Disclaimer:
[1] This article is based on publicly available information and represents a compilation and summary of such data. Due to limitations in data collection, some information may be incomplete.
[2] The summaries of enforcement actions presented in this article do not constitute any official conclusions.
[3] For the official interpretation and details of enforcement information, please refer to the announcements issued by the authorities.
【2Firsts Exclusive】On December 5, the U.S. FDA announced the issuance of warning letters to 115 physical retail stores. The cited businesses were penalized for selling unauthorized e-cigarette products, including brands such as Geek Bar Pulse, Geek Bar Skyview, Geek Bar Platinum, and Elf Bar.
This action marks the FDA’s 20th crackdown on illegal e-cigarettes in 2024 (based on incomplete statistics by 2firsts). A review of the agency’s enforcement efforts reveals a consistent focus on illegal e-cigarette products that appeal to youth and lack premarket tobacco product authorization (PMTA).
Key Characteristics of FDA's 2024 Enforcement on Illegal E-Cigarettes
2Firsts has analyzed the FDA’s enforcement actions throughout 2024 and identified the following key characteristics:
1. Comprehensive Supply Chain Enforcement:
The FDA’s enforcement actions against illegal e-cigarettes extended across the entire supply chain, including customs checkpoints for imports and exports, wholesale operations, and retail channels.
The announcement in early December by Congressman Raja Krishnamoorthi to investigate Chinese illegal e-cigarette manufacturers further underscores the U.S. intent to target the entire supply chain of illegal e-cigarette trade.
2. Targeting Key Manufacturers and Brands:
An analysis of FDA enforcement actions reveals a repeated focus on brands under Geekvape and Heaven Gifts, such as Geek Bar and Elf Bar. Newly developed brands from these companies, like EB Design, have also been included in enforcement targets.
In multiple FDA enforcement announcements (at least eight, according to 2Firsts' incomplete statistics), these brands were specifically named—sometimes exclusively—highlighting Geekvape and Heaven Gifts as key subjects of FDA scrutiny.
3. Collaborative Enforcement Across Agencies:
The FDA collaborated with U.S. Customs and Border Protection (CBP) and the Department of Justice (DOJ) to tackle cross-border trade of illegal e-cigarette products. A notable example includes the October 2024 seizure of 3 million illegal e-cigarette products.
Additionally, Congress and several lawmakers have repeatedly urged the FDA to strengthen its regulation and enforcement of e-cigarettes through various measures.
4. Diversified Enforcement Strategies:
The FDA employed a variety of enforcement measures, including:
• Warning Letters: Issued widely to retailers, urging them to immediately cease the sale of illegal products.
• Fines: Imposed civil monetary penalties on non-compliant businesses to deter illegal sales, with fines reaching as high as $20,000 for some violators.
• Product Seizures: Conducted at customs to intercept illegal products and disrupt illicit trade.
FDA Emphasizes Premarket Authorization Requirements
In response to an inquiry from 2Firsts in October, the FDA reiterated that only 34 e-cigarette products have been authorized for legal sale in the U.S. FDA also provided 2Firsts with a detailed list of these authorized products.
Appendix: 2024 FDA Regulatory Actions Involving Geekvape and Heaven Gifts Brands
(Listed in reverse chronological order)
1. US FDA Issues Warning Letters to 115 Retailers, Naming Geek Bar and Elf Bar
Date: December 5, 2024
Action: The US FDA has issued warning letters to 115 retailers, with Geek Bar and Elf Bar being named again, including Geek Bar Pulse, Geek Bar Skyview, Geek Bar Platinum, and Elf Bar.
2. US FDA and Customs Seize 3 Million Illegal Vaping Products from Geek Bar, Valued at $76 Million
Date: October 22, 2024
Action: The US FDA, in collaboration with Customs and Border Protection, seized 3 million illegal vaping products, including those from Geek Bar, with an estimated retail value of $76 million. This marks the highest-valued operation to date for the FDA. Notably, Geek Bar is the only e-cigarette brand mentioned in the report.
3. Geek Bar's Rising US Sales Draw FDA Attention, Warning Letters Sent to 5 Retailers
Date: July 31, 2024
Action: The US FDA issued warning letters to five online retailers for selling unauthorized disposable e-cigarette products, including brands such as Geek Bar, Lost Mary, and Bang. The agency specifically highlighted the surge in sales of the Chinese e-cigarette brand Geek Bar, which poses a potential risk of attracting teenagers.
Date: July 25, 2024
Action: The US FDA issued warning letters to 80 retailers across 15 states for selling unauthorized Elf Bar, Lost Mary, and other products.
5. FDA Seeks Civil Penalties for 10 Retailers Selling Unauthorized Elf Bar
Date: May 30, 2024
Action: The US FDA is imposing civil penalties on 10 retailers for selling unauthorized "Elf Bar" e-cigarettes, fining each $20,678 to combat youth vaping. According to a survey, more than 50% of teenage smokers use "Elf Bar".
6. US FDA Fines 22 Retailers $20,000: Major Brands Owned by Elf Bar
Date: April 23, 2024
Action: The US FDA fined 22 retailers $20,000 for selling unauthorized e-cigarettes, including the popular brand "Elf Bar" among young people.
7. US FDA Warns 61 Retailers: Unauthorized Sales of Elf Bar, EB Design, and Lava Products
Date: March 26, 2024
Action: The US FDA announced warning letters to 61 physical retailers for selling unauthorized vaping products, mentioning the sale of disposable e-cigarettes under the Elf Bar/EB Design and Lava brands.
8. FDA Fines 20 Retailers for Illegal Sale of Elf Bar E-cigarettes
Date: February 26, 2024
Action: The US FDA filed civil money penalty complaints (CMPs) against 20 physical retailers for selling unauthorized Elf Bar e-cigarette brands.
Data Note: The enforcement information above is sourced from the 2Firsts news database and may not cover all enforcement actions.
2Firsts will continue to monitor and report on the U.S. e-cigarette market.
We welcome additional information, corrections to this article, and feedback at: info@2firsts.com
*This article is an original article of 2FIRSTS Technology Co., Ltd. The copyright and license rights belong to the company. Any entity or individual shall make link and credit 2FIRSTS when taking actions to copy, reprint or distribute the original article. The company retains the right to pursue its legal responsibility.
