A Product of Geekvape's Subsidiary Zhuhai Qisitech Listed in FDA Import Alert, Facing Risk of Automatic Detention

Regulations by 2FIRSTS
Oct.16.2024
A Product of Geekvape's Subsidiary Zhuhai Qisitech Listed in FDA Import Alert, Facing Risk of Automatic Detention
FDA updates import alert on a product of Zhuhai Qisitech Co., Ltd., a subsidiary of Geekvape, for tobacco product violations.

Editor's Note:

After the publication of this article, some experts pointed out that Import Alert 98-06 is aimed at products rather than companies, that is, this time it targets the RAZ DC25000 ENDS products, not all products of Qisitech. 
For the sake of accuracy, this article has been specially updated.


 

Recently, the official website of the U.S. Food and Drug Administration (FDA) updated Import Alert 98-06. 2Firsts noticed that a product of Zhuhai Geekvape Technology Co., Ltd. (hereinafter referred to as "Geekvape"), was included in the latest import alert list.

A Product of Geekvape's Subsidiary Zhuhai Qisitech Listed in FDA Import Alert, Facing Risk of Automatic Detention
Information disclosed on the FDA website for Zhuhai Qisitech Co., Ltd. | Image source: FDA website

 

According to the FDA website, ZHUHAI QISITECH CO., LTD was listed in the "Import Alert 98-06" also known as the "Red List" updated on September 26th, titled "Detention Without Physical Examination of New Tobacco Products Without Required Marketing Authorization".

A Product of Geekvape's Subsidiary Zhuhai Qisitech Listed in FDA Import Alert, Facing Risk of Automatic Detention
ZhuHai QiSitech Co., Ltd.'s address matches the one published on the FDA official website. | Image source: Tianyancha

 

Comparison between information released by the FDA and information from Tianyancha shows that ZHUHAI QISITECH CO., LTD, also known as Zhuhai Qisi Manufacturing Co., Ltd., was established in 2021 and is a wholly-owned subsidiary of Shenzhen Geekvape Technology Co., Ltd. Geekvape is the brand owner of Geek Bar and Geek Vape, two of the most well-known e-cigarette brands in the United States, while Qisitech is one of the main contract manufacturers under Geekvape.

 

A Product of Geekvape's Subsidiary Zhuhai Qisitech Listed in FDA Import Alert, Facing Risk of Automatic Detention
Zhuhai Qisi Intelligent Manufacturing Co., Ltd. is a wholly-owned subsidiary of Geekvape Technology Co., Ltd. in Shenzhen | Image source: Tianyancha

 

According to the FDA official website, departments can detain tobacco products listed on the Red List of this Import Alert without needing to conduct physical examinations. If a company wants to remove their products from the list, they must provide information to the relevant agencies to demonstrate that they have addressed the issues leading to non-compliance.

 

According to the above provisions, Qisitech's exports of the mentioned product to the United States will be detained until they are removed from Import Alert 98-06 list.

 

Compliance expert Kurt informed 2Firsts that Import Alert 98-06 is a list of companies that have submitted PMTAs (Pre-Market Tobacco Product Applications). Meanwhile, Import Alert 98-07, as listed on the FDA website, is focused on companies that have submitted PMTA applications.

 

2Firsts will continue to monitor the development of the event and provide timely updates on related coverage.

 

Notice

1. This article is provided exclusively for professional research purposes related to industry, technology and policy. Any reference to brands or products is made solely for the purpose of objective description and does not constitute an endorsement, recommendation, or promotion of any brand or product.

2. The use of nicotine products, including but not limited to cigarettes, e-cigarettes, and heated tobacco products, is associated with significant health risks. Users are required to comply with all relevant laws and regulations in their respective jurisdictions.

3. This article is strictly restricted from being accessed or viewed by individuals under the legal age.

Copyright

This article is either an original work by 2Firsts or a reproduction from third-party sources with the original source clearly indicated. The copyright and usage rights of this article belong to 2Firsts or the original source. Unauthorized reproduction, distribution, or any other unauthorized use of this article by any entity or individual is strictly prohibited. Violators will be held legally responsible. For copyright-related matters, please contact: info@2firsts.com

AI Assistance Disclaimer

This article may have utilized AI to enhance translation and editing efficiency. However, due to technical limitations, errors may occur. Readers are advised to refer to the sources provided for more accurate information.

This article should not be used as a basis for any investment decisions or advice, and 2Firsts assumes no direct or indirect liability for any errors in the content.

From “2+10” Market Saturation to Prime Time: CFU Vaping Experience Offers a New Compliance Blueprint
From “2+10” Market Saturation to Prime Time: CFU Vaping Experience Offers a New Compliance Blueprint
At Vaper Expo UK, CFU Vaping Experience launched Prime 2ML, a superior alternative to traditional disposables, and Prime 10ML, a compliant solution for legal big puff. MixIn, the first smart hybrid device combining harm reduction with enhanced flavor, provides a viable option for smokers. Through technological innovation, CFU has brought sustainable solutions to the industry, leading it into a new “Prime Time.”
May.12
Thailand's Education Ministry Enforces School E-Cigarette Ban Amid Rising Youth Vaping Concerns
Thailand's Education Ministry Enforces School E-Cigarette Ban Amid Rising Youth Vaping Concerns
Thailand's Ministry of Education has announced a comprehensive ban on e-cigarettes within all educational institutions and government agencies, responding to a significant increase in youth vaping rates. The measures include the establishment of "No E-Cigarette Zones," enhanced enforcement protocols, and educational campaigns to raise awareness about the health risks associated with e-cigarette use.
May.09 by 2FIRSTS.ai
Product | GEEKBAR Unveils New "2+10" E-Cigarette with Transparent Tank and 10,000 Puffs
Product | GEEKBAR Unveils New "2+10" E-Cigarette with Transparent Tank and 10,000 Puffs
GeekBar has launched the UP 10000 e-cigarette with a “2+10” design, offering a 12ml e-liquid capacity and up to 10,000 puffs. It features a transparent 10ml tank for easy monitoring of e-liquid levels. The product is available on the official website but not yet for online sale.
Jun.10 by 2FIRSTS.ai
Five Key Takeaways from the E-Cigarette Regulatory Press Conference: Stricter Oversight, Production Control, and Crackdown on Grey Market — In-Depth Analysis by 2Firsts’ Alan Zhao on Policy Logic and Industry Impact
Five Key Takeaways from the E-Cigarette Regulatory Press Conference: Stricter Oversight, Production Control, and Crackdown on Grey Market — In-Depth Analysis by 2Firsts’ Alan Zhao on Policy Logic and Industry Impact
Ahead of World No Tobacco Day, China’s tobacco regulator signaled a push for stricter e-cigarette oversight at a press conference. 2Firsts CEO Alan Zhao noted that regulation is entering a deeper phase, with new focus on export re-entry, international pressure, and the inclusion of herbal vapor products. Authorities also vowed to crack down on illegal operations and unapproved projects.
May.30 by 2FIRSTS.ai
Thailand Seizes Over 20,000 E-Cigarette Devices in May Worth Nearly $220,000
Thailand Seizes Over 20,000 E-Cigarette Devices in May Worth Nearly $220,000
Thai customs have intensified their crackdown on illegal imports, seizing goods worth 12.56 million baht (about $380,000). E-cigarettes and related devices were a key focus, accounting for approximately 7.43 million baht (about $220,000) of the total.
May.27 by 2FIRSTS.ai
BAT to Launch glo Hilo in Japan on June 9, Alongside Exclusive virto Sticks
BAT to Launch glo Hilo in Japan on June 9, Alongside Exclusive virto Sticks
BAT Japan has announced that its latest heated tobacco device, glo Hilo, will debut in Miyagi Prefecture on June 9, 2025, together with its dedicated virto sticks. Notably, Miyagi was also the launch site for the g
Jun.04 by 2FIRSTS.ai