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.

NATO Executive Director David Spross Sees U.S. Vape Regulation Improving, Calls for More PMTA Authorizations and Warns of 2027 State Tax Pressure
NATO Executive Director David Spross Sees U.S. Vape Regulation Improving, Calls for More PMTA Authorizations and Warns of 2027 State Tax Pressure
The National Association of Tobacco Outlets is calling for more FDA marketing authorizations, greater transparency in the PMTA process and continued enforcement against unauthorized e-cigarettes, even as its executive director, David Spross, points to recent regulatory developments as signs of progress. At the state level, excise taxes, flavor restrictions and vapor product directories remain major issues for tobacco retailers. By August 2026, 17 states had enacted laws establishing state-managed e-cigarette directories or similar systems.
Innovation
Sep.29 by 2Firsts Perspectives
JTI Liggett Puts U.S. Value Cigarette Brands in Spotlight at 2026 NACS Show
JTI Liggett Puts U.S. Value Cigarette Brands in Spotlight at 2026 NACS Show
At the 2026 NACS Show in Las Vegas, JTI Liggett highlighted its value-priced cigarette portfolio, including LD and Montego, following JT Group's acquisition of Vector Group. The company's U.S. business reported market share gains, with LD sales volume rising 32.6% in the first half of 2026. Meanwhile, Ploom was displayed separately at Altria's booth under an existing partnership. JTI Liggett booth staff told 2Firsts that the company had not yet launched nicotine pouch products in the United States.
EXPO
Oct.09
BAT CFO Dragos Constantinescu Takes Office, Returning After Seven Years and Former Asahi Europe Leadership Role
BAT CFO Dragos Constantinescu Takes Office, Returning After Seven Years and Former Asahi Europe Leadership Role
Dragos Constantinescu has officially taken up his role as Chief Financial Officer and Executive Director at British American Tobacco (BAT). He previously spent 16 years at BAT across finance and general management roles in Europe before joining Asahi in 2019 and becoming CEO of Asahi Europe & International in 2025. His return comes as BAT continues to advance its “A Better Tomorrow” transformation.
BAT
Sep.01
Product | JT Expands Vote-Winning EVO Cacao Mint Crystal to Nationwide Retail in Japan, Adds 22-Stick Limited Pack at Same Price
Product | JT Expands Vote-Winning EVO Cacao Mint Crystal to Nationwide Retail in Japan, Adds 22-Stick Limited Pack at Same Price
Japan Tobacco (JT) will expand EVO Cacao Mint Crystal from limited channels to nationwide retail in Japan from October 6, 2026. The Ploom tobacco stick ranked first in the brand's first consumer voting campaign for new tobacco-stick SKUs held earlier this year. JT will also introduce a limited 22-stick pack at the same JPY 620 price as the standard 20-stick pack. The capsule-format product combines menthol with sweet, bittersweet cacao notes and adds a berry nuance when the capsule is crushed.
Sep.09
Philip Morris Malaysia Again Meets Religious Authority Over Cigarette Alternatives as Perlis Mufti Responds on Halal Criteria
Philip Morris Malaysia Again Meets Religious Authority Over Cigarette Alternatives as Perlis Mufti Responds on Halal Criteria
Philip Morris Malaysia Managing Director Naeem Shahab Khan met Perlis Mufti Mohd Asri Zainul Abidin on September 17 and presented the company's shift from conventional cigarettes toward alternative products. The mufti said a product could be considered halal if it is clean, its side effects are not harmful or can be controlled, and it does not involve excessive waste. His remarks did not mention IQOS or any other specific PMI product and did not amount to a new product-specific religious ruling. It was at least the second publicly reported engagement between Philip Morris Malaysia and a Malaysian religious institution over cigarette alternatives within six months.
Regulations
Sep.18 by 2Firsts Perspectives
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