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

2Firsts Data | China’s Vape Exports Rise 3.1% in H1 2026 as 6-Methyl Nicotine-Related Products Surge 65.2%
2Firsts Data | China’s Vape Exports Rise 3.1% in H1 2026 as 6-Methyl Nicotine-Related Products Surge 65.2%
China’s vape exports showed resilience in the first half of 2026 after a short-term shock from China’s export rebate adjustment. But customs data points to more than a simple recovery: the structure of growth is changing. Vaping devices and atomization hardware emerged as the strongest growth driver, while nicotine-containing vaping products remained broadly stable. Meanwhile, nicotine substitute-related products represented by 6-methyl nicotine expanded rapidly, becoming a new category to watch for both industry and regulators. After the U.S. market went through a cycle of shortages, replenishment and inventory rebuilding in 2025, China’s vape supply chain is entering a new phase of reallocation.
Special Report
Jul.20
Product | APUS Launches Chloe 50K, Bringing Purse-Inspired Design to the U.S. High-Puff Disposable Market
Product | APUS Launches Chloe 50K, Bringing Purse-Inspired Design to the U.S. High-Puff Disposable Market
APUS has introduced the Chloe 50K disposable vape, which has appeared across U.S.-facing online retail channels including Element Vape and Vapesourcing. The device combines a purse-inspired body and chain attachment with a 20ml e-liquid capacity, 1,250mAh rechargeable battery, dual mesh coil, and battery and e-liquid indicators. It is rated for up to 50,000 puffs. The product does not appear on the FDA’s current list of authorized e-cigarettes, and U.S. retail availability does not indicate FDA marketing authorization.
Jul.15
KT&G’s Lil Strengthens Market Lead in Korea as Heated Tobacco Share Reaches 47.4%
KT&G’s Lil Strengthens Market Lead in Korea as Heated Tobacco Share Reaches 47.4%
According to South Korea’s UpKorea, KT&G’s heated tobacco brand Lil reached a 47.4% share of Korea’s heated tobacco stick market in the first quarter of 2026. The company is expanding its next-generation products (NGP) business through product development, technology investment and overseas growth. KT&G reported NGP sales of 890.1 billion won (approximately US$650 million) in 2025, up significantly from 279.3 billion won in 2020. Lil products are now available in 34 markets, while KT&G continues building its technology portfolio through patents and multiple product platforms.
Jul.23
Former FDA Scientist Questions ZYN Review Over Pouch Material and Microplastic Risk
Former FDA Scientist Questions ZYN Review Over Pouch Material and Microplastic Risk
A former FDA toxicologist has questioned whether the agency fully assessed the material used in ZYN nicotine pouches before authorizing them for sale, raising concerns over possible microplastic exposure, according to STAT and The Examination.
Jul.16
Chinese Disposable Brands OXBAR, LYCO Challenge Vuse and JUUL: Pennsylvania’s Pending List Offers a Glimpse of the Future Legal Vape Market
Chinese Disposable Brands OXBAR, LYCO Challenge Vuse and JUUL: Pennsylvania’s Pending List Offers a Glimpse of the Future Legal Vape Market
Pennsylvania’s June 26 ENDS Pending Certifications list previews the state’s future legal vape market, placing Vuse, JUUL and Logic alongside Chinese-linked disposable brands OXBAR and LYCO. Shaped by PMTA eligibility and state rules, the list shows competition shifting from market share to market access.
Special Report
Jul.06
Germany Seizes 56 Pallets of Illegal Vapes, Probe Estimates €1.8 Million Tax Loss
Germany Seizes 56 Pallets of Illegal Vapes, Probe Estimates €1.8 Million Tax Loss
German authorities have seized dozens of pallets of illegal disposable vapes in a criminal investigation, with the products estimated to have caused at least €1.8 million in tax losses. The case has also raised concerns over cross-border supply chains linked to unauthorized nicotine products entering the European market.
Jul.14