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 | JT Upgrades with2 Infused Tobacco Capsules With Double-Size BIG PACK
Product | JT Upgrades with2 Infused Tobacco Capsules With Double-Size BIG PACK
Japan Tobacco Inc. (JT) announced that it will introduce a BIG PACK version of all five tobacco capsule variants designed for its with2 infused tobacco system. Scheduled for release in Japan on August 4, 2026, the refreshed packaging doubles the contents from five capsules and one cartridge to ten capsules and two cartridges while maintaining the same flavors and formulations
News
Jun.26 by 2Firsts Perspectives
Haypp Report: Women Emerge as a Key Growth Driver in the UK Nicotine Pouch Market
Haypp Report: Women Emerge as a Key Growth Driver in the UK Nicotine Pouch Market
According to Haypp’s 2026 UK Nicotine Report, women are a key growth driver in the UK nicotine pouch market. Overall sales for Haypp and Northerner rose 60% year‑on‑year in 2025, but purchases by women surged 202%, versus 25% for men. Women’s share of consumers jumped from 22% to 40%. The report attributes this to discretion, perceived health benefits, and more gender‑neutral product positioning, suggesting future growth will come from a broader range of adult nicotine users.
Jul.01
Changing Assumptions in U.S. Cigar Consumption: 2Firsts Interviews Cigar Educator Mechelle Merkerson
Changing Assumptions in U.S. Cigar Consumption: 2Firsts Interviews Cigar Educator Mechelle Merkerson
U.S. premium cigar culture is shifting toward education, broader choice and deeper links to craftsmanship and origin, cigar educator Mechelle Merkerson told 2Firsts. She sees boutique brands, women consumers and production-region experiences making knowledge central to cigar participation. For global brands, retailers and emerging markets such as China, education may help turn curiosity into sustained engagement.
Special Report
Jul.06
AP Questions FDA Rationale as Glas Fruit-Flavored Vapes Won Authorization Without Added Cessation Benefit
AP Questions FDA Rationale as Glas Fruit-Flavored Vapes Won Authorization Without Added Cessation Benefit
The U.S. Food and Drug Administration (FDA) recently authorized two fruit-flavored vaping products from Glas, but a newly released agency memo shows the products did not demonstrate greater smoking-cessation benefits than tobacco-flavored e-cigarettes. The Associated Press said the findings are likely to raise further questions about the FDA’s regulatory rationale and standards for flavored vaping products.
Jun.12
Special Report | Russian Vape Compromise Faces First Hurdles
Special Report | Russian Vape Compromise Faces First Hurdles
Russia’s regional vape-ban model is facing early legal and political tests, as Perm Krai moves ahead before federal legislation is fully adopted. The case highlights uncertainty over regional authority, concerns from business groups about market fragmentation, and the risk that pressure against regional bans could revive calls for a stricter nationwide prohibition.
Industry Insight
May.28
Product | JTI Expands Ploom Ecosystem as LYO Tobacco-Free Nicotine Sticks Roll Out Across Europe
Product | JTI Expands Ploom Ecosystem as LYO Tobacco-Free Nicotine Sticks Roll Out Across Europe
Japan Tobacco International (JTI) is expanding its Ploom heated product ecosystem with LYO tobacco-free nicotine sticks. Designed specifically for Ploom devices, LYO contains nicotine but no tobacco. Public information shows that the product has gradually entered several European markets, including Spain, Portugal and Germany, and was officially introduced in Romania in July 2026. The launch highlights JTI’s efforts to explore broader nicotine consumable formats beyond traditional tobacco-based sticks.
JTI
Jul.21 by 2Firsts Perspectives