The Australian Government is taking an informed and considered approach to e-cigarettes and is continuing to monitor emerging evidence regarding their safety, role in smoking cessation and concerns around take-up by non-smokers. The Government’s position on e-cigarettes is based on the need to consider the overall impacts that e-cigarettes pose to population health, including on non-smokers and smokers.
The Ministerial Drug and Alcohol Forum, which includes Commonwealth and state and territory Ministers, has agreed to national guiding principles for e-cigarettes. The guiding principles reflect the Government’s considered approach to e-cigarettes and affirm that the current national regulatory framework remains appropriate.
The existing evidence indicates that e-cigarettes are not harmless products. 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 consumers and policymakers in understanding the current evidence about the safety and efficacy of e-cigarettes. The statement notes that there is insufficient evidence to support claims that e-cigarettes are safe or to conclude whether e-cigarettes can assist smokers to quit. The statement also recommends that health authorities and policymakers 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. The statement also identified a number of concerns in relation to the 2014 study which reported that e-cigarettes are 95% less harmful than tobacco cigarettes. The statement is available on the NHMRC website.
More broadly, the Government recognises the need for further research into e-cigarettes and notes that the NHMRC has funded ten grants, committing over $8.5 million for research into e-cigarettes since 2011.
E-cigarette regulation is a shared responsibility between the Commonwealth, state and territory governments. The current regulatory framework draws on existing legislation and regulations that may apply to tobacco products, therapeutic goods, poisons and consumer goods.
Unlike any e-cigarette product, all smoking cessation products lawfully available for sale in Australia have been evaluated by the Therapeutic Goods Administration (TGA) for safety and efficacy, and have been registered with the TGA. There are no restrictions on who might apply to the TGA. However, no e-cigarettes have been approved by the TGA to date.
Although e-cigarettes containing nicotine are not currently available for sale in Australia, it may be lawful for people to import nicotine for use in e-cigarettes with a prescription for up to three months of personal therapeutic use under the TGA’s Personal Importation Scheme (PIS). Under this scheme an importer must hold a prescription from a registered Australian medical practitioner, and the possession and use of nicotine for this purpose must also be legal within the importer’s state or territory. While schemes such as the PIS may be used to import unapproved therapeutic goods into Australia, they are intended to enable access to products only in cases when suitable TGA-approved alternatives that achieve the same therapeutic purpose are not available on the Australian market. Unapproved therapeutic goods imported into Australia have not been evaluated by the TGA and therefore there are no guarantees about their quality, safety or efficacy. Further information is available on the TGA’s website.
In March 2017, the TGA rejected an application to allow nicotine for use in e-cigarettes to be sold commercially in Australia for harm reduction purposes, subject to implementation by states and territories. The Government is confident that the TGA’s scheduling legislation and underlying decision-making processes provided a robust mechanism for an assessment and determination of this issue to be made, which appropriately balanced potential risks and benefits and was informed by relevant evidence. The availability of nicotine for use in e-cigarettes will continue to be determined through the scheduling process. Under this process, anyone may make an application to schedule or reschedule a substance. Further information is available on the TGA website.
Further information about the TGA’s final decision in respect to this application is also available on the TGA website.
On 25 May 2017, the Standing Committee on Health, Aged Care and Sport commenced an Inquiry into the Use and Marketing of Electronic Cigarettes and Personal Vaporisers in Australia. The Inquiry’s final report was published on 28 March 2018, and the Government will carefully consider the Inquiry’s findings before providing a response. The Inquiry’s final report is available on the Parliament of Australia website.