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

Imperial Brands Pulls myblu Vape Business From U.S., Citing Prolonged FDA Approval Process
Imperial Brands Pulls myblu Vape Business From U.S., Citing Prolonged FDA Approval Process
Imperial Brands said it will phase out its myblu vaping business in the United States, citing prolonged FDA approval timelines for new vape products. The company said it will instead focus on modern oral nicotine products in the U.S., including the expansion of its Zone brand and new flavors. While overall next-generation product revenue continued to grow, revenue from the category in the Americas declined sharply.
May.12
Exhibition Insights | Geek Bar Booth Shows Two Fasoul Heat-Not-Burn Devices in Prague
Exhibition Insights | Geek Bar Booth Shows Two Fasoul Heat-Not-Burn Devices in Prague
At EVO NXT 2026 in Prague, the Geek Bar booth displayed two Fasoul heat-not-burn devices, Q1 Pro and C2. One stressed compact size, screen-led control and dual modes, while the other highlighted faster heating, a larger battery and added functions. Both were presented as compatible with IQOS TEREA and SENTIA sticks. Materials on a website displaying Fasoul-related information also show recent market activity in Japan and Italy.
Apr.20 by 2FIRSTS.ai
Poland Seizes 223,688 Disposable Vapes Without Required Excise Marks
Poland Seizes 223,688 Disposable Vapes Without Required Excise Marks
Poland’s Customs and Tax Service in Łódź carried out an inspection at a property near Zgierz and seized 223,688 disposable e-cigarettes without the required excise markings.
Apr.07 by 2FIRSTS.ai
Kentucky Governor Signs Tobacco, Nicotine, and Vapor Product Licensing Bill Into Law
Kentucky Governor Signs Tobacco, Nicotine, and Vapor Product Licensing Bill Into Law
A Kentucky bill relating to tobacco, nicotine, and vapor product licensing was signed by the governor on April 10, 2026, and enacted as Acts Chapter 70. The measure sets application requirements for tobacco, nicotine, and vapor product licenses, governs batch licensing, renewals, ownership changes, and denial grounds, and requires the Department of Alcoholic Beverage Control to publish application forms and related regulations within 30 days of the law’s effective date.
Apr.14 by 2FIRSTS.ai
Ispire Reports Fiscal Q3 2026 Revenue of $18.7 Million and Net Loss of $9.5 Million
Ispire Reports Fiscal Q3 2026 Revenue of $18.7 Million and Net Loss of $9.5 Million
Ispire Technology reported financial results on May 7, 2026, for the third quarter of fiscal 2026, covering the three months ended March 31, 2026. Revenue was $18.7 million, compared with $26.2 million in the third quarter of fiscal 2025 and $20.3 million in the prior quarter. Gross profit was $2.0 million, with gross margin of 10.7%. Net loss was $9.5 million, or $0.17 per share. The company said it held $18.0 million in cash as of March 31, 2026, up $468,000 sequentially.
May.08 by 2FIRSTS.ai
PMI U.S. White Paper Calls for Greater Access to FDA-Authorized Smoke-Free Alternatives and Risk-Based Taxation
PMI U.S. White Paper Calls for Greater Access to FDA-Authorized Smoke-Free Alternatives and Risk-Based Taxation
PMI’s U.S. business released a white paper and cited a national online survey showing that 79.00% of Americans surveyed believe more should be done to reduce smoking-related harm. The paper calls on policymakers, public health authorities, and medical professionals to place cigarette smoking back at the center of public health priorities, and recommends broader access to FDA-authorized smoke-free alternatives, clearer nicotine risk communication, and risk-based taxation.
Apr.15 by 2FIRSTS.ai