Tighter regulatory controls of nicotine pouches needed to avoid harm
The Australian Medical Association is calling for increased regulation of nicotine pouches, warning the products are being promoted and sold in ways that risk repeating the public health harms seen with vaping.
In a submission to the Therapeutic Goods Administration’s targeted consultation on the regulation of nicotine pouches, the AMA has urged the federal government and enforcement agencies to move quickly to close loopholes that are allowing unapproved nicotine products to enter the market.
Federal AMA Vice President Associate Professor Julian Rait said reported harms from nicotine pouches included mouth and gum irritation, upset stomachs, nausea and high blood pressure.
“A non-industry study showed that nicotine absorption from pouches containing 30 mg nicotine was comparable with that from one cigarette and some pouches contain up to 150mg of nicotine,” A/Prof Rait said.
“These pouches are being marketed with youth-attractive branding and sold online with minimal friction, despite having no approved therapeutic indication in Australia. Regulators must not wait until the use of nicotine pouches becomes entrenched in Australia.”
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.
A/Prof Rait said the AMA supports the TGA’s proposed amendments to prevent access to unapproved nicotine pouches via existing pathways including the Special Access Scheme, the Authorised Prescriber scheme, personal importation arrangements, and extemporaneous compounding.
The AMA has also warned that the rapid growth of online promotion and sales, alongside the increasing use of synthetic nicotine, is exposing gaps in regulation and enforcement.
“Without stronger, technology-neutral rules and consistent national enforcement, suppliers will continue to exploit grey areas,” A/Prof Rait said.
“We need stronger safeguards, including effective online compliance and takedown processes, clear and consistent health warnings, child-resistant packaging, and better monitoring of adverse events and poisoning presentations to inform ongoing regulatory action.”
The AMA submission says implementing the proposed amendments would support more consistent national regulation and reduce the burden on state and territory governments who are using piecemeal mechanisms to address nicotine pouches as an emerging product category.
“While some jurisdictions have acted — such as South Australia and Queensland under their tobacco legislation — others have not,” A/Prof said.
“Action at the federal government level will help harmonise expectations, improve inter-jurisdictional consistency, and strengthen the overall enforcement environment.”
