AMA welcomes announcement on nicotine pouches but calls for more action

The Australian Medical Association supports the federal government’s proposed restrictions on nicotine pouches but warns it must be part of wider regulations to address a national health crisis. 

Health Minister Mark Butler today announced proposed amendments to prevent access to unapproved nicotine pouches via existing channels, including the Special Access Scheme and the Authorised Prescriber Scheme. The announcement follows the Therapeutic Goods Administration’s targeted consultation on the regulation of nicotine pouches earlier this year, with the AMA’s submission calling for urgent action. 

Nicotine for human use is a Schedule 4 prescription-only medicine. However, there are currently no nicotine pouches included on the Australian Register of Therapeutic Goods (ARTG), meaning there is no approved product that should be supplied through routine channels. 

AMA President Dr Danielle McMullen welcomed today’s announcement as a first step in closing loopholes around illicit tobacco products. 

“Some of these unapproved pouches contain huge doses of nicotine, much higher than what is absorbed smoking one cigarette. They should not be positioned as a ‘healthier alternative’ to smoking or as a proven smoking cessation therapy,” Dr McMullen said. 

“The proposed reforms will help to stop nicotine pouches being promoted and supplied in the absence of adequate safety data, standardised health warnings, and child-resistant packaging. However, there is much still to be done by governments and enforcement agencies to prevent ready access to these unapproved and harmful products. 

“Much of the promotion and sales occur via online and social media marketplaces, and cross-border e-commerce, so the effectiveness of the proposed amendments will require active monitoring, cooperation between regulators and platform and payment providers, and timely action to remove the adverts and products, as well as enforcement at our borders.” 

The AMA also calls for existing regulations framed primarily around “tobacco products” to be updated to reflect the growth in the use of synthetic nicotine. A campaign of clear public and clinician communication is also needed to educate and reinforce that nicotine pouches are unapproved and unproven as cessation aids. 

Today’s announcement comes as the latest National Drug Strategy Household Survey reveals that daily smoking among people aged 14+ in Australia has dropped to 5.6 per cent (down from 8.3 per cent in 2022-23, and 19.5 per cent in 2001). This means the figure is within striking distance of the National Tobacco Strategy’s ultimate aim of less than 5 per cent by 2030. 

Australia is now likely among the lowest-smoking high-income countries, and the data also shows that e-cigarette use among 18-24-year-olds also dropped from 20.6 per cent in 2022-23, to 14 per cent in the latest survey. 

But the data indicates there is no room for complacency. While Australia’s nicotine market is shrinking, it is also fragmenting. The survey showed that oral nicotine pouch use was highest among 18–24-year-olds (with 8.4 per cent having used in the past year) which aligns with broader international trends and the WHO’s concerns that new nicotine products are undermining tobacco control gains, particularly among younger people. 

The AMA continues to argue for nationally consistent tobacco retail licensing, stronger enforcement, cross-jurisdictional data capability, closure powers, and future-proofing for emerging nicotine products. This multi-pronged and coordinated approach would support an effective effort to ensure tobacco and nicotine use continues to fall in Australia. 

Notes to editors: 

The latest National Drug Strategy Household Survey was held in 2025 and surveyed more than 17,500 people across Australia.