US Judge Rules Against FDA on Premium Cigar Regulation

Jul.07.2022
US Judge Rules Against FDA on Premium Cigar Regulation
A US judge ruled FDA's decision on regulating premium cigars as arbitrary and capricious, asks for briefing on decision reversal.

On Tuesday, a federal judge in the U.S. ruled that the FDA's decision to regulate premium cigars under the same federal laws as cigarettes and other tobacco products was arbitrary and capricious.


District Judge Amit Mehta in Washington D.C. has stated that the FDA disregarded relevant data on the health risks associated with high-quality cigars. He has requested the FDA and industry groups that question this regulation, including the Premium Cigar Association and the Cigar Rights of America, to submit briefs explaining why he should overturn the FDA's decision.


Michael Edney, the attorney for the plaintiff firm Steptoe & Johnson, stated that the family-owned manufacturer and retailer of high-quality cigars has long believed that the FDA has mishandled its regulation of premium cigars. He expressed gratitude for the court's ruling and the opportunity to pursue further legal action on this matter.


At this time, it is not possible to immediately reach out to the FDA for comment on this matter.


The focus of the lawsuit is the so-called certification rules passed by the agency in 2016, in which it exercised regulatory authority over a wide range of tobacco products, including premium cigars and cigarettes, under the Family Smoking Prevention and Tobacco Control Act.


The plaintiff stated that the organization considered and rejected high-quality cigars before finalizing its regulations, as well as during additional consultations in 2017 and 2018.


According to them, the FDA's regulations require cigar manufacturers to register their products annually and provide a list of ingredients for each product. They also require all products to undergo laboratory testing, which is impractical for "craftsmen" who produce high-quality handmade cigars.


Industry organizations state that unlike cigarettes and e-cigarettes, high-quality cigars are not appealing to young people and are not associated with addiction. They cite research indicating that young people are unlikely to use high-quality cigars, and those who do use them are unlikely to smoke cigars on a regular basis, thus not contributing to increased death rates.


On Monday, Mehta agreed that the FDA did not adequately consider the studies cited by the plaintiffs and instead claimed "there is no evidence to suggest" that high-quality cigars pose less of a health risk.


The judge wrote that when an institution unequivocally claims there is no evidence, while in fact there are relevant documented pieces of evidence, and the institution ignores or disregards it, it acts arbitrarily and capriciously.


The case is the lawsuit filed by the U.S. Cigar Association against the FDA in the District Court of Columbia, case number 16-cv-01460.


This article is a compilation of information from third-party sources and is intended solely for educational and informational purposes. All copyrights to the compiled information belong to the original media and authors, and any infringements should be reported for prompt removal.



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.

France Vape Market 2026: Use Reaches 7.9% Amid Tax, Regulatory and Scientific Debate
France Vape Market 2026: Use Reaches 7.9% Amid Tax, Regulatory and Scientific Debate
France remains one of Europe’s active vape markets in 2026, with adult vaping prevalence rising to 7.9%; at the same time, e-liquid taxation, public-space restrictions, advertising compliance and health-risk debate are pushing the industry into a critical policy period.
Jun.23
Imperial Brands Plans Thousands of Job Cuts Across U.S. and Europe in Cost Restructuring
Imperial Brands Plans Thousands of Job Cuts Across U.S. and Europe in Cost Restructuring
According to Reuters, citing Bloomberg News, British tobacco company Imperial Brands PLC plans to cut thousands of jobs across the United States and Europe as part of a cost reduction and organizational restructuring effort. The announcement drew market attention to the company’s shares. The move comes as global tobacco companies continue adjusting their operations amid slower cigarette market growth, changing consumer preferences and the transition toward next-generation nicotine products.
Aug.11
Scottish Vape Display Rules Could Cost Businesses £61 Million, Affecting More Than 11,000 Retail Outlets
Scottish Vape Display Rules Could Cost Businesses £61 Million, Affecting More Than 11,000 Retail Outlets
A Scottish government impact assessment estimates that proposed vape display and packaging rules could create up to £61 million ($82 million) in compliance costs for businesses, affecting more than 11,000 retail outlets. The estimated costs are mainly linked to inventory adjustments, retail storage changes and the resources required for businesses to understand and implement the new requirements. The measures form part of the UK’s broader efforts to tighten vape regulation, particularly around product displays, packaging and sales practices.
Aug.10
FDA Authorizes Four More Nicotine Pouches as Review Pilot Expands Beyond Initial Decisions
FDA Authorizes Four More Nicotine Pouches as Review Pilot Expands Beyond Initial Decisions
The FDA has authorized four additional on! nicotine pouches, bringing the U.S. total to 30. The decision marks another outcome of the agency’s nicotine pouch review pilot, whose communication and review practices are now being applied more broadly across the category. It also extends Helix’s authorized portfolio from on! PLUS to the earlier on! line. Yet all FDA-authorized nicotine pouches still come from subsidiaries of PMI or Altria, underscoring how concentrated U.S. regulatory access remains.
Aug.05
UK Proposes Stricter Vape Packaging Rules as Retailers Warn of £330 Million Impact
UK Proposes Stricter Vape Packaging Rules as Retailers Warn of £330 Million Impact
The UK government has launched a nationwide consultation on vape packaging, appearance and retail displays, proposing tighter rules to reduce youth appeal while industry groups warn of significant compliance costs.
Innovation
Jul.20
PMI Oral Products Chief Says Lack of Rules May Push Nicotine Pouch Market Into Illicit Trade
PMI Oral Products Chief Says Lack of Rules May Push Nicotine Pouch Market Into Illicit Trade
Nick Ricketts, President of Oral Products at Philip Morris International (PMI), told Logos Press that nicotine pouches should be brought under clear regulatory frameworks covering nicotine limits, flavor rules, age verification, sales controls and marketing standards, arguing that the absence of clear rules or blanket bans may push consumer demand into illegal or semi-legal channels.
Jul.06