The Department of Health (the Department) 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. In March 2015, the Chief Executive Officer (CEO) of the National Health and Medical Research Council (NHMRC) issued a statement on e-cigarettes, to inform the Australian community about the current status of the evidence about the potential risks and benefits of e-cigarettes. The statement noted that there was insufficient evidence to conclude whether e-cigarettes can benefit smokers in quitting, or about the extent of their potential harms. The statement also recommended that health authorities act to minimise harm until evidence of safety, quality and efficacy can be produced. The NHMRC is reviewing its CEO statement, which is expected to be updated and finalised in March-April 2017.
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 is currently considering 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 interim decision on the nicotine application published by the TGA on 2 February 2017 is that the current scheduling of nicotine remains appropriate. After a further 10-day consultation period a final decision is expected to be made. The final decision will be published on the TGA website in March 2017 after all advice and information has been considered.
The Australian Government is confident that the TGA’s scheduling legislation and underlying decision making processes provide a robust mechanism for an assessment and determination of this issue to be made, which appropriately balances potential risks and benefits and is informed by relevant evidence.
Further information about the status of the scheduling application is available on the TGA website.
Further questions about the scheduling application should be directed to the TGA via telephone on 1800 020 653 (free call) or email to firstname.lastname@example.org.