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.

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
Kuwait Tightens Tobacco and Nicotine Rules, Bans Under-21 Sales and Extends Public Smoking Restrictions to Vapes and Heated Tobacco
Kuwait Tightens Tobacco and Nicotine Rules, Bans Under-21 Sales and Extends Public Smoking Restrictions to Vapes and Heated Tobacco
Kuwait has issued a comprehensive new regulatory framework covering tobacco, e-cigarettes, heated tobacco and other nicotine products. Ministerial Decision No. 237 of 2026, signed by Health Minister Ahmad Al-Awadhi, will take effect on January 1, 2027. The rules prohibit sales to people under 21 and ban sales through websites, apps, social media and delivery services. E-cigarettes and heated tobacco products will also be treated as smoking in public and enclosed places where smoking is prohibited. Nicotine pouches and other oral nicotine products not registered as medicines are banned.
Regulations
Aug.17 by 2Firsts Perspectives
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-China Operation Dismantles Tobacco Smuggling Network: 112 Containers, 60 Arrests and A$92 Million in Illicit Tobacco
Australia-China Operation Dismantles Tobacco Smuggling Network: 112 Containers, 60 Arrests and A$92 Million in Illicit Tobacco
According to The Maritime Executive on August 19, 2026, the Australian Border Force (ABF) and China’s Anti-Smuggling Bureau of General Administration of China Customs worked together to dismantle an international illicit tobacco smuggling network targeting Australia. According to information released by ABF on August 20, sustained information sharing and cooperation led to investigations into 112 shipping containers, with 91 found to contain illicit tobacco. Authorities seized more than 60 million cigarettes and 60 kilograms of loose-leaf tobacco, representing more than A$92 million in unpaid duties. More than 60 people suspected of involvement in the network were arrested in China.
Aug.20
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
Malaysia Withdraws Appeal Against Liquid Nicotine Ruling as Vape Regulation Framework Enters New Phase
Malaysia Withdraws Appeal Against Liquid Nicotine Ruling as Vape Regulation Framework Enters New Phase
Malaysia’s government has withdrawn its appeal against a High Court ruling concerning the regulatory status of liquid nicotine used in vape and e-cigarette products, according to reports by New Straits Times, Free Malaysia Today and CodeBlue on August 18, 2026. The Kuala Lumpur High Court ruled on May 15 that the government’s decision to remove liquid nicotine from the scheduled poisons list under the Poisons Act 1952 was irrational and made without proper consultation with the Poisons Board. The withdrawal ends the government’s appeal process, while the future regulatory framework for nicotine vape products remains under discussion.
Aug.21