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Nicotine vaping products: Frequently Asked Questions

22 September 2021

Nicotine vaping products are finished products (i.e. products ready to supply to consumers) that:

  • contain nicotine (whether in base or salt form) in solution, and
  • are intended to be vaporised or inhaled using a vaping device (e.g. an e-cigarette or other electronic nicotine delivery system).

Common nicotine vaping products are liquid nicotine (e.g. nicotine e-liquids, e-juices and vape juices), including high-concentration liquid nicotine that is intended for dilution by consumers prior to use, and the nicotine solution in prefilled nicotine e-cigarettes and pods.

Vaping devices are the electronic devices used to heat vaping products to produce an aerosol that can be inhaled. Vaping devices include e-cigars, vape pens, other electronic nicotine delivery systems (ENDs) and the electrical and heating elements of prefilled nicotine e-cigarettes and pods.

Scheduling changes

From 1 October 2021, consumers will need a valid prescription to legally obtain nicotine vaping products, such as nicotine e-cigarettes, nicotine pods and liquid nicotine, from an overseas website. A valid prescription is already required to purchase nicotine vaping products from Australian pharmacies. Purchase of nicotine vaping products from other Australian sources is already not permitted and will remain illegal.

These changes balance the need to prevent adolescents and young adults from taking-up nicotine vaping (and potentially smoking), while enabling current smokers to readily access these products for smoking cessation with appropriate medical advice.

These changes affect nicotine vaping products.

Nicotine replacement therapies (including sprays, patches, lozenges and chews) that do not require a prescription will continue to be available from pharmacies and some retail outlets.

Heat-not-burn tobacco, and many other tobacco products, continue to be controlled as ‘prohibited imports’ and are only to be imported for commercial or personal use with a permit from Australian Border Force. These products cannot be imported via the international mail under the Personal Importation Scheme. A valid doctor’s prescription will continue to be required to access these products domestically via one of the established access schemes for unapproved goods. The doctor would need to obtain the necessary TGA approvals and consider whether it is appropriate to prescribe such a product, having regard to the relevant standards of good medical practice and informed consent.

A senior medical officer at the Therapeutic Goods Administration (TGA) acting as a Delegate of the Secretary of the Department of Health made the changes. It is not a decision of the Minister or of Government.

There are currently no nicotine vaping products registered in the Australian Register of Therapeutic Goods (ARTG). The Therapeutic Goods Administration (TGA) does not assess the safety, quality and efficacy of ‘unapproved’ nicotine vaping products or products listed in the ARTG as export only medicines. The long-term health risks of unapproved nicotine vaping products are still unclear and evidence of their potential efficacy for smoking cessation is currently mixed, with more reliable, large scale studies required. Further information is provided in our Guidance for Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110)) Order 2021 and related matters.

There are significant health risks associated with nicotine use.

Please refer to the public notice of the final decision for a review of the evidence related to nicotine vaping use leading to nicotine addiction and tobacco use, particularly among adolescents.

There are a number of differences between nicotine replacement therapies (NRTs) such as sprays, patches, inhalators and gums compared to nicotine vaping products. NRTs deliver nicotine to the body through the lining of the mouth and cheeks (sprays, inhalator, gums and lozenges) or the skin (patches). Importantly, they are designed to reduce nicotine withdrawal and cravings while minimising the potential for abuse, compared with nicotine vaping products that deliver rapid boluses of nicotine to the lungs. Inhalators do not deliver nicotine to the lower respiratory system in the same manner as nicotine vaping products.

The Therapeutic Goods Administration (TGA) has assessed the safety, quality and efficacy of NRTs that are on the Australian Register of Therapeutic Goods and determined that they can be sold in retail outlets with reasonable safety. They deliver nicotine at much lower concentrations than many nicotine vaping products. NRTs, such as patches, were initially approved as prescription medicines and were down-scheduled when supporting safety data became available.

Nicotine is a poisonous substance. Given its toxicity and potential for serious harms to human health, including death if ingested, nicotine vaping products are subject to controls under the Commonwealth Standard for the Uniform Scheduling of Medicines and Poisons (Poisons Standard). Nicotine when in tobacco prepared and packed for smoking is exempt from the Poisons Standard and can therefore be sold in general retail stores. This is a historical position from when the Poisons Standard was first made some decades ago, where a range of substances and products that were otherwise regulated through state and territory laws were excluded from the Poisons Standard.

You may still be able to access nicotine vaping products if your doctor considers them to be an appropriate treatment to help you stop smoking and gives you a valid medical prescription. However, you will need to discuss your needs with a doctor first.

You will not be able to access nicotine vaping products without a valid medical prescription, regardless of the purpose for which you use them. Currently, it is illegal in each state and territory to sell nicotine vaping products to someone without a prescription and possession or use of nicotine vaping products without a valid prescription is illegal in every state and territory except South Australia.

Read our information for consumers page for an overview of how consumers can access nicotine vaping products if their doctor considers them to be appropriate.

TGO 110: Standard for unapproved and export only nicotine vaping products

TGO 110 - the Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Order 2021 - is a product standard made under section 10 of the Therapeutic Goods Act 1989. TGO 110 sets out minimum safety and quality requirements for unapproved and export only nicotine vaping products.

TGO 110 applies to nicotine vaping products supplied in Australia under the Authorised Prescriber Scheme (APS) or Special Access Scheme (SAS), extemporaneously compounded products, products supplied as part of a clinical trial and products listed in the Australian Register of Therapeutic Goods (ARTG) as export only. Some, but not all, of the requirements in TGO 110 apply to nicotine vaping products imported and exported from Australia, including products imported directly by consumers under the Personal Importation Scheme. The ‘Application of TGO 110 requirements’ section in our Guidance for Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110)) Order 2021 and related matters explains when the different requirements of TGO 110 apply.

TGO 110 does not apply to products imported under the Traveller’s Exemption, vaping products that do not contain nicotine and starting materials intended for use in further manufacture. TGO 110 will also not apply to any nicotine vaping products registered in the ARTG in the future.

TGO 110 only applies to unapproved and export only nicotine vaping products. The Therapeutic Goods Administration (TGA) does not assess the safety, quality and efficacy of these products. The long-term health risks of unapproved nicotine vaping products are still unclear and evidence of their potential efficacy for smoking cessation is currently mixed, with more reliable, large scale studies required. TGO 110 contains minimum safety and quality requirements for these products based on the information available.

You are encouraged to confirm with the overseas retailer if the product you are considering complies with the applicable requirements in TGO 110, comes with child-resistant packaging, appropriate labelling and is manufactured with appropriate controls. The ‘Health practitioners and consumers using the Personal Importation Scheme’ section of our Guidance for Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110)) Order 2021 and related matters contains a list of questions you might want to ask the overseas retailer.

Not necessarily. You will firstly need to speak to your doctor about whether a nicotine vaping product is a suitable smoking cessation aid for you. If your doctor thinks a nicotine vaping product is suitable for you, they will prescribe a product appropriate for your needs. You will only be able to get the concentration of product on your prescription. The Royal Australian College of General Practitioners is preparing guidelines that will assist doctors to determine what concentration of product should be prescribed, depending on an individual’s needs.

The maximum nicotine concentration limit in TGO 110 does not mean that 100 mg/mL products are safe or necessarily appropriate for use. TGO 110 only applies to unapproved and export only nicotine vaping products. The Therapeutic Goods Administration (TGA) does not assess the safety, quality and efficacy of these products. Higher concentration nicotine vaping products, particularly those requiring dilution by the consumer prior to use, carry additional risks to lower, pre-mixed nicotine vaping products. Further information about these risks is provided in the ‘Limits on nicotine concentration’ section of our Guidance for Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110)) Order 2021 and related matters.

Our Guidance for Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110)) Order 2021 and related matters contains detailed information on how to comply with the requirements of TGO 110.

Importing, manufacturing and wholesale supplying nicotine vaping products

No, but you will need to make an import declaration to the Australian Border Force (ABF). The type of declaration required will depend on the value of the goods being imported. Information about the ABF’s requirements is available on the ABF’s ‘Declaration for imported goods’ webpage. The ABF can also be contacted via its website or on 02 6196 0196.

Australian sponsors are required to submit a 6 monthly report to the Therapeutic Goods Administration (TGA) listing the brand and nicotine concentration of each kind of unapproved nicotine vaping product the sponsor supplied in Australia in the relevant period. Reporting periods are 1 January – 30 June (inclusive) and 1 July – 31 December (inclusive). Reports must be submitted within 1 month of the end of the relevant reporting period.

The TGA will publish a form which sponsors will need to use to submit these reports by January 2022.

The wholesaler must reasonably expect that the unapproved nicotine vaping product will be supplied to the ultimate consumer under the Authorised Prescriber Scheme, Special Access Scheme or Clinical Trial Approval scheme. Supply to a retailer who is not a pharmacist (e.g. a vape store) is likely to breach this requirement.

A wholesale licence for Schedule 4 (prescription only) medicines must be obtained from the relevant state or territory health department to wholesale supply unapproved nicotine vaping products. Applicants will need to meet the requirements under the relevant state or territory legislation. The TGA publishes the Australian Code of Good Wholesaling Practice for Medicines in Schedules 2, 3, 4 and 8 (Wholesale Code), which is implemented through the states and territories.

People who wholesale supply unapproved nicotine vaping products or vaping devices within Tasmania, or to Australian pharmacies in the ACT, may also need a licence to sell smoking/tobacco products from the Tasmanian or ACT health department (as relevant).

Please contact your relevant state or territory health department for further information about any of the wholesale licence requirements. Enquiries about licences to sell smoking/tobacco products into the ACT may also be made to the Health Protection Service at 02 6205 2155 or HPS@act.gov.au.

The usual prescription medicines registration process applies. A submission to register a prescription medicine consists of:

  • data that supports the quality, safety and efficacy of the product for its intended use. Evidence for efficacy and safety would be required to come from clinical trials
  • completed forms, and
  • the payment of fees.

Further information on registering nicotine vaping products in the ARTG is available on our Information for sponsors, manufacturers and wholesalers page.

Supplying nicotine vaping products to consumers

No. Vape shops are not legally allowed to sell nicotine vaping products, either before or after the 1 October 2021 regulatory changes. This is because prescription medicines can only be dispensed by pharmacies to consumers with a valid medical prescription. Vape shops can still sell non-nicotine containing vaping products, subject to state and territory requirements.

The Therapeutic Goods Administration (TGA) also offers a dedicated service to help small to medium enterprises (SMEs), researchers, start-ups and those unfamiliar with regulation to understand their regulatory and legislative obligations. Visit the TGA website to find out more information on how the SME Assist team can help you.

If you suspect that a retailer other than a pharmacist is selling nicotine vaping products, we encourage you to make a report to us.

Yes. Many pharmacies already provide a service supplying prescription medicines through the mail, subject to the presentation of a valid prescription. More information is available at the Pharmacy Board Guideline for Dispensing of Medicines.

Patients ordering prescription medicines through the Personal Importation Scheme usually hold the original prescription and provide a copy of the prescription to the supplier.

Authorised Prescribers of nicotine vaping products listed on the TGA website have given consent to have their information publicly displayed. This is not a conclusive list; there are additional Authorised Prescribers of nicotine vaping products who have not consented to have their name and consulting location published.

The list does not provide authority for pharmacists to dispense nicotine vaping products.  Pharmacists can only dispense a prescription for an ‘unapproved’ nicotine vaping product with evidence of approval under the Authorised Prescriber scheme or through the Special Access Scheme Category B pathway.

Prescribing nicotine vaping products

The main difference is that once a doctor becomes an Authorised Prescriber (AP), they do not need to notify the Therapeutic Goods Administration (TGA) each time they prescribe nicotine vaping products for smoking cessation. Medical practitioners are able to apply to become an AP of nicotine for smoking cessation without the need for ethics committee approval. For the five year duration of the approval no further applications or permissions are required. However the AP must submit reports of patients treated to the TGA every six months.

Application to become an AP is free of charge. A simplified nicotine-specific online form is available on the AP dashboard of the SAS & Authorised Prescriber Online System.

Special Access Scheme - Category B (SAS B) applications are approved on an individual patient basis, which means that a separate application needs to be submitted to the TGA for each patient. However, prescribers other than medical practitioners may be able to apply under the SAS B.

Yes. A doctor may write a script for a patient to access nicotine vaping products imported through the Personal Importation Scheme for up to 3 months supply.

If you wish to bring in more than 3 months supply at the one time into Australia, an Australian-registered doctor will first need to apply to the TGA for approval through SAS B or to become an Authorised Prescriber using the forms available on the TGA website.

The Royal Australian College of General Practitioners (RACGP) is updating its smoking cessation guidelines. The updated guidelines are expected to cover, among other things, practical information on prescribing nicotine vaping products.

There are currently no TGA approved nicotine vaping products registered in the Australian Register of Therapeutic Goods. There is a product standard, TGO 110, which sets minimum safety and quality requirements for unapproved and export only nicotine vaping products.

Nicotine vaping products are administered using vaping devices and will be packaged differently depending on the type of device they are to be used with. There are two main types of devices: open system devices and closed system devices. Closed system devices include pod-based systems and disposables.

Diagram showing types of vaping products

Image: University of Wollongong

Further practical information about the different types of systems and their respective advantages and disadvantages is provided in the following materials prepared by a team at the University of Wollongong: Nicotine vaping products analysis: Evidence from University of Wollongong and Nicotine vaping products: University of Wollongong flowchart.

No, there are currently no TGA approved nicotine vaping products registered in the Australian Register of Therapeutic Goods

Evidence of the potential efficacy of nicotine vaping products for smoking cessation is currently mixed, with more reliable, large-scale studies required (references are provided in our Guidance for Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Order 2021 and related matters).

An updated Cochrane Review1 (published September 2021) compared the effects of nicotine vaping products with other ways of delivering nicotine, such as nicotine replacement therapies (NRTs) like patches and chewing gum, e-cigarettes without nicotine, and behavioural support only/no support. The review included 61 studies (16,759 participants), including 34 randomised controlled studies and 27 other studies. Seven studies were rated as having a low risk of bias, 42 at high risk of overall bias, and the remainder were of unclear risk. In relation to the quit rates:

  • Four studies, involving 1924 participants, showed higher quit rates in people randomised to nicotine vaping products than those randomised to NRT (risk ratio RR = 1.53). This might lead to three additional people per 100 quitting smoking using nicotine vaping products compared to NRT. This was moderate-certainty evidence, limited by imprecision.
  • Five studies, involving 1447 participants, showed higher quit rates in people randomised to nicotine vaping products than to e-cigarettes without nicotine (risk ratio RR = 1.94). This might lead to seven additional people per 100 quitting smoking using nicotine vaping products versus non-nicotine e-cigarettes. This was also moderate-certainty evidence, limited by imprecision.
  • Six studies, involving 2886 participants, showed higher quit rates in people randomised to nicotine vaping products compared to those who received only behavioural support or no support (risk ratio RR = 2.61). This might lead to six additional people per 100 quitting smoking using nicotine vaping products versus behavioural support only/no support. This was very low-certainty evidence, due to issues with imprecision and bias risks.

The Cochrane Collaboration is an international non-profit organisation formed to organise medical research findings to facilitate evidence-based choices about health interventions. A Cochrane Review is a systematic review of research in health care and health policy.

A recent (August 2021) meta-analysis from the University of Queensland2 provided similar results. The study found that participants randomised to receive nicotine vaping products were 49% more likely to remain abstinent from smoking than those who received other NRTs (risk ratio RR = 1.49, 9 trials with 6080 participants). Those randomised to receive nicotine vaping products were 109% more likely to remain abstinent from smoking than those in control conditions where no nicotine was supplied (risk ratio RR = 2.08, 7 trials with 5674 participants). However, it concluded that more high quality studies are required to ascertain the effect of nicotine vaping products on smoking cessation due to risk of bias in the included studies.

Another recent (September 2021) meta-analysis from the Australian National University3 also demonstrated a small benefit in smoking cessation for freebase nicotine vaping products compared to approved NRT, in the clinical context and based on low certainty evidence. Significantly greater quit rates for participants randomised to freebase nicotine vaping product were found compared to no intervention or usual care; evidence was also of low certainty.

 

1 Hartmann-Boyce J, McRobbie H, Butler A, Lindson N, Bullen C, Begh R, Theodoulou A, Notley C, Rigotti N, Turner T, Fanshawe T, Hajek P. Electronic cigarettes for smoking cessation. Cochrane Database of Systematic Reviews. 14 September 2021. URL: Electronic cigarettes for smoking cessation - Hartmann-Boyce, J - 2021 | Cochrane Library

2 Chan G, Stjepanović D, Lim C, Sun T, Anandan A, Connor J, Gartner C, Hall W, Leung J. A systematic review of randomized controlled trials and network meta-analysis of e-cigarettes for smoking cessation. Addict. Behav. Aug 2021. Electronic publication 15 March 2021. URL: https://pubmed.ncbi.nlm.nih.gov/33798919/

3 Yazidjoglou A, Ford L, Baenziger O, Brown S, Martin M, Zulfiqar T, Joshy G, Beckwith K, Banks E. Efficacy of e-cigarettes as aids to cessation of combustible tobacco smoking: updated evidence review. Final report prepared for the Australian Government Department of Health: online version, September 2021. URL: http://hdl.handle.net/1885/247864

Advice and treatment will vary according to whether the patient is an existing user of nicotine vaping products or a smoker who does not currently use nicotine vaping products.

The Royal Australian College of General Practitioners (RACGP) Supporting smoking cessation: A guide for health professionals (RACGP Guidelines) stipulate that nicotine vaping products are not a first line treatment for smoking cessation.

Smokers should have exhausted combination nicotine replacement therapies and varenicline with psychological support (including that consideration has been given to what could have been done differently) before nicotine vaping products are prescribed. The mixed efficacy evidence base and the unknown long-term health effects of nicotine vaping products should be explained to, and acknowledged by, the patient. Patients should also be advised that nicotine vaping products are not appropriate for long term use.

You can refuse to prescribe nicotine vaping products for your patients. If you think a nicotine vaping product might be appropriate for your patient but do not feel you are able to make the assessment yourself, you may want to refer your patient to a prescriber more experienced with nicotine vaping products. The TGA has released a list of Authorised Prescribers of unapproved nicotine vaping products who have consented to have their name and consulting location published.

A patient should not continue to smoke as well as use nicotine vaping products. Patients should also be advised that nicotine vaping products are not appropriate for long term use.

If your patient is already using an open vaping device system, and you intend to prescribe a nicotine vaping product for use in that system (i.e. a liquid nicotine product such as an e-liquid), the Nicotine vaping product analysis: Evidence from University of Wollongong  suggests that your conversations with that patient should include training on best practice for syringe transfer, ensuring children are not present whilst the product is open and use of appropriate personal protective equipment (especially gloves), to avoid the risk of accidental exposure or ingestion.

Patients should also be advised of the risk of accidental child poisoning if nicotine vaping products are used in vaping devices without child-resistant safety features (including where a child is able to suck on the vaping device).

Patients should be advised to seek urgent medical attention if they think that they, or anyone else, may have been exposed to or ingested a nicotine vaping product. Emergency services can be contacted by calling 000 and the Poisons Information Centre can be contacted by calling 131 126.

Additional support is available at Quit Victoria or NSW Get Healthy Service.

Regular follow up is advised.

There is no clinical trial evidence of the efficacy of nicotine salts to assist smoking cessation. The two trials demonstrating nicotine vaping product efficacy used freebase nicotine concentration of less than or equal to 20 mg/ml.[1]

The Nicotine vaping products analysis: Evidence from the University of Wollongong provides additional information about the chemical and pharmacokinetic differences between nicotine freebase and nicotine salt products. It also provides practical information about the potential advantages and disadvantages of the different types of products, including in relation to the different vaping device systems that tend to be used with each product type.


[1]Hajek P, Phillips-Waller A, Przulj D, et al. A randomized trial of e-cigarettes versus Nicotine-Replacement Therapy. New England Journal of Medicine 2019;380(7):629-37. doi: 10.1056/NEJMoa1808779 [published Online First: 2019/01/31] and Myers Smith K, Phillips-Waller A, Pesola F, McRobbie H, Przulj D, Orzol M, & Hajek P. (2021). E-cigarettes versus nicotine replacement treatment as harm reduction interventions for smokers who find quitting difficult: Randomised controlled trial. Addiction. doi:doi.org/10.1111/add.15628

A prescriber’s name and practice address will be published on the TGA website if Authorised Prescriber approval to supply ‘unapproved’ nicotine vaping products has been granted and the prescriber has consented to publication.  Names can take up to a month to be published.