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.

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".

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.

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.

References:

[1] FDA网站

Also Read:

[1] FDA Updates Import Alert Including Red List of E-Cigarettes

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