Violation Code: 3852
FDA Violation
Charge Code: TPLACKSNC
Violation Details
- Violation Code (ASC ID)
- 3852
- Charge Code
- TPLACKSNC
- 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)(B) of the FD&C Act in that the label does not provide an accurate statement of the quantity of contents in terms of weight, measure or numerical count.
- Legal Section
- 903(a)(2)(B); 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Dongguan Xingda Electronic Technology, Co., LTD | Dongguan, CHINA | 70 |
| 2 | Swedish Match Ab | Stockholm, SWEDEN | 52 |
| 3 | BFL METAL PRODUCTION | Foshan, CHINA | 18 |
| 4 | Skruf Snus Ab | Stockholm, SWEDEN | 13 |
| 5 | Shenzhen Yibo Technology Co., Ltd. | Shenzhen, CHINA | 12 |
| 6 | Shenzhen Fango Technology Co | Shajing Guangdong, CHINA | 10 |
| 7 | SHENZHEN XUEWU INTERNATIONAL TECHNOLOGY CO., LTD | Shenzhen, CHINA | 9 |
| 8 | SHENZHEN SHENG'ANLI TRADING CO.,LTD | Shenzhen, CHINA | 7 |
| 9 | Fiedler & Lundgren Ab | Malmo, SWEDEN | 6 |
| 10 | CBI SRO | Teplice, CZECH REPU | 6 |
| 11 | NGP TOBACCO APS | Norager, DENMARK | 6 |
| 12 | Rsl Blunt Productions S.A. | Santiago, DOMINICAN | 5 |
| 13 | K K TECHNOLOGY CO. LTD | Shenzhen, CHINA | 5 |
| 14 | 77 POUCHES | Cracow, POLAND | 5 |
| 15 | A&L AROMES ET LIQUIDES | -Bouth On, FRANCE | 5 |
| 16 | Finta Inc.,S.A. | Colonpanama, PANAMA | 3 |
| 17 | XQS INTERNATIONAL AB | Borlange, SWEDEN | 3 |
| 18 | GUANGDONG TOULANG INTERNATIONALLOGISTICS CO., LTD | Shenzhen, CHINA | 2 |
| 19 | ZHONGSHAN HEWO ELECTRONIC TECH CO.,LTD | Zhongshan City, CHINA | 2 |
| 20 | Swedish Match Ab | Stockholm, DENMARK | 2 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/23/2025 | NICOTINE POUCH 98NCA11 | CBI SROCZECH REPU |
| 12/18/2025 | NICOTINE POUCH 98NCA11 | TIN JAR ABSWEDEN |
| 12/18/2025 | NICOTINE POUCH 98NCA11 | KURBITS SNUS ABSWEDEN |
| 12/17/2025 | NICOTINE POUCH 98NCA11 | Swedish Match AbDENMARK |
| 12/9/2025 | NICOTINE POUCH 98NCA11 | JUUL LABS UKUNITED KIN |
| 12/5/2025 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | XQS INTERNATIONAL ABSWEDEN |
| 12/5/2025 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | XQS INTERNATIONAL ABSWEDEN |
| 11/25/2025 | NICOTINE POUCH 98NCA11 | Swedish Match AbSWEDEN |
| 11/25/2025 | NICOTINE POUCH 98NBA11 | Swedish Match AbSWEDEN |
| 11/25/2025 | NICOTINE POUCH 98NBA11 | Swedish Match AbSWEDEN |
| 11/25/2025 | NICOTINE POUCH 98NBA11 | Swedish Match AbSWEDEN |
| 11/25/2025 | NICOTINE POUCH 98NCA11 | NGP TOBACCO APSDENMARK |
| 11/25/2025 | NICOTINE POUCH 98NBA11 | Swedish Match AbSWEDEN |
| 11/25/2025 | NICOTINE POUCH 98NBA11 | Swedish Match AbSWEDEN |
| 11/25/2025 | NICOTINE POUCH 98NBA11 | Swedish Match AbSWEDEN |
Frequently Asked Questions
What is FDA violation code 3852?
3852 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)(B) of the FD&C Act in that the label does not provide an accurate statement of the quantity of contents in terms of weight, measure or numerical count.". This violation is based on 903(a)(2)(B); 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3852?
According to FDA Import Refusal data, there have been 279 import refusals issued for violation code 3852, affecting 55 unique firms.
When was the most recent refusal for violation 3852?
The most recent import refusal for violation 3852 was on December 23, 2025.
What products are commonly refused for violation 3852?
Products commonly refused under violation 3852 include: NICOTINE POUCH. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3852?
Violation code 3852 is based on 903(a)(2)(B); 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.