Is Nicotine Pouches Legal in Australia

The pouches are sold in small, colourful tins which normally contain between 15 – 20 pouches.

In early 2024, the New South Wales Health and Therapeutic Goods Administration conducted raids across Sydney, seizing illegal nicotine-related products including 30,000 e-cigarettes, 118,000 cigarettes, 45 kilograms of flavoured and loose-leaf tobacco and 284 containers of nicotine pouches.

This was across 60 retailers, amounting to a ‘total street value’ of over $1.1 million.

No nicotine pouches have been evaluated by the Therapeutic Goods Administration (‘TGA’) for quality, safety, or efficacy in Australia, meaning that there are none on the Australian Register of Therapeutic Goods.

This means that under Australian law, it is illegal for nicotine pouches to be commercially sold, imported, or advertised – as nicotine pouches are therapeutic goods.

If a therapeutic good is to be lawfully supplied in Australia, it must be included in the Register or otherwise have an authority or approval under the Therapeutic Goods Act 1989 (Cth).

Therefore, tobacconists, convenience stores and other retailers cannot sell this good to customers.

Furthermore, nicotine pouches are classified as a ‘prescription medicine’, which means that they may only lawfully be purchased with a valid prescription from an Australian doctor.

Whilst there are no Australian retailers that are permitted to sell nicotine pouches, consumers can nonetheless import them under the ‘Personal Importation Scheme’ – if they have a valid prescription.

Any use of the scheme is subject to its conditions.

The personal importation scheme permits an individual within Australia arranging for a therapeutic good to be sent to them from an overseas supplier, with the good to be used by that individual or an immediate family member (if they have a valid prescription, in this circumstance).

It is not permissible for the good to be sold or supplied to any other person.

You can import a 3-month supply per order. This is calculated by reference to the maximum dose recommended by the manufacturer.

The total quantity of the goods imported within a 12-month period cannot exceed a 15-month’s supply of the goods. If an import fails to meet these conditions, the products may be seized and destroyed.

The Therapeutic Goods Act 1989 (Cth) is a Commonwealth Act, which means it is applicable across the country, to individuals and businesses in each state and territory.

The Act provides that it is an offence to import or supply a therapeutic good (i.e., nicotine pouches), where this is not authorised or permitted.

If it is deemed that the import or supply of the relevant nicotine pouches would result or is likely to result in harm or injury to any person, the offence carries a maximum penalty of 5 years imprisonment and/or a $1,252,000 fine (4,000 penalty units x current value of $313), as per section 19B(1).

Where this harm is deemed not to be present, a maximum penalty of 12 months imprisonment and/or a $313,000 is nonetheless applicable (1,000 penalty units x current value of $313).

As there are no nicotine pouches on the Register, it is also unlawful to advertise nicotine pouches.

This includes advertising nicotine pouches for the purposes of smoking or vaping cessation, including online advertising.

A maximum penalty of a $1,565,000 fine is applicable for individuals (5,000 penalty units x current value of $313), whereas a maximum fine of $15,650,000 (50,000 penalty units x current value of $313) is applicable for a corporation, under section 42DLB.

Instead of formally charging individuals or businesses, the TGA may instead issue an infringement notice to a business or an individual for import, supply, or advertising of nicotine pouches, as an alternative to undertaking formal court action.

An infringement notice carries a financial penalty (i.e., a fine), which does not result in a criminal conviction when paid, avoiding the court process.