On 26 June 2024, Australia’s second stage vaping reform bill, the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024 (the Bill) was passed. 

Consequently, from 1 July 2024, domestic controls on all vaping products have been implemented, meaning that retailers such as tobacconists, vape shops and convenience stores are no longer able to lawfully supply any type of vapes (regardless of whether or not they contain nicotine). Vapes containing nicotine can currently only be supplied by pharmacies to customers who have a prescription from their doctor. Additionally, the manufacture and commercial possession of non-therapeutic and disposable vapes in Australia has also been banned.

However, therapeutic vapes will become more broadly available (albeit in a much more regulated manner) from 1 October 2024. Specifically, vapes containing nicotine will be downgraded from Schedule 4 (Prescription Only Medicines) to Schedule 3 (Pharmacist Only Medicines) of the Poisons Standard.  As a result, from 1 October 2024 individuals aged over 18 years old will be able to purchase therapeutic vapes containing nicotine at pharmacies without the need for a prescription. Pharmacists will need to sight evidence of a patient’s identity and age, and supply no more than the quantity reasonably required for the patient’s therapeutic use for one month. The concentration of nicotine in the vaping product must not exceed 20 mg/mL and flavours are restricted to mint, menthol and tobacco.

The loosening of the restrictions on vapes from 1 October 2024 were made to address the concern that the government's original proposed reforms would push users to the black market. The Minister for Health and Aged Care, Mark Butler (Minister), expressed that the amendments as implemented reflect “a sensible balance between access and serious reform, to return [vape] to its original intention, which was a therapeutic good”.

However, the Pharmaceutical Society of Australia (the professional body for pharmacists) and the Pharmacy Guild of Australia have both voiced their disagreement to the amendments. In particular, these organisations have expressed concerns in asking pharmacists to dispense unapproved, unregulated, untested vaping products to the public.

Currently in Australia, vapes are unapproved therapeutic goods. Vaping products have not been approved by the Therapeutic Goods Administration (TGA) and no nicotine-containing vape is listed on the Australian Register of Therapeutic Goods (ARTG). This means that vapes have not been assessed by the TGA for quality, safety and efficacy or performance. Therapeutic vaping goods must comply with the Therapeutic Goods (Standard for Therapeutic Vaping Goods) (TGO 110) Order 2021 (TGO 110), which includes requirements about the following:

• product labelling (including an oversticker or in an information sheet provided with the product)
• child resistant packaging
• maximum nicotine concentration (although currently consumers can only access the nicotine concentration prescribed to them)
• requiring actual nicotine concentration/content of the vape to reflect the product label
• prohibited ingredients
• accepted flavours of mint, menthol and tobacco
• quality management system requirements for vaping devices and vaping device accessories
• documentation that needs to be kept by the Australian sponsor of the product.

There are also advertising restrictions on vaping products, as the Australian Government seeks to clamp down on the idea that vapes are recreational products. Advertising of vaping products is prohibited, unless otherwise authorised by the Secretary of the Department of Health. Criminal and/or civil penalties apply for the unauthorised advertising of vaping products. For individuals penalties are up to 7 years' imprisonment and/or 5,000 penalty units (AU$1,565,000 as of June 2024), and for corporations civil penalties are up to 70,000 penalty units (AU$21,910,000 as of June 2024).

These second stage vaping reforms reflect the Australian Government’s focus on stamping out recreational vaping and restricting access to vapes by minors. Earlier this year, the Australian Government commenced the first stage of Australia’s vaping reforms (see our article on the first stage of Australia’s vaping reforms).  The first stage vaping reforms included import bans on disposable vapes and all non-therapeutic vapes.