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

Product | JT Launches Ploom AURA Glacier White in Japan, Expanding the Device Ecosystem Through Color and Accessories
Product | JT Launches Ploom AURA Glacier White in Japan, Expanding the Device Ecosystem Through Color and Accessories
Japan Tobacco Inc. (JT) has introduced the Ploom AURA Glacier White heated tobacco device in Japan, adding a new color option to the existing Ploom AURA lineup. The device maintains the existing SMART HEATFLOW technology and HEAT SELECT SYSTEM with four heating modes, while expanding the ecosystem through new accessories including front panels, back covers, a car holder and wireless charging covers. The product entered pre-sale in Japan on June 30, 2026, followed by broader retail availability from July 7.
Aug.03
BAT Expands ITC Infotech Partnership Across Poland, Romania and India to Advance AI
BAT Expands ITC Infotech Partnership Across Poland, Romania and India to Advance AI
ITC Infotech has expanded its multi-year strategic technology partnership with British American Tobacco (BAT), providing technology services across Poland, Romania and India while continuing to support BAT's newly launched Future Capabilities Centre in India and existing technology hubs in Malaysia and Mexico. The companies said the agreement will focus on AI-enabled innovation, technology capability building and greater operational efficiency. The partnership also aligns with BAT's broader Fit2Win transformation programme, under which the group is expanding the use of external technology and business-services partners to simplify its global operating model.
Aug.13
FDA Proposes Foreign Tobacco Factory Registration Rule to Tighten Import Oversight
FDA Proposes Foreign Tobacco Factory Registration Rule to Tighten Import Oversight
The FDA has proposed a rule requiring foreign tobacco manufacturers to register facilities and list products before exporting to the U.S. If finalized, the rule could affect overseas OEM/ODM factories, contract manufacturers, specification developers, bulk product makers, and repackaging or relabeling firms. FDA says the proposal would help identify unauthorized imported tobacco products, including e-cigarettes.
Special Report
Jun.26
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
Smoore Wins Three Heated Device Supply Lots in China Tobacco Jiangsu’s Overseas Market Project Covering Japan, South Korea and Southeast Asia
Smoore Wins Three Heated Device Supply Lots in China Tobacco Jiangsu’s Overseas Market Project Covering Japan, South Korea and Southeast Asia
China Tobacco Jiangsu Industrial Co., Ltd. (JSIC) has completed its 2026-2028 heated device procurement project, with Shenzhen Smoore Technology Limited securing final supply contracts for three lots: U1, C1 and C2. The project was launched through a public tender in June 2026 to support overseas markets and involved heated tobacco devices carrying JSIC’s “iRod” trademark. Candidate supplier results published on July 13 showed Smoore ranked first for the three awarded lots, while Shenzhen Yunxi Intelligent Technology Co., Ltd. and Shenzhen Bodi Technology Development Co., Ltd. participated in the bidding process.
Aug.03
FIFA Bans Vaping in 2026 World Cup Stadiums, Putting Nicotine Rules in Event Compliance Focus
FIFA Bans Vaping in 2026 World Cup Stadiums, Putting Nicotine Rules in Event Compliance Focus
FIFA’s 2026 World Cup stadium rules prohibit smoking, vaping and the use of any tobacco products or electronic smoking devices inside stadiums, including inner and outer perimeters, while electronic smoking devices, tobacco products, lighters and matches are listed as prohibited items, bringing nicotine-product management, venue compliance and cross-border legal differences into focus at a major global sporting event.
Jul.06