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

Namibia Moves to Tighten Laws on E-Cigarettes and Emerging Nicotine Products
Namibia Moves to Tighten Laws on E-Cigarettes and Emerging Nicotine Products
Namibia is moving to tighten regulation of e-cigarettes and other emerging nicotine products as part of broader tobacco control efforts. Deputy health minister Susan Ndjaleka said the government is reviewing the Tobacco Products Control Act to close regulatory gaps and address emerging tobacco products. Namibia is also working toward joining the Protocol to Eliminate Illicit Trade in Tobacco Products in order to curb the black market and protect public revenue.
Apr.17 by 2FIRSTS.ai
Russia May Allow Regions to Introduce Experimental Vape Sales Bans
Russia May Allow Regions to Introduce Experimental Vape Sales Bans
Russia’s government commission on legislative activity has approved second-reading amendments to a bill on licensing trade in tobacco and nicotine-containing products that would allow Russian regions to introduce experimental bans on vape sales.
Mar.31 by 2FIRSTS.ai
Netherlands Plans Law to Ban Possession of Large Quantities of Vapes Intended for Trade
Netherlands Plans Law to Ban Possession of Large Quantities of Vapes Intended for Trade
Dutch Health Minister Hermans is drafting legislation that would also ban possession of larger quantities of vapes, allowing the Netherlands Food and Consumer Product Safety Authority to intervene earlier and seize stock before proving that trade has taken place.
Apr.13 by 2FIRSTS.ai
Product | Labeled “Built in the USA” Up to 60,000 Puffs: DOJO PUREX 60K Launches on U.S. Sales Channels
Product | Labeled “Built in the USA” Up to 60,000 Puffs: DOJO PUREX 60K Launches on U.S. Sales Channels
DOJO unveiled the PUREX 60K e-cigarette at TPE 2026 held in Las Vegas, United States. The product is labeled “Built in the USA,” supports up to 60,000 puffs, and features 16ml e-liquid capacity, a 1000mAh battery, and ECO and SMART output modes. It has gone live on DOJO’s official website and select U.S. online sales channels at a price of $18.99.
Apr.07 by 2FIRSTS.ai
Thailand’s DDC Files Complaint Over Online Sales of Nicotine Pouches
Thailand’s DDC Files Complaint Over Online Sales of Nicotine Pouches
Thailand’s Department of Disease Control has lodged a complaint over the alleged online sale of nicotine pouches. The department said its monitoring found the products were being advertised and sold through electronic media, and a further inquiry later identified a physical shop linked to a store in Pathum Thani province.
Mar.23 by 2FIRSTS.ai
2Firsts Holds Second PMTA Compliance Training in Shenzhen, Highlighting U.S. Regulatory Framework and Corporate Compliance Capabilities
2Firsts Holds Second PMTA Compliance Training in Shenzhen, Highlighting U.S. Regulatory Framework and Corporate Compliance Capabilities
2Firsts held its second U.S. PMTA compliance training in Shenzhen, providing a systematic overview of the U.S. regulatory framework for e-cigarettes and corporate compliance strategies. Nearly 20 industry professionals from manufacturing, e-liquid and supply-chain companies attended. Participants who passed the exam received compliance certification. Registration for the third training session will open soon, alongside customized corporate training programs.
Mar.09