Import Alert 98-08
(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 98-08
Published Date: 04/15/2025
Type: DWPE
Import Alert Name:
“Detention Without Physical Examination of Certain Regulated Tobacco Products Lacking Labeling Requirements Specified in Section 903(a)(2) of the FD&C Act”
Reason for Alert:
NOTE: The revision of this Import Alert, dated 09/13/2024, updates the reason for alert and guidance section, updates PAC code and Agency contacts. Changes are bracketed by asterisks (***).
In June 2009, the Family Smoking Prevention and Tobacco Control Act (TCA) provided FDA with authority to regulate tobacco products by recognizing it as the primary Federal regulatory authority with respect to the manufacture, marketing, and distribution of cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.
The Deeming rule, which published in the Federal Register on May 10, 2016, and took effect on August 8, 2016, extended FDA’s authority to additional tobacco products such as electronic cigarettes, cigars, hookah tobacco, and pipe tobacco, including their components and parts, but not their accessories. Deemed tobacco products immediately became subject to Chapter IX of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations, including the misbranding provisions in section 903 of the FD&C Act (21 U.S.C 387c).
Under section 903(a)(2) of the FD&C Act (21 U.S.C. 387c(a)(2)), a tobacco product shall be deemed to be misbranded if in package form unless it bears a label that contains certain information, including:
1) the name and place of business of the tobacco product manufacturer, packer, or distributor. See 903(a)(2)(A) of the FD&C Act (21 U.S.C. 387c(a)(2)(A));
2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. See 903(a)(2)(B) of the FD&C Act (21 U.S.C. 387c(a)(2)(B)); and
3) the statement required by section 920(a) of the FD&C Act (21 U.S.C. 387t(a)) (i.e., “sale only allowed in the United States”). See 903(a)(2)(D) of the FD&C Act (21 U.S.C. 387c(a)(2)(D)).
These labeling requirements became effective for deemed tobacco products on August 10, 2018.
***Additional information on the requirements of section 903(a)(2) of the FD&C Act (21 U.S.C. 387c(a)(2)) is available at https://www.fda.gov/tobacco-products/products-guidance-regulations/labeling-and-warning-statements-tobacco-products.***
In June 2009, the Family Smoking Prevention and Tobacco Control Act (TCA) provided FDA with authority to regulate tobacco products by recognizing it as the primary Federal regulatory authority with respect to the manufacture, marketing, and distribution of cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.
The Deeming rule, which published in the Federal Register on May 10, 2016, and took effect on August 8, 2016, extended FDA’s authority to additional tobacco products such as electronic cigarettes, cigars, hookah tobacco, and pipe tobacco, including their components and parts, but not their accessories. Deemed tobacco products immediately became subject to Chapter IX of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations, including the misbranding provisions in section 903 of the FD&C Act (21 U.S.C 387c).
Under section 903(a)(2) of the FD&C Act (21 U.S.C. 387c(a)(2)), a tobacco product shall be deemed to be misbranded if in package form unless it bears a label that contains certain information, including:
1) the name and place of business of the tobacco product manufacturer, packer, or distributor. See 903(a)(2)(A) of the FD&C Act (21 U.S.C. 387c(a)(2)(A));
2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. See 903(a)(2)(B) of the FD&C Act (21 U.S.C. 387c(a)(2)(B)); and
3) the statement required by section 920(a) of the FD&C Act (21 U.S.C. 387t(a)) (i.e., “sale only allowed in the United States”). See 903(a)(2)(D) of the FD&C Act (21 U.S.C. 387c(a)(2)(D)).
These labeling requirements became effective for deemed tobacco products on August 10, 2018.
***Additional information on the requirements of section 903(a)(2) of the FD&C Act (21 U.S.C. 387c(a)(2)) is available at https://www.fda.gov/tobacco-products/products-guidance-regulations/labeling-and-warning-statements-tobacco-products.***
Guidance:
Divisions may detain, without physical examination, the ***specific*** tobacco products identified on the Red List of this Import Alert.
***Note: Individual listings will include applicable charge code(s). If Divisions encounter shipments of specific products identified under the Red List of this Import Alert, the articles are subject to refusal of admission using the applicable OASIS charge code indicated in the Notes section of the firm listing. No products subject to IA should be released prior to CTP review and concurrence.***
CTP concurrence is required to add a product to the Red List.
Removal from Detention without Physical Examination (REMOVE FROM RED LIST):
In order to remove a firm's product from the Red List, information should be provided to the Agency to adequately demonstrates that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act). For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)."
If a firm and/or a representative thereof would like to request removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be forwarded to the following address:
Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857
Or sent via email to: Importalerts2@fda.hhs.gov
All requests for removal from DWPE will be forwarded by DIO to CTP for evaluation.
Questions or issues involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.
Questions related to tobacco products may be directed to the Center for Tobacco Products, Office of Compliance at CTP-ComplianceImports@fda.hhs.gov.
***Note: Individual listings will include applicable charge code(s). If Divisions encounter shipments of specific products identified under the Red List of this Import Alert, the articles are subject to refusal of admission using the applicable OASIS charge code indicated in the Notes section of the firm listing. No products subject to IA should be released prior to CTP review and concurrence.***
CTP concurrence is required to add a product to the Red List.
Removal from Detention without Physical Examination (REMOVE FROM RED LIST):
In order to remove a firm's product from the Red List, information should be provided to the Agency to adequately demonstrates that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act). For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)."
If a firm and/or a representative thereof would like to request removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be forwarded to the following address:
Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857
Or sent via email to: Importalerts2@fda.hhs.gov
All requests for removal from DWPE will be forwarded by DIO to CTP for evaluation.
Questions or issues involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.
Questions related to tobacco products may be directed to the Center for Tobacco Products, Office of Compliance at CTP-ComplianceImports@fda.hhs.gov.
Product Description:
Regulated Tobacco Products Lacking Labeling Requirements.
Charge:
This article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it is a tobacco product in package form that appears to be misbranded under section 903(a)(2)(A) of the FD&C Act in that the label does not contain the name and place of business of the tobacco product manufacturer, packer or distributor. [Misbranding, Section 903(a)(2)(A)]
OASIS charge code: TPLACKFIRM
This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it is a tobacco product in package form that appears to be misbranded under section 903(a)(2)(B) of the FD&C Act in that the label does not provide an accurate statement of the quantity of contents in terms of weight, measure or numerical count. [Misbranding, Section 903(a)(2)(B)]
OASIS charge code: TPLACKSNC
The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it is a tobacco product in package form that appears to be misbranded under section 903(a)(2)(D) of the FD&C Act in that the label does not provide the statement “sale only allowed in the United States” and the tobacco product is not subject to any exemptions or variations. [Misbranding, Section 903(a)(2)(D)]
OASIS charge code: TPLKUSSLLB
OASIS charge code: TPLACKFIRM
This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it is a tobacco product in package form that appears to be misbranded under section 903(a)(2)(B) of the FD&C Act in that the label does not provide an accurate statement of the quantity of contents in terms of weight, measure or numerical count. [Misbranding, Section 903(a)(2)(B)]
OASIS charge code: TPLACKSNC
The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it is a tobacco product in package form that appears to be misbranded under section 903(a)(2)(D) of the FD&C Act in that the label does not provide the statement “sale only allowed in the United States” and the tobacco product is not subject to any exemptions or variations. [Misbranding, Section 903(a)(2)(D)]
OASIS charge code: TPLKUSSLLB
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)
CHINA
Dongguan Xingda Electronic Technology, Co., LTD
Date Published : 07/12/2022
4/F Zone B, Baifuhi, Science Technology Park , 9 Yucheng Road
, Dongguan,
Guangdong CHINA
98 L - - 01 E-Cigarette
Date Published: 07/12/2022
Desc: FUME VAPES- LUSH ICE DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 01 E-Cigarette
Date Published: 07/12/2022
Desc: FUME VAPES- MANGO DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 01 E-Cigarette
Date Published: 07/12/2022
Desc: FUME VAPES- PINA COLADA DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 01 E-Cigarette
Date Published: 07/12/2022
Desc: FUME VAPES- BANANA ICE DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 01 E-Cigarette
Date Published: 07/12/2022
Desc: FUME VAPES- TROPICAL FRUIT DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 01 E-Cigarette
Date Published: 07/12/2022
Desc: FUME VAPES- STRAWBERRY DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 01 E-Cigarette
Date Published: 07/12/2022
Desc: FUME VAPES- STRAWBERRY WATERMELON DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 01 E-Cigarette
Date Published: 07/12/2022
Desc: FUME VAPES- ICE MINT DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 01 E-Cigarette
Date Published: 07/12/2022
Desc: FUME VAPES- DESERT BREEZE DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 01 E-Cigarette
Date Published: 07/12/2022
Desc: FUME VAPES- STRAWBERRY MANGO DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 01 E-Cigarette
Date Published: 07/12/2022
Desc: FUME VAPES- STRAWBERRY BANANA DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 01 E-Cigarette
Date Published: 07/12/2022
Desc: FUME VAPES- BLUEBERRY MINT DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 01 E-Cigarette
Date Published: 07/12/2022
Desc: FUME VAPES- YOGURT ICE CREAM DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 01 E-Cigarette
Date Published: 07/12/2022
Desc: FUME VAPES- MELON ICE DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 01 E-Cigarette
Date Published: 07/12/2022
Desc: FUME VAPES- CUBANO TOBACCO DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 01 E-Cigarette
Date Published: 07/12/2022
Desc: FUME VAPES- BLUEBERRY C C DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 01 E-Cigarette
Date Published: 07/12/2022
Desc: FUME VAPES- RAINBOW CANDY DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 01 E-Cigarette
Date Published: 07/12/2022
Desc: FUME VAPES- PINEAPPLE ICE DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 01 E-Cigarette
Date Published: 07/12/2022
Desc: FUME VAPES- GRAPE DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 01 E-Cigarette
Date Published: 07/12/2022
Desc: FUME VAPES- TANGERINE ICE DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 01 E-Cigarette
Date Published: 07/12/2022
Desc: FUME VAPES- PEACH ICE DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 01 E-Cigarette
Date Published: 07/12/2022
Desc: FUME VAPES- PURPLE RAIN DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 01 E-Cigarette
Date Published: 07/12/2022
Desc: FUME VAPES- BLUE RAZZ DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 11 Vape Pen
Date Published: 07/12/2022
Desc: FUME VAPES- BLUEBERRY C C DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 11 Vape Pen
Date Published: 07/12/2022
Desc: FUME VAPES- BLUEBERRY MINT DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 11 Vape Pen
Date Published: 07/12/2022
Desc: FUME VAPES- GRAPE DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 11 Vape Pen
Date Published: 07/12/2022
Desc: FUME VAPES- CUBANO TOBACCO DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 11 Vape Pen
Date Published: 07/12/2022
Desc: FUME VAPES- STRAWBERRY BANANA DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 11 Vape Pen
Date Published: 07/12/2022
Desc: FUME VAPES- TANGERINE ICE DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 11 Vape Pen
Date Published: 07/12/2022
Desc: FUME VAPES- PINEAPPLE ICE DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 11 Vape Pen
Date Published: 07/12/2022
Desc: FUME VAPES- BANANA ICE DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 11 Vape Pen
Date Published: 07/12/2022
Desc: FUME VAPES- BLUE RAZZ DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 11 Vape Pen
Date Published: 07/12/2022
Desc: FUME VAPES- PEACH ICE DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 11 Vape Pen
Date Published: 07/12/2022
Desc: FUME VAPES- YOGURT ICE CREAM DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 11 Vape Pen
Date Published: 07/12/2022
Desc: FUME VAPES- PURPLE RAIN DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 11 Vape Pen
Date Published: 07/12/2022
Desc: FUME VAPES- MANGO DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 11 Vape Pen
Date Published: 07/12/2022
Desc: FUME VAPES- STRAWBERRY WATERMELON DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 11 Vape Pen
Date Published: 07/12/2022
Desc: FUME VAPES- DESERT BREEZE DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 11 Vape Pen
Date Published: 07/12/2022
Desc: FUME VAPES- STRAWBERRY DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 11 Vape Pen
Date Published: 07/12/2022
Desc: FUME VAPES- LUSH ICE DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 11 Vape Pen
Date Published: 07/12/2022
Desc: FUME VAPES- ICE MINT DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 11 Vape Pen
Date Published: 07/12/2022
Desc: FUME VAPES- RAINBOW CANDY DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 11 Vape Pen
Date Published: 07/12/2022
Desc: FUME VAPES- MELON ICE DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 11 Vape Pen
Date Published: 07/12/2022
Desc: FUME VAPES- STRAWBERRY MANGO DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 11 Vape Pen
Date Published: 07/12/2022
Desc: FUME VAPES- TROPICAL FRUIT DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 11 Vape Pen
Date Published: 07/12/2022
Desc: FUME VAPES- PINA COLADA DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 99 Electronic Nicotine Delivery System, NEC
Date Published: 07/12/2022
Desc: FUME VAPES- PURPLE RAIN DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 99 Electronic Nicotine Delivery System, NEC
Date Published: 07/12/2022
Desc: FUME VAPES- STRAWBERRY BANANA DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 99 Electronic Nicotine Delivery System, NEC
Date Published: 07/12/2022
Desc: FUME VAPES- ICE MINT DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 99 Electronic Nicotine Delivery System, NEC
Date Published: 07/12/2022
Desc: FUME VAPES- MANGO DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 99 Electronic Nicotine Delivery System, NEC
Date Published: 07/12/2022
Desc: FUME VAPES- YOGURT ICE CREAM DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 99 Electronic Nicotine Delivery System, NEC
Date Published: 07/12/2022
Desc: FUME VAPES- STRAWBERRY MANGO DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 99 Electronic Nicotine Delivery System, NEC
Date Published: 07/12/2022
Desc: FUME VAPES- PEACH ICE DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 99 Electronic Nicotine Delivery System, NEC
Date Published: 07/12/2022
Desc: FUME VAPES- LUSH ICE DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 99 Electronic Nicotine Delivery System, NEC
Date Published: 07/12/2022
Desc: FUME VAPES- TANGERINE ICE DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 99 Electronic Nicotine Delivery System, NEC
Date Published: 07/12/2022
Desc: FUME VAPES- BLUE RAZZ DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 99 Electronic Nicotine Delivery System, NEC
Date Published: 07/12/2022
Desc: FUME VAPES- GRAPE DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 99 Electronic Nicotine Delivery System, NEC
Date Published: 07/12/2022
Desc: FUME VAPES- DESERT BREEZE DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 99 Electronic Nicotine Delivery System, NEC
Date Published: 07/12/2022
Desc: FUME VAPES- BLUEBERRY C C DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 99 Electronic Nicotine Delivery System, NEC
Date Published: 07/12/2022
Desc: FUME VAPES- CUBANO TOBACCO DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 99 Electronic Nicotine Delivery System, NEC
Date Published: 07/12/2022
Desc: FUME VAPES- TROPICAL FRUIT DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 99 Electronic Nicotine Delivery System, NEC
Date Published: 07/12/2022
Desc: FUME VAPES- STRAWBERRY WATERMELON DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 99 Electronic Nicotine Delivery System, NEC
Date Published: 07/12/2022
Desc: FUME VAPES- BLUEBERRY MINT DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 99 Electronic Nicotine Delivery System, NEC
Date Published: 07/12/2022
Desc: FUME VAPES- RAINBOW CANDY DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 99 Electronic Nicotine Delivery System, NEC
Date Published: 07/12/2022
Desc: FUME VAPES- MELON ICE DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 99 Electronic Nicotine Delivery System, NEC
Date Published: 07/12/2022
Desc: FUME VAPES- PINEAPPLE ICE DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 99 Electronic Nicotine Delivery System, NEC
Date Published: 07/12/2022
Desc: FUME VAPES- PINA COLADA DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 99 Electronic Nicotine Delivery System, NEC
Date Published: 07/12/2022
Desc: FUME VAPES- BANANA ICE DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
98 L - - 99 Electronic Nicotine Delivery System, NEC
Date Published: 07/12/2022
Desc: FUME VAPES- STRAWBERRY DISPOSABLE-EXTRA
Notes: TPLKUSSLLB
Shenzhen Yibo Technology Co., Ltd.
Date Published : 03/02/2023
B Building F 7 , Gongming; Guangming District Town Industrial Zone
, Shenzhen,
Guangdong CHINA
98 L - - -- Electronic Nicotine Delivery System
Date Published: 03/02/2023
Desc: ZStick - Disposable ENDS Stick 5% Salt Nicotine - Strawberry
Notes: TPLKUSSLLB;
TPLACKFIRM;
TPLACKSNC
98 L - - -- Electronic Nicotine Delivery System
Date Published: 03/02/2023
Desc: ZStick - Disposable ENDS Stick 5% Salt Nicotine - Strawberry Lemonade
Notes: TPLKUSSLLB;
TPLACKFIRM;
TPLACKSNC
98 L - - -- Electronic Nicotine Delivery System
Date Published: 03/02/2023
Desc: ZStick - Disposable ENDS Stick 5% Salt Nicotine - Tobacco
Notes: TPLKUSSLLB;
TPLACKFIRM;
TPLACKSNC
98 L - - -- Electronic Nicotine Delivery System
Date Published: 03/02/2023
Desc: ZStick - Disposable ENDS Stick 5% Salt Nicotine - Berry Mix
Notes: TPLKUSSLLB;
TPLACKFIRM;
TPLACKSNC
98 L - - -- Electronic Nicotine Delivery System
Date Published: 03/02/2023
Desc: ZStick - Disposable ENDS Stick 5% Salt Nicotine - Banana
Notes: TPLKUSSLLB;
TPLACKFIRM;
TPLACKSNC
98 L - - -- Electronic Nicotine Delivery System
Date Published: 03/02/2023
Desc: ZStick - Disposable ENDS Stick 5% Salt Nicotine - Watermelon
Notes: TPLKUSSLLB;
TPLACKFIRM;
TPLACKSNC
98 L - - -- Electronic Nicotine Delivery System
Date Published: 03/02/2023
Desc: ZStick - Disposable ENDS Stick 5% Salt Nicotine - Banana Pineapple
Notes: TPLKUSSLLB;
TPLACKFIRM;
TPLACKSNC
98 L - - -- Electronic Nicotine Delivery System
Date Published: 03/02/2023
Desc: ZStick - Disposable ENDS Stick 5% Salt Nicotine - Clear
Notes: TPLKUSSLLB;
TPLACKFIRM;
TPLACKSNC
98 L - - -- Electronic Nicotine Delivery System
Date Published: 03/02/2023
Desc: ZStick - Disposable ENDS Stick 5% Salt Nicotine - Grape
Notes: TPLKUSSLLB;
TPLACKFIRM;
TPLACKSNC
98 L - - -- Electronic Nicotine Delivery System
Date Published: 03/02/2023
Desc: ZStick - Disposable ENDS Stick 5% Salt Nicotine - Mint
Notes: TPLKUSSLLB;
TPLACKFIRM;
TPLACKSNC
98 L - - -- Electronic Nicotine Delivery System
Date Published: 03/02/2023
Desc: ZStick - Disposable ENDS Stick 5% Salt Nicotine - Watermelon Lemonade
Notes: TPLKUSSLLB;
TPLACKFIRM;
TPLACKSNC
98 L - - -- Electronic Nicotine Delivery System
Date Published: 03/02/2023
Desc: ZStick - Disposable ENDS Stick 5% Salt Nicotine - Mango
Notes: TPLKUSSLLB;
TPLACKFIRM;
TPLACKSNC
DENMARK
Swedish Match Ab
Date Published : 12/10/2024
Rosenlundsgatan 36
, Stockholm,
Stockholms Lan DENMARK
98 - - A -- Tobacco Products, For Consumer Use
Date Published: 03/11/2025
Desc: GENERAL brand smokeless tobacco and nicotine delivery products for consumer use
Notes: TPLACKFIRM; TPLKUSSLLB
98 - - A -- Tobacco Products, For Consumer Use
Date Published: 12/10/2024
Desc: Goteborgs Rape brand smokeless tobacco and nicotine delivery products for consumer use
Notes: TPLKUSSLLB; TPLACKFIRM
98 - - A -- Tobacco Products, For Consumer Use
Date Published: 03/11/2025
Desc: G.3 brand smokeless tobacco and nicotine delivery products for consumer use
Notes: TPLACKFIRM; TPLKUSSLLB
98 - - A -- Tobacco Products, For Consumer Use
Date Published: 04/15/2025
Desc: Zyn Brand nicotine pouches lacking labeling requirements specified in section 903(a)(2) of the FD&C Act
Notes: TPLKUSSLLB
Applicable only to ZYN brand nicotine pouches and other nicotine delivery products that are otherwise not authorized for marketing in U.S. The list of ZYN brand nicotine pouch products authorized for marketing in the U.S. is found at https;//www.accessdata.fda.gov/scripts/searchtobacco
SWEDEN
Fiedler & Lundgren Ab
Date Published : 03/03/2025
Box 90041 , Stenaldersgatan 23
, Malmo,
Skane Lan SWEDEN
98 - - A -- Tobacco Products, For Consumer Use
Date Published: 03/03/2025
Desc: LUNDGRENS tobacco products
Notes: TP LACKFIRM
TPLKUSSLLB
Gn Tobacco Sweden Ab
Date Published : 11/07/2024
Box 537
, Bispgarden,
SWEDEN
98 N - C 99 Nicotine Delivery Product, NEC, For Investigational Use
Date Published: 12/06/2024
Desc: White Fox brand smokeless tobacco and nicotine delivery products
Notes: TPLKUSSLLB
98 N - C 99 Nicotine Delivery Product, NEC, For Investigational Use
Date Published: 12/06/2024
Desc: Odens brand smokeless tobacco and nicotine delivery products
Notes: TPLKUSSLLB
98 - - A -- Tobacco Products, For Consumer Use
Date Published: 12/06/2024
Desc: White Fox brand smokeless tobacco and nicotine delivery products
Notes: TPLKUSSLLB
98 - - A -- Tobacco Products, For Consumer Use
Date Published: 12/06/2024
Desc: Odens brand smokeless tobacco and nicotine delivery products
Notes: TPLKUSSLLB
98 - - A -- Tobacco Products, For Consumer Use
Date Published: 11/07/2024
Desc: SIBERIA 80 DEGREES smokeless tobacco products
Notes: TPLKUSSLLB; TPLACKFIRM
Skruf Snus Ab
Date Published : 02/28/2024
Box 3068
, Stockholm,
SWEDEN
98 C - - -- Smokeless Tobacco
Date Published: 02/28/2024
Desc: Scruf Roda Lacket
Notes: TPLKUSSLLB
98 C - - -- Smokeless Tobacco
Date Published: 02/28/2024
Desc: Scruf White Portion No. 27
Notes: TPLKUSSLLB
98 C - - -- Smokeless Tobacco
Date Published: 02/28/2024
Desc: Knox Loose snus
Notes: TPLKUSSLLB
98 C - - -- Smokeless Tobacco
Date Published: 02/28/2024
Desc: Scruf Portion No. 2 Mint medium
Notes: TPLKUSSLLB
98 C - - -- Smokeless Tobacco
Date Published: 02/28/2024
Desc: Scruf Portion No. 24 White XTRA STRONG
Notes: TPLKUSSLLB
98 N - - -- Nicotine Delivery Product
Date Published: 02/28/2024
Desc: Knox Loose snus
Notes: TPLKUSSLLB
98 N - - -- Nicotine Delivery Product
Date Published: 02/28/2024
Desc: Scruf Roda Lacket
Notes: TPLKUSSLLB
98 N - - -- Nicotine Delivery Product
Date Published: 02/28/2024
Desc: Scruf White Portion No. 27
Notes: TPLKUSSLLB
98 N - - -- Nicotine Delivery Product
Date Published: 02/28/2024
Desc: Scruf Portion No. 2 Mint medium
Notes: TPLKUSSLLB
98 N - - -- Nicotine Delivery Product
Date Published: 02/28/2024
Desc: Scruf Portion No. 24 White XTRA STRONG
Notes: TPLKUSSLLB
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: Scruf White Portion No. 27
Notes: TPLKUSSLLB
98 C - - -- Smokeless Tobacco
Date Published: 02/28/2024
Desc: Scruf Portion No. 24 White XTRA STRONG
Notes: TPLKUSSLLB
98 C - - -- Smokeless Tobacco
Date Published: 02/28/2024
Desc: Scruf Roda Lacket
Notes: TPLKUSSLLB
98 C - - -- Smokeless Tobacco
Date Published: 02/28/2024
Desc: Scruf Portion No. 2 Mint medium
Notes: TPLKUSSLLB
98 C - - -- Smokeless Tobacco
Date Published: 02/28/2024
Desc: Knox Loose snus
Notes: TPLKUSSLLB
98 N - - -- Nicotine Delivery Product
Date Published: 02/28/2024
Desc: Knox Loose snus
Notes: TPLKUSSLLB
98 N - - -- Nicotine Delivery Product
Date Published: 02/28/2024
Desc: Scruf White Portion No. 27
Notes: TPLKUSSLLB
98 N - - -- Nicotine Delivery Product
Date Published: 02/28/2024
Desc: Scruf Portion No. 2 Mint medium
Notes: TPLKUSSLLB
98 N - - -- Nicotine Delivery Product
Date Published: 02/28/2024
Desc: Scruf Portion No. 24 White XTRA STRONG
Notes: TPLKUSSLLB
98 N - - -- Nicotine Delivery Product
Date Published: 02/28/2024
Desc: Scruf Roda Lacket
Notes: TPLKUSSLLB
Swedish Match Ab
Date Published : 03/11/2025
Swedish Match North Europe Ab , Xxx
, Stockholm,
Stockholms Lan SWEDEN
98 - - A -- Tobacco Products, For Consumer Use
Date Published: 04/15/2025
Desc: Zyn Brand nicotine pouches lacking labeling requirements specified in section 903(a)(2) of the FD&C Act.
Notes: TPLKUSSLLB
Applicable only to ZYN brand nicotine pouches and other nicotine delivery products that are otherwise not authorized for marketing in U.S. The list of ZYN brand nicotine pouch products authorized for marketing in the U.S. is found at https;//www.accessdata.fda.gov/scripts/searchtobacco
98 - - A -- Tobacco Products, For Consumer Use
Date Published: 03/11/2025
Desc: G.3 brand smokeless tobacco and nicotine delivery products for consumer use
Notes: TPLACKFIRM; TPLKUSSLLB
98 - - A -- Tobacco Products, For Consumer Use
Date Published: 03/11/2025
Desc: GENERAL brand smokeless tobacco and nicotine delivery products for consumer use
Notes: TPLACKFIRM; TPLKUSSLLB
Swedish Match Denmark
Date Published : 12/10/2024
Georg Jensens Vej 7
, Silkeborg,
Midtjylland SWEDEN
98 - - A -- Tobacco Products, For Consumer Use
Date Published: 12/10/2024
Desc: Goteborgs Rape brand smokeless tobacco and nicotine delivery products for consumer use
Notes: TPLKUSSLLB; TPLACKFIRM
Swedish Match North Europe
Date Published : 12/10/2024
Swedish Match North Europe Ab , Maria Skolgata 83
, Stockholm,
Stockholms Lan SWEDEN
98 - - A -- Tobacco Products, For Consumer Use
Date Published: 12/10/2024
Desc: Goteborgs Rape brand smokeless tobacco and nicotine delivery products for consumer use
Notes: TPLKUSSLLB; TPLACKFIRM
98 - - A -- Tobacco Products, For Consumer Use
Date Published: 03/11/2025
Desc: G.3 brand smokeless tobacco and nicotine delivery products for consumer use
Notes: TPLACKFIRM; TPLKUSSLLB
98 - - A -- Tobacco Products, For Consumer Use
Date Published: 03/11/2025
Desc: GENERAL brand smokeless tobacco and nicotine delivery products for consumer use
Notes: TPLACKFIRM; TPLKUSSLLB
XQS INTERNATIONAL AB
Date Published : 12/02/2024
Hammargatan 2
, Borlange,
Dalarnas Lan SWEDEN
98 - - A -- Tobacco Products, For Consumer Use
Date Published: 12/02/2024
Desc: XQS brand smokeless tobacco and nicotine delivery products for consumer use
Notes: TPLKUSSLLB
98 - - C -- Tobacco Products, For Investigational Use
Date Published: 12/02/2024
Desc: XQS brand smokeless tobacco and nicotine delivery products for consumer use
Notes: TPLKUSSLLB