18B.8 Legal status in Australia

Last updated:  October 2022

Suggested citation: Greenhalgh, EM, Smith, L, Grace, C, & Scollo, MM. InDepth 18B.8 Legal status in Australia. In Greenhalgh, EM, Scollo, MM and Winstanley, MH [editors]. Tobacco in Australia: Facts and issues. Melbourne: Cancer Council Victoria; 2021. Available from:  http://www.tobaccoinaustralia.org.au/chapter-18-harm-reduction/indepth-18b-e-cigarettes

 

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. Their current status in Australia is as follows:

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.1

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. 2-9

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. 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.

Although nicotine vaping products may be prescribed for smoking cessation, they have not been approved by the Therapeutic Goods Administration (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. 10,11 Nicotine vaping products are supplied by means of three access pathways for goods that are not on the ARTG:

  • The Authorised Prescriber Scheme. 10; 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. 11; r 12B(1B)
  • The Special Access Scheme. 10; s 19(1)  A medical practitioner may apply to the TGA for approval to prescribe a nicotine vaping product to a particular patient.
  • The Personal Importation Scheme. 11; r 12(1), Sch 5 Consumers with a prescription for a nicotine vaping product from any medical practitioner registered in Australia may import it. The amount may be no more than a 3 months’ supply at a time, and no more than 15 months’ supply over 12 months.

In addition, passengers arriving in Australia by ship or plane may bring in personal supplies of nicotine vaping products without a prescription. This is known as the ‘Traveller’s Exemption’. All of these schemes are established under Commonwealth therapeutic goods legislation.

Although the TGA has not assessed the safety, quality and efficacy of nicotine vaping products, it has released a product standard that sets out minimum safety and quality requirements: the Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Order 2021.12 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. Not all of the elements of TGO 110 can be enforced for products that are imported by individual consumers. Nicotine vaping products brought into Australia under the Personal Importation Scheme and Traveller’s Exemption are not required to be in child‑resistant packaging or to specify the ingredients and nicotine concentration level and display safety warning statements.

Tobacco control and smokefree laws apply to e-cigarettes that contain nicotine in all states and territories except Western Australia and the Northern Territory.

E-cigarettes that do not contain nicotine. There are no restrictions on the importation of e‑cigarettes that do not contain nicotine. They may be sold by retailers in all states and territories except Western Australia but may not be sold to minors. In some states and territories, they may be sold only by licensed retailers—see Table 18B.8.1.

There is no way to determine whether or not an e-cigarette contains nicotine, short of subjecting it to laboratory analysis. This may have implications for effective law enforcement.

Table 18B.8.1 E-cigarette retail licences, Australia [i] (as at October 2022)

 

Term fee p.a.

Enforcement

Features

Conditions (minimum)

Penalties (maximum)

Same as tobacco retail?

Selling without a licence

Not complying with licence conditions or Act

ACT [ii]

 

1 yr [iii]

$577  [iv]

 

Commissioner for Fair Trading regulates licenses.

May apply to ACAT for an occupational discipline order if (among other things) licensee contravenes Act or licence condition; is convicted of an offence punishable by imprisonment for one or more years: or is bankrupt or personally insolvent. ACAT can vary licence conditions, suspend licence etc. [v]

Enforcement by Commissioner for Fair Trading, any police officer, public health officers, and investigators appointed under consumer law. [vi]

Employer is liable for employee’s actions in course of employment. [vii]

Licensees are listed in a public register. [viii]

 

Commissioner for Fair Trading may specify, vary or cancel conditions.

Licence may limit number and location of points of sale.

If the applicant has committed 2 offences in the past 2 yrs for selling to a minor, the Commission may impose a condition that the applicant undergo training, rather than refuse the application. [ix]

50 penalty units [x] ($8,000 individual, $40,500 corporation) 

 

 

 

50 penalty units [xi] ($8,000 individual, $40,500 corporation) 

Licence cancelled plus disqualified from holding licence for 5 yrs if convicted a second time within 2 yrs for an offence against the Act.

 

 

Yes [xii]

NT [xiii]

 

1, 3 or 5 yrs

$254  [xiv]

Director of Tobacco Control regulates licenses.

Enforcement by authorised officers, including all police officers plus officers appointed by the Chief Health Officer. [xv]

 

Licences may be transferred with the approval of the Director of Tobacco Control. [xvi]

The applicant must provide a national police certificate about the person who is proposed to be the manager of the business. [xvii]

The Director of Tobacco Control may vary the conditions on own initiative or at a licensee’s request. [xviii]

 

500 penalty units [xix] ($81,000)

100 penalty units ( $16,200) [xx]

Licence cancelled or suspended if licensee, employee or agent is: guilty of 2 or more offences of supplying directly or indirectly to minors; issued 2 or more infringement notices within 12 mths; found to have provided false or misleading info when applying for licence. [xxi]

Yes [xxii]

SA [xxiii]

1 yr

$315  [xxiv]

Minister for Health and Wellbeing is the regulator.

Enforcement by authorised officers, including all police officers plus officers appointed by the Minister [xxv]

Licensees are listed in a public register. [xxvi]

Employer is liable for employee’s or agent’s actions. [xxvii]

Minister may specify conditions.

May vary the licence on own initiative or at a licensee’s request.

Licence may limit number and location of points of sale.

$20,000 or $1,000 (expiation fee) [xxviii]

$10,000 or $500 (expiation fee) [xxix]

Yes [xxx]

TAS [xxxi]

 

 

1 yr

$612  (e‑cigs)

$1218.905 (e‑cigs and tobacco) [xxxii]

Director of Public Health.

Enforcement by authorised officers, including the Director and environmental health officers (who may be appointed by councils), and police officers.

Licensees are listed in a public register. [xxxiii]

Smoking product licence to sell either tobacco products, personal vaporiser products, or both.

The Director has a statutory requirement to consider whether the applicant is a fit and proper person to hold a smoking product licence.

The Director is expressly empowered to require police reports about prior convictions, investigations and prosecution for offences in any Australia jurisdiction. [xxxiv]

 

Director may specify conditions and may vary them conditions on own initiative or at a licensee’s request.

Specialist tobacconists may not be licensed to sell personal vaporiser products.

 

50 penalty units (first offence) ($9,050)

100 penalty units (subsequent offences) ($18,100) [xxxv]

50 penalty units (first offence) ($9,050)

100 penalty units (subsequent offences) ($18,100) [xxxvi]

Yes [xxxvii]

*The costs in this table are current at October 2022. Licence fees may be adjusted in the future; the value of penalty units is different for each jurisdiction and changes on 1 July each year in line with the CPI (except in the ACT, where it changes under the Legislation Act 2001 (ACT) s 133 at least once every 4 years).


[i] Licenses are not needed in Queensland and Victoria (which have negative schemes) or in NSW (where a notification scheme applies under the Public Health (Tobacco) Act 2008 (NSW) s 39). In WA, retailers of ‘tobacco products’ must be licensed ( Tobacco Products Control Act 2006 (WA) s 16). The definition of ‘tobacco product’ excludes nicotine or a product that contains nicotine in a form that is a Schedule 4 poison.

[ii] Tobacco and Other Smoking Products Act 1927 (ACT), s 47.

[iii] Common expiry/ renewal time of 31 August (Tobacco and Other Smoking Products Act 1927 (Act) s 49.

[iv] May pay by quarter: Tobacco and Other Smoking Products (Fees) Determination 2022 (No 2) (ACT) DI2022-205 (commenced 1 September 2022).

[v] Tobacco and Other Smoking Products Act 1927 (ACT ), ss 57-58. ACAT is the ACT Civil and Administrative Tribunal.

[vi] Tobacco and Other Smoking Products Act 1927 (ACT), s 32.

[vii] Tobacco and Other Smoking Products Act 1927 (ACT), s 46.

[viii] Tobacco and Other Smoking Products Act 1927 (ACT), s 53.

[ix] Tobacco and Other Smoking Products Act 1927 (ACT), s 48.

[x] Tobacco and Other Smoking Products Act 1927 (ACT), ss 61(2).

[xi] Tobacco and Other Smoking Products Act 1927 (ACT), ss 60, 61, 63.

[xii] The licence is to sell ‘smoking products’ which are defined to include e-cigarettes: see definitions of ‘smoking product’ and ‘personal vaporiser’ and ‘personal vaporiser related product: Tobacco and Other Smoking Products Act 1927 (ACT), ss 3A, 3B.

[xiii] Tobacco Control Act 2002 (NT), s 28.

[xiv] 200 revenue units: Tobacco Control Regulations 2002 (NT), r 25(2).

[xv] Tobacco Control Act 2002 (NT), s 47.

[xvi] Tobacco Control Act 2002 (NT), s 36.

[xvii] Tobacco Control Regulations 2002 (NT), r 25(1).

[xviii] Tobacco Control Act 2002 (NT), s 35.

[xix] Tobacco Control Act 2002 (NT), s 28.

[xx] Tobacco Control Act 2002 (NT), s 30.

[xxi] Tobacco Control Act 2002 (NT), s 38.

[xxii] The Tobacco Control Act 2002 (NT) applies to ‘e-cigarettes, e-cigarette accessories and any other device or accessory prescribed by the Regulations’ as if they were tobacco products: s 4A.

[xxiii] Tobacco and E-Cigarette Products Act 1997 (SA), s 6.

[xxiv] Tobacco E-cigarette Products (Fees) Notice 2021 , Gazette 3 June 2021, p 2128.

[xxv] Tobacco and E-cigarette Products Act 1997 (SA) s 63.

[xxvi] Tobacco and E-cigarette Products Act 1997 (SA) s 73.

[xxvii] Tobacco and E-cigarette Products Act 1997 (SA) s 81.

[xxviii] Tobacco and E-cigarette Products Act 1997 (SA) s 6.

[xxix] Tobacco and E-cigarette Products Act 1997 (SA) s 9(5).

[xxx] Tobacco and E-cigarette Products Act 1997 (SA) s 6.

[xxxi] Public Health Act 1997 (Tas), s 74A.

[xxxii] 360 fee units for each premises to sell personal vaporiser products only; 717 fee units for each premises to sell both tobacco and vaporiser products: Public Health (Smoking Product Licence) Regulations 2019 (Tas), r 4.

[xxxiii] Public Health Act 1997 (Tas), s 74J.

[xxxiv] Public Health Act 1997 (Tas), s 74C.

[xxxv] Public Health Act 1997 (Tas), s 74A.

[xxxvi] Public Health Act 1997 (Tas), ss 74I, 74L.

[xxxvii] Licence is to sell a ‘smoking product’, which is defined as any tobacco product or personal vaporiser product: Public Health Act 1997 (Tas), s 3.

 

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.13 Use of e-cigarettes (whether or not they contain nicotine) is banned in smokefree areas, at smokefree public events and at all underage functions.14

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.15

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. 16 The Smoke-free Environment Act prohibits the use of e-cigarettes in smoke-free areas.16, 17

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.18

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.19

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.20

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.21

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.

 

Relevant news and research

For recent news items and research on this topic, click  here. ( Last updated August 2022)

 

 

References 

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

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

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

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

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

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

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

8. 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.

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

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

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

12. Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Order 2021 (CTH). Available from: https://www.legislation.gov.au/Details/F2021L00595/Download.

13. 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).

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

15. 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

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

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

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

19. 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.

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

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