New standards for nicotine vaping products from July 2025

The Therapeutic Goods Administration (TGA) continues to implement stronger safety and quality standards for therapeutic vapes in Australia.

Starting 1 July 2025, strengthened standards will come into effect for all therapeutic vaping goods for smoking cessation and nicotine dependence.

Pharmacies can only supply vapes that meet the TGA’s strengthened product standards.

These measures are designed to mitigate certain risks associated with therapeutic vape use by enforcing stronger safety and quality standards, including stricter requirements for ingredients, packaging, and labelling.

The TGA published enhanced product standards for therapeutic vaping goods in October 2024, giving manufacturers time to update their products for compliance. The enhanced product standards were developed as part of the vaping reforms, which also strengthened regulation of all vaping goods since 1 July 2024.

As a result of this, products that do not meet the new standards will be removed from the notified vape list, and may be replaced by new products that have been stated to comply with the new standards. The TGA has worked with the sector as part of implementation of the strengthened standards. This included delivering webinars on the enhanced product standards to industry and related stakeholders in April 2024 and October 2024.

Currently, the TGA has not received an application from a sponsor of a vape product for inclusion in the Australian Register of Therapeutic Goods (ARTG). This means that the TGA has not evaluated any therapeutic vaping good for safety, quality, effectiveness, or performance.

It is important to remember that vapes are not recommended as the first-line treatment for smoking cessation support. First-line treatments include behavioural support and TGA-approved nicotine replacement therapy products such as patches, gum, and lozenges - some of which are subsidised under the Pharmaceutical Benefits Scheme.

Key changes to product standards in effect from 1 July 2025

• Permitted ingredients are only:
  • Nicotine (max 50mg/mL)
  • Propylene glycol
  • Glycerol
  • Water
  • Mint, menthol or tobacco flavour
• Packaging: plain packaging, information leaflets, and name restrictions
• Labelling: new labelling and usage instructions for devices and accessories
• Design: plain design and packaging for devices and accessories
• Technical standards: devices and accessories must meet stricter standards for:
  • Medical device quality
  • Risk management
  • Battery and electrical safety
  • Specific design and construction
  • Toxicological risk assessment

Information for consumers

Therapeutic vapes for smoking cessation and the management of nicotine dependence will continue to be available from participating pharmacies, subject to state and territory laws, and where clinically appropriate.

Starting in July 2025, the implementation of stricter product standards may lead some sponsors to withdraw certain vaping products from the market. A range of therapeutic vaping products, including substances, devices, kits, and accessories, will still be available where they have been notified by sponsors as complying with the strengthened TGA product standards.

The TGA maintains a notified vape list that includes therapeutic vaping products for smoking cessation or managing nicotine dependence.

If the therapeutic vaping product you are using is no longer available, consult your pharmacist or prescriber for alternative options.

Information for pharmacists

Pharmacies can take the following actions to ensure they are prepared for the changes on 1 July 2025:

• Review vapes product inventory: review your inventory to identify any vape products that do not meet the strengthened products standards.
• Remove non-compliant vaping products: remove these products from your inventory. From 1 July 2025, they can no longer be sold or supplied.
• Return or dispose: return non-compliant products to the supplier or follow proper disposal procedures as per local regulations.
• Educate staff: ensure pharmacy staff are aware of the strengthened product standards, product compliance and availability, and alternative brands.
• Inform patients: Communicate with consumers and prescribers about the changes to vaping product standards, and available products.

Pharmacists should consult the TGA notified vape list to identify therapeutic vaping products that comply with product standards for smoking cessation or managing nicotine dependence.

Information for prescribers

If a prescription has been issued for a specific vaping product or brand that no longer complies with TGA product standards, it cannot be filled after 1 July 2025. A new prescription will be required.

Prescribers should consult the TGA notified vape list to identify therapeutic vaping products that comply with product standards for smoking cessation or managing nicotine dependence.

Speak with your pharmacy about product availability.

Additional resources

The TGA has published a webinar on the new standards for nicotine vapes and vaping devices.

The Pharmaceutical Society of Australia (PSA) has released webinars on navigating vaping reforms for pharmacists.

There is more information about the regulation of vapes and the product standards for therapeutic vapes at the TGA vaping hub

Cannabis vapes are subject to separate strict regulations (see the Medicinal cannabis hub).