JTI SWEDEN AB
⚠️ High Risk
FEI: 3014745624 • Stockholm, Stockholms Lan • SWEDEN
FEI Number
3014745624
Location
Stockholm, Stockholms Lan
Country
SWEDENAddress
Sveavagen 53, , Stockholm, Stockholms Lan, Sweden
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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.
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.
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).
TP FLAVOR
This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that it is, or purports to be or is represented as, a tobacco product that is subject to a tobacco product standard established under section 907, and violates 907 (a) (1) (A) in that the article appears to contain, as a constituent or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, that is a characterizing flavor of the tobacco product or tobacco smoke.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/27/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 9/26/2025 | 98NBA11NICOTINE POUCH | 3842TP NO PMTA | Division of Southeast Imports (DSEI) |
| 9/26/2025 | 98NCA11NICOTINE POUCH | 3842TP NO PMTA | Division of Southeast Imports (DSEI) |
| 9/26/2025 | 98NCA11NICOTINE POUCH | 3842TP NO PMTA | Division of Southeast Imports (DSEI) |
| 9/23/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 9/23/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 9/23/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 9/18/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 9/18/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 9/11/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 9/10/2025 | 98NCA11NICOTINE POUCH | 3842TP NO PMTA | Division of Southeast Imports (DSEI) |
| 9/4/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 9/4/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 9/4/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 8/29/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 8/29/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 8/29/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 8/27/2025 | 98NCA11NICOTINE POUCH | 3854TPLKUSSLLB | Division of Southeast Imports (DSEI) |
| 8/27/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 8/26/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 8/26/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 8/26/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 8/25/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 8/25/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 8/25/2025 | 98NEA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 8/25/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 8/22/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 8/22/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 8/22/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 8/22/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 8/21/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 8/21/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 8/21/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 8/13/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 8/8/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 8/6/2025 | 98NCA11NICOTINE POUCH | 3854TPLKUSSLLB | Division of Southeast Imports (DSEI) |
| 8/5/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is JTI SWEDEN AB's FDA import refusal history?
JTI SWEDEN AB (FEI: 3014745624) has 37 FDA import refusal record(s) in our database, spanning from 8/5/2025 to 10/27/2025.
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. JTI SWEDEN AB's FEI number is 3014745624.
What types of violations has JTI SWEDEN AB received?
JTI SWEDEN AB has been cited for 5 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 JTI SWEDEN AB come from?
All FDA import refusal data for JTI SWEDEN AB 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.