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

Malaysia Nicotine Vape Market Faces Legal Uncertainty Over Tax and Poisons List Ruling
Malaysia Nicotine Vape Market Faces Legal Uncertainty Over Tax and Poisons List Ruling
Malaysia’s Finance Minister Anwar Ibrahim said duties and taxes on nicotine-containing vape products will be determined in line with the Court of Appeal’s ruling on whether liquid or gel nicotine can be exempted from the Poisons List under the Poisons Act 1952, a case that could affect the legal basis for vape taxation, retail sales and future ban policy.
Jun.29
Product | BAT Launches glo Hyper pro+ in Japan, Upgrading the Hyper Platform With Faster Start and Smart Device Management
Product | BAT Launches glo Hyper pro+ in Japan, Upgrading the Hyper Platform With Faster Start and Smart Device Management
British American Tobacco Japan (BAT Japan) has introduced glo Hyper pro+, an upgraded device within the existing glo Hyper platform. The device adds QuickStart™ rapid heating technology, an EasyView™ display and maintenance notification features to improve daily usability. Launched in Japan on July 13, 2026, glo Hyper pro+ maintains compatibility with existing Hyper-format tobacco sticks, including neo, Lucky Strike and KENT.
Jul.30
IQOS Global Flagship Space to Open in Tokyo Ginza as PMI Expands Consumer Experience Strategy
IQOS Global Flagship Space to Open in Tokyo Ginza as PMI Expands Consumer Experience Strategy
Philip Morris Japan (PMJ) announced that it will open “IQOS Flagship Ginza” in Tokyo on September 4, 2026. The location will become the first global flagship space for PMI’s IQOS brand. PMJ said the venue will target adult smokers aged 20 and above and combine product experiences, community engagement and local cultural elements. The design will incorporate Japanese natural aesthetics and traditional craftsmanship. The launch reflects PMI’s broader strategy of strengthening consumer engagement through experiential retail and brand spaces. The existing IQOS Store Ginza is scheduled to close on August 30, 2026.
Jul.21
ATF Cancels Webloc Contract, Raising Questions Over Commercial Location Data in Enforcement
ATF Cancels Webloc Contract, Raising Questions Over Commercial Location Data in Enforcement
The U.S. Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) has stopped using Webloc, a commercial phone-tracking tool, after lawmakers, a prosecutor and a judge raised legal and privacy concerns over warrantless use of ad-tech location data, a development that may affect data-use boundaries in U.S. enforcement against illicit tobacco, nicotine products and cross-border distribution networks.
Jun.29
FDA Foreign Tobacco Registration Proposal Could Strengthen ENDS Import Oversight, Azim Chowdhury Says
FDA Foreign Tobacco Registration Proposal Could Strengthen ENDS Import Oversight, Azim Chowdhury Says
FDA’s proposed rule requiring foreign tobacco manufacturers to register establishments and list products is more than routine paperwork, Keller and Heckman LLP partner Azim Chowdhury told 2Firsts. He said it could strengthen FDA’s import enforcement, inspections and market surveillance. Chinese e-cigarette OEM/ODM manufacturers, specification developers, brand owners and component suppliers may need to review their roles, product data and U.S. market authorization status.
Special Report
Jun.29
ZYN ULTRA Expands Haypp’s U.S. E-Commerce Lineup With 9 mg Pouches
ZYN ULTRA Expands Haypp’s U.S. E-Commerce Lineup With 9 mg Pouches
Haypp Group said ZYN ULTRA became available nationwide in the United States on June 15 through its e-commerce platforms Nicokick.com and Northerner.com for verified adult nicotine consumers.
Jun.17