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New regulations strengthen controls on nicotine pouches

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New regulations are now in place across Australia to protect public health, by restricting access to nicotine pouches.

The changes follow targeted consultation with stakeholders and reflect concerns about the health risks associated with emerging nicotine products, particularly their potential appeal to young people and increased risks of nicotine dependence.

From 24 July 2026, people can no longer import nicotine pouches through the Personal Importation Scheme, access them through the Special Access Scheme or Authorised Prescriber Scheme, or have them compounded by pharmacists.

The Personal Importation Scheme allows individuals to legally import therapeutic goods for personal use under certain conditions. Nicotine pouches can no longer be imported for personal use through this scheme.

The Special Access Scheme and Authorised Prescriber Schemes enable health practitioners to prescribe unapproved therapeutic goods to patients when use is clinically justified. Nicotine pouches can no longer be accessed through these pathways.

Pharmacists and certain other healthcare practitioners may compound medicines for individual patients when an approved medicine is not suitable. Under the new regulations, nicotine pouches cannot be compounded for individual patient use.

Professor Anthony Lawler, Deputy Secretary of the Department of Health, Disability and Ageing and Head of the TGA, said "These changes respond to growing public health concern about nicotine pouches and their increasing availability in the Australian market. They strengthen the ability of the TGA and its partner agencies to combat the unlawful importation, advertising and supply of nicotine pouches, while ensuring Australians have access to safe, approved and evidence-based options to quit smoking and manage nicotine dependence."

Nicotine is highly addictive, and its use during adolescence can affect brain development and increase the risk of ongoing dependence. There is limited evidence that nicotine pouches help people to quit smoking or manage nicotine dependence, and their full health impacts remain unknown. They may pose significant health risks, including high or inconsistent nicotine content, potential contaminants and misleading labelling.

Australians have access to a range of safe, approved and evidence-based options to help them quit smoking and manage nicotine dependence. These include nicotine replacement therapies, such as patches, gum and lozenges, as well as other medicines where clinically appropriate.

People seeking support should speak with their doctor, pharmacist or other health practitioner, call Quitline on 13 7848 (13 QUIT), visit quit.org.au, or download the MyQuitBuddy app. These services can provide advice, support and access to treatment options tailored to individual needs.

There is more information about nicotine pouches and the changes to regulations on the TGA website at: Nicotine pouches.

Any organisation or individual with information about the unlawful sale or supply of nicotine pouches is encouraged to report it to the TGA.

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