FDA response to 2Firsts: Emphasizing that obtaining an STN number does not necessarily mean marketing authorization, currently only 34 electronic cigarette products can be legally sold (complete list attached)

FDA response to 2Firsts: Emphasizing that obtaining an STN number does not necessarily mean marketing authorization, currently only 34 electronic cigarette products can be legally sold (complete list attached)

2Firsts contacted the FDA to obtain relevant information and interpretation regarding the "Zhuhai Qisi OEM product listed in the FDA import alert". The FDA emphasized to 2Firsts that "submitting a tracking number" (STN) is not equivalent to product authorization, reminding e-cigarette exporters to obtain market access permission, and emphasizing that currently only 34 e-cigarette products have been legally licensed for sale in the United States. 2Firsts has checked the complete list and published it in the article.

 

On October 16, 2024, two to two Firsts reported that a product from ZHUHAI QISITECH CO., LTD was included in the US Food and Drug Administration (FDA) Import Alert 98-06 list. This matter has attracted significant attention in the supply chain and market. In order to further understand the regulatory requirements for electronic cigarettes in the United States, two or more firsts have contacted the FDA. The FDA has disclosed and explained relevant information to 2Firsts.

 

 

1. Reasons for inclusion in import alert
 

The FDA stated that the reason for including Zhuhai Qisi Intelligent Manufacturing Co., Ltd.'s RAZ DC25000 in the alert is that it is a new tobacco product that has not been authorized by the FDA.

 

 

2. Impact

 

Products listed in the import alert can be detained without physical inspection, and future product batches can also be automatically detained without testing or inspection.

 

 

3. The difference between STN and authorization

 

The FDA assigns a "Submission Tracking Number" (STN) to the materials submitted by applicants (such as pre-market tobacco product PMTA applications), but STN does not mean that the product has been authorized by the FDA. Any new tobacco product that wants to be legally marketed must obtain FDA authorization.

 

 

4. Classification of FDA product codes

 

The FDA explains that product codes are a system used for classification upon importation, which can categorize products into categories such as smokeless tobacco or electronic cigarette components. The FDA may use industry wide codes (such as "98") or more specific category codes (such as 98L or 98M).

 

However, the classification code itself does not affect law enforcement actions, and all products listed in the import alert, including Zhuhai Qisih's RAZ DC25000, will be detained without physical inspection.

 

The FDA also informed 2Firsts that its official website has a dedicated page providing tools and detailed information for the product code system. Detailed information about the various parts of FDA product codes can be found at this link: Product Codes and Product Code Builder | FDA This information emphasizes the importance of accurately using product codes.

The homepage of the FDA product code generator page displays tools and tutorials for generating codes based on product type, purpose, and packaging. Image source: FDA

After selecting the 'Product Code Generator', users can search for FDA product codes based on specific categories. Image source: FDA

 

5. Three ways for new tobacco products to obtain marketing authorization in the United States

 

The FDA explained to 2Firsts that in order to legally sell New Tobacco Products in the United States, they must obtain written market access permission from the FDA. There are currently three ways to obtain this license.

The definition of "new tobacco products" on the FDA website specifies which new or modified products require authorization before they can be legally sold. Image source: FDA

There are three ways for New Tobacco Product to obtain marketing authorization in the United States. Image source: FDA

 

34 electronic cigarettes authorized for legal sale in the United States

 

The FDA emphasizes that 34 tobacco flavored and menthol flavored electronic cigarette products and devices have been approved so far, which are all electronic cigarette products that can be legally sold in the United States.

List of 34 electronic cigarette products that have been legally authorized for listing in the United States (page 1). Image source: FDA

List of 34 electronic cigarette products that have been legally authorized for listing in the United States (page 2). Image source: FDA

List of 34 electronic cigarette products that have been legally authorized for listing in the United States (page 3). Image source: FDA

 

The above information has been published on the FDA official website for a long time and is open to the public. The FDA reiterated in response to 2Firsts that these are the only legally approved e-cigarette products, further highlighting the necessity for companies seeking to enter the US market to comply with regulations.

 

At present, the electronic cigarette industry is feeling the increasingly strict enforcement efforts of the FDA. On October 22nd, the FDA, in collaboration with the US Customs and Border Protection, seized 3 million unauthorized electronic cigarette products, including GEEKBAR and other products, with an estimated retail value of approximately $76 million.

 

2Firsts will continue to track and bring the latest reports.