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

Japan’s Heated Tobacco Tax Reform Drives Price Increase as JT Raises All Ploom Sticks by ¥40
Japan’s Heated Tobacco Tax Reform Drives Price Increase as JT Raises All Ploom Sticks by ¥40
Japan Tobacco Inc. (JT) has applied to Japan’s finance minister for approval to revise retail prices of its Ploom heated tobacco sticks following planned changes to the heated tobacco tax system from October 1, 2026. If approved, all 31 Ploom stick products will increase by ¥40. After the adjustment, EVO products will cost ¥620 per 20-stick pack, MEVIUS products ¥590 and CAMEL products ¥570. JT said the price revision is intended to respond to tax changes while maintaining product quality and brand value. The tax reform is expected to narrow the tax gap between combustible cigarettes and heated tobacco products, potentially reshaping pricing strategies in Japan’s heated tobacco market.
Jul.22
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
Data|China’s January-May Vape Exports: U.S. Shipments Fall 13.8% as Japan Posts Fastest Growth
Data|China’s January-May Vape Exports: U.S. Shipments Fall 13.8% as Japan Posts Fastest Growth
According to China Customs export data analyzed by 2Firsts, the United States remained China’s largest destination for vape-related exports during January-May 2026 despite a 13.82% year-on-year decline in export value. Meanwhile, exports to Japan, Russia, Indonesia and the United Arab Emirates recorded strong growth, highlighting continued diversification across China’s export markets.
Special Report
Jun.29
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
Illicit Vape and Nicotine Pouch Seizures Concentrated in UK Hotspots, New Data Shows
Illicit Vape and Nicotine Pouch Seizures Concentrated in UK Hotspots, New Data Shows
Freedom of Information (FOI) data from the UK shows that more than 3,000 seizures of illegal nicotine products were recorded in the 2024/25 financial year, with Hull, Liverpool and Bolton emerging as the most active enforcement hotspots — highlighting that the problem of illicit vapes, nicotine pouches and smokeless tobacco products persists across many parts of the country.
Jun.16
BP, Marathon and Valero Warn U.S. Gas-Station Stores: Illegal Vape Sales Could Bring Heavy Fines and Card-Processing Limits
BP, Marathon and Valero Warn U.S. Gas-Station Stores: Illegal Vape Sales Could Bring Heavy Fines and Card-Processing Limits
Fiserv and service station operators including BP, Marathon Petroleum and Valero have warned U.S. partners and gas-station convenience-store owners that selling illegal vapes could lead to heavy fines, breach brand agreements and even put stores’ card-processing access at risk, according to Reuters.
Regulations
Jul.07 by 2Firsts Perspectives