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Priority review Guidance Amended Final

FDA Import Alert 98-06: New Tobacco Products Detained Without Authorization

FDA Import Alerts

Published February 27th, 2026

Detected March 1st, 2026

Summary

The FDA has updated Import Alert 98-06, which detains new tobacco products lacking required marketing authorization. This revision clarifies guidance and agency contacts, noting that ENDS products are now covered under a separate alert (98-07). Manufacturers and importers must ensure proper authorization to avoid detention.

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What changed

The FDA has amended Import Alert 98-06, "Detention Without Physical Examination of New Tobacco Products, Other Than ENDS, Without Required Marketing Authorization." The revision, dated December 20, 2024, updates guidance and agency contacts, specifically noting that Electronic Nicotine Delivery Systems (ENDS) are now addressed under Import Alert 98-07. The alert reiterates that new tobacco products commercially marketed after February 15, 2007, require premarket review or substantial equivalence findings, and those without authorization are considered adulterated and misbranded.

This alert instructs FDA field personnel to detain new tobacco products (excluding ENDS) that lack the necessary marketing authorization. Companies seeking to remove their products from this detention list must provide information demonstrating resolution of the violation conditions to the FDA via email at Importalerts2@fda.hhs.gov. The FDA emphasizes that this alert serves as guidance to field personnel and does not create new rights or bind the agency or the public. Questions regarding import operations should be directed to OII/DIO, while tobacco product-specific questions should go to the Center for Tobacco Products, Office of Compliance.

What to do next

Review Import Alert 98-06 for specific requirements regarding new tobacco products.
Ensure all imported tobacco products (excluding ENDS) have the required FDA marketing authorization.
Contact the FDA at Importalerts2@fda.hhs.gov to request removal from detention if applicable.

Penalties

Products may be detained without physical examination.

Source document (simplified)

Home
Import Program
Import Alerts
Imports Alerts by Number (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: 02/27/2026 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.

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.

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

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 NGP TOBACCO Date Published : 01/27/2026 Karlskogavej 6a
, Aalborg Sv,
Nordjylland DENMARK 98 - - A -- Tobacco Products, For Consumer Use
Date Published: 01/27/2026

Desc: GLITCH brand nicotine pouches Notes: TP NO PMTA
TP NO SE NGP TOBACCO APS Date Published : 01/27/2026 Industriparken 35
, Norager,
Nordjylland DENMARK 98 - - A -- Tobacco Products, For Consumer Use
Date Published: 01/27/2026

Desc: GLITCH brand nicotine pouches Notes: TP NO PMTA
TP NO SE 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 TROPICAL HOUSE OF POUCHES Date Published : 11/17/2025 8960 Randers
, Danskes,
DENMARK 98 - - A -- Tobacco Products, For Consumer Use
Date Published: 11/17/2025

Desc: Blow brand nicotine delivery products for consumer use Notes: TP NO PMTA
TP NO SE

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 NICOBROS OU Date Published : 11/04/2025 Paevalille Tn 6-13
, Tallinn,
Harju maakond ESTONIA 98 - - A -- Tobacco Products, For Consumer Use
Date Published: 11/04/2025

Desc: CHAPO smokeless tobacco and nicotine delivery products for consumer use NICOTECH OU Date Published : 10/23/2025 Suurvalja Tee 5
, Harjumaa,
ESTONIA 98 - - A -- Tobacco Products, For Consumer Use
Date Published: 02/19/2026

Desc: EZY brand nicotine delivery products for consumer use 98 - - A -- Tobacco Products, For Consumer Use
Date Published: 10/23/2025

Desc: Zeus brand nicotine delivery products for consumer use POUCHPOINT O Date Published : 01/27/2026 Kivimurru Tn 18
, Tallinn,
Harju maakond ESTONIA 98 - - A -- Tobacco Products, For Consumer Use
Date Published: 01/27/2026

Desc: GLITCH brand nicotine pouches Notes: TP NO PMTA
TP NO SE

ICELAND

NICOPODS EHF Date Published : 11/10/2025 Idngardar 4a
, Sudurnesjabar,
ICELAND 98 - - A -- Tobacco Products, For Consumer Use
Date Published: 11/10/2025

Desc: Ice brand 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 ICEBERG NICOTINE Date Published : 12/01/2025 Ul. Grzybowska 87
, Warsaw,
Mazowieckie POLAND 98 - - A -- Tobacco Products, For Consumer Use
Date Published: 12/01/2025

Desc: Iceberg brand 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 NICOTOBACCO Date Published : 10/22/2025 Sokolowska 47a
, Sokolow,
POLAND 66 B - - 44 Nicotine Delivery System
Date Published: 11/03/2025

Desc: All nicotine delivery products for consumer use containing the brand name; CUBA Notes: Problem(s):
TP NO PMTA
TP NO SE 98 - - A -- Tobacco Products, For Consumer Use
Date Published: 11/03/2025

Desc: All nicotine delivery products for consumer use containing the brand name; CUBA Notes: Problem(s):
TP NO PMTA
TP NO SE 98 - - B -- Tobacco Products, For Further Manufacturing
Date Published: 11/03/2025

Desc: All nicotine delivery products for consumer use containing the brand name; CUBA Notes: Problem(s):
TP NO PMTA
TP NO SE

SWEDEN

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 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 APRES NICOTINE AB Date Published : 09/03/2025 Nydalavagen 3
, Vetlanda,
Jonkopings Lan SWEDEN 98 - - - -- Tobacco Products
Date Published: 09/03/2025

Desc: All nicotine delivery products for consumer use containing the brand name; Apres Notes: Problem(s):
TP NO PMTA
TP NO SE BAS NORDIC AB Date Published : 10/22/2025 Bariumgatan 1
, Malmo,
Skane Lan SWEDEN 98 - - A -- Tobacco Products, For Consumer Use
Date Published: 10/22/2025

Desc: All nicotine delivery products for consumer use containing the brand name; XO 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 CHAINPOP AB Date Published : 10/07/2025 Skummjolksgatan 14
, Goteborg,
Vastra Gotalands Lan SWEDEN 98 - - A -- Tobacco Products, For Consumer Use
Date Published: 10/07/2025

Desc: smokeless tobacco and nicotine delivery products for consumer use containing the brand name; CHAINPOP CHAINPOP AB Date Published : 10/07/2025 Skummjolksgatan 14
, Goteborg,
Vastra Gotalands Lan SWEDEN 98 - - A -- Tobacco Products, For Consumer Use
Date Published: 10/07/2025

Desc: smokeless tobacco and nicotine delivery products for consumer use containing the brand name; CHAINPOP Chainpop Sweden AB Date Published : 02/04/2026 Kungsholms Strand 175/112 48
, Stockholm,
Stockholms Lan SWEDEN 98 - - A -- Tobacco Products, For Consumer Use
Date Published: 02/04/2026

Desc: smokeless tobacco and nicotine delivery products for consumer use containing the brand name; CHAINPOP 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 - - A -- Tobacco Products, For Consumer Use
Date Published: 03/17/2025

Desc: FIX brand smokeless tobacco and nicotine delivery products for consumer use HABIT FACTORY IN SWEDEN AB Date Published : 10/24/2024 Segersbyvagen 4
, Norsborg,
Stockholms Lan SWEDEN 98 - - A -- Tobacco Products, For Consumer Use
Date Published: 03/17/2025

Desc: FIX brand smokeless tobacco and nicotine delivery products for consumer use HELIX SWEDEN AB Date Published : 10/21/2025 Florettgatan 19
, Helsingborg,
Skane Lan SWEDEN 98 - - A -- Tobacco Products, For Consumer Use
Date Published: 10/21/2025

Desc: FUMI brand smokeless tobacco and nicotine delivery products for consumer 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 LIW INNOVATION AB Date Published : 09/15/2025 Stationsvagen 11
, Hokerum,
Vastra Gotalands Lan SWEDEN 98 - - A -- Tobacco Products, For Consumer Use
Date Published: 09/15/2025

Desc: All smokeless tobacco and nicotine delivery products for consumer use containing the brand name; XPCT MICROZERO AB Date Published : 07/24/2025 Hildedalsgatan 172
, Goteborg,
Vastra Gotalands Lan SWEDEN 66 B - - 44 Nicotine Delivery System
Date Published: 07/24/2025

Desc: ZIXS brand smokeless tobacco and nicotine delivery products Notes: Problem(s);
TP NO PMTA
TP NO SE 98 - - A -- Tobacco Products, For Consumer Use
Date Published: 07/24/2025

Desc: ZIXS brand smokeless tobacco and nicotine delivery products Notes: Problem(s);
TP NO PMTA
TP NO SE NORDIC BRANDS Date Published : 02/12/2026 Ab Strandvagen
, Lidkoping,
SWEDEN 98 - - A -- Tobacco Products, For Consumer Use
Date Published: 02/12/2026

Desc: VILD brand nicotine pouches Notes: TP NO PMTA
TP NO SE SILVERTON AB Date Published : 02/27/2026 Saterigatan 25
, Goteborg,
Vastra Gotalands Lan SWEDEN 98 - - A -- Tobacco Products, For Consumer Use
Date Published: 02/27/2026

Desc: White Gold Brand Nicotine Pouches SILVERTON AB Date Published : 02/27/2026 Sveavagen 44
, Stockholm,
Stockholms Lan SWEDEN 98 - - A -- Tobacco Products, For Consumer Use
Date Published: 02/27/2026

Desc: White Gold Brand Nicotine Pouches 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 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 Swedish Match Ab Date Published : 04/23/2025 Swedish Match North Europe Ab , Sveavagen 44 Stockholm
, Stockholm,
Stockholms Lan SWEDEN 98 - - A -- Tobacco Products, For Consumer Use
Date Published: 04/23/2025

Desc: Volt smokeless tobacco and nicotine delivery products 98[][]A[] Swedish Match North Europe Date Published : 04/23/2025 Swedish Match North Europe Ab , Maria Skolgata 83
, Stockholm,
Stockholms Lan SWEDEN 98 - - A -- Tobacco Products, For Consumer Use
Date Published: 04/23/2025

Desc: Volt smokeless tobacco and nicotine delivery products 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 YOIK AB Date Published : 07/21/2025 N 136, 355 99
, Gemla,
SWEDEN 98 - - A -- Tobacco Products, For Consumer Use
Date Published: 07/21/2025

Desc: All Helwit Nicotine Pouches

UNITED KINGDOM

TRIDOTS UK Date Published : 01/16/2026 65 London Wall
, London,
LND UNITED KINGDOM 98 - - A -- Tobacco Products, For Consumer Use
Date Published: 01/16/2026

Desc: SNOWMAN brand nicotine pouches Notes: TP NO PMTA
TP NO SE