Australia’s nicotine laws have changed considerably in recent years. Today, all nicotine products-whether or not they contain nicotine-can only be legally sold by participating pharmacies for the purpose of helping people quit smoking or manage nicotine dependence.
For Australians accustomed to seeing nicotine products sold by tobacconists, convenience stores and specialist nicotine retailers, the pharmacy-only model can be confusing. It also raises important questions: What makes a product a therapeutic nicotine product? Does it need to be approved by the Therapeutic Goods Administration? Who needs a medical authorisation? Why does a pharmacist need to speak with the patient before supply?
This guide explains how pharmacy-supplied therapeutic nicotine products are regulated in Australia, what the current access pathways involve, and what patients should understand before considering therapeutic nicotine use as part of a smoking-cessation or nicotine-dependence treatment plan. The Department of Health (smoking and tobacco) have helpful additional information about nicotine use and e-cigarettes.
Why are therapeutic nicotine products now supplied through pharmacies?
On 1 July 2024, Australian law changed so that all therapeutic nicotine products and nicotine devices, including products that do not contain nicotine, could only be sold through pharmacies for a therapeutic purpose.
Non-pharmacy retailers-including tobacconists, convenience stores, nicotine product shops and online retailers-cannot legally sell any form of therapeutic nicotine product. Pharmacies cannot sell single-use disposable nicotine devices either.
The reforms were introduced as part of a broader public-health response to rising nicotine use rates, particularly among young people, and concerns about the composition and supply of illicit products. The Australian Government states that illegal therapeutic nicotine products may not accurately disclose their ingredients and may contain nicotine even when labelled nicotine-free.
The pharmacy model is intended to preserve access where therapeutic nicotine products are considered clinically appropriate, while moving supply away from general retail and into a healthcare setting.
This does not mean every pharmacy must stock or supply therapeutic nicotine products. Pharmacists and medical practitioners are under no obligation to participate, and any supply must comply with Commonwealth requirements as well as applicable state or territory laws. The TGA provide information on therapeutic nicotine products for smoking cessation and the management of nicotine dependence
What is a therapeutic nicotine product?
A therapeutic nicotine product is a nicotine solution, nicotine device or nicotine accessory supplied for the purpose of:
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helping a person stop smoking;
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helping a person stop using therapeutic nicotine products; or
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managing nicotine dependence.
The intended therapeutic purpose is important. The legal pharmacy pathway does not provide general retail access to therapeutic nicotine products for recreational use.
Therapeutic nicotine products may include reusable devices, pods, cartridges and liquid nicotine solutions. However, single-use disposable nicotine devices cannot be legally supplied through Australian pharmacies. Flavours are restricted to mint, menthol and tobacco, and products are subject to pharmaceutical-style packaging and labelling requirements.
Are pharmacy-supplied therapeutic nicotine products TGA approved?
No. This is one of the most important distinctions for patients to understand.
There are currently no therapeutic nicotine products that have been evaluated by the TGA and included in the Australian Register of Therapeutic Goods for smoking cessation or the management of nicotine dependence.
Products that are not included in the ARTG are described as unregistered or unapproved therapeutic goods. The TGA has not assessed these products in the same way it assesses a registered medicine for quality, safety, efficacy or performance.
A product appearing on the TGA’s notified therapeutic nicotine product list does not mean that it is “TGA approved”.
Instead, the Australian sponsor responsible for the product has notified the TGA that the product complies with applicable standards. The notified list identifies the therapeutic nicotine goods that may be legally supplied through participating Australian pharmacies. Healthcare practitioners can use the list when considering which products may be suitable for supply.
The distinction can be summarised as follows:
|
Term |
What it means |
|
Included in the ARTG |
The therapeutic good has been evaluated through the applicable TGA market-authorisation process. |
|
Unapproved therapeutic good |
The product is not included in the ARTG and has not been evaluated by the TGA for quality, safety, efficacy or performance. |
|
Notified therapeutic nicotine product |
The sponsor has notified the TGA that the product complies with applicable therapeutic nicotine standards, allowing it to be considered for legal supply through the relevant pathways. |
Patients should therefore be cautious when a therapeutic nicotine product is described as “TGA approved”, because that description does not accurately reflect the current regulatory status of therapeutic nicotine products in Australia.
What product standards apply?
The TGA has established mandatory product standards for unapproved therapeutic nicotine goods. These standards are intended to reduce some of the risks associated with their use and regulate areas such as:
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permitted and prohibited ingredients;
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nicotine concentration;
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flavour restrictions;
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device characteristics;
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labelling;
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packaging;
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child-resistant requirements; and
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information that must accompany the product.
The standards do not establish that nicotine use is safe. The TGA expressly states that compliance with the standards does not guarantee a product’s safety, quality, efficacy or performance.
This is another important distinction between compliance with a minimum regulatory standard and formal evaluation and approval of a medicine.
The notified framework nevertheless creates clearer obligations for sponsors, importers, manufacturers, pharmacists and other participants in the supply chain than exist in the illicit market.
How can adults access therapeutic nicotine products?
There are two principal legal access pathways:
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the pharmacist model; and
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the medical authorisation model.
Which pathway applies depends on factors including the patient’s age, the nicotine concentration required, state or territory law and the patient’s clinical circumstances.
The pharmacist model
An adult aged 18 years or older may be able to obtain a therapeutic nicotine product containing no more than 20 mg/mL of nicotine from a participating pharmacy without a medical authorisation, where the relevant state or territory law permits it.
This is not an ordinary over-the-counter retail sale. Before supplying the product, the pharmacist must be satisfied that it is clinically appropriate for smoking cessation or the management of nicotine dependence.
The pharmacist is also required to:
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request and sight evidence of the patient’s identity and age;
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explain that the product is not included in the ARTG;
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obtain the patient’s informed consent;
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discuss registered smoking-cessation treatments;
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provide advice about dose, frequency and potential medicine interactions;
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ensure the amount supplied does not exceed one month’s supply in a one-month period; and
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provide information about cessation-support services.
The pharmacist may decide that supply is not clinically appropriate or that the patient should speak with a medical practitioner.
The medical authorisation model
A medical authorisation from a medical practitioner or nurse practitioner is required when:
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the patient is under 18 years of age;
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the product contains more than 20 mg/mL of nicotine;
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the relevant state or territory requires a medical authorisation; or
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the patient has more complex clinical needs requiring medical assessment and support.
A product containing more than 20 mg/mL of nicotine cannot be supplied without a medical authorisation under any circumstances.
A medical authorisation does not oblige a pharmacy to dispense the product. The pharmacist must still meet professional, legal and supply requirements and may exercise independent professional judgement.
Why does the pharmacist need to speak with the patient?
A pharmacist consultation is a core part of the therapeutic supply framework, not simply an administrative step.
The Pharmaceutical Society of Australia’s professional guidance identifies significant obligations for pharmacists involved in nicotine-dependence services. These include patient identification, assessing clinical appropriateness, obtaining informed consent, completing required documentation and meeting relevant Commonwealth and jurisdictional requirements.
During the consultation, a pharmacist may discuss:
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the patient’s smoking or therapeutic nicotine history;
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previous attempts to quit;
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other cessation treatments already tried;
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current medicines and health conditions;
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the proposed nicotine concentration;
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possible adverse effects;
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correct use and storage;
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the importance of avoiding ongoing dual use of cigarettes and therapeutic nicotine products; and
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the patient’s longer-term treatment goals.
These conversations help ensure that supply occurs within a treatment context rather than as an unrestricted product transaction.
Patients should also expect to verify their identity and age. This is a legal and professional safeguard, particularly under the pharmacist-only pathway.
How is pharmacy supply different from illicit supply?
The most important difference is not that pharmacy-supplied therapeutic nicotine products are harmless-they are not. The difference is that lawful pharmacy supply operates within an identifiable regulatory and professional framework.
|
Pharmacy supply pathway |
Illicit retail supply |
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Limited to a therapeutic purpose |
Sold outside the therapeutic framework |
|
Product must be eligible for lawful pharmacy supply |
Product origin and regulatory status may be unknown |
|
Pharmacist assessment or medical authorisation required |
No clinical assessment |
|
Identity and age requirements apply |
Controls may be absent or inconsistently applied |
|
Labelling and packaging standards apply |
Contents and labelling may be inaccurate |
|
Sponsor and supply-chain responsibilities apply |
Accountable supplier may be difficult to identify |
|
Adverse events and product problems can be reported |
Formal safety-monitoring pathways may be absent |
|
Quantity and nicotine-strength restrictions apply |
Strength and quantity may be uncontrolled |
Illegal therapeutic nicotine products may contain nicotine despite being labelled nicotine-free, and their ingredient information may be incomplete or unreliable.
Pharmacy supply does not remove the health risks associated with nicotine use. It does, however, provide a lawful pathway with identifiable products, professional involvement and regulatory responsibilities.
Are therapeutic nicotine products safe?
No therapeutic nicotine product should be described as safe or risk-free.
The long-term health effects of nicotine use are still being studied. Known risks include nicotine dependence, poisoning, airway irritation, nausea, seizures, lung injury and injuries caused by faulty or overheating devices. Nicotine-containing liquid can also be dangerous if swallowed or absorbed through the skin, particularly for children.
Therapeutic nicotine products are not considered a first-line treatment for smoking cessation, nicotine cessation or nicotine-dependence management. Registered nicotine-replacement therapies and other approved treatments may be more appropriate for many patients.
A healthcare professional can help a patient understand the available options and weigh the potential risks and benefits according to their individual circumstances.
How do I find a pharmacy that supplies therapeutic nicotine products?
Finding a pharmacy that supplies therapeutic nicotine products requires navigating a regulated, clinical pathway. Because individual pharmacies are under no obligation to stock these products or participate in this service, please consider the following steps:
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Contact your local pharmacy: This is the most direct approach. Before visiting, call your local pharmacy to confirm if they currently supply therapeutic nicotine products or can refer you to a local practitioner who does. This ensures you do not waste a trip if they are not participating.
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Utilise the myduke support pathway: myduke can support you by providing access to Australian doctors and dispensing partners who are equipped to provide compliant nicotine products.
Please note that this is a clinical process, not a standard retail transaction. Regardless of the pathway, you should expect a consultation where the pharmacist will assess your clinical needs, verify your identity, and ensure the treatment is appropriate for your situation.
What should patients expect from the pharmacy process?
Although individual pharmacy procedures differ, a patient may generally expect the following process:
1. Assessment of the treatment pathway
The patient may first speak with a medical practitioner, nurse practitioner or pharmacist to discuss smoking cessation or nicotine dependence.
2. Confirmation of legal and clinical requirements
The practitioner will consider whether a medical authorisation is required and whether the proposed treatment is appropriate.
3. Identity verification and consultation
The pharmacy will verify the patient’s identity and, where relevant, age. The pharmacist will then complete the required consultation and counselling.
4. Product and regulatory checks
Before dispensing or supply, the pharmacy must confirm that the product is eligible for lawful supply and that all applicable requirements are met.
5. Dispensing and patient advice
Where supply proceeds, the pharmacist provides instructions and relevant safety information.
6. Ongoing review
Smoking cessation and nicotine-dependence management may require follow-up, treatment adjustment and support over time. The longer-term objective should be discussed with the treating healthcare professional.
Frequently asked questions
Can therapeutic nicotine products be bought from a tobacconist or convenience store?
No. Australian law prohibits tobacconists, convenience stores, nicotine product shops and other non-pharmacy retailers from selling any therapeutic nicotine product, whether or not it contains nicotine.
Can I order therapeutic nicotine products from an overseas website?
No. Personal importation from an overseas retailer or website is prohibited, even with a medical authorisation. Limited traveller exemptions may apply when entering Australia with therapeutic nicotine goods for the traveller’s own treatment.
Does everyone need a medical authorisation?
Not necessarily. Adults aged 18 and over may be able to access products containing 20 mg/mL of nicotine or less through the pharmacist model, where state or territory law permits, and the pharmacist considers supply clinically appropriate.
A medical authorisation is required for anyone under 18, for nicotine concentrations above 20 mg/mL, where jurisdictional law requires it, or where medical assessment is needed.
Does appearing on the notified therapeutic nicotine product list mean a product is TGA approved?
No. Notification means the sponsor has notified the TGA that the product complies with applicable standards. It does not mean the TGA has evaluated or approved the product for quality, safety, efficacy or performance. More information can be found on the therapeutic nicotine goods for smoking cessation or nicotine dependence page.
Can a pharmacist refuse to supply a therapeutic nicotine product?
Yes. Pharmacists and medical practitioners are not required to participate in therapeutic nicotine supply. A pharmacist may also decide that supply is not clinically appropriate or that further medical assessment is needed.
What should I do if I experience a side effect?
Seek medical advice and inform your pharmacist or treating practitioner. Suspected side effects or device problems can also be reported to the TGA.
Urgent medical attention is required if nicotine poisoning is suspected. In Australia, the Poisons Information Centre can be contacted on 13 11 26.
Are therapeutic nicotine products subsidised?
There is currently no government subsidy available for therapeutic nicotine products. Because these items are classified as unapproved therapeutic goods and have not undergone the standard TGA evaluation for efficacy, safety, and quality, they do not qualify for the funding structures typically applied to registered pharmaceuticals.
Making an informed decision
Australia’s pharmacy-only framework places therapeutic nicotine use within a healthcare and regulatory setting. It establishes clearer product, supply and professional requirements than apply in the illicit market, but it does not make therapeutic nicotine products risk-free or TGA approved.
For patients, the most important principles are:
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seek advice from an appropriately qualified healthcare professional; more information is available here from Quit.
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understand the registered treatments available;
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access products only through lawful Australian pharmacy pathways;
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follow the treatment plan and pharmacist instructions;
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report suspected side effects or product problems; and
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continue working towards agreed smoking-cessation and nicotine-dependence goals.
Adults seeking support to stop smoking or manage nicotine dependence can learn more and should speak with a pharmacist.
Conclusion
Written by Dr Amalini De Silva MD
The move to Australia’s pharmacy-only model is a significant step, but as a GP, I see it as more than just a change in where you buy a product. It’s about ensuring that if you do use therapeutic nicotine, you’re doing so with the right clinical support and a plan that’s tailored specifically for you.
While these products are now more regulated, it is important to remember they aren’t a "magic bullet" and they aren’t risk-free. In my experience, the most successful journeys away from smoking or nicotine dependence happen through shared decision-making. We look at your history and goals together, choosing a path that feels right for your life and health.
I also want to emphasise that pharmacological treatments are often only one part of the puzzle. Combining these with behavioural support-like coaching, habit-tracking, or counselling-can make a world of difference in your long-term success. It’s about treating the whole person, not just the dependence.
I encourage you to have an open, honest chat with your doctor or pharmacist. We are here to provide that oversight and support, helping you navigate all the available options-from registered cessation medicines to these newer pathways-to find the safest and most effective way forward for you.
This article provides general information only and does not replace individual medical or pharmaceutical advice. Treatment suitability and supply are determined independently by the relevant medical practitioner, nurse practitioner or pharmacist. Requirements may also differ between Australian states and territories.
Further reading
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Therapeutic Goods Administration: Notified therapeutic nicotine product list
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Therapeutic Goods Administration: Product standards for unapproved therapeutic nicotine products
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Quit: Support for quitting smoking and therapeutic nicotine use