The Department of Health is taking a precautionary approach to e-cigarettes and is continuing to examine the regulatory framework governing e-cigarettes in Australia. The Department’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.
On 22 June 2017, the Senate referred the Vaporised Nicotine Products Bill 2017 (the Bill) to the Senate Community Affairs Legislation Committee (the Committee) for inquiry and report by 13 September 2017. In its report, the Committee recommended that the Senate not pass the Bill until further scientific evaluation of the efficacy and safety of e-cigarettes and related products has been undertaken. Further information is available on the Parliament of Australia website.
On 25 May 2017, it was announced that the Standing Committee on Health, Aged Care and Sport will inquire into and report on the use and marketing of e-cigarettes and personal vaporisers in Australia. Further information is available on the Parliament of Australia website.
The Department has advised that there is evidence that e-cigarettes are harmful. 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 updated 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 updated 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 updated statement is available on the NHMRC website.
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.
The Therapeutic Goods Act 1989 (TG Act) and associated Regulations establish national regulatory controls that ensure the timely availability of therapeutic goods. To date, the Therapeutic Goods Administration (TGA) has not evaluated or approved any e-cigarettes for this purpose.
Some of the substances found in e-cigarettes (such as nicotine) are regulated as poisons in Australia. The TG Act establishes a framework for the TGA to make decisions independent of government on the control and availability of medicines and poisons, for inclusion in relevant state and territory legislation.
The effect of Commonwealth, state and territory legislation is that e-cigarettes containing nicotine are not currently available for commercial sale in Australia. Nevertheless, it may be lawful in some circumstances for people to import nicotine in e cigarettes for 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.
There are also other avenues, besides the PIS, that are available to access unapproved therapeutic goods, including the Special Access Scheme (SAS) and the Authorised Prescriber (AP) Scheme. Under the SAS and the AP Scheme, medical practitioners are required to apply to access the unapproved therapeutic good on behalf of their patient(s). While these schemes may be used to import unapproved therapeutic goods into Australia, the TGA advises that these goods have not been evaluated in Australia by the TGA and therefore there are no guarantees about their quality, safety or efficacy.
In 2016 and early 2017, the TGA considered an application to allow nicotine for use in e cigarettes to be commercially sold in Australia for the purpose of tobacco harm reduction, subject to implementation by the states and territories. After a public consultation period, and having considered advice from relevant independent expert advisory committees (who have relevant expertise, including medical practitioners, pharmacologists and toxicologists), the final decision on the nicotine application published by the TGA on 23 March 2017 is that the current scheduling of nicotine remains appropriate. The effect of this final decision is that the commercial supply of nicotine for use in e-cigarettes remains prohibited in Australia under state and territory legislation.
The Australian 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.
Further information about the TGA’s final decision in respect to this application is available on the TGA website.