Australia's TGA reiterates: Nicotine pouches are prescription drugs in Australia, and unapproved products pose safety risks.

Aug.08
Australia's TGA reiterates: Nicotine pouches are prescription drugs in Australia, and unapproved products pose safety risks.
Illegal sale of nicotine pouches in Australia is on the rise, posing health risks and legal consequences.

Key points:

 

·Illegal sales on the rise: The illegal advertising and online sales of nicotine pouches in Australia have increased, with many products coming from overseas and not approved by the Therapeutic Goods Administration (TGA). 

·Legal restrictions: Nicotine pouches are considered prescription drugs in Australia and cannot be sold in retail stores or advertised. 

·Health risks: Nicotine pouches contain high concentrations of nicotine, which can lead to addiction, brain development issues, and various side effects. 

·Legal consequences: Those who violate the law may face up to 5 years in prison and a fine of up to 1.32 million Australian dollars (approximately 860,000 US dollars). 

·Consumer advice: Before purchasing nicotine pouches, make sure to have a prescription or written authorization, and consult a doctor or pharmacist.

 


 

According to the official website of the Therapeutic Goods Administration (TGA) on August 7th, illegal advertisements and online sales of nicotine pouches in Australia have increased, with many of these products being imported from overseas. It is important to note that nicotine pouches are considered prescription drugs in Australia and currently no nicotine pouch products have been approved by the TGA. This means that nicotine pouch products have not undergone safety, quality, and efficacy testing in Australia.

 

Nicotine pouches are small pouches placed between the lips and gums, typically containing varying strengths of nicotine, as well as other ingredients such as sweeteners and flavors. They are often marketed as a "smoke-free" or "tobacco-free" alternative to e-cigarettes. However, there is little evidence to suggest that they are effective in helping people quit smoking or reduce their dependence on nicotine.

 

According to Australian law, nicotine pouches are classified as prescription medications. This means that they:

 

It cannot be sold in retail stores or tobacco shops; advertising is not allowed; it cannot be imported or sold without approval from the TGA or a valid written authorization or prescription from an Australian healthcare practitioner.

 

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

 

Violating the law could lead to serious consequences. According to the 1989 Therapeutic Goods Act, significant fines, including up to 5 years imprisonment, a maximum fine of 1.32 million Australian dollars (approximately 860,000 US dollars), or both, may be imposed for illegal advertising and supply activities. Additionally, further fines may be imposed under state and territory medicines and poisons laws.

 

Nicotine pouches can be dangerous. Some nicotine pouches contain high concentrations of nicotine, which may lead to side effects. They are not produced according to Australian standards, and their safety has not been inspected.

 

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

 

Side effects associated with nicotine pouches include: increased heart rate and high blood pressure; nausea, dizziness, and headaches; mouth ulcers.

 

Some products may not list nicotine on the ingredients label. The lack of clear ingredient information on the label could potentially lead to delayed treatment if the product is ingested, which is especially dangerous for children. Furthermore, mislabeled products are considered counterfeit and should not be imported or supplied under any circumstances.

 

Before purchasing nicotine pouches, make sure you have a prescription or written authorization, and meet all legal requirements. Discuss with your doctor or pharmacist how to properly obtain unapproved medications. Read information from the Therapeutic Goods Administration (TGA) regarding unapproved therapeutic goods.

 

The Therapeutic Goods Administration (TGA) has approved nicotine replacement therapies, including patches, sprays, and lozenges. Unlike nicotine pouches, these products meet Australian quality, safety, and effectiveness standards. They are available for purchase at pharmacies and supermarkets.

 

We welcome news tips, article submissions, interview requests, or comments on this piece.

Please contact us at info@2firsts.com, or reach out to Alan Zhao, CEO of 2Firsts, on LinkedIn


Notice

1.  This article is intended solely for professional research purposes related to industry, technology, and policy. Any references to brands or products are made purely for objective description and do not constitute any form of endorsement, recommendation, or promotion by 2Firsts.

2.  The use of nicotine-containing products — including, but not limited to, cigarettes, e-cigarettes, nicotine pouchand heated tobacco products — carries significant health risks. Users are responsible for complying with all applicable laws and regulations in their respective jurisdictions.

3.  This article is not intended to serve as the basis for any investment decisions or financial advice. 2Firsts assumes no direct or indirect liability for any inaccuracies or errors in the content.

4.  Access to this article is strictly prohibited for individuals below the legal age in their jurisdiction.

 

Copyright

 

This article is either an original work created by 2Firsts or a reproduction from third-party sources with proper attribution. All copyrights and usage rights belong to 2Firsts or the original content provider. Unauthorized reproduction, distribution, or any other form of unauthorized use by any individual or organization is strictly prohibited. Violators will be held legally accountable.

For copyright-related inquiries, please contact: info@2firsts.com

 

AI Assistance Disclaimer

 

This article may have been enhanced using AI tools to improve translation and editorial efficiency. However, due to technical limitations, inaccuracies may occur. Readers are encouraged to refer to the cited sources for the most accurate information.

We welcome any corrections or feedback. Please contact us at: info@2firsts.com

InterTabac 2025 | Interview with German Vaping Trade Association: Opposition to Flavor and Disposable Bans as Black Market and Compliance Dominate the Agenda
InterTabac 2025 | Interview with German Vaping Trade Association: Opposition to Flavor and Disposable Bans as Black Market and Compliance Dominate the Agenda
During InterTabac 2025, 2Firsts spoke with the German vaping trade association (Verband des eZigarettenhandels e. V. (VdeH)). The association noted that while Germany’s market continues to grow, the black market may account for nearly half of total volume; disposables are reshaping retail channels. VdeH is firmly opposed to flavor bans and disposable bans, arguing such measures would expand the black market and drive users back to cigarettes.
Sep.19 by 2FIRSTS.ai
The top five states for e-cigarette use among U.S. youth are released. West Virginia and other states rank in the top five for e-cigarette use among youth.
The top five states for e-cigarette use among U.S. youth are released. West Virginia and other states rank in the top five for e-cigarette use among youth.
West Virginia leads U.S. with 27.5% of teens using e-cigarettes, surpassing national average, facing illegal sales accusations.
Sep.16 by 2FIRSTS.ai
Altria and Reynolds American announce launch of new smokeless tobacco products without FDA approval; anti-smoking advocates express concerns over potential impact on youth health
Altria and Reynolds American announce launch of new smokeless tobacco products without FDA approval; anti-smoking advocates express concerns over potential impact on youth health
Altria and Reynolds American are rolling out smoke-free products without FDA approval due to delays. They highlight that illegal e-cigarettes, with candy flavors, are gaining market share while legal products await approval. Altria will release a new nicotine pouch in select states, and Reynolds will launch a disposable e-cigarette. Advocates fear these unauthorized products may attract new users and harm youth.
Sep.01 by 2FIRSTS.ai
InterTabac 2025 Insights|RELX Unveils “Vaporless” Showcase Cabinet Featuring Nicotine Airpouch and Prototype Vaporless Device
InterTabac 2025 Insights|RELX Unveils “Vaporless” Showcase Cabinet Featuring Nicotine Airpouch and Prototype Vaporless Device
At InterTabac 2025, RELX’s oral-nicotine showcase featured leaf-shaped Nicotine Airpouch products under the WAKA, RELX, and DOSH brands, alongside a prototype “vaporless oral product.” The device produces no visible aerosol upon exhalation during light puffs and is currently for exhibition only, with no confirmed launch timeline. RELX also displayed a nose-inhaled e-cigarette that differs from conventional mouth-inhaled vaping by requiring nasal inhalation.
Sep.20 by 2FIRSTS.ai
Bedford supermarket ordered to close for three months for selling illegal tobacco and e-cigarettes
Bedford supermarket ordered to close for three months for selling illegal tobacco and e-cigarettes
Officials from the Trading Standards Department of Bedford City Council in the UK have issued a three-month closure order to a supermarket because it repeatedly violated regulations by selling illegal tobacco and e-cigarette products.
Sep.29 by 2FIRSTS.ai
South Korea’s KT&G Faces Mounting Cost Pressures: Imported Tobacco Leaf Prices Double in Four Years, Surpass Domestic Leaves for the First Time in 16 Years
South Korea’s KT&G Faces Mounting Cost Pressures: Imported Tobacco Leaf Prices Double in Four Years, Surpass Domestic Leaves for the First Time in 16 Years
South Korea’s KT&G, which relies on imported tobacco leaves for about 84% of its production, is under growing pressure as global leaf tobacco prices soar. In the first half of 2024, KT&G’s purchase price for imported tobacco leaves rose 8.4% year-on-year to KRW 11,000 per kg, surpassing domestic leaf prices for the first time in 16 years. Price hikes in Brazil and India are cited as the main drivers. KT&G plans to expand global production bases and cut processing costs to manage rising expenses.
Aug.25 by 2FIRSTS.ai