The Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 will take effect on 1 July 2024, following passage through the Australian Parliament.
The new legislation introduces a single, consistent framework that applies nationally to regulate the importation, domestic manufacture, supply, commercial possession and advertisement of all vapes.
From 1 July 2024:
- the way Australians can access vapes will change
- non-pharmacy retailers, such as tobacconists, vape shops and convenience stores, cannot sell any type of vape
- therapeutic vapes will continue to be available from pharmacies where clinically appropriate
- to purchase vapes containing nicotine or a zero-nicotine substance, everyone will continue to need a prescription from a medical or nurse practitioner
- flavours for therapeutic vapes are restricted to mint, menthol and tobacco
- anyone involved in transporting, storing or handling vapes must comply with strict requirements
- the advertising or promotion of vapes is generally prohibited.
These new laws help address the increasing health risks posed by vaping, while preserving legitimate patient access to therapeutic vapes for smoking cessation and the management of nicotine dependence, where clinically appropriate.
Patient access to therapeutic vapes
Patients will continue to need a prescription under a special access pathway from a medical practitioner or nurse practitioner to purchase a therapeutic vaping substance from a pharmacy until 30 September 2024.
From 1 October 2024, therapeutic vapes with a nicotine concentration of 20 mg/mL or less will be available from pharmacies to patients 18 years or over without a prescription, where a pharmacist assesses this to be clinically appropriate.
Therapeutic vapes for patients under 18 years and/or with a nicotine concentration of more than 20 mg/mL will continue to be available with a prescription from a medical or nurse practitioner, subject to state and territory laws.
Supply chain controls
The domestic manufacture, supply and commercial possession of non-therapeutic and disposable single use vapes is unlawful from 1 July 2024.
From 1 July 2024, only established pharmaceutical supply chains are permitted to distribute and supply vapes. Non-pharmacy retailers, such as tobacconists, vape shops and convenience stores, are prohibited to supply any type of vape, including existing stock.
Vapes may only be imported, manufactured, possessed or supplied in Australia if for smoking cessation and the management of nicotine dependence and notified to the TGA as complying with TGA regulatory requirements. These regulatory requirements include rules relating to product labels, packaging, ingredients and flavours. Importers continue to be required to hold a customs licence and permit from the Office of Drug Control.
Only finished products are lawful to dispense. Pharmacists cannot dispense ingredients for patients to use to mix their own vaping substances.
National approach to compliance and enforcement
By strengthening the regulation of vapes through enhancing border controls, banning all disposable single-use vapes, introducing an advertising ban, and ending the supply of vapes outside of pharmacy settings, it will be easier to identify and disrupt the illicit supply of vapes and to take effective enforcement action across all jurisdictions.
Illicit vapes will be easier to detect and the opportunities for unlawful trade in these products will be significantly reduced.
Laboratory testing will no longer be required to identify unlawful vapes. States and territories will be able to take fast enforcement action on non-pharmacy stores selling vapes, without the need to determine if the vapes, regardless of the labelling, actually contain nicotine.
The Australian Border Force (ABF) is leading enforcement at the border, in partnership with the TGA, with any vaping goods imported without relevant licences and permits to be seized and destroyed.
A National Vaping Enforcement Framework, agreed between health and law enforcement agencies, sets out a united approach to enforcing the laws for vapes.
Strengthened advertising laws
The new legislation strengthens the advertising framework for vapes by banning advertising, except where specifically authorised. The ban covers all media platforms, including social media, as well as other forms of advertising, promotion and sponsorship.
The TGA has written to major social media and digital platforms to advise them of the updated requirements.
New criminal and civil penalties
From 1 July 2024, new criminal offences and civil penalty provisions will apply under the Therapeutic Goods Act 1989 relating to the importation, domestic manufacture, supply, commercial possession and advertisement of vaping goods, including vaping devices, other than in circumstances or by persons specified in exceptions.
The Government’s reforms target commercial actors in the unlawful supply chain. They do not target individual users of vapes.
The maximum penalties that will apply from 1 July 2024 are up to 7 years in jail per offence and/or up to $21.91 million per contravention.
The TGA encourages people to report any perceived breach or questionable practices relating to the importation, manufacture, supply, and advertising of therapeutic vapes, including the supply of vapes by a non-pharmacy retailer.
Vaping reforms
The reforms and legislative changes complement a wider set of actions being taken by the Australian Government in line with the National Tobacco Strategy 2023-2030 to reduce rates of tobacco and vape use (see Taking action on smoking and vaping).
Comprehensive information on the legislative and regulatory changes will be published on our Vaping hub from 1 July 2024.
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