Understanding smoking cessation product legislation changes
The Australian government continues to refine the regulatory framework for therapeutic nicotine vaping products (NVPs) to ensure product safety and address public health concerns. Following the updates in October 2024, additional changes will come into effect from 1 March 2025, with strengthened standards designed to enhance the safety and efficacy of smoking cessation products.
As healthcare providers, pharmacists must stay informed about these legislative updates to effectively support their patients and ensure compliance. Here’s what you need to know about the upcoming changes.
Key legislation changes Starting 1 March 2025
Updated compliance standards
From 1 March 2025, therapeutic NVPs must meet new Therapeutic Goods Order (TGO) standards. These standards include:
- Nicotine limits: a maximum concentration of 50mg/mL
- Menthol limits: a maximum concentration of 20mg/mL
- Container volume and ingredient restrictions: ensuring safe and standardised formulations
Pharmacists must ensure that only compliant products are imported, manufactured or stocked to maintain lawful supply.
Transition period: March – July 2025
To facilitate a smooth transition, pharmacists may supply products compliant with either the 2024 or 2025 standards during this period. After 1 July 2025, only products meeting the updated 2025 may be supplied.
This flexibility allows manufacturers and suppliers time to adapt while helping pharmacists manage inventory transitions effectively.
Plain packaging and mandatory documentation
The new regulations introduce plain packaging requirements for all NVPs and accessories. Each product must include:
- A patient information leaflet outlining proper usage and safety instructions.
- Product names that comply with strict guidelines to prevent misleading branding.
Pharmacists must verify these requirements before supplying any products.
Supply and storage restrictions
Therapeutic NVPs must now be stored behind the counter, reinforcing the importance of pharmacist oversight. Pharmacists must ensure:
- Supply aligns with clinical appropriateness for smoking cessation or dependence management.
- Patients provide informed consent and valid identification at the point of purchase.
- Adverse events are reported through appropriate channels.
These measures strengthen the role of pharmacists in promoting safe and effective product use.
Stricter device regulations
Devices and accessories used for smoking cessation must comply with updated technical and safety standards, including:
- Adherence to quality management systems.
- Completion of risk assessments and design reviews.
Pharmacies must confirm that all devices and accessories meet these stringent requirements before sale.
Notification and record-keeping requirements
For Schedule 3 NVPs, pharmacists must continue to:
- Submit a notification through the TGA’s Special Access Scheme (SAS-C) for each supply instance.
- Maintain comprehensive records to ensure compliance with federal, state and territory legislation.
These measures align with broader efforts to enhance transparency and accountability in the supply of NVPs.
Supporting patients through legislative changes
The strengthened standards aim to ensure safer, more effective therapeutic options for smoking cessation while minimising the potential for misuse. Pharmacists are essential in guiding patients through these changes by:
- Providing personalised advice on product suitability and usage.
- Maintaining compliance with evolving regulations.
This information was sourced directly from the TGA. For more information, click here.
Past legislation changes
1 October 2024
Several critical changes were introduced in October 2024, laying the foundation for the 2025 updates:
- Reclassification of certain products: some therapeutic NVPs were reclassified from Schedule 4 (prescription only) to Schedule 3 (pharmacist only), allowing easier access through pharmacies for patients aged 18 and older.
- Stricter flavour and concentration limits: regulations capped concentrations at 20mg/mL for Schedule 3 products and introduced limits on other additives to improve product safety.
- Mandatory plain packaging: all therapeutic NVPs were required to feature plain packaging and include patient information leaflets to reduce appeal and provide clear guidance on use.
1 July 2024
Earlier in 2024, new regulations emphasised enhanced control and oversight, including:
- The introduction of minimum standards for labeling and packaging, ensuring consistency across all therapeutic products.
- The establishment of stricter supply guidelines, requiring pharmacists to notify the TGA via the Special Access Scheme (SAS-C) when supplying NVPs.
These earlier changes marked significant steps toward aligning therapeutic NVPs with broader public health goals.
Impact on prescribers
Prescribers may continue to see an increase in patients seeking prescriptions for smoking cessation products that don’t meet the 20 mg/mL limit and a decrease in patients that were previously being prescribed lower dose smoking cessation products. Prescribers must stay up to date with the new standards to provide appropriate guidance and support to their patients.
For more information about smoking cessation legislation changes, click here.
Find more information and FAQs about smoking cessation here.
Source
Therapeutic Goods Administration (TGA). “Enhanced product standards for therapeutic vapes in 2025.” https://www.tga.gov.au/news/media-releases/enhanced-product-standards-therapeutic-vapes-2025. (retrieved on 6 December 2024)