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

Major U.S.  Vape Distributor Demand Vape Pays at Least $300,000 for White House Lobbying Amid Enforcement Pressure
Major U.S. Vape Distributor Demand Vape Pays at Least $300,000 for White House Lobbying Amid Enforcement Pressure
New York vape distributor Ecto World, which operates as Demand Vape, hired political consultant Roger Stone to lobby the Executive Office of the President on regulation of vaping and related products while facing state enforcement and multiple lawsuits. Public lobbying disclosures show that Ecto World paid at least $300,000 for the work through June 30, 2026. Separately, New York State announced in March that more than 28,500 pounds of vaping products tied to the company had been seized, while New York City and the state have pursued legal or enforcement actions. Public records do not show that the lobbying directly changed any specific regulatory or enforcement outcome.
Sep.08
Product | DOJO Launches BLAST10K Fresh in UK With 0+10ml E-Liquid Structure, Retaining 2+8ml Pod Compatibility
Product | DOJO Launches BLAST10K Fresh in UK With 0+10ml E-Liquid Structure, Retaining 2+8ml Pod Compatibility
DOJO launched the BLAST10K Fresh in the UK on September 4, 2026, introducing its INSTA-JUICED™ technology and a new 0+10ml structure that keeps e-liquid separated from the coil before activation. The device features a 1000mAh rechargeable battery, COREX BLAST dual-mesh technology and SSS leak-resistant technology, with a manufacturer-rated capacity of up to 10,000 puffs. It also retains compatibility with existing 2+8ml pods across the BLAST ecosystem. The launch introduces eight new flavors, including Matcha Strawberry, which DOJO describes as an industry first.
Market
Sep.04
Bret Koplow Takes Permanent Charge of FDA Tobacco Center After Pushing Faster PMTA Reviews, as HHS Emphasizes Innovation and Access to Lower-Risk Alternatives
Bret Koplow Takes Permanent Charge of FDA Tobacco Center After Pushing Faster PMTA Reviews, as HHS Emphasizes Innovation and Access to Lower-Risk Alternatives
The U.S. Department of Health and Human Services has named Bret Koplow permanent director of the FDA’s Center for Tobacco Products, ending his period as acting chief. Koplow has spent years working on tobacco regulation, law and policy inside the FDA and, while serving as acting director, pushed for faster PMTA reviews and nicotine pouch review pilots. HHS also said CTP will prioritize innovation and access to less harmful alternatives for adult smokers while continuing efforts to protect youth.
Sep.09
As Regulators Focus on Nicotine Pouch Child Safety, Safeguard Pursues an External Packaging Route
As Regulators Focus on Nicotine Pouch Child Safety, Safeguard Pursues an External Packaging Route
As regulators pay closer attention to child safety in nicotine pouches, manufacturers face a practical challenge: how to strengthen child-resistant packaging without unnecessarily reworking products, production lines and regulatory submissions already in place. In a written interview with 2Firsts, Chemular detailed Safeguard’s external packaging approach, its customer-specific testing requirements and possible PMTA pathways. The model remains early-stage, but it offers a new way to think about an increasingly important regulatory and manufacturing issue.
Industry Insight
Sep.19
HG Innovation, linked to IMiracle and ELFBAR, wins China patent for 6-methylnicotine salts covering vaping and oral products
HG Innovation, linked to IMiracle and ELFBAR, wins China patent for 6-methylnicotine salts covering vaping and oral products
HG Innovation Limited has been granted a Chinese invention patent covering 6-methylnicotine salt formulations and their use in oral and vaping products. The technology forms salts between 6-methylnicotine and alicyclic carboxylic acids, with granted claims extending to oral products, atomization substrates and electronic atomization devices. Applicant-generated tests reported differences in oxidation stability, in-vitro cytotoxicity and aerosol heavy-metal performance compared with selected benzoate or lactate controls. HG Innovation is directly linked to the broader IMiracle and ELFBAR business network.
Sep.04
Couche-Tard Posts Double-Digit U.S. Same-Store Growth in Other Nicotine Products, Led by Pouches
Couche-Tard Posts Double-Digit U.S. Same-Store Growth in Other Nicotine Products, Led by Pouches
Alimentation Couche-Tard said U.S. same-store sales in its “other nicotine products” category grew at a double-digit rate in the first quarter of fiscal 2027, led by nicotine pouches, while overall U.S. same-store merchandise revenues increased 1.7%. The company also said its Canadian nicotine business continued to face regulatory pressure and illicit-market headwinds. The U.S. performance coincides with Couche-Tard's participation in efforts to reopen Canadian convenience-store access to authorized nicotine pouches, though the company has not established a direct causal link between the two.
Sep.14