Violation Code: 3520
FDA Violation
Charge Code: TP FLAVOR
Violation Details
- Violation Code (ASC ID)
- 3520
- Charge Code
- TP FLAVOR
- Description
- This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that it is, or purports to be or is represented as, a tobacco product that is subject to a tobacco product standard established under section 907, and violates 907 (a) (1) (A) in that the article appears to contain, as a constituent or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, that is a characterizing flavor of the tobacco product or tobacco smoke.
- Legal Section
- 902(a)(5), 927(a)(1)(A), 801(a)(3); ADULTERATION
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | NGP TOBACCO APS | Norager, DENMARK | 52 |
| 2 | CBI SRO | Teplice, CZECH REPU | 35 |
| 3 | Swedish Match Ab | Stockholm, SWEDEN | 32 |
| 4 | APRES NICOTINE AB | Vetlanda, SWEDEN | 15 |
| 5 | ACTIV SP ZOO | Warsaw, POLAND | 15 |
| 6 | LIW INNOVATION AB | Hokerum, SWEDEN | 14 |
| 7 | Kamena | Giza, EGYPT | 14 |
| 8 | NICOBROS OU | Tallinn, ESTONIA | 13 |
| 9 | CHAINPOP AB | Goteborg, SWEDEN | 13 |
| 10 | TABACALERA DON CHENCHO | Santiago, DOMINICAN | 12 |
| 11 | RSL BLUNT PRODUCTIONS | Santiago, DOMINICAN | 8 |
| 12 | JTI SWEDEN AB | Stockholm, SWEDEN | 8 |
| 13 | BRITISH AMERICAN TOBACCO | Malmo, SWEDEN | 8 |
| 14 | MICROZERO AB | Goteborg, SWEDEN | 7 |
| 15 | SWEDISH SMOKELESS SOLUTIONS | Jarfalla, SWEDEN | 7 |
| 16 | Shenzhen Kanger Technology Co | Shenzhen, CHINA | 7 |
| 17 | NORDIC BRANDS | Lidkoping, SWEDEN | 6 |
| 18 | GLOBAL SNUS UAB | Vilnius, LITHUANIA | 6 |
| 19 | YOIK AB | Gemla, SWEDEN | 5 |
| 20 | Skruf Snus Ab | Stockholm, SWEDEN | 5 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 11/6/2025 | NICOTINE POUCH 98NCA11 | Swedish Match AbSWEDEN |
| 11/6/2025 | NICOTINE POUCH 98NCA11 | CBI SROCZECH REPU |
| 10/24/2025 | CIGARETTE PAPER 98ECA01 | REPUBLIC TECHNOLOGIESFRANCE |
| 10/10/2025 | NICOTINE POUCH 98NCA11 | |
| 10/6/2025 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | BRITISH AMERICAN TOBACCOSWEDEN |
| 10/6/2025 | NICOTINE POUCH 98NCA11 | Swedish Match AbDENMARK |
| 10/6/2025 | NICOTINE POUCH 98NCA11 | Swedish Match AbDENMARK |
| 10/6/2025 | NICOTINE POUCH 98NCA11 | HIGH VOLTAGE GROUP OYFINLAND |
| 10/6/2025 | NICOTINE POUCH 98NBA11 | |
| 9/24/2025 | NICOTINE POUCH 98NCA11 | BRITISH AMERICAN TOBACCOSWEDEN |
| 9/5/2025 | NICOTINE POUCH 98NCA11 | Swedish Match AbSWEDEN |
| 9/5/2025 | NICOTINE POUCH 98NBA11 | Swedish Match AbSWEDEN |
| 9/5/2025 | NICOTINE POUCH 98NCA11 | Swedish Match AbSWEDEN |
| 9/5/2025 | NICOTINE POUCH 98NCA11 | LIW INNOVATION ABSWEDEN |
| 9/5/2025 | NICOTINE POUCH 98NCA11 | CBI SROCZECH REPU |
Frequently Asked Questions
What is FDA violation code 3520?
3520 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 in that it is, or purports to be or is represented as, a tobacco product that is subject to a tobacco product standard established under section 907, and violates 907 (a) (1) (A) in that the article appears to contain, as a constituent or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, that is a characterizing flavor of the tobacco product or tobacco smoke.". This violation is based on 902(a)(5), 927(a)(1)(A), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3520?
According to FDA Import Refusal data, there have been 384 import refusals issued for violation code 3520, affecting 73 unique firms.
When was the most recent refusal for violation 3520?
The most recent import refusal for violation 3520 was on November 6, 2025.
What products are commonly refused for violation 3520?
Products commonly refused under violation 3520 include: NICOTINE POUCH, CIGARETTE PAPER, NICOTINE DELIVERY PRODUCT, NEC. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3520?
Violation code 3520 is based on 902(a)(5), 927(a)(1)(A), 801(a)(3); ADULTERATION 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.