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 | PMI Launches ZYN Melts in UK, Extending ZYN Beyond Nicotine Pouches Into Dissolvable Tablets
Product | PMI Launches ZYN Melts in UK, Extending ZYN Beyond Nicotine Pouches Into Dissolvable Tablets
Philip Morris International (PMI) has launched ZYN Melts in the UK, introducing a fully dissolvable oral nicotine tablet format alongside the brand's existing nicotine pouches. The range includes Cool Mint and Peppermint, each offered at 1mg and 2mg of nicotine per tablet, creating four SKUs. Each can contains 20 tablets and is priced at £6.50 in the UK. Unlike ZYN nicotine pouches, Melts are placed between the upper lip and gum and dissolve completely during use.
News
Sep.29 by 2Firsts Perspectives
Sweden Threatens EU Tobacco Tax Deal as Nicotine Pouch Duty Dispute Looms Over November 9 Meeting
Sweden Threatens EU Tobacco Tax Deal as Nicotine Pouch Duty Dispute Looms Over November 9 Meeting
Sweden is expected to oppose a European Union proposal to raise minimum tobacco excise duties, Law360 reported on October 26, 2026, citing an EU official. A provisional Council agenda dated October 23 confirms that the tobacco taxation package is scheduled for discussion at the November 9 finance ministers' meeting, where member states will seek a general approach. The proposed reforms would raise minimum taxes on conventional tobacco products and establish EU-wide excise rules for vaping liquids, heated tobacco and nicotine pouches. Sweden supports harmonising tobacco taxation rules but objects to requiring nicotine pouches to bear the same minimum tax burden as certain smoking tobacco products. As EU indirect tax legislation requires unanimous Council approval, Swedish opposition could block the proposal in its current form.
Regulations
Oct.29
Special Report | Russia Places Four JTI Businesses Under Temporary Management, a First for Tobacco Majors
Special Report | Russia Places Four JTI Businesses Under Temporary Management, a First for Tobacco Majors
Russia has placed shares in four Japan Tobacco International businesses under temporary management, the first such move involving a major global tobacco manufacturer, according to Interfax. JTI held 35.8% of Russia's tobacco market by volume in the first nine months of 2026. While British American Tobacco and Imperial Brands have exited Russia, Philip Morris International continues operating there. As the market changes and diplomatic efforts continue, could international tobacco companies that left Russia eventually return?
Nov.06
FDA Revises Import Alert 98-07 Rules, Bringing May Enforcement Priorities Into Unauthorized ENDS Detentions
FDA Revises Import Alert 98-07 Rules, Bringing May Enforcement Priorities Into Unauthorized ENDS Detentions
The U.S. Food and Drug Administration has revised the rules under Import Alert 98-07 to incorporate its May 2026 enforcement-priority policy for certain electronic nicotine delivery systems marketed without premarket authorization. The alert continues to allow detention without physical examination, or DWPE, for ENDS lacking required marketing authorization, while directing field divisions to apply the May risk-based framework. When necessary, detention or refusal decisions must also undergo review by the FDA's Center for Tobacco Products. Products including PACHA and Vuse Pro have already emerged as industry examples of the May policy, although enforcement discretion does not constitute FDA marketing authorization.
News
Sep.28 by 2Firsts Perspectives
Virginia Tobacco Retail Permit Takes Effect October 1, Covering Vapes as More Than 3,000 Businesses Apply in September
Virginia Tobacco Retail Permit Takes Effect October 1, Covering Vapes as More Than 3,000 Businesses Apply in September
Virginia's new retail tobacco permit system took effect October 1, requiring sellers of vapes, nicotine products and related devices and accessories to obtain a Retail Tobacco Permit for each business location. Virginia ABC said more than 3,000 businesses applied in September alone, creating a processing backlog. Qualifying applicants that filed before October 1 may temporarily operate under a Letter of Authorization. The new store-level permit also sits alongside Virginia's existing vape product directory, where sales of unlisted liquid nicotine or nicotine vapor products can trigger civil penalties starting at $5,000.
Regulations
Oct.03
Latest UK ONS Data: Vaping Rate Edges Down to 9.9% in 2025, a Year After Overtaking Cigarette Smoking
Latest UK ONS Data: Vaping Rate Edges Down to 9.9% in 2025, a Year After Overtaking Cigarette Smoking
Vaping prevalence in Great Britain edged down to 9.9% in 2025 from 10.0% in 2024, with the number of adult users holding at approximately 5.4 million for a second consecutive year, according to the Office for National Statistics (ONS). E-cigarette use had risen from 6.4% in 2020 to 10.0% in 2024, when it exceeded cigarette smoking prevalence for the first time. Cigarette smoking continued to decline to 8.7% in 2025, widening the gap to 1.2 percentage points. Daily vaping declined slightly, while usage among adults aged 25–34 increased despite falling rates in other age groups.
DATA
Oct.14