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

2Firsts Interview | Cigarette Sales Fall as Smokeless Alternatives Gain in U.S. Convenience Stores, NACS Says
2Firsts Interview | Cigarette Sales Fall as Smokeless Alternatives Gain in U.S. Convenience Stores, NACS Says
Ahead of the 2026 NACS Show, 2Firsts interviewed Chris Rapanick, NACS managing director of research, on changes reshaping the U.S. convenience-store tobacco and nicotine market. NACS data show cigarette sales declining while smokeless alternatives, including nicotine pouches, continue to grow. The interview also examines higher OTP margins, shifting backbar space, weaker store traffic, regulatory uncertainty and NACS’ outlook for 2027, offering a retailer-side view of one of the world’s largest nicotine markets.
Interview
Oct.03
Product | BAT Launches VELO WRKS Nicotine Pouches in Sweden, Introducing Dual-Compartment Cans With Two Flavours
Product | BAT Launches VELO WRKS Nicotine Pouches in Sweden, Introducing Dual-Compartment Cans With Two Flavours
British American Tobacco (BAT)'s VELO brand launched the VELO WRKS nicotine pouch range in Sweden on November 2, 2026. The initial release features three Dual Can variants, each containing two separate flavours in a dual-compartment container. Each can holds 20 slim pouches with 8mg of nicotine per pouch and retails for SEK 52.99. According to VELO, the first release, Drop 1, is limited to 75,000 cans and will remain available until February 2027 or while stocks last. VELO positions WRKS as a platform for testing new product concepts and has introduced an online consumer feedback survey. EU trademark records show BAT applied to register VELO WRKS in March 2026 under Class 34, covering nicotine pouches, e-cigarettes, heated tobacco products and other tobacco-related goods.
product
Nov.03
UK Extends Age-18 Rules to Zero-Nicotine Vapes and Nicotine Pouches From Oct. 29, Bans Vending Machines and Promotional Giveaways
UK Extends Age-18 Rules to Zero-Nicotine Vapes and Nicotine Pouches From Oct. 29, Bans Vending Machines and Promotional Giveaways
Key provisions of the UK's Tobacco and Vapes Act 2026 will take effect on Oct. 29, extending an age-18 sales restriction to all vaping and non-medicinal nicotine products. In England, Wales and Northern Ireland, the change brings zero-nicotine vapes within statutory age-of-sale rules and also covers products including nicotine pouches, strips and pearls. The law will also prohibit proxy purchasing for under-18s, consumer-facing vending machines, promotional giveaways and substantial discounts intended to promote vaping and nicotine products.
Regulations
Oct.10
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
South Korea's Tobacco Plan Excludes 6-Methyl Nicotine as Customs Tightens Import Controls and Analog Liquid Imports Fall 83%
South Korea's Tobacco Plan Excludes 6-Methyl Nicotine as Customs Tightens Import Controls and Analog Liquid Imports Fall 83%
South Korea's government unveiled its first Tobacco Harm Management Basic Plan for 2027–2031 on October 29, 2026, proposing broader testing of vaping and heated tobacco products while excluding nicotine analogs such as 6-methyl nicotine. Synthetic nicotine came under tobacco regulation on April 24, and a June investigation found 6-methyl nicotine in 12 liquid inhalation products marketed as nicotine-free. Customs data released in September showed that imports of nicotine analog solutions fell 83.3%, from 12 metric tons in January–April to 2 metric tons in May–August. By September 20, imports had reached approximately 15 metric tons for the year, with 99.99% originating from China. Customs authorities have tightened pre-clearance testing and supply-chain documentation requirements, while the MFDS expects to complete its assessment of nicotine analog hazards by the end of 2026.
Regulations
Nov.04
US ITC Judge Finds Glas Infringed Two JUUL Vape Patents, Recommends Restrictions on Related Imports——Glas Received FDA Marketing Authorization for Four Vape Pods in May 2026; Proposed Restrictions Remain Under Commission Review
US ITC Judge Finds Glas Infringed Two JUUL Vape Patents, Recommends Restrictions on Related Imports——Glas Received FDA Marketing Authorization for Four Vape Pods in May 2026; Proposed Restrictions Remain Under Commission Review
A U.S. International Trade Commission (USITC) administrative law judge issued an initial determination on October 20, 2026, finding that certain Glas vaping devices, cartridges and components infringed 12 claims across two patents asserted by JUUL, constituting a violation of Section 337 of the Tariff Act of 1930. The judge recommended a limited exclusion order and a cease and desist order against the Glas respondents. Five months earlier, the FDA authorized four Glas e-cigarette pods, including mango, blueberry and two menthol variants. The patent investigation concerns device and cartridge structures and is separate from FDA premarket review. The proposed import restrictions have not become final, and their product-level scope remains unresolved.
company
Nov.05