TGA warning about unapproved nicotine gum products

The Therapeutic Goods Administration (TGA) is warning consumers about unapproved nicotine gum products being unlawfully supplied in Australia.

During a recent enforcement operation, the TGA seized large quantities of suspected unlawful, counterfeit nicotine chewing gum labelled as containing high doses of nicotine. These are pictured below.

These products are not entered in the Australian Register of Therapeutic Goods (ARTG) and have not been assessed by the TGA for quality, safety or efficacy. Consumers cannot be confident that these products contain the ingredients or amount of nicotine stated on the label, or that they have been manufactured to appropriate quality standards.

Nicotine is highly addictive and can be harmful to health. The TGA warns consumers against using these unapproved products.

Information for consumers

Nicotine can be toxic, particularly to children. Nicotine products should be kept out of the reach of children. If you suspect a child has swallowed nicotine gum or any other nicotine product, contact the Poisons Information Centre on 13 11 26 for advice.

Consumers are advised to:

• not use unapproved nicotine gum products
• seek advice from a doctor, pharmacist or other health professional if they have used the product and have concerns
• purchase only approved or TGA-notified nicotine products from legitimate Australian pharmacies or suppliers.

There are approved nicotine gum products in the ARTG that have been assessed by the TGA.

These approved nicotine replacement therapy (NRT) products are lawfully supplied in Australia and contain 2-4mg of nicotine per piece.

People seeking help to quit smoking or manage nicotine dependence should speak with their doctor, pharmacist or other healthcare practitioner about appropriate treatment options, including NRT.

Support is also available through Quitline on 13 7848 (13 QUIT).

Why unapproved nicotine gum products are a concern

Products registered in the ARTG are subject to Australian requirements for quality, safety and efficacy.

Consumers should be cautious about nicotine products purchased online, through social media or from other unverified sources.

Products obtained through these channels may:

• be fake
• contain higher or inconsistent amounts of nicotine than stated on the label
• contain undisclosed or potentially harmful ingredients
• be in packaging that children can easily open
• fail to meet Australian quality and safety standards
• be advertised, manufactured, imported and/or supplied in Australia unlawfully.

Action we are taking

The TGA is investigating the importation, advertising and supply of these suspected unlawful, counterfeit nicotine products.

Therapeutic goods must not be imported into or supplied in Australia unless they are entered on the ARTG, or are otherwise subject to a relevant exemption, approval or authority under the Therapeutic Goods Act 1989 (Cth). It is also generally unlawful to advertise unapproved therapeutic goods, or therapeutic goods that contain substances that are classified as pharmacist only, prescription only or controlled drugs. Our investigation is ongoing. Further action may be taken where breaches of therapeutic goods legislation are identified.

The TGA has recently strengthened regulations for emerging nicotine products. From 24 July 2026, there is no longer a lawful pathway to import nicotine pouches for personal use in Australia. It remains illegal for retailers, including online sellers, to sell nicotine pouches in Australia.

Reporting problems

If you experience a suspected side effect or adverse event after using a nicotine product, please report it to the TGA. This helps us to monitor and respond to emerging safety concerns.

If you suspect non-compliance in relation to therapeutic goods, you can report a perceived breach or questionable practice to the TGA.

Phone: 1800 020 653
Email: info@tga.gov.au

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