As vaping regulations tighten in Australia, staying informed about the latest changes is crucial for vapers who rely on therapeutic nicotine vaping products (NVPs) to quit smoking. The government is refining the framework to ensure safety, efficacy, and accessibility. Here’s a recap of what happened in 2024 and what you can expect in 2025.
Key Changes Introduced in 2024
In 2024, significant steps were taken to improve the safety and accessibility of NVPs:
1 July 2024:
- Minimum standards for labeling and packaging were introduced to standardise therapeutic NVPs.
- Pharmacists were required to notify the Therapeutic Goods Administration (TGA) via the Special Access Scheme (SAS-C) when supplying NVPs.
1 October 2024:
- Certain therapeutic NVPs were reclassified from Schedule 4 (prescription only) to Schedule 3 (pharmacist only), making it easier for adults 18+ to access them.
- Stricter flavour and concentration limits capped nicotine levels at 20mg/mL for Schedule 3 products.
- Plain packaging became mandatory, including patient information leaflets to improve transparency and reduce the appeal of vaping products to non-smokers.
What’s Changing in 2025?
From 1 March 2025, new regulations will take effect, further tightening standards for vaping products. Here’s what vapers need to know:
1. Stricter Nicotine and Menthol Limits:
- Maximum nicotine concentration will increase slightly to 50mg/mL.
- Menthol concentrations will be capped at 20mg/mL.
- Ingredient and container volume restrictions will ensure standardised, safe formulations.
2. Transition Period: Between March and July 2025, products meeting either the 2024 or 2025 standards can still be sold. After 1 July 2025, only products compliant with the 2025 standards will be allowed on the market.
3. Plain Packaging & Product Transparency:
- All NVPs and accessories must feature plain packaging and include a patient information leaflet with clear usage and safety instructions.
- Strict guidelines on product names aim to prevent misleading branding.
4. Supply and Storage Restrictions: Therapeutic NVPs must now be stored behind the counter at pharmacies. To purchase, vapers will need:
- Valid ID and informed consent at the point of purchase.
- To report any adverse effects through appropriate channels to ensure product safety.
5. Stricter Device Regulations: Devices and accessories must comply with enhanced technical and safety standards. Manufacturers and suppliers are required to:
- Adhere to quality management systems.
- Conduct detailed risk assessments and design reviews.
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 Australian Vapers
The 2025 updates are designed to make therapeutic NVPs safer and more effective for smoking cessation. While these regulations may feel like additional hurdles, they’re aimed at ensuring vapers have access to high-quality, reliable products.
To make the most of these changes:
- Choose compliant products: Starting in July 2025, only products meeting the new standards will be available.
- Work with your pharmacist: Pharmacists are now key partners in guiding you toward safe and effective options
- Stay informed: Knowing what to expect will help you plan ahead and adapt to the new rules.
