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Background
From 1 July 2024, all therapeutic vaping substances and therapeutic vaping substance accessories (pods, cartridges, capsules or other vessels containing vaping substances), that are supplied, imported or manufactured in Australia, irrespective of nicotine content, are required to be supplied to patients by registered pharmacists or other persons authorised to supply prescription medicines under state or territory laws.
The standard for therapeutic vaping goods, the Therapeutic Goods (Standard for Therapeutic Vaping Goods) (TGO 110) Order 2021 (TGO 110) (the current TGO 110) commenced on 1 January 2024. It applies to therapeutic vaping goods supplied, imported or manufactured on or after 1 July 2024.
The current TGO 110 sets out the minimum safety and quality standards for therapeutic vaping goods (except standalone therapeutic vaping devices and therapeutic vaping device accessories), irrespective of nicotine content, provided those goods are indicated for smoking cessation or the management of nicotine dependence.
The current TGO 110 was further revised in 2024 to limit nicotine concentration, introduce plain packaging and require pharmaceutical labelling. This revision will come into effect from 1 March 2025.
Testing
The TGA Laboratories conduct compliance testing of available and imported products to assess if those products meet the requirements specified in the current (and former) TGO 110.
From 1 July 2024, any therapeutic vaping good containing a vaping substance or supplied in a therapeutic vaping pack, imported into or manufactured in Australia, irrespective of nicotine content, and indicated for smoking cessation or the management of nicotine dependence, must meet the requirements of the new TGO 110.
All laboratory testing undertaken by the TGA in accordance with the current TGO 110 will largely be the same as that conducted under the former TGO 110. The current TGO 110 does not add any new requirements relevant to lab testing (i.e. by adding new prohibited ingredients, or changing permissible nicotine concentrations).
Rather, it restricts the flavours that may be used in therapeutic vapes and broadens the application of TGO 110 to therapeutic vaping goods that do not contain nicotine, including therapeutic vaping devices and therapeutic vaping device accessories that form part of a therapeutic vaping pack.
Presently, vapes are tested for the following:
- Identification of nicotine
This test determines the presence or absence of nicotine in vapes
- Correct content of nicotine
For vapes to comply with the current standard, the maximum concentration permitted is 100 mg/mL and within the range of 90.0 -110.0% of the labelled content. The concentration must be stated in the base form of nicotine or the equivalent base concentration of nicotine in units of mg/mL.
For vapes where the content of nicotine is not labelled in terms of mg/mL as nicotine base or not declared, a value of ‘Not assessed’ is recorded in the table below.
- Absence of prohibited ingredients
Vapes are screened for the presence of the following ingredients: 2,3-pentanedione, acetoin, benzaldehyde, cinnamaldehyde, diacetyl, diethylene glycol, dl-alpha-tocopheryl acetate, ethylene glycol.
To comply with the current standard, the presence of any of these compounds must be below a level of 10 ppm.
- Compliance with TGO 110 Labelling
Vapes must comply with the labelling requirements stated in the TGO 110. Vapes that contain nicotine must be labelled correctly with the content of nicotine with the correct units and include appropriate warning statements.
The table below summarises testing results to date and is only for seized products. Compliance and enforcement action is taken in relation to vapes that fail to comply with the applicable standards.
The table will be regularly updated as additional vapes are assessed.