US FDA updates import alert to include elego, heaven gifts, HQD, qisitech, and BAT

Nov.01.2024
US FDA updates import alert to include elego, heaven gifts, HQD, qisitech, and BAT
US FDA updates import alert: e-cigarette and nicotine pouch brands like elego, heaven gifts, HQD, qisitech, and BAT added to "red list"

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).

 

Notice

1. This article is provided exclusively for professional research purposes related to industry, technology and policy. Any reference to brands or products is made solely for the purpose of objective description and does not constitute an endorsement, recommendation, or promotion of any brand or product.

2. The use of nicotine products, including but not limited to cigarettes, e-cigarettes, and heated tobacco products, is associated with significant health risks. Users are required to comply with all relevant laws and regulations in their respective jurisdictions.

3. This article is strictly restricted from being accessed or viewed by individuals under the legal age.

Copyright

This article is either an original work by 2Firsts or a reproduction from third-party sources with the original source clearly indicated. The copyright and usage rights of this article belong to 2Firsts or the original source. Unauthorized reproduction, distribution, or any other unauthorized use of this article by any entity or individual is strictly prohibited. Violators will be held legally responsible. For copyright-related matters, please contact: info@2firsts.com

AI Assistance Disclaimer

This article may have utilized AI to enhance translation and editing efficiency. However, due to technical limitations, errors may occur. Readers are advised to refer to the sources provided for more accurate information.

This article should not be used as a basis for any investment decisions or advice, and 2Firsts assumes no direct or indirect liability for any errors in the content.

Malaysian PAS Youth Committee Urges Ban on E-cigarette Sales
Malaysian PAS Youth Committee Urges Ban on E-cigarette Sales
The Youth Wing of Malaysia’s Pahang state Islamic Party (PAS) has urged the state government to legislate a ban on the sale and use of e-cigarettes to protect youth from nicotine addiction. The committee's chairman called on the government to follow the example of other states in restricting e-cigarette sales to minors.
May.16 by 2FIRSTS.ai
2Firsts Observation | DEMANDVAPE and Other Leading U.S. E-Cigarette Distributors Launch Registration Systems, Open Only to Businesses
2Firsts Observation | DEMANDVAPE and Other Leading U.S. E-Cigarette Distributors Launch Registration Systems, Open Only to Businesses
U.S. e-cigarette distributor DEMANDVAPE has launched a registration system for corporate users only, with new warnings on nicotine health risks and battery safety.
May.22 by 2FIRSTS.ai
FDA Embraces AI: Generative System to Be Fully Operational by June's End
FDA Embraces AI: Generative System to Be Fully Operational by June's End
FDA plans to fully integrate a generative AI system across its centers by June 30, 2025. This follows the successful completion of an initial pilot, marking a shift in the agency's approach to regulatory processes. The AI tools are expected to streamline the drug approval process, which typically takes six to ten months, by reducing time spent on repetitive tasks.
May.09 by 2FIRSTS.ai
FDA Launches National Priority Review Program: Drugs Aligned with U.S. Priorities May Be Approved in as Little as One Month
FDA Launches National Priority Review Program: Drugs Aligned with U.S. Priorities May Be Approved in as Little as One Month
The FDA has launched the Commissioner’s National Priority Voucher (CNPV) program, reducing the review time for certain drugs to as little as 1–2 months. While the program currently applies only to pharmaceuticals, it demonstrates the FDA’s capacity to reform its review pathways. Whether a similar mechanism could extend to tobacco products now appears to be a matter of timing and technical details.
Jun.18
From “2+10” Market Saturation to Prime Time: CFU Vaping Experience Offers a New Compliance Blueprint
From “2+10” Market Saturation to Prime Time: CFU Vaping Experience Offers a New Compliance Blueprint
At Vaper Expo UK, CFU Vaping Experience launched Prime 2ML, a superior alternative to traditional disposables, and Prime 10ML, a compliant solution for legal big puff. MixIn, the first smart hybrid device combining harm reduction with enhanced flavor, provides a viable option for smokers. Through technological innovation, CFU has brought sustainable solutions to the industry, leading it into a new “Prime Time.”
May.12
Poland to Ban Disposable E-Cigs and Flavored Nicotine Pouches
Poland to Ban Disposable E-Cigs and Flavored Nicotine Pouches
Poland's Ministry of Health plans to ban disposable e-cigarettes and flavored nicotine pouches, and prohibit e-cigarette sales to anyone under 18. The draft has been approved by the government's legislative group and backed unanimously by the parliamentary health committee.
May.08 by 2FIRSTS.ai