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.

UK Retailers Call on Government to Better Resource Trading Standards to Fight Illicit Tobacco and Vape Trade
UK Retailers Call on Government to Better Resource Trading Standards to Fight Illicit Tobacco and Vape Trade
Retailers in the UK have called on the government to provide greater resources to Trading Standards in response to the growing trade in illicit tobacco and vapes. Fed national vice-president Hemanshu Patel made the call during a panel discussion at the National Convenience Show in Birmingham on April 15.
Apr.21 by 2FIRSTS.ai
German Environment Minister Plans Bill to Ban Disposable E-Cigarettes This Year
German Environment Minister Plans Bill to Ban Disposable E-Cigarettes This Year
German Federal Environment Minister Carsten Schneider said he is preparing legislation to ban disposable e-cigarettes and will present a bill this year. Industry data estimated that legal e-cigarette sales in Germany rose by about one quarter in 2025 to €2.4 billion. Refillable devices are not expected to be affected by the ban.
May.09 by 2FIRSTS.ai
AP Questions FDA Rationale as Glas Fruit-Flavored Vapes Won Authorization Without Added Cessation Benefit
AP Questions FDA Rationale as Glas Fruit-Flavored Vapes Won Authorization Without Added Cessation Benefit
The U.S. Food and Drug Administration (FDA) recently authorized two fruit-flavored vaping products from Glas, but a newly released agency memo shows the products did not demonstrate greater smoking-cessation benefits than tobacco-flavored e-cigarettes. The Associated Press said the findings are likely to raise further questions about the FDA’s regulatory rationale and standards for flavored vaping products.
Jun.12
Disposable Vape Ban Shifts Purchasing Formats as UK Vape Volume Falls 10.3%
Disposable Vape Ban Shifts Purchasing Formats as UK Vape Volume Falls 10.3%
Data from convenience insight agency Talysis shows that the value of tobacco, vapes and smoking alternatives in the independent convenience sector fell by 4.4% in the first quarter of 2026, while volume fell by 7.8%. The vaping subcategory declined by 3.9% in value and 10.3% in volume over the same period. Talysis said the impact of the disposable vape ban continues to pressure turnover and footfall.
May.08 by 2FIRSTS.ai
Acting CTP Director Says FDA Cut Premarket Tobacco Application Backlog by About 70% Over the Past Year
Acting CTP Director Says FDA Cut Premarket Tobacco Application Backlog by About 70% Over the Past Year
FDA Center for Tobacco Products Acting Director Bret Koplow said at the American Tobacco and Nicotine Forum that the agency has reduced its premarket tobacco application backlog by about 70% over the past year and eliminated the acceptance queue. He said FDA has reviewed about 27 million applications, but only a small number have been authorized, mainly because most submissions lacked the scientific data needed to demonstrate public health benefits.
Apr.23 by 2FIRSTS.ai
Exclusive | China Starts Mandatory National Standards Process for Heated Cigarettes and Nicotine Pouches
Exclusive | China Starts Mandatory National Standards Process for Heated Cigarettes and Nicotine Pouches
China has launched mandatory national standards work for heated cigarettes and nicotine pouches, further formalizing regulation of both categories. The move may help lay groundwork for future market entry, but does not signal imminent domestic commercialization.
Apr.15