A short history of e-cigarette policy in Australia

Abstract

E-cigarettes are becoming increasingly popular within Australia with uptake particularly amongst the younger population. This article covers the history of e-cigarette legislation within Australia, focusing on the first e-cigarette specific legislation in 2021 (TGO110) and the major reforms that have taken place since and are yet to be implemented throughout 2024/2025.

There have been two major changes to the regulation of electronic cigarette (e-cigarette) products in Australia, the first in 2021 and the second in 2024. The first modern e-cigarette was developed in 2003 with these products becoming commercially available during the mid-2000s. ¹ In Australia, at the time, nicotine for use in e-cigarettes was classed as a Schedule 7 (poison) and nicotine-containing e-cigarettes could not be sold over the counter. ¹ However, a 3-month supply of nicotine-containing e-cigarette products could be imported by individuals into Australia (via the Personal Importation Scheme) as an unapproved therapeutic good if they held a prescription from an Australian medical practitioner. ² The sale of nicotine-free e-cigarette products was, however, subject to individual Australian state and territory laws which varied considerably. ² Multiple appeals were made to change the scheduling of nicotine to allow for easier access to nicotine-containing e-cigarette products within Australia which were unsuccessful.^1,2 The increasing uptake of e-cigarettes in Australia, particularly among younger people, ³ and the death of an Australian toddler following accidental nicotine ingestion in 2018, ⁴ were partially behind the e-cigarette law reforms introduced in 2021.

On 1 October 2021, the Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO110) Order 2021 was introduced ⁵ and was accompanied by the rescheduling of nicotine in e-cigarettes to Schedule 4 (prescription only). ⁶ This permitted the sale of nicotine-containing e-cigarette products to individuals, either from an Australian pharmacy or imported from overseas, with the prescription requirement still in place. ⁵ TGO110 set out product standards for all nicotine-containing e-cigarettes in Australia, including the use of child-resistant packaging, requirements for an ingredient list, accurate nicotine labelling, a nicotine concentration limit of 100 mg/ml, prohibition of certain ingredients and a requirement for warning labels. ⁵ Following the October 2021 regulatory changes, manufacturers appeared to remove any mention of the presence of nicotine from e-cigarette packaging in an attempt to sell these products as nicotine-free e-cigarettes. These could be sold over the counter by any retailer to individuals over the age of 18 years without a prescription in most Australian states and territories. ⁷ As a result, the usage of e-cigarettes in Australia continued to increase ³ as nicotine-containing e-cigarettes were available to purchase around Australia without a prescription from a widespread illicit market. ⁷

In response to the thriving illicit e-cigarette market and the rapid e-cigarette uptake by adolescents in Australia, ³ the Minister for Health and Aged Care announced in May 2023 that the Government intended to change the legislation around e-cigarettes and increase funding for enforcement, education and cessation support programmes. ⁸ Following this announcement, the first stage of the 2024 reforms were implemented on 1 January, prohibiting the importation of disposable e-cigarettes into Australia.^9,10 This ban primarily intended to prevent access to disposable e-cigarettes by adolescents. ⁸ All retailers who had already imported legal disposable e-cigarettes (nicotine-free or those meeting legislative requirements intended for sale in a pharmacy) were permitted to continue their sale to exhaust stock before further restrictions were introduced.^9,10 In addition, Special Access Scheme C was also introduced to remove the requirement for prescribers to apply for Therapeutic Goods Administration (TGA) approval. ¹¹

On 1 March 2024, the disposable importation ban was further expanded to include all non-therapeutic e-cigarette products and the Personal Importation Scheme was terminated.^9,10 Consequently, no e-cigarette products could be imported into Australia regardless of their nicotine content or the possession of a prescription. Non-therapeutic, nicotine-free e-cigarettes imported before this date were still allowed to be sold with retailers further advised to exhaust the remaining stock.^9,10 Any importation of therapeutic e-cigarettes after 1 March 2024 was limited to mint, menthol and tobacco flavours and required a customs licence, permit and prior notification to the TGA that these products met the updated TGO110 product standard (Therapeutic Goods (Standard for Therapeutic Vaping Goods) (TGO110) Order 2021).^9,10,12 On 27 June 2024, e-cigarette reforms, introduced in March, passed both the Australian House of Representatives and Senate with changes implemented from 1 July 2024. The most significant of these changes was the prohibition of both nicotine and non-nicotine e-cigarette manufacture, commercial possession, and supply within Australia with limited exemptions. ¹³ This change aimed to prevent all businesses selling e-cigarette products within Australia, limiting their sale only to pharmacies, with increased powers for enforcement and toughened penalties for non-compliance. ¹³ Further reforms also included increased restrictions on all e-cigarette advertising; with all e-cigarette products required to meet TGO110 guidelines; and the restriction of non-therapeutic e-cigarette flavours to mint, menthol and tobacco, in line with therapeutic nicotine-containing e-cigarettes.^12,13

On 1 October 2024, nicotine in e-cigarette products underwent an additional rescheduling to a Schedule 3 (pharmacist-only medication). ¹³ These changes removed the requirement for users to hold a prescription for accessing e-cigarette products for nicotine concentrations below 20 mg/ml (only available for those aged 18 years and older) with any products containing nicotine in concentrations above this limit still requiring a prescription. ¹³ In parallel, an amendment of TGO110 updated requirements for therapeutic e-cigarette products in Australia and included the following: restrictions on the names of e-cigarette products (banning names that would be attractive to children or imply the products are safe or healthy); a lowered maximum nicotine concentration of 50 mg/ml; a permitted ingredients list with flavours restricted to mint, menthol or tobacco; and an expansion of the prohibited ingredient list to include a more exhaustive list of compounds, metals and tobacco-specific nitrosamines. ¹⁴ A grace period means products manufactured in Australia or imported can comply with the previous version of the TGO110 (2021) until the 1 March 2025, while products supplied in Australia are not required to comply with the updated requirements until the 1 July 2025. ¹⁴

Despite having one of the toughest e-cigarette regulations, globally, Australia’s e-cigarette usage rates, especially among our young population, are high and comparable to other countries.^3,7 Only time will tell if these reforms and those to be implemented in the future will have a substantial effect on lowering e-cigarette usage and uptake in Australia.