The Therapeutic Goods Administration (TGA), Australia's therapeutic goods regulator, has released a summary of feedback received from a public consultation on possible reforms to Australia's nicotine vaping product (NVP) regulation launched in November 2022.

The TGA received more than 4,000 responses requesting comments on the following questions:

Enhanced border controls for NVPs;

Requiring premarket TGA assessment of NVPs against minimum quality and safety standards;

Requires minimum quality and safety standards for NVP;

Clarify the status of NVP as a therapeutic;

Current regulation of NVPs.

Currently, NVP is regulated as a medicine under the Therapeutic Goods Act 1989. This means that NVPs cannot be imported, manufactured or supplied (except for retail supply) unless they are listed on the Australian Register of Therapeutic Goods (ARTG).

Current smokers can get NVP to help quit smoking after consultation with their doctor and a prescription. Prescription holders can directly import up to 3 months of NVP for personal use.

NVP can only be legally supplied by pharmacies in Australia. It is illegal for other Australian retailers, such as tobacconists, vape shops and convenience stores, to sell NVP to consumers, even with a valid doctor's prescription. Nonetheless, vaping products, including NVP, are readily (and illegally) available from a plethora of convenience and other outlets across Australia and are being purchased by minors.

Feedback on Proposed Reforms

Strengthened border controls for NVP:

The TGA's preferred reform proposal on this issue is to end the individual import scheme and require importers to obtain an import licence. This is supported by all Australian state/territory governments and the vast majority of public health associations, health professional bodies and individuals. If the proposal is passed, any attempt to import NVP without a proper import permit would be illegal and any NVP found by the Australian Border Force would be confiscated. Penalties will also apply to importers.

Many groups also point to the need for border controls on vaping products without nicotine (this is broader than the advisory).

2. Requires premarket TGA assessment of NVPs against minimum quality and safety standards:

The TGA's preferred option is to require pre-market TGA assessment of NVPs against product standards that specify specific quality and safety requirements. This is supported by a wide range of State/Territory governments and health professional bodies and individuals.

3. Requires minimum quality and safety standards for NVP:

The preferred option for the TGA is to include drug-like packaging, warning statements, ban or limit flavors and certain other ingredients, and limit NVP volume and total nicotine content.

This has strong support from state/territory governments, health professional bodies and individuals. There is also strong support for banning one-time NVPs.

4. Clarify the status of NVP as a therapeutic:

This is generally supported (except for e-cigarette retailers/manufacturers/importers, pro-vaping associations and individual vapers).

Next step

The TGA has considered the feedback and is now advising the government on possible reform options. The government will then consider the TGA consultation and recommendations and implement any legislative changes.

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