De Zewei noticed that the US PMTA, which had always seemed to have little deterrence, was changing. As far as we know, the FDA will have closer communication and cooperation with the U.S. Customs and Border Protection (CBP) starting in 2024. This year, CBP has issued three messages in a row, proposing new requirements for import customs clearance of e-cigarettes, and proof of having applied for PMTA must be submitted.
The three messages were released through its Cargo System Message Service (CSMS) on January 17, January 29, and February 15, 2024 Eastern Time. The original screenshots are as follows:
The three messages all say that e-cigarettes are regulated by the US FDA, and all e-cigarettes entering the United States must comply with FDA regulations. In order to avoid delays in review, the following information must be submitted for e-cigarette import declarations (the information requirements issued by the FDA are attached) ), De Zewei excerpted and translated the key contents:
Based on the above content, the summary is as follows:
1. In addition to the most basic manufacturer, importer, product name, quantity, flavor, and nicotine, the tobacco application traceability code STN is also required. This STN code is assigned by the FDA after the PMTA application is submitted.
2. Products that have not yet submitted a PMTA application are missing this STN code. It will become a key enforcement target of the U.S. Customs and Border Protection and face the risk of being unable to enter the U.S. market normally.
3. After searching in the CSMS system, it was found that there had been no such news released before. In the past, it was more about "action", and joint actions were taken on a whim to catch a wave. Now the customs issues notices directly and implements them into the daily work of the customs.
According to the above news, PMTA will begin strict enforcement after the end of 2023, which will be stronger than the previous MDO. Goods that have not submitted an application will be detained by customs and legal entry into the U.S. market will be impossible.
At present, although the FDA is currently relatively gentle on reported products, it also reminds manufacturers that they have a limited time to make money and apply. If kicked out of the U.S. market, re-entry will be difficult because the suspension of operations combined with high application fees will be unaffordable for many companies.
Shen Gongwang Security: 44030602006947