New regulations are in place across Australia to restrict access to nicotine pouches to protect public health, said the country’s Therapeutic Goods Administration.The changes follow consultations with stakeholders and reflect concerns over the health risks associated with emerging nicotine products, particularly their potential appeal to young people and the increased risk of nicotine dependence. From July 24, people can no longer import nicotine pouches through the Personal Importation Scheme, nor access them through the Special Access Scheme or Authorised Prescriber Scheme, nor have them compounded by pharmacists.The Personal Importation Scheme allowed individuals to import therapeutic goods for personal use under certain conditions. The Special Access Scheme and Authorised Prescriber Scheme enabled health practitioners to prescribe unapproved therapeutic goods to patients when the use is clinically justified. Pharmacists and certain other healthcare practitioners could 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.Prof. Anthony Lawler, Deputy Secretary of the Department of Health, Disability and Ageing, and Head of 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 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.(Source: TGA)Published on July 27, 2026