The Laws
From January 1, 2024: the Australian Government banned the importation of disposable vapes into Australia.
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this includes vapes with and without nicotine. Disposable vapes are e-cigarette devices that can’t be recharged, or reused.
Importation of single-use, disposable vapes was prohibited (regardless of nicotine content).1,2 This prohibition covers products ordered before 1 January 2024, which have not yet arrived in Australia.
New ‘Special Access Scheme C’ pathway commenced for medical practitioners and nurse practitioners to prescribe therapeutic vaping products. According to the TGA, this new pathway is intended to reduce the administrative burden involved for medical and nurse practitioners, and facilitate legitimate access to therapeutic vaping products under medical supervision. Under this new pathway, practitioners no longer need to apply to the TGA for prior approval in order to prescribe therapeutic vaping products.31 March 2024
Importation of all non-therapeutic vaping products was prohibited (regardless of nicotine content).1,2
Importation of all vaping products under the ‘Personal Importation Scheme’ ended. As a result of this change, individuals are no longer able to order vaping products directly from overseas, even with a prescription.
New ‘pre-market notification requirements’ commenced for the importation and manufacture of all therapeutic vapes. Importers and manufacturers are therefore required to notify the TGA that their products comply with product standards set out in TGO110 before the products can be imported/manufactured. A list of ‘notified products’ was made publicly available on the TGA website from 1 March 2024.-
From March 1, 2024: more requirements were introduced including:
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a ban on the importation of all vapes, including rechargeables, without an import licence and permit
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specific product requirements for vapes imported with a licence or permit, such as flavours limited to mint, menthol or tobacco.
Importation of all non-therapeutic vaping products was prohibited (regardless of nicotine content).1,2
Importation of all vaping products under the ‘Personal Importation Scheme’ ended. As a result of this change, individuals are no longer able to order vaping products directly from overseas, even with a prescription.
New ‘pre-market notification requirements’ commenced for the importation and manufacture of all therapeutic vapes. Importers and manufacturers are therefore required to notify the TGA that their products comply with product standards set out in TGO110 before the products can be imported/manufactured. A list of ‘notified products’ was made publicly available on the TGA website from 1 March 2024.
Initial amendments to the product standard known as ‘TGO110’ came into effect (with further amendments to be implemented in 2025).4 From 1 March 2024, the standard was amended to (1) limit the use of flavouring ingredients in a vaping substance to those that produce the taste or smell of mint, menthol or tobacco flavour and (2) introduce new minimum safety requirements for therapeutic vaping devices.4
Initially, therapeutic vaping products imported or manufactured before 1 March 2024 were not required to meet the amended standards, provided they met the product standards that applied at the time of the importation or manufacture.ii However, this exception ended on 1 July 2024. As a result, all vaping products must now comply with the amended product standards (regardless of when they were imported or manufactured).
Compliance with the TGA’s product standards does not mean that a product has been approved by the TGA. The long-term health risks of products that comply with TGO110 are still unknown.
Importers also need to obtain a customs license and permit from the Office of Drug Control (ODC) to import therapeutic vaping products.1 July 2024
Amendments to the Therapeutic Goods Act 1989 (Cth) commenced prohibiting the manufacture, supply and commercial possession of all disposable vapes and non-therapeutic vapes.5 However, these new laws do not involve criminalisation of individuals in possession of vapes for personal use.
Manufacture, supply and commercial possession of vapes is only legal if the products are intended for smoking cessation or the management of nicotine dependence, and the TGA’s ‘pre-market notification requirements’ (referred to above) have been satisfied.
General retailers (such as tobacconists, vape shops and convenience stores) are prohibited from supplying vapes (including existing stock).
New advertising controls also commenced, which completely prohibit the advertising of vapes, except where specifically authorised.-
Between 1 July 2024 to 30 September 2024, nicotine vaping products could only be legally purchased from Australian pharmacies with a prescription. While a prescription was not technically required for non-nicotine vapes, patients were still required to speak with a medical or nurse practitioner in order to legally purchase non-nicotine vapes until 30 September 2024.6
New advertising controls also commenced, which completely prohibit the advertising of vapes, except where specifically authorised. From 1 July 2024, a number of specific forms of advertising were authorised.7 These include:-
Advertising that is on the label of notified vaping goods, on the package in which notified vaping goods are contained, and on any material with that package;
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Advertising directed exclusively to a medical practitioner, nurse practitioner or pharmacist (or a practice manager or purchasing officer for such persons);
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Advertising that is directed exclusively to and between those engaged in the business of wholesale supply and retail supply of notified vaping goods;
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Advice or information given directly to a patient by a medical practitioner, nurse practitioner or pharmacist in relation to their treatment for smoking cessation or the management of nicotine dependence;
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Advertising that forms part of a Commonwealth or State health campaign in relation to vaping goods.
Each of the above authorised forms of advertising is subject to very specific conditions. For example, advertising that is directed at a medical practitioner, nurse practitioner or pharmacist must (among other things) only contain information that (i) is necessary for the safe and effective use of the vaping goods, (ii) relates to the availability and price of the goods or (iii) relates to information about the vaping goods, including the indications or intended purpose of the goods, the ingredients, formulation, composition etc.81 October 2024
Therapeutic vapes with a nicotine concentration of 20 mg/ml or less became available for purchase from pharmacies by patients 18 years or over, without the need for a prescription.i However, certain conditions must be satisfied for pharmacists to legally supply vaping products without a prescription, including (among other things):
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The pharmacist must request and sight evidence of the patient’s identity and age;
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The pharmacist must supply the products in accordance with good pharmacy practice;
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The quantity of the goods supplied must not exceed the quantity that is reasonably required for 1 month of therapeutic use (and that quantity must only be supplied to the patient once per month);
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The pharmacist must provide advice about the appropriate dose and frequency, length of treatment, interactions with other medicines etc;
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The pharmacist must provide the patient with advice on alternative cessation supports and therapies, along with contact details about smoking cessation support services.iii
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From October 1, 2024: therapeutic vapes can now be bought from pharmacies by people over 18 without a prescription.
Therapeutic vapes are for someone quitting smoking, or managing a nicotine dependence (addiction).
These products must meet certain requirements:
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flavours will be limited to mint, menthol or tobacco
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packaging will be a plain pharmaceutical style
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nicotine concentration cannot be higher than 20mg/ml
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people who need vapes with a higher concentration of nicotine will require a prescription.
*These changes are still subject to state laws. For example, Tasmania and Western Australia both recently announced they are introducing their own legislation which will be different to the federal vaping laws. These state laws will maintain the requirement for people over 18 to have a prescription from a medical practitioner to purchase a pharmaceutical vape. Whether other states follow suit remains to be seen.
Therapeutic vapes for patients under 18 years will also depend on individual state/territory laws. The laws in some jurisdictions prevent the supply of vapes to people under 18, even with a prescription. But, in other jurisdictions people under 18 will be able to access a therapeutic vape with a prescription.
To find out more about these changes visit the Therapeutic Goods Administration’s vaping hub or the Government’s vaping webpage.
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Further amendments to the product standards in TGO110 will come into effect in 2025.9
These amendments include (among other things):
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Restrictions on the names of vaping products. For example, product names must not:
a. be in any way attractive to children or adolescents;
b. suggest or associate vapes with any food, beverage, confectionery or cosmetic product;
c. suggest the product has any health benefit;
d. suggest the product is safe or without harm/side effects;
e. promote the use/supply of the product;
f. exaggerate the efficacy or performance of the product;
g. encourage inappropriate or excessive use of the product. -
Increased restrictions on how vapes appear and the information that must be included on product labels. These include restrictions regarding the size of text for labels, the colours that may be used for labels and packs, the size and content of warning statements etc. Labels and packs must not contain certain prohibited features (such as heat activated inks or embellishments designed to appear gradually over time).
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Restrictions on the ingredients that can be included in vaping substances. For example, the amendments include a requirement that vaping products contain only certain permitted ingredients.vi
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Restrictions on menthol concentration. Menthol must not exceed 20mg/ml in a vaping substance.
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A maximum permitted nicotine concentration of 50mg/ml (or equivalent base form). Vaping products that exceed this concentration therefore cannot be imported, manufactured or supplied.
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Maximum permitted volumes for vaping substance containers (including as pods and cartridges). An individual vaping substance container must not contain more than 60ml of vaping substance. Pods or cartridges for ‘closed system’ vapes must not contain more than 5ml of vaping substance.
From 1 March 2025, only vaping products that meet these updated standards can be imported into the country.
Vaping products supplied in Australia can continue to comply with the previous product standards until 1 July 2025.-
Vaping products supplied in Australia can continue to comply with the previous product standards until 1 July 2025.
1 July 2025
Only those vapes that meet the updated product standards in TGO110 can be lawfully supplied in Australia.
Therapeutic Goods Administration – Vaping Hub
https://www.tga.gov.au/products/unapproved-therapeutic-goods/vaping-hub
Vaping goods include devices, vaping accessories, vaping substances and all liquid nicotine, whether or not the liquid nicotine is intended for vaping.
Regulation 5A of the Customs (Prohibited Imports) Regulations 1956 prohibits the import of vaping goods unless you have prior permission.
Vaping goods are controlled for health reasons. All vaping goods are prohibited, irrespective of the type of device or whether the product includes nicotine, makes a therapeutic claim, or is used for drugs or medicines.
Licenses and permits are restricted to commercial importers or researchers importing vaping goods for:
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the purposes of manufacture and supply (to pharmacies); or
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scientific or medical research, such as clinical trials.
No one in Australia will be able to import vaping goods from overseas, even with a prescription.
For more information about vape reforms, visit the Therapeutic Goods Administration.
For more information about the permit requirements for vaping goods, visit the Office of Drug Control.
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