Australia | Potential reforms to the regulation of nicotine vaping products - consultation paper
Title of document
Potential reforms to the regulation of nicotine vaping products - consultation paper
The Therapeutic Goods Administration (TGA) is seeking comments on possible reforms to the regulation of ENDs. This includes vape liquids, e-liquids and e-juices that contain nicotine and/or nicotine salts. This does not include other nicotine replacement therapies (NRTs) containing nicotine, such as patches, gum, lozenges, mouth spray and inhalators nor nicotine-containing products that are not intended for use in ENDs, such as chewing tobacco and snuff.One of the possible reform options would also affect the importation of vaping devices that do not contain nicotine. Since 1 October 2021, ENDs have been regulated as prescription medicines in Australia. The aim of the 2021 reforms was to prevent children and adolescents from accessing ENDs, whilst allowing smokers to access these products for smoking cessation with a doctor’s prescription. However, evidence is emerging that the reforms are not meeting these aims. The TGA is considering whether refinements to the existing regulatory requirements for ENDs could be introduced to better support the intent of the 2021 reforms, namely preventing children and adolescents from accessing ENDs while supporting access to products of known composition and quality for smoking cessation with a doctor’s prescription.The TGA is seeking comment on potential reforms in 4 main areas:Changes to border controls for ENDs – to curb the unlawful supply of ENDs in Australia (one option includes to change the border controls for ENNDs to assist with the enforcement of the controls on ENDs (rather than with the aim of limiting access to ENNDs))Pre-market TGA assessment of ENDs against a product standard – to create a regulated source of quality ENDs to encourage doctors to prescribe, pharmacies to supply and vaping consumers to purchase ‘safer’ products lawfullyStrengthening the product standard regarding minimum quality and safety standards for ENDs – to make them less attractive to children and adolescents, for example by not permitting certain flavours or labellingClarifying the status of ENDs as ‘therapeutic goods’ – to ensure that any vaping product containing nicotine is captured by the regulatory framework.
Notifying member: Australia
Protection of human health or safety (TBT); Consumer information, labelling (TBT); Quality requirements (TBT); Prevention of deceptive practices and consumer protection (TBT)