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 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. 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 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 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.
The TGA recently 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 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.