Violation Code: 3894
FDA Violation
Charge Code: TPNICWARN
Violation Details
- Violation Code (ASC ID)
- 3894
- Charge Code
- TPNICWARN
- 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)(B) in that it is sold or distributed in violation of regulations prescribed under 906(d), namely its package fails to bear the required warning statement "WARNING: This product contains nicotine. Nicotine is an addictive chemical." Or if applicable the required statement "This product is made from tobacco."
- Legal Section
- 903(a)(7)(B); 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Beijing Shiqiao Bio-pharmaceutical Co., LTD | Beijing, CHINA | 16 |
| 2 | Dongguan Xingda Electronic Technology, Co., LTD | Dongguan, CHINA | 16 |
| 3 | ANOTHER SNUS FACTORY STOCKHOLM AB | Stockholm, SWEDEN | 11 |
| 4 | HUAZHIHENG TECHNOLOGY CO., LTD(SHENZHEN) | Guangdong, CHINA | 10 |
| 5 | SHENZHEN XUEWU INTERNATIONAL TECHNOLOGY CO., LTD | Shenzhen, CHINA | 9 |
| 6 | Swedish Match Ab | Stockholm, SWEDEN | 7 |
| 7 | K K TECHNOLOGY CO. LTD | Shenzhen, CHINA | 5 |
| 8 | Skruf Snus Ab | Stockholm, SWEDEN | 4 |
| 9 | PROMOTORZY TRADING SP .ZO.O.SP | Warszawa, POLAND | 3 |
| 10 | ANOTHER SNUS FACTORY STOCKHOLM AB | Stockholm, SWEDEN | 3 |
| 11 | DONGGUAN SHIKAI TECHNOLOGY CO.,LTD | Dongguan, CHINA | 3 |
| 12 | Juul Labs, Inc. | San Francisco, UNITED STA | 2 |
| 13 | TRIDOTS UK | London, UNITED KIN | 2 |
| 14 | Swedish Match Ab | Stockholm, DENMARK | 2 |
| 15 | JUUL LABS UK | London, UNITED KIN | 2 |
| 16 | GUANGDONG TOULANG INTERNATIONALLOGISTICS CO., LTD | Shenzhen, CHINA | 2 |
| 17 | PILLBOX UK LTD | Blackburn, UNITED KIN | 2 |
| 18 | HUIZHOU TAOKE TECH | Huizhou, CHINA | 2 |
| 19 | JUUL LABS UK LTD | London, UNITED KIN | 1 |
| 20 | SHENZHEN IVPS TECHNOLOGY CO LTD | Shenzhen, CHINA | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/18/2025 | NICOTINE POUCH 98NCA11 | TIN JAR ABSWEDEN |
| 12/18/2025 | NICOTINE POUCH 98NCA11 | PHILIP MORRIS ABSWEDEN |
| 12/18/2025 | NICOTINE POUCH 98NCA11 | TRIDOTS UKUNITED KIN |
| 12/18/2025 | NICOTINE POUCH 98NCA11 | KURBITS SNUS ABSWEDEN |
| 12/18/2025 | NICOTINE POUCH 98NCA11 | TRIDOTS UKUNITED KIN |
| 12/9/2025 | NICOTINE POUCH 98NCA11 | JUUL LABS UKUNITED KIN |
| 12/2/2025 | NICOTINE POUCH 98NCA11 | JUUL LABS UKUNITED KIN |
| 8/20/2025 | CIGARETTES 98BBA01 | |
| 8/18/2025 | NICOTINE POUCH 98NCA11 | NICOPODS EHFICELAND |
| 5/2/2025 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | PREMIUM POUCH FINLAND OYFINLAND |
| 5/2/2025 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | YOIK ABSWEDEN |
| 5/2/2025 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | SMITIFY LIMITEDSWEDEN |
| 4/10/2025 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | Swedish Match AbSWEDEN |
| 4/10/2025 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | XPCT PRODUCTSSWEDEN |
| 3/27/2025 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | Swedish Match AbSWEDEN |
Frequently Asked Questions
What is FDA violation code 3894?
3894 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)(B) in that it is sold or distributed in violation of regulations prescribed under 906(d), namely its package fails to bear the required warning statement "WARNING: This product contains nicotine. Nicotine is an addictive chemical." Or if applicable the required statement "This product is made from tobacco."". This violation is based on 903(a)(7)(B); 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3894?
According to FDA Import Refusal data, there have been 132 import refusals issued for violation code 3894, affecting 49 unique firms.
When was the most recent refusal for violation 3894?
The most recent import refusal for violation 3894 was on December 18, 2025.
What products are commonly refused for violation 3894?
Products commonly refused under violation 3894 include: NICOTINE POUCH. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3894?
Violation code 3894 is based on 903(a)(7)(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.