Posted on January 8, 2024 By Colin
VAPING REGULATIONS ARE CONSTANTLY CHANGING in Australia and most vapers are confused. This blog provides an up-to-date summary of the current regulations at 17 January 2024 and the proposed future changes.
It is important to note that these regulations only apply to the legal market which is currently <10% of the total vape market in Australia, and is expected to reduce further.
A nicotine prescription from a doctor or nurse practitioner is required to legally possess or vape nicotine e-liquid. However, the federal Health Minister has said that vapers will not be prosecuted if they do not have a prescription. Legal action will focus on illegal imports and sales.
All doctors and nurse practitioners are now allowed to prescribe nicotine without prior approval from the TGA (under the Special Access Scheme C). The practitioner must submit a form for each individual patient to notify the TGA within 28 days. The Authorised Prescriber Scheme will continue to be available as well.
Prescriptions are not issued automatically. Under the RACGP guidelines, “It is reasonable for medical practitioners to choose not to prescribe them”. Most doctors are skeptical about vaping and are poorly informed. Further training for health care professionals has been promised, but no details are available.
The RACGP guidelines recommend that doctors limit the prescription to a maximum of 3 months’ supply. It is recommended that patients return "for regular review and monitoring".
Premixed ‘closed’ systems are preferred to open and tank devices "so that users cannot purchase and add their own flavours".
Nicotine e-liquid is available in two forms
There are two legal pathways for purchasing nicotine e-liquids. Both require a nicotine prescription.
The importation of single-use disposable vapes is prohibited, whether they contain nicotine or not - even if you have a prescription (effective 1 Jan 2024). Importing disposables is only approved for businesses if the importer holds a licence and permit issued by the Office of Drug Control (ODC) under the PI Regulations (see here).
From1 January 2024, travellers entering Australia can only bring a maximum of 2 disposable vapes with them. (see here)
Currently no restrictions. Empty refillable vapes can be purchased from vape shops (most are now closed), tobacconists, online from Australian and international websites. Devices and parts can be imported from overseas.
Basic minimum standards apply for e-liquids under the Therapeutic Goods (Standard for Nicotine Vaping Products) Order 2021 (TGO110). Updated standards (the Therapeutic Goods (Standard for Therapeutic Vaping Goods) (TGO 110) Order 2021 (TGO 110) were released in early January 2024 here.
The standards specify a range of labelling, packaging, ingredient, nicotine concentration and record-keeping requirements for nicotine e-liquids. The standards regulate nicotine as a medicine.
The following changes are proposed from 1 March 2024. Some will require legislation to pass through both houses of federal parliament. Debate on this Bill is expected at the end of February 2024. Other changes can be introduced by the Health Minister or the TGA.
From 1 March 2024, all vaping products (e-liquids with and without nicotine and hardware) will be deemed 'prohibited imports' and all vaping liquids will only be sold in pharmacies with a valid prescription.
From 1 March 2024, the import of all e-liquids will be prohibited without an import licence and permit from the Office of Drug Control. The only legal source of e-liquid (nicotine and nicotine-free) will be Australian pharmacies, with a doctor’s prescription. This includes bottled refills and prefilled pods.
The Personal Importation Scheme is to be cancelled on 1 March 2024 and it will be an offence to import e-liquid from overseas for personal use. This includes bottled refills, prefilled pods and disposables.
All international couriers were notified of the import restrictions on 13 December 2023. See here.
From 1 March 2024, it will also be an offence to import
Businesses wishing to import approved devices and accessories will require a licence and permit issued by the Office of Drug Control (see here).
You will be able to buy a limited range of refillable devices from pharmacies only - with a prescription. General retailers and vape shops will not be able to sell these devices. It will be legal to use refillable devices and many vapers are stocking up with devices in advance.
Under the guidelines, heated tobacco products are also prohibited and require an import permit under Regulation 5A and a permit under regulation 4DA of the Prohibited Imports Regulations as tobacco products. (here)
From 1 March 2024, all vaping products including reusable vaping devices (whether or not they contain nicotine) will be prohibited imports into Australia.
Section 9L of the Therapeutic Goods Act 1989 (Cth) makes it an offence to import, as well as to export, manufacture or supply a prohibited therapeutic good. This offence carries a maximum penalty of $93,900 with harsher penalties apply to corporations importing prohibited therapeutic goods for sale.
Similarly, section 233 of the Customs Act 1901 (Cth) outlines an offence where a person:
The maximum penalty for importing or dealing with a prohibited import under this section is a fine of up to three times the value of the goods, or up to $275,000 (whichever is greater).
Vaping products may also constitute a ‘tier 1 good' under section 233BAA of the Act which applies to non-narcotic drugs intentionally imported contrary to the Customs Act. This offence carries a maximum penalty of 5 years imprisonment, or a fine of $275,000 or both.
Reference: here (Mondaq Lawyers)
Update. Another reference suggests the penalties for illegal importationor supply will be up to 5 years imprisonment and/or a fine of $1,252,000 (4000 penalty units x current value $313)
Reference: Mondaq Lawyers 15 Feb 2024
The TGA is upgrading the standards for e-liquids and devices. Some of the expected changes are:
The January 2024 update of the TGO 110 standards is available here.
From 1 March 2024, travellers entering Australia can only bring a small quantity of vapes with them. The vapes must be for use in the treatment of the traveller or someone they are caring for, who is entering Australia on the same ship or aircraft. (see here)
The maximum allowable quantity is:
Many vape shops have already closed, but all are likely to close by 1 March 2024. Vape shops will not be able to sell
The Government will introduce a Bill into Parliament early in 2024, seeking to impose a domestic ban on the (see here)
of disposable vapes, and non-therapeutic vapes to ensure comprehensive controls across all levels of the supply chain. These changes require amendments to the Therapeutic Goods Act 1989.
New regulation of vapes starting January 2024, 15 December 2023
Reforms to the regulation of vapes
Vapes: information for prescribers, 15 December 2023
RACGP. Supporting smoking cessation: A guide for health professionals. Guidance updates on smoking and vaping cessation support related to changes to Australia’s vaping regulation. Provisional draft for consultation. December 2023
TGA. Requirements for unapproved therapeutic vapes for smoking cessation and the management of nicotine dependence. Guidance on the Therapeutic Goods (Standard for Therapeutic Vaping Goods) (TGO 110) Order 2021 and related matters. Version 1.4, January 2024
Importing vaping goods into Australia, Office of Drug Control 1 January 2024
Australian Customs Notice no. 2023/51. New Import Control on Vaping Goods. Advice to Couriers. 13 December 2023
Is Vaping a Criminal Offence in New South Wales? Sydney Criminal Lawyers 27 January 2024