With vapes now able to be bought from pharmacies without a prescription, the Therapeutic Goods Administration (TGA) has announced new standards for the product.
In a statement today, the TGA said it was strengthening product standards for therapeutic vapes including vaping substances, vaping substance accessories, vaping devices and vaping device accessories.
It said the new standards would be implemented in stages to allow industry time to update their products to comply.
“From 1 March 2025, only vapes that meet the updated product standards can be imported into or manufactured in Australia. From 1 July 2025, only those vapes that meet the updated standards can be lawfully supplied in Australia,” the statement read.
The TGA said key changes included:
- Restrictions to the formulation of vaping substances to permitted ingredients only and changed restrictions on the level of allowed nicotine (50 mg/mL limit).
- Enhancement of the packaging and labelling of vapes, including requirements for plain packaging, information leaflets, traceability and restrictions on product names.
- Restrictions to the maximum permitted container volume.
It said the changes would provide patients and health practitioners with increased confidence in the quality and safety of vapes used for the purpose of smoking cessation or nicotine dependence.
The standards’ announcement came on the same day (October 1) Australians, 18 years or over, could purchase therapeutic vapes from participating pharmacies without a prescription.
The TGA said a consultation with a pharmacist was required and the purchase was subject to certain conditions, as well as any state and territory restrictions.
It said there were now two lawful pathways for accessing therapeutic vapes:
- Pharmacist only model: Where it is clinically appropriate for the purpose of smoking cessation or the management of nicotine dependence, pharmacists can supply therapeutic vapes containing 20 mg/mL or less of nicotine to patients who are 18 years or older without a prescription, subject to certain conditions.
- Prescription model: If patients are under 18 years of age, require a higher nicotine concentration than 20 mg/mL or have complex medical needs and require additional advice and support they will need to obtain a prescription from a medical or nurse practitioner.
