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 | BAT Expands VELO Peach Ice Medium to FamilyMart Stores Nationwide in Japan
Product | BAT Expands VELO Peach Ice Medium to FamilyMart Stores Nationwide in Japan
British American Tobacco Japan (BAT Japan) expanded VELO Peach Ice Medium to FamilyMart stores nationwide in Japan from September 7, 2026. The oral tobacco product first launched on July 6 and had previously been sold through VELO's official online store, glo Store Ginza and tobacco retailers. It combines peach flavor with menthol cooling at a Medium strength level and is priced at JPY 360. Japanese tobacco retailers list 15 pouches per pack. The move adds the new SKU to an existing nationwide FamilyMart distribution network for VELO rather than marking the brand's first entry into the convenience-store chain.
Sep.15
Indiana Halts Sales of Elf Bar, Lost Mary, MR FOG and iJOY Vapes Under Foreign-Adversary Rules; Some Products Return After Compliance Filings
Indiana Halts Sales of Elf Bar, Lost Mary, MR FOG and iJOY Vapes Under Foreign-Adversary Rules; Some Products Return After Compliance Filings
Indiana's Alcohol and Tobacco Commission (ATC) ordered tobacco certificate holders in September to remove certain vaping products marketed under Elf Bar, Lost Mary, MR FOG, iJOY and other brands from inventory under the state's foreign-adversary product law. The agency later listed 257 MR FOG products and 77 Lost Mary product entries as lawful for sale. The Lost Mary revision expressly stated that compliance evidence had been received for 20 additional products. 2Firsts compliance expert Kurt said potential filings could include e-liquid and ingredient-origin records, U.S. nicotine-analog supply-chain documentation and FDA premarket application status.
Regulations
Oct.08
Cochrane 2026 Update Adds Nine Trials, Keeps High-Certainty Finding That Nicotine E-Cigarettes Improve Quit Rates Over NRT
Cochrane 2026 Update Adds Nine Trials, Keeps High-Certainty Finding That Nicotine E-Cigarettes Improve Quit Rates Over NRT
Cochrane’s 2026 update of its living review on electronic cigarettes for smoking cessation included 80 randomized controlled trials involving 29,861 adult smokers, with nine trials added in this update. The review retained its high-certainty conclusion that nicotine e-cigarettes increase smoking cessation rates compared with nicotine replacement therapy. In absolute terms, about 10 in 100 people using nicotine e-cigarettes may quit smoking for at least six months, compared with about 6 in 100 using NRT. The review found no clear difference in serious adverse event rates between the two groups, while longer-term safety and the relative effectiveness of newer device types remain less certain.
Sep.07
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
U.S. Expands Illicit Vape Enforcement as ATF Brings PACT Act Powers Into Trade Fraud Task Force
U.S. Expands Illicit Vape Enforcement as ATF Brings PACT Act Powers Into Trade Fraud Task Force
The U.S. Bureau of Alcohol, Tobacco, Firearms and Explosives said on September 23 that it has joined the interagency Trade Fraud Task Force to strengthen enforcement against illegal, misdeclared and smuggled vape and tobacco products. ATF will bring its authority under the Prevent All Cigarette Trafficking Act into the task force, including registration, reporting, shipping and record-inspection requirements covering interstate sales of electronic nicotine delivery systems. ATF said the move will strengthen its ability to trace illicit products from U.S. points of entry through domestic trafficking and distribution networks.
News
Sep.28 by 2Firsts Perspectives
Why AIRSCREAM Built its European Production Hub for Regulated Market Growth
Why AIRSCREAM Built its European Production Hub for Regulated Market Growth
AIRSCREAM’s production hub in the Czech Republic brings nicotine pouch manufacturing, e-liquid bottling, product documentation, warehousing and international logistics into one operation, giving brands and commercial partners a practical platform from which to launch, expand and enter new markets.
Market
Sep.16 by 2Firsts Perspectives