Published by Quit.org.au
Legal status of electronic cigarettes in Australia Updated March 2015 There are no laws specifically addressing the regulation of electronic cigarettes in Australia; instead, a number of laws relating to poisons, therapeutic goods and tobacco control apply to electronic cigarettes in some circumstances. This makes the regulation of electronic cigarettes complex. Below is a summary of key laws and regulations that impact electronic cigarettes. Some of these issues have yet to be clarified; therefore this summary may be updated as further information becomes available. Commercial retail sale and personal possession/use of nicotine electronic cigarettes The sale and personal possession or use (among other things) of nicotine electronic cigarettes is currently unlawful in every jurisdiction in Australia unless specifically approved/authorised/ licenced/etc) (1) (2) (3) (4) (5) (6) (7) (8) (9). This is due to controls on nicotine that apply in each state and territory by reason of it being classified as a ‘Schedule 7- Dangerous Poison’ under the Commonwealth Poisons Standard (10). This position could change in the future should an electronic cigarette product be registered by the Therapeutic Goods Administration (‘TGA’) (discussed below). Where a nicotine electronic cigarette is for therapeutic uses, such as smoking cessation or alleviation of nicotine withdrawal, the electronic cigarette must be registered by the TGA in order to be sold lawfully (9). This involves an assessment of elements including the safety, quality and efficacy of the liquid nicotine and an assessment of the design of the electronic cigarette to ensure it is safe to use (11) (12). Liquid nicotine for inhalation for therapeutic uses is a ‘Schedule 4 – Prescription only’ medicine under the national Poisons Standard (13), which means that any TGA registered nicotine electronic cigarette products would be available by prescription only. There are currently no TGA registered electronic cigarettes (11) and importation, exportation, manufacture and supply of unregistered therapeutic goods is a criminal offence under the Therapeutic Goods Act 1989 (Cth) (9). Where the nicotine electronic cigarette is represented as being for recreational purposes only (that is, not for therapeutic use), the nicotine is classified as a 2 ‘Schedule 7 – Dangerous Poison’ under the national Poisons Standard (13). This means that the manufacture, sale and possession of this kind of recreational product is currently unlawful in all states and territories (unless an approval, authority/ licence/ permit (as the case may be) can be sought and is granted by the relevant state or territory authority) (1) (2) (3) (4) (5) (6) (7) (8) (9) (14). Even if a specific electronic cigarette product were to receive TGA registration in the future, it is possible that its sale would still be banned in states and territories that specifically prohibit the retail sale of products that are designed to resemble tobacco products (i.e, South Australia (‘SA’) (15) and Western Australia (‘WA’) (16). Commercial importation and retail sale of non-nicotine electronic cigarettes Importation for commercial purposes and retail sale of non-nicotine electronic cigarettes that are marketed with therapeutic claims is unlawful across Australia unless the product is registered by the TGA (9). There are currently no TGA registered electronic cigarettes (11). Importation and retail sale of non-nicotine electronic cigarettes that do not make therapeutic claims is not covered by laws relevant to therapeutic goods, meaning that they can be imported and sold by retailers without needing to comply with laws relevant to therapeutic goods. Restrictions under customs and/or drugs and poisons laws may apply depending on the constituents of a particular product (and often constituents are not fully disclosed). As noted above, SA (15) and WA (16) laws prohibit retail sale of products that resemble tobacco products. Therefore, even if non-nicotine electronic cigarette products make no therapeutic claims, the retail sale of particular models in those jurisdictions may still be an offence. Importation of nicotine electronic cigarettes for personal use Importation of nicotine electronic cigarettes for personal therapeutic use (e.g, use as a quitting aid) is exempt from TGA registration requirements (but other conditions apply, noted below). This exemption arises under the personal importation scheme provided for under the Therapeutic Goods Regulations 1990 (Cth) (Schedule 5). It is therefore possible to lawfully import nicotine electronic cigarettes for personal use if the importer is able to comply with the 3 requirements of the TGA’s personal importation scheme. Under this scheme (among other requirements): o As the goods are listed in Schedule 4 of the Poisons Standard (Prescription only), the importer must have a prescription from a medical practitioner registered in the relevant state or territory (unless the importer carries the goods as a passenger on a ship or plane) (17). o The goods must be imported for use in the treatment of the importer or the importer’s immediate family. o The quantity imported in one importation must not be more than three months’ supply at the maximum dose recommended by the manufacturer. o The goods must not contain a substance the importation of which is prohibited under the Customs Act 1901 (Cth) (while nicotine is not a prohibited import, other constituents of electronic cigarettes might be. Often constituents are not fully disclosed). o The total quantity of the goods imported in a 12 month period must not exceed 15 months’ supply (18) (19). The requirement for a medical prescription may pose practical barriers for people in Australia wishing to order nicotine electronic cigarettes online, in the event that medical practitioners are unwilling or unable (for legal reasons) to provide a prescription for a product that has not been approved by the TGA. Even if TGA laws and regulations permit nicotine to be imported for personal use with a medical prescription, state and territory drugs and poisons laws may or may not permit possession of that product as different restrictions apply to “prescription” medicines. It would be prudent for consumers to check restrictions under their applicable state and territory poisons laws to see if there are any other restrictions on the possession and use of electronic cigarettes obtained with a medical prescription from overseas. Importation and/or possession of nicotine electronic cigarettes for recreational use is not covered by the TGA personal importation scheme but will be in breach of state and territory drugs and poisons laws (as such a product would be considered a Schedule 7 – Dangerous Poison) (1) (2) (3) (4) (5) (6) (7) (8) (9) (14). 4 Importation of non-nicotine electronic cigarettes for personal use Importation of non-nicotine electronic cigarettes that are marketed with therapeutic claims is covered by therapeutic goods laws and regulations and it is lawful to import these products for personal use or use by an immediate family member if the importer complies with the personal importation scheme (described above). Because the products do not contain a prescription only medicine (i.e. nicotine), no medical prescription is required, but the other conditions outlined above (for example, regarding personal/family use, three months’ supply and 15 months’ supply within 12 months and restrictions on prohibited imports) all apply. Importation of non-nicotine electronic cigarettes that do not make therapeutic claims is not covered by laws relevant to therapeutic goods, meaning that they can be imported for personal use and commercial purposes without needing to comply with laws relevant to therapeutic goods. However, restrictions under customs and/or drugs and poisons laws may apply depending on the constituents of a particular product (and often constituents are not fully disclosed). Applicability of tobacco control laws There may be a case that certain promotions of electronic cigarettes are in breach of the Tobacco Advertising Prohibition Act 1992 (Cth) (‘TAP Act’); however, there are currently no legislative provisions in the TAP Act that specifically refer to electronic cigarettes. In states and territories other than Queensland, it is unlikely that electronic cigarettes fall within laws regarding smokefree areas; however, individual businesses and the public sector can develop their own policies on use of electronic cigarettes in their organisations. In Queensland, tobacco control laws prohibiting sales to minors, restricting advertising and display at retail outlets, and prohibiting use in smokefree areas now also apply to “personal vaporises”, which includes electronic cigarettes. These restrictions apply to all electronic cigarettes, even those that may be TGA listed in the future. These laws came into effect on 1 January 2015 (20). Please note: This information sheet does not constitute legal advice and should not be relied on as such. Consider whether you or your organisation should seek legal advice tailored to your specific circumstances. 5 The Quit Victoria and Quitline logos are registered trademarks of The Cancer Council Victoria. Quit Victoria is a joint initiative of The Cancer Council Victoria, the Department of Health, the National Heart Foundation and the Victorian Health Promotion Foundation. Produced by Quit Victoria. 615 St Kilda Rd, Melbourne VIC 3004 Date: 06/14 References 1. Drugs, Poisons and Controlled Substances Regulations 2006 (Vic) r 65. See also Victorian Department of Health, Electronic cigarettes containing nicotine are prohibited in Victoria. Available from: http://docs.health.vic.gov.au/docs/doc/Electronic-cigarettes-containing-nicotineare-prohibited-in-Victoria. 2. Poisons and Therapeutic Goods Regulation 2008 (NSW) r 20. See also NSW Government, Are electronic cigarettes legal in NSW?’. Available from: http://www.health.nsw.gov.au/tobacco/Factsheets/e-cigs-are-they-legal.pdf. 3. Health (Drugs and Poisons) Regulation 1996 (Qld) r 271. See also Queensland Health, Electronic cigarettes. Available from: https://www.health.qld.gov.au/publichealth/topics/atod/tobacco-laws/electronic-cigarettes/default.asp. 4. Controlled Substances (Poisons) Regulations 2011 (SA) regs 9, 11, 12, 15 and 30; Controlled Substances Act 1984 (SA) sections 13, 15, 16 and 27. 5. Poisons Act 1964 (WA) sections 23, 24(1)(d), 25(1) and 40. See also Government of Western Australia, Department of Health, Electronic cigarettes (e-cigarettes). Available from: http://www.healthywa.wa.gov.au/HealthyWA/Articles/A_E/Electronic-cigarettes-e-cigarettes. 6. Poisons Act 1971 (Tas) s 37(2); Poisons Regulations 2008 (Tas) r 74(11). See also Tasmanian Government, Population Health Services, E-cigarette facts. Available from: http://www.dhhs.tas.gov.au/__data/assets/pdf_file/0018/151182/PHS_ECigarettes_Final.pdf. 7. Medicines, Poisons and Therapeutic Goods Act 2012 (NT) ss 42-44. 8. Medicines, Poisons and Therapeutic Goods Act 2008 (ACT) sections 26(1), 33, 35(1), s 36 9. Therapeutic Goods Act 1989 (Cth) s 19B. 10. Standard for the Uniform Scheduling of Medicines and Poisons, commonly referred to as the ‘Poisons Standard’. 11. Therapeutic Goods Administration. Electronic cigarettes. Symonston, Australian Capital Territory: Australian Government Department of Health and Ageing; 2013 [15 October 2013]; Available from: http://www.tga.gov.au/consumers/ecigarettes.htm. 12. National Coordinating Committee on Therapeutic Goods. Scheduling Policy Framework for Medicines and Chemicals. Symonston, Australian Capital Territory: Department of Health; 2010. 6 13. Standard for the Uniform Scheduling of Medicines and Poisons No 4 (‘Poisons Standard 2013’). 14. Each state and territory has its own scheme for approving/authorising/ licensing dealings with dangerous poisons. It is beyond the scope of this paper to address these schemes. 15. Tobacco Products Regulation Act 1997 (SA) s 36. 16. Tobacco Products Control Act 2006 (WA) s 106. See also Hawkins v Van Heerden  WASC 127. 17. Item 1(d) of Schedule 5 of the Therapeutic Goods Regulations 1990 (Cth) states that a person needs a ‘written authority’ issued by a registered medical practitioner for the purpose of the personal importation scheme. The TGA has made clear that it considers a valid prescription to be the ‘written authority’ required under the regulations. See: http://www.tga.gov.au/newsroom/btn-liquidnicotine.htm#.U6EDx-RQG5I. 18. Therapeutic Goods Act 1989 (Cth) s 18(1); Therapeutic Goods Regulations 1990 r 12(1) and Schedule 5, item 1(d). 19. Therapeutic Goods Administration. Personal Importation Scheme. Australian Government Department of Health; 2013 [7 April 2014]; Available from: http://www.tga.gov.au/consumers/personal-importation-scheme.htm. 20. See the Tobacco and Other Smoking Products Act 1998 (QLD), s 5A and Part 2-2C; Health Legislation Amendment Bill 2014 (Qld), Explanatory Notes p. 1; pp. 8-9; Health Legislation Amendment Bill 2014 (Qld), Explanatory Notes for amendments to be moved during consideration in detail by the Honourable Lawrence Springborg MP, pp.4-6.