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

Product | Pixx Nicotine Toothpicks Listed on UK Retail Website, Said to Be Unaffected by Upcoming Vape Tax
Product | Pixx Nicotine Toothpicks Listed on UK Retail Website, Said to Be Unaffected by Upcoming Vape Tax
2Firsts has noted that a nicotine toothpick product named Pixx has appeared on a UK retailer website. The product page describes it as a smoke-free nicotine product, and the packaging image shows “UK MADE.” A nicotine-industry professional wrote on LinkedIn that the UK is set to introduce vape tax changes that may increase pressure on the retail side, and said Pixx is expected not to be included in the upcoming vape tax.
Mar.05 by 2FIRSTS.ai
Product | 25-second preheat and 2,250mAh battery: Heaven Gifts’ REJO launches new HNB device on Japanese and UK e-commerce platforms
Product | 25-second preheat and 2,250mAh battery: Heaven Gifts’ REJO launches new HNB device on Japanese and UK e-commerce platforms
REJO, Heaven Gifts’ heated tobacco (HNB) brand, has listed the REJO CUBE on its official website. The device features a magnetic modular design with a detachable battery and an OmniHeat™ 360° heating system, and is now available via e-commerce channels in Japan and the UK, priced at 6,980 yen (about $45) in Japan.
Mar.06 by 2FIRSTS.ai
JT Delivers Record FY2025 Results as RRP Accelerates and Ploom Expands Globally
JT Delivers Record FY2025 Results as RRP Accelerates and Ploom Expands Globally
JT reported record FY2025 revenue and adjusted operating profit, supported by combustible resilience and accelerating reduced-risk product growth. Heated tobacco volumes surged, led by Ploom. The group confirmed a major three-year RRP investment plan and projected further growth in 2026.
Feb.12
PMI launches IQOS Iluma i One in the UK, compatible with TEREA tobacco sticks
PMI launches IQOS Iluma i One in the UK, compatible with TEREA tobacco sticks
Philip Morris Limited (PML), the UK affiliate of Philip Morris International (PMI), has launched the latest addition to its heated tobacco IQOS lineup, the IQOS Iluma i One, in the UK. The device uses a bladeless induction-heating system and adds features such as a touchscreen and automatic start-up, while being designed for use with TEREA tobacco sticks, including the Pearls range.
Feb.10 by 2FIRSTS.ai
Philippine public health groups urge an absolute ban on e-cigarettes and heated tobacco products
Philippine public health groups urge an absolute ban on e-cigarettes and heated tobacco products
Public health groups in the Philippines are urging the government to impose an absolute ban on e-cigarettes, heated tobacco products, and other nicotine delivery products, citing health harms and increasing accessibility among youth. The call follows Myanmar’s move to become the eighth ASEAN country to implement a total vape ban and comes as the Philippine Congress deliberates tobacco and vape taxation.
Feb.28 by 2FIRSTS.ai
South Dakota Senate Committee Advances Bill Tightening Nicotine Retail Rules
South Dakota Senate Committee Advances Bill Tightening Nicotine Retail Rules
South Dakota Senate Bill 221 (SB 221), which seeks to regulate the retail sale of nicotine products, has passed the Senate Health and Human Services Committee with a unanimous 7–0 recommendation. The bill was significantly amended, expanding from three to nine pages and shifting its focus from vapor products alone to all nicotine products.
Regulations
Feb.22