The Government has proposed a wave of sweeping reforms targeting the use of vapes in Australia. These reforms seek to control the importation, manufacture, supply, advertisement and commercial possession of vapes in an effort to "turn the tide against the rising use of vapes by young Australians". The proposed reforms were announced by the Minister for Health and Aged Care on 28 November 2023 and will be achieved by amending the Therapeutic Goods Act 1989 (Cth) (TG Act), the Therapeutic Goods Regulations 1990 (Cth) and the Customs (Prohibited Imports) Regulations 1956 (Cth). This article outlines the proposed reforms and the implications for businesses involved in the importation, manufacture or supply of vapes.
Timing of proposed vaping reforms
The first stage of the proposed reforms is intended to commence on 1 January 2024. From that date, it is proposed that the importation of disposable single use vapes (subject to very limited exceptions) will be banned. In parallel, a new Special Access Scheme pathway will be established to allow the prescription of vapes for therapeutic use.
It is proposed that the second stage of these reforms will involve a wholesale ban on the manufacture, supply, advertisement and commercial possession of all non-therapeutic vapes. The bill effecting the second stage of reform is anticipated to be introduced for Parliament's consideration in or about March 2024.
Prescription of therapeutic vapes
As part of the first stage of the reforms, it is proposed that a new 'Special Access Scheme' pathway for therapeutic vapes will be established from 1 January 2024. This will enable health practitioners to prescribe therapeutic vapes, where clinically appropriate in connection with smoking cessation or treating nicotine dependence. In its media release on 28 November 2023, the Therapeutic Goods Administration (TGA) advised that importers and domestic manufacturers of therapeutic vapes will be required to provide pre-market notifications to the TGA demonstrating compliance with the prescribed product standards (such as ISO 9002 and existing Therapeutic Goods (Standard for Nicotine Vaping Products) (TG-010) Order 2021) prior to their importation or supply from 1 March 2024.
The unequivocal advice from the TGA is that importers, manufacturers, wholesalers and retailers of vapes that will not be able to comply with the proposed pre-market notification process, should reduce any future orders and sell-down existing stock ahead of these regulatory changes.
As part of the second stage of reform, the TGA intends to strengthen standards for the supply and promotion of therapeutic vapes. The TGA has advised that this may include limiting flavours, reducing permissible nicotine concentrations as well as implementing requirements to use plain pharmaceutical packaging for therapeutic vapes. The Commonwealth's plain packaging reforms in relation to tobacco products (introduced over a decade ago) was the subject of two High Court challenges and a World Trade Organisation dispute. While we would not expect these issues to be relitigated, it remains to be seen how companies will respond to the reforms.
Enforcement by the TGA regarding vapes
Given the TGA has previously identified the import, advertising and supply of nicotine vaping products as a priority area of compliance activity for the 2023 – 2024 financial year, we expect that the TGA will closely and proactively monitor compliance with any new reforms. During the course of 2023, the TGA has taken enforcement action against multiple businesses for the unlawful supply of nicotine vaping products. For example in Federal Court proceedings in October 2023, the TGA obtained a combined $5 million penalty against Vapor Kings Pty Ltd and one of that company's directors for unlawfully advertising nicotine vaping products in contravention of the TG Act.
Whilst the TGA has advised that a transition period will be allowed for compliance with any new requirements, it would be prudent for businesses involved in the importation, manufacture or supply of vapes to now consider how they will comply with the foreshadowed reforms. Caution will also need to be taken to ensure that therapeutic vapes are not advertised or promoted to consumers, given they will be prescription products.
How we can help
Our Life Science and Health Regulatory teams at MinterEllison can support you in the assessment and management of compliance risks in anticipation of these upcoming reforms.
If you would like to discuss your regulatory obligations in relation to these reforms or within the Healthcare and Life Science industries more broadly, please do not hesitate to contact us.
