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

Australian Government and Spotify Launch Third Phase of Youth Vaping Education Campaign
Australian Government and Spotify Launch Third Phase of Youth Vaping Education Campaign
The Australian Government and Spotify have launched the third phase of the Youth Vaping Education Campaign under the theme “Buddy Up – Make a Pact to Quit Together.” This phase shifts the focus toward peer and community support by encouraging young people to quit vaping together.
Apr.16 by 2FIRSTS.ai
Finnish Customs Investigate Firm Suspected of Importing and Selling Nicotine Pouches Without Paying Tobacco Tax
Finnish Customs Investigate Firm Suspected of Importing and Selling Nicotine Pouches Without Paying Tobacco Tax
Finnish Customs are investigating a firm suspected of importing and selling nicotine pouches without paying tobacco tax. Two Finnish citizens have been questioned as part of the probe. The authority believes the nicotine pouches were imported into Finland from other EU countries before being distributed to Finnish retailers.
Mar.11 by 2FIRSTS.ai
Product | 30ml E-Liquid, 40,000 Puffs, and Three Power Settings: OXBAR Launches New DTL Product ROVOTA
Product | 30ml E-Liquid, 40,000 Puffs, and Three Power Settings: OXBAR Launches New DTL Product ROVOTA
E-cigarette brand OXBAR has launched its new DTL e-cigarette, the OXBAR ROVOTA, on its official website. The product contains 30ml of e-liquid and is officially rated for up to approximately 40,000 puffs. It has a nicotine strength of 6mg and offers around 15 flavor options. The device is equipped with a 1400mAh battery, supports Type-C charging, features a 0.4Ω dual mesh coil, and supports three power settings of 20W, 30W, and 40W.
Mar.31 by 2FIRSTS.ai
FDA Issues Draft PMTA Guidance for Flavored E-Cigarettes, Maintaining Higher Evidence Bar for Fruit and Sweet Flavors
FDA Issues Draft PMTA Guidance for Flavored E-Cigarettes, Maintaining Higher Evidence Bar for Fruit and Sweet Flavors
The U.S. Food and Drug Administration (FDA) on March 9 released a draft guidance outlining its current thinking on premarket tobacco product applications (PMTAs) for flavored electronic nicotine delivery systems (ENDS). The document reiterates that fruit, candy, dessert, and other sweet-flavored e-cigarettes present a “significant public health risk” to youth and therefore face a higher evidentiary burden if manufacturers seek marketing authorization.
Mar.10 by 2FIRSTS.ai
Product | Vaporless Mode + Transparent Display Screen: Kanger Launches Subox Mix 50K in the U.S.
Product | Vaporless Mode + Transparent Display Screen: Kanger Launches Subox Mix 50K in the U.S.
E-cigarette brand Kanger has recently launched its new e-cigarette, the Subox Mix 50K, across multiple online channels in the United States. The product features a “vaporless mode” and a transparent digital display design, supporting switching between approximately 25K vapor puffs and 25K vaporless puffs, for a total of 50,000 puffs, while displaying battery level and mode status in the transparent pod section.
Apr.13 by 2FIRSTS.ai
Australia’s NSW Finds Lower Vaping Rates Among Teenagers Aged 14 to 17
Australia’s NSW Finds Lower Vaping Rates Among Teenagers Aged 14 to 17
A new report from Cancer Council’s Generation Vape research project shows that fewer teenagers in New South Wales are trying vaping after the state government introduced tougher vaping goods laws. Among surveyed NSW teenagers aged 14 to 17, the proportion who had tried vaping fell from 29.6% in April 2024 to 20.1% in October 2025.
Mar.17 by 2FIRSTS.ai