18.13 Legal status in Australia

Last updated: March 2024

Suggested citation: Grace, C, Greenhalgh, EM, Smith, L, & Scollo, MM. 18.13 Legal status in Australia. In Greenhalgh, EM, Scollo, MM and Winstanley, MH [editors]. Tobacco in Australia: Facts and issues. Melbourne: Cancer Council Victoria; 2024. Available from: https://www.tobaccoinaustralia.org.au/chapter-18-e-cigarettes/18-3-legal  

 

In Australia, the regulation of e-cigarettes is encompassed by a number of laws relating to tobacco control, therapeutic goods, poisons and consumer protection laws, and is shared between the Commonwealth and the states and territories.

The legal framework applying to e-cigarettes in Australia is rapidly changing. In May 2023, the Federal Government announced that it would implement a set of new measures aimed at tightening control of e-cigarettes across Australia. Once fully implemented, these proposed new laws will prohibit the general retail sale of all e-cigarette products in Australia, regardless of nicotine content. Under the reforms, e-cigarette products (or ‘vaping products’) will only be sold in pharmacies, and vaping liquids will only be accessible with a prescription. The Government has proposed that these new measures will be introduced in a number of ‘stages’ over the course of 2024.

A timeline summarising the proposed new laws is included in Table 18.13.1, below. This timeline is current as of March 2024. These laws will apply across Australia. State and Territory tobacco control laws applying to e-cigarettes (include smokefree laws, retail display laws and licensing requirements) will continue to apply in each jurisdiction unless amended or repealed.

Table 18.13.1. Timeline of proposed changes to vaping legislation in Australia

Date

Proposed change announced by Federal Government

1 January 2024

Importation of single-use, disposable vapes 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.3

1 March 2024

Importation of all non-therapeutic vaping products to be prohibited (regardless of nicotine content).1 , 2 This measure is expected to cover products ordered before 1 March 2024, which have not yet arrived in Australia.

Importation of all vaping products under the ‘Personal Importation Scheme’ is expected to end. Following this change, individuals will no longer be able to order vaping products directly from overseas, even with a prescription.

New ‘pre-market notification requirements’ are also expected to commence for the importation and manufacture of all therapeutic vapes. Importers and manufacturers will be 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’ is expected to be publicly available from 1 March 2024.

Amendments to the product standard known as ‘TGO110’ will come into effect (with further amendments to be made later in the year).4 From 1 March 2024, the amended standards will: (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

Therapeutic vaping products imported or manufactured before 1 March 2024 will not be required to meet the amended standards, provided they meet the product standards that applied at the time of the importation or manufacture. i

Importers will also need to obtain a customs license and permit from the Office of Drug Control (ODC) to import therapeutic vaping products.

Later in 2024

New legislation is expected to be introduced to prohibit the manufacture, supply and commercial possession of all non-therapeutic vapes. As noted further above, the Federal Government has indicated on a number of occasions that these new laws will not involve criminalisation of individuals in possession of e-cigarettes for personal use. New advertising controls are also expected to be introduced. These changes will require amendments to the Therapeutic Goods Act 1989 (Cth).5

These proposed new laws are expected to be introduced into Federal Parliament in Autumn 2024.5 As at January 2024, there is no proposed commencement date for these changes.

1 December 2024

It is anticipated that further amendments to TGO110 will come into effect later in 2024. These proposed amendments include a reduction in permissible nicotine concentrations, and a requirement that products be in pharmaceutical packaging.6

The TGA has indicated that a transition period will be allowed for businesses to comply with these changes, which are not expected to commence until 1 December 2024.6

Source: Information in this table has been largely adapted from information available on the TGA website as at January 2024. In particular, ‘Vapes: Information for prescribers’, available from: https://www.tga.gov.au/resources/resource/guidance/vapes-information-prescribers.

 

Every effort has been made to ensure the information on this page is up to date. However, given the law in this area is evolving rapidly, it is probable that the information on this page will not always be current throughout the course of 2024. Information should therefore be cross-checked with other sources to ensure accuracy. Information regarding recent developments in this area can be found on the Therapeutic Goods Administration (TGA) and Department of Health and Aged Care websites.  

The legal status of e-cigarettes in Australia is currently as follows:

Single-use, disposable e-cigarettes. From 1 January 2024, the importation of all single-use, disposable e-cigarettes is prohibited (regardless of whether they contain nicotine).7 The prohibition covers e-cigarette products ordered before 1 January 2024, which have not yet arrived in the country. Single-use, disposable e-cigarette products which entered the country before 1 January 2024 can still be sold (subject to the State and Territory laws outlined below), although this is expected to change later in 2024 (see Table 18.13.1, above).

E-cigarettes that contain nicotine.  Nicotine is classified under the Standard for the Uniform Scheduling of Poisons (Cth) (‘the Poisons Standard’) as a schedule 4 ‘prescription only medicine’, except where it occurs (1) in tobacco prepared and packed for smoking or (2) in preparations for oromucosal or transdermal administration (such as nicotine patches, gum, mouth spray, lozenges and inhalators) that are used as an aid in withdrawal from tobacco smoking.8

The Poisons Standard classifies medicines and poisons into schedules according to level of risk to public health and safety. For each schedule, there are recommended controls on access to the scheduled substances. The controls are implemented and enforced under state and territory legislation.9-16

As nicotine is a schedule 4 ‘prescription-only medicine’, e-cigarettes that contain nicotine are subject to the same state and territory laws that apply to other schedule 4 medicines obtained on prescription from a doctor. Under these laws, it is illegal everywhere in Australia to sell any e‑cigarette containing nicotine, any nicotine liquid for vaping, or any other nicotine vaping product, to a customer who does not have a prescription for it.

State and territory laws vary when it comes to unauthorised possession of prescription medicines. In most jurisdictions, the possession of a prescription only substance without a valid prescription amounts to an offence. It follows that in most jurisdictions, the possession of nicotine vaping products without a prescription is technically an offence (under the relevant state or territory drugs and poisons legislation). These offences are not new, and the penalties they impose relate to the possession/use of any prescription-only substance (and not specifically to nicotine vaping products). The Federal Government has confirmed on a number of occasions that the proposed new national vaping laws (discussed further below) will not involve criminalisation of individuals in possession of e-cigarettes for personal use.3

Although nicotine vaping products may be prescribed for smoking cessation, they have not been approved by the TGA for this or any other therapeutic purpose. Normally, prescription medicines can be supplied in Australia only if they have been approved by the TGA, following an assessment of their safety, quality and efficacy, and they have been included in the Australian Register of Therapeutic Goods (ARTG).

Exceptions apply where permitted under Commonwealth therapeutic goods legislation.17 , 18 Nicotine vaping products can currently be  supplied by means of three access pathways for goods that are not on the ARTG:

  • The Authorised Prescriber Scheme.17; s 19(5) A medical practitioner registered in Australia may apply to the TGA for authorisation to prescribe nicotine vaping products for smoking cessation to patients under their immediate care.18; r 12B(1B)
  • The Special Access Scheme.17; s 19(1)  Ordinarily, under this access pathway a medical practitioner may apply to the TGA for prior approval to prescribe an unapproved product to a particular patient. From 1 January 2024, under a pathway known as ‘Special Access Scheme C’, any medical or nurse practitioner can prescribe therapeutic vaping substances (where clinically appropriate), without the need to apply to the TGA for prior approval. Instead, practitioners must notify the TGA within 28 days of prescribing the unapproved vaping product.6 The TGA has indicated this change is intended to reduce the administrative burden on prescribers, and facilitate legitimate access to therapeutic vaping products under medical supervision.3
  • The Personal Importation Scheme.18; r 12(1), Sch 5 Previously, consumers with a prescription for a nicotine vaping product from any medical practitioner registered in Australia were able to import the product themselves (subject to certain quantity restrictions).However, from 1 January 2024, the personal importation of all single-use, disposable vapes is prohibited. From 1 March 2024, the personal importation of all vaping substances and vaping devices is expected be prohibited (regardless of their nicotine content).3 After 1 March 2024, consumers will therefore no longer be able to order vaping products from overseas, even with a prescription.

Passengers arriving in Australia by ship or plane are able to bring in personal supplies of nicotine vaping products without a prescription. This is known as the ‘Traveller’s Exemption’. However, stricter quantity limits will apply under the new laws implemented by the Federal Government. Travellers entering Australia will only be able to bring in a maximum of two vapes, 20 vape accessories (such as cartridges, capsules or pods), and 200ml of liquid vape substance. From 1 January 2024, the two vape limit applies to all single-use, disposable vapes. The vapes must be used for the treatment of the traveller or someone the traveller is caring for who is entering Australia on the same ship or aircraft.

All of the above schemes are established under Commonwealth therapeutic goods legislation.

Product standard – TGO110

Although the TGA has not assessed the safety, quality and efficacy of nicotine vaping products, it has developed a product standard that sets out minimum safety and quality requirements. The Therapeutic Goods (Standard for Therapeutic Vaping Goods) (TGO110) Order 2021 (known as ‘TGO110’), commenced on 1 January 2024 and replaces the previous product standard. TGO 110 helps to ensure that health practitioners and consumers know what the products contain. It also prohibits substances with known, demonstrable health risks if inhaled; bans active ingredients other than nicotine; specifies a maximum nicotine concentration level; and reduces the health and safety risks of accidental exposure and/or ingestion.

The new product standard limits the flavours and scents used in products to mint, menthol or tobacco, and introduces certain safety requirements for vaping devices.19 As outlined in Table 18.13.1 above, further amendments to TGO110 are expected to be introduced later in 2024.

Compliance with TGO110 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.

Nicotine vaping products brought into Australia under the Traveller’s Exemption are not required to comply with TGO110.20

Tobacco control and smokefree laws apply to both nicotine and non-nicotine e-cigarettes in all states and territories except Western Australia.

E-cigarettes that do not contain nicotine. As noted above, the importation of all single use, disposable e-cigarette products is prohibited from 1 January 2024 (regardless of nicotine content). As of January 2024, the importation of e-cigarettes that do not contain nicotine is not otherwise restricted (although this is expected to change, as discussed above). E-cigarettes that do not contain nicotine may be sold by retailers in all states and territories except Western Australia, but may not be sold to minors.

Retail display restrictions apply in all jurisdictions where retailers are permitted to sell non-nicotine e-cigarettes. In some states and territories, these non-nicotine e-cigarettes currently (as at March 2024) may be sold only by licensed retailers.

There is no way to determine whether or not an e-cigarette contains nicotine, short of subjecting it to laboratory analysis. This has had implications for effective law enforcement across Australia. As noted above, the new measures announced by the Federal Government in May 2023 are aimed at addressing this loophole by prohibiting the general retail sale of all vape products in Australia, regardless of nicotine content. Once the proposed reforms are fully implemented, vaping products will only be legally available for sale in pharmacies, and vaping liquids will only be accessible with a prescription.

Australian Capital Territory

In the ACT, the sale of electronic cigarettes that do not contain nicotine is currently allowed provided the business holds a tobacco licence and the person purchasing the product is over 18 years of age. The advertising, display, and marketing of products are strictly regulated.21 Use of e-cigarettes (whether or not they contain nicotine) is banned in smokefree areas, at smokefree public events and at all underage functions.22

Western Australia

In Western Australia, the Tobacco Products Control Act 2006 (s. 106) states that a person must not sell any food, toy or other product that is designed to resemble a tobacco product or package. The Supreme Court and Court of Appeal of Western Australia have confirmed that this prohibits the sale of e-cigarettes.23

New South Wales

In NSW, the Public Health (Tobacco) Act 2008 prohibits the sale or supply of e-cigarettes and accessories to minors; restricts vending machine locations for e-cigarettes; and provides NSW police with powers to seize e-cigarettes from minors.  It also restricts the display of e‑cigarettes and accessories and bans the use of electronic cigarettes in cars carrying children.24 The Smoke-free Environment Act prohibits the use of e-cigarettes in smoke-free areas.24 , 25

Queensland

Queensland’s Tobacco and Other Smoking Products Act 1998 applies to e-cigarettes (referred to in the Act as personal vaporisers). These products may not be sold to minors, used in smokefree areas, or advertised, promoted or displayed at retail outlets.26

South Australia

The Tobacco and E-Cigarette Products Act 1997 (SA) prohibits the sale or supply of e‑cigarettes to minors, the retail sale of e-cigarettes without a licence, the use of e‑cigarettes in legislated smokefree areas and the sale of e-cigarettes from temporary outlets and vending machines. In addition, retail advertising for e-cigarettes is regulated in a similar way to retail advertising for tobacco products. The sale of e-cigarettes by indirect orders (including internet sales) is also prohibited.27

Tasmania

The Public Health Act 1997 (TAS) prohibits the sale of e-cigarettes to minors, the use of e‑cigarettes in legislated smoke-free areas, the sale of e-cigarettes without a licence and the sale of e-cigarettes in specialist tobacconist stores. In addition, retail advertising of e‑cigarettes is regulated in much the same way as for tobacco products.28

Victoria

The Tobacco Act 1987 (Vic) bans the sale of e-cigarettes to minors, the sale of e-cigarettes from vending machines, and the use of any e-cigarettes in legislated smoke-free areas. It also restricts the advertising and promotion of e-cigarette products in retail stores.29

Northern Territory

The Tobacco Control Act 2002 (NT) regulates the availability and promotion of e-cigarettes that do not contain nicotine. The sale of these products without a licence, and to or by minors, is prohibited, and they may not be used in smoke-free areas. Retail advertising and promotion are regulated in the same way as for tobacco products.



i However, this exception for products imported or manufactured before 1 March 2024 will end on 1 July 2024. This means that from 1 July 2024, all products will need to comply with the amended product standards set out in TGO110 (regardless of when they were imported or manufactured). See section 24 of the Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO110) Amendment (Vaping) Order 2023.

Relevant news and research

For recent news items and research on this topic, click here. ( Last updated March 2024)

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 Administration. New Regulations to Place Stronger Controls on Importation, Manufacture and Supply of Vapes, 2023. Available from: https://www.tga.gov.au/news/media-releases/new-regulations-place-stronger-controls-importation-manufacture-and-supply-vapes.

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

7. Customs (Prohibited Imports) Regulations 1956 (Cth), regulations 5A and 18. Available from: https://www.legislation.gov.au/F1996B03651/latest/text.

8. The Poisons Standard (the SUSMP). Canberra: Australian Government, 2018. Available from: https://www.tga.gov.au/publication/poisons-standard-susmp.

9. Medicines, Poisons and Therapeutic Goods Act 2008: (ACT). Available from: https://www.legislation.act.gov.au/a/2008-26/.

10. Poisons and Therapeutic Goods Act 1966 No 31: (NSW). Available from: https://legislation.nsw.gov.au/view/html/inforce/current/act-1966-031.

11. Medicines Poisons and Therapeutic Goods Act 2012: (NT). Available from: https://legislation.nt.gov.au/Legislation/MEDICINES-POISONS-AND-THERAPEUTIC-GOODS-ACT-2012.

12. Medicines and Poisons Act 2019: (QLD). Available from: https://www.legislation.qld.gov.au/view/html/inforce/current/act-2019-026.

13. Controlled Substances Act 1984: (SA). Available from: https://www.legislation.sa.gov.au/LZ/C/A/CONTROLLED%20SUBSTANCES%20ACT%201984.aspx.

14. Poisons Act 1971: (TAS). Available from: https://www.legislation.tas.gov.au/view/html/inforce/current/act-1971-081.

15. Drugs, Poisons and Controlled Substances Act 1981: (VIC). Available from: https://www.legislation.vic.gov.au/in-force/acts/drugs-poisons-and-controlled-substances-act-1981/130.

16. Medicines and Poisons Act 2014: (WA). Available from: https://www.legislation.wa.gov.au/legislation/statutes.nsf/main_mrtitle_13172_homepage.html.

17. Therapeutic Goods Act 1989: (CTH). Available from: https://www.legislation.gov.au/Details/C2021C00207.

18. Therapeutic Goods Regulations 1990: (CTH). Available from: https://www.legislation.gov.au/Details/F2021C00839.

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

20. Therapeutic Goods (Standard for Therapeutic Vaping Goods) (TGO110) Order 2021, section 6(2). Available from: https://www.legislation.gov.au/F2021L00595/latest/text.

21. Tobacco and Other Smoking Products Act 1927 (ACT). s 21. See notice contained in Tobacco (Prohibited Smoking Products) Declaration 2011 (No 1) (Notifiable instrument NI2011-584).

22. Smoke-Free Public Places Act 2003: (ACT). Available from: https://www.legislation.act.gov.au/a/2003-51/.

23. Van Heerden v Hawkins [2016] WASCA 42 (10 March 2016). Available from: https://www.austlii.edu.au/cgi-bin/viewdoc/au/cases/wa/WASCA/2016/42.html?context=1;query=Van%20Heerden%20tobacco%20products%20control%20e-cigarette;mask_path=au/cases/wa/WASC+au/cases/wa/WASCA+au/cases/wa/WALawRp

24. Public Health (Tobacco) Act 2008 (NSW). s 29. See notice contained in New South Wales Government Gazette dated 15 January 2010, at 136.

25. Smoke-free Environment Act 2000 (NSW). Available from: https://www.legislation.nsw.gov.au/#/view/act/2000/69/full.

26. Tobacco and Other Smoking Products Act 1998: (QLD). Available from: https://www.legislation.qld.gov.au/view/whole/html/inforce/current/act-1998-001.

27. Tobacco and E-Cigarette Products Act 1997: (SA). Available from: https://www.legislation.sa.gov.au/LZ/C/A/TOBACCO%20AND%20E-CIGARETTE%20PRODUCTS%20ACT%201997.aspx.

28. Public Health Act 1997: (TAS). Available from: https://www.legislation.tas.gov.au/view/html/inforce/current/act-1997-086.

29. Tobacco Act 1987: (VIC). Available from: https://www.legislation.vic.gov.au/in-force/acts/tobacco-act-1987/094.