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

Moscow Police Seize About 65,000 E-Cigarettes Worth More Than RUB 30 Million
Moscow Police Seize About 65,000 E-Cigarettes Worth More Than RUB 30 Million
Russian Interior Ministry spokesperson Irina Volk said on May 6 that police in Moscow seized about 65,000 nicotine-containing products from a man during searches of residential and warehouse premises. The products were valued at about RUB 30 million, or about USD 395,727 based on an exchange rate of USD 1 = RUB 75.81.
May.11 by 2FIRSTS.ai
Reuters: Big Tobacco Emerges as Winner After FDA Regulatory Shift
Reuters: Big Tobacco Emerges as Winner After FDA Regulatory Shift
According to Reuters, major tobacco companies may emerge as key beneficiaries after the U.S. FDA loosened regulations on vaping and nicotine pouch products, a shift that has sparked debate over public health risks.
Industry Insight
May.26
Imperial Brands Explains What the UK Tobacco and Vapes Act 2026 Means for Retailers
Imperial Brands Explains What the UK Tobacco and Vapes Act 2026 Means for Retailers
Imperial Brands has outlined what the newly approved UK Tobacco and Vapes Act 2026 means for retailers. The legislation received Royal Assent on April 29, 2026, and gives the Government powers to extend tobacco-style regulation to a wider range of products, including vaping products, heated tobacco, nicotine pouches and cigarette papers. Imperial Brands emphasized that most measures will be introduced in phases rather than taking effect immediately.
May.11 by 2FIRSTS.ai
WHO’s First Global Report on Nicotine Pouches: Harm Reduction Questions Remain Amid Global Regulatory Warning
WHO’s First Global Report on Nicotine Pouches: Harm Reduction Questions Remain Amid Global Regulatory Warning
Ahead of World No Tobacco Day 2026, WHO released its first global report on nicotine pouches, warning that rapid market growth, youth-oriented marketing and weak regulation are converging. 2Firsts views the report as an important warning, but not a complete risk assessment, with harm-reduction questions still unresolved.
Special Report
May.17
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
Türkiye Records 4,163 E-Cigarette Smuggling Raids Over Five Years, With Seizures Worth TRY 1.84 Billion
Türkiye Records 4,163 E-Cigarette Smuggling Raids Over Five Years, With Seizures Worth TRY 1.84 Billion
Turkish Trade Minister Ömer Bolat disclosed enforcement figures on e-cigarette smuggling in response to a written parliamentary question. Over the past five years, Türkiye recorded 4,163 raids targeting e-cigarette smuggling, preventing illegal e-cigarettes, liquids and components worth TRY 1.84 billion, or about USD 40.68 million based on an exchange rate of USD 1 = TRY 45.2339, from reaching the market.
May.07 by 2FIRSTS.ai