FDA Takes Civil Penalty Lawsuits Against 25 US Retailers for Illegally Selling Unapproved Vapes

Regulations by 2FIRSTS.ai
Dec.06.2023
FDA Takes Civil Penalty Lawsuits Against 25 US Retailers for Illegally Selling Unapproved Vapes
FDA fines 25 US retailers and online shops for illegally selling unapproved e-cigarette products, targeting youth-favored brand ELFBAR.

According to an announcement made by the US Food and Drug Administration (FDA) on December 5th, the FDA has filed civil monetary penalty (CMP) lawsuits against 25 physical stores and online retailers in the United States. These retailers have been illegally selling e-cigarette products that have not yet obtained FDA approval.

 

The FDA had previously issued warning letters to each retailer, urging them to cease the sale of unauthorized tobacco products. However, subsequent inspections revealed that these retailers failed to rectify their non-compliant behavior, resulting in the imposition of these civil fines by the FDA.

 

According to the 2023 National Youth Tobacco Survey data, e-cigarette products are especially popular among young people. The survey revealed that ELFBAR is the most frequently used brand of e-cigarettes among middle and high school students, with a usage rate as high as 56.7%.

 

Lawsuits demand that a maximum fine of $19,192 be imposed on each retailer for a single violation. Retailers have the option to either pay the fine, reach a settlement agreement based on mitigating factors, request an extension to respond to the lawsuit, or submit a reply and request a court hearing. Failure to take any action within 30 days of receiving the lawsuit may result in a default judgment requiring the retailer to bear the full amount of the fine.

 

As of today, a total of 67 lawsuits have been filed against retailers for selling unauthorized e-cigarettes. In September and November, the FDA initiated similar monetary requests for civil money penalties (CMP) against 42 physical retail establishments in 18 states for selling unauthorized products.

 

This operation encompasses retailers from 14 states, marking the first time cases have been brought against online retailers.

 

We welcome news tips, article submissions, interview requests, or comments on this piece.

Please contact us at info@2firsts.com, or reach out to Alan Zhao, CEO of 2Firsts, on LinkedIn


Notice

1.  This article is intended solely for professional research purposes related to industry, technology, and policy. Any references to brands or products are made purely for objective description and do not constitute any form of endorsement, recommendation, or promotion by 2Firsts.

2.  The use of nicotine-containing products — including, but not limited to, cigarettes, e-cigarettes, nicotine pouchand heated tobacco products — carries significant health risks. Users are responsible for complying with all applicable laws and regulations in their respective jurisdictions.

3.  This article is not intended to serve as the basis for any investment decisions or financial advice. 2Firsts assumes no direct or indirect liability for any inaccuracies or errors in the content.

4.  Access to this article is strictly prohibited for individuals below the legal age in their jurisdiction.

 

Copyright

 

This article is either an original work created by 2Firsts or a reproduction from third-party sources with proper attribution. All copyrights and usage rights belong to 2Firsts or the original content provider. Unauthorized reproduction, distribution, or any other form of unauthorized use by any individual or organization is strictly prohibited. Violators will be held legally accountable.

For copyright-related inquiries, please contact: info@2firsts.com

 

AI Assistance Disclaimer

 

This article may have been enhanced using AI tools to improve translation and editorial efficiency. However, due to technical limitations, inaccuracies may occur. Readers are encouraged to refer to the cited sources for the most accurate information.

We welcome any corrections or feedback. Please contact us at: info@2firsts.com

Philip Morris Romania Executive on Smoke-Free Strategy: How IQOS Spaces Are Moving Beyond Retail to Consumer Connection
Philip Morris Romania Executive on Smoke-Free Strategy: How IQOS Spaces Are Moving Beyond Retail to Consumer Connection
In an interview with Romanian marketing publication IQads, Marek Gębski, Director of Smoke-Free Products at Philip Morris Romania, said IQOS experience spaces are evolving from traditional retail locations into platforms for consumer engagement and brand connection. Through locations such as IQOS Boutique Victoriei, PMI aims to use design, culture and consumer experiences to strengthen communication with adult consumers about smoke-free products. The interview highlights how tobacco companies are expanding smoke-free strategies beyond products toward experiential marketing and consumer relationships.
Aug.11
 $20 Million, a Permanent Injunction and Distributor Controls: Posh Deal Tightens Illinois Vape Compliance
$20 Million, a Permanent Injunction and Distributor Controls: Posh Deal Tightens Illinois Vape Compliance
An Illinois court ordered three companies tied to Posh vapes to pay $20 million and permanently restricted the sale, marketing and distribution in Illinois of products lacking required FDA authorization. The consent order also imposes downstream distributor controls, age-verification measures and social-media marketing limits, creating a new state-level compliance benchmark for disposable vape businesses.
Regulations
Aug.05
2Firsts Hosts U.S. Market Mid-Year Briefing: Companies Need to Reassess Product and Market-Access Strategies
2Firsts Hosts U.S. Market Mid-Year Briefing: Companies Need to Reassess Product and Market-Access Strategies
2Firsts held its 2026 U.S. Market Compliance and Development Mid-Year Briefing in Shenzhen, China, on July 28. The discussion examined how state-level requirements, proposed foreign-establishment registration rules and expanding supply-chain responsibilities are changing product and investment decisions in the U.S. tobacco and nicotine market.
Jul.29
Changing Assumptions in U.S. Cigar Consumption: 2Firsts Interviews Cigar Educator Mechelle Merkerson
Changing Assumptions in U.S. Cigar Consumption: 2Firsts Interviews Cigar Educator Mechelle Merkerson
U.S. premium cigar culture is shifting toward education, broader choice and deeper links to craftsmanship and origin, cigar educator Mechelle Merkerson told 2Firsts. She sees boutique brands, women consumers and production-region experiences making knowledge central to cigar participation. For global brands, retailers and emerging markets such as China, education may help turn curiosity into sustained engagement.
Special Report
Jul.06
Product | IQOS ILUMA i REMIX Limited Edition Launches in Japan, Bringing New Design Elements to Heated Tobacco Devices
Product | IQOS ILUMA i REMIX Limited Edition Launches in Japan, Bringing New Design Elements to Heated Tobacco Devices
Philip Morris Japan (PM Japan) has introduced the IQOS ILUMA i REMIX Limited Edition series, including the IQOS ILUMA i Prime REMIX, IQOS ILUMA i REMIX and IQOS ILUMA i ONE REMIX devices. The limited-edition models were officially announced in Japan on June 9, 2026, and began a phased market rollout from June 10. Featuring gradient color designs and visual customization elements, the collection highlights PMI’s continued use of limited editions to enhance brand experience within its heated tobacco portfolio.
Innovation
Jul.21 by 2Firsts Perspectives
Product | OXVA Launches ONEO Pro in France, Upgrading Its Open-Pod Platform
Product | OXVA Launches ONEO Pro in France, Upgrading Its Open-Pod Platform
Vape brand OXVA has introduced the ONEO Pro, a refillable open-pod system that entered the French market in July 2026. The device features a 2,100mAh battery, up to 40W output, a 4ml refillable cartridge, multiple coil options and a 0.96-inch color TFT display. The launch reflects continued performance upgrades within the refillable open-pod segment, with brands adding higher capacity, adjustable output and smarter device interaction.
Aug.03