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

Exclusive | China Starts Mandatory National Standards Process for Heated Cigarettes and Nicotine Pouches
Exclusive | China Starts Mandatory National Standards Process for Heated Cigarettes and Nicotine Pouches
China has launched mandatory national standards work for heated cigarettes and nicotine pouches, further formalizing regulation of both categories. The move may help lay groundwork for future market entry, but does not signal imminent domestic commercialization.
Apr.15
Philip Morris Ukraine Says It Will Invest Another USD 10.00 Million in ZYN Nicotine Pouches This Year
Philip Morris Ukraine Says It Will Invest Another USD 10.00 Million in ZYN Nicotine Pouches This Year
Philip Morris said that after investing USD 5.00 million last year to promote its ZYN nicotine pouch brand in Ukraine, it plans to invest another USD 10.00 million this year to develop the nicotine pouch category and launch a new ZYN line.
Apr.08 by 2FIRSTS.ai
Russian Lawmaker Says Vape Circulation Licensing Will Be Regulated by Law in the Coming Months
Russian Lawmaker Says Vape Circulation Licensing Will Be Regulated by Law in the Coming Months
Alexander Tolmachev, deputy chairman of the Russian State Duma Committee on Youth Policy, said the issue of licensing vape circulation will be resolved at the legislative level in the coming months. He said a significant share of such products currently on the market are counterfeit, that their real nicotine concentration may be several times higher than stated, and that the composition of the liquid is unknown.
Mar.18 by 2FIRSTS.ai
Altria and Juul Ask Court to Pause Antitrust Case Pending Ninth Circuit Review
Altria and Juul Ask Court to Pause Antitrust Case Pending Ninth Circuit Review
Altria and Juul are asking a California federal court to pause an antitrust case while they appeal a class certification ruling to the Ninth Circuit. The case alleges that Altria’s 2018 investment in Juul, a $12.8 billion deal for a 35% stake.
May.07 by 2FIRSTS.ai
Trump Reportedly Signs Off on Plan to Fire FDA Commissioner Marty Makary
Trump Reportedly Signs Off on Plan to Fire FDA Commissioner Marty Makary
According to The Wall Street Journal, people familiar with the matter said President Trump has signed off on a plan to fire FDA Commissioner Marty Makary, though the plan is not yet final and could change. The report said Makary’s tenure has included clashes over vaping, abortion and drug policy, and that some senior administration officials view him as struggling to manage the agency.
May.09 by 2FIRSTS.ai
Latvian Parliament Gives Initial Support to E-Cigarette Deposit Scheme Amendments
Latvian Parliament Gives Initial Support to E-Cigarette Deposit Scheme Amendments
On April 1, Latvia’s parliament gave conceptual support to amendments to the Waste Management Law that would introduce a deposit system for e-cigarettes in order to reduce pollution and environmental harm caused by these products.
Apr.03 by 2FIRSTS.ai