Nicotine pouches
We are aware of the rising profile of nicotine pouches in Australia, particularly the promotion of nicotine pouches as an aid to support smoking or vaping cessation.
Nicotine pouches are subject to strict regulation and can only be imported, supplied and advertised in accordance with the Therapeutic Goods Act 1989 and state and territory medicines and poisons law.
No nicotine pouches have been evaluated by us for quality, safety or efficacy in Australia. No nicotine pouch is included in the Australian Register of Therapeutic Goods (ARTG).
Nicotine pouches are small pouches (or bags) containing nicotine and sometimes other ingredients such as sweeteners and flavours. Designed to be placed between the lip and gum, nicotine pouches do not contain tobacco leaf, dust, or stem, and are usually described as containing ‘synthetic nicotine’.
There is no strong evidence to support the use of nicotine pouches for smoking or vaping cessation. Evidence shows nicotine can be harmful and may have adverse impacts on adolescent brain development.
Anyone, including young people, requiring support to quit smoking or vaping are encouraged to reach out to a health professional or call the Quitline on 137848 (13QUIT).
Advertising
As there are no nicotine pouches on the ARTG, it is unlawful to advertise nicotine pouches, including when advertising these products for the purposes of smoking or vaping cessation. This includes online advertising.
In addition, a nicotine pouch cannot be publicly advertised because the supply of a nicotine pouch for a purpose other than smoking cessation requires a prescription. The advertisement of prescription medicines is prohibited.
We are monitoring and taking compliance and enforcement action where advertisements breach the Therapeutic Goods Act 1989. Penalties may apply to those who are alleged to have advertised nicotine pouches in Australia.
Supply
Under Australian law, nicotine pouches are therapeutic goods. To be lawfully supplied in Australia, nicotine pouches must be included in the ARTG or have an authority or approval under the Therapeutic Goods Act 1989.
At the time of publication, no nicotine pouch has been included in the ARTG or received an authority or approval.
A TGA approval or authority to supply goods of this nature would be conditional on the product being sold in pharmacy settings.
Any nicotine pouch that is not expressly intended for smoking cessation - including when represented to be for recreational use - is a prescription medicine under Australian law. This means that it is illegal for consumers to buy nicotine pouches online or from retail outlets without a valid prescription from an Australian doctor.
It is unlawful for retailers such as tobacconists and convenience stores, to sell prescription medicines, even to customers with a prescription.
Applicable penalties under the Therapeutic Goods Act 1989 for advertising and supply offences include imprisonment for up to 5 years or up to 4,000 penalty units or both, depending on the circumstances, and for corresponding civil penalties, up to 5,000 penalty units for an individual or 50,000 penalty units for a company. Further sanctions under state and territory medicines and poisons laws may also apply.
Importation
As no nicotine pouch is included in the ARTG, an exemption, approval or authority from us under the Therapeutic Goods Act 1989 is required for lawful importation.
Consumers can import nicotine pouches under the Personal Importation Scheme with a valid prescription from an Australian-registered medical practitioner. Any use of the personal importation scheme is subject to the other conditions of scheme.
If an import does not meet these conditions, and no other exception applies, the products may be seized and destroyed.
In all instances, a nicotine pouch would also need to meet state or territory requirements to be imported.
We are working with the Australian Border Force and continuing to monitor and take action against unlawful importation and supply of nicotine pouches as appropriate and necessary in the circumstances.
Oral tobacco
There is a ban on chewing tobacco and snuffs intended for oral use. Oral tobacco products have been prohibited in Australia since June 1991.
Reporting non-compliance
If you suspect non-compliance in relation to therapeutic goods or their advertising, you can report it to us at any time.
Further information
More information on the rollout of reforms to vape regulation in Australia is available on the Vaping hub.
Contact for members of the media:
- Email: news@health.gov.au
- Phone: 02 6289 7400