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.

Special Report | Can Nicotine Be Replaced? 6-MN Is Already on the Market While Key Human Evidence Is Still Missing
Special Report | Can Nicotine Be Replaced? 6-MN Is Already on the Market While Key Human Evidence Is Still Missing
Nicotine analogues such as 6-methylnicotine are already appearing in e-cigarettes and oral pouches, even as key human evidence remains limited. A new Nixodine-S study adds nonclinical data showing differences from nicotine in cytotoxicity and receptor activity, while independent studies point to a more complex toxicological picture. With supply-chain activity growing and FDA seeking clearer authority over nicotine analogues, the industry now faces a larger question: what evidence is needed before these substances can credibly replace nicotine?
SCIENCE
Sep.23
PMI Global Communications Chief Moira Gilchrist: Why AI Matters More Than Ever in the Smoke-Free Transition
PMI Global Communications Chief Moira Gilchrist: Why AI Matters More Than Ever in the Smoke-Free Transition
Philip Morris International (PMI) Chief Global Communications Officer Moira Gilchrist said artificial intelligence is changing how companies understand audiences, manage owned information channels and communicate business transformation. PMI is using AI-generated audience personas to test messaging while optimizing its corporate website and other owned channels for large language models. As PMI continues its transition from cigarettes toward smoke-free products, Gilchrist said owned data and corporate channels are becoming increasingly important in demonstrating the scale of that transformation.
Aug.26
JTI Research Finds 31% of UK Respondents Offered Illicit Tobacco, While 63% of Ennis Packs Lack Duty Marks
JTI Research Finds 31% of UK Respondents Offered Illicit Tobacco, While 63% of Ennis Packs Lack Duty Marks
Multiple JTI-backed studies in the UK and Ireland indicate that illicit tobacco remains visible across consumer interactions and local markets. In the UK, JTI research found that 31% of respondents said they had been offered illicit tobacco products. In Ireland’s Ennis area, a JTI-commissioned empty pack survey found that 63% of sampled cigarette packs did not carry Irish duty-paid markings. The findings come from industry research rather than official government estimates of illicit tobacco market size, but highlight continued concerns among regulators, legitimate retailers and tobacco companies over illicit trade.
Aug.19
Australian Coalition Taskforce Calls for 80% Tobacco Tax Cut to Combat Illicit Market
Australian Coalition Taskforce Calls for 80% Tobacco Tax Cut to Combat Illicit Market
According to SGST on August 26, 2026, Australia’s Coalition Illegal Tobacco Taskforce released a report recommending an up to 80% cut in tobacco excise to reduce the appeal of the illicit tobacco market. The report claimed organised crime groups now control about 80% of Australia’s tobacco market and argued that high excise rates have widened the price gap between legal and illegal products. The recommendation remains a policy proposal and has not been adopted by the Australian government, which said its focus remains on enforcement, compliance and additional resources.
Aug.27
UK HMRC Urges Public to Report Suspicious Vape Shops in Crackdown on Tax Fraud, Money Laundering and Illicit Tobacco Sales
UK HMRC Urges Public to Report Suspicious Vape Shops in Crackdown on Tax Fraud, Money Laundering and Illicit Tobacco Sales
HM Revenue & Customs is urging members of the public to report vape shops, barber shops and other high-street businesses suspected of tax fraud, money laundering or other illegal activity, with informants not required to provide personal details. HMRC plans more than 30,000 interventions in 2026-27 targeting tax fraud, organised crime and illicit activity, including the sale of illegal vapes and tobacco. The push forms part of a broader UK effort to tackle organised crime on high streets, backed by a £30 million government enforcement programme.
Regulations
Aug.17 by 2Firsts Perspectives
Retail Case Study | Wisconsin Vape Market One Year After New Regulations: Johnny Vapes Reports 80% Sales Decline as Consumers Shift Online and Across State Lines
Retail Case Study | Wisconsin Vape Market One Year After New Regulations: Johnny Vapes Reports 80% Sales Decline as Consumers Shift Online and Across State Lines
According to WNCY on August 24, 2026, some independent vape retailers in Wisconsin say they have faced significant business pressure one year after new vape regulations took effect. Johnny Vapes, a retailer operating in northeast Wisconsin, said its store count fell from seven locations to four, sales declined by about 80%, and roughly 90% of its inventory was affected. Retailers said some consumers have shifted to online purchases or traveled to neighboring Michigan to buy vape products. The case highlights how local regulations can reshape retail operations, inventory management and consumer purchasing patterns.
Aug.28