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Several Chinese vaping companies placed on U.S. FDA import alert list

Key takeaway: On May 17, 2023, the U.S. FDA updated Import Alert 98-06, stating that new tobacco products on the list without marketing authorization may be detained and refused entry.
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On May 17, 2023, the US FDA updated the import alert list import alert 98-06, the FDA stated that for non-marketing approvals included in this import alert listnew tobaccoProducts can be directly seized by each department without any inspection and testing, which means they are included in the import blacklist.

According to the list,  The companies involved in this import alert mainly include ELFBAR, EBDESIGN, Esco Bar, etc.e-cigarette brandsImporters, manufacturers, transporters, etc., covering three countries: China, South Korea, and the United States.

What is an import alert import alert?Import alerts are also known as import bans. If products imported into the United States violate FDA legal provisions, the FDA will issue an import alert to notify local FDA staff and the public to show that the FDA has sufficient evidence to implement a no-test seizure (DWPE) on the product.  That is, 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 Province Qisi Intelligent Manufacturing Co., Ltd)

HAIQIANG LOGISTICS INTERNATIonAL CO., LTD (Haiqiang Logistics International Company)
HEAVEN GIFTS INTERNATIonAL LIMITED(Love miraclesInternational Limited)
IMIRACLE SHENZHEN TECHNOLOGY CO., LTD.& nbsp;(Shenzhen Aimiracle Technology Co., Ltd.)
SCHENZEH Innokin TECHNOLOGY CO., LTD. (Shenzhen #p#paginated title #e#real InnokinTechnology Co., Ltd.)
SHENZHEN FIRST UNIOn TECHNOLOGY CO., LTD.& nbsp;(Shenzhen CityHeyuanTechnology Co., Ltd.)
SHENZHEN FUNYIN ELETRonIC TECHNOLOGY CO., LTD.& nbsp;(Shenzhen Fangying Electronic Technology Co., Ltd.)
SHENZHEN FUNYIN INTELLIGENT MANUFACTURING CO., LTD. (Shenzhen Fangying Intelligent Manufacturing Co., Ltd.)
SHENZHEN PINGRAY TECHNOLOGY CO., LTD. (Shenzhen Pinrui Technology Co., Ltd.)

South Korea:

WOOJIN ELECTRonICS INC

United States:

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, under the Federal Food, Drug and Cosmetic Act (FDC Act), any new tobacco product marketed in the United States requires FDA's premarket review (PMTA).# p#pagination title #e#

The Tobacco Products Center (CTP) has determined that the above-mentioned companies may import, manufacture or transport new tobacco products under the Elfbar/EBDESIGN/EscoBar brand without marketing authorization, and tobacco products that lack pre-market review are considered adulterated.

In recent years, the FDA has frequently investigatede-cigarette companiesIssuing warning letters, issuing marketing refusal orders, filing civil fines, etc., the United Statese-cigarette marketRegulation is constantly tightening.  Just a few days ago,  FDA provides 10e-cigarettesThe company issued marketing refusals (MDOs) requiring the companies to stop selling approximately 6500 flavored electronics in the United Statessmoke oilande-cigarette productsIf you insist on selling, you will face enforcement action from the FDA.  

In November last year, the FDA also issued warning letters to four e-cigarette companies, including three China companies, requiring them to stop selling cigarettes.  E-cigarette products that have been reviewed before market.
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HNB Editorial Team

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