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

UK Vape Brands Face White-Packaging and Flavour-Name Curbs in Youth-Appeal Crackdown
UK Vape Brands Face White-Packaging and Flavour-Name Curbs in Youth-Appeal Crackdown
The UK government and devolved administrations have launched a 12-week consultation on proposals to make vapes less appealing to children, including plain white packaging, limits on device colours, restrictions on flavour names and changes to how products are displayed in shops.
Jul.10
Changing Assumptions in U.S. Cigar Consumption: 2Firsts Interviews Cigar Educator Mechelle Merkerson
Changing Assumptions in U.S. Cigar Consumption: 2Firsts Interviews Cigar Educator Mechelle Merkerson
U.S. premium cigar culture is shifting toward education, broader choice and deeper links to craftsmanship and origin, cigar educator Mechelle Merkerson told 2Firsts. She sees boutique brands, women consumers and production-region experiences making knowledge central to cigar participation. For global brands, retailers and emerging markets such as China, education may help turn curiosity into sustained engagement.
Special Report
Jul.06
Product | VEEV One Plus Goes Official as PMI Strengthens Its Closed-Pod Vaping Portfolio
Product | VEEV One Plus Goes Official as PMI Strengthens Its Closed-Pod Vaping Portfolio
Philip Morris International (PMI) has officially introduced the VEEV One Plus, the next-generation device in its closed-pod vaping lineup. The product is now featured on the official VEEV website in Portugal, bringing hardware upgrades including a new dual-pod storage system, a larger battery, and an updated device design while maintaining compatibility with existing VEEV One pods.
Jul.02
Reemtsma says German illegal e-cigarette seizures reached 70% of 2025 total, pouches 179%
Reemtsma says German illegal e-cigarette seizures reached 70% of 2025 total, pouches 179%
Reemtsma said its first-half 2026 black-market tracker for tobacco and nicotine products showed a continued rise in officially reported seizures in Germany, with illegal e-cigarette seizures reaching 70% of the full-year 2025 level and snus and nicotine pouch seizures reaching 179% of last year’s total.
Jul.08
Vapesourcing Lists RELX Creator Pro 15K as “Coming Soon,” Shows U.S. Warehouse Shipping Options
Vapesourcing Lists RELX Creator Pro 15K as “Coming Soon,” Shows U.S. Warehouse Shipping Options
2Firsts found that U.S.-facing and cross-border vape retailer Vapesourcing has created a product page for the “RELX Creator Pro 15K Disposable Vape Kit 3%,” marked as “Coming Soon.” The page lists U.S. warehouse shipping options, but does not show that the product is currently available for purchase.
Market
Jun.08
Canada Recalls Siberia and ZYN Nicotine Pouches Over Unauthorized Sales
Canada Recalls Siberia and ZYN Nicotine Pouches Over Unauthorized Sales
Health Canada has issued a nationwide recall for nicotine pouch products sold under the Siberia and ZYN brands, citing a lack of market authorization. All affected lots are subject to the recall.
Jun.15