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

Germany Plans Tobacco Tax Hike, With Cigarette Prices Nearing €12 Per Pack by 2030
Germany Plans Tobacco Tax Hike, With Cigarette Prices Nearing €12 Per Pack by 2030
Germany plans to raise tobacco taxes over the coming years, potentially pushing the average price of a 20-cigarette pack to about €11.78 by 2030. The proposal also covers fine-cut tobacco, cigars, pipe tobacco and e-cigarette liquids.
Jul.14
UK Councils Seize More Than 1.3 Million Non-Compliant Vapes One Year After Disposable Ban
UK Councils Seize More Than 1.3 Million Non-Compliant Vapes One Year After Disposable Ban
One year after the UK disposable vape ban came into force, local authorities continue to seize illegal and non-compliant vaping products. FOI data compiled by nicotine retailer Northerner shows more than 1.3 million products were seized between June 2025 and May 2026, with Bolton recording the highest number of seizures and Swansea reporting the highest estimated value.
Jul.21
French Vape Market Under Pressure as Europe’s First Listed Vape Company Kumulus Vape Reports 7.8% H1 Revenue Decline, Retail Sales Rise 41.5%
French Vape Market Under Pressure as Europe’s First Listed Vape Company Kumulus Vape Reports 7.8% H1 Revenue Decline, Retail Sales Rise 41.5%
Kumulus Vape, Europe’s first publicly listed vape company, reported a 7.8% year-on-year decline in first-half 2026 revenue. Amid changing conditions in France’s vape market, the company said channel diversification helped offset pressure, with physical store sales increasing 41.5% year on year. Listed on Euronext Access Paris in 2019 and later transferred to Euronext Growth Paris, Kumulus Vape is viewed as a representative company of Europe’s vape sector. Its performance highlights the industry’s shift from rapid expansion toward more operationally focused growth.
Jul.27
Malaysia Police Seize RM12.7 Million in Illegal Vapes and Cigarettes as Probe Points to Sea Shipments From China
Malaysia Police Seize RM12.7 Million in Illegal Vapes and Cigarettes as Probe Points to Sea Shipments From China
Police in Malaysia’s Selangor state seized illegal vape products and contraband cigarettes worth about RM12.7 million (approximately $3 million) in two enforcement operations. According to New Straits Times and The Star, the vape-related operation uncovered 131,036 boxes of vape products, 4,900 bottles of e-liquid and 25,510 vape devices, valued at about RM9.4 million. Police said preliminary investigations indicated that some illegal vape products entered Malaysia through sea shipments from China before moving through storage and distribution networks.
Aug.10
Product | KT&G Brings LOOP Nicotine Pouches to South Africa, Supporting ASF’s Expansion Across Africa
Product | KT&G Brings LOOP Nicotine Pouches to South Africa, Supporting ASF’s Expansion Across Africa
KT&G has introduced nicotine pouch brand LOOP in South Africa, expanding its modern oral nicotine portfolio. Developed by Swedish company Another Snus Factory (ASF), LOOP is a tobacco-free nicotine pouch brand. KT&G and U.S. tobacco company Altria previously participated in ASF’s strategic development, and the South Africa launch represents a further step in LOOP’s international expansion.
Aug.06
PMI Expands Colorado Investment to $1.2 Billion to Boost ZYN Nicotine Pouch Production
PMI Expands Colorado Investment to $1.2 Billion to Boost ZYN Nicotine Pouch Production
Philip Morris International (PMI) is expanding its investment in its Golden, Colorado campus, bringing total investment to approximately $1.2 billion to support its smoke-free products business. The investment will strengthen PMI’s research, production and innovation capabilities in smoke-free products. As one of the world’s largest tobacco companies, PMI has continued advancing its “Smoke-Free Future” strategy through heated tobacco, oral nicotine and other reduced-risk product categories.
PMI
Jul.28