Nicotine pouches

Nicotine pouches are small, tobacco-free sachets that can contain high levels of nicotine. They may also contain other chemicals such as sweeteners, flavours and undeclared substances. They are placed in the mouth between the lip and the gum, where the nicotine is absorbed rapidly into the bloodstream. Nicotine pouches are often marketed as smoke-free alternatives to smoking or vaping including through lifestyle and performance enhancing claims. They are available in a range of flavours and packaging that may appeal to young people.

Nicotine pouches have not been evaluated by the TGA for quality, safety or efficacy. There is no nicotine pouch product included on the Australian Register of Therapeutic Goods (ARTG).

Nicotine pouches are distinct from snus, which is a smokeless oral tobacco product that has been prohibited from supply in Australia since 1991.

The unlawful advertising and sale of nicotine pouches has increased, with many of these products being imported from overseas.

Their increasing availability and promotion, particularly to young people through social media, increases the risk of nicotine dependence. This may also undermine public health measures designed to reduce tobacco and vaping use.

The changes follow targeted consultation with health practitioners, healthcare representatives and tobacco control experts. This consultation demonstrated strong support for greater regulation of nicotine pouches.

Some states or territories have implemented strict controls or bans on nicotine pouches, and these remain in place.

The changes will provide greater clarity within the national regulatory framework and strengthen the ability to address unlawful importation, advertising and supply of nicotine pouches.

The long-term health effects of nicotine pouches remain unknown, and there is limited evidence that they support smoking cessation.

Nicotine is highly addictive and nicotine pouches can contribute to dependence. Nicotine use during adolescence can affect brain development, memory and learning, and increase vulnerability to ongoing dependence and other substance use. Emerging evidence also suggests that the use of nicotine pouches, especially by young people, may be associated with use of other nicotine-containing products.

Potential risks associated with nicotine pouches include:

• high and inconsistent nicotine content
• presence of unknown contaminants in products
• lack of child-resistant packaging and inadequate risk warnings on labels
• short-term adverse effects such as nausea, mouth lesions and dental damage, and
• potential cardiovascular effects associated with nicotine.

Consumers can no longer import nicotine pouches under the Personal Importation Scheme, even with a prescription from a medical practitioner.

Travellers cannot bring nicotine pouches into Australia as the traveller’s exemption no longer applies to nicotine pouches.

Nicotine pouches imported into Australia will be seized at the border and destroyed by the Australian Border Force.

Nicotine pouches are no longer available for supply on prescription.

Healthcare practitioners, including pharmacists, can no longer lawfully prescribe or supply nicotine pouches under the following unapproved therapeutic goods pathways:

• Special Access Scheme (SAS)
• Authorised Prescriber (AP) Scheme
• Personal Importation Scheme (PIS)
• Pharmacist compounding exemption.

Healthcare practitioners may see an increase in people who have been using nicotine pouches seeking support to manage nicotine dependence. The regulatory changes do not affect access to approved nicotine replacement therapies (NRTs), Pharmaceutical Benefit Scheme subsidised quit medicines, or therapeutic vaping goods.

Quit Centre provides health professionals with the latest clinical information, resources and training on smoking and vaping cessation. For more information see Quit Centre.

Nicotine pouches cannot be lawfully imported into or supplied in Australia unless they are included in the ARTG, used for research purposes under the Clinical Trials Notification (CTN) or Clinical Trials Approval (CTA) schemes, or subject to another statutory exemption pathway.

Sponsors of nicotine pouches may still apply for inclusion on the ARTG. See Overview of applying for market authorisation for more information.

It is unlawful to advertise nicotine pouches, including advertising that promotes these products for smoking or vaping cessation. This applies across all media, including online platforms.

It is also unlawful for retailers, including online sellers, to supply or sell nicotine pouches in Australia.

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 ($1.456 million) or both, depending on the circumstances, and for corresponding civil penalties, up to 5,000 penalty units for an individual ($1.82 million) or 50,000 penalty units for a company ($18.2 million).

Further penalties under state and territory medicines and poisons laws may also apply.

Many resources and support options are available to help people quit smoking or vaping, or manage their nicotine dependence.

Individuals can:

• speak with their health practitioner, pharmacist or counsellor at 13 QUIT (13 7848) about what options may be best to support their quit journey
• use quit medicines or nicotine replacement therapy (NRT) to help manage cravings
• visit quit.org.au for more information or to create a personalised quit plan, or
• download the My QuitBuddy app for tips and tricks to successfully quit and stay quit.

The most effective way to successfully quit is to combine behavioural support with either a quit medicine or NRT such as patches, gum, mouth sprays and lozenges. These products have a well-established role in quitting smoking and vaping. Subsidised access may be available through the Pharmaceutical Benefits Scheme.

People who have been unable to quit smoking with approved cessation therapies may be able to access therapeutic vapes through participating pharmacies, with advice and support from a health practitioner, subject to state and territory requirements.

Find out more about How to quit smoking and vaping.