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

Trump Reportedly Signs Off on Plan to Fire FDA Commissioner Marty Makary
Trump Reportedly Signs Off on Plan to Fire FDA Commissioner Marty Makary
According to The Wall Street Journal, people familiar with the matter said President Trump has signed off on a plan to fire FDA Commissioner Marty Makary, though the plan is not yet final and could change. The report said Makary’s tenure has included clashes over vaping, abortion and drug policy, and that some senior administration officials view him as struggling to manage the agency.
May.09 by 2FIRSTS.ai
Product | Geek Bar BURJ 80K Extends High-Puff Competition Into Hookah-Style DTL Use
Product | Geek Bar BURJ 80K Extends High-Puff Competition Into Hookah-Style DTL Use
2Firsts has noted that Geek Bar has added BURJ to its official product portfolio under the E-HOOKAH category. Public information shows that BURJ 80K is a hookah-style disposable vape featuring a 25ml e-liquid capacity, a 1500mAh battery, 0.4Ω dual coils and three operating modes: ECO, Regular and Pulse. According to publicly available product information, the device is rated for up to 80,000 puffs in ECO mode and uses a nicotine strength of 0.5% (5mg/ml).
Market
May.29
Imperial Brands Explains What the UK Tobacco and Vapes Act 2026 Means for Retailers
Imperial Brands Explains What the UK Tobacco and Vapes Act 2026 Means for Retailers
Imperial Brands has outlined what the newly approved UK Tobacco and Vapes Act 2026 means for retailers. The legislation received Royal Assent on April 29, 2026, and gives the Government powers to extend tobacco-style regulation to a wider range of products, including vaping products, heated tobacco, nicotine pouches and cigarette papers. Imperial Brands emphasized that most measures will be introduced in phases rather than taking effect immediately.
May.11 by 2FIRSTS.ai
CBP and FDA Seize 18 Million Illegal Vapes Worth $175 Million in Maritime Cargo Operation
CBP and FDA Seize 18 Million Illegal Vapes Worth $175 Million in Maritime Cargo Operation
U.S. Customs and Border Protection (CBP) announced that more than 18 million illegal e-cigarettes valued at over $175 million were seized during “Operation Red Mist,” a joint enforcement initiative involving the U.S. Coast Guard and the FDA. The operation primarily targeted maritime vape shipments originating from China and focused on combating illicit importation, transportation, and distribution activities.
Regulations
May.14
German Environment Minister Plans Bill to Ban Disposable E-Cigarettes This Year
German Environment Minister Plans Bill to Ban Disposable E-Cigarettes This Year
German Federal Environment Minister Carsten Schneider said he is preparing legislation to ban disposable e-cigarettes and will present a bill this year. Industry data estimated that legal e-cigarette sales in Germany rose by about one quarter in 2025 to €2.4 billion. Refillable devices are not expected to be affected by the ban.
May.09 by 2FIRSTS.ai
 Zyn Emerges as MAGA Cultural Symbol Amid FDA Policy Shift
Zyn Emerges as MAGA Cultural Symbol Amid FDA Policy Shift
According to The Wall Street Journal, nicotine pouch brand Zyn has rapidly gained popularity across the Trump administration and conservative political circles, including among U.S. Health Secretary Robert F. Kennedy Jr.
Business
May.20