December 4 - 10, 2022: Issue 565


TGA Consultation On Nicotine Vaping Product Regulatory Reforms: Minister Butler Launches 'Reignite Tobacco Reforms'

Image: NSW Health's 2022 Get the Facts – Vaping Toolkit

In March 2022 the NSW Department of Health commenced an initiative to encourage young people to quit vaping and know the facts and dangers of e-cigarettes, which can contain harmful substances found in cleaning products, nail polish remover, weed killer and bug spray.

Health Minister Brad Hazzard and Minister for Education and Early Learning Sarah Mitchell launched Get the Facts – Vaping Toolkit and a NSW Health awareness campaign.

The campaign, which is aimed at secondary students, reminds parents, carers, young people and teachers vaping is not safe and can have harmful, long-term effects to the physical and brain development of young people.

Minister Hazzard said that research has proven that e-cigarettes are just as addictive and harmful as regular cigarettes.

“A respiratory researcher once told me that e-vaping liquids have chemicals that are similar to antifreeze, with 500 different flavours to attract kids,” Mr Hazzard said.

“It makes it pretty obvious as to the harm it can cause to youngsters’ lungs.”

Many vapes contain nicotine, some at extremely high concentrations, even if they are not labelled as such, and evidence suggests they can lead to a lifelong nicotine addiction.

NSW Health worked with the NSW Department of Education to develop the Vaping Toolkit, which contains evidence-based resources and educational materials for parents, carers, young people and schools, to combat the rising number of children and young people who are trying or taking up vaping.

Minister Mitchell urged parents to discuss the dangers of e-cigarettes with their children and to report any usage in schools to principals.

“The number of young people vaping without consideration to the effects is concerning. I encourage all parents and young people to find out more and talk about the hidden, dangerous impacts of e-cigarettes,” Ms Mitchell said.

“Educating our young people about the dangers of vaping is essential when there continues to be a large number of reckless individuals selling nicotine products to minors.”

The Vaping Toolkit and campaign is designed to increase young people’s awareness of the dangers of vaping and support parents, carers, families, schools and educators, health and community bodies with information and strategies to educate and protect young people from the harms of e-cigarettes.

The campaign will target secondary students to raise awareness of the hidden chemicals in vapes, and provide a resource for teachers, parents and carers to kick start conversations.

It is illegal to sell e-cigarettes or vapes to anyone under the age of 18. There are severe penalties for business or others who provide them to minors, including fines of up to $11,000 for individuals, and up to $55,000 for corporations, for first offences.

NSW Health continues to take action against retailers who sell e-cigarettes and e-liquids containing nicotine and seized over 100,000 e-cigarettes worth an estimated street value of over $2 million from 1 July 2020 to 31 December 2021. 

Parents and young people can get the facts about the dangers of vaping by visiting

Population data from NSW has found that 32.7% of persons aged 16–24 have used an e-cigarette in 2021 – the highest rate of all population groups. Media, school and community reports suggest that vaping among young people in NSW has proliferated in recent years.

This growth in vaping is corroborated by NSW compliance data showing that 54,556 illegal nicotine products were seized from retailers in the first half of 2021, up from 4,667 in the same period of 2020. [1.]

From October 1st 2021, consumers require a prescription for all purchases of nicotine vaping products, such as nicotine e-cigarettes, nicotine pods and liquid nicotine. This includes purchases from Australian pharmacies and from overseas. It remains illegal for other Australian retailers, such as tobacconists, 'vape' shops and convenience stores, to sell you nicotine vaping products, even if you have a prescription.

However a quick search of the internet shows that local 'vape stores', in our area, are employing an enabling narrative and displaying the products. 

On November 18th the TGA announced it has issued an infringement notice of $2,664 to a NSW-based medical practitioner for alleged unlawful advertising of nicotine vaping products in a social media post. TGA alleges that in social media, the health practitioner promoted a specific brand of nicotine vaping product.

The advertising rules for therapeutic goods apply equally to social media posts, websites, and traditional forms of advertising such as in-store and magazines.

Nicotine vaping products are prescription-only medicines and it is generally unlawful to advertise them to the public. The TGA has granted a legal permission which only allows pharmacies and pharmacy marketing groups to advise where a person can fill their prescription for a nicotine vaping product but also not to mention specific brands or types of products. Other individuals, such as medical practitioners and businesses are not permitted to advertise these products in any way.  

Nicotine replacement therapies (including sprays, patches, lozenges, chews and gums) that do not require a prescription will continue to be available from pharmacies and some retail outlets.

On November 30th the Therapeutic Goods Administration (TGA) announced it is seeking public comment on potential reforms to the regulation of nicotine vaping products in Australia. The potential reforms are aimed at preventing children and adolescents from accessing nicotine vaping products, while supporting access to products of known composition and quality for smoking cessation with a doctor’s prescription.

Evidence is emerging that more could be done to ensure that the reforms that commenced on October 1st 2021, which classified nicotine vaping products as prescription medicines, are meeting these aims. 

Children are continuing to access nicotine vaping products in higher numbers, and many adults are accessing them on the black market, rather than lawfully with a prescription from an Australian registered doctor.

Public comment on potential reforms is sought in four main areas:
  1. Changes to border controls for nicotine vaping products to curb the unlawful supply of nicotine vaping products in Australia
  2. Pre-market TGA assessment of nicotine vaping products against a product standard to create a regulated source of quality products to encourage doctors to prescribe, pharmacies to supply and vaping consumers to purchase safer and quality assured products lawfully
  3. Strengthening the product standard regarding minimum quality and safety standards for nicotine vaping products to make them less attractive to children and adolescents
  4. Clarifying the status of nicotine vaping products as therapeutic goods to ensure that any vaping product containing nicotine is captured by the regulatory framework.

The public consultation will be open until COB January 16th 2023 and feedback can be submitted via the TGA Consultation Hub. The responses will be analysed and any proposed reforms will be taken forward in discussion with the Government. If changes to the regulatory framework are made, suitable transition periods will apply. 

The Consultation commenced on the same day that The Hon Mark Butler MP, Federal Minister for Health and Aged Care, gave an Address on the 10th anniversary of tobacco plain packaging. December 1st 2022 marks the 10th anniversary since world-first plain packaging was introduced in Australia on December 1st 2012. 

''There is now a whole generation of Australians who have no memory of a time when cigarette packets were sold prior to the government mandate requiring the removal of branding colours and designs. Since 2012 cigarette packs have been a drab dark brown with large graphic health warnings.'' the Cancer Council stated

''A major evaluation of plain packaging was conducted by Cancer Council Victoria’s Centre for Behavioural Research in Cancer, led by Prof. Melanie Wakefield. The evaluation found a marked reduction in the appeal of cigarette packs, particularly among young people. '' Cancer Council Victoria explains

''Noticeability and impact of the graphic health warnings increased. And plain packaging also went some way towards correcting the mistaken belief that some brands are less harmful than others.  

Other research found that calls to Quitline increased immediately after plain packaging was introduced and one-third of young people reported a quitting related response. A government-commissioned independent review concluded that plain packaging had significantly contributed to reducing smoking prevalence in the years after its implementation.''

Emboldened by Australia’s leadership, 27 countries have since implemented their own plain packaging legislation including the United Kingdom, Norway, Turkey, France, Sweden, Belgium, Netherlands and New Zealand, with more countries taking steps to pass plain packaging laws. 

In the decade since, tobacco companies have not rested, innovating with a range of problematic product marketing strategies to continue to retain customers and attract new ones.  

Building on the success of plain packaging, The Minister for Health Hon. Mark Butler announced a new range of measures to re-ignite the fight against tobacco and start a new phase of tobacco control in Australia.   

The new package will extend and tighten the intent of plain packaging by standardising the size of tobacco packs and pouches and limiting the design and look of cigarette filters. It will limit the use of appealing names on tobacco products, such as ‘organic,’ that falsely imply they are less harmful. Instead of their current clean white appearance, in another world-first, cigarette sticks are also to become an unpleasant colour such as brown or dark green. 

The initiatives will also update current graphic health warnings to include all the diseases now established as caused by smoking that consumers have a right to know about, and introduce pack inserts that provide practical tips to quit and information about quitting services. Warnings will also appear on individual cigarette sticks, so the stark reminder of risk would be brought to the moment of smoking itself. 

The package goes further by banning the addition of menthol and other flavourings. This is welcomed by the Cancer Council and health advocates as these additives make tobacco easier to smoke, especially for young people.  

Other provisions of the package will modernise tobacco advertising restrictions to include digital media. And the government announced the review of options for tightening regulation of e-cigarettes in Australia.  

“On the 10th anniversary of plain packaging in Australia we celebrate the positive achievements of the legislation for public health in Australia as well as the enormous international legacy it has provided,” said Cancer Council Victoria’s CEO Todd Harper. “We congratulate government on this strong comprehensive tobacco control package that will drive down smoking prevalence. 

“As the industry evolves and becomes stealthier in its marketing practices, Cancer Council will continue to support further tobacco control action.” 

''Smoking is the leading cause of preventable death and disease in Australia, with two in three long-term Australian smokers dying prematurely. Smoking causes many types of cancer, heart disease and stroke, chest and lung illnesses and stomach ulcers. It claims the lives of 15,000 Australians every year, yet frustratingly, the devastating harm caused by tobacco smoking is preventable.  

We are keenly aware that our work is not done whilst smoking continues to cause such a devastating impact on Victorians and the Australian and global community. With your support we continue to investigate and advocate for policies to reduce smoking related harm.''

Below runs the The Hon Mark Butler MP's full address on the 10th anniversary of tobacco plain packaging. The speech was heard by The Hon. Nicola Roxon who served as Health and Ageing Minister and then went on to become Australia's first woman to serve as Attorney-General in the Gillard Ministry. The former Federal Health Minister implemented Australia’s tobacco plain packaging legislation. In a 2012 interview with the ABC's Australian Story  stated she was motivated to take on tobacco giants and see the legalisation through after father's death from tobacco related cancer.

Ms Roxon was 10 years old when her father passed away from cancer of the oesophagus.

Australia, with the enactment of the Tobacco Plain Packaging Act on  December 1st 2011, became the first country in the world to require tobacco products to be sold in plain packaging. Products manufactured after October 1st 2012, and all on sale after December 1st 2012 must be in the plain packaging.

Minister For Health And Aged Care - Speech - 30 November 2022: 'Reignite Tobacco Reforms'

(Transcript via Department of Health and Aged Care media centre)

Thanks everyone for joining us here today.

I want to acknowledge first of all that we’re coming together on the land of the Ngunnawal and Ngambri people, and pay my respects to Elders both past and present. In that vain, particularly welcome Tom Calma here, who is just such a giant of the Australian community, particularly in this particular policy space.  So thank you Tom for joining us today and for all the work that you do.

I’m delighted to have Ged and Emma with me, two Assistant Ministers in the Health Portfolio. Emma’s only the first female pharmacist ever elected to Parliament, only the eighth pharmacist in the 120 years of Parliament. I think Victoria sends well more than eight lawyers to this Parliament every single election.

And Ged, as everyone knows is just an absolutely terrific visionary leader in the health sector as a qualified RN and nurses leader. So, it’s just such a pleasure to have them working in our health team.

But I particularly want to welcome Nicola here. I was remembering, I think it was in this room that she launched the plain packaging laws and it’s such a pleasure to have you back here. Both at a professional level and a personal level, I had the honour of working for Nicola as her Junior Minister for two and a half years.

And it was one of the absolute highlights of my professional life, it really was. I can't imagine a smarter, more generous person to work with as a leader. I learnt an enormous amount from her, and hopefully am applying some of that in the portfolio that I have the pleasure of having here now. So, it's just an absolute pleasure to welcome you back here, Nicola, at a personal level, and I think entirely proper, that we welcome you back here at a professional level to recognise the scale of the reforms you drove 10 years ago, the impact that it has on the community. And the responsibility now that we as the current generation of people with our hands on the policy levers have to build on that - the responsibility we have to build on that. So thank you.

Can I also acknowledge so many guests here from the tobacco control sector, it looks like Nicola getting the band back together, a little bit. Some of you who have been playing this song for a long time, in spite of your extraordinarily youthful looks, Mike, Simon and Melanie, and others who have just worked so hard to put Australia at the forefront of tobacco control. And I know Nicola would be the first to say, just the importance of the role that you played leading up to the reforms that she drove through the Parliament. And so welcome. Welcome back to Parliament, welcome back to the room where such a momentous reform was launched 10 years ago.

I also want to pay tribute to the public service people who work so hard to put the details of this reform together, and who, as objective, public servants have nonetheless been passionate drivers of good public health policy and this is starling example of good public health policy. Some of them are here today. Some, like Jane Halton, who worked so closely with Nicola as the Secretary of the Department of Health can't be with us today but, but also played an extraordinary role.

Tobacco plain packaging was bold policy achieved in the face of some often savage legal and rhetorical assault, but it was imaginative policy. And it was world-leading policy. We know that because 26 countries since then have followed Australia's example. And it's a policy that has saved lives and will continue to save lives.

10 years ago, when Nicola launched this reform, around 16% of Australians smoked, and today that rate is down to just under 11%. A 5% drop in smoking rates is equivalent to 1 million fewer Australians smoking. The health impacts of that are just enormous. Thanks to a comprehensive strategy involving tobacco plain packaging and graphic health warnings, rolling tobacco excise increases, advertising restrictions, public health campaigns, and quit smoking support, those fewer people are smoking today.

Tens of thousands of families that might never struggle through the tragedy of lung cancer, and the vast range of other diseases caused by tobacco smoking. Countless lives saved. And yet powerful forces lined up to block this life saving reform.

The tobacco industry had deep pockets and powerful friends. The then opposition leader Tony Abbott, himself a former Health Minister who should have known better, would often denigrate these reforms by saying they weren't health policy, but tax policy. In 2009, the same year that the Coalition raked in nearly $300,000 in donations from Big Tobacco. The Shadow Health Minister Peter Dutton said that these world leading lifesaving reforms were in his words, ‘a bridge too far’.

A bridge too far.

Just imagine where we would be if Peter Dutton had managed to block Nicola’s reforms, imagine where those 1 million Australians would be. Thankfully, Nicola prevailed. She dragged the Coalition kicking and screaming to support this policy, aided it must be said by some farsighted members of the Coalition who spoke up bravely in support of the plain packaging reforms.

In particular, I want to mention Mal Washer, a GP who played a pivotal role in forcing the hand of Mr Abbott and Mr Dutton to ensure that the legislation passed the Parliament and was then able to be implemented by Nicolas's successor after she'd moved to the Attorney General portfolio, Tanya Plibersek. And when the Coalition came to power, Australia, I think people in this room would acknowledge, was a world leader in tobacco control. But after a decade of really nothing else happening, we're now a laggard.

Tobacco smoking remains the leading cause of preventable death and disability. In my lifetime, as young as I am, in my lifetime smoking has killed more than a million Australians. Every year, tobacco still claims the lives of more than 20,000.

The gains of Nicola’s world-leading reforms has stalled for 10 years. And it is the poorest and the most marginalised Australians that have paid the price. In both health and economic terms, disadvantaged groups are hit more than three times harder than others in the community. So it's not just about quality of life, but length of life too. We know that long term smokers died 10 years earlier than non-smokers, 10 years, it’s a decade of lost time with friends with family and loved ones.

And we cannot close the gap in health outcomes between First Nations communities, and other Australians without addressing smoking. 23% of the gap in health outcomes is driven by smoking is the most significant modifiable risk factor in the Closing the Gap Initiative. First Nations peoples and disadvantaged Australians are disproportionately paying the price for the past 10 years of inaction.

And now terrifyingly, so are our children. We all read the horrifying stories earlier this year of a five-year-old, being hospitalised from vaping, after two seven-year-olds brought them to his Geelong Primary School. The vape had no labelling on it, and who knows what was in it. More than 50 children under the age of four, including eight babies still in their first year of life have been exposed to potentially toxic vapes in the past year according to Victoria's poisons hotline.

Primary School teachers are being forced to step in and educate grade five and grade six students about the dangers of inhaling nicotine from vapesChildren are buying and selling vapes in schools after buying them online or from illegal retailers. Principals have even reported some students being given vapes by their parents in the mistaken belief that they are safe. Alamanda College Principal Lynette Jobson, said kids at her Point Cook school, were telling teachers: ‘I’m not smoking, I’m vaping’. Principals of primary and high school students are continually telling me and my colleagues that vaping is their biggest behavioural challenge that they face in their schools.

The former government was frankly asleep at the wheel as vaping rates skyrocketed. The former Health Minister, to his credit, wanted to take action on vaping but was rolled within only a couple of days in his party room. And our children are paying the price today for that division and that delay.

Today I announce that the Therapeutic Goods Administration will kick off a public consultation process on nicotine vaping products. We need to understand where the current regulatory framework falls short, and what action governments can take to move the dial across four main areas:

Firstly, changes to border controls for nicotine vaping products to curb the unlawful supply of those products in Australia.

Secondly, pre-market TGA assessment of nicotine vapes to create a regulated source of products to encourage doctors to prescribe, and pharmacies to supply, and vaping consumers frankly, to purchase safer and quality assured products lawfully.

Thirdly, strengthening the product standard to make them unattractive to children and to adolescents by addressing things like labelling and flavours, learning from the lessons of the past 10 years in tobacco.

And fourthly clarifying the status of nicotine vaping products as therapeutic goods to ensure that any vaping product containing nicotine is captured by that regulatory framework.

That public consultation will be open until 16 January next year.

And that same month in January, I'll meet with Health Ministers from every state and territory to discuss how we can mount a coordinated response to this problem.

All Health Ministers have agreed that this is a priority area for us for strong action, but it will require coordinated action across a range of portfolios at both Commonwealth and state levels.

It's not just vaping. I'm determined to see Australia reclaim its position as a world leader on tobacco control because quite frankly, lives are at stake. Disadvantaged Australians are paying the price for Big Tobacco’s profits.

Which is why today I announce that the Albanese government plans to introduce new legislation to drive down smoking rates. We've listened to the experts - many of whom were generous enough to spend a few hours with me in Adelaide a month or two ago. We've also looked at what our international neighbours and friends are doing. And we're ready now to take action.

Australia's current tobacco related measures are split across as many as eight different laws, regulations, instruments and court decisions. The Government's legislation prohibiting certain forms of tobacco advertising is now 30 years old.

This convoluted patchwork of regulations with gaps, and smokers are falling through those cracks. The Government plans to bring together its current tobacco measures along with 11 new measures, which I'll outline in a second, into a single streamlined and effective Act of Parliament, which will reignite the fight against tobacco and nicotine addiction.

After nine years of inaction, the graphic warnings on cigarette packs that were once world-leading have frankly started to lose their impact. At best, those warnings are ignored, and at worst, they are mocked.

We will pursue measures to update and improve health warnings with new graphic warnings on all tobacco products. We know these warnings work. But when a smoker pulls a cigarette out of the pack, there is nothing at the moment to remind them of the harms that cigarettes cause.

Which is why for the first time, the Government will look to require individual cigarettes to be dissuasive by making them unattractive colours or printing warnings - like “smoking kills” - on every individual stick.

We will also move to remove the loopholes that have allowed tobacco companies to promote and market their products by firstly standardising the size of tobacco packs and products.

Secondly, preventing the use of specified additives and tobacco products including flavours and menthol. And thirdly standardising the design and the look of sticks and filters.

We will seek to limit the use of appealing names on products that, frankly, falsely imply that these products are less harmful things like organic or light. There is nothing light about lung cancer.

We will require health promotion inserts to be put into every pack and every pouch, and update advertising regulation to capture e-cigarettes. This Act will also require tobacco companies mandated to be open and transparent about their sales volumes and their pricing, their product ingredients, and their emissions, along with their advertising, promotion and sponsorship activities.

Australia was once a world leader on tobacco control, and we are now a laggard. The 11 measures in the Government's Reignite Tobacco Reforms will put us back into a world leading position alongside fellow OECD nations. So we're moving forward like New Zealand and Canada.

Today is an important first step in re-establishing our reputation as a global leader in tobacco control. We will continue to engage with the public and stakeholders on these important reforms before of course they are finalised. For the next generation, tobacco control reforms will work to achieve Australia's next tobacco strategy, which the Australian Government, before the election and since has been working to progress alongside states and territories as well as the public health sector.

This strategy will provide a new world leading framework to improve the health of the community by reducing tobacco use, and its associated health, social, environmental and economic costs and the inequalities that it causes and perpetuates. The aim is to achieve a national daily smoking prevalence of less than 10% by 2025, just three years, and 5% or less by 2030.

I’m prepared for the fact that just like Nicola’s plain packaging reforms, these reforms will be hard fought, we wouldn't be doing our job if they weren't. The tobacco industry continues to have deep pockets and powerful friends. Since plain packaging came into effect, tobacco companies have given more than $430,000 in donations to the Coalition.

This Government is up for the fight because we fight on behalf of the most vulnerable and disadvantaged in our society, who bear the brunt of these tobacco company profits. We're going bring the same spirit of courage, spirit of action, the same clarity of thought, and I hope the same conviction that Nicola Roxon brought to plain packaging reforms 10 years ago, and we're going to reaffirm Australia's reputation as a world leader in tobacco control.

Thank you very much.
1. New South Wales Ministry of Health. Enforcement of Nicotine Containing E-cigarette Laws [Internet]. Sydney (AUST): Government of NSW; 2021 [cited 2022 Jan 19]. Available from: