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.

Sweden Finds ZYN Ingredient Labels Noncompliant Over Generic Flavoring Disclosure, Swedish Match Faces SEK 2 Million Monthly Penalty
Sweden Finds ZYN Ingredient Labels Noncompliant Over Generic Flavoring Disclosure, Swedish Match Faces SEK 2 Million Monthly Penalty
Sweden's Public Health Agency has found ingredient labels on ZYN nicotine pouches sold by Philip Morris International subsidiary Swedish Match to be noncompliant, according to Dagens industri. The products' packaging listed 10 to 13 ingredients, compared with 11 to 42 in regulatory submissions, with multiple flavoring ingredients grouped under the generic term "aromer." The agency ordered corrective action, warning of a conditional penalty of SEK 2 million per month for noncompliance. The order applies only to products manufactured after the decision becomes legally effective and does not require recalls. Swedish Match disputes the agency's interpretation and plans to appeal.
PMI
Oct.22
2Firsts Data|China’s Vape-Related Exports Rose 3.3% in August 2026 as UK Shipments Jumped 51.4% and U.S. Exports Fell 12.4%
2Firsts Data|China’s Vape-Related Exports Rose 3.3% in August 2026 as UK Shipments Jumped 51.4% and U.S. Exports Fell 12.4%
China exported $979 million of vape-related products in August 2026, up 3.3% from a year earlier but down 6.4% from July. The UK replaced the U.S. as the main source of growth: UK-bound shipments jumped 51.4% to a 2026 high of $177 million, while exports to the U.S. fell 12.4% to $339 million. Shipments to markets outside the U.S. increased 14.2%, broadening growth beyond the market that had driven July’s rebound.
News
Sep.23 by 2Firsts Perspectives
Special Report | From Oversupply to Supply Gaps: Global Tobacco Leaf Markets Diverge Ahead of 2027
Special Report | From Oversupply to Supply Gaps: Global Tobacco Leaf Markets Diverge Ahead of 2027
Global tobacco leaf markets diverged sharply in 2026, with India cutting authorised FCV production amid oversupply while Malawi faced a supply shortfall. U.S. demand improved in some leaf categories, but growers in Brazil, Colombia, Tanzania and Zimbabwe faced pressure from prices, buyer access, costs and weather. With nicotine consumption patterns also shifting, 2027 will test whether supply, demand and grower profitability can move back toward balance.
Oct.26
Special Report|From CrossBar 20K to 6-Methyl Nicotine KUMI: Two Routes Into U.S. State Vape Directories?
Special Report|From CrossBar 20K to 6-Methyl Nicotine KUMI: Two Routes Into U.S. State Vape Directories?
Several U.S. states have incorporated the September 9, 2020 PMTA filing deadline into eligibility rules for certain vaping products. CrossBar 20K drew attention after appearing on Pennsylvania's 163-entry directory. A broader 2Firsts investigation found that related registration businesses also listed KUMI and CROSSBAR SIX products, with 171 KUMI-related entries across Louisiana, Nebraska and Wisconsin. Corporate records link Scott Silverman to Blue Nine LLC and VR Products I LLC. PMTA compliance expert Mr. K said historical applications and nicotine-analogue products may offer two different approaches to state-directory access.
Regulations
Oct.26
BAT Adds Former Apple General Counsel Bruce Sewell to Board as Finance, Legal, Marketing and Regional Leadership Shift
BAT Adds Former Apple General Counsel Bruce Sewell to Board as Finance, Legal, Marketing and Regional Leadership Shift
British American Tobacco has appointed former Apple Senior Vice President, General Counsel and Secretary Bruce Sewell as an independent non-executive director, effective January 1, 2027. He will also join BAT's Audit and Nominations Committees. BAT Chair Luc Jobin highlighted Sewell's experience in technology, government and regulatory affairs, public-company governance and AI-company boards. Over the past 18 months, BAT has changed or announced changes to its CFO, general counsel, CMO and APMEA regional leadership, while the main board has also seen multiple changes. The appointment comes as BAT advances Horizon 2030 and its Fit2Win transformation while expanding New Categories and reshaping parts of its digital, technology and operating structure.
Business
Oct.29
2Firsts First Look|China to End VAT Export Rebates on Vape Devices and Nicotine in April 2027, Following Earlier Removal for HTP Devices and Nicotine Vapes
2Firsts First Look|China to End VAT Export Rebates on Vape Devices and Nicotine in April 2027, Following Earlier Removal for HTP Devices and Nicotine Vapes
China's Ministry of Finance and State Taxation Administration announced on October 12, 2026, that value-added tax (VAT) export rebates for vape devices, nicotine and its salts, and certain non-combustible inhalation products will be eliminated from April 1, 2027. The measure adds four tobacco- and nicotine-related customs codes, including 8543400010, which covers vape devices and qualifying empty pods. China previously eliminated rebates for nicotine-containing vaping products and devices under code 8543400090 in April 2026. According to industry classification information held by 2Firsts, the latter currently corresponds to heated tobacco devices. Export excise tax refund and exemption arrangements will remain unchanged.
Special Report
Oct.12