In this article
Why there are different product standardsWhat strengthened in 2025?Notification is different from regulator evaluationWhy standards are not advertising permissionFrequently asked questionsDoes TGO 110 cover every vaping device?Does compliance with a product standard mean a product is TGA-approved?Further readingOfficial sourcesRelated articles
Australia's product standards for therapeutic vapes focus on minimum quality and safety requirements. Their application depends on the kind of goods involved: a vaping substance, a device, a kit or an accessory may be subject to different requirements.
Why there are different product standards
The TGA distinguishes therapeutic vaping substances and substance accessories from therapeutic vaping devices and device accessories. TGO 110 applies to defined substance-related goods, kits and packs for smoking cessation or nicotine-dependence indications. Device-related goods are dealt with through the relevant therapeutic vaping medical-device standard and associated requirements. The TGA's medicinal cannabis guidance describes a separate medical-device framework for devices intended to administer medicinal cannabis.
What strengthened in 2025?
The TGA announced enhanced standards with staged commencement, including requirements applying to imports and manufacturing from March 2025 and lawful supply from July 2025. The reforms addressed permitted ingredients, packaging, labelling and traceability for relevant substances, while device requirements addressed labelling, technical safety, electrical and battery considerations, design and construction. The detailed standard must be consulted for the exact product and date.
Notification is different from regulator evaluation
Therapeutic nicotine vapes may appear on the notified vape list after a sponsor notifies the TGA that relevant requirements are met. The TGA is explicit that notified goods are not included in the ARTG and have not been assessed by the regulator for quality, safety, efficacy or performance. The list is therefore not a public endorsement of product effectiveness.
Why standards are not advertising permission
Meeting product standards is one dimension of lawful supply. Import controls, sponsor requirements, pharmacy pathways and advertising laws are separate. A label describing standards compliance does not itself authorise public promotions, treatment claims or internet marketing of a vaping device. For a medicinal cannabis device, an ARTG entry and the intended purpose must be checked separately.
Frequently asked questions
Does TGO 110 cover every vaping device?
No. TGO 110 and the medical-device vaping standard apply to different specified classes of therapeutic vaping goods.
Does compliance with a product standard mean a product is TGA-approved?
No. Compliance notification is not the same as formal inclusion in the ARTG after evaluation.
Further reading
- Australian vaporiser laws and regulations
- What Are Therapeutic Vaping Goods in Australia?
- Pharmacy Supply of Therapeutic Vaping Goods: An Overview
- How to Identify and Avoid Unsupported Device Claims
Official sources
- TGA — Understanding product standards for unapproved therapeutic vapes
- TGA — Therapeutic Vaping Devices Medical Device Standard
- TGA — Enhanced product standards for therapeutic vapes in 2025
- TGA — Notified vape list
- TGA — Medicinal cannabis vaping devices: importer and manufacturer guidance
Information current to 9 October 2026. Australian law and regulatory guidance may change. This page provides general information rather than legal or clinical advice.