Violation Code: 3859
FDA Violation
Charge Code: TPFDA4BLBL
Violation Details
- Violation Code (ASC ID)
- 3859
- Charge Code
- TPFDA4BLBL
- 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 903(a)(1) in that the label or labeling is false or misleading because it conveys that the product is safe or less harmful by virtue of its compliance with regulatory requirements set by the FDA.
- Legal Section
- 903(a)(1); 801(a)(3); 301(tt)(4)(B); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Dong Guan Best of Best Technologies Co., Ltd | Dongguan City, CHINA | 25 |
| 2 | INAWERA DOT COM SP ZOO | Wolka, POLAND | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 3/14/2025 | E-CIGARETTE 98LCA01 | |
| 3/14/2025 | E-CIGARETTE 98LCA01 | |
| 3/14/2025 | E-CIGARETTE 98LCA01 | |
| 3/14/2025 | E-CIGARETTE 98LCA01 | |
| 3/14/2025 | E-CIGARETTE 98LCA01 | |
| 3/14/2025 | E-CIGARETTE 98LCA01 | |
| 3/14/2025 | E-CIGARETTE 98LCA01 | |
| 3/14/2025 | E-CIGARETTE 98LCA01 | |
| 3/14/2025 | E-CIGARETTE 98LCA01 | |
| 3/14/2025 | E-CIGARETTE 98LCA01 | |
| 3/14/2025 | E-CIGARETTE 98LCA01 | |
| 3/14/2025 | E-CIGARETTE 98LCA01 | |
| 3/14/2025 | E-CIGARETTE 98LCA01 | |
| 3/14/2025 | E-CIGARETTE 98LCA01 | |
| 3/14/2025 | E-CIGARETTE 98LCA01 |
Frequently Asked Questions
What is FDA violation code 3859?
3859 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 903(a)(1) in that the label or labeling is false or misleading because it conveys that the product is safe or less harmful by virtue of its compliance with regulatory requirements set by the FDA.". This violation is based on 903(a)(1); 801(a)(3); 301(tt)(4)(B); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3859?
According to FDA Import Refusal data, there have been 26 import refusals issued for violation code 3859, affecting 2 unique firms.
When was the most recent refusal for violation 3859?
The most recent import refusal for violation 3859 was on March 14, 2025.
What products are commonly refused for violation 3859?
Products commonly refused under violation 3859 include: E-CIGARETTE. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3859?
Violation code 3859 is based on 903(a)(1); 801(a)(3); 301(tt)(4)(B); 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.