New regulations to place stronger controls on importation, manufacture and supply of vapes
Stronger controls are expected to be imposed progressively on the importation, manufacture, supply, advertising and commercial possession of vapes in 2024. The first stage of the vaping reforms is anticipated to commence on 1 January 2024, subject to amendments being made to therapeutic goods and customs regulations by the Governor-General in Federal Executive Council.
During an announcement today, Minister Butler outlined stronger legislation, enforcement, education and support initiatives to address the significant public health issues caused by vaping in Australia.
The changes would address the risks associated with the use of vapes, particularly among children and young people, while preserving legitimate patient access to therapeutic vapes, under medical supervision, for smoking cessation and the management of nicotine dependence. Under the reforms, therapeutic vapes would remain available to patients with a prescription, dispensed through pharmacies. These vapes would be subject to enhanced regulatory requirements to ensure compliance with relevant quality standards.
The importation of disposable single use vapes would be banned from 1 January 2024, subject to very limited exceptions. The importation of all other vapes, irrespective of nicotine content or therapeutic claims, would be banned from 1 March 2024 unless certain conditions are complied with. From that time, importers will need to hold licences and permits from the Office of Drug Control (ODC) to lawfully import vapes. At the same time, the personal importation scheme for therapeutic vapes will cease to operate.
Importers and domestic manufacturers of therapeutic vapes would be required from 1 March 2024 to provide pre-market notifications to the Therapeutic Goods Administration (TGA) declaring compliance with the relevant product standards, prior to the importation or supply of those goods. It will not be possible to obtain a customs permit without first notifying compliance to the TGA.
In anticipation of the new restrictions, both the TGA and the ODC are preparing forms and instructions to notify compliant products and obtain customs licences and permits. This would allow notifications and applications to be made and processed ahead of the expected commencement on 1 March 2024. In addition, some changes to product standards for therapeutic vapes are anticipated to be made to facilitate the introduction of these new processes.
The second stage of the reforms would involve imposing a domestic ban on the manufacture, supply, advertising and commercial possession of disposable single use, and non-therapeutic, vapes, in order to ensure comprehensive controls across all levels of the supply chain. These changes will require amendments to the Therapeutic Goods Act 1989, which are expected to be introduced in Autumn 2024 for Parliament’s consideration.
The third stage of the reforms would involve strengthening the standards for therapeutic vapes, including by limiting flavours, reducing permissible nicotine concentrations and requiring plain pharmaceutical packaging. These changes are expected to be made by 1 March 2024, but transition periods would be specified to allow businesses to comply with the new requirements.
Changes are also proposed to be made to the special access scheme pathways, to enable medical practitioners and nurse practitioners to prescribe therapeutic vapes for smoking cessation or the management of nicotine dependence, where clinically appropriate. These changes are expected to commence on 1 January 2024 to facilitate and support legitimate patient access to therapeutic vapes without pre-approval or authority from the TGA.
Guidelines from the Royal Australian College of General Practitioners are currently being updated to include new guidance on prescribing therapeutic vapes and supporting vaping cessation (see Supporting smoking cessation: A guide for health professionals).
Importers, manufacturers, wholesalers and retailers of disposable single use, non-therapeutic vapes, and therapeutic vapes that will not be able to comply with the pre-market notification process, are advised to reduce orders and run down stocks ahead of the regulatory changes.
The reforms complement a wider set of actions being taken by the Government in line with the National Tobacco Strategy 2023-2030 to reduce rates of tobacco and vape use (see Taking action on smoking and vaping). Further information is available on the Reforms to the regulation of vapes page of the TGA's website.
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