Updated Therapeutic Vape Standards in Effect from 1 July 2025

From 1 July 2025, the Therapeutic Goods Administration (TGA) has introduced enhanced safety and quality standards for all therapeutic nicotine vaping products supplied in Australia. These new requirements form part of the government’s broader regulatory reforms and apply specifically to products available via prescription for smoking cessation and nicotine dependence.

Summary of Key Changes

All therapeutic vape products supplied through pharmacies must now meet the updated TGA standards. Products that do not comply have been removed from the TGA notified vape list, and can no longer be legally supplied, prescribed, or dispensed.

Several brands have been withdrawn from the market entirely, and stock availability may be limited as new, compliant alternatives are introduced.

Breakdown of the New Requirements

Permitted Ingredients

Only the following ingredients are authorised for use in therapeutic nicotine vapes:

• Nicotine (up to 50mg/mL)

• Propylene glycol

• Glycerol

• Water

• Flavours: Mint, menthol, or tobacco only

No other flavourings or excipients are permitted under the updated framework.

Packaging and Labelling Requirements

New rules now apply to both devices and their components:

• Plain packaging with minimal branding or design

• Mandatory inclusion of patient information leaflets

• Updated usage instructions and safety warnings on all products

Device and Manufacturing Standards

Therapeutic vape devices must now meet elevated compliance standards, including:

• Battery and electrical safety safeguards

• Toxicological risk assessments

• Risk management and traceability protocols

• Compliance with medical device manufacturing principles

Implications for Healthcare Practice

These regulatory updates carry important operational implications for healthcare professionals:

• Pharmacies must ensure that all stocked products meet the TGA’s new requirements

• Non-compliant items must be removed from sale and either returned to suppliers or safely disposed of

• Prescribers need to update all scripts to ensure they reference compliant products listed on the TGA notified list

• Any prescription issued prior to 1 July 2025 for a now non-compliant product is no longer valid or fillable

Patient Support Considerations

Healthcare teams may receive increased queries from patients who notice changes in product availability or experience disruptions to their regular access. Clear communication is essential, including:

• Educating patients on the reason behind the product changes

• Offering guidance on compliant alternatives

• Referring individuals to quit support services where appropriate

It’s important to reiterate that no vaping product is currently registered on the Australian Register of Therapeutic Goods (ARTG). All therapeutic vapes remain unapproved medicines, supplied only under exemption pathways with strict oversight.

Continuing to Support Smoking Cessation

While therapeutic vapes are one option for nicotine dependence management, the TGA continues to recommend evidence-based first-line treatments, including:

• Behavioural counselling

• Nicotine Replacement Therapy (NRT) such as patches, gum, and lozenges — several of which are subsidised under the PBS

Clinicians should continue to assess the best individual approach for each patient.

Additional Resources

To stay informed and support clinical teams and patients through this transition:

• Visit the TGA Vaping Hub for regulatory updates

• Access webinars and CPD content from the Pharmaceutical Society of Australia (PSA)

• Refer patients to trusted quit support services for additional help