The Australian Government has introduced a comprehensive range of regulatory reforms to address vaping, changing the way vapes can be imported, manufactured, supplied, and advertised. The new laws aim to tighten control over vaping products and ensure public safety.

Key Legislative Changes

Vaping Legislation Passed

The Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 came into effect on July 1, 2024. This legislation includes significant changes:

• Retail Restrictions: Non-pharmacy retailers, such as tobacconists, vape shops, and convenience stores, are prohibited from selling any type of vape.
• Pharmacy Sales: Therapeutic vapes that meet TGA requirements will still be available from pharmacies where clinically appropriate.
• Strict Compliance: Entities involved in transporting, storing, or handling vapes must comply with stringent requirements.
• Advertising Ban: The advertisement or promotion of vapes is strictly prohibited unless specifically authorised.
• Import Regulations: Importers and sponsors must hold an import licence and permit from the Office of Drug Control and meet relevant product standards.

Transitional Period

Until September 30, 2024, patients must consult with a medical or nurse practitioner to:

• Obtain a prescription to buy vapes containing nicotine.
• Access zero-nicotine vapes.

Cannabis Vapes

Cannabis vapes are regulated separately under strict guidelines provided in the Medicinal cannabis hub.

Regulatory Focus Areas

Information for Individuals and Patients

Patients can lawfully access vapes if deemed clinically appropriate by a health practitioner. There are clear rules regarding the number of vapes one can lawfully hold, including those acquired before July 1, 2024.

Information for Prescribers

Prescribers need to understand the regulatory changes for prescribing therapeutic vapes for smoking cessation or managing nicotine dependence.

Information for Pharmacists

Pharmacists must be aware of the new sourcing and dispensing requirements for vapes under the new regulations.

Information for Sponsors, Importers, and Manufacturers

Sponsors, importers, and manufacturers need to comply with the updated regulations concerning the importation and manufacture of therapeutic vapes.

Information for Wholesale, Transport, Logistics, and Storage Facilities

Businesses involved in the supply and commercial possession of therapeutic vapes must adhere to the new regulatory requirements.

Information for Retailers

Retailers such as tobacconists, vape shops, and convenience stores will be significantly impacted by these regulatory changes and must cease selling vapes.

Compliance and Enforcement

The TGA will actively manage compliance with these new regulations to ensure adherence and public safety.

Nicotine Pouches

Nicotine pouches can only be imported, supplied, and advertised in accordance with the Therapeutic Goods Act 1989 and state/territory law.

List of Notified Vapes

The TGA provides a list of vapes that sponsors have declared compliant with applicable standards for smoking cessation or managing nicotine dependence. However, these vapes have not been assessed by the TGA for quality, safety, efficacy, or performance.

Source: TGA