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.

2Firsts On-Site | CTIHK Showcases Nicotine Pouches, Heated Tobacco and Chinese Cigars at InterTabac 2026
2Firsts On-Site | CTIHK Showcases Nicotine Pouches, Heated Tobacco and Chinese Cigars at InterTabac 2026
At InterTabac 2026 in Dortmund, China Tobacco International (HK) Company Limited (CTIHK) is exhibiting across two separate booths in Hall 5 and Hall 4. Products observed by 2Firsts include heated tobacco products, nicotine pouches, Chinese cigars and tobacco leaf. Nicotine pouch products on display include TOOP, Shuangxi and Ashima.
Market
Sep.16
NAS 2026 | Former FDA Tobacco Chief Mitch Zeller Calls for Shift From “End Game” to “End State”
NAS 2026 | Former FDA Tobacco Chief Mitch Zeller Calls for Shift From “End Game” to “End State”
At the 2026 New Approaches Summit in New York, former FDA Center for Tobacco Products Director Mitch Zeller called for the tobacco harm reduction debate to shift from the traditional “end game” toward defining a desired “end state.” He also highlighted unresolved concerns around dual use, argued that biomarkers of exposure may be more meaningful than cigarettes-per-day in assessing risk reduction, and said nicotine misperceptions remain a major barrier to public health progress.
Sep.25
Special Report | From New York to Washington: How FDA’s Tobacco Center Is Reworking Product Review
Special Report | From New York to Washington: How FDA’s Tobacco Center Is Reworking Product Review
FDA’s Center for Tobacco Products is reshaping how it approaches tobacco product review. Based on 2Firsts’ on-site reporting in New York and Washington, this report traces CTP’s emerging direction: stronger links between PMTA and tobacco harm reduction, more category-specific review, greater emphasis on decision-relevant science, more predictable timelines and expanded use of sPMTA for product modifications. CTP also acknowledged major constraints, including just nine PMTA review teams, persistent backlogs and limits on hiring capacity.
Regulations
Oct.08
UK ONS Data: Vaping Rate Among Women Aged 25–34 Reaches 18.3%, Compared With 14.4% for Men
UK ONS Data: Vaping Rate Among Women Aged 25–34 Reaches 18.3%, Compared With 14.4% for Men
The vaping rate among women aged 25 to 34 in Great Britain reached 18.3% in 2025, up from 13.7% in 2024 and 8.3% in 2020, according to data from the Office for National Statistics (ONS). The figure was the highest for this group since records began in 2014 and exceeded the 14.4% recorded among men of the same age. Adults aged 25 to 34 also overtook those aged 16 to 24 as the age group with the highest vaping prevalence. Overall, about 5.4 million adults in Great Britain used e-cigarettes in 2025, broadly unchanged from the previous year.
DATA
Oct.13
German Bundestag Passes Tobacco Tax Hikes: Vape Liquid Duty to Reach €0.44/ml, Heated Tobacco Taxes to Rise and Cigarettes Seen Near €12 a Pack
German Bundestag Passes Tobacco Tax Hikes: Vape Liquid Duty to Reach €0.44/ml, Heated Tobacco Taxes to Rise and Cigarettes Seen Near €12 a Pack
Germany's Bundestag passed amendments to the Tobacco Tax Act on October 15, 2026, setting out annual excise tax increases from 2027 through 2030 for e-cigarette liquids, heated tobacco, cigarettes and other tobacco products. Under the Finance Committee's amended bill, duty on qualifying e-liquids will rise from €0.32/ml in 2026 to €0.44/ml in 2030, an increase of 37.5%. Heated tobacco will retain its tax calculation based on 80% of the corresponding cigarette excise duty. The average price of a 20-cigarette pack is projected to approach €12 by 2030, with some brands potentially reaching €14. The legislation is projected to generate approximately €11.8 billion in additional tax revenue over four years and remains subject to further legislative procedures.
Regulations
Oct.19
JTI Invests ₱2.1 Billion to Upgrade Batangas Manufacturing Hub, Adds First Southeast Asia DIET Facility
JTI Invests ₱2.1 Billion to Upgrade Batangas Manufacturing Hub, Adds First Southeast Asia DIET Facility
JTI Asia Manufacturing Corp. has invested ₱2.1 billion, or about $37 million, in its manufacturing site in Malvar, Batangas, Philippines, to expand tobacco-processing capabilities. About ₱1.9 billion is allocated to JTI's first Dry Ice Expanded Tobacco, or DIET, facility in Southeast Asia, while more than ₱177 million has been spent on expanding its Controlled Atmosphere treatment facility. The Batangas plant supplies the Philippine market and exports to 22 overseas markets, making it one of JTI's key manufacturing hubs in Asia.
Sep.24