US Appeals Court Orders FDA to Re-examine E-cigarette Regulations

Sep.16.2022
US Appeals Court Orders FDA to Re-examine E-cigarette Regulations
US court approves appeal of 4 e-cigarette companies, requiring the FDA to reconsider their tobacco product applications.

Recently, the United States Court of Appeals for the Eleventh Circuit approved the appeals of four electronic cigarette companies, demanding that the U.S. Food and Drug Administration (FDA) reconsider the pre-market tobacco product applications submitted by these four companies. The court stated that the FDA did not conduct a thorough and reasonable evaluation of these four companies, and that the FDA's decision was too arbitrary. The court ruled that before the FDA issues a ban, it must consider all legal regulations and relevant factors. In the future, the FDA must have sufficient legal basis and corresponding evidence before making decisions, rather than relying solely on the results of a vote.


This article contains excerpts or reprints of content from third-party sources, the copyright of which belongs to the original media and authors. If there is any infringement, please contact us for deletion. Any organization or individual wishing to reprint should contact the author and not reproduce the content directly.



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.

FDA Grants PMTA Authorization to 11 ZYN ULTRA Nicotine Pouches, Bringing Total Authorized Pouches to 43
FDA Grants PMTA Authorization to 11 ZYN ULTRA Nicotine Pouches, Bringing Total Authorized Pouches to 43
The U.S. Food and Drug Administration authorized 11 ZYN ULTRA nicotine pouch products made by Swedish Match USA through the premarket tobacco product application pathway on August 21, 2026. Ten of the authorized products have a labeled nicotine content of 9 mg, while ZYN ULTRA Smooth was authorized at 11 mg. The reviews were conducted through FDA’s nicotine pouch PMTA pilot program. FDA has now authorized 43 nicotine pouch products, including 23 through the pilot.
Aug.24
Product | PMI Japan Expands ZYN by IQOS Strength Portfolio With Strong Series, Increasing Lineup to 12 Products
Product | PMI Japan Expands ZYN by IQOS Strength Portfolio With Strong Series, Increasing Lineup to 12 Products
Philip Morris Japan (PMJ) has expanded the ZYN by IQOS oral tobacco pouch portfolio in Japan with four new ZYN Strong products, adding a third intensity level alongside the existing Low and Medium ranges. The Strong series first entered selected duty-free channels in Japan on July 1, 2026, before expanding to IQOS stores, the ZYN Online Store and selected tobacco retailers from August 18. The expansion increases the Japanese ZYN by IQOS lineup from eight to 12 products.
Aug.20
Canada Considers Easing Pharmacy-Only Nicotine Pouch Sales Rules, Potentially Reopening Convenience Store Channel
Canada Considers Easing Pharmacy-Only Nicotine Pouch Sales Rules, Potentially Reopening Convenience Store Channel
Canada's federal government is considering changes to current restrictions on where nicotine pouches can be sold, potentially allowing authorized products to return to convenience stores and other general retail channels, although no decision has been made. Since 2024, emerging nicotine replacement therapy products such as nicotine pouches have been largely restricted to behind-the-counter pharmacy sales. Health Canada, meanwhile, continues to recall unauthorized and higher-strength nicotine pouches, indicating that the current discussion concerns retail access for authorized products rather than a broad relaxation of nicotine pouch regulation.
Sep.14
IKE Tech Launches IKE 2.0 Compliance Platform for Nicotine Products
IKE Tech Launches IKE 2.0 Compliance Platform for Nicotine Products
IKE Tech launched IKE 2.0 on September 28, initially targeting nicotine products with a platform that combines user identity verification, product authentication, configurable policy controls and data analytics. Products can be authenticated through direct device integration or NFC smart tags. IKE Tech was formed with participation from Ispire's Aspire North America, Berify and Chemular, with Ispire currently holding a 40% interest. Its age-verification component PMTA was accepted by the FDA in 2025 and remains under review. The company did not disclose customer names, commercial deployment volumes, pricing or revenue tied to IKE 2.0.
News
Sep.29 by 2Firsts Perspectives
Product | KT&G to Launch lil Tonino Lamborghini in South Korea, Bringing 3-Second Heat-Up to New HTP Platform
Product | KT&G to Launch lil Tonino Lamborghini in South Korea, Bringing 3-Second Heat-Up to New HTP Platform
KT&G will launch the lil Tonino Lamborghini heated tobacco device in Seoul on September 15, 2026. The product introduces a new heating technology called Flashwave Heating, which uses microwaves to heat tobacco sticks internally and delivers a manufacturer-rated heat-up time of about three seconds. The device features an all-metal aluminum body, a color display and a dedicated GUI, and launches alongside a new line of NAU tobacco sticks that are incompatible with existing lil consumables. Korean media describe the product as KT&G's first new heated tobacco platform since lil AIBLE was introduced in 2022.
Aug.31
Russia’s Vape Device Labeling Regime Enters Force: Registration Starts in September, Mandatory Coding in December
Russia’s Vape Device Labeling Regime Enters Force: Registration Starts in September, Mandatory Coding in December
Russia's digital labeling regime for reusable e-cigarettes and similar personal vaping devices entered its first mandatory phase in September 2026. From September 1, manufacturers, importers and other market participants must register with the national Chestny ZNAK tracking system. From December 1, newly manufactured and imported covered devices will be required to carry digital identification codes and be reported as entering circulation. Russia has also issued new operational guidance for imports, marking the transition from a voluntary pilot to phased mandatory implementation.
Sep.15