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In May 2023, the Australian Government announced reforms to the regulation of vaping products. These reforms are being implemented in partnership with states and territories in stages over the course of 2024 and 2025 and change the way that vapes can be imported, manufactured, supplied and advertised in Australia.
Vapes include vaping substances, vaping accessories and vaping devices.
The centrepiece of these reforms is the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 which commenced on 1 July 2024.
The Act prohibits the importation, domestic manufacture, supply, commercial possession and advertisement of disposable single use and non-therapeutic vapes. It does not ban all vapes.
Strengthened standards were published by the TGA in October 2024 and include new requirements for devices, ingredients, packaging and labelling. The strengthened standards will be implemented in stages during the first half of 2025.
For more information about the regulation of medicinal cannabis for use in vapes, see the medicinal cannabis hub.
Changes from 1 October 2024
From 1 October 2024, and subject to state and territory government requirements:
- Therapeutic vapes containing 20 mg/mL of nicotine or less will be available from participating pharmacies without a prescription where clinically appropriate, to adults aged 18 years and over.
- In order for a pharmacist to supply a vape without a prescription a consultation must be conducted with the patient to ensure that a vaping good is the appropriate treatment option.
- A prescription is required to dispense a therapeutic vape in some instances. This includes but may not be limited to instances where the patient is under 18 years of age, or for those who require a higher nicotine concentration.
Pharmacists cannot be compelled to stock or supply therapeutic vapes, regardless of whether a patient holds a prescription.
Further information on the current regulation of vapes
Follow the links below to learn about the current regulations relating to the following groups:
- Patients / consumers
- Prescribers (medical and nurse practitioners)
- Pharmacists
- Importers, manufacturers and wholesalers
- Retailers
Summary of changes from 1 July 2024
Key changes from 1 July:
- The domestic manufacture, commercial possession and sale of non-therapeutic vapes and disposable vapes is banned, regardless of whether they include nicotine or other controlled substances.
- Therapeutic vapes for smoking cessation, or the management of nicotine dependence, continue to be available from a pharmacy if they meet TGA regulatory requirements.
- Introduction of a strengthened advertising framework for vapes. The framework bans advertising of vapes, except where specifically authorised. The ban covers all media platforms, including social media, as well as other forms of advertising, promotion and sponsorship.
- New offence and civil penalties for unlawful importation, domestic manufacture, supply, advertisement and commercial possession of vapes.
- Organisations responsible for enforcement now have greater powers to investigate non-compliance, seize unlawful goods and share relevant information with other compliance and enforcement bodies, both across the Commonwealth as well as with states and territories.
- Flavours of therapeutic vapes have been restricted to unflavoured, mint, menthol and tobacco.
Regulations and instruments
The vaping reforms are being implemented through the:
- Therapeutic Goods Act 1989 and instruments made under it
- Customs (Prohibited Imports) Regulations 1956 and instruments made under it.
The relevant instruments are:
- Therapeutic Goods Regulations 1990- external site
- Customs (Prohibited Imports) Regulations 1956- external site
- Therapeutic Goods (Medical Devices) Regulations 2002- external site
- Therapeutic Goods (Excluded Goods) Determination 2018- external site
- Therapeutic Goods (Medical Devices—Specified Articles) Instrument 2020- external site
- Therapeutic Goods (Articles that are Not Medical Devices) Declaration 2023- external site
- Therapeutic Goods (Medicines and OTG—Authorised Supply) Rules 2022- external site
- Therapeutic Goods (Medical Devices—Authorised Supply) Rules 2022- external site
- Therapeutic Goods (Biologicals—Authorised Supply) Rules 2022- external site
- Therapeutic Goods (Standard for Therapeutic Vaping Goods) (TGO 110) Order 2021- external site
- Therapeutic Goods (Exempt Monographs) Determination 2021- external site
- Customs (Prohibited Imports) (Vaping Goods) Approval 2023- external site
- Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024- external site
- Therapeutic Goods (Vaping Goods—Possession and Supply) Amendment Determination (No. 2) 2024
- Therapeutic Goods (Determined Goods) Determination 2024- external site
- Therapeutic Goods (Information Specification—Therapeutic Vaping Goods and Vaping Goods) Instrument 2024- external site
- Therapeutic Goods (Vaping Goods—Advertising) Authorisation 2024- external site
- Therapeutic Goods (Authorised Officers) Authorisation (No. 2) 2024
- Therapeutic Goods (Authorised Persons) Authorisation (No. 2) 2024
- Therapeutic Goods (Medical Devices—Authorised Persons) Authorisation (No. 2) 2024
- Therapeutic Goods (Excluded Goods) Amendment (Vaping) Determination 2024
- Therapeutic Goods (Vaping Goods) Determination 2024
- Therapeutic Goods (Vaping Goods—Other Indications) Determination 2024
- Therapeutic Goods (Poisons Standard) (Therapeutic Vaping Goods) Labelling Exemption 2024
Stay updated
Information will continue to be published on the TGA website. Please check back regularly for updates.