Import Alert 98-06
(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 # 98-06
Published Date: 04/21/2025
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of New Tobacco Products, Other Than ENDS, Without Required Marketing Authorization"
Reason for Alert:
Note: The revision of this Import Alert (IA) dated 12/20/2024 updates the guidance section and agency contacts. Changes to the import alert are bracketed by asterisks (***).
The Federal Food, Drug, and Cosmetic Act (FD&C Act) generally requires premarket review for any "new tobacco product," which means any tobacco product that was not commercially marketed in the United States as of February 15, 2007, or any modification of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007 (section 910(a) of the FD&C Act; 21 U.S.C. 387j(a)). A marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. 387j(c)(1)(A)(i)) is required for a new tobacco product unless (1) FDA issues an order finding the product substantially equivalent to a predicate tobacco product (section 910(a)(2)(A) of the FD&C Act) or (2) FDA issues an order finding the product to be exempt from the requirements of substantial equivalence and the required submission is made under section 905(j)(1)(A)(ii) of the FD&C Act (21 U.S.C. 387e(j)(1)(A)(ii)).
***New tobacco products that do not have the required FDA marketing authorization are adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) of the FD&C Act.***
The Federal Food, Drug, and Cosmetic Act (FD&C Act) generally requires premarket review for any "new tobacco product," which means any tobacco product that was not commercially marketed in the United States as of February 15, 2007, or any modification of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007 (section 910(a) of the FD&C Act; 21 U.S.C. 387j(a)). A marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. 387j(c)(1)(A)(i)) is required for a new tobacco product unless (1) FDA issues an order finding the product substantially equivalent to a predicate tobacco product (section 910(a)(2)(A) of the FD&C Act) or (2) FDA issues an order finding the product to be exempt from the requirements of substantial equivalence and the required submission is made under section 905(j)(1)(A)(ii) of the FD&C Act (21 U.S.C. 387e(j)(1)(A)(ii)).
***New tobacco products that do not have the required FDA marketing authorization are adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) of the FD&C Act.***
Guidance:
***Divisions may detain, without physical examination, the tobacco products identified on the Red List of this Import Alert. If the division is not sure whether a tobacco product is the same product as one identified on the Red List, the division should consult with the Center for Tobacco Products (CTP). Upon detention, divisions should follow OIO’s pre-established admissibility processes.
Note: Electronic nicotine delivery systems or ENDS products previously listed in this Red List are now subject to the 98-07 Import Alert.***
***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 information on removal from detention without physical examination, refer to FDA’s Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)."
If a firm and or it representative 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:
Importalerts2@fda.hhs.gov
All requests for removal from DWPE will be forwarded by OII/DIO to CTP for evaluation.
Questions or issues involving import operations should be addressed to OII/DIO (301) 796-0356 or Imports@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: Electronic nicotine delivery systems or ENDS products previously listed in this Red List are now subject to the 98-07 Import Alert.***
***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 information on removal from detention without physical examination, refer to FDA’s Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)."
If a firm and or it representative 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:
Importalerts2@fda.hhs.gov
All requests for removal from DWPE will be forwarded by OII/DIO to CTP for evaluation.
Questions or issues involving import operations should be addressed to OII/DIO (301) 796-0356 or Imports@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:
New tobacco products, ***other than ENDS,*** that do not have the required FDA marketing authorization.
Charge:
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 that appears to be adulterated under section 902(6)(A) of the FD&C Act in that it
appears it does not have an FDA marketing order in effect under section 910(c)(1)(A)(i) of the FD&C Act. [Adulteration, Section 902(6)(A)]
OASIS charge code: TP NO PMTA
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 that appears to be misbranded under section 903(a)(6) of the FD&C Act in that it appears a notice or other information respecting it was not provided as required by section 905(j). [Misbranded, Section 903(a)(6)]
OASIS charge code - TP NO SE
appears it does not have an FDA marketing order in effect under section 910(c)(1)(A)(i) of the FD&C Act. [Adulteration, Section 902(6)(A)]
OASIS charge code: TP NO PMTA
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 that appears to be misbranded under section 903(a)(6) of the FD&C Act in that it appears a notice or other information respecting it was not provided as required by section 905(j). [Misbranded, Section 903(a)(6)]
OASIS charge code - TP NO SE
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)
DENMARK
MINISTRY A/S
Date Published : 01/27/2025
Gronnemosevej 6
, Svendborg,
Syddanmark DENMARK
98 - - A -- Tobacco Products, For Consumer Use
Date Published: 01/27/2025
Desc: ACE smokeless tobacco and nicotine delivery products for consumer use
MINISTRY OF SNUS
Date Published : 01/27/2025
Tinghusgade 20a
, Svendborg,
Syddanmark DENMARK
98 - - A -- Tobacco Products, For Consumer Use
Date Published: 01/27/2025
Desc: ACE smokeless tobacco and nicotine delivery products for consumer use
Swedish Match Ab
Date Published : 04/21/2025
Rosenlundsgatan 36
, Stockholm,
Stockholms Lan DENMARK
98 - - A -- Tobacco Products, For Consumer Use
Date Published: 04/21/2025
Desc: Volt smokeless tobacco and nicotine delivery products
ESTONIA
HRJ PRODUCTION OU
Date Published : 11/21/2024
Peterburi Tee 46
, Tallinn,
Harju ESTONIA
98 - - A -- Tobacco Products, For Consumer Use
Date Published: 11/21/2024
Desc: NOIS Brand All smokeless tobacco and nicotine delivery products for consumer use
POLAND
77 POUCHES
Date Published : 03/07/2025
Al. 29 Listopada 94
, Cracow,
Malopolskie POLAND
98 - - A -- Tobacco Products, For Consumer Use
Date Published: 03/07/2025
Desc: "77" brand smokeless tobacco and nicotine delivery products for consumer use
Luna Corporate
Date Published : 03/07/2025
Ul. Obornicka 174
, Suchy Las,
Wielkopolskie POLAND
98 - - A -- Tobacco Products, For Consumer Use
Date Published: 03/07/2025
Desc: "77" brand smokeless tobacco and nicotine delivery products for consumer use
SWEDEN
ANOTHER SNUS FACTORY STOCKHOLM AB
Date Published : 03/07/2025
Stora Nygatan 33
, Stockholm,
Stockholms Lan SWEDEN
98 - - A -- Tobacco Products, For Consumer Use
Date Published: 03/07/2025
Desc: Loop brand tobacco products
ANOTHER SNUS FACTORY STOCKHOLM AB
Date Published : 01/27/2025
Box 49052
, Stockholm,
Stockholms Lan SWEDEN
98 - - A -- Tobacco Products, For Consumer Use
Date Published: 01/27/2025
Desc: Loop brand smokeless tobacco and nicotine delivery products for consumer use
BELAGOM AB
Date Published : 02/25/2025
Hollandargatan 22
, Stockholm,
Stockholms Lan SWEDEN
98 - - A -- Tobacco Products, For Consumer Use
Date Published: 02/25/2025
Desc: "Lagom" brand smokeless tobacco and nicotine delivery products for consumer use
BRITISH AMERICAN TOBACCO
Date Published : 10/24/2024
Hyllie Stationsvag 14 , 31/ Floor
, Malmo,
Skane Lan SWEDEN
98 - - A -- Tobacco Products, For Consumer Use
Date Published: 10/24/2024
Desc: "Lyft Cool Air" Nicotine Pouch products
98 - - A -- Tobacco Products, For Consumer Use
Date Published: 03/07/2025
Desc: Lundgrens brand smokeless tobacco and nicotine delivery products for consumer use
98 - - A -- Tobacco Products, For Consumer Use
Date Published: 12/11/2024
Desc: Velo smokeless tobacco and nicotine delivery products
Fiedler & Lundgren Ab
Date Published : 12/11/2024
Box 90041 , Stenaldersgatan 23
, Malmo,
Skane Lan SWEDEN
98 - - A -- Tobacco Products, For Consumer Use
Date Published: 12/11/2024
Desc: Velo smokeless tobacco and nicotine delivery products
HABIT FACTORY IN SWEDEN AB
Date Published : 10/24/2024
Ostmastargrand 5
, Arsta,
Stockholms Lan SWEDEN
98 C - - -- Smokeless Tobacco
Date Published: 10/24/2024
Desc: Klint smokeless tobacco and nicotine delivery products
Notes:
98 N - - -- Nicotine Delivery Product
Date Published: 10/24/2024
Desc: Klint smokeless tobacco and nicotine delivery products
Notes:
98 - - A -- Tobacco Products, For Consumer Use
Date Published: 03/17/2025
Desc: FIX brand smokeless tobacco and nicotine delivery products for consumer use
98 - - A -- Tobacco Products, For Consumer Use
Date Published: 10/24/2024
Desc: Klint smokeless tobacco and nicotine delivery products
Notes:
HABIT FACTORY IN SWEDEN AB
Date Published : 10/24/2024
Segersbyvagen 4
, Norsborg,
Stockholms Lan SWEDEN
98 C - - -- Smokeless Tobacco
Date Published: 10/24/2024
Desc: Klint smokeless tobacco and nicotine delivery products
Notes:
98 N - - -- Nicotine Delivery Product
Date Published: 10/24/2024
Desc: Klint smokeless tobacco and nicotine delivery products
Notes:
98 - - A -- Tobacco Products, For Consumer Use
Date Published: 03/17/2025
Desc: FIX brand smokeless tobacco and nicotine delivery products for consumer use
98 - - A -- Tobacco Products, For Consumer Use
Date Published: 10/24/2024
Desc: Klint smokeless tobacco and nicotine delivery products
Notes:
KELLY WHITE
Date Published : 03/25/2025
Grev Turegatan 30
, Stockholm,
Stockholms Lan SWEDEN
98 - - A -- Tobacco Products, For Consumer Use
Date Published: 03/25/2025
Desc: Kelly White brand smokeless tobacco and nicotine delivery products for consumer use
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
THE SNUS FACTORY
Date Published : 03/11/2025
Box 2180
, Lidkoping,
Vastra Gotalands Lan SWEDEN
98 - - A -- Tobacco Products, For Consumer Use
Date Published: 03/11/2025
Desc: NICO brand smokeless tobacco and nicotine delivery products for consumer use
THE SNUS FACTPRY
Date Published : 03/11/2025
Box 107
, Odeshog,
Ostergotlands Lan SWEDEN
98 - - A -- Tobacco Products, For Consumer Use
Date Published: 03/11/2025
Desc: NICO brand smokeless tobacco and nicotine delivery products for consumer use