Australia is facing the early emergence of an unregulated public health crisis linked to unapproved nicotine pouches, with top medical authorities calling on the federal government to act fast to close regulatory gaps before the problem escalates into a repeat of the nation’s devastating vaping epidemic.
In an official submission shared with the Therapeutic Goods Administration (TGA), the Australian Medical Association (AMA) is pressing the Albanese Government to immediately close existing loopholes that are allowing unapproved nicotine-containing products to flow freely into the domestic Australian market. As federal AMA vice president Associate Professor Julian Rait emphasized, regulatory inaction right now will allow these addictive products to become deeply entrenched across the country, a mistake Australia has already made with unregulated vapes in recent years.
Currently, not a single nicotine pouch product holds formal approval on the Australian Register of Therapeutic Goods (ARTG), yet these products are widely available to consumers, including minors, Rait says. Unlike approved therapeutic nicotine products intended to help adults quit smoking, these unregulated pouches are marketed with bright, youth-appealing branding and sold through online platforms with almost no barriers to purchase. Some products have been found to carry extremely high concentrations of the addictive substance: independent, non-industry research has recorded nicotine levels as high as 150mg per pouch – equivalent to 50 cigarettes, given a 30mg pouch matches the nicotine content of a single conventional cigarette.
Beyond addiction, these unregulated pouches carry confirmed negative health impacts for users, Rait explained. Common adverse effects include persistent mouth and gum irritation, gastrointestinal distress, nausea, and elevated blood pressure, with long-term health risks still understudied because of the product’s unapproved status.
The submission also highlights that the combination of fast-growing social media promotion, loose online sales rules, and the rising use of unregulated synthetic nicotine has stretched Australia’s patchwork current regulatory framework to breaking point. Rait warned that without updated, technology-neutral national regulations and consistent cross-jurisdictional enforcement, unlicensed suppliers will keep exploiting grey market gaps to reach Australian consumers.
To address the crisis, the AMA is calling for a suite of targeted public health safeguards. These include mandatory, effective online compliance protocols to remove illicit product listings, clear and standardized health warnings on all packaging, child-resistant packaging requirements to prevent accidental child poisoning, and enhanced national monitoring of adverse health events and poisoning cases to inform ongoing regulatory adjustments.
Right now, Australia’s response to nicotine pouches is fragmented: state and territory governments have implemented inconsistent rules, with only a handful of jurisdictions such as South Australia and Queensland acting to restrict the products under existing tobacco legislation, while others have taken no formal action. The AMA’s proposed national regulatory framework would harmonize rules across the country, simplify enforcement for local authorities, eliminate inconsistencies between regions, and create a unified, robust enforcement environment to block unapproved products from the market.
“Without urgent federal action, we risk repeating every mistake that allowed the vaping epidemic to take hold and harm a generation of young Australians,” Rait said.