Vaping Regulations in Australia: What Pharmacists Need to Know for 2025

As vaping regulations tighten in Australia, it's essential for pharmacists to stay up-to-date on changes affecting therapeutic nicotine vaping products (NVPs). The government is refining the framework to improve safety, efficacy, and accessibility for those using NVPs to quit smoking. Here's what happened in 2024 and what pharmacists need to prepare for in 2025.

Key Changes Introduced in 2024

Several key developments took place in 2024 to enhance the safety and accessibility of NVPs:

1 July 2024:

• Standardised labeling and packaging: Minimum standards were introduced to ensure consistency across therapeutic NVPs.
• SAS-C notification: Pharmacists must now notify the Therapeutic Goods Administration (TGA) via the Special Access Scheme (SAS-C) when supplying NVPs.

1 October 2024:

• Reclassification of NVPs: Certain therapeutic NVPs moved from Schedule 4 (prescription only) to Schedule 3 (pharmacist-only), making access easier for adults 18+.
• Nicotine and flavour limits: Nicotine levels for Schedule 3 products were capped at 20mg/mL, and stricter flavour and concentration limits were introduced.
• Plain packaging requirements: NVPs must now have plain packaging and include patient information leaflets to reduce appeal to non-smokers.

What’s Changing in 2025?

New regulations coming into effect on 1 March 2025 will further tighten standards for vaping products. Here’s what you need to know:

1. Stricter Nicotine and Menthol Limits:

   • The maximum nicotine concentration will increase to 50mg/mL.
   • Menthol concentrations will be capped at 20mg/mL.
   • Ingredient and container volume restrictions will ensure consistent, safe formulations.

2. Transition Period:

   • Between March and July 2025, products meeting either 2024 or 2025 standards can still be sold. After 1 July 2025, only products compliant with the 2025 standards will be allowed.

3. Plain Packaging & Product Transparency:

   • All NVPs and accessories must feature plain packaging and include a patient information leaflet with clear safety and usage instructions.
   • Guidelines on product names will prevent misleading branding.

4. Supply and Storage Restrictions:

   • Therapeutic NVPs must be stored behind the counter at pharmacies. Vapers will need:
     • Valid ID and informed consent at the point of purchase.
     • To report any adverse effects to ensure product safety.

5. Stricter Device Regulations:

   • Devices and accessories must comply with enhanced technical and safety standards, including quality management systems and detailed risk assessments.

6. Documentation Requirements:

   • Pharmacists must:
     • Notify the TGA for every sale of Schedule 3 NVPs through the SAS-C.
     • Keep detailed records to comply with state and federal legislation.

What These Changes Mean for Pharmacists

The 2025 updates are designed to make therapeutic NVPs safer and more effective for smoking cessation. Although these regulations may present additional hurdles, they ensure that vapers have access to high-quality, reliable products.

Pharmacists play a crucial role in guiding patients toward compliant, safe options. To make the most of these changes, it’s important to:

• Choose compliant products: Starting July 2025, only products meeting the new standards will be available.
• Work closely with your patients: Guide them to safe, effective vaping options.
• Stay informed: Understanding these changes will help you adapt to the new rules and continue providing quality care.

By staying updated on these regulatory changes, pharmacists can continue to support their patients effectively and navigate the evolving vaping landscape.

References: https://www.tga.gov.au/products/unapproved-therapeutic-goods/vaping-hub/changes-regulation-vapes