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

Altria Reports Full-Year 2025 Results: Revenue Down 3.1%, Cigarette Volumes Slide 10% as NJOY Takes Impairment Hit
Altria Reports Full-Year 2025 Results: Revenue Down 3.1%, Cigarette Volumes Slide 10% as NJOY Takes Impairment Hit
Altria has released its full-year 2025 results, reporting full-year net revenues of $23.279 billion, down 3.1% year over year. Domestic cigarette shipment volume fell 10% for the year. on! nicotine pouches reached a 7.7% share of the U.S. oral tobacco category in the fourth quarter. NJOY posted $21 million in net revenues in Q4, while full-year net revenues were negative $13 million (mainly due to returns and related factors).
Jan.30 by 2FIRSTS.ai
China Caps E-Cigarette Capacity and Requires Export Compliance Proof to Curb “Involution”
China Caps E-Cigarette Capacity and Requires Export Compliance Proof to Curb “Involution”
China’s top tobacco regulator has issued a directive aimed at preventing excess capacity and curbing “involution-style” competition in the e-cigarette sector. The notice tightens investment controls, formalizes verified capacity management and requires exporters to submit compliance proof for destination markets, signaling a push toward higher industry concentration and stricter cross-border oversight.
Special Report
Feb.13
Product | Claiming “U.S.-Made E-Liquid” and “80,000 Puffs,” VOOPOO Launches NAVI×Cyph 80K
Product | Claiming “U.S.-Made E-Liquid” and “80,000 Puffs,” VOOPOO Launches NAVI×Cyph 80K
VOOPOO’s website shows the company has introduced the NAVI×Cyph Kit 80K, an open-system, refillable vaping kit claimed to deliver up to 80,000 puffs. The device features a 1,500mAh battery with USB Type-C charging and comes in 12 flavors. A promotional image posted on VOOPOO’s official Instagram account includes the phrase “E-LIQUID BUILT IN THE USA.”
Feb.10 by 2FIRSTS.ai
Tajikistan Weighs a Total Vape Ban as Upper House Chair Orders Draft Bill
Tajikistan Weighs a Total Vape Ban as Upper House Chair Orders Draft Bill
Tajikistan is preparing legislation that could impose a nationwide ban on e-cigarettes. Upper house chair Rustami Emomali (Рустами Эмомали) has ordered the drafting of a bill, which is still under development. Retailers have begun scaling back sales amid tightening signals, while existing tobacco-control rules already restrict smoking in many public places and set fines.
Jan.26 by 2FIRSTS.ai
NASCAR adds nicotine pouch sponsor Grizzly as official partner; zone renews RCR deal for 2026
NASCAR adds nicotine pouch sponsor Grizzly as official partner; zone renews RCR deal for 2026
NASCAR Holdings has struck a partnership with Grizzly, a nicotine pouch brand under Reynolds American, making it an official sponsor across NASCAR and its track portfolio, with financial terms undisclosed. Separately, zone, a nicotine pouch brand owned by Imperial Brands’ U.S. subsidiary ITG Brands, renewed its relationship with Richard Childress Racing (RCR) and will continue sponsoring Kyle Busch’s No. 8 car during the 2026 season.
Jan.26
France’s ANSES Report Reframes the Vape Debate: Harm Reduction Confirmed, Regulatory Barriers Rising
France’s ANSES Report Reframes the Vape Debate: Harm Reduction Confirmed, Regulatory Barriers Rising
France’s top health agency has confirmed that vaping is less harmful than smoking — but not risk-free — reshaping the country’s regulatory trajectory. As Paris withdraws a proposed vape tax and debates stricter ingredient, emissions and youth-protection rules, the ANSES report signals not prohibition, but tighter technical oversight. For manufacturers, retailers and EU policymakers, France may be previewing Europe’s next phase of nicotine governance.
Special Report
Feb.23