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

Special Report|Disposable Heated Tobacco? A China Tobacco Patent Reimagines the Heated-Tobacco Stick as a Self-Contained Product
Special Report|Disposable Heated Tobacco? A China Tobacco Patent Reimagines the Heated-Tobacco Stick as a Self-Contained Product
A newly published China Tobacco patent proposes a holder-free heat-not-burn stick that integrates the filter, tobacco substrate, heating element, controller and power source into one cigarette-shaped product. It stands out not just for eliminating the external heating device, but for explicitly highlighting two less common goals in heated tobacco: restoring cigarette-like social sharing and enabling post-use recovery through a recoverable component group.
Innovation
Mar.18
Brazil’s Teen E-Cigarette Experimentation Rate Rises to 29.6% Over Five Years
Brazil’s Teen E-Cigarette Experimentation Rate Rises to 29.6% Over Five Years
Brazil’s National School Health Survey (PeNSE) 2024 found that e-cigarette experimentation among students aged 13 to 17 rose from 16.8% in 2019 to 29.6% in 2024, while use in the previous 30 days increased from 8.6% to 26.3%. Over the same period, conventional cigarette experimentation fell from 22.6% to 18.5%, and hookah use declined from 26.9% to 16.4%.
Mar.26 by 2FIRSTS.ai
KT&G to cancel 10.866 mln treasury shares, about 9.5% of shares outstanding
KT&G to cancel 10.866 mln treasury shares, about 9.5% of shares outstanding
KT&G said it plans to cancel all treasury shares it holds, totaling 10,866,189 shares, representing about 9.5% of shares outstanding, in line with Korea’s third amendment to the Commercial Act requiring companies to cancel repurchased shares within one year. The company also disclosed progress on its shareholder-return plan and multiple agenda items for next month’s shareholders meeting.
Feb.26
2Firsts Holds Second PMTA Compliance Training in Shenzhen, Highlighting U.S. Regulatory Framework and Corporate Compliance Capabilities
2Firsts Holds Second PMTA Compliance Training in Shenzhen, Highlighting U.S. Regulatory Framework and Corporate Compliance Capabilities
2Firsts held its second U.S. PMTA compliance training in Shenzhen, providing a systematic overview of the U.S. regulatory framework for e-cigarettes and corporate compliance strategies. Nearly 20 industry professionals from manufacturing, e-liquid and supply-chain companies attended. Participants who passed the exam received compliance certification. Registration for the third training session will open soon, alongside customized corporate training programs.
Mar.09
Glasgow bin lorry fires spark calls to broaden vape and battery disposal messaging
Glasgow bin lorry fires spark calls to broaden vape and battery disposal messaging
Glasgow residents have been warned that throwing batteries and vapes away at home can endanger refuse workers, amid bin lorries catching fire. The city council said it will launch a communications campaign next month to tell people to place batteries in special bins at supermarkets or household waste recycling centres, supported by a dedicated web page listing other disposal sites.
Feb.11 by 2FIRSTS.ai
West Virginia Governor Signs Bill Directing USD 2.9 Million From Juul Settlement to Youth Tobacco Prevention
West Virginia Governor Signs Bill Directing USD 2.9 Million From Juul Settlement to Youth Tobacco Prevention
The American Cancer Society Cancer Action Network said West Virginia Governor Patrick Morrisey has signed House Bill 5691 into law, directing USD 2.9 million from the Juul settlement to youth tobacco prevention and programs that help people quit. The bill is a supplemental appropriation measure, and the Legislature’s bill history shows it passed the House on March 11, passed the Senate on March 13 and was sent to the governor on March 18.
Mar.20 by 2FIRSTS.ai