The U.S. Food and Drug Administration (FDA) has recently updated its import alert, adding 13 new companies to the “Red List” for 2024. This list identifies e-cigarette products that may be detained without physical examination, primarily to prevent unauthorized new tobacco products from entering the U.S. market. The updated list, numbered 98-06, has significant implications for the affected companies and the broader tobacco product market.
The FDA’s import alert system is designed to control the entry of certain products into the United States. The Red List specifically targets products that do not meet the FDA’s market authorization requirements, allowing for their detention without physical examination. This system is critical for ensuring that only authorized and compliant products are available to consumers.
For 2024, the FDA has added 13 new companies to the Red List. These companies and their related products are now considered unauthorized, posing potential regulatory and financial challenges. Without the necessary market authorization, these products cannot be imported into the U.S.
New List：
CHINA
SHENZHEN RONGDA CO.,LTD
Date Published : 03/11/2024
Room 903 , Ballonda Business Center, No.25 Ansheng Road, Ma ‘Anshan, Baoan District , Shenzhen, CHINA
98 L – – — Electronic Nicotine Delivery System
Date Published: 03/11/2024
Desc: Juicy Bar Brand Products
98 M – – — Electronic Nicotine Delivery System Component/Part
Date Published: 03/11/2024
Desc: Juicy Bar Brand Products
SHENZHEN WIMIN TECH CO.,LTD
Date Published : 03/11/2024
No. 2 Building,Giantai Industrial Park, Xinhe-Village, Fuyong, Bao ‘An District , Shenzhen, CHINA
98 L – – — Electronic Nicotine Delivery System
Date Published: 03/11/2024
Desc: Juicy Bar Brand Products
98 M – – — Electronic Nicotine Delivery System Component/Part
Date Published: 03/11/2024
Desc: Juicy Bar Brand Products
SMISS TECHNOLOGY CO LTD
Date Published : 04/01/2024
Kenuo Bldg, Hightech Ind Pk 5th Fl , No 7 Rd Tongguan Ave, Guangming , Shenzhen, CHINA
98 L – – — Electronic Nicotine Delivery System
Date Published: 04/01/2024
Desc: TYSON 2.0 HEAVYWEIGHT ENDS
98 M – – — Electronic Nicotine Delivery System Component/Part
Date Published: 04/01/2024
Desc: TYSON 2.0 HEAVYWEIGHT ENDS
SMISS TECHNOLOGY CO., LTD.
Date Published : 04/01/2024
Building 3 , No. 1 Songgang Avenue; Baoan District , Shenzhen City, Guangdon CHINA
98 L – – — Electronic Nicotine Delivery System
Date Published: 04/01/2024
Desc: TYSON 2.0 HEAVYWEIGHT ENDS
98 M – – — Electronic Nicotine Delivery System Component/Part
Date Published: 04/01/2024
Desc: TYSON 2.0 HEAVYWEIGHT ENDS
ShenZhen Fumot Technology Co., Ltd
Date Published : 05/20/2024
4th Floor, No. 6, Shangwei 1st Alley Xiaobian Town , Dongguan, CHINA
98 L – – — Electronic Nicotine Delivery System
Date Published: 05/20/2024
Desc: All Electronic Nicotine Delivery Systems (ENDS) products
98 M – – — Electronic Nicotine Delivery System Component/Part
Date Published: 05/20/2024
Desc: All Electronic Nicotine Delivery Systems (ENDS) products
ShenZhen Fumot Technology Co., Ltd
Date Published : 05/20/2024
2nd floor, building 6, Haomai industrial zone, Dalang street, Longhua district , Shenzhen, CHINA
98 L – – — Electronic Nicotine Delivery System
Date Published: 05/20/2024
Desc: All Electronic Nicotine Delivery Systems (ENDS) products
98 M – – — Electronic Nicotine Delivery System Component/Part
Date Published: 05/20/2024
Desc: All Electronic Nicotine Delivery Systems (ENDS) products
ZHAOQING ORDEN TRADE CO., LTD
Date Published : 03/11/2024
Sunshine Apartment , No. 125 Commercial Avenue, Yucheng Neighborhood Committee, Dongcheng Street , Zhaoqing, CHINA
98 L – – — Electronic Nicotine Delivery System
Date Published: 03/11/2024
Desc: Juicy Bar Brand Products
98 M – – — Electronic Nicotine Delivery System Component/Part
Date Published: 03/11/2024
Desc: Juicy Bar Brand Products
SHENZHEN IJOY TECHNOLOGY CO LTD
Date Published : 05/08/2024
Xiangxing Street Shajing F 3 , 13 Bldg Hengmingzhu; Longgang , Shenzhen, Guangdong CHINA
98 L – – — Electronic Nicotine Delivery System
Date Published: 05/08/2024
Desc: IJOY LIO STONE
98 M – – — Electronic Nicotine Delivery System Component/Part
Date Published: 05/08/2024
Desc: IJOY LIO STONE
SHENZHEN IPLAYVAPE TECHNOLOGY
Date Published : 05/23/2024
Block B Rm 1005 , 1 Fuhai Street, Tongtai , Shenzhen, CHINA
98 L – – — Electronic Nicotine Delivery System
Date Published: 05/23/2024
Desc: IPLAY Max 2500 ENDS products
98 M – – — Electronic Nicotine Delivery System Component/Part
Date Published: 05/23/2024
Desc: IPLAY Max 2500 ENDS products
SHENZHEN KANGVAPE TECHNOLOGY CO., L
Date Published : 04/01/2024
B Building Room 403 , Qiaotoushequ; Baoan , Shenzhen, Guangdong CHINA
98 L – – — Electronic Nicotine Delivery System
Date Published: 04/01/2024
Desc: All Electronic Nicotine Delivery Systems (ENDS) products for consumer use containing the name “Kangvape Onee Stick” or “Kang Vape Onee Stick”
Notes: CTP has determined that this firm may be importing/manufacturing/shipping new tobacco products (Kangvape Onee Stick/ Kang Vape Onee Stick) without marketing authorization. Tobacco products that lack the premarket authorization requirements are considered adulterated.
98 M – – — Electronic Nicotine Delivery System Component/Part
Date Published: 04/01/2024
Desc: All Electronic Nicotine Delivery Systems (ENDS) products for consumer use containing the name “Kangvape Onee Stick” or “Kang Vape Onee Stick”
Notes: CTP has determined that this firm may be importing/manufacturing/shipping new tobacco products (Kangvape Onee Stick/ Kang Vape Onee Stick) without marketing authorization. Tobacco products that lack the premarket authorization requirements are considered adulterated.
Dongguan Hengtai Biotechnology Co Ltd
Date Published : 03/28/2024
Room 5028, No. 915 , Chang’an Section, Tai’an Road , Dongguan, CHINA
98 L – – — Electronic Nicotine Delivery System
Date Published: 03/28/2024
Desc: MR FOG Max Pro
98 M – – — Electronic Nicotine Delivery System Component/Part
Date Published: 03/28/2024
Desc: MR FOG Max Pro
DONGGUAN DELIN TECHNOLOGY CO., LTD
Date Published : 03/11/2024
3rd Floor , 3 Lane No. 5, Kangxiang East Street, Yongtou Community, Chang’An Town , Dongguan City, CHINA
98 L – – — Electronic Nicotine Delivery System
Date Published: 03/11/2024
Desc: Juicy Bar Brand Products
98 M – – — Electronic Nicotine Delivery System Component/Part
Date Published: 03/11/2024
Desc: Juicy Bar Brand Products
SWEDEN
Skruf Snus Ab
Date Published : 02/28/2024
Vinkelgatan 2-4 , Savsjo, Jonkopings Lan SWEDEN
98 C – – — Smokeless Tobacco
Date Published: 02/28/2024
Desc: SKRUF SUPERWHITE or SKRUF SUPER WHITE
98 N – – — Nicotine Delivery Product
Date Published: 02/28/2024
Desc: SKRUF SUPERWHITE or SKRUF SUPER WHITE
Skruf Snus Ab
Date Published : 02/28/2024
Box 3068 , Stockholm, SWEDEN
98 C – – — Smokeless Tobacco
Date Published: 02/28/2024
Desc: SKRUF SUPERWHITE or SKRUF SUPER WHITE
98 N – – — Nicotine Delivery Product
Date Published: 02/28/2024
Desc: SKRUF SUPERWHITE or SKRUF SUPER WHITE
FAQ
What is the FDA’s Red List?
The FDA’s Red List is part of its import alert system, identifying products that may be detained without physical examination due to non-compliance with FDA regulations.
Why were 13 new companies added to the Red List for 2024?
These companies were added because their e-cigarette products were found to be unauthorized and not meeting the FDA’s market authorization requirements.
What are the consequences for companies on the Red List?
Companies on the Red List face potential detention of their products, leading to business interruptions and financial losses until they comply with FDA requirements.
How can companies be removed from the Red List?
Companies need to ensure their products meet the FDA’s market authorization standards, involving thorough testing, documentation, and submission of the necessary applications.
What is import alert number 98-06?
Import alert number 98-06 is a specific alert issued by the FDA to prevent unauthorized new tobacco products from entering the U.S. market.
How does the Red List affect consumers?
The Red List helps protect consumers by ensuring that only authorized and compliant e-cigarette products are available in the U.S. market.
