Chinese e-cigarette companies are warned by the US FDA
Time： 2023-05-18
Views： 575
U.S. FDA has updated Import Alert 98-06. According to the FDA, for the new tobacco products included in this import alert list without marketing approval, vario...
U.S. FDA has updated Import Alert 98-06. According to the FDA, for the new tobacco products included in this import alert list without marketing approval, various departments can directly seize them without any inspection and testing, that is to say, they are included in the import black list. list.
According to the list, the companies involved in the import alert mainly include importers, manufacturers, and transporters of e-cigarette brands such as ELFBAR, EBDESIGN, and Esco Bar, covering three countries: China, South Korea, and the United States.
What is Import Alert Import Alert? Import alerts are also known as import bans. If a product imported into the United States violates FDA legal terms, FDA will issue an import alert to notify FDA local staff and the public to explain that FDA has sufficient evidence to implement a no-test seizure (DWPE) on the product, namely Imported products can be directly seized without inspection and analysis.
The list of relevant companies involved in this import alert is as follows:
China:
GUANGDONG QISITECH CO., LTD (Guangdong Qisi Intelligent Manufacturing Co., Ltd.)
HAIQIANG LOGISTICS INTERNATIONAL CO., LTD
HEAVEN GIFTS INTERNATIONAL LIMITED
IMIRACLE SHENZHEN TECHNOLOGY CO., LTD.
SCHENZEH INNOKIN TECHNOLOGY CO., LTD.
SHENZHEN FIRST UNION TECHNOLOGY CO., LTD.
SHENZHEN FUNYIN ELETRONIC TECHNOLOGY CO., LTD.
SHENZHEN FUNYIN INTELLIGENT MANUFACTURING CO., LTD.
SHENZHEN PINGRAY TECHNOLOGY CO., LTD.
South Korea:
WOOJIN ELECTRONICS INC.
U.S:
AFFILIATED IMPORTS LLC
COBEN YUME INTERNATIONAL INC
Eonsmoke, LLC
FAST RUNNING INTERNATIONAL INC
FRESH FARMS
HAPPY FISHING CO LTD
JOCOR ENTERPRISED LLC
JR FAST TRADING INC
KTM, LLC
PASTEL CARTEL LLC
RARED WHOLSALER LTD
Savage Enterprises
According to the FDA, according to the US Federal Food, Drug and Cosmetic Act (FD&C Act), any new tobacco products marketed in the United States need to go through the FDA's premarket review (PMTA).
The Center for Tobacco Products (CTP) has determined that the above companies may be importing, manufacturing or shipping Elfbar/EBDESIGN/EscoBar brand new tobacco products without marketing authorization, and tobacco products lacking pre-market review are considered adulterated.
In recent years, the FDA has frequently issued warning letters, issued marketing refusal orders, and filed civil fines against e-cigarette companies. The regulation of the U.S. e-cigarette market is constantly tightening. Just a few days ago, the FDA issued Marketing Denial Orders (MDOs) to 10 e-cigarette companies, requiring these companies to stop selling about 6,500 flavored e-liquids and e-cigarette products in the United States. If they insist on selling, they will face FDA enforcement actions .
In November last year, the FDA also issued warning letters to four e-cigarette companies, including three Chinese companies, asking these companies to stop selling e-cigarette products that have not been pre-marketed.
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