Federal AMA submission: regulation of unapproved nicotine pouches
Our submission to the Therapeutic Goods Administration’s targeted consultation on the regulation of nicotine pouches urges the federal government and enforcement agencies to close loopholes that are allowing unapproved nicotine pouches to enter the market.
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.
Our submission 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 submission warns that the rapid growth of online promotion and sales, alongside the increasing use of synthetic nicotine, is exposing gaps in regulation and enforcement. It 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.
