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.


This document has been generated through artificial intelligence translation and is provided solely for the purposes of industry discourse and learning. Please note that the intellectual property rights of the content belong to the original media source or author. Owing to certain limitations in the translation process, there may be discrepancies between the translated text and the original content. We recommend referring to the original source for complete accuracy. In case of any inaccuracies, we invite you to reach out to us with corrections. If you believe any content has infringed upon your rights, please contact us immediately for its removal.

BAT AGM Highlights Smokeless Strategy, AI Capability and Regulatory Engagement
BAT AGM Highlights Smokeless Strategy, AI Capability and Regulatory Engagement
BAT Chair Luc Jobin told shareholders at the company’s 2026 Annual General Meeting that BAT delivered on its plans in 2025 despite a challenging external environment, with the U.S. business returning to growth, smokeless consumers increasing by more than 15%, improved New Categories contribution, and GBP 6.3 billion returned to shareholders.
Apr.16 by 2FIRSTS.ai
 FDA Begins Review of 22nd Century’s VLN MRTP Renewal Applications
FDA Begins Review of 22nd Century’s VLN MRTP Renewal Applications
The U.S. Food and Drug Administration (FDA) has initiated scientific review of renewal applications for 22nd Century Group’s VLN reduced-nicotine cigarettes under the Modified Risk Tobacco Product (MRTP) pathway, with current authorizations set to expire in December 2026.
News
May.13
 Bangladesh Approves Amended Tobacco Control Law Expanding Ad Bans and Smoke-Free Areas
Bangladesh Approves Amended Tobacco Control Law Expanding Ad Bans and Smoke-Free Areas
Bangladesh’s new government has approved a broad tobacco control amendment that bans tobacco advertising, promotion and display across print, electronic, digital and social media, entertainment platforms and points of sale. The law does not cover newer products such as vapes, heated tobacco products, electronic nicotine delivery systems or nicotine pouches.
Apr.22 by 2FIRSTS.ai
FDA Launches Elsa 4.0 and Completes HALO Data Platform Consolidation
FDA Launches Elsa 4.0 and Completes HALO Data Platform Consolidation
The U.S. Food and Drug Administration announced on May 6 that it has advanced its modernization initiative by launching Elsa 4.0, an upgraded internal AI tool, and consolidating more than 40 application and submission data sources, systems and portals into a new platform called HALO. FDA said the integration of HALO and Elsa will allow staff to query data and build workflows without manually uploading documents in each chat.
May.07 by 2FIRSTS.ai
Imperial Tobacco Canada Responds to Anti-Smoking Groups on Youth Vaping
Imperial Tobacco Canada Responds to Anti-Smoking Groups on Youth Vaping
Imperial Tobacco Canada responded to the April 17 press conference by anti-smoking groups by calling for a more focused, fact-based discussion on youth vaping that targets the illicit market. The company said youth should not be using nicotine products and that it supports strong measures to prevent youth access, but argued that the discussion failed to clearly distinguish between the regulated market and the illicit market that is driving youth access.
Apr.22 by 2FIRSTS.ai
France Bans Zyn and Other Nicotine Pouches, Violators Face Jail and Fines
France Bans Zyn and Other Nicotine Pouches, Violators Face Jail and Fines
France has officially banned nicotine pouches and other oral nicotine products, including Zyn. The new regulation classifies such products as “toxic substances” and imposes criminal penalties on their use, possession, purchase, and sale. Violators may face up to five years in prison and fines of up to €400,000 (approximately $436,600).
Regulations
May.25