Violation Code: 3853
FDA Violation
Charge Code: TPLKDOMFOR
Violation Details
- Violation Code (ASC ID)
- 3853
- Charge Code
- TPLKDOMFOR
- 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 in package form that appears to be misbranded under section 903(a)(2)(C) in that the label does not provide an accurate statement of the percentage of the tobacco used in the product that is domestically grown tobacco and the percentage foreign grown tobacco.
- Legal Section
- 903(a)(2)(C); 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Swedish Match Ab | Stockholm, DENMARK | 1 |
| 2 | Gn Tobacco Sweden Ab | Bispgarden, SWEDEN | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 5/28/2025 | SNUS 98CBA06 | Gn Tobacco Sweden AbSWEDEN |
| 4/9/2025 | NICOTINE POUCH 98NCA11 | Swedish Match AbDENMARK |
Frequently Asked Questions
What is FDA violation code 3853?
3853 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 in package form that appears to be misbranded under section 903(a)(2)(C) in that the label does not provide an accurate statement of the percentage of the tobacco used in the product that is domestically grown tobacco and the percentage foreign grown tobacco.". This violation is based on 903(a)(2)(C); 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3853?
According to FDA Import Refusal data, there have been 2 import refusals issued for violation code 3853, affecting 2 unique firms.
When was the most recent refusal for violation 3853?
The most recent import refusal for violation 3853 was on May 28, 2025.
What products are commonly refused for violation 3853?
Products commonly refused under violation 3853 include: SNUS, NICOTINE POUCH. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3853?
Violation code 3853 is based on 903(a)(2)(C); 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.