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.

Italian Financial Police Seize 4.3 Million E-Cigarettes and Smoking Accessories; 28 Reported to Judicial Authorities Across Operations
Italian Financial Police Seize 4.3 Million E-Cigarettes and Smoking Accessories; 28 Reported to Judicial Authorities Across Operations
Italy's Guardia di Finanza announced on October 28 that officers in Latina province had seized approximately 4.3 million e-cigarettes and smoking accessories at an unauthorized warehouse in an operation involving restrictions on the possession and sale of tobacco-related products. Another 300,000 suspected counterfeit or unsafe items were confiscated during separate inspections, bringing total seizures across the operations to more than 4.6 million products. Twenty-eight people were reported to judicial authorities over suspected smuggling and counterfeiting offenses. Officials did not disclose separate vape quantities, the value of the merchandise or alleged violations associated with individual brands.
Enforcement
Oct.29
2Firsts On-Site | CTIHK Showcases Nicotine Pouches, Heated Tobacco and Chinese Cigars at InterTabac 2026
2Firsts On-Site | CTIHK Showcases Nicotine Pouches, Heated Tobacco and Chinese Cigars at InterTabac 2026
At InterTabac 2026 in Dortmund, China Tobacco International (HK) Company Limited (CTIHK) is exhibiting across two separate booths in Hall 5 and Hall 4. Products observed by 2Firsts include heated tobacco products, nicotine pouches, Chinese cigars and tobacco leaf. Nicotine pouch products on display include TOOP, Shuangxi and Ashima.
Market
Sep.16
German Tobacco Tax Revenue Falls 10.8% Through August as Tax-Paid Cigarette Volume Drops 12.6%
German Tobacco Tax Revenue Falls 10.8% Through August as Tax-Paid Cigarette Volume Drops 12.6%
Germany collected €9.789 billion in total tobacco tax revenue from January through August 2026, down 10.8% from a year earlier, according to the Federal Ministry of Finance. Germany's tobacco tax base covers not only cigarettes and fine-cut tobacco but also heated tobacco and vaping liquids taxed as tobacco substitutes. The German Association of the Tobacco Industry and Novel Products, or BVTE, citing federal statistical data, said tax-paid cigarette volume fell 12.6% to 40.6 billion sticks. BVTE is using the latest figures to argue against further tax increases planned from 2027 through 2030, while Germany's parliament is scheduled to hold a first reading of the bill on September 24.
Sep.23
Australia Tobacco Tax Debate Spreads Within Labor as NSW Premier Minns Reaffirms Support for a Cut
Australia Tobacco Tax Debate Spreads Within Labor as NSW Premier Minns Reaffirms Support for a Cut
Australia’s tobacco excise debate is increasingly exposing differences within the governing Labor Party. New South Wales Labor Premier Chris Minns reaffirmed on September 8 that he supports reducing tobacco excise, arguing that current tax settings are pushing consumers toward cheaper black-market cigarettes. Federal Health Minister Mark Butler continues to oppose an excise cut, while Treasurer Jim Chalmers and Assistant Treasurer Daniel Mulino have recently stopped short of ruling out future changes. The divergence follows the opposition Coalition’s proposal to cut tobacco excise by 80%.
Sep.08
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
Product | Philip Morris Japan Teams Up With Renowned French Audio Brand DEVIALET for Limited-Edition IQOS Priced 60% Above Standard Model
Product | Philip Morris Japan Teams Up With Renowned French Audio Brand DEVIALET for Limited-Edition IQOS Priced 60% Above Standard Model
Philip Morris Japan (PMJ) launched the limited-edition IQOS ILUMA i PRIME Soundsorial Model in collaboration with French audio brand DEVIALET on October 1, 2026. Featuring sound-wave patterns, a silver-and-black finish and a gradient holder, the heated tobacco device is priced at JPY 15,980, including tax, and is available at four IQOS stores in Japan. According to Japanese media citing a PMJ representative, about 1,900 units were allocated to the Japanese retail market. A separate Soundsorial Collection, combining the device with DEVIALET Gemini II earbuds, includes 440 sets allocated to Japan for a membership prize draw.
product
Oct.23