March 30. It was reported that on March 23, The Therapeutic Goods Administration (TGA), Australia's therapeutic goods regulator, has released a summary of feedback received from a public consultation launched in November 2022 on possible changes to the regulation of nicotine vape products (NVP) in Australia.

The TGA received more than 4,000 responses asking for views on:

Strengthen border control of NVP;

Require premarket TGA evaluation of NVPS against minimum quality and safety standards;

Require minimum quality and safety standards for NVPS;

Clarify the status of NVP as therapeutic products;

Current regulation of NVPs.

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

Current smokers can get NVP to help them quit after consulting a doctor and getting a prescription. Prescription holders can directly import up to three months 'worth 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 NVPS to consumers, even if the consumer has a valid doctor's prescription. Despite this, vape products, including NVPS, are easily (illegally) obtained from a large number of convenience stores and other stores across Australia, and are being purchased by minors.

Feedback on proposed reforms

Strengthen border control of NVP:

The TGA's preferred reform option 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 professionals and individuals. If the proposal is passed, any attempt to import NVPS without the proper import licence will be illegal and any found by the Australian Border Force will be confiscated. Penalties will also apply to importers.

Many groups also point to the need for border controls on nicotine-free vape products (which is broader than the consultation).

2. Require premarket TGA evaluation of NVPS according to minimum quality and safety standards:

The preferred option for TGAs is to require a premarket TGA evaluation of NVPS against product standards that specify specific quality and safety requirements. This is supported by a large number of State/Territory Governments as well as health professionals and individuals.

3. Minimum quality and safety standards required for NVP:

The preferred option for TGAs is to include drug-like packaging, warning statements, bans or restrictions on fragrances and certain other ingredients, and limits on NVP volume and total nicotine content.

This is strongly supported by State/Territory governments, health professionals and individuals. There is also strong support for banning one-off NVPS.

4. Clarify the status of NVP as therapeutic products:

This is generally supported (with the exception of e-cigarette retailers/manufacturers/importers, pro-e-cigarette associations and individual e-cigarette users).

The next step

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