Violation Code: 2200
FDA Violation
Charge Code: DIET INGRE
Violation Details
- Violation Code (ASC ID)
- 2200
- Charge Code
- DIET INGRE
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be for use as an ingredient in a dietary supplement and appears to be or may be otherwise unfit for food.
- Legal Section
- 402(a)(3), 801(a)(3); Adulteration
Most Affected Firms
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 1/28/2025 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FCF99 | 99 PURITYCANADA |
| 1/6/2020 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FBR99 | |
| 12/6/2018 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FBY99 | |
| 2/29/2016 | BANABA (HERBAL & BOTANICAL TEAS) 54EYY95 | AnggiaINDONESIA |
| 9/24/2015 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FBY99 | |
| 9/9/2015 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FBY99 | |
| 5/12/2015 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YYS99 | |
| 4/28/2015 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YER99 | |
| 7/2/2014 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FBR99 | |
| 7/2/2014 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FBR99 | |
| 6/18/2014 | PEPTIDE N.E.C. 56FAZ99 | |
| 6/11/2014 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VCR99 | |
| 11/7/2012 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YYR99 | |
| 10/25/2012 | OTHER FRAGRANCE PREPARATIONS, N.E.C. 53DH99 | Borneo BotanicalsINDONESIA |
| 10/15/2012 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YBS99 |
Related Violations
Other violations under the same legal section: 402(a)(3), 801(a)(3); Adulteration
| Code | Charge Code | Cases |
|---|---|---|
| 2201 | BSE FILTH | 18 |
Frequently Asked Questions
What is FDA violation code 2200?
2200 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be for use as an ingredient in a dietary supplement and appears to be or may be otherwise unfit for food.". This violation is based on 402(a)(3), 801(a)(3); Adulteration of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 2200?
According to FDA Import Refusal data, there have been 147 import refusals issued for violation code 2200, affecting 69 unique firms.
When was the most recent refusal for violation 2200?
The most recent import refusal for violation 2200 was on January 28, 2025.
What products are commonly refused for violation 2200?
Products commonly refused under violation 2200 include: HERBALS & BOTANICALS (NOT TEAS), N.E.C., BANABA (HERBAL & BOTANICAL TEAS). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 2200?
Violation code 2200 is based on 402(a)(3), 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.