Therapeutic vapes for smoking cessation and the management of nicotine dependence are only available for sale from participating pharmacies, where clinically appropriate.
It is illegal for all other retailers such as tobacconists, vape shops and convenience stores to sell any kind of vape, regardless of whether they contain nicotine.
Vapes cannot be purchased from overseas retailers or websites for personal use.
The changes are part of a wider set of vaping reforms being implemented jointly between the Australian Government and state and territory governments. They have been designed to protect young Australians and the broader community from the risks posed by vapes, while preserving access to therapeutic vapes where clinically appropriate.
More information about the range of reforms being implemented is available at: Changes to the regulation of vapes.
Cannabis vapes are subject to separate strict regulations (see the Medicinal cannabis hub).
Vapes are unapproved goods
There are currently no therapeutic vapes that have been evaluated by the TGA and included in the Australian Register of Therapeutic Goods (ARTG) for smoking cessation or the management of nicotine dependence.
Therapeutic goods not included in the ARTG are known as unregistered or unapproved goods.
These products have not been assessed by the TGA for quality, safety and efficacy or performance.
Therapeutic vapes are not a first line of treatment for smoking cessation, vaping cessation or the management of nicotine dependence.
However, where clinically appropriate, there are access pathways for registered health care professionals to prescribe or supply therapeutic vapes for their patients where it is agreed that this is an appropriate course of treatment.
See Access unapproved products (consumers)
Accessing therapeutic vapes
Patients wanting to quit smoking or vaping and would like to find out more about therapeutic vapes as a treatment option should speak to a medical practitioner, nurse practitioner or pharmacist about the available options, and the restrictions that may apply in their state or territory.
Prescribers and pharmacists are under no obligation to prescribe, dispense or supply therapeutic vapes.
There are two lawful pathways for accessing therapeutic vapes, with different rules and restrictions. These are:
- pharmacist model
- prescription model.
Under the pharmacist model, patients who are 18 years or over may be able to access therapeutic vapes with a nicotine concentration of 20 mg/mL or less without a prescription.
Patients are only able to access therapeutic vapes under this model if the participating pharmacist
- is satisfied that supply is clinically appropriate for smoking cessation or the management of nicotine dependence
- has requested and sighted evidence of the patient’s identity and age
- informed the patient that the goods are not included in the ARTG and obtained the patient’s informed consent
- provided professional advice to the patient in relation to alternative registered (Australian Register of Therapeutic Goods) therapies, appropriate dose and frequency and interactions with other medicines
- ensured the quantity of goods supplied by the pharmacist to the relevant patient does not exceed one month supply in any one month
- provided contact details about cessation support services to the patient
- supplied the goods in accordance with state and territory legislation and good pharmacy practice.
Under the prescription model, patients require a prescription from a medical or nurse practitioner before a participating pharmacy will dispense a therapeutic vape. This requirement may apply for a range of reasons including:
- there is a requirement under state and territory legislation for a prescription
- the patient is under 18 years of age
- the patient requires therapeutic vapes with a nicotine concentration greater than 20 mg/mL
- the patient is assessed as having more complex medical needs and requires additional advice and support from a medical practitioner.
Therapeutic vapes containing more than 20 mg/mL of nicotine are not permitted for sale without a prescription in any circumstances.
In all circumstances, a pharmacist can only supply a vaping device if satisfied it will be for use for smoking cessation or the management of nicotine dependence. The TGA has published a list of notified vapes that can be legally supplied by participating pharmacies in Australia. This list may be used by relevant health practitioners to determine whether a particular therapeutic vaping good may be suitable for a patient.
Strengthened product quality standards
The TGA has developed product standards that apply to all therapeutic vapes lawfully available in Australia for smoking cessation or the management of nicotine dependence.
These standards have been designed to minimise the risks associated with therapeutic vape use. However, even among products that are compliant with these standards, there are no guarantees about their safety, quality, efficacy or performance.
These standards are being strengthened and will include new requirements for devices, ingredients, packaging and labelling. These new standards will be implemented during the first half of 2025.
Read more about the product standards
Health risks associated with vape use
It is important to remember that evidence about the impacts of vaping on health is still emerging and requires more long-term research.
A systematic review of global evidence found that vaping increases the risk of a range of adverse outcomes. This includes risks of poisoning, seizures, toxicity from inhalation, addiction to nicotine and lung injury. The review also highlighted early signs of adverse effects of vapes on cardiovascular health, including blood pressure and heart rates. More recent evidence suggests that vape use may increase the risk of heart failure.
Vaping may also increase the risk of adverse oral health outcomes. Evidence suggests that vaping promotes inflammation of the gums, changes the profile of mouth bacteria toward more harmful bacteria, and reduces the gums’ healing capacity.
Aids for smoking cessation or managing nicotine dependence
The overall evidence of the effectiveness of vapes to support smoking cessation or the management of nicotine dependence remains limited. Given this and the health risks of vaping, therapeutic vapes are not a first line of treatment for smoking cessation, vaping cessation or the management of nicotine dependence.
There are a range of other medicines available in Australia that have been evaluated and approved by the TGA for smoking cessation that do not have the same health risks as vapes. Some of these medicines are also subsidised on the Pharmaceutical Benefits Scheme, such as nicotine patches. These medicines are different to therapeutic vapes and are not affected by the Government’s vaping reforms.
There are many methods to manage nicotine addiction, including going cold turkey, gradually cutting down, seeking support from a health professional and using nicotine replacement therapies or prescription medicines.
If you are interested in additional support to quit, qualified health practitioners such as doctors, nurse practitioners and pharmacists can help. They can provide advice on the options available to help quit smoking, quit vaping or to manage nicotine dependence.
Quitline (13 7848) is staffed by qualified counsellors and provides confidential, professional, evidence-based counselling and information on how to quit smoking and/or vaping.
For more information on support services available, the new national digital quitting platform at quit.org.au contains a range of free tools and resources to help you on your quitting journey.
Remember - Support to quit is available. You can phone the Quitline on 13 7848, download the My QuitBuddy app or visit quit.org.au to learn about the various options available to help you quit smoking, vaping, or to manage nicotine dependence.
Possession penalties
The Australian Government’s vaping reforms do not penalise individuals who possess small amounts of vapes for personal use.
New penalties on possessing vapes are targeted at the commercial and retail suppliers of unlawful vapes and black market supply chains.
Some states and territories prohibit individuals possessing any unprescribed nicotine vapes and these prohibitions may continue to operate.
Bringing vapes into Australia
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.
Vapes that contain substances that are controlled drugs under regulation 5 of the Customs (Prohibited Imports) Regulations 1958, such as cannabis, are not counted in the above limits.
Further information from the Australian Border Force (ABF) for travellers bringing goods into Australia can be found here: Can you bring it in? (abf.gov.au)
Personal importation is prohibited
Vapes cannot be purchased from overseas retailers or websites for personal use, even with a prescription.
ABF officials can seize and destroy goods at the border that are suspected to be unlawful imports.
There are significant penalties for unlawfully importing vaping goods
What is not affected by the reforms?
Nicotine replacement therapies (NRTs) that are currently registered on the Australian Register of Therapeutic Goods are not affected by the changes, including:
- patches
- lozenges
- inhalers
- mouth sprays
- chews
- gums.
These therapies are available without prescription from pharmacies and some retail outlets. Some nicotine patches are subsidised through the PBS or RPBS for eligible people with a prescription.
Report side effects and problems
Patients and health professionals should report any suspected side effects or malfunctions related to therapeutic vapes.
Seek urgent medical attention for suspected nicotine poisonings
Nicotine poisoning can affect anyone of any age. However, the greatest risk of nicotine poisoning is in children because of their lower body weight – small quantities of the vaping substance (3-10 mL) can be fatal to children without medical intervention.
Nicotine can enter the body through:
- absorption through the skin if a vaping substance is spilled on the skin or touched
- inhalation into the lungs, or
- ingestion of vaping substances.
Symptoms of nicotine poisoning include nausea and vomiting, headaches, dizziness, breathing difficulties, seizures and cardiac arrest.
If the vaping substance is spilled on the skin, flush skin with running water.
If the vaping substance is in the eyes, flush immediately with running water.
Seek immediate medical attention if you think that you, or anyone else, may have been exposed to, or ingested, a vaping substance.
For advice, contact a Poisons Information Centre (e.g. phone Australia 13 11 26; New Zealand 0800 764 766) or a doctor.
Reporting breaches or questionable practices
We encourage you to report any perceived breach of the Therapeutic Goods Act 1989 or questionable practices relating to the importation, manufacture, supply, and advertising of vapes to the TGA. This includes the supply of vapes by a retailer other than a pharmacist (e.g. by a vape store).