Violation Code: 3888
FDA Violation
Charge Code: TPLABFALSE
Violation Details
- Violation Code (ASC ID)
- 3888
- Charge Code
- TPLABFALSE
- 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)(1) in that it appears that its labeling is false or misleading.
- Legal Section
- 903(a)(1); 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Juul Labs, Inc. | San Francisco, UNITED STA | 2 |
| 2 | DIY FLAVORS INC | Abbotsford, CANADA | 2 |
| 3 | Shenzhen Smoore Technology Limited | Shenzhen, CHINA | 1 |
| 4 | WOODY VAPES INC | Shenzhen, CHINA | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 1/5/2021 | SMOKELESS TOBACCO POUCHES 98CCA16 | DIY FLAVORS INCCANADA |
| 1/5/2021 | SMOKELESS TOBACCO POUCHES 98CAA16 | DIY FLAVORS INCCANADA |
| 8/28/2020 | E-CIGARETTE, KIT 98LAA02 | WOODY VAPES INCCHINA |
| 8/28/2020 | E-CIGARETTE, KIT 98LAA02 | |
| 3/31/2020 | ENDS CARTRIDGE 98MCB07 | Juul Labs, Inc.UNITED STA |
| 3/31/2020 | ENDS CARTRIDGE 98MCB07 | Juul Labs, Inc.UNITED STA |
Frequently Asked Questions
What is FDA violation code 3888?
3888 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)(1) in that it appears that its labeling is false or misleading.". This violation is based on 903(a)(1); 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3888?
According to FDA Import Refusal data, there have been 6 import refusals issued for violation code 3888, affecting 4 unique firms.
When was the most recent refusal for violation 3888?
The most recent import refusal for violation 3888 was on January 5, 2021.
What products are commonly refused for violation 3888?
Products commonly refused under violation 3888 include: SMOKELESS TOBACCO POUCHES, E-CIGARETTE, KIT, ENDS CARTRIDGE. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3888?
Violation code 3888 is based on 903(a)(1); 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.