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.

JAMA Issues First U.S. Clinical Guidance on Vaping for Smoking Cessation, Urging Complete Switch From Cigarettes
JAMA Issues First U.S. Clinical Guidance on Vaping for Smoking Cessation, Urging Complete Switch From Cigarettes
JAMA has published a Special Communication offering systematic recommendations for U.S.-based clinicians on the use of nicotine e-cigarettes in adult smoking cessation. Developed by the Harm Reduction Workgroup of the Society for Research on Nicotine and Tobacco’s Treatment Research Network, the paper recommends including e-cigarettes alongside FDA-approved cessation medications in risk-benefit discussions. It cites high-certainty evidence that nicotine e-cigarettes achieve higher quit rates than nicotine replacement therapy and evidence suggesting efficacy comparable to highly effective medications such as varenicline and cytisine. For adults who choose vaping to quit, the authors recommend FDA-authorized products, sufficient nicotine delivery and a rapid, complete transition away from cigarettes rather than prolonged dual use.
Aug.13
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 | KIWI Launches Spark 2 and Spark 2 Pro in Germany, Two Hardware Tiers Share Backward-Compatible 2ml Pods
Product | KIWI Launches Spark 2 and Spark 2 Pro in Germany, Two Hardware Tiers Share Backward-Compatible 2ml Pods
KIWI has launched the Spark 2 and Spark 2 Pro refillable pod systems in Germany at official prices of €18 and €29, respectively. Spark 2 uses an 800mAh removable lithium-ion battery in a pen-style body, while Spark 2 Pro features a 1,400mAh removable battery, a box-shaped design and vibration feedback every 20 puffs. Both devices use the same 2ml Spark V2 pods in 0.8Ω and 1.2Ω versions, with AirSync airflow adjustment and a choice between Cotton Tips and conventional Drip Tips. The new pods also remain compatible with the original KIWI Spark.
News
Sep.29 by 2Firsts Perspectives
Product | PMJ Adds Bold Ruby to IQOS ILUMA i Lineup in Japan, Convenience-Store Rollout Starts Sept. 29
Product | PMJ Adds Bold Ruby to IQOS ILUMA i Lineup in Japan, Convenience-Store Rollout Starts Sept. 29
Philip Morris Japan (PMJ) launched Bold Ruby as a new regular color for the IQOS ILUMA i and IQOS ILUMA i ONE in Japan on September 16, 2026, priced at JPY 6,980 and JPY 3,980, respectively. Initial sales began through IQOS online and physical channels, with convenience stores and selected tobacco retailers set to follow from September 29. Bold Ruby is a regular rather than limited-edition colorway and is available for the ILUMA i and ILUMA i ONE, but not the ILUMA i PRIME. The release does not involve changes to the devices' core hardware or functions.
Sep.22
UK PM Andy Burnham Reshapes Vape Retail Rules as Licensing Could Raise Barriers for New Shops
UK PM Andy Burnham Reshapes Vape Retail Rules as Licensing Could Raise Barriers for New Shops
UK Prime Minister Andy Burnham is pushing a high street reform agenda that could give local authorities greater powers over commercial activity, including vape retail. The reforms could involve expanded planning powers and a potential vape retail licensing system, allowing councils to play a larger role in store locations and market access. The measures are part of the UK’s broader shift toward tighter vape regulation, although no nationwide vape retail restrictions have yet been implemented.
Aug.11
Reynolds Seeks to Join Altria Lawsuit Challenging FDA PMTA Rule and Calculation of 180-Day Deadline
Reynolds Seeks to Join Altria Lawsuit Challenging FDA PMTA Rule and Calculation of 180-Day Deadline
Three R.J. Reynolds companies are seeking to intervene in a lawsuit filed by Altria subsidiaries Helix Innovations and NJOY challenging the FDA's 2021 PMTA final rule. The companies dispute how the agency uses Acceptance and Filing reviews and completeness determinations to establish when the Tobacco Control Act's 180-day decision period begins. Reynolds has also linked prolonged PMTA reviews to competition from unauthorized vaping products. The FDA, meanwhile, has been accelerating reviews and reducing its backlog.
Sep.14