention on Tobacco Control. FCTC/COP5(10). Control and prevention of smokeless tobacco products and electronic nicotine delivery systems, including electronic cigarettes. Fifth session, Seoul, Republic of Korea, 12–17 November 2012. Geneva: WHO, 2012. Available from: http://apps.who.int/gb/fctc/PDF/cop5/FCTC_COP5(10)-en.pdf

12. Abrams D, Axello T, Bartsch P, Bauld L, Borland R, et al. Reducing the toll of death and disease from tobacco - tobacco harm reduction and the Framework Convention on Tobacco Control 2014. Available from: https://nicotinepolicy.net/documents/letters/MargaretChan.pdf

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16. WHO Framework Convention on Tobacco Control, India to host the seventh session of the conference of the parties (COP7) and the first session of the meeting of the parties (MOP1). Geneva: WHO; 2016. Available from: http://www.who.int/fctc/news/cop7tobehostedinindia/en/

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22. Brandon T, Goniewicz M, Hanna N, Hatsukami D, Herbst R, et al. Electronic nicotine delivery systems: A policy statement from the American Association for Cancer Research and the American Society of Clinical Oncology. Journal of Clinical Oncology, 2015; 33(8):952–63. Available from: http://jco.ascopubs.org/content/33/8/952.long

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