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

How Many Nicotine Pouch Factories Does Europe Need? 2Firsts Interviews AIRSCREAM on the OEM Market
How Many Nicotine Pouch Factories Does Europe Need? 2Firsts Interviews AIRSCREAM on the OEM Market
At InterTabac 2026, nicotine pouch growth was visible not only in brands but across equipment, raw materials and OEM manufacturing. 2Firsts interviewed AIRSCREAM commercial head Steve Moore on how many pouch factories Europe may ultimately need and where manufacturers can differentiate, from formulation and flavour to pouch materials, production consistency and customer service. The category continues to expand, but questions remain over future capacity, consolidation and the long-term structure of the supply chain.
Sep.18
German Tobacco Tax Revenue Falls 10.8% Through August as Tax-Paid Cigarette Volume Drops 12.6%
German Tobacco Tax Revenue Falls 10.8% Through August as Tax-Paid Cigarette Volume Drops 12.6%
Germany collected €9.789 billion in total tobacco tax revenue from January through August 2026, down 10.8% from a year earlier, according to the Federal Ministry of Finance. Germany's tobacco tax base covers not only cigarettes and fine-cut tobacco but also heated tobacco and vaping liquids taxed as tobacco substitutes. The German Association of the Tobacco Industry and Novel Products, or BVTE, citing federal statistical data, said tax-paid cigarette volume fell 12.6% to 40.6 billion sticks. BVTE is using the latest figures to argue against further tax increases planned from 2027 through 2030, while Germany's parliament is scheduled to hold a first reading of the bill on September 24.
Sep.23
North Carolina Tightens Vape Product Directory Enforcement, Expands State and Local Powers as Violators Face Fines, Product Seizures and License Suspension or Revocation
North Carolina Tightens Vape Product Directory Enforcement, Expands State and Local Powers as Violators Face Fines, Product Seizures and License Suspension or Revocation
North Carolina has expanded enforcement of its vapor product directory rules, authorizing more state and local law enforcement participation and establishing a task force led by the State Bureau of Investigation. The legislation requires at least one unannounced compliance inspection annually for retailers, distributors and wholesalers handling covered products. Penalties effective October 1, 2026, include civil fines of $500–$750 for a first violation and $1,000–$1,500 for repeated violations within 12 months, along with potential license suspension or revocation. Manufacturers may face penalties of $10,000 per unlisted product. The measures strengthen the product directory system established in 2024.
Regulations
Oct.28
Japan Survey Finds 49.5% Would Cut Tobacco Use if Prices Rise, 64.6% Show Interest in Nicotine-Free Alternatives
Japan Survey Finds 49.5% Would Cut Tobacco Use if Prices Rise, 64.6% Show Interest in Nicotine-Free Alternatives
A September online survey commissioned by Japanese smoking-accessories company Lightec found that 49.5% of respondents would consider reducing tobacco use if prices rose further, while 25.1% would consider switching to cheaper brands and 14.5% would consider using or combining alternatives such as vapes and nicotine-free herbal sticks. Another 64.6% expressed some level of interest in such alternatives. The survey covered 1,088 respondents aged 20 to 70 and was conducted by a company that sells NICOLESS nicotine-free vaping and herbal-stick products, meaning its findings should not be treated as representative of Japan's smoking population.
DATA
Oct.12
Altria Showcases Ploom, Marlboro Heated Tobacco Sticks and Non-Nicotine Energy Products at NACS Show 2026
Altria Showcases Ploom, Marlboro Heated Tobacco Sticks and Non-Nicotine Energy Products at NACS Show 2026
At the 2026 NACS Show, Altria displayed Ploom devices alongside imagery of Marlboro-branded heated tobacco sticks, while also featuring RIOT Energy and Proper Wild non-nicotine products. The booth showcased on! PLUS nicotine pouches, including 12 mg variants not listed among FDA-authorized products as of October 9, and NJOY e-cigarettes. Altria also presented convenience-store traffic figures highlighting its retail presence. 2Firsts examines the company's expanded product portfolio, non-nicotine business activities and the regulatory status of products displayed at the show.
EXPO
Oct.10
Smoore Seeks to Toss CCELL Price-Fixing Claim as Court Weighs Vertical Distribution Versus Horizontal Conspiracy
Smoore Seeks to Toss CCELL Price-Fixing Claim as Court Weighs Vertical Distribution Versus Horizontal Conspiracy
Smoore and four authorized U.S. CCELL distributors are asking a California federal court to permanently dismiss a core antitrust claim brought by direct purchasers. Plaintiffs allege that Smoore coordinated minimum wholesale prices, customer allocation and limits on price competition among distributors, amounting to a per se unlawful horizontal conspiracy. The defendants say the alleged conduct reflects ordinary vertical relationships between a manufacturer and its distributors. The court previously dismissed a similar claim, and the latest dispute centers on whether the second amended complaint adds sufficient facts to establish a horizontal agreement.
Sep.14