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Therapeutic vapes sold in Australian pharmacies must comply with relevant product standards for safety and quality.
Therapeutic vapes can only be supplied to help people quit smoking or manage nicotine dependence.
There are currently no nicotine vaping goods included in the Australian Register of Therapeutic Goods (ARTG). Therapeutic vapes have not been evaluated by us for safety, quality, efficacy, or performance.
To reduce certain risks associated with therapeutic vapes, the TGA has introduced minimum product standards. Sponsors must notify us that their vaping goods comply with these standards before they can be supplied in Australian pharmacies.
It is important to note that even among therapeutic vapes that are compliant with TGA product standards, there are no guarantees about their safety, quality, efficacy, or performance.
Product standards for therapeutic vapes
- Product standards for vaping substance and vaping substance accessories: Therapeutic Goods (Standard for Therapeutic Vaping Goods) (TGO110) Order 2021
- Product standards for vaping devices and accessories: Therapeutic Goods (Medical Device Standard—Therapeutic Vaping Devices) Order 2023
Summary of product standards
Some of the specific requirements of the standards include, but are not limited to, the information below.
Permitted ingredients
- nicotine (max 50mg/mL for prescription vapes, or max 20mg/mL for pharmacist supplied vapes)
- propylene glycol
- glycerol
- water
- permitted flavours.
Permitted flavours
- mint
- menthol
- tobacco.
Packaging requirements
- plain packaging only
- must include information leaflets.
Product naming restrictions
Product names must not be in any way attractive to children or adolescents or suggest that the goods have health benefits.
Labelling requirements
Labels must be in English, with appropriate warning and usage instructions for devices and accessories.
Technical product requirements
Including compliance with:
- medical device quality management systems
- risk management standards
- battery and electrical safety standards
- specific design and construction requirements
- requirements for a toxicological risk assessment.
Further guidance
For further guidance about our product standards for vaping goods see: