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.

FDA and IKE Tech Hold Formal Listening Session on Youth Access and Illicit ENDS Products
FDA and IKE Tech Hold Formal Listening Session on Youth Access and Illicit ENDS Products
U.S. Food and Drug Administration’s Center for Tobacco Products held a formal listening session with IKE Tech LLC to discuss youth prevention at the point of use for ENDS products, the circulation of illicit products in the supply chain, and the regulatory treatment of software in tobacco products.
Apr.10 by 2FIRSTS.ai
Special Report| War continues to shape the Ukrainian tobacco market
Special Report| War continues to shape the Ukrainian tobacco market
Four years into the war, Ukraine’s tobacco market is being reshaped by stress-driven consumption, tax pressure, youth e-cigarette use and a growing illicit segment. Surveys point to rising tobacco and nicotine product use, while higher excise duties and shadow trade are adding new complexity to the market.
Apr.17
FDA Tobacco Center Pushes Review-Efficiency Statement After Commissioner’s Exit
FDA Tobacco Center Pushes Review-Efficiency Statement After Commissioner’s Exit
FDA CTP issued a May 7 statement on accelerating product review and improving PMTA efficiency, but did not push it via official X and newsletter until May 13, one day after FDA Commissioner Marty Makary’s resignation was confirmed. FDA has not explained the delay, and no public evidence links it directly to the leadership change. The timing is notable given CTP’s usual 24-hour distribution practice.
Special Report
May.14
    Shenzhen Tobacco Monopoly Bureau Moves to Advance E-Cigarette Regulatory System 2.0
Shenzhen Tobacco Monopoly Bureau Moves to Advance E-Cigarette Regulatory System 2.0
The Shenzhen Tobacco Monopoly Bureau recently held the city’s 2026 e-cigarette regulation work conference to implement higher-level meeting requirements, review the city’s e-cigarette regulatory work in 2025 and during the 14th Five-Year Plan period, assess the current situation, and deploy the rollout of E-cigarette Regulatory System 2.0 across Shenzhen’s tobacco commercial system.
Apr.28 by 2FIRSTS.ai
U.S. Senator Durbin Criticizes FDA’s First Flavored Vape Authorization, Says Trump Administration Conceded to Big Tobacco
U.S. Senator Durbin Criticizes FDA’s First Flavored Vape Authorization, Says Trump Administration Conceded to Big Tobacco
U.S. Senator Dick Durbin on May 13 criticized the Trump Administration’s Food and Drug Administration for approving the sale and marketing of fruit-flavored e-cigarettes for the first time, while also allowing some illegal vaping products to remain on the market. He also linked the regulatory shift to the departure of FDA Commissioner Marty Makary, saying White House pressure on regulators to approve tobacco product applications could create serious public-health consequences.
Regulations
May.15
Swedish Politicians Ask European Commission to Clarify Legality of France’s Nicotine Pouch Ban
Swedish Politicians Ask European Commission to Clarify Legality of France’s Nicotine Pouch Ban
France’s ban on oral nicotine pouches has triggered an immediate response in Sweden. Swedish Minister for Foreign Trade Benjamin Dousa said Sweden had mobilized strongly against the ban and argued that it constitutes a clear obstacle to the free movement of goods within the EU single market. Swedish officials say the measure affects a strategically important domestic industry and conflicts with Sweden’s harm-reduction approach to public health.
Apr.14 by 2FIRSTS.ai