The US Food and Drug Administration (FDA) updated its "Import Alert 98-06" (also known as the "Red List") on October 31, adding several brands of electronic nicotine delivery systems (ENDS) and nicotine pouches involving numerous Chinese and international companies.
The October 31st update to the *Detention Without Physical Examination of New Tobacco Products Without Required Marketing Authorization* (known as "Import Alert 98-06" or the "Red List") includes a new batch of e-cigarette companies, primarily from China, Sweden, Poland, and the United States.
These companies are accused of importing unapproved ENDS products. The FDA stated that "tobacco products listed on the Red List of this import alert may be detained without physical inspection.
The alert specifically targets e-cigarette brands under the names "CALI" and "Aroma King" and covers various product types, including unflavored, flavored, tobacco-flavored, and unspecified categories.
In addition, BAT Sweden AB's "Lyft Cool Air" nicotine pouches and HABIT FACTORY's "Klint" smokeless tobacco products were added to the regulatory list.
The specific list is as follows:
China
1. Elego Operation Company Limited (Shenzhen) – CALI ENDS products, classified under non-flavored, flavored (other), flavored (tobacco), and non-applicable categories.
2. Heaven Gifts Incorporated Limited (Shenzhen) – Aroma King ENDS.
3. Shenzhen HQD Technology Co., Ltd. (Shenzhen) – CALI ENDS products, multiple categories.
4. Shenzhen Leelvis Technology Co., Ltd. (Shenzhen) – Aroma King ENDS.
5. Shenzhen Shocklin Tech Co., Ltd. (Shenzhen) – CALI ENDS products, multiple categories.
6. Shenzhen Yihuikang Technology Co., Ltd. (Shenzhen) – CALI ENDS products, multiple categories.
7. Zhuhai Qisitech Co., Ltd. (Zhuhai) – RAZ DC25000 series and Aroma King ENDS products.
Outside China
Poland:
8. SYMETRICUS SP Z O
• Location: Katowice, Poland
• Product: Electronic Nicotine Delivery System (ENDS) under the brand “Aroma King”
Sweden:
9. BAT SWEDEN AB
• Location: Malmö, Sweden
• Product: “Lyft Cool Air” nicotine pouch product
10. HABIT FACTORY IN SWEDEN AB (appears twice, with another registered address at Ostmastargrand 5, Arsta, Stockholms Lan SWEDEN)
• Location: Stockholm, Sweden
• Product: Smokeless tobacco and nicotine delivery products under the brand “Klint”
• Classification: Smokeless tobacco (98-C), nicotine delivery products (98-N), consumer tobacco products (98-A)
United States:
11. ACCESS VAPOR LLC (appears twice, with another registered address at 2426 Viscount Row)
• Location: Orlando, Florida, USA
• Product: All “CALI” branded Electronic Nicotine Delivery System (ENDS) products
• Classification: Non-flavored (98-A), flavored (other) (98-C), flavored (tobacco) (98-D), non-applicable (98-E)
12. CICIDO TRADE LLC
• Location: 432 Tennyson Rd, Bartlett, IL 60103-4617, USA
• Product: All “CALI” branded Electronic Nicotine Delivery System (ENDS) products
• Classification: Non-flavored (98-A), flavored (other) (98-C), flavored (tobacco) (98-D), non-applicable (98-E)
13. JOINT KA TRADE LLC
• Location: 2539 N Wayne Ave, Chicago, IL 60614, USA
• Product: Electronic Nicotine Delivery System (ENDS) under the brand “Aroma King”
14. LILA TRADE LLC
• Location: 1909 S May St, Chicago, IL 60608-5381, USA
• Product: Electronic Nicotine Delivery System (ENDS) under the brand “Aroma King”
15. PIONEER TRADE LLC
• Location: 3638 S Union Ave, Chicago, IL 60609-1647, USA
• Product: Electronic Nicotine Delivery System (ENDS) under the brand “Aroma King”
16. RONGDA TRADE LLC
• Location: 2453 N Talman Ave, Chicago, IL 60647-1809, USA
• Product: Electronic Nicotine Delivery System (ENDS) under the brand “Aroma King”
17. UCAN TRADE LLC
• Location: 2338 W Cortez St, Chicago, IL 60622-3519, USA
• Product: Electronic Nicotine Delivery System (ENDS) under the brand “Aroma King”
Covered Product Categories
- 98-A: All non-flavored consumer tobacco products.
- 98-C: Other flavored tobacco products.
- 98-D: Tobacco-flavored products.
- 98-E: Non-applicable tobacco product categories.
- 98-N: Smokeless tobacco and nicotine delivery products (e.g., nicotine pouches).
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