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.

Special Report | Can Nicotine Be Replaced? 6-MN Is Already on the Market While Key Human Evidence Is Still Missing
Special Report | Can Nicotine Be Replaced? 6-MN Is Already on the Market While Key Human Evidence Is Still Missing
Nicotine analogues such as 6-methylnicotine are already appearing in e-cigarettes and oral pouches, even as key human evidence remains limited. A new Nixodine-S study adds nonclinical data showing differences from nicotine in cytotoxicity and receptor activity, while independent studies point to a more complex toxicological picture. With supply-chain activity growing and FDA seeking clearer authority over nicotine analogues, the industry now faces a larger question: what evidence is needed before these substances can credibly replace nicotine?
SCIENCE
Sep.23
Reynolds Seeks to Join Altria Lawsuit Challenging FDA PMTA Rule and Calculation of 180-Day Deadline
Reynolds Seeks to Join Altria Lawsuit Challenging FDA PMTA Rule and Calculation of 180-Day Deadline
Three R.J. Reynolds companies are seeking to intervene in a lawsuit filed by Altria subsidiaries Helix Innovations and NJOY challenging the FDA's 2021 PMTA final rule. The companies dispute how the agency uses Acceptance and Filing reviews and completeness determinations to establish when the Tobacco Control Act's 180-day decision period begins. Reynolds has also linked prolonged PMTA reviews to competition from unauthorized vaping products. The FDA, meanwhile, has been accelerating reviews and reducing its backlog.
Sep.14
Global Nicotine-Pouch E-Commerce Group Haypp Shuts Sweden’s Snusnetto Over Age Verification as Identity Checks Become Industry Infrastructure for New Nicotine Products
Global Nicotine-Pouch E-Commerce Group Haypp Shuts Sweden’s Snusnetto Over Age Verification as Identity Checks Become Industry Infrastructure for New Nicotine Products
Sweden's Supreme Administrative Court has declined to hear an appeal over age verification for tobacco and nicotine products collected from parcel lockers, leaving in place a lower-court ruling that geo-located BankID verification is insufficient to securely verify the actual recipient. Haypp Group has stopped tobacco and nicotine sales through Snusnetto and is deploying a new system across its other Swedish e-commerce sites to verify the age of the person who actually opens the locker and receives the shipment. The change comes as age verification across next-generation nicotine products expands from purchase checks into retail, delivery and, for some e-cigarettes, device access itself.
Regulations
Oct.20
Malaysia Liquid Nicotine Returns to Poisons List, Leaving Vape Retail and RM354 Million Tax Collection in Legal Uncertainty
Malaysia Liquid Nicotine Returns to Poisons List, Leaving Vape Retail and RM354 Million Tax Collection in Legal Uncertainty
Malaysia’s withdrawal of its appeal in a landmark liquid-nicotine case has left a High Court ruling that struck down the 2023 nicotine exemption in force, bringing liquid and gel nicotine used in vaping products back under the Poisons Act 1952. At the same time, the Control of Smoking Products for Public Health Act 2024 continues to provide a regulatory framework for vaping products, creating uncertainty over retail sales, taxation and existing inventory. MPs are calling for nicotine vape sales and excise collection to stop, including refunds of more than RM354 million collected since 2023, while industry and consumer groups are asking the government to clarify the current legal position.
Sep.04
UK ONS Data: Vaping Rate Among Women Aged 25–34 Reaches 18.3%, Compared With 14.4% for Men
UK ONS Data: Vaping Rate Among Women Aged 25–34 Reaches 18.3%, Compared With 14.4% for Men
The vaping rate among women aged 25 to 34 in Great Britain reached 18.3% in 2025, up from 13.7% in 2024 and 8.3% in 2020, according to data from the Office for National Statistics (ONS). The figure was the highest for this group since records began in 2014 and exceeded the 14.4% recorded among men of the same age. Adults aged 25 to 34 also overtook those aged 16 to 24 as the age group with the highest vaping prevalence. Overall, about 5.4 million adults in Great Britain used e-cigarettes in 2025, broadly unchanged from the previous year.
DATA
Oct.13
Product | JT Refreshes Ploom CUBE Design and Expands Japan Retail Distribution, Targeting Younger Men and Female Users
Product | JT Refreshes Ploom CUBE Design and Expands Japan Retail Distribution, Targeting Younger Men and Female Users
Japan Tobacco (JT) launched a refreshed Ploom CUBE design in Japan on September 8, 2026, with broader convenience-store and tobacco-retail distribution planned from October 13. The updated device retains the existing Rounded Cube form and heating platform while replacing four previous body colors with Pebble White and Cobalt Black. JT is also introducing new Front Panels and Fabric Back Covers, although the new accessories are not compatible with the previous Ploom CUBE design. The company says the update is intended to broaden appeal among younger male and female users.
Sep.09