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18.13 Regulation of vapes in Australia
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Grace, C |Greenhalgh, EM |Smith, L |Scollo, MM. 18.13 Regulation of vapes in Australia . In Greenhalgh, EM |Scollo, MM |Winstanley, MH [editors]. Tobacco in Australia: Facts and issues. Melbourne : Cancer Council Victoria; 2019. Available from https://www.tobaccoinaustralia.org.au/chapter-18-e-cigarettes/18-13-regulation-of-vapes-in-australia
Last updated: May 2025

18.13 Regulation of vapes in Australia

18.13.1 How vapes are regulated in Australia

Information regarding recent developments in the legal status of e-cigarettes in Australia can be found on the Therapeutic Goods Administration (TGA) and Department of Health and Aged Care websites. 

In Australia, the regulation of e-cigarettes (or ‘vapes’) is encompassed by a number of laws relating to tobacco control, customs and import control, therapeutic goods and poisons regulation, and is shared between the Commonwealth and the states and territories.

The legal framework applying to e-cigarettes in Australia underwent significant reform in 2024. While the sale of nicotine vaping products without a medical prescription has been illegal in Australia for many years, until recently the sale of non-nicotine products in general retail stores was legal in all states and territories (except Western Australia).

In May 2023, the Federal Government announced that it would implement a set of new measures aimed at tightening the control of e-cigarettes across Australia. The new laws prohibit the general retail sale of all e-cigarette products in Australia, regardless of nicotine content. As of 1 July 2024, e-cigarette products, referred to hereon in as ‘vapes’, must only be sold in pharmacies.  Vapes containing less than 20mgs/ml of nicotine may be sold over-the-counter (without a prescription) in all states and territories except Tasmania and Western Australia (which require a prescription regardless of nicotine level).

Certain conditions will need to be satisfied in order for pharmacists to legally supply vaping products without a prescription (discussed further below in Table 18.13.1).

The 2024 legislation requires an independent review of the new laws to commence no later than 1 July 2027. The review is intended to provide an opportunity for the new laws to be monitored and evaluated.

A timeline summarising the commencement of the new Federal laws is included in Table 18.13.1, below.

18.13.1.1 State and Territory regulation of vapes

Although Federal laws permit the supply of vaping products by pharmacists to adults without a prescription, in Tasmania and Western Australia a prescription is still required for anyone over 18 to legally purchase a vaping product.10-12

State and Territory tobacco control laws applying to e-cigarettes (including smokefree laws, retail display laws and licensing requirements) will continue to apply in each jurisdiction unless amended or repealed. Pharmacists must supply vaping products in accordance with state and territory legislation (although where an inconsistency arises between State/Territory and Federal vaping laws, the Federal law will prevail to the extent of the inconsistency). A summary of state and territory licensing requirements (and other legal requirements relevant to the supply of vaping products) is available on the Pharmaceutical Society of Australia website.

In all jurisdictions, tobacco control legislation prohibits the use of e-cigarettes in legislated smokefree areas. In Queensland, littering of a vaping device or accessory is specifically classified as ‘dangerous littering’ and is therefore prohibited.13 In South Australia, the sale of e-cigarette products by mail, phone or over the internet is specifically prohibited.14 In Tasmania, pharmacies are required to hold a smoking product licence in order to sell e-cigarettes, at a cost of $678.15

18.13.2 Compliance with and enforcement of Australian vape regulations

18.13.2.1 Enforcement of regulations on importations and sales

The Australian Government has provided funding to the Australian Border Force (ABF) and the TGA to enforce the vaping reforms. The TGA is also collaborating with state and territory authorities. Enforcement activities can include education, warning letters, seizure of goods under warrant, infringement notices, and where necessary criminal prosecution and civil penalty proceedings.16

Prior to the 2024 vaping reforms, when non-nicotine products could be legally imported and sold, illegal products (i.e., those that contained nicotine) could in reality be imported in large quantities and sold by general retailers such as convenience stores and tobacconists as it was too resource-intensive for authorities to test individual products and shipments.17 Pharmacy-only supply of therapeutic vapes (regardless of nicotine content) facilitates easier enforcement of regulations and identification of illegal imports and sales.16 Importers of vaping products must now hold a licence and a permit,18 and notify the TGA that the product complies with the standard (TGO110).5   

Since the new laws came into effect, the ABF and TGA have reported seizing large quantities of illegal vapes worth millions of dollars.19,20 For example, following the ban on importations of disposable vapes at the beginning of 2024, the ABF reported seizing more than $12.4 million worth of disposable vapes in a single detection at the border.19 Large fines have also been issued to retailers illegally supplying vapes,21,22 and individuals have been charged for their roles in an organised crime syndicate that was involved in the illegal trade of vapes.23

18.13.2.2 Compliance with the product standard (TGO110)

TGO 110 2021 requirements

A product standard for vaping products was first implemented in 2021 (TGO110 Order 2021)24 and applied to products that contain nicotine. Requirements included that the correct content of nicotine concentration was stated on the label; certain ingredients were prohibited; and products were labelled correctly and included warning statements.

The TGA conducted compliance testing of available and imported products to assess if they met these requirements.25 The outcome of 314 products that had undergone TGA testing to May 2023 is summarised in Figure 18.13.1. Nicotine was present in 84% of the 314 products tested. Of those 264 products that contained nicotine, just 4% complied with nicotine content requirements, and 1% were found not to comply. For the vast majority of products, compliance could not be assessed because either the nicotine content was not labelled or not labelled in the required format (and therefore, did not meet labelling requirements). One-third of products that contained nicotine did not comply with prohibited ingredients requirements. In total, just 0.4% (one) of the 264 products that contained nicotine complied with TGA labelling requirements.

The product standard sets strict limits on eight toxic chemicals due to known health risks,26 including: acetyl propionyl, acetoin, benzaldehyde, cinnamaldehyde, diacetyl, diethylene glycol, DL-alpha-tocopheryl acetate and ethylene glycol. Testing by the TGA showed that 33.7% of the nicotine-containing e-liquids did not comply with the 10 ppm limit for one or more of these chemicals (Figure 18.13.1).25

The 2021 product standard did not restrict product names; nonetheless, the TGA also reported flavour descriptors in its product testing results. Figure 18.13.2 summarises the flavour descriptors of the product names that were listed in the 2023 TGA report. Of the 314 products listed, 98% had flavour descriptors in their product name. The most common descriptor category was fruit flavours, featured in 78% of product names. Menthol and ‘ice’ flavours were the next most common, seen in 38% of products. Two-in-five (43%) contained more than one flavour category, not including those with multiple fruit flavours (e.g. Apple Kiwi).

TGO 110 2024 requirements

As described above, in March 2024, initial amendments to the product standard came into effect (TGO110 Instrument 2024)9 that limit the use of flavouring ingredients to mint, menthol or tobacco flavour and introduce new minimum safety requirements for therapeutic vaping devices. Additional requirements for devices, ingredients, packaging and labelling came into effect on 1st March 2025, which all vapes supplied in Australia must comply with from 1st July 2025. Prior to importing or supplying a product, the TGA must be notified that the product complies with the product standards, and a list of notified products is published online.27

Of the 291 notified vaping substances and substance accessories at July 2024, 13% contained no nicotine, compared to 6% of 231 additional products notified between 2 October 2024 and 1 January 2025. In each period examined, more than half of all substances and substance accessories contained up to 20 mg/ml of nicotine: 56% at July 2024, 76% at October 2024, and 54% at January 2025.

Of those notified products that contained nicotine, in the majority of cases the nicotine was in the form of nicotine salts—see Figure 18.13.4. Two-thirds of nicotine-containing notified products were nicotine salts at July 2024 and October 2024, while 82% were salts at January 2025. The remaining products contained freebase nicotine. See Sections 18.5.3 and 12.4.3.1 for more information about free-base nicotine and nicotine salts.

Menthol and tobacco flavoured products were similarly popular among those products that appeared on the TGA’s List of ‘notified vaping substances’, substance accessories, and kits as of July 2024. Figure 18.13.5 shows that 8% of notified products were unflavoured, compared to 45% menthol or mint and 47% tobacco flavoured. A higher proportion of menthol or mint products were among the notified products at October 2024 (66%) and January 2025 (54%).


 i See section 24 of the Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO110) Amendment (Vaping) Order 2023.

ii Note: As of April 2025, it remains illegal to supply a vaping product to anyone without a prescription in Tasmania and Western Australia, regardless of age (see further below).

iii See Schedule 4 of the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 (Cth). See in particular the amendments to the Therapeutic Goods (Medicines and OTG – Authorised Supply) Rules 2022 and the Therapeutic Goods (Poisons Standard – June 2024) Instrument 2024.

 iv See the new section 5A(7) of the Therapeutic Goods (Medicines and OTG – Authorised Supply) Rules 2022, as inserted by the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 (Cth).

v See, in particular, the reference table available at: https://www.tga.gov.au/products/unapproved-therapeutic-goods/vaping-hub/vapes-information-prescribers/prescribing-and-dispensing-therapeutic-vapes-patients-under-18-years

vi According to section 11 and schedule 1 of Therapeutic Goods Legislation Amendment (Standard for Therapeutic Vaping Goods) (TGO110) Instrument 2024, the permitted ingredients are: flavouring agents (that produce menthol, mint or tobacco flavour), glycerol, nicotine, propylene glycol and water.

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References

1.Customs (Prohibited Imports) Regulations 1956. Available from: https://www.legislation.gov.au/F1996B03651/latest/text.

2. Customs Legislation Amendment (Vaping Goods) Regulations (Cth), 2023. Available from: https://www.legislation.gov.au/F2023L01666/latest/text.

3. Therapeutic Goods Administration. New regulation of vapes starting January 2024. 2023. Available from: https://www.tga.gov.au/news/media-releases/new-regulation-vapes-starting-january-2024.

4. Therapeutic Goods (Standard for Therapeutic Vaping Goods) (TGO 110) Order 2023. Available from: https://www.legislation.gov.au/F2023L01680/latest/text.

5. Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 (Cth). Available from: https://www.legislation.gov.au/C2024A00050/asmade/text.

6. Vapes: Information for Prescribers, 2024. Available from: https://www.tga.gov.au/resources/resource/guidance/vapes-information-prescribers.

7. Therapeutic Goods (Vaping Goods - Advertising) Authorisation 2024. Available from: https://www.legislation.gov.au/F2024L00844/latest/text.

8. Schedule 1, item 2 of Therapeutic Goods (Vaping Goods - Advertising) Authorisation 2024. Available from: https://www.legislation.gov.au/F2024L00844/latest/text

9. Therapeutic Goods Legislation Amendment (Standard for Therapeutic Vaping Goods) (TGO110) Instrument 2024 (Cth). Available from: https://www.legislation.gov.au/F2024L01232/asmade/text

10. Guidelines for the sale of Personal Vaporiser Products (effective 1 October 2024). Available from: https://www.health.tas.gov.au/sites/default/files/2024-09/download_the_guidelines_for_the_sale_of_personal_vaporiser_products.pdf.

11. Bourke K and Burmas G. Western Australia to override national vaping laws, but just two retailers have been prosecuted for illegal sales, in ABC News2024. Available from: https://www.abc.net.au/news/2024-09-25/wa-overrides-national-vaping-sale-laws-pharmacy-vape-sales/104392882.

12. Medicines and Poisons Amendment Regulations (No. 3) 2024. Available from: https://www.legislation.wa.gov.au/legislation/prod/filestore.nsf/FileURL/mrdoc_47864.pdf/$FILE/Medicines%20and%20Poisons%20Amendment%20Regulations%20(No%203)%202024%20-%20%5B00-00-00%5D.pdf?OpenElement.

13. Waste Reduction and Recycling Act 2011 (QLD), section 103. Available from: https://www.legislation.qld.gov.au/view/pdf/inforce/current/act-2011-031

14. Tobacco and E-cigarette Products Act 1997 (SA), section 30(1)(e). Available from: https://www.legislation.sa.gov.au/__legislation/lz/c/a/tobacco%20and%20e-cigarette%20products%20act%201997/current/1997.26.auth.pdf.

15. Tasmanian Government Department of Health. Licence fees to sell Personal Vaporiser Products.  2024. Available from: https://www.health.tas.gov.au/health-topics/smoking/selling-smoking-products/smoking-product-legislation#applying-for-a-new-licence.

16. Therapeutic Goods Administration. Vaping hub. Australian Government Department of Health and Aged Care, 2024. Available from: https://www.tga.gov.au/products/unapproved-therapeutic-goods/vaping-hub.

17. Scollo M, Grace C, Buchanan T, and Dessaix A. A prescription model for vapes: the way we 'do' medicines policy in Australia. Public Health Research & Practice, 2024; 34(2). Available from: https://www.phrp.com.au/issues/june-2024-volume-34-issue-2/a-prescription-model-for-vapes-the-way-we-do-medicines-policy-in-australia/

18. Australian Border Force. Australian Customs Notice. No. 2023/51. New Import Control on Vaping Goods.  2023. Available from: https://www.abf.gov.au/help-and-support-subsite/CustomsNotices/2023-51.pdf

19. Australian Border Force. More than $12.4 million worth of vapes seized in Sydney in four days, 2024, Australian Government. Available from: https://www.abf.gov.au/newsroom-subsite/Pages/More-than-$12-4-million-worth-of-vapes-seized-in-Sydney-in-four-days-25-05-2024.aspx.

20. Therapeutic Goods Administration. $8 million of illicit vapes located in collaboration between TGA and Victoria Police, 2024, Australian Government Department of Health and Aged Care. Available from: https://www.tga.gov.au/news/media-releases/8-million-illicit-vapes-located-collaboration-between-tga-and-victoria-police.

21. Therapeutic Goods Administration. Retail businesses across Melbourne issued infringement notices totalling almost $400k for alleged unlawful supply of vapes, 2025, Australian Government Department of Health and Aged Care. Available from: https://www.tga.gov.au/news/media-releases/retail-businesses-across-melbourne-issued-infringement-notices-totalling-almost-400k-alleged-unlawful-supply-vapes.

22. Therapeutic Goods Administration. Sunshine Coast business fined over $37k for alleged unlawful sale of vapes, 2024, Australian Government Department of Health and Aged Care. Available from: https://www.tga.gov.au/news/media-releases/sunshine-coast-business-fined-over-37k-alleged-unlawful-sale-vapes.

23. Therapeutic Goods Administration. Joint enforcement activity with TGA and partner authorities sees Victoria Police arrest eight individuals, 2024, Australian Government Department of Health and Aged Care. Available from: https://www.tga.gov.au/news/media-releases/joint-enforcement-activity-tga-and-partner-authorities-sees-victoria-police-arrest-eight-individuals.

24. Therapeutic Goods (Standard for Therapeutic Vaping Goods) (TGO110) Order 2021. Available from: https://www.legislation.gov.au/F2021L00595/latest/text.

25. Therapeutic Goods Administration. Testing of nicotine vaping products. Australian Government, Department of Health,  2022. Available from: https://www.tga.gov.au/testing-nicotine-vaping-products

26. Therapeutic Goods Administration. Nicotine vaping products and vaping devices: Guidance for the therapeutic goods (standard for nicotine vaping products) (TGO 110) Order 2021 and related matters Version 1.2. Canberra: Government of Australia, 2021. Available from: https://vape-testing.com/wp-content/uploads/2023/07/nicotine-vaping-products-and-vaping-devices_0.pdf.

27. Therapeutic Goods Administration. Notified vape list: goods for smoking cessation or nicotine dependence.  Available from: https://www.tga.gov.au/products/unapproved-therapeutic-goods/vaping-hub/notified-vape-list-goods-smoking-cessation-or-nicotine-dependence.

 

Intro
Chapter 2