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 the associated regulations.1, 2 In particular, therapeutic goods are generally required to be listed on the Australian Register of Therapeutic Goods (the ARTG) 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.3
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 where it occurs:4
- in tobacco prepared and packed for smoking; or
- in preparations for ‘oromucosal or transdermal administration’ (such as nicotine patches, gum, mouth spray, lozenges etc) for human therapeutic use as an aid in withdrawal from tobacco smoking.
Where nicotine falls within (1) or (2), and complies with the Therapeutic Goods Act 1989 (Cth), it can be supplied by general retailers without a prescription, which is why nicotine replacement therapy such as patches and gums are available for sale in supermarkets. Where nicotine does not fall within paragraph (1) or (2) above, it is subject to the same state and territory laws that apply to other ‘prescription only’ medicines.5-12 Under these laws, nicotine cannot be supplied to consumers without a prescription. Consumers can import nicotine pouches under the Personal Importation Scheme with a valid prescription from an Australian-registered medical practitioner, subject to the other conditions of scheme. In all instances, a nicotine pouch would also need to meet state or territory requirements to be imported.3
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.
References
1. Therapeutic Goods Act 1989: (CTH). Available from: https://www.legislation.gov.au/Details/C2021C00207.
2. Therapeutic Goods Regulations 1990: (CTH). Available from: https://www.legislation.gov.au/Details/F2021C00839.
3. 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
4. The Poisons Standard (the SUSMP). Canberra: Australian Government, 2018. Available from: https://www.tga.gov.au/publication/poisons-standard-susmp.
5. Medicines, Poisons and Therapeutic Goods Act 2008: (ACT). Available from: https://www.legislation.act.gov.au/a/2008-26/.
6. Poisons and Therapeutic Goods Act 1966 No 31: (NSW). Available from: https://legislation.nsw.gov.au/view/html/inforce/current/act-1966-031.
7. Medicines Poisons and Therapeutic Goods Act 2012: (NT). Available from: https://legislation.nt.gov.au/Legislation/MEDICINES-POISONS-AND-THERAPEUTIC-GOODS-ACT-2012.
8. Medicines and Poisons Act 2019: (QLD). Available from: https://www.legislation.qld.gov.au/view/html/inforce/current/act-2019-026.
9. Controlled Substances Act 1984: (SA). Available from: https://www.legislation.sa.gov.au/LZ/C/A/CONTROLLED%20SUBSTANCES%20ACT%201984.aspx.
10. Poisons Act 1971: (TAS). Available from: https://www.legislation.tas.gov.au/view/html/inforce/current/act-1971-081.
11. 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.
12. Medicines and Poisons Act 2014: (WA). Available from: https://www.legislation.wa.gov.au/legislation/statutes.nsf/main_mrtitle_13172_homepage.html.