The Therapeutic Goods Administration (TGA) is introducing strengthened product standards for therapeutic vapes including vaping substances, vaping substance accessories, vaping devices and vaping device accessories.
The strengthened standards will be implemented in stages to allow industry time to update their products to comply.
From 1 March 2025, only vapes that meet the updated product standards can be imported into or manufactured in Australia. From 1 July 2025, only those vapes that meet the updated standards can be lawfully supplied in Australia.
Any vapes supplied in Australia from 1 October 2024 to 1 March 2025 may comply with the updated standards but must also continue to meet the product standards made in January 2024. Between 1 March and 1 July 2025, vapes that meet either the current or updated product standards may be lawfully supplied.
The changes form part of the broader vaping reforms being undertaken by the Australian Government that regulates the way vapes can be imported, manufactured, supplied and advertised in Australia.
The current standards applying to vapes are:
- Therapeutic Goods (Standard for Therapeutic Vaping Goods) (TGO 110) Order 2021, and the latest updates to TGO 110 are in;
- the Therapeutic Goods (Medical Device Standard-Therapeutic Vaping Devices) Order 2023 (MDSO), and the latest updates to MDSO are in;
The TGA has published information on the strengthened versions of these standards, noting the standards will not apply until 2025.
Key changes to TGO 110 include:
- restrictions to the formulation of vaping substances to permitted ingredients only and changed restrictions on the level of allowed nicotine (50 mg/mL limit)
- enhancement of the packaging and labelling of vapes, including requirements for plain packaging, information leaflets, traceability and restrictions on product names
- restrictions to the maximum permitted container volume.
Key changes to MDSO include:
- new requirements for device labelling and instructions for use
- plain design and plain packaging requirements for the device and its accessories
- the device and accessories must meet a range of new and more stringent technical product requirements.
These changes will provide patients and health practitioners with increased confidence in the quality and safety of vapes used for the purpose of smoking cessation or nicotine dependence.
However, it is important to note that there are currently no therapeutic vapes that have been evaluated by the TGA and included in the Australian Register of Therapeutic Goods (ARTG) for this purpose.
Therapeutic goods not included in the ARTG are known as unregistered or 'unapproved' goods. These products have not been assessed by the TGA for quality, safety and efficacy or performance.
Suppliers of therapeutic vapes may be requested to make new declarations of compliance with the strengthened product standards and obtain updated import permits ahead of the changes in 2025.
Comprehensive information on the broader legislative and regulatory changes is available on the TGA's Vaping hub.
