Violation Code: 3854
FDA Violation
Charge Code: TPLKUSSLLB
Violation Details
- Violation Code (ASC ID)
- 3854
- Charge Code
- TPLKUSSLLB
- Description
- 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.
- Legal Section
- 903(a)(2)(D); 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Swedish Match Ab | Stockholm, SWEDEN | 2222 |
| 2 | XQS INTERNATIONAL AB | Borlange, SWEDEN | 786 |
| 3 | NGP TOBACCO APS | Norager, DENMARK | 341 |
| 4 | Swedish Match Ab | Stockholm, DENMARK | 339 |
| 5 | Swedish Match North Europe | Stockholm, SWEDEN | 305 |
| 6 | CBI SRO | Teplice, CZECH REPU | 262 |
| 7 | Gn Tobacco Sweden Ab | Bispgarden, SWEDEN | 170 |
| 8 | Fiedler & Lundgren Ab | Malmo, SWEDEN | 165 |
| 9 | Skruf Snus Ab | Stockholm, SWEDEN | 157 |
| 10 | APRES NICOTINE AB | Vetlanda, SWEDEN | 137 |
| 11 | NGP TOBACCO | Aalborg Sv, DENMARK | 93 |
| 12 | BRITISH AMERICAN TOBACCO | Malmo, SWEDEN | 80 |
| 13 | CHAINPOP AB | Goteborg, SWEDEN | 71 |
| 14 | YOIK AB | Gemla, SWEDEN | 67 |
| 15 | LIW INNOVATION AB | Hokerum, SWEDEN | 67 |
| 16 | HELIX SWEDEN AB | Helsingborg, SWEDEN | 60 |
| 17 | ACTIV SP ZOO | Warsaw, POLAND | 57 |
| 18 | Dongguan Xingda Electronic Technology, Co., LTD | Dongguan, CHINA | 56 |
| 19 | GLOBAL SNUS UAB | Vilnius, LITHUANIA | 48 |
| 20 | THE SNUS BROTHERS | Odeshog, SWEDEN | 44 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/30/2025 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | BRITISH AMERICAN TOBACCOSWEDEN |
| 12/30/2025 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | BRITISH AMERICAN TOBACCOSWEDEN |
| 12/29/2025 | SNUS 98CCA06 | VIKA SVENSSON GOTHENBURGSWEDEN |
| 12/29/2025 | SNUS 98CCA06 | VIKA SVENSSON GOTHENBURGSWEDEN |
| 12/23/2025 | NICOTINE POUCH 98NCA11 | CBI SROCZECH REPU |
| 12/19/2025 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | |
| 12/19/2025 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | XQS INTERNATIONAL ABSWEDEN |
| 12/19/2025 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | XQS INTERNATIONAL ABSWEDEN |
| 12/19/2025 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | |
| 12/19/2025 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | CHAINPOP ABSWEDEN |
| 12/19/2025 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | CHAINPOP ABSWEDEN |
| 12/19/2025 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | CHAINPOP ABSWEDEN |
| 12/19/2025 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | HELIX SWEDEN ABSWEDEN |
| 12/18/2025 | NICOTINE POUCH 98NBA11 | NGP TOBACCO APSDENMARK |
| 12/18/2025 | NICOTINE POUCH 98NBA11 | NGP TOBACCO APSDENMARK |
Frequently Asked Questions
What is FDA violation code 3854?
3854 is an FDA violation code that indicates: "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.". This violation is based on 903(a)(2)(D); 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3854?
According to FDA Import Refusal data, there have been 6752 import refusals issued for violation code 3854, affecting 265 unique firms.
When was the most recent refusal for violation 3854?
The most recent import refusal for violation 3854 was on December 30, 2025.
What products are commonly refused for violation 3854?
Products commonly refused under violation 3854 include: NICOTINE DELIVERY PRODUCT, NEC, SNUS, NICOTINE POUCH. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3854?
Violation code 3854 is based on 903(a)(2)(D); 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This section of the law establishes requirements that imported products must meet to be allowed entry into the United States.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.