Major Changes in Importation, Manufacturing, and Supply Set to Impact Vapers.
Wyndham residents who vape are bracing for a seismic shift as the Australian government unveils comprehensive reforms targeting the importation, manufacture, supply, advertising, and possession of vapes. The first wave of changes is slated to roll out on January 1, 2024, pending regulatory adjustments.
In a press conference today, Minister Butler announced a multifaceted approach focusing on legislation, enforcement, education, and support to combat the escalating public health concerns linked to vaping in the country.
The reforms aim to mitigate the risks associated with vaping, especially among youth, while ensuring continued access to therapeutic vapes for smoking cessation and nicotine dependence under medical supervision. Therapeutic vapes will remain available with a prescription, dispensed through pharmacies, subject to heightened regulatory standards.
Starting January 1, 2024, the importation of disposable single-use vapes will be banned, with limited exceptions. Further, from March 1, 2024, the importation of all other vapes, regardless of nicotine content or therapeutic claims, will be prohibited unless specific conditions are met. Importers must obtain licenses and permits from the Office of Drug Control (ODC) to lawfully import vapes.
Importers and manufacturers of therapeutic vapes will need to submit pre-market notifications to the Therapeutic Goods Administration (TGA) from March 1, 2024, ensuring compliance with product standards before importation. The personal importation scheme for therapeutic vapes will cease.
The TGA and ODC are actively preparing forms and instructions for compliant product notifications and customs licenses, anticipating the changes.
The second phase of reforms, anticipated in Autumn 2024, will enforce a domestic ban on disposable single-use and non-therapeutic vapes, requiring amendments to the Therapeutic Goods Act 1989.
The third phase, effective March 1, 2024, will bolster standards for therapeutic vapes, restricting flavors, reducing nicotine concentrations, and mandating plain pharmaceutical packaging.
Proposed changes to special access scheme pathways, commencing January 1, 2024, will enable medical practitioners to prescribe therapeutic vapes without TGA pre-approval.
Guidelines from the Royal Australian College of General Practitioners are being updated to provide health professionals with new insights into prescribing therapeutic vapes and supporting vaping cessation.
Importers, manufacturers, wholesalers, and retailers are advised to reduce orders and deplete stocks of disposable single-use, non-therapeutic vapes, and therapeutic vapes unable to comply with the premarket notification process ahead of the impending regulatory changes.