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.

FDA Commissioner Marty Makary Resigns After Opposing Trump Administration’s Flavored Vape Push
FDA Commissioner Marty Makary Resigns After Opposing Trump Administration’s Flavored Vape Push
FDA Commissioner Marty Makary resigned on May 12 after opposing the Trump administration’s push to authorize fruit-flavored vaping products, according to reporting by The New York Times. Makary reportedly objected over concerns that flavored vapes could attract young people and refused to support broader approvals.
News
May.13
Haypp Report Shows Nicotine Pouches Gaining Ground as a Vape Alternative in the UK
Haypp Report Shows Nicotine Pouches Gaining Ground as a Vape Alternative in the UK
According to Haypp’s 2026 UK Nicotine Report, nicotine pouches are increasingly replacing both cigarettes and vaping. The UK market grew sharply, with Haypp and Northerner reporting a 60% year‑on‑year sales increase in 2025. Notably, 40% of users adopted pouches to quit vaping, nearly matching the 43% who used them to stop smoking. This indicates pouches are expanding beyond traditional smoking cessation and gaining traction among adults seeking non‑inhalable nicotine alternatives.
Jul.01
Data|China’s January-May Vape Exports: U.S. Shipments Fall 13.8% as Japan Posts Fastest Growth
Data|China’s January-May Vape Exports: U.S. Shipments Fall 13.8% as Japan Posts Fastest Growth
According to China Customs export data analyzed by 2Firsts, the United States remained China’s largest destination for vape-related exports during January-May 2026 despite a 13.82% year-on-year decline in export value. Meanwhile, exports to Japan, Russia, Indonesia and the United Arab Emirates recorded strong growth, highlighting continued diversification across China’s export markets.
Special Report
Jun.29
Product | VEEV One Plus Goes Official as PMI Strengthens Its Closed-Pod Vaping Portfolio
Product | VEEV One Plus Goes Official as PMI Strengthens Its Closed-Pod Vaping Portfolio
Philip Morris International (PMI) has officially introduced the VEEV One Plus, the next-generation device in its closed-pod vaping lineup. The product is now featured on the official VEEV website in Portugal, bringing hardware upgrades including a new dual-pod storage system, a larger battery, and an updated device design while maintaining compatibility with existing VEEV One pods.
Jul.02
Bloomberg: Zyn’s Dry-Mouth Problem Threatens Its Hold on Nicotine Pouch Market
Bloomberg: Zyn’s Dry-Mouth Problem Threatens Its Hold on Nicotine Pouch Market
According to Bloomberg, Philip Morris International’s Zyn is facing growing competition in the U.S. nicotine pouch market as consumers shift toward moister alternatives such as British American Tobacco’s Velo Plus.
BATPMI
May.22
Putin Signs Russia’s Tobacco and Nicotine Product Licensing Law, Banning Unlicensed Sales From 2027
Putin Signs Russia’s Tobacco and Nicotine Product Licensing Law, Banning Unlicensed Sales From 2027
Russian President Vladimir Putin has signed a law introducing mandatory licensing for wholesale and retail trade in tobacco and nicotine-containing products, with the system taking effect on October 1, 2026, and unlicensed operations banned from March 1, 2027, while vape and e-liquid retail may also face uncertainty from temporary regional sales-ban powers.
Jul.01