Violation Code: 3889
FDA Violation
Charge Code: TPADFALSE
Violation Details
- Violation Code (ASC ID)
- 3889
- Charge Code
- TPADFALSE
- 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 appears to be misbranded under section 903(a)(7) in that it appears that its advertising is false or misleading.
- Legal Section
- 903(a)(7)(A); 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Skruf Snus Ab | Stockholm, SWEDEN | 2 |
| 2 | Shenzhen Smoore Technology Limited | Shenzhen, CHINA | 1 |
| 3 | SHENZHEN IMPETUS TECHNOLOGY CO L | Shenzhen, CHINA | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 2/16/2024 | SNUS 98CBA06 | Skruf Snus AbSWEDEN |
| 2/5/2024 | SNUS 98CCA06 | Skruf Snus AbSWEDEN |
| 1/6/2022 | ELECTRONIC NICOTINE DELIVERY SYSTEM, NEC 98LAA99 | |
| 9/8/2020 | E-CIGARETTE, KIT 98LAA02 |
Frequently Asked Questions
What is FDA violation code 3889?
3889 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 appears to be misbranded under section 903(a)(7) in that it appears that its advertising is false or misleading.". This violation is based on 903(a)(7)(A); 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3889?
According to FDA Import Refusal data, there have been 4 import refusals issued for violation code 3889, affecting 3 unique firms.
When was the most recent refusal for violation 3889?
The most recent import refusal for violation 3889 was on February 16, 2024.
What products are commonly refused for violation 3889?
Products commonly refused under violation 3889 include: SNUS, ELECTRONIC NICOTINE DELIVERY SYSTEM, NEC, E-CIGARETTE, KIT. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3889?
Violation code 3889 is based on 903(a)(7)(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.