New Vaping Regulations: Essential Information for Australian Pharmacists

Effective 1 July 2024, the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 has introduced significant changes to the regulation of vaping products in Australia. This new legislation establishes a consistent national framework for the importation, manufacture, supply, possession, and advertisement of all vapes. Here’s what Australian pharmacists need to know to navigate these changes and ensure compliance.

Key Changes Starting 1 July 2024

Pharmacy-Exclusive Sales

• Non-Pharmacy Retail Ban: Non-pharmacy retailers, such as tobacconists, vape shops, and convenience stores, will be prohibited from selling any type of vape. Pharmacists will be the sole authorized retailers of therapeutic vapes.
• Prescription Requirements: Patients will need a prescription from a medical or nurse practitioner to purchase vapes containing nicotine or zero-nicotine substances. This underscores the importance of pharmacists' role in managing and dispensing these products.
• Limited Flavour Options: Therapeutic vapes available in pharmacies will be restricted to mint, menthol, and tobacco flavours, focusing on clinical appropriateness over consumer preference.

Supply Chain Controls

• Prohibition on Single-Use Vapes: The domestic manufacture, supply, and commercial possession of non-therapeutic and disposable single-use vapes will be outlawed.
• Pharmaceutical Supply Channels: Only established pharmaceutical supply chains can distribute and supply vapes. Pharmacists must ensure their suppliers comply with all TGA regulations.
• Strict Import and Manufacture Rules: Vapes must adhere to TGA regulatory requirements, including product labels, packaging, ingredients, and flavours. Importers must hold a customs license and permit.
• Finished Products Only: Pharmacists can only dispense finished vaping products and cannot provide ingredients for patients to mix their own vaping substances.

Compliance and Enforcement

• Enhanced Border Controls: The Australian Border Force (ABF) and TGA will enforce stringent regulations at the border, seizing and destroying any unauthorized vaping products.
• National Vaping Enforcement Framework: A unified approach to enforcement will be adopted across all states and territories, facilitating consistent compliance measures.
• Detection and Disruption of Illicit Vapes: Enhanced regulatory measures will make it easier to identify and disrupt illegal vape trading, thereby reducing the prevalence of illicit products in the market.

Advertising Ban

• Comprehensive Advertising Ban: All forms of advertising, promotion, and sponsorship of vapes are banned across all media platforms, including social media. Pharmacists must be aware of these restrictions to ensure compliance in their own promotional activities.
• Digital Platform Compliance: Major social media and digital platforms have been informed of the new advertising restrictions to ensure adherence.

Penalties for Non-Compliance

• Severe Penalties: Violations of the new regulations can result in significant penalties, including up to 7 years in jail per offence and/or fines up to $21.91 million per contravention.
• Commercial Focus: The reforms primarily target commercial entities involved in the unlawful supply chain. However, pharmacists must remain vigilant to avoid inadvertent non-compliance.
• Encouraging Reports: The TGA encourages reporting any breaches or questionable practices related to the importation, manufacture, supply, and advertising of vapes.

Patient Access to Therapeutic Vapes

• Prescription Requirement Until September: Until 30 September 2024, patients will still need a prescription to purchase therapeutic vaping substances from pharmacies.
• Simplified Access Starting October: From 1 October 2024, therapeutic vapes with nicotine concentrations of 20 mg/mL or less will be available without a prescription to adults if a pharmacist deems it clinically appropriate.
• Continued Restrictions for Minors: Patients under 18 and those requiring higher nicotine concentrations will still need a prescription.

Preparing for the Changes

As these new regulations come into effect, pharmacists will play a crucial role in ensuring compliance and supporting patient access to therapeutic vapes. Staying informed about these changes and implementing the necessary adjustments in pharmacy practice is essential. By adhering to these new regulations, pharmacists can help promote a healthier community while ensuring that patients who need therapeutic vapes for smoking cessation and nicotine dependence management can access them safely and legally. Stay informed, ensure compliance, and continue to support your patients effectively.