Nicotine pouches are illegal in Australia unless prescribed

There has been an increase in the illegal advertising and online sales of nicotine pouches, with many of these products being imported from overseas. It is important to note that nicotine pouches are considered therapeutic goods and there are no nicotine pouches approved in Australia by the TGA. This means that nicotine pouch products have not been tested for safety, quality, or effectiveness.

Nicotine pouches

They are small pouches (or bags) placed between the lip and gum. They typically contain nicotine in various strengths, along with other substances such as sweeteners and flavourings.

They are often marketed as a “smoke-free” or “tobacco-free” alternative to smoking or vaping. However, there is little evidence that they are effective in helping people quit smoking or vaping or in managing nicotine dependence.

What you need to know

Under Australian law, nicotine pouches are prescription only medicines. This means they:

• cannot be sold by retail outlets or tobacconists
• cannot be advertised
• cannot be imported or sold without TGA approval or a valid written authority or prescription from an Australian health practitioner.

Some states or territories may have additional restrictions. For example, in South Australia, nicotine pouches are banned under new tobacco and e-cigarette legislation.

Breaking the law can lead to serious consequences. Significant penalties under the Therapeutic Goods Act 1989 apply for advertising and supply offences. This includes imprisonment for up to 5 years, a fine of up to $1.32 million, or both. Further penalties may also apply under state and territory medicines and poisons laws.

Health risks

Nicotine pouches can be dangerous. Some contain high levels of nicotine, which can lead to side effects or overdose. They are not made to Australian standards and their safety hasn’t been checked. They may contain unknown and dangerous ingredients.

Nicotine is highly addictive, especially for young people. It can interfere with brain development, affecting memory, learning, and attention.

Side effects linked to nicotine pouches include:

• fast heart rate and high blood pressure
• nausea, dizziness, and headaches
• dry mouth and strange jaw sensations
• mouth sores.

Some of these products may not list nicotine as an ingredient. The lack of clear ingredient information on the label can cause delays in treatment if the product is swallowed. This is particularly dangerous for children. Additionally, mis-declared or mislabelled products are considered counterfeit and cannot be imported or supplied under any circumstances.

What you should do

• Make sure you have a prescription or written authority and meet all legal conditions before purchasing nicotine pouches. Speak with your doctor or pharmacist about the right way to access unapproved medicines. Read the TGA information about unapproved therapeutic goods.
• Don’t swallow nicotine pouches – if you or someone else does, call the Poisons Information Centre on 13 11 26.
• Seek urgent medical help if an infant or child swallows a nicotine pouch
• Report illegal ads or sales to the TGA
• Want to quit smoking or vaping? Talk to your health practitioner or go to:
  • quit.org.au
  • the free My QuitBuddy app
  • Quitline on 13 7848 (13 QUIT)

Information for health care practitioners

There are TGA-approved nicotine replacement therapies like patches, mist, and lozenges. Unlike pouches, these products meet Australia’s standards for quality, safety and efficacy. They are available in pharmacies and supermarkets.

Healthcare practitioners should be aware of their responsibilities when recommending nicotine pouches.

For clinical resources and training regarding smoking and vaping cessation, visit the Quit Centre.