Violation Code: 3781
FDA Violation
Charge Code: TPNOWRNLBL
Violation Details
- Violation Code (ASC ID)
- 3781
- Charge Code
- TPNOWRNLBL
- Description
- 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).
- Legal Section
- 903(a)(8)(B)(i);801(a)(3);MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Skruf Snus Ab | Stockholm, SWEDEN | 94 |
| 2 | Swedish Match North Europe | Stockholm, SWEDEN | 94 |
| 3 | Make Webo | Lidkoping, SWEDEN | 49 |
| 4 | Swedish Match Ab | Stockholm, SWEDEN | 33 |
| 5 | Dong Guan Best of Best Technologies Co., Ltd | Dongguan City, CHINA | 26 |
| 6 | Snus Till Vaerlden | Molndal, SWEDEN | 23 |
| 7 | Gn Tobacco Sweden Ab | Bispgarden, SWEDEN | 19 |
| 8 | Gotlandssnus | Romakloster, SWEDEN | 14 |
| 9 | Mysnus Ab | Arlandastad, SWEDEN | 14 |
| 10 | Swedish Match Ab | Stockholm, DENMARK | 14 |
| 11 | SHENZHEN AVIDVAPE TECHNOLOGY CO | Shenzhen, CHINA | 13 |
| 12 | J WELL FRANCE | Paris, FRANCE | 4 |
| 13 | Finta Inc.,S.A. | Colonpanama, PANAMA | 4 |
| 14 | Fiedler & Lundgren Ab | Malmo, SWEDEN | 4 |
| 15 | Skruf Snus Ab | Savsjo, SWEDEN | 3 |
| 16 | E-Commerce Direct | Grebbestad, SWEDEN | 3 |
| 17 | Swedish Match Ab | Stockholm, SWEDEN | 3 |
| 18 | Wilsons And Co Sharrow Ltd | Sheffieldsheffield, UNITED KIN | 2 |
| 19 | Kishore Zarda Factory | Varansi, INDIA | 2 |
| 20 | Korea Ginseng Corp | Daejeon, SOUTH KORE | 2 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 8/20/2025 | CIGARETTES 98BAA01 | Korea Ginseng CorpSOUTH KORE |
| 8/20/2025 | CIGARETTES 98BAA01 | Korea Ginseng CorpSOUTH KORE |
| 8/20/2025 | CIGARETTES 98BBA01 | |
| 7/15/2025 | NICOTINE POUCH 98NCA11 | Swedish Match AbSWEDEN |
| 7/15/2025 | NICOTINE POUCH 98NCA11 | Swedish Match AbSWEDEN |
| 7/3/2025 | NICOTINE POUCH 98NCA11 | Swedish Match AbSWEDEN |
| 6/24/2025 | NICOTINE POUCH 98NCA11 | NICOTOBACCOPOLAND |
| 6/12/2025 | SNUS 98CCA06 | Swedish Match AbDENMARK |
| 5/23/2025 | NICOTINE POUCH 98NCA11 | MAKE WEBO ABSWEDEN |
| 5/20/2025 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | Luna CorporatePOLAND |
| 5/20/2025 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | Swedish Match AbSWEDEN |
| 5/20/2025 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | Swedish Match AbSWEDEN |
| 5/20/2025 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | Swedish Match AbSWEDEN |
| 5/20/2025 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | Swedish Match AbSWEDEN |
| 5/13/2025 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | PREMIUM POUCH FINLAND OYFINLAND |
Frequently Asked Questions
What is FDA violation code 3781?
3781 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 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).". This violation is based on 903(a)(8)(B)(i);801(a)(3);MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3781?
According to FDA Import Refusal data, there have been 452 import refusals issued for violation code 3781, affecting 49 unique firms.
When was the most recent refusal for violation 3781?
The most recent import refusal for violation 3781 was on August 20, 2025.
What products are commonly refused for violation 3781?
Products commonly refused under violation 3781 include: CIGARETTES, NICOTINE POUCH. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3781?
Violation code 3781 is based on 903(a)(8)(B)(i);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.