Violation Code: 3851
FDA Violation
Charge Code: TPLACKFIRM
Violation Details
- Violation Code (ASC ID)
- 3851
- Charge Code
- TPLACKFIRM
- Description
- 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.
- Legal Section
- 903(a)(2)(A); 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Swedish Match Ab | Stockholm, SWEDEN | 349 |
| 2 | CBI SRO | Teplice, CZECH REPU | 97 |
| 3 | Swedish Match Ab | Stockholm, DENMARK | 89 |
| 4 | Fiedler & Lundgren Ab | Malmo, SWEDEN | 80 |
| 5 | Skruf Snus Ab | Stockholm, SWEDEN | 71 |
| 6 | Dongguan Xingda Electronic Technology, Co., LTD | Dongguan, CHINA | 70 |
| 7 | Gn Tobacco Sweden Ab | Bispgarden, SWEDEN | 65 |
| 8 | NGP TOBACCO APS | Norager, DENMARK | 52 |
| 9 | Swedish Match North Europe | Stockholm, SWEDEN | 37 |
| 10 | DONGGUAN KA MEI INDUSTRIAL CO. LTD. | Guangdong Province, CHINA | 30 |
| 11 | DONGGUAN ANDAOER TECHNOLOGY CO.,LTD | Dongguan, CHINA | 27 |
| 12 | Dong Guan Best of Best Technologies Co., Ltd | Dongguan City, CHINA | 25 |
| 13 | SHENZHEN JILIAN INTERNATIONAL FREIGHT FORWARDING C | Shenzhen, CHINA | 25 |
| 14 | SHENZHEN OVANVAPE TECHNOLOGY CO | Shenzhen, CHINA | 19 |
| 15 | BFL METAL PRODUCTION | Foshan, CHINA | 18 |
| 16 | XQS INTERNATIONAL AB | Borlange, SWEDEN | 18 |
| 17 | Unknown | Unknown, CHINA | 14 |
| 18 | CHAPMAN SUPPLY CHAIN LIMITED | Hong Kong, HONG KONG | 13 |
| 19 | AEON GMBH | Friedrichsdorf, GERMANY | 12 |
| 20 | Shenzhen Yibo Technology Co., Ltd. | Shenzhen, CHINA | 12 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 1/14/2026 | NICOTINE POUCH 98NBA11 | CBI SROCZECH REPU |
| 1/14/2026 | NICOTINE POUCH 98NCA11 | CBI SROCZECH REPU |
| 1/14/2026 | NICOTINE POUCH 98NCA11 | CBI SROCZECH REPU |
| 1/14/2026 | NICOTINE POUCH 98NBA11 | CBI SROCZECH REPU |
| 1/14/2026 | NICOTINE POUCH 98NCA11 | HELIX SWEDEN ABSWEDEN |
| 1/14/2026 | NICOTINE POUCH 98NBA11 | Swedish Match AbSWEDEN |
| 1/14/2026 | NICOTINE POUCH 98NBA11 | Swedish Match AbSWEDEN |
| 1/14/2026 | NICOTINE POUCH 98NCA11 | NGP TOBACCO APSDENMARK |
| 1/14/2026 | NICOTINE POUCH 98NCA11 | CBI SROCZECH REPU |
| 1/14/2026 | NICOTINE POUCH 98NCA11 | CBI SROCZECH REPU |
| 1/14/2026 | NICOTINE POUCH 98NCA11 | CBI SROCZECH REPU |
| 1/14/2026 | NICOTINE POUCH 98NCA11 | CBI SROCZECH REPU |
| 1/14/2026 | NICOTINE POUCH 98NCA11 | NGP TOBACCO APSDENMARK |
| 1/14/2026 | NICOTINE POUCH 98NBA11 | CBI SROCZECH REPU |
| 1/14/2026 | NICOTINE POUCH 98NBA11 | CBI SROCZECH REPU |
Frequently Asked Questions
What is FDA violation code 3851?
3851 is an FDA violation code that indicates: "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.". This violation is based on 903(a)(2)(A); 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3851?
According to FDA Import Refusal data, there have been 1430 import refusals issued for violation code 3851, affecting 156 unique firms.
When was the most recent refusal for violation 3851?
The most recent import refusal for violation 3851 was on January 14, 2026.
What products are commonly refused for violation 3851?
Products commonly refused under violation 3851 include: NICOTINE POUCH. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3851?
Violation code 3851 is based on 903(a)(2)(A); 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.