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.

EU ‘TPD3’ Enters Next Phase on Aug. 14 as Fragmented Vape and Nicotine Pouch Rules Push the Single Market Toward Regulatory Overhaul
EU ‘TPD3’ Enters Next Phase on Aug. 14 as Fragmented Vape and Nicotine Pouch Rules Push the Single Market Toward Regulatory Overhaul
A 12-week European Commission consultation on revising the Tobacco Products Directive and Tobacco Advertising Directive is due to close on Aug. 14, 2026. The Commission has identified e-cigarette flavours, disposable vapes, tobacco heating devices, nicotine pouches, nicotine-free e-cigarettes, packaging and digital marketing among areas for possible new EU rules. National regulations already vary significantly across the bloc, a fragmentation the Commission says creates internal-market barriers and distorts competition. No formal revised TPD/TAD legislative text has yet been published, with the Commission currently indicating December 2026 for the legislative initiative.
Aug.14
IVG Parent Secures HMRC Excise Warehouse and Duty Stamp Approvals Ahead of UK Vape Tax
IVG Parent Secures HMRC Excise Warehouse and Duty Stamp Approvals Ahead of UK Vape Tax
Acme Vape Ltd, the company behind UK vaping brand IVG, has received HM Revenue & Customs approval to operate an excise warehouse for vaping products and participate in the Vaping Duty Stamps Scheme. The UK's Vaping Products Duty will take effect on October 1, 2026, at a flat rate of £2.20 per 10ml of vaping liquid. Acme Vape Ltd says its approved warehouse in Preston will become operational under the new regime on the same date.
Regulations
Sep.18 by 2Firsts Perspectives
Former Roche Neuroscience and Rare Diseases Communications Director Ria Kioupritzi Joins PMI as Scientific Affairs Director
Former Roche Neuroscience and Rare Diseases Communications Director Ria Kioupritzi Joins PMI as Scientific Affairs Director
Eleftheria (Ria) Kioupritzi, a biopharmaceutical professional with more than 15 years of experience, has joined Philip Morris International as Director Scientific Affairs within Corporate Affairs. She previously served at Roche as Senior Scientific Communications Director for Neuroscience and Rare Diseases and worked extensively in spinal muscular atrophy. Her earlier career also covered competitive intelligence, clinical and regulatory monitoring, pipeline development and launch preparation. During her time working in Roche's SMA field, Evrysdi passed through several U.S. FDA milestones, including its initial approval, an expanded indication for younger infants and approval of a tablet formulation. Public records do not show that Kioupritzi herself led the FDA submissions.
Sep.22
Altria’s USSTC Starts $250 Million Kentucky Expansion, Adding More Than 200 Jobs
Altria’s USSTC Starts $250 Million Kentucky Expansion, Adding More Than 200 Jobs
U.S. Smokeless Tobacco Company, an Altria Group company, has broken ground on an approximately $250 million manufacturing expansion in Hopkinsville, Kentucky. The roughly 270,000-square-foot facility is expected to create more than 200 jobs and absorb processing, manufacturing and packaging operations currently split between Hopkinsville and Nashville, Tennessee. USSTC previously said production at its Nashville facility is expected to wind down by early 2028. The project forms part of Altria’s broader effort to modernize and consolidate its U.S. smokeless tobacco manufacturing network.
Sep.10
Product | JT to Launch MEVIUS Tropical Option in Japan, Expanding Ploom Tobacco Stick Lineup to 32
Product | JT to Launch MEVIUS Tropical Option in Japan, Expanding Ploom Tobacco Stick Lineup to 32
Japan Tobacco (JT) will launch MEVIUS Tropical Option, a new tobacco stick for Ploom, nationwide in Japan from October 6, 2026. The capsule-format product combines mango-oriented sweetness with menthol cooling, adding a tropical flavor to the MEVIUS Ploom tobacco-stick lineup for the first time. Each pack contains 20 sticks and will launch at JPY 590. The product is compatible with all Ploom devices, and its addition will expand the Ploom tobacco-stick portfolio to 32 variants.
Sep.08
JUUL Purchasers Ask Ninth Circuit to Preserve Antitrust Classes in Case Over Altria’s $12.8 Billion Investment
JUUL Purchasers Ask Ninth Circuit to Preserve Antitrust Classes in Case Over Altria’s $12.8 Billion Investment
Private antitrust litigation stemming from Altria's 2018 $12.8 billion investment for a 35% economic interest in JUUL is advancing before the U.S. Court of Appeals for the Ninth Circuit. Direct purchasers, indirect purchasers and indirect resellers of JUUL products filed answering briefs this week seeking to preserve class certifications granted by a California federal court in February. Altria and JUUL argue that individual consumers and large distributors differ too much in purchasing terms to remain in a single direct-purchaser class, while a separate dispute concerns whether California antitrust law can apply to indirect purchasers across 27 jurisdictions. A September trial has been put on hold during the appeal.
Sep.23