Just released by DoH.. Principles that Underpin the Current Policy and Regulatory Approach to Electronic Cigarettes (E-Cigarettes) in Australia Latest Evidence In August 2016, a World Health Organization (WHO) report concluded that the evidence for the safety of e-cigarettes 1 and their capacity to aid smoking cessation has not been established, and that there are possible risks from active and passive exposure to electronic cigarette vapour. The WHO raises additional concerns about the risk that e-cigarettes may serve to initiate young people into nicotine use and smoking. The WHO highlights a range of scientific uncertainties in relation to e-cigarettes, including that simple comparisons of toxicant levels in e-cigarette aerosol to the high levels in tobacco smoke, as advocated by the tobacco industry, may be of little value given the absence of science on safe tolerance limits for smoke constituents or their specific effects on the multiple diseases caused by tobacco smoking. A 2016 US Surgeon General's report stated that exposure to nicotine in adolescents via e-cigarettes may have long-term consequences for brain development, potentially leading to learning and mood disorders. The report also stated that ‘the use of products containing nicotine poses dangers to youth, pregnant women, and fetuses. The use of products containing nicotine in any form among youth, including in e-cigarettes, is unsafe.’ On 3 April 2017, the Chief Executive Officer of the National Health and Medical Research Council(NHMRC) issued an updated statement on e-cigarettes, to assist Australian consumers and policymakers in understanding the current evidence about the safety and efficacy of e-cigarettes. The NHMRC’s statement concluded that action should be taken by health authorities and policy makers to minimise harm to users and bystanders, and to protect vulnerable groups such as young people, until evidence of safety, quality and efficacy of e-cigarettes can be produced. The NHMRC’s statement also notes that: While e-cigarettes may expose users to fewer toxic chemicals than conventional tobacco cigarettes, the extent to which this reduces harm to the user has not been determined; E-cigarettes may expose users to chemicals and toxins at levels that have the potential to cause adverse health effects. There is growing evidence to suggest that the long-term inhalation of flavourings used in most e-liquids is likely to pose a risk to health; There is currently insufficient evidence to conclude whether e-cigarettes can assist smokers to quit; There is some evidence to suggest that e-cigarette use in non-smokers is associated with future uptake of tobacco cigarette smoking; and There are concerns that the potential benefits of e-cigarettes in reducing harm to smokers may be outweighed by the risks that they may undermine tobacco control efforts. Principles that Underpin the Current Policy and Regulatory Approach 1. Evidence-based. The current evidence base supports maintaining and, where appropriate, strengthening the current controls that apply to the marketing and use of e-cigarettes in Australia. Decisions should take into account the conclusions reached by credible health and scientific agencies in relation to the interpretation and advice about that evidence, including for example the WHO, the NHMRC and the US Surgeon General.2 A notable example is the Therapeutic Goods Administration’s (TGA’s) scheduling legislation and underlying decision making processes which are informed by relevant evidence and provide a robust mechanism to balance potential risks and benefits of substances such as nicotine for use in e-cigarettes. The TGA’s consideration and final decision on an application to allow nicotine for use in e-cigarettes to be commercially sold in Australia during 2016 and early 2017, provides a valuable analysis to guide action (Scheduling delegate's final decisions, March 2017). Health claims for e-cigarettes, such as that they are effective smoking cessation aids or safe alternatives to conventional tobacco products, should be rejected by health authorities in the absence of robust supporting scientific evidence to substantiate these claims. 2. Relevant to Australia’s national circumstances. The appropriate policy and regulatory response to e-cigarettes should take into account Australia’s national circumstances, including in the context of the existing approaches taken by the Australian and state and territory governments to reduce tobacco smoking prevalence and its associated harms and costs. Australia’s favourable progress in tobacco control to date is also an important factor. Current and future approaches taken by other countries to e-cigarettes are relevant to the formulation of potential national policy and regulatory responses to these products. At present, there is no international consensus on the most appropriate policy response or regulatory framework for e-cigarettes. Current and planned regulatory approaches vary considerably and across countries, ranging from treatment as tobacco products, poisons, medicines (including medical devices), and consumer products. Additionally, in some countries, the sale of e-cigarettes is prohibited, while in many developing countries, it is likely that minimal or no regulatory controls apply. 3. Precautionary approach. This acknowledges the potential risks associated with the marketing and use of e-cigarettes. The precautionary approach encourages action to prevent harm when there is scientific uncertainty and until a body of evidence establishes the requirement for alternative regulation. This includes the lack of conclusive evidence around the safety risks posed to users by the unknown inhalation toxicity of nicotine and other chemicals used with e-cigarettes, passive exposure to e-cigarette vapour, risks associated with child poisoning, and issues around quality control and efficacy. The precautionary approach also takes into account the broader risks that e-cigarettes may pose to population health, namely their potential to disrupt the decline in tobacco use in Australia. 4. Protecting public health gains. While there have been significant gains made in reducing smoking rates and reducing exposure to tobacco smoke and smoking culture in Australia, an increase in e-cigarette marketing and use may undermine tobacco control success by establishing new cohorts with nicotine dependence, renormalising smoking, encouraging dual use of tobacco and e-cigarettes, and discouraging quitting. Policy and regulatory decisions on e-cigarettes should aim to minimise the proliferation of e-cigarette marketing and use, particularly among young people while maximising the impact of effective tobacco control measures. Policy and regulation for e-cigarettes should aim to protect public health gains in relation to smoking prevalence as well as smoke-free culture, including smoke-free areas and other measures that have contributed to the continued denormalisation of smoking in Australia. 5. Protecting public health policy from all commercial and other vested interests related to e-cigarettes, including interests of the tobacco industry. This acknowledges Australia’s obligations under Article 5.3 of the WHO FCTC, to which Australia is a party. Under Article 5.3 of the WHO FCTC, parties are obliged to act to protect their public health policies with respect to tobacco control from commercial and other vested interests of the tobacco industry, in accordance with national law. 6. Legal clarity to the public. Information from a range of sources highlights that there may be some confusion to users, retailers, employers and the general public about the legality of e-cigarettes and/or nicotine, especially in terms of the regulations that apply to their importation, marketing (including sale) and use. It is important that Governments provide clarity to the public about their legal obligations in relation to these products. The commercial supply of nicotine for use in e-cigarettes is prohibited under all state and territory poisons legislation. 7. Complementary with jurisdictional regulation and existing health and social policy frameworks. National policy and regulation of e-cigarettes and nicotine should aim to complement jurisdictional legislation, to the greatest degree possible. It is also important that any action taken at a national or jurisdictional level for e-cigarettes and nicotine supports existing health and social policy frameworks. These include but are not limited to the WHO FCTC (and also including recent decisions of the Conference of the Parties to the WHO FCTC as noted above) the National Drug Strategy 2017-2026, the National Tobacco Strategy 2012-2018 and the Scheduling Policy Framework. 1 Otherwise known as electronic nicotine delivery systems (ENDS), electronic non-nicotine delivery systems (ENNDS) or personal vaporisers. 2 In November 2016, the seventh session of the Conference of the Parties to the WHO Framework Convention on Tobacco Control (WHO FCTC) invited Parties to consider applying regulatory measures 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’. Further information is available at available at: www.who.int/fctc/cop/cop7/FCTC_COP7_9_EN.pdf?ua=1.