Australia's TGA Issues Infringement Notice for Nicotine E-Cigarette Promotion

Aug.03.2022
The TGA has issued a $2664 infringement notice to an individual in NSW for promoting and selling nicotine e-cigarettes without proper registration.

The Australian Therapeutic Goods Administration (TGA) has issued a $2664 infringement notice to an individual in New South Wales for allegedly promoting and selling nicotine e-cigarette products on their website.


Despite being informed of the relevant laws, this individual continued to promote nicotine e-cigarette products to the public. In Australia, these products are considered prescription drugs and can only be obtained through a valid prescription from a registered Australian doctor. Advertising to the public is only allowed under the conditions of the 2021 Therapeutic Goods (Restriction and Prohibition of Nicotine) Advertising Code (No. 2).


The law focuses on the importation, manufacture, advertisement, and supply of nicotine e-cigarette products. It aims to balance the need to prevent youth and young adults from using nicotine e-cigarettes (and potentially developing a smoking habit) while providing support for current smokers to access appropriate medical means to quit smoking.


This article's content is compiled from third-party information and is intended solely for industry exchange and learning.


This article does not represent the viewpoint of 2FIRSTS, and 2FIRSTS cannot confirm the truth or accuracy of the content. The compilation of this article is only intended for industry communication and research purposes.


Due to limitations in the translator's skill level, the translated article may not fully express the same meaning as the original. Please refer to the original article for accuracy.


2FIRSTS is completely aligned with the Chinese government's views and positions on any domestic, Hong Kong, Macau, Taiwan, and international issues.


The copyright of the compiled information belongs to the original media and author. If there is any infringement, please contact for deletion.



Disclaimer

This article is provided solely for professional research, industry discussion, and informational purposes. Any references to brands, companies, products, technologies, or policies are made for factual reporting and analytical purposes only, and do not constitute endorsement, recommendation, promotion, or advertising by 2Firsts.

Nicotine-containing products, including but not limited to cigarettes, e-cigarettes, heated tobacco products, and nicotine pouches, carry significant health risks. Readers are responsible for complying with all applicable laws and regulations in their respective jurisdictions, including age restrictions and access limitations.

The information contained in this article should not be regarded as investment, legal, medical, regulatory, or commercial advice. While 2Firsts strives to ensure the accuracy and reliability of its content, it does not assume liability for any direct or indirect loss arising from errors, omissions, inaccuracies, or reliance on the information contained herein.

This article is not intended for individuals below the legal age for accessing tobacco or nicotine-related information in their jurisdiction.

 

Copyright Notice

This article is either original content produced by 2Firsts or content reproduced, translated, summarized, or adapted from third-party sources with attribution where applicable. The intellectual property rights of the original content remain with 2Firsts or the respective original rights holders.

No individual or organization may copy, reproduce, distribute, republish, modify, translate, or otherwise use this content without prior authorization. Any unauthorized use may result in legal action.

For copyright-related inquiries, corrections, or removal requests, please contact: info@2firsts.com.

 

AI-Assisted Translation and Editing Notice

Portions of this article may have been translated, edited, or reviewed with the assistance of artificial intelligence tools to improve efficiency and readability. Due to the limitations of AI-assisted translation and editing, discrepancies, omissions, or inaccuracies may exist when compared with the original source.

Where applicable, readers are advised to refer to the original source for the most complete and accurate information. If you identify any errors or believe that any content infringes upon your rights, please contact us at info@2firsts.com, and we will review and address the matter promptly.

Athletes Back Skoka's $21.5 Million Nicotine Pouch Venture: Can Its Consumer Health Founder Make an FDA-Focused Strategy Pay Off?
Athletes Back Skoka's $21.5 Million Nicotine Pouch Venture: Can Its Consumer Health Founder Make an FDA-Focused Strategy Pay Off?
U.S. nicotine pouch startup Skoka Inc. has raised $21.5 million and committed $15 million to an FDA regulatory and scientific research program. Founder Dan Aziz previously built dietary supplement brand Premama, which was acquired by Dr. Reddy's Laboratories in 2023. Skoka is combining proprietary formulations, ingredient transparency and equity investment from professional athletes. The company submitted a bundled PMTA covering 55 products on October 1, 2026. Aziz said Skoka declined an opportunity to enter retail in 2025, prioritizing product research and regulatory submissions instead. It now targets a U.S. retail launch in 2027, subject to FDA requirements. Its products have not received marketing authorization.
Business
Nov.04
PMI Expands U.S. ZYN Portfolio With New 1.5 mg and 8 mg Strengths, Moves Toward a Unified 20-Pouch-Per-Can Format
PMI Expands U.S. ZYN Portfolio With New 1.5 mg and 8 mg Strengths, Moves Toward a Unified 20-Pouch-Per-Can Format
Philip Morris International is expanding its U.S. ZYN nicotine pouch portfolio with new 1.5 mg and 8 mg strengths and plans to move its core 3 mg and 6 mg dry-pouch products from 15 to 20 pouches per can in the fourth quarter of 2026. ZYN ULTRA is also commercially available, with FDA authorization covering 10 products at 9 mg and one 11 mg Smooth product. PMI U.S. lists the new 1.5 mg and 8 mg strengths as commercially available, but as of September 10 they do not appear on the FDA’s public authorization list. Public materials do not identify which PMTA submissions cover the two new strengths or their current review status.
Sep.11
Italian Financial Police Seize 4.3 Million E-Cigarettes and Smoking Accessories; 28 Reported to Judicial Authorities Across Operations
Italian Financial Police Seize 4.3 Million E-Cigarettes and Smoking Accessories; 28 Reported to Judicial Authorities Across Operations
Italy's Guardia di Finanza announced on October 28 that officers in Latina province had seized approximately 4.3 million e-cigarettes and smoking accessories at an unauthorized warehouse in an operation involving restrictions on the possession and sale of tobacco-related products. Another 300,000 suspected counterfeit or unsafe items were confiscated during separate inspections, bringing total seizures across the operations to more than 4.6 million products. Twenty-eight people were reported to judicial authorities over suspected smuggling and counterfeiting offenses. Officials did not disclose separate vape quantities, the value of the merchandise or alleged violations associated with individual brands.
Enforcement
Oct.29
Sweden Finds ZYN Ingredient Labels Noncompliant Over Generic Flavoring Disclosure, Swedish Match Faces SEK 2 Million Monthly Penalty
Sweden Finds ZYN Ingredient Labels Noncompliant Over Generic Flavoring Disclosure, Swedish Match Faces SEK 2 Million Monthly Penalty
Sweden's Public Health Agency has found ingredient labels on ZYN nicotine pouches sold by Philip Morris International subsidiary Swedish Match to be noncompliant, according to Dagens industri. The products' packaging listed 10 to 13 ingredients, compared with 11 to 42 in regulatory submissions, with multiple flavoring ingredients grouped under the generic term "aromer." The agency ordered corrective action, warning of a conditional penalty of SEK 2 million per month for noncompliance. The order applies only to products manufactured after the decision becomes legally effective and does not require recalls. Swedish Match disputes the agency's interpretation and plans to appeal.
PMI
Oct.22
Product | Four CrossBar 20K 13mL High-Puff Vapes Listed on Pennsylvania's ENDS Directory, Rated for Up to 20,000 Puffs
Product | Four CrossBar 20K 13mL High-Puff Vapes Listed on Pennsylvania's ENDS Directory, Rated for Up to 20,000 Puffs
Four CrossBar 20K disposable e-cigarettes appeared on Pennsylvania's 163-entry ENDS directory ahead of enforcement beginning October 19, 2026. The devices feature 13mL e-liquid reservoirs, 50mg/mL nicotine, 2,000mAh batteries and 0.9Ω mesh coils, with advertised puff counts of up to 20,000. CrossBar was the only modern high-puff disposable series among the directory's 15 disposable entries. Its packaging emphasizes New York design and Japanese-origin flavoring, while historical CrossBar records identify a registered U.S. tobacco manufacturing-related establishment. The link between the newer 13mL devices and earlier 1.3mL PMTA filings remains unconfirmed.
product
Oct.26
Ispire Q4 Revenue Rebounds 33% but Full-Year Sales Still Fall 25% as FY2027 Focus Shifts to Malaysia Manufacturing, ODM, Nicotine Pouches and Age Verification
Ispire Q4 Revenue Rebounds 33% but Full-Year Sales Still Fall 25% as FY2027 Focus Shifts to Malaysia Manufacturing, ODM, Nicotine Pouches and Age Verification
Ispire Technology reported FY2026 revenue of about $96 million, down 24.7% year over year, as U.S. cannabis-vapor hardware and European e-cigarette sales declined by $17.4 million and $12.7 million, respectively. Fourth-quarter revenue rose 32.5% to $26.7 million, while quarterly gross margin fell to 6.3%. For FY2027, the company is prioritizing Malaysia manufacturing and vapor ODM while continuing to develop nicotine pouches, IKE Tech age-verification technology and G-Mesh licensing. Ispire has not separately disclosed the revenue or profit contribution of those newer businesses.
Regulations
Sep.17 by 2Firsts Perspectives