This article was updated on 22 November 2024.

Who can supply vapes?

On 1 October 2024, certain provisions in the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 (Cth) took effect to permit the supply without a prescription of reusable therapeutic nicotine vapes in pharmacy settings to patients 18 years and over. Before that change, an adult required a prescription to purchase a nicotine vape at a pharmacy. A person under 18 still requires a prescription to buy a nicotine vape from a pharmacy.

The change followed the change in law that took effect from 1 July 2024 which prohibited non-pharmacy retailers (e.g. tobacconists, vape shops and convenience stores) from selling nicotine vapes. Over the past few months, the Therapeutic Goods Administration (TGA) has issued numerous infringement notices and fines for the unlawful supply of nicotine vapes.

We’ve also started to see the states taking action to clamp down on unlawful supply; for example, the Public Health (Tobacco) Amendment Bill 2024 is currently before the NSW Parliament. That Bill seeks to amend the Poisons and Therapeutic Goods Act 1966 (NSW) (among other Acts) so that unlawful suppliers of vapes face 7 years imprisonment, and/or a fine of $1.54m. This comes as the NSW Government has reportedly seized over 300,000 vapes over the past year, and plans to recruit an additional 14 enforcement officers to strengthen compliance efforts for vaping and tobacco products across NSW.

What vapes can be supplied by a pharmacy to adults without a prescription?

There are currently no vapes indicated for smoking cessation or the management of nicotine dependence included in the Australian Register of Therapeutic Goods (ARTG).

However, nicotine vaping goods are exempt from the requirement to be included in the ARTG if the requirements of TG110 are met which currently include:

• the vape only contains one active ingredient, being nicotine;
• the vape has a maximum nicotine concentration of not more than 100mg/mL;
• the flavour of the vaping substance is mint, menthol or tobacco flavour (and not a combination of those flavours with other flavours e.g. chocolate mint);
• the vaping substance does not include a ‘prohibited ingredient’ such as diethylene glycol or ethylene glycol;
• the label contains the necessary warning statements and ingredient list;
• the packaging is compliant (including being child-resistant); and
• relevant records are maintained.

Additionally, an imported vape supplied by a pharmacy must be reusable; the importation of disposable vapes has been prohibited since 1 January 2024.

Cannabis vapes are subject to different requirements.

What are the new standards coming into effect in 2025?

The TGA recently published changes to the standards of vapes (i.e. TG110 and MDSO) that will come into force on 1 March 2025 for vapes imported into, or manufactured in, Australia. The key changes include:

• reduction in the maximum nicotine concentration in the vape from 100mg/mL to 50mg/mL;
• new maximum volume of 60mL for vaping substances and 5mL for vaping substance accessories;
• new requirement for packaging to be plain (i.e. be predominantly with no promotional pictures/designs);
• new restriction on use of certain product names (e.g. those names that may considered to be attractive to children and adolescents, suggests that the vape has health benefits and/or is safe, or promotes the use or supply of vapes cannot be used); and
• new requirement for the vape and accessories to meet new technical product requirements including quality management systems, risk management standards, battery and electrical safety standards, specific design and construction requirements, and requirements for a toxicological risk assessment.

We have recently advised clients on these new requirements, including on requirements for the importation of vapes such as import permits and licences (which are separate to the therapeutic goods laws). Please reach out to us if you would like to learn more.