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

EU ‘TPD3’ Enters Next Phase on Aug. 14 as Fragmented Vape and Nicotine Pouch Rules Push the Single Market Toward Regulatory Overhaul
EU ‘TPD3’ Enters Next Phase on Aug. 14 as Fragmented Vape and Nicotine Pouch Rules Push the Single Market Toward Regulatory Overhaul
A 12-week European Commission consultation on revising the Tobacco Products Directive and Tobacco Advertising Directive is due to close on Aug. 14, 2026. The Commission has identified e-cigarette flavours, disposable vapes, tobacco heating devices, nicotine pouches, nicotine-free e-cigarettes, packaging and digital marketing among areas for possible new EU rules. National regulations already vary significantly across the bloc, a fragmentation the Commission says creates internal-market barriers and distorts competition. No formal revised TPD/TAD legislative text has yet been published, with the Commission currently indicating December 2026 for the legislative initiative.
Aug.14
Malaysia Withdraws Appeal Against Liquid Nicotine Ruling as Vape Regulation Framework Enters New Phase
Malaysia Withdraws Appeal Against Liquid Nicotine Ruling as Vape Regulation Framework Enters New Phase
Malaysia’s government has withdrawn its appeal against a High Court ruling concerning the regulatory status of liquid nicotine used in vape and e-cigarette products, according to reports by New Straits Times, Free Malaysia Today and CodeBlue on August 18, 2026. The Kuala Lumpur High Court ruled on May 15 that the government’s decision to remove liquid nicotine from the scheduled poisons list under the Poisons Act 1952 was irrational and made without proper consultation with the Poisons Board. The withdrawal ends the government’s appeal process, while the future regulatory framework for nicotine vape products remains under discussion.
Aug.21
GAO Audit Finds Nearly 132,000 FDA Tobacco Applications Waiting an Average 1,266 Days as Nicotine Pouch Pilot Practices Move Into Vape PMTA Reviews
GAO Audit Finds Nearly 132,000 FDA Tobacco Applications Waiting an Average 1,266 Days as Nicotine Pouch Pilot Practices Move Into Vape PMTA Reviews
A U.S. Government Accountability Office audit found that 131,915 tobacco product applications submitted to the FDA since 2018 remained without a final review as of December 31, 2025, with pending applications waiting an average of 1,266 days. GAO also found FDA lacks the data needed to systematically determine whether scientific reviews meet applicable timelines. HHS agreed to upgrade the agency's tracking systems. At the same time, FDA has begun applying lessons from its nicotine pouch PMTA pilot to e-cigarette reviews, while changes to enforcement policy and electronic submissions are making the specific stage of a PMTA increasingly relevant to market access.
FDA
Oct.03
Australia’s Victoria Steps Up Illegal Tobacco Enforcement With Store Closures and Penalties of Up to A$2.5 Million
Australia’s Victoria Steps Up Illegal Tobacco Enforcement With Store Closures and Penalties of Up to A$2.5 Million
Australia’s state of Victoria has activated new powers allowing Tobacco Licensing Victoria and police to shut premises suspected of selling, supplying or possessing illicit tobacco for up to 90 days. Longer closures can be ordered by a magistrates’ court. Businesses subject to closure orders must generally cease all trading and will be placed on a public list. Breaching a closure order can carry penalties of up to A$2.5 million and 20 years in prison.
Sep.10
Russian Strikes Destroy JTI and Imperial Brands Ukraine Warehouses, With Losses Reaching Tens of Millions of Hryvnias
Russian Strikes Destroy JTI and Imperial Brands Ukraine Warehouses, With Losses Reaching Tens of Millions of Hryvnias
According to Ukrainska Pravda, Russian strikes on the Kyiv region during the night of Aug. 4-5, 2026, damaged warehouses storing products of Japan Tobacco International (JTI) and Imperial Brands Ukraine. JTI said a finished goods warehouse in Kyiv Oblast was destroyed, with no employees injured, and that it did not expect disruptions to retail supplies. Imperial Brands Ukraine said products stored at warehouses of distributors and retail partners were affected and estimated losses from the strikes at “tens of millions of Ukrainian hryvnias” (roughly hundreds of thousands of U.S. dollars).
JTI
Aug.07
IKE Tech Launches IKE 2.0 Compliance Platform for Nicotine Products
IKE Tech Launches IKE 2.0 Compliance Platform for Nicotine Products
IKE Tech launched IKE 2.0 on September 28, initially targeting nicotine products with a platform that combines user identity verification, product authentication, configurable policy controls and data analytics. Products can be authenticated through direct device integration or NFC smart tags. IKE Tech was formed with participation from Ispire's Aspire North America, Berify and Chemular, with Ispire currently holding a 40% interest. Its age-verification component PMTA was accepted by the FDA in 2025 and remains under review. The company did not disclose customer names, commercial deployment volumes, pricing or revenue tied to IKE 2.0.
News
Sep.29 by 2Firsts Perspectives