December 3 - 9, 2023: Issue 608


Next steps on vaping reforms announced by australian government

signboard outside an e-cigarette store at Mona Vale faces towards the main bus-stop where young members of the community congregate

The Federal Government announced on Tuesday November 28, the first stage of Australia's new vaping reforms are set to commence on 1 January, with further protections implemented and strengthened over the course of 2024.

The government states these reforms will protect Australians, particularly young people, from the harms of vaping and nicotine dependence. All Australian Health Ministers have agreed to implement a nationally consistent and concerted response to vaping.

From 1 January 2024, the Government will implement a ban on the importation of disposable single use vapes. This is subject to legislative and administrative arrangements being approved, including by the Governor-General in Federal Executive Council.  

In parallel with this ban, a new Special Access Scheme pathway to prescribe vapes will commence on 1 January 2024, which will facilitate improved access to therapeutic vapes, whereby all medical practitioners and nurse practitioners will be able to prescribe their use where clinically appropriate.

From 1 March 2024, further changes are expected to commence, including the:

  • cessation of the personal importation of vapes
  • ban on the importation of non-therapeutic vapes
  • requirement for therapeutic vape importers and manufacturers to notify the Therapeutic Goods Administration of their product’s compliance with the relevant product standards
  • requirement for importers to obtain a licence and permit from the Australian Government’s Office of Drug Control before the products are imported.

During 2024, product standards for therapeutic vapes will also be strengthened, including to limit flavours, reduce permissible nicotine concentrations and require pharmaceutical packaging. A transition period will be allowed for businesses to comply with the new requirements. 

The Government will introduce legislation in 2024 to prevent domestic manufacture, advertisement, supply and commercial possession of non-therapeutic and disposable single use vapes to ensure comprehensive controls on vapes across all levels of the supply chain.

The vaping reforms were the focus of a joint meeting of all Australian Health and Police Ministers last week. At this important meeting, Ministers agreed to task officials with developing a national enforcement framework for vaping products – to stamp out unlawful vapes in the community and prevent illegal markets from emerging. It was agreed that a multi-agency National Vaping Working Group will be established to oversee development and implementation of the national enforcement framework.

This strong, comprehensive action, complemented by enhanced compliance and enforcement activity across all governments, will turn the tide against the rising use of vapes by young Australians.

We know that vapes pose a range of known and unknown risks to Australians, particularly among young people.

The latest data, from the first quarter of 2023, shows that about one in seven 14- to 17-year-olds and one in five 18- to 24-year-olds are current vapers.

There is strong and consistent evidence that young Australians who vape are around 3 times more likely to take up tobacco smoking compared to young Australians who have never vaped.

To introduce and enforce these reforms, the Government will provide an additional $25 million to Australian Border Force and $56.9 million to the Therapeutic Goods Administration over two years.

Alongside these measures, the Government is expanding and strengthening vaping and smoking cessation support services. The 2023-24 Budget provided $29.5 million in funding to help Australians quit. This includes funding to support improved access to Quitline services and creation of an online cessation hub, updated clinical guidance for health practitioners and the redevelopment of the My Quit Buddy app.

Australian Health Minister Butler said: 

“Vaping is creating a whole new generation of nicotine dependency in our community. It poses a major threat to Australia’s success in tobacco control and the Albanese Government is not going to stand by and let this happen.

“Vaping was sold to governments and communities around the world as a therapeutic product to help long-term smokers quit. It was not sold as a recreational product - especially not one targeted to our kids but that is what it has become.

“All Australian governments are committed to working together to stop the disturbing growth in vaping among our young people.

“We’re taking tough action because this is a major public health issue.

“The great majority of vapes contain nicotine and children are becoming addicted. Vaping is a gateway to smoking and smoking remains the leading preventable cause of death and disease in Australia. Smoking continues to kill approximately 20,000 Australians every year.

“The government is alive to the implementation obstacles, like all other illegal drugs, there will no doubt be some vapes that get into the country but they will no longer be easy for school children, our most vulnerable and impressionable members of society, to get their hands on them.”

Minister O’Neil stated: 

“This measure will enable the ABF to take targeted action to stem the flow of vapes at the border.

“As our first line of defence, the ABF will detect, seize and destroy vape products under a new border control measure.

“What we do at the border will make a difference but reducing the amount of vapes in the community requires a multi-faceted approach across all levels of government, involving both enforcement and better education around the harmful impact of vaping.”

The AMA has applauded the federal government for moving quickly to implement initial changes to protect Australians from the harms of vaping.

AMA President Professor Steve Robson said the changes would prevent a new generation of people becoming addicted to nicotine.

“The AMA has advocated for years for the introduction of stronger, strictly enforced regulation of vapes, and we applaud the measures announced by Health Minister Mark Butler,” Professor Robson said.

The AMA also welcomed the introduction of the new Special Access Scheme pathway for doctors to prescribe vapes, which will facilitate improved access for Australians when there is a clinically appropriate need.

''The AMA thoroughly welcomes the federal government’s decisive action on vaping and will work to support the required regulatory and legislative changes.''

The TGA advises the importation of disposable single use vapes would be banned from 1 January 2024, subject to very limited exceptions. The importation of all other vapes, irrespective of nicotine content or therapeutic claims, would be banned from 1 March 2024 unless certain conditions are complied with. From that time, importers will need to hold licences and permits from the Office of Drug Control (ODC) to lawfully import vapes. At the same time, the personal importation scheme for therapeutic vapes will cease to operate.  

Importers and domestic manufacturers of therapeutic vapes would be required from 1 March 2024 to provide pre-market notifications to the Therapeutic Goods Administration (TGA) declaring compliance with the relevant product standards, prior to the importation or supply of those goods. It will not be possible to obtain a customs permit without first notifying compliance to the TGA.

In anticipation of the new restrictions, both the TGA and the ODC are preparing forms and instructions to notify compliant products and obtain customs licences and permits. This would allow notifications and applications to be made and processed ahead of the expected commencement on 1 March 2024. In addition, some changes to product standards for therapeutic vapes are anticipated to be made to facilitate the introduction of these new processes.

The second stage of the reforms would involve imposing a domestic ban on the manufacture, supply, advertising and commercial possession of disposable single use, and non-therapeutic, vapes, in order to ensure comprehensive controls across all levels of the supply chain. These changes will require amendments to the Therapeutic Goods Act 1989, which are expected to be introduced in Autumn 2024 for Parliament’s consideration.

The third stage of the reforms would involve strengthening the standards for therapeutic vapes, including by limiting flavours, reducing permissible nicotine concentrations and requiring plain pharmaceutical packaging. These changes are expected to be made by 1 March 2024, but transition periods would be specified to allow businesses to comply with the new requirements.

Changes are also proposed to be made to the special access scheme pathways, to enable medical practitioners and nurse practitioners to prescribe therapeutic vapes for smoking cessation or the management of nicotine dependence, where clinically appropriate. These changes are expected to commence on 1 January 2024 to facilitate and support legitimate patient access to therapeutic vapes without pre-approval or authority from the TGA.

The TGA advises that importers, manufacturers, wholesalers and retailers of disposable single use, non-therapeutic vapes, and therapeutic vapes that will not be able to comply with the pre-market notification process, are advised to reduce orders and run down stocks ahead of the regulatory changes.