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Summary
Product standards apply to all unapproved vaping goods lawfully available in Australia for smoking cessation or the management of nicotine dependence. This includes vaping substances, vaping substance accessories, vaping devices and vaping device accessories.
These standards have been designed to minimise the risks associated with the use of therapeutic vapes that may be supplied by pharmacists. Importers, manufacturers and sponsors must notify the TGA of compliance with these standards through a sponsor notice prior to importing or supplying the product.
It is important to note that even among therapeutic vapes that are compliant with these standards, there are no guarantees about their safety, quality, efficacy or performance. The long-term health risks of vapes are unclear and the evidence of their potential efficacy for smoking cessation or the management of nicotine dependence is currently limited.
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. Once fully implemented, these strengthened standards will replace earlier standards which commenced on 1 January 2024.
Neither the current or strengthened standards apply to therapeutic cannabis vapes which are subject to separate requirements. More information about medical cannabis is available on the Medicinal Cannabis Hub.
Current standards as of January 2024
To be lawfully supplied in Australia, unapproved therapeutic vapes for smoking cessation or the management of nicotine dependence must comply with the:
- Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110)
- Therapeutic Goods (Medical Device Standard—Therapeutic Vaping Devices) Order (MDSO)
The MDSO applies to therapeutic vaping devices and accessories whilst the TGO applies to therapeutic vaping substance and vaping substance accessories.
Strengthened standards - changes from 2025
Strengthened standards will be implemented in stages during 2025 and have now been published. These have been made available to allow manufacturers time to update their products to comply with the new standards.
From 1 March 2025, only products that meet the updated standards will be able to be imported into or manufactured in Australia.
From 1 July 2025, only products that meet the updated standards can be lawfully supplied in Australia.
The changes mean that any vapes supplied in Australia from 1 October 2024 to 1 March 2025 may comply with the strengthened 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 strengthened product standards may be lawfully supplied.
Key changes under the updated TGO 110 include the following:
- only permitted ingredients will be allowed in vaping substance formulations
- the maximum nicotine concentration limit will be 50 mg/mL (base form or equivalent base form concentration)
- the maximum menthol concentration limit will be 20 mg/mL
- the maximum volume for vaping substance containers will be 60 mL
- the maximum volume for vaping substance accessories will be 5 mL
- requirements for plain packaging, information leaflets, and restrictions on product names will apply.
Key changes to the updated MDSO include:
- new requirements for device labelling and instructions for use for the device and its accessories
- plain design and plain packaging requirements for the device and its accessories
- the device and accessories must meet new and more stringent technical product requirements including compliance with:
- medical device quality management systems
- risk management standards
- battery and electrical safety standards, and
- specific design and construction requirements
- requirements for a toxicological risk assessment
For more information on the updated product standards - including legislation and guidance materials to assist sponsors, manufacturers, patients, and health care providers - please refer to: