New vape regulations start today – what you need to know

Posted on June 30, 2024 By Colin

VAPES ARE ONLY LEGALLY AVAILABLE from pharmacies with a doctor's prescription from today, under Mark Butler's prohibitionist Vaping Reforms Act. From 1 October 2024, a prescription will only be necessary for nicotine base concentrations over 20mg/mL.

Vapes are only permitted for smoking cessation or for the management of nicotine dependence. Recreational vaping is banned.

However, it is expected that most vapers will continue to access supplies from the usual black market sources, such as tobacconists, convenience stores, and via social media. Some vapers will go back to smoking

Here are the latest guidelines

1 July-30 September 2024

E-liquid

A prescription is required from a medical or nurse practitioner for e-liquid with or without nicotine. However, very few are willing to write prescriptions
E-liquid (with or without nicotine) can only be purchased legally from pharmacies
Flavours are restricted to mint, menthol, and tobacco (transitional arrangements for other flavours end)
Maximum bottle volume 60mL
Only one month's supply can be purchased at any one time, once per month
The current maximum nicotine concentration is 100mg/mL
Only products notified to the TGA as complying with regulations (labels, packaging, ingredient, flavours etc) can be sold. See here for a full list of compliant products
Advertising and promotion are banned including on social media
Do-it-yourself (DIY) home mixing is banned. Only finished products are lawful to dispense. Pharmacists cannot dispense ingredients for patients to use to mix their own vaping substances
Non-therapeutic vapes are banned ie only vapes used to stop smoking and for the treatment of nicotine dependence are allowed

Devices (without nicotine)

Are now classified as medical or therapeutic devices (see below for Standards)
Can be legally purchased only in pharmacies. A prescription is not needed. Sale from tobacconists, vape shops and convenience stores is banned.
Single-use vapes with or without nicotine are banned (cannot be imported, sold or manufactured)
The importation of vape products into Australia for personal use remains banned

From 1 October 2024

Nicotine liquid will be reclassified in the Poisons Standard from Schedule 4 (prescription-only medicine) to Schedule 3 (pharmacist-only medicine). From this date

Adults can purchase nicotine liquid <20mg/mL without a prescription
A prescription will be needed for nicotine >20mg/mL. Note that an upper limit of 50mg/mL will apply for the first 12 months for prescriptions. No doubt it will be removed after that
Nicotine liquid can only be purchased after a 'conversation' with the pharmacist (not the pharmacy assistant) to ensure the nicotine is for a ‘therapeutic purpose’, ie to stop smoking, and to verify you are at least 18 years old. At each visit, the pharmacist must
- Inform you that the products are not “listed or registered”
- Obtain informed consent
- Provide advice on alternative quitting aids
- Provide contact details about smoking cessation support services
- Notify the TGA and the product sponsor if there are side effects or a defect in the product
- Hand the products personally to the patient
- Notify the TGA of the purchase, citing the person's identification and age and possibly other information
- Under 18s can purchase vapes with a prescription (where it is allowed)

Later [link]

Vapes will be sold in plain pharmaceutical packaging like medicines (date to be announced)
Permissible nicotine concentrations to be reduced further
TGO 110 standards will be strengthened

Finding a pharmacy

Finding a pharmacy selling vapes will be challenging. The Pharmacy Guild which represents the 6,000 pharmacy owners in Australia “strongly opposes the pharmacy model” and regards it as “insulting”.

TerryWhite Chemmart, Priceline, Blooms, National Pharmacies in South Australia and 777 Pharmacy Group in West Australia announced they would not supply vapes and it is likely that many independent pharmacies will also not stock vapes

Some online pharmacies are also available with a wide range of products. However, I am not allowed to tell you which ones.

Penalties

Personal possession

Personal possession and use of nicotine e-liquie without a prescription is an offence under state laws, with jail terms up to 2 years and fines up to $45,000. Once nicotine becomes Schedule 3 on 1 October 2024, these penalties will no longer apply.

The health minister has repeatedly said that illegal purchase or possession will not be an offence under federal law.

Commercial offences

For commercial offences, new maximum penalties of up to 7 years in jail and fines up to $2.2 million for individuals and $21.91 million for corporations apply.

No prohibitions apply to possession of less than a ‘commercial quantity’ of vapes.

Until 30 September 2024, the commercial quantities are [link]:

14 vaping devices,
90 vaping accessories, and
600mL of liquid vaping substance.

From 1 October 2024, the commercial quantities will be:

9 vaping devices,
60 vaping accessories, and
400 mL of liquid vaping substance.

Standards

For vaping substances:
Therapeutic Goods (Standard for Therapeutic Vaping Goods) (TGO 110) Order 2021 (TGO 110), and

For vaping devices or accessories
Either:

The Essential Principles or
The Therapeutic Goods (Medical Device Standard—Therapeutic Vaping Devices) Order 2023
(MDSO). The MDSO only applies to vaping devices and accessories that were excluded from the therapeutic goods regulatory framework prior to 1 January 2024.

Traveller's exemption

Persons entering Australia by ship or aircraft may bring a small quantity of vapes under a traveller’s exemption. The vapes must be for use in the treatment of the traveller or someone the traveller is caring for, who is entering Australia on the same ship or aircraft.

The maximum allowable quantity is:

2 vapes
20 vape accessories (including cartridges, capsules or pods), and
200 mL of vape substance in liquid form.

Schedule 3 but unregistered

All Schedule 3 products (pharmacist-only medicines) are registered by the TGA and listed on the Australian Register of Therapeutic Goods (ARTG). This requires an onerous and expensive process by the manufacturer confirming safety and effectiveness. Vapes are the only S3 products that are currently not registered.