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

Nasdaq-Listed Vape Company iSpire Technology Restructures Leadership as Tuanfang Liu Becomes Sole CEO, BTIG Initiates Coverage on ODM Growth Opportunity
Nasdaq-Listed Vape Company iSpire Technology Restructures Leadership as Tuanfang Liu Becomes Sole CEO, BTIG Initiates Coverage on ODM Growth Opportunity
Nasdaq-listed vape company iSpire Technology has restructured its leadership team, with Tuanfang Liu becoming the company’s sole chief executive officer (CEO) and Michael Wang appointed CEO of Aspire North America. The move ends iSpire’s previous co-CEO structure and creates clearer responsibilities between group strategy and regional execution. Separately, BTIG initiated coverage on iSpire Technology with a Buy rating and a $3.50 price target, identifying ODM growth opportunities as a key investment factor.
Jul.27
Product | BAT Japan Launches virto Bright Peach Click in Japan, Expanding glo Hilo’s Capsule-Based Flavor Portfolio
Product | BAT Japan Launches virto Bright Peach Click in Japan, Expanding glo Hilo’s Capsule-Based Flavor Portfolio
British American Tobacco Japan (BAT Japan) has introduced virto Bright Peach Click, a new heated tobacco stick designed for the glo Hilo system. The product expands the existing virto consumable lineup with a combination of tobacco, menthol and ripe peach flavors, featuring a capsule mechanism that releases additional fruit flavor when activated. The product launched in Japan on July 27, 2026, through glo official online channels, convenience stores and tobacco retailers.
Aug.03
EU Tobacco Tax Reform Targets November Push as Sweden Holds Nicotine-Pouch Minimum at €20 per Kilogram
EU Tobacco Tax Reform Targets November Push as Sweden Holds Nicotine-Pouch Minimum at €20 per Kilogram
The Irish presidency of the Council of the European Union is using bilateral talks to push the bloc’s Tobacco Taxation Directive toward a political agreement in November. According to Law360, citing an EU official, Sweden is unwilling to accept a minimum excise threshold above €20 per kilogram for nicotine pouches. Council negotiations have already lowered the European Commission’s original proposal, but a May 2026 presidency compromise still set the minimum at 10% of the tax-inclusive retail price or €30 per kilogram in 2028-29, with higher levels later.
Market
Sep.17 by 2Firsts Perspectives
Product | PMJ Adds Bold Ruby to IQOS ILUMA i Lineup in Japan, Convenience-Store Rollout Starts Sept. 29
Product | PMJ Adds Bold Ruby to IQOS ILUMA i Lineup in Japan, Convenience-Store Rollout Starts Sept. 29
Philip Morris Japan (PMJ) launched Bold Ruby as a new regular color for the IQOS ILUMA i and IQOS ILUMA i ONE in Japan on September 16, 2026, priced at JPY 6,980 and JPY 3,980, respectively. Initial sales began through IQOS online and physical channels, with convenience stores and selected tobacco retailers set to follow from September 29. Bold Ruby is a regular rather than limited-edition colorway and is available for the ILUMA i and ILUMA i ONE, but not the ILUMA i PRIME. The release does not involve changes to the devices' core hardware or functions.
Sep.22
Australia’s TGA Places Nicotine Pouches Under Therapeutic Goods Rules From July 24, Blocking Imports of Unapproved Products
Australia’s TGA Places Nicotine Pouches Under Therapeutic Goods Rules From July 24, Blocking Imports of Unapproved Products
Australia is strengthening controls on nicotine pouches under its existing therapeutic goods regulatory framework. According to the Therapeutic Goods Administration (TGA), nicotine pouch products must meet regulatory requirements, and unapproved products cannot be legally imported. The move follows Australia’s broader approach of maintaining strict oversight of nicotine products, including nicotine-containing vapes. As nicotine pouches expand globally, Australia’s regulatory approach highlights growing differences in how countries manage emerging smoke-free nicotine products.
Regulations
Jul.27
2Firsts On-Site | PMI Brings IQOS, ZYN, VEEV and Marlboro Together at Its “Boulevard” at InterTabac 2026
2Firsts On-Site | PMI Brings IQOS, ZYN, VEEV and Marlboro Together at Its “Boulevard” at InterTabac 2026
At InterTabac 2026 in Dortmund, PMI is presenting multiple brands and products along “The PMI Boulevard,” including IQOS, ZYN, VEEV and Marlboro. On-site images captured by 2Firsts show dedicated spaces including the IQOS Boutique, ZYN Café, PMI Gallery and Marlboro Office
Market
Sep.16 by 2Firsts Perspectives