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.

Product | DOJO Launches BLAST10K Fresh in UK With 0+10ml E-Liquid Structure, Retaining 2+8ml Pod Compatibility
Product | DOJO Launches BLAST10K Fresh in UK With 0+10ml E-Liquid Structure, Retaining 2+8ml Pod Compatibility
DOJO launched the BLAST10K Fresh in the UK on September 4, 2026, introducing its INSTA-JUICED™ technology and a new 0+10ml structure that keeps e-liquid separated from the coil before activation. The device features a 1000mAh rechargeable battery, COREX BLAST dual-mesh technology and SSS leak-resistant technology, with a manufacturer-rated capacity of up to 10,000 puffs. It also retains compatibility with existing 2+8ml pods across the BLAST ecosystem. The launch introduces eight new flavors, including Matcha Strawberry, which DOJO describes as an industry first.
Market
Sep.04
Australia Brings in Deloitte to Support Illicit Tobacco and Vape Enforcement Across Data, Processes and Project Delivery
Australia Brings in Deloitte to Support Illicit Tobacco and Vape Enforcement Across Data, Processes and Project Delivery
Australia’s Department of Home Affairs has hired Deloitte to provide data analytics, business-process, communications and project-delivery support to the Office of the Illicit Tobacco and E-Cigarette Commissioner. The government says Deloitte personnel do not provide policy advice to the Commissioner or the Australian government, with policy development and decision-making remaining with public officials. The arrangement has nevertheless drawn scrutiny because Deloitte has previously provided professional services to several tobacco and vaping companies.
Sep.03
How Large Is France’s Off-Channel Tobacco Market? Logista Says It Has Become Structural, While the Official Estimate Is 17.7% and Some Industry Studies Put It Above 50%
How Large Is France’s Off-Channel Tobacco Market? Logista Says It Has Become Structural, While the Official Estimate Is 17.7% and Some Industry Studies Put It Above 50%
Logista France says tobacco consumption outside France’s official tobacconist network has become a large and structural market phenomenon, but official and industry estimates differ sharply. France’s TAFE study estimates that 17.7% of tobacco consumption escaped domestic taxation in 2023, with most of that volume attributed to cross-border purchasing rather than street sales. Some industry studies use broader off-channel definitions and put the figure above 50%. Meanwhile, French Customs seized 547.94 tonnes of tobacco in 2025, up 12%, showing continued pressure from illicit trade.
Sep.04
Inside Nicotine-Pouch M&A Through Imperial's Yoik Deal: Latham, KPMG, PwC, Goldman Sachs and Morgan Stanley Form the Adviser Lineup
Inside Nicotine-Pouch M&A Through Imperial's Yoik Deal: Latham, KPMG, PwC, Goldman Sachs and Morgan Stanley Form the Adviser Lineup
Imperial Brands' acquisition of Swedish Helwit owner Yoik Group AB has highlighted the professional-services firms supporting cross-border oral nicotine M&A. Latham & Watkins and KPMG advised Imperial, while PwC and TM & Partners advised Yoik. KPMG also appeared on Imperial's acquisition of Black Buffalo earlier in 2026, while PwC played an extensive role in KT&G's acquisition of Swedish nicotine-pouch company Another Snus Factory. Imperial's public disclosures put the global modern oral nicotine delivery market at approximately £8.8 billion in retail sales and 23.5 billion pouches in 2024
Sep.20
Kelly White Bets on Female Consumers as Nicotine Pouch Competition Intensifies | 2Firsts Interview
Kelly White Bets on Female Consumers as Nicotine Pouch Competition Intensifies | 2Firsts Interview
Swedish nicotine pouch brand Kelly White is building its strategy around adult female consumers. Founder and CEO Sophia Wilsby told 2Firsts that women accounted for around 70% of the brand’s repeat customers on HAYPP in Sweden in 2025. The interview explores female consumer segmentation, product and design differentiation, gender stereotypes, packaging regulation, and how independent brands can compete with global players such as ZYN and VELO while considering funding, partnerships and future ownership options.
Business
Sep.24
Product | R.J. Reynolds Launches Four Flavored Vuse Pro Pods for Vuse Alto Devices in U.S.
Product | R.J. Reynolds Launches Four Flavored Vuse Pro Pods for Vuse Alto Devices in U.S.
R.J. Reynolds Vapor Company has introduced Vuse Pro prefilled pods in Peach, Berry, Watermelon and Fresh Mint in selected U.S. states. Vuse’s U.S. website says the pods are intended for use with existing Vuse Alto devices. Each contains 2.0 mL of e-liquid at 5.0% nicotine by weight, uses nicotine salts and is offered in two- and four-pod packs. Reynolds said the rollout includes mandatory ID scanning for every purchase, purchase limits, stronger retailer-accountability requirements and strict age-restricted marketing standards. The four pods have not received marketing authorization from the U.S. Food and Drug Administration.
Sep.10