Swedish Match Denmark
⚠️ Moderate Risk
FEI: 3009758417 • Silkeborg, Midtjylland • SWEDEN
FEI Number
3009758417
Location
Silkeborg, Midtjylland
Country
SWEDENAddress
Georg Jensens Vej 7, , Silkeborg, Midtjylland, Sweden
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
TPLKUSSLLB
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.
TPLACKFIRM
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.
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 FDA has found to be adulterated under section 902(6)(A) of the FD&C Act in that it does not have an FDA marketing order in effect under section 910(c)(1)(A)(i) of the FD&C Act.
TP NO SE
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 FDA has found to be misbranded under section 903(a)(6) of the FD&C Act in that a notice or other information respecting it was not provided as required by section 905(j).
TPNOWRNLBL
This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that it is a tobacco product which appears to be misbranded under section 903(a)(8)(B)(i) and 903(a)(1) because its package label does not include a brief statement of the relevant warnings (i.e., one of the four warnings required by section 3 of the Comprehensive Smokeless Tobacco Health Education Act).
TPNICWARN
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)(7)(B) in that it is sold or distributed in violation of regulations prescribed under 906(d), namely its package fails to bear the required warning statement "WARNING: This product contains nicotine. Nicotine is an addictive chemical." Or if applicable the required statement "This product is made from tobacco."
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/1/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 4/22/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 4/9/2025 | 98NAA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 2/18/2025 | 98NAA99NICOTINE DELIVERY PRODUCT, NEC | Division of Northeast Imports (DNEI) | |
| 1/31/2025 | 98NCA99NICOTINE DELIVERY PRODUCT, NEC | 3854TPLKUSSLLB | Division of Southeast Imports (DSEI) |
| 1/27/2025 | 98CCA06SNUS | Division of Southeast Imports (DSEI) | |
| 1/24/2025 | 98CAA06SNUS | Division of Southeast Imports (DSEI) | |
| 1/10/2025 | 98CAA06SNUS | Division of Northeast Imports (DNEI) | |
| 8/22/2024 | 98CCA06SNUS | Division of Northeast Imports (DNEI) | |
| 2/26/2024 | 98CAA06SNUS | 3854TPLKUSSLLB | Division of Northeast Imports (DNEI) |
| 2/4/2015 | 98C06SNUS | 3781TPNOWRNLBL | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Swedish Match Denmark's FDA import refusal history?
Swedish Match Denmark (FEI: 3009758417) has 11 FDA import refusal record(s) in our database, spanning from 2/4/2015 to 12/1/2025.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Swedish Match Denmark's FEI number is 3009758417.
What types of violations has Swedish Match Denmark received?
Swedish Match Denmark has been cited for 6 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Swedish Match Denmark come from?
All FDA import refusal data for Swedish Match Denmark is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.