Violation Code: 3857
FDA Violation
Charge Code: TPFDA3LBLG
Violation Details
- Violation Code (ASC ID)
- 3857
- Charge Code
- TPFDA3LBLG
- 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 the label or labeling is false or misleading because it conveys that the product is endorsed by the FDA for use by consumers.
- Legal Section
- 903(a)(1); 801(a)(3); 301(tt)(3); MISBRANDING
Frequently Asked Questions
What is FDA violation code 3857?
3857 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 the label or labeling is false or misleading because it conveys that the product is endorsed by the FDA for use by consumers.". This violation is based on 903(a)(1); 801(a)(3); 301(tt)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3857?
According to FDA Import Refusal data, there have been 0 import refusals issued for violation code 3857, affecting 0 unique firms.
When was the most recent refusal for violation 3857?
There is no recent refusal data available for violation 3857.
What products are commonly refused for violation 3857?
Various imported products may be refused under violation 3857 when they do not meet FDA requirements.
What is the legal basis for FDA violation code 3857?
Violation code 3857 is based on 903(a)(1); 801(a)(3); 301(tt)(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.