AMA Calls for Stronger Regulation of Nicotine Pouches

AMA Calls for Stronger Regulation of Nicotine Pouches

07 May 2026

The AMA says the federal government and enforcement agencies should act to close regulatory gaps that are allowing unapproved nicotine pouches to enter the Australian market.

Under current rules, nicotine for human use is a Schedule 4 prescription-only medicine. However, no nicotine pouch products are listed on the Australian Register of Therapeutic Goods (ARTG), meaning there are no approved products for supply through normal channels.

The AMA supports proposed TGA changes aimed at blocking access to unapproved nicotine pouches through existing pathways, including the Special Access Scheme, Authorised Prescriber scheme, personal importation, and compounding arrangements.

The submission also raises concerns about growing online sales and promotion of nicotine pouches, along with the rise of synthetic nicotine. It warns these trends are creating gaps in regulation and enforcement.

The AMA says stronger national rules would improve consistency across Australia and reduce reliance on state and territory measures to manage this emerging product.

https://www.ama.com.au/

Source: Australian Medical Association (Federal submission to TGA consultation)
 

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