18C.7 Legal status of oral nicotine products in Australia

In Australia, nicotine pouches are ‘therapeutic goods’. All therapeutic goods must comply with a range of requirements contained in the Therapeutic Goods Act 1989 (Cth) and associated regulations.^1,2 In particular, therapeutic goods are generally required to be listed on the Australian Register of Therapeutic Goods (ARTG)³ following assessment by the Therapeutic Goods Administration (TGA). To date, there are no nicotine pouches that have been assessed by the TGA and entered on the ARTG, and it is therefore not legal to supply or market these products in Australia.⁴

Nicotine for human use is classified under the Standard for the Uniform Scheduling of Medicines and Poisons (the Poisons Standard) as a Schedule 4 ‘prescription only medicine’, except:⁵

1. when included in Schedule 3 (i.e. in therapeutic vaping goods); or
2. in tobacco prepared and packed for smoking; or
3. in preparations for ‘oromucosal or transdermal administration’ for human therapeutic use when included in the ARTG as an aid in withdrawal from tobacco smoking or nicotine vaping (i.e. nicotine patches, gum, mouth spray, lozenges etc).

Where nicotine falls within the second or third exemption and complies with the Therapeutic Goods Act 1989 (Cth), it can be supplied by general retailers without a prescription. This is why nicotine replacement therapy (NRT) such as patches and gums are available for sale over the counter in supermarkets, convenience stores and other retailers.

Nicotine products for human use which fall outside the three exemptions are Schedule 4 ‘prescription only medicines’ and are subject to state and territory laws applicable to prescription only medicines.^6-13 Schedule 4 substances like nicotine cannot be supplied to consumers without a valid prescription.

Nicotine pouches can be imported under the Personal Importation Scheme with a valid prescription from an Australian-registered medical practitioner, subject to the other conditions of the scheme. In all instances, a nicotine pouch would also need to meet state or territory requirements to be lawfully imported.⁴ 

In most states and territories, it is an offence for a retailer to supply (sell),¹⁴ possess,¹⁵ or advertise¹⁶ nicotine pouches, without authorisation. Queensland and South Australia have further incorporated the regulation of oral nicotine pouches within their respective tobacco control legislation and associated tobacco licensing schemes.

In South Australia, on 28 January 2025 the Minister for Health and Wellbeing declared nicotine pouches as a ‘prohibited product’ under the Tobacco and E-Cigarette Products Act 1997 (SA).¹⁷ In Queensland, on 2 April 2025 the State Government prescribed by regulation nicotine pouches as an ‘illicit nicotine product’ under the Tobacco and Other Smoking Products Act 1998 (Qld).¹⁸ In these states, tobacco retailers found to be selling or commercially possessing nicotine pouches can be subject to the same licensing enforcement powers as applicable to the trading of tobacco products, such as closure orders, termination of leases and high pecuniary and imprisonment penalties. For more information on state and territory tobacco licensing schemes, see InDepth 11B, Table 11B.1.

Oral pouches containing tobacco (e.g., snus) have been banned in Australia since 1991, pursuant to a consumer product ban on all smokeless tobacco products issued under national consumer protection legislation—see Section 18A.5.

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References

1. Therapeutic Goods Act 1989 (Cth). Available from: https://www.legislation.gov.au/C2004A03952/latest/text.

2. Therapeutic Goods Regulations 1990 (Cth). Available from: https://www.legislation.gov.au/F1996B00406/latest/text.

3. Australian Register of Therapeutic Goods (ARTG). Available from: https://www.tga.gov.au/resources/australian-register-therapeutic-goods-artg.

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

5. Therapeutic Goods (Poisons Standard—June 2025) Instrument 2025 (Cth). Available from: https://www.legislation.gov.au/F2025L00599/asmade/text.

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

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

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

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

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

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

12. 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.

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

14. Medicines, Poisons and Therapeutic Goods Act 2008 (ACT) s 26(1); Poisons and Therapeutic Goods Act 1966 No 31 (NSW) s 36A(1); Medicines, Poisons and Therapeutic Goods Act 2012 (NT) s 40; Medicines and Poisons Act 2019 (Qld) s 35(1); Controlled Substances Act 1984 (SA) s 17; Poisons Act 1971 (Tas) ss 26(1B), 38(1); Drugs, Poisons and Controlled Substances Act 1981 (Vic) s 27; Medicines and Poisons Act 2014 (WA) s 14(1).

15. Medicines, Poisons and Therapeutic Goods Act 2008 (ACT) s 36; Poisons and Therapeutic Goods Act 1966 No 31 (NSW) ss 4(1) (definition of ‘supply’ includes to keep or have in possession for sale, dispensing or distribution), 36A(1); Medicines, Poisons and Therapeutic Goods Act 2012 (NT) s 39; Medicines and Poisons Act 2019 (Qld) s 34(1); Controlled Substances Act 1984 (SA) s 18(3); Drugs, Poisons and Controlled Substances Act 1981 (Vic) s 36B(2); Medicines and Poisons Act 2014 (WA) s 14(4).

16. Medicines, Poisons and Therapeutic Goods Regulation 2008 (ACT) reg 651(1); Poisons and Therapeutic Goods Act 1966 No 31 (NSW) ss 4(1) (definition of ‘supply’ includes supply by way of advertisement), 36A(1); Medicines, Poisons and Therapeutic Goods Act 2012 (NT) s 113(1); Medicines and Poisons (Medicines) Regulation 2021 (Qld) reg 234; Controlled Substances Act 1984 (SA) s 28; Controlled Substances (Poisons) Regulations 2011 (SA) reg 32(1)(c); Poisons Regulations 2018 (Tas) reg 44; Drugs, Poisons and Controlled Substances Act 1981 (Vic) s 27A(3A); Medicines and Poisons Act 2014 (WA) s 8(2)(b).

17. Hon. Chris Picton MP, Minister for Health and Wellbeing, ‘Tobacco and E-Cigarette Products Act 1997, Section 39C(1), Declaration of Prohibited Product’ in South Australia, The South Australian Government Gazette, No. 7, 30 January 2025, 102.

18. Tobacco and Other Smoking Products Regulation 2021 (Qld) reg 15AB.