Testing of vapes
Background
From 1 March 2024, all therapeutic vaping substances and therapeutic vaping substance accessories (pods, cartridges, capsules or other vessels containing vaping substances), that are 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 imported or manufactured on or after 1 March 2024. The standard was previously known as the Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Order 2021 (the former TGO 110).
The former TGO 110 sets out the minimum safety and quality standards for vapes containing nicotine that are imported into, manufactured or supplied in Australia. It will continue to apply to vapes containing nicotine that are imported or manufactured in Australia before 1 March 2024, until 1 July 2024 when these transitional arrangements cease.
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 will be further revised in 2024 to limit nicotine concentration, introduce plain packaging and require pharmaceutical labelling.
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 March 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. 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.
Testing results
Product name | Batch number | Expiry date | Identification of Nicotine | Correct content of Nicotine | Absence of prohibited ingredients | Compliance with TGO 110 labelling |
---|---|---|---|---|---|---|
Acid Juice.Co Apple Sour Candy (70VG/30PG) 60ml (0MG) | 36721054EAC000 | 31/3/2024 | Nicotine not present | Not applicable | Not applicable | Not applicable |
Acid Juice.Co Pineapple Sour Candy (70VG/30PG) 60ml (0MG) | 36721054EPC000 | 31/3/2024 | Nicotine not present | Not applicable | Not applicable | Not applicable |
Acid Juice.Co Watermelon Sour Candy (70VG/30PG) 60ml (0MG) | 36721060EWC000 | 31/3/2024 | Nicotine not present | Not applicable | Not applicable | Not applicable |
BAM - Big Ass Melons Sweet Watermelon E-Liquid 120mL 0 mg/mL | Not stated | 24/7/2025 | Nicotine not present | Not applicable | Not applicable | Not applicable |
BAM - Big Ass Melons Watermelon Gum E-Liquid 120mL 0 mg/mL | Not stated | 15/12/2024 | Nicotine not present | Not applicable | Not applicable | Not applicable |
Bang XXL Cool Mint disposable pod device 2000 puffs 6mL 6% Nicotine | Not stated | - | Nicotine present | Not assessed | Does not comply | Does not comply |
Bang XXL Red Raz Passion Fruit disposable pod device 2000 puffs 6mL 6% Nicotine | Not stated | - | Nicotine present | Not assessed | Complies | Does not comply |
By Killer Alphonso Mango (70VG/30PG) 100ml (0mg Nicotine) | 36721101EAM000 | 28/2/2024 | Nicotine not present | Not applicable | Not applicable | Not applicable |
By Killer Melon Fruit (70VG/30PG) 100ml (0mg Nicotine) | 36721EMF000 | 28/2/2024 | Nicotine not present | Not applicable | Not applicable | Not applicable |
By Killer Passionfruit (70VG/30PG) 100ml (0mg Nicotine) | 36721091EPF000 | 28/2/2024 | Nicotine not present | Not applicable | Not applicable | Not applicable |