Standard for unapproved and export only nicotine vaping products
This standard sets out minimum safety and quality requirements for unapproved and export only nicotine vaping products that are imported into, manufactured or supplied in, or exported from, Australia.
The Therapeutic Goods (Standard for Nicotine Vaping Products (TGO 110) Order 2021 (TGO 110) came into effect on 1 October 2021. TGO 110 sets out minimum safety and quality requirements for unapproved and export only nicotine vaping products that are imported into, manufactured or supplied in, or exported from, Australia.
There are currently no nicotine vaping products that have been assessed by the TGA and registered in the Australian Register of Therapeutic Goods (ARTG). Products that are not in the ARTG are known as 'unapproved' goods. The long-term health risks of nicotine vaping products, even those that comply with TGO 110, are still unclear and the evidence of their potential efficacy for smoking cessation is currently mixed.
TGO 110 incorporates feedback received during public consultation. Thank you to everyone who provided feedback.
Requirements in TGO 110
TGO 110 includes rules about:
- product labelling (including an oversticker or in an information sheet provided with the product)
- childresistant packaging
- maximum nicotine concentration (although people will still only be able to access the nicotine concentration in their prescription)
- requiring actual nicotine concentration/content to reflect what the product's label says
- prohibited ingredients
- records that need to be kept by the Australian sponsor for the product.
Our Guidance for Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Order 2021 and related matters (Guidance on TGO 110) helps explain the requirements in TGO 110 as well as other matters related to nicotine vaping products, such as our role in regulating vaping devices.
Domestic products vs personally imported products
Products supplied in Australia (i.e. through Australian physical and online pharmacies) need to meet all of the requirements of TGO 110.
Products purchased from overseas via the Personal Importation Scheme are subject to some, but not all, of the requirements of TGO 110. The TGA cannot enforce the requirements in TGO 110 against overseas retailers. Prescribers and consumers considering using the Personal Importation Scheme are encouraged to confirm if the product they are considering meets the applicable requirements in TGO 110 and that it also has appropriate packaging, labelling and manufacturing controls.
Please use this list of questions prescribers and consumers might want to ask overseas retailers prior to prescribing or using the Personal Importation Scheme.
Review of TGO 110
A review of TGO 110 will commence in the second half of 2022. More information about the review, including the terms of reference and the reviewer, will be released in early-2022.
Further information
Further information about importing, supplying, prescribing, dispensing and accessing nicotine vaping products, including in relation to TGO 110, can be found on the following pages: