Clearing the air: what you need to know about Australia's new regulation of vapes

What you need to know

• New regulations which will significantly change the importation, manufacture and supply of vapes have been announced by the Australian Government.
• The new regulations will be implemented in stages throughout 2024.
• Stage one of the reforms commenced on 1 January 2024 and includes stricter import controls on vapes.
• The remaining reforms are set to come into effect on 24 March 2024.
• The reforms come as the Government has recently increased its enforcement action against entities and individuals in breach of vaping regulations.

What you need to do

• The changes are being implemented through therapeutic goods and customs legislation. The reforms will cover all vapes regardless of nicotine content or therapeutic claims.
• Given the increased commitment to the enforcement of vaping regulations and the large penalties faced by those in breach, becoming acquainted with the new reforms is vital to ensure compliance.

Changes commencing January 2024

From 1 January 2024, the importation of disposable vapes is prohibited. Disposable vapes are pre-filled vaping devices that are fully assembled and are not designed or intended to be disassembled or refilled. The prohibition is subject to a limited exemption for disposable vapes used for medical or scientific research.

There is a transitional period for legitimate retailers of disposable vapes to deal with existing stock. During the transitional period, disposable vapes imported before 1 January 2024 may be supplied on the following basis:

• Nicotine containing disposable vapes: supplied through Australian pharmacies to patients with prescriptions, in accordance with laws for prescription medicines.
• Non-nicotine or other medicine containing disposable vapes that do not make therapeutic claims: supplied through Australian retailers in accordance with relevant laws.

Changes commencing March 2024

From 1 March 2024, the importation of all vapes will be prohibited, unless the importer is the holder of an import licence and permit granted under the customs regulations. The following conditions will apply for licence holders and importers:

• Licence applications must be made in the approved form and will only be granted to businesses if the licensing authority is satisfied that the applicant is to import:

for disposable vapes: only for the purposes of supply or use for medical or scientific research; and

for all other vapes: for the purposes of manufacture and supply as part of the applicant's business or only for the purposes of supply or use for medical or scientific research.

• Importers will be required to provide pre-market notifications to the TGA declaring compliance with relevant product standards.
• Certain quality and labelling requirements for therapeutic vapes, including a limit of the taste and smell of such vapes to mint, methanol or tobacco.

Additionally, the personal importation of vaping devices will no longer be permitted. This includes importation by patients with valid prescriptions.

Increased enforcement action to combat unlawful conduct

In recent months, the TGA has taken significant action to combat the unlawful importation, advertising and supply of vapes.

In October 2023, the Federal Court of Australia ordered Vapor Kings Pty Ltd and its director to pay civil penalties for the unlawful advertising of nicotine vapes, in breach of the Therapeutic Goods Act 1989. Vapor Kings was ordered to pay a $4.9 million civil penalty, and its director was ordered to pay a $100,000 civil penalty. This is the first instance of the TGA obtaining a civil penalty order for the unlawful advertising of vapes. The Court also ordered an injunction to restrain ongoing non-compliance.

Other recent enforcement action by the TGA includes:

• The seizure of over 130,000 vaping products from premises across New South Wales and Queensland in August and September 2023, with a combined street value of over $3.9 million.
• The issuing of infringement notices totalling $105,600 to Nature's Puff Pty Ltd and a director in July 2023 for the unlawful advertising of eight flavours of two disposable nicotine vaping products on their website.
• The issuing of infringement notices totalling $588,840 to four Sydney based entities in June 2023 for allegedly importing a total of 379,600 nicotine containing vapes. The unapproved vapes were intercepted by the Australian Border Force.
• The issuing of infringement notices totally $15,984 to a Queensland individual in May 2023 for allegedly importing six different types of nicotine containing vapes, which were intercepted by the Australian Border Force.

Next steps

The combination of tougher regulations and increased enforcement action means that companies involved in the manufacture, import or supply of vaping products should ensure they are compliant with the new regime.

Authors: Nina Fitzgerald, Partner; Stevie Gough, Senior Associate; and Annaleise Forbes, Seasonal Clerk.