Australia Considers Tightening Regulation of Nicotine Vaping Products
Today’s news, March 30: According to foreign media reports, on March 23, Australia’s Therapeutic Goods Administration (TGA) released a summary of feedback received during a public consultation launched in November 2022 on possible reforms to the regulation of nicotine vaping products (NVPs) in Australia.
The TGA received more than 4,000 responses seeking views on the following issues:
Strengthening border controls on NVPs;
Requiring pre-market TGA assessment of NVPs against minimum quality and safety standards;
Requiring minimum quality and safety standards for NVPs;
Clarifying the status of NVPs as therapeutic goods;
Current regulation for NVPs.
At present, under the Therapeutic Goods Act 1989, NVPs are regulated as medicines. This means NVPs cannot be imported, manufactured, or supplied (other than retail supply) unless they are included in the Australian Register of Therapeutic Goods (ARTG).
After consulting a doctor and obtaining a prescription, current smokers may access NVPs to help quit smoking. People holding a prescription may directly import up to a three-month supply of NVPs for personal use.
NVPs may only be legally supplied by pharmacies in Australia. It is illegal for other Australian retailers (such as tobacco sellers, vape shops, and convenience stores) to sell NVPs to consumers, even if the consumer has a valid doctor’s prescription. Despite this, vaping products including NVPs remain readily available illegally from many convenience stores and other shops across Australia, and they are being purchased by minors.
Feedback on the proposed reforms
Strengthening border controls on NVPs:
The TGA’s preferred reform option on this issue is to end the personal importation scheme and require importers to obtain an import license. This was supported by all Australian state and territory governments, as well as the overwhelming majority of public health associations, health professional bodies, and individuals. If this proposal is adopted, any NVPs imported without the proper license would be illegal, and any NVPs discovered by the Australian Border Force would be confiscated. Penalties would also apply to importers.
1. Many groups also noted that border controls should be applied to non-nicotine vaping products as well (which goes beyond the scope of the consultation).
2. Requiring pre-market 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 particular quality and safety requirements. This received support from many state and territory governments, as well as health professional bodies and individuals.
3. Requiring minimum quality and safety standards for NVPs: The TGA’s preferred option includes pharmaceutical-style packaging, warning statements, prohibitions or restrictions on flavors and certain other ingredients, and limits on NVP volume and total nicotine content.
This received strong support from state and territory governments, health professional bodies, and individuals. A ban on disposable NVPs also received strong support.
4. Clarifying the status of NVPs as therapeutic goods:
This received broad support (except from vape retailers/manufacturers/importers, pro-vaping associations, and individual vape users).
Next steps
The TGA has considered the feedback and is now providing advice to the government on possible reform options. The government will then consider the TGA’s consultation and recommendations and implement any legislative changes.
