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

Tobacco Farming in the New Nicotine Era: Why Indian Farmers Struggle to Transition — Contributed by Samrat Chowdhery
Tobacco Farming in the New Nicotine Era: Why Indian Farmers Struggle to Transition — Contributed by Samrat Chowdhery
In this contributed article to 2Firsts, Mumbai-based journalist and harm reduction advocate Samrat Chowdhery examines India’s tobacco transition from the perspective of agriculture, supply chains and regulation. As noted by 2Firsts, India offers a relevant case for understanding how new nicotine technologies may affect not only consumption, trade and policy, but also tobacco farming.
Special Report
May.29
KT&G Launches Two New lil AIBLE Dedicated Sticks as Aim Portfolio Expands to 13
KT&G Launches Two New lil AIBLE Dedicated Sticks as Aim Portfolio Expands to 13
KT&G said on April 20 that it has launched two new “AIIM” sticks for its lil AIBLE heated tobacco device at convenience stores nationwide in South Korea. The new products are “AIIM CHANGE UP” and “AIIM COOL SHOT.” The company said the products were developed based on the existing lil SOLID dedicated sticks “Fiit Change Up” and “Fiit Cool Shot.” With the launch, the Aim lineup for lil AIBLE has expanded to 13 products.
Apr.20 by 2FIRSTS.ai
BAT Appoints Constantinescu as CFO,He Previously Spent 16 Years at the Company
BAT Appoints Constantinescu as CFO,He Previously Spent 16 Years at the Company
BAT has appointed Dragos Constantinescu as chief financial officer. Constantinescu, currently head of Asahi Europe & International, will join the company on September 1 and replace Javed Iqbal, who has served as interim finance chief since August last year
Apr.09 by 2FIRSTS.ai
German Environment Minister Plans Bill to Ban Disposable E-Cigarettes This Year
German Environment Minister Plans Bill to Ban Disposable E-Cigarettes This Year
German Federal Environment Minister Carsten Schneider said he is preparing legislation to ban disposable e-cigarettes and will present a bill this year. Industry data estimated that legal e-cigarette sales in Germany rose by about one quarter in 2025 to €2.4 billion. Refillable devices are not expected to be affected by the ban.
May.09 by 2FIRSTS.ai
KT&G Overseas Tobacco Revenue Jumps 24.6%, Attracting Global Capital
KT&G Overseas Tobacco Revenue Jumps 24.6%, Attracting Global Capital
South Korean tobacco company KT&G is drawing growing global investor attention after reporting record overseas tobacco sales, with international institutions including Capital Group and BlackRock increasing their stakes.
Business
May.19
Nature Health Comment Urges Wider Role for Smoke-Free Nicotine Products in Tobacco Control
Nature Health Comment Urges Wider Role for Smoke-Free Nicotine Products in Tobacco Control
Ahead of World No Tobacco Day, a Nature Health Comment by Robert Beaglehole, Ruth Bonita and Tikki Pang argues that regulated smoke-free nicotine products could help accelerate the global decline in smoking. The authors propose a “smoke-free 2040” goal and call for risk-proportionate regulation distinguishing cigarettes from lower-risk nicotine alternatives.
News
May.20