This move may have a devastating impact on the e-cigarette industry. The US Food and Drug Administration has issued an "Import Alert 98-06", stating that the regulatory agency will detain new tobacco products, such as e-cigarettes, at the border without marketing permission.

The affected companies will include all importers, manufacturers, and transporters of electronic cigarette product brands such as ELFBAR, EB DESIGN, Eonsmoke, Esco Bar, and Stik on the organization's "Red List".

This alert covers China, South Korea, and the United States.

The relevant department may withhold tobacco products identified in the red list of this import alert without conducting a medical examination. If the department is unsure whether a tobacco product is the same as the product identified in the red list, the department should consult the Tobacco Product Center (CTP), "the warning said. Adding products to the red list requires CTP approval

In order to remove a company's product from the red list, the company must provide information to the FDA to fully demonstrate that the company has resolved the conditions that led to the violation.

The purpose of this is to convince the agency that future shipments/entries will comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act). For further guidance on releasing detention without medical examination, please refer to the FDA's Regulatory Procedure Manual (RPM), Chapters 9-8, "Detention without Medical Examination (DWPE)," the warning states.


The FDA stated that the import alert is aimed at preventing the sale of potentially illegal goods in the United States; Release agent resources to inspect other goods; Provide unified coverage nationwide; According to the agency, responsibility will be transferred to importers to ensure that products imported into the United States comply with FDA laws and regulations.

In June 2009, the Family Smoking Prevention and Tobacco Control Act granted the FDA the authority to regulate tobacco products, recognizing it as the primary federal regulatory agency for the manufacturing, marketing, and distribution of cigarettes, cigarette tobacco, and smokeless tobacco.

The designated rules were published in the Federal Register on May 10, 2016 and came into effect on August 8, 2016, extending FDA's authority to designated tobacco products, such as e-cigarettes, cigars, hookah bags, and pipe tobacco, as well as their components and parts, but not their accessories.


According to this import alert (also known as the Red List), the list of companies and their products that have been detained without medical examination (DWPE)

China

Guangsong Technology Co., Ltd

Release date: 05/17/2023

Room 201, No. 3, Dongguan City, Guangdong Province, China

98 L - Electronic Nicotine Delivery System

Release date: May 17, 2023

Description: Elf Bar or Elfbar or EBDESIGN ENDS product

Note: CTP has determined that this company may import/manufacture/transport a new tobacco product ("Elf Bar/Elfbar" or "EBDESIGN") without marketing authorization. Tobacco products that lack pre market authorization requirements are considered adulterated.

98 M - Electronic Nicotine Delivery System Components/Parts

Release date: May 17, 2023

Description: Elf Bar or Elfbar or EBDESIGN ENDS product

Note: CTP has determined that this company may import/manufacture/transport a new tobacco product ("Elf Bar/Elfbar" or "EBDESIGN") without marketing authorization. Tobacco products that lack pre market authorization requirements are considered adulterated.


Guangdong Qisi Technology Co., Ltd

Release date: 05/17/2023

Room 201, Building 3, No. 36 Fuxing Road, Chang'an Town, Dongguan City, Guangdong Province, China

98 L - Electronic Nicotine Delivery System

Release date: May 17, 2023

Description: Elf Bar or Elfbar or EBDESIGN ENDS product

Note: CTP has determined that this company may import/manufacture/transport a new tobacco product ("Elf Bar/Elfbar" or "EBDESIGN") without marketing authorization. Tobacco products that lack pre market authorization requirements are considered adulterated.

98 M - Electronic Nicotine Delivery System Components/Parts

Release date: May 17, 2023

Description: Elf Bar or Elfbar or EBDESIGN ENDS product

Note: CTP has determined that this company may import/manufacture/transport a new tobacco product ("Elf Bar/Elfbar" or "EBDESIGN") without marketing authorization. Tobacco products that lack pre market authorization requirements are considered adulterated.



Haiqiang International Logistics Co., Ltd

Release date: 05/17/2023

Rooms 428-430, Building B, Building 4, Taoyuan Business Center; Bao'an District, Shenzhen, China

98 L - Electronic Nicotine Delivery System

Release date: May 17, 2023

Description: Elf Bar or Elfbar or EBDESIGN ENDS product

Note: CTP has determined that this company may import/manufacture/transport a new tobacco product ("Elf Bar/Elfbar" or "EBDESIGN") without marketing authorization. Tobacco products that lack pre market authorization requirements are considered adulterated.

98 M - Electronic Nicotine Delivery System Components/Parts

Release date: May 17, 2023

Description: Elf Bar or Elfbar or EBDESIGN ENDS product

Note: CTP has determined that this company may import/manufacture/transport a new tobacco product ("Elf Bar/Elfbar" or "EBDESIGN") without marketing authorization. Tobacco products that lack pre market authorization requirements are considered adulterated.



Paradise Gift International Co., Ltd

Release date: 05/17/2023

F/3/3, Bldg Huada Inststrpark Fuqiao 3rd; Fuyong Industrial Zone, China

98 L - Electronic Nicotine Delivery System

Release date: May 17, 2023

Description: Elf Bar or Elfbar or EBDESIGN ENDS product

Note: CTP has determined that this company may import/manufacture/transport a new tobacco product ("Elf Bar/Elfbar" or "EBDESIGN") without marketing authorization. Tobacco products that lack pre market authorization requirements are considered adulterated.

98 M - Electronic Nicotine Delivery System Components/Parts

Release date: May 17, 2023

Description: Elf Bar or Elfbar or EBDESIGN ENDS product

Note: CTP has determined that this company may import/manufacture/transport a new tobacco product ("Elf Bar/Elfbar" or "EBDESIGN") without marketing authorization. Tobacco products that lack pre market authorization requirements are considered adulterated.



Paradise Gift International Co., Ltd

Release date: 05/17/2023

Room J5685, Building 2, Shanghai, China

98 L - Electronic Nicotine Delivery System

Release date: May 17, 2023

Description: Elf Bar or Elfbar or EBDESIGN ENDS product

Note: CTP has determined that this company may import/manufacture/transport a new tobacco product ("Elf Bar/Elfbar" or "EBDESIGN") without marketing authorization. Tobacco products that lack pre market authorization requirements are considered adulterated.

98 M - Electronic Nicotine Delivery System Components/Parts

Release date: May 17, 2023

Description: Elf Bar or Elfbar or EBDESIGN ENDS product

Note: CTP has determined that this company may import/manufacture/transport a new tobacco product ("Elf Bar/Elfbar" or "EBDESIGN") without marketing authorization. Tobacco products that lack pre market authorization requirements are considered adulterated.


Shenzhen Fantasy Technology Co., Ltd

Release date: 05/17/2023

206 Xinmin Road, Wusha Community, Chang'an Town, Dongguan City, Guangdong Province, China

98 L - Electronic Nicotine Delivery System

Release date: May 17, 2023

Description: Elf Bar or Elfbar or EBDESIGN ENDS product

Note: CTP has determined that this company may import/manufacture/transport a new tobacco product ("Elf Bar/Elfbar" or "EBDESIGN") without marketing authorization. Tobacco products that lack pre market authorization requirements are considered adulterated.

98 M - Electronic Nicotine Delivery System Components/Parts

Release date: May 17, 2023

Description: Elf Bar or Elfbar or EBDESIGN ENDS product

Note: CTP has determined that this company may import/manufacture/transport a new tobacco product ("Elf Bar/Elfbar" or "EBDESIGN") without marketing authorization. Tobacco products that lack pre market authorization requirements are considered adulterated.


InnoHealth Technology

Release date: 05/15/2023

6 New Xintian Industrial Park, Shenzhen, China

98 L - Electronic Nicotine Delivery System

Release date: May 15, 2023

Description: All Esco Bar or Escobar ENDS products

Note: CTP has determined that this company may import/manufacture/transport a new tobacco product ("Esco Bar"/"Escobar") without marketing authorization. Tobacco products that lack pre market authorization requirements are considered adulterated.

98 M - Electronic Nicotine Delivery System Components/Parts

Release date: May 15, 2023

Description: All Esco Bar or Escobar ENDS products

Note: CTP has determined that this company may import/manufacture/transport a new tobacco product ("Esco Bar"/"Escobar") without marketing authorization. Tobacco products that lack pre market authorization requirements are considered adulterated.


Shenze Yingnuojian Technology Co., Ltd

Release date: 05/15/2023

No. 6 Industrial Park Road, Guanghua District, Guangdong Province, China

98 L - Electronic Nicotine Delivery System

Release date: May 15, 2023

Description: All Esco Bar or Escobar ENDS products

Note: CTP has determined that this company may import/manufacture/transport a new tobacco product ("Esco Bar"/"Escobar") without marketing authorization. Tobacco products that lack pre market authorization requirements are considered adulterated.

98 M - Electronic Nicotine Delivery System Components/Parts

Release date: May 15, 2023

Description: All Esco Bar or Escobar ENDS products

Note: CTP has determined that this company may import/manufacture/transport a new tobacco product ("Esco Bar"/"Escobar") without marketing authorization. Tobacco products that lack pre market authorization requirements are considered adulterated.



Shenzhen Xianlian Technology Co., Ltd

Release date: 05/15/2023

01 Jianan Road, Tangwei Village, Fuyong Town, Shenzhen City, Guangdong Province

98 L - Electronic Nicotine Delivery System

Release date: May 15, 2023

Description: All Esco Bar or Escobar ENDS products

Note: CTP has determined that this company may import/manufacture/transport a new tobacco product ("Esco Bar"/"Escobar") without marketing authorization. Tobacco products that lack pre market authorization requirements are considered adulterated.

98 M - Electronic Nicotine Delivery System Components/Parts

Release date: May 15, 2023

Description: All Esco Bar or Escobar ENDS products

Note: CTP has determined that this company may import/manufacture/transport a new tobacco product ("Esco Bar"/"Escobar") without marketing authorization. Tobacco products that lack pre market authorization requirements are considered adulterated.



Shenzhen Fuyin Electronic Technology Co., Ltd

Release date: 05/15/2023

And 401 Bldg A, 205 Fuhai Street; Fuyuan Industrial Zone, Shenzhen, China

98 L - Electronic Nicotine Delivery System

Release date: May 15, 2023

Description: All Esco Bar or Escobar ENDS products

Note: CTP has determined that this company may import/manufacture/transport a new tobacco product ("Esco Bar"/"Escobar") without marketing authorization. Tobacco products that lack pre market authorization requirements are considered adulterated.

98 M - Electronic Nicotine Delivery System Components/Parts

Release date: May 15, 2023

Description: All Esco Bar or Escobar ENDS products

Note: CTP has determined that this company may import/manufacture/transport a new tobacco product ("Esco Bar"/"Escobar") without marketing authorization. Tobacco products that lack pre market authorization requirements are considered adulterated.


Shenzhen Fuyin Intelligent Manufacturing Co., Ltd

Release date: 05/15/2023

3/4/5/F, Building 1, No. 2010 West Ring Road, Shajing Street, Bao'an City

98 L - Electronic Nicotine Delivery System

Release date: May 15, 2023

Description: All Esco Bar or Escobar ENDS products

Note: CTP has determined that this company may import/manufacture/transport a new tobacco product ("Esco Bar"/"Escob") without marketing authorization