Innokin Faces 337 Investigation by Reynolds: Ready to Respond to Lawsuit

Regulations by 2FIRSTS.ai
Oct.23.2023
Innokin Faces 337 Investigation by Reynolds: Ready to Respond to Lawsuit
Innokin, a Chinese e-cigarette company, faces investigation by the US International Trade Commission (ITC) following a complaint by Reynolds Tobacco.

In early October, Reynolds Tobacco, a subsidiary of British American Tobacco, filed a complaint with the United States International Trade Commission (ITC), initiating an investigation known as the "337 investigation." Chinese e-cigarette company Innokin was listed as one of the companies being investigated. This is not the first time Innokin has been involved in controversy. In May of this year, the U.S. Food and Drug Administration (FDA) issued a warning letter to Innokin regarding PMTA issues. In response to these incidents, on October 24th, Innokin's Director of Innovation, Strategy, and Compliance, Cui Tao, addressed inquiries from 2FIRSTS.

 

Regarding the 337 investigation initiated by Renault, Cui Tao stated that Innokin has been named as a subject of investigation as the manufacturer for ESCOBAR, a US e-cigarette brand. However, in reality, the collaboration between Innokin and ESCOBAR has long been terminated and there is no longer any relationship between the two parties. Renault listed Innokin in the investigation without conducting any investigation or verifying with the company, which lacks factual basis. Although the 337 investigation is still ongoing and the International Trade Commission (ITC) has not yet filed a case, Innokin is prepared to defend itself.

 

Innokin has recently faced a 337 investigation, similar to the incident where they received a warning letter from the US FDA in May. On May 25th of this year, the FDA issued a warning letter to Innokin, the manufacturer of ESCOBAR e-cigarettes, demanding the cessation of unauthorized product sales and a response within 15 days.

 

According to Cui Tao, Innokin was previously contracted by the American e-cigarette brand ESCOBAR for production. However, the US authorities considered both the brand and the manufacturing factory as responsible for production, leading to a joint warning against them. Subsequently, the FDA issued an import alert and a warning letter to Innokin. However, it should be noted that Innokin had already terminated its manufacturing agreement with ESCOBAR in early May due to adjustments in its client's business. In response, Innokin promptly engaged lawyers to communicate with the FDA, and their appeal has been successfully recognized and accepted.

 

It is worth mentioning that Cui Tao stated that Innokin had previously manufactured products for ESCOBAR because ESCOBAR had submitted a Pre-Market Tobacco Application (PMTA). According to US laws and regulations, products that have submitted a PMTA can be sold legally. However, as ESCOBAR started selling more products, it caught the attention of the FDA, leading to an investigation. Innokin, as the manufacturing factory, got implicated in the investigation as a result.

 

Disclaimer: 
This article is translated from an original Chinese article available on 2firsts.cn by AI, and has been reviewed and edited by 2FIRSTS's English editorial team. The Chinese original text is the only authoritative source of information. The exclusive copyright and license rights to this article are held by 2FIRSTS Technology Co., Ltd. Any reproduction, reprinting, or redistribution of this article, either in part or in full, requires express written permission from 2FIRSTS and must include clear attribution along with a link to this content. Non-compliance may result in legal action. 2FIRSTS Technology Co., Ltd. reserves the right to pursue legal actions in case of unauthorized use or distribution.

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