In March 2023, the Albanese Government announced its commitment to reform of the regulatory framework for nicotine vaping products (NVP), unveiling a major crackdown on recreational vaping that includes additional enforcement to prevent unlawful NVP markets in Australia.
This reform follows consultation in November 2022 by the Therapeutic Goods Administration (TGA), which sought comments on proposed recommendations to update the regulatory requirements around NVPs. The TGA received over almost 4,000 submissions from a diverse array of stakeholders. Most of the Government’s proposed areas of reform were addressed in the TGA’s Consultation Paper.
The Government has also endorsed the National Tobacco Strategy of 2023–2030, which aims to strengthen regulations on e-cigarettes and novel and emerging products as well as providing greater access to evidence-based cessation services to support people to quit these products and smoking and nicotine products in general.
Proposed changes
Reducing importation
The Government plans to ban the importation of non-prescription NVPs. The Government has not yet made it clear how this will be achieved. The current mechanism of importation is via the personal importation scheme (PI Scheme) which provides an exception to rules around importing therapeutic products that are not listed on the Australian Register of Therapeutic Goods. It is not clear whether this pathway will be closed to NVPs.
In submissions on the Consultation Paper, all State and Territory governments supported tightening border controls for NVPs, with most also supporting closing the PI Scheme and in favour of requiring specific import permits for NVPs. Some suggested amending customs regulations to require the Australian Border Force to seize NVPs imported without medical authority. Health groups have also given their support to customs seizures.
The Government’s approach may also look to restrict the importation of vaping products (including e-cigarettes) and vaping devices that do not contain nicotine (non-nicotine vaping products or NNVPs). Currently, the import, use or possession of these NNVPs is legal (except for Western Australia where the sale of a vaporiser is not permitted). The TGA recently investigated the sale of NNVPs and found that 168 of 296 products tested (57 percent) contained undeclared nicotine.
Increase quality standards
The Government also proposes to increase the minimum quality standards for NVPs including by restricting flavours, colours, and other ingredients. It also proposes to require NVPs to be presented in ‘pharmaceutical like’ packaging, to make them less attractive, particularly to children.
Accompanying these measures is a proposed ban on single-use, disposable NVPs and a reduction in the allowed concentrations and volumes of nicotine permitted in NVPs.
Restrict sales
The Government will also work with the States and Territories to close down the sale of NVPs outside pharmacies, ending NVP sales in convenience stores and other retail settings.
Supporting legitimate therapeutic use
Central to the Government’s plan is restricting the sale of NVPs to therapeutic purposes only. As part of this, the Government has suggested that the application of the authorised prescriber scheme to NVPs, which would allow all GPs to prescribe nicotine vaping products (as part of a nicotine withdrawal program).
Comparison with other jurisdictions
NVP regulatory reform is also being undertaken in jurisdictions like New Zealand, the United Kingdom, the European Union, and Canada.
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REGULATORY FRAMEWORK
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INDIVIDUAL
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Example
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New Zealand
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On 11 August 2021, New Zealand restricted the sale of NVPs in flavours other than tobacco, mint and menthol with only specialist retailers able to sell other flavours. Colouring agents have also been banned in NVPs in New Zealand. New Zealand has limited base form nicotine concentration to 20 mg/mL and nicotine salt concentration to 50 mg/mL in NVPs sold as consumer goods. This is significantly lower than the concentration allowed in Australian NVPs. New Zealand also requires warning labels about the addictiveness of nicotine, child safety and a toxicity and first aid treatment statement. |
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UK, EU, and Canada
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The United Kingdom, European Union, and Canada prohibit colouring agents in NVPs sold as consumer goods and also require various warning signs on NVPs. The maximum nicotine concentration allowed for NVPs is 20 mg/mL (though this is not in the context of a prescription-only scheme). In addition, Canada is also considering further limiting the flavours of NVPs to tobacco, mint and menthol and the European Union is considering a ban on all flavoured NVPs. |
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Next steps
Though States and Territories will still need to work out a penalty regime with the Federal Government, there does appear to be a sense of urgency around introducing the proposed reforms in relation to NVPs.
In the 2023-24 Budget announced in May this year, the Government will provide $29.5 million to increase and enhance smoking and vaping cessation support, $141.2 million to expand the Tackling Indigenous Smoking program and $63.4 million for national health campaigns designed to discourage vaping and smoking.
We will be closely monitoring where the Federal, State and Territory governments land in their reform of NVP and NNVP regulation in Australia.
