Violation Code: 3842
FDA Violation
Charge Code: TP NO PMTA
Violation Details
- Violation Code (ASC ID)
- 3842
- Charge Code
- TP NO PMTA
- Description
- 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.
- Legal Section
- 801(a)(3);902(6)(A);ADULTERATION
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | BRITISH AMERICAN TOBACCO | Malmo, SWEDEN | 897 |
| 2 | Swedish Match Ab | Stockholm, SWEDEN | 613 |
| 3 | APRES NICOTINE AB | Vetlanda, SWEDEN | 561 |
| 4 | HABIT FACTORY IN SWEDEN AB | Arsta, SWEDEN | 458 |
| 5 | NGP TOBACCO APS | Norager, DENMARK | 333 |
| 6 | LIW INNOVATION AB | Hokerum, SWEDEN | 276 |
| 7 | YOIK AB | Gemla, SWEDEN | 272 |
| 8 | Skruf Snus Ab | Stockholm, SWEDEN | 270 |
| 9 | ANOTHER SNUS FACTORY STOCKHOLM AB | Stockholm, SWEDEN | 255 |
| 10 | Fiedler & Lundgren Ab | Malmo, SWEDEN | 241 |
| 11 | Luna Corporate | Suchy Las, POLAND | 238 |
| 12 | CBI SRO | Teplice, CZECH REPU | 215 |
| 13 | CHAINPOP AB | Goteborg, SWEDEN | 204 |
| 14 | GUANGDONG TOULANG INTERNATIONALLOGISTICS CO., LTD | Shenzhen, CHINA | 180 |
| 15 | Swedish Match Ab | Stockholm, DENMARK | 166 |
| 16 | HELIX SWEDEN AB | Helsingborg, SWEDEN | 163 |
| 17 | 77 POUCHES | Cracow, POLAND | 147 |
| 18 | 77 GROUP SP. Z O.O. | Suchy Las, POLAND | 114 |
| 19 | MICROZERO AB | Goteborg, SWEDEN | 113 |
| 20 | SHENZHEN JILIAN INTERNATIONAL FREIGHT FORWARDING C | Shenzhen, CHINA | 103 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 1/22/2026 | NICOTINE POUCH 98NCA11 | Skruf Snus AbSWEDEN |
| 1/22/2026 | NICOTINE POUCH 98NAA11 | PHILIP MORRIS ABSWEDEN |
| 1/22/2026 | NICOTINE POUCH 98NCA11 | LIW INNOVATION ABSWEDEN |
| 1/22/2026 | NICOTINE POUCH 98NBA11 | NGP TOBACCO APSDENMARK |
| 1/21/2026 | NICOTINE POUCH 98NCA11 | PHILIP MORRIS ABSWEDEN |
| 1/21/2026 | NICOTINE POUCH 98NCA11 | PHILIP MORRIS ABSWEDEN |
| 1/21/2026 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | ORDERUP SWEDEN ABSWEDEN |
| 1/21/2026 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | |
| 1/21/2026 | NICOTINE POUCH 98NCA11 | NICOBROS OUESTONIA |
| 1/20/2026 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | LIW INNOVATION ABSWEDEN |
| 1/18/2026 | NICOTINE POUCH 98NCA11 | HELIX SWEDEN ABSWEDEN |
| 1/18/2026 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | LIW INNOVATION ABSWEDEN |
| 1/18/2026 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | HELIX SWEDEN ABSWEDEN |
| 1/16/2026 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | PHILIP MORRIS ABSWEDEN |
| 1/16/2026 | NICOTINE POUCH 98NCA11 | Phillip Morris Products SASWITZERLAN |
Frequently Asked Questions
What is FDA violation code 3842?
3842 is an FDA violation code that indicates: "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.". This violation is based on 801(a)(3);902(6)(A);ADULTERATION of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3842?
According to FDA Import Refusal data, there have been 10145 import refusals issued for violation code 3842, affecting 439 unique firms.
When was the most recent refusal for violation 3842?
The most recent import refusal for violation 3842 was on January 22, 2026.
What products are commonly refused for violation 3842?
Products commonly refused under violation 3842 include: NICOTINE POUCH. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3842?
Violation code 3842 is based on 801(a)(3);902(6)(A);ADULTERATION 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.