The evolution of 'light touch' medicines regulation for nicotine vaping products in Australia

Nicotine vaping products (NVPs) have never been legal to sell as consumer products in Australia. However, a substantial illicit market in NVPs developed with retailers selling these products under the pretence of retailing nicotine-free vaping products (NFVPs), which were legal to sell in most states and territories until July 2024. Australia implemented a 'light touch' medicines regulation approach for NVPs in October 2021, in response to public concerns about a growing number of young people vaping while retaining access to NVPs for smoking cessation purposes. Substantial changes to the model were made throughout 2024, including the ending of general retail sales of NFVPs, strengthening the quality requirements for NVPs and dropping the prescription requirement for low-dose (≤20 mg/mL) NVPs. There have been several challenges to encouraging uptake of the model among both consumers and health practitioners, including low acceptability, concerns about legal liability and competition with a substantial illicit NVP market. Assuming the reforms implemented federally and by the states and territories are able to effectively curtail the illicit supply, it is unclear whether current consumers who are accessing NVPs illicitly will migrate to the legal pathway or stop NVP use. Success of the medical regulatory model will depend on support from NVP manufacturers, health practitioners, the public and policy makers. Other countries who may be considering implementing a 'light touch' medicines regulation model can learn from Australia's experience.