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.

Japan’s Heated Tobacco Tax Changes Reshape Consumer Choices, Survey Reveals Impact of Price and Income
Japan’s Heated Tobacco Tax Changes Reshape Consumer Choices, Survey Reveals Impact of Price and Income
A consumer survey by Japanese heated tobacco information platform RELAZO found that rising tobacco prices and planned heated tobacco tax changes may influence smoking decisions among Japanese consumers. The survey covered 49,879 men and women aged 20 to 69 nationwide. It found that around 40% of respondents cumulatively indicated they may consider quitting when a pack reaches ¥600 (approximately US$4.1), while nearly 90% expressed potential quitting intentions at a ¥1,000 (approximately US$6.8) price level. The survey also found significant differences by income level, with lower-income respondents showing greater sensitivity to price increases.
Jul.24
Shopify Requires Merchants to Remove All Vape Products by July 8, Reshaping Online Sales Channels
Shopify Requires Merchants to Remove All Vape Products by July 8, Reshaping Online Sales Channels
Shopify has instructed merchants using its web-hosting services to remove vape products from their online stores by July 8, 2026. The policy expands beyond illegal products and applies to all electronic nicotine delivery systems (ENDS), marking a broader shift in online platform oversight of nicotine sales.
Innovation
Jul.14 by 2Firsts Perspectives
Trump Picks White House Health Policy Aide Heidi Overton to Lead FDA, Pending Senate Confirmation
Trump Picks White House Health Policy Aide Heidi Overton to Lead FDA, Pending Senate Confirmation
U.S. President Donald Trump has chosen White House health policy aide Heidi Overton to lead the Food and Drug Administration, Bloomberg reported, citing a person familiar with the matter. Overton currently works on health policy at the White House and previously held a senior role at the America First Policy Institute. If confirmed by the Senate, she would take over an FDA that has experienced months of senior-level turnover. The agency regulates products representing roughly one-fifth of U.S. consumer spending, including e-cigarettes, drugs, vaccines and much of the food supply.
News
Aug.19
JT Plans ¥800 Billion Investment in Heated Tobacco Over Three Years, Betting on Ploom as Second Growth Engine
JT Plans ¥800 Billion Investment in Heated Tobacco Over Three Years, Betting on Ploom as Second Growth Engine
Japan Tobacco Inc. (JT) CEO Takehiko Tsutsui said the company plans to invest about ¥800 billion (approximately US$5.4 billion) in heated tobacco products over three years through 2028, aiming to establish Ploom as a second growth engine after combustible cigarettes. Tsutsui said Ploom AURA helped JT increase its share of Japan’s heated tobacco market to 15.8% in the first quarter of 2026. Ploom products are now available in 29 markets, with Ploom AURA sold in 25 markets including Japan. JT also plans to continue its cigarette business while positioning its food operations, particularly frozen noodle products in North America, as another growth opportunity.
Jul.23
Philippine Local Governments Urge Marcos to Prioritize Smoke- and Vape-Free Bill
Philippine Local Governments Urge Marcos to Prioritize Smoke- and Vape-Free Bill
The League of Municipalities of the Philippines (LMP) has urged President Ferdinand Marcos Jr. to prioritize the Smoke- and Vape-Free Bill, seeking a nationwide legal framework for tobacco and vape regulation. Local government leaders said national legislation would help standardize enforcement and strengthen public health measures. The proposal remains at the advocacy stage and has not yet become law.
Jul.29
IQOS Global Flagship Space to Open in Tokyo Ginza as PMI Expands Consumer Experience Strategy
IQOS Global Flagship Space to Open in Tokyo Ginza as PMI Expands Consumer Experience Strategy
Philip Morris Japan (PMJ) announced that it will open “IQOS Flagship Ginza” in Tokyo on September 4, 2026. The location will become the first global flagship space for PMI’s IQOS brand. PMJ said the venue will target adult smokers aged 20 and above and combine product experiences, community engagement and local cultural elements. The design will incorporate Japanese natural aesthetics and traditional craftsmanship. The launch reflects PMI’s broader strategy of strengthening consumer engagement through experiential retail and brand spaces. The existing IQOS Store Ginza is scheduled to close on August 30, 2026.
Jul.21