Violation Code: 2460
FDA Violation
Charge Code: UNSFDIETLB
Violation Details
- Violation Code (ASC ID)
- 2460
- Charge Code
- UNSFDIETLB
- Description
- The article appears to be a dietary supplement or contain a dietary ingredient that presents a significant or unreasonable risk of illness or injury under the conditions of use set out in the labeling or, if none are set out in the labeling, under customary conditions of use.
- Legal Section
- 402(f)(1)(A), 801(a)(3) Adulteration
Most Affected Firms
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/27/2024 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FCA99 | |
| 9/5/2023 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCT99 | |
| 8/10/2022 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YBR99 | |
| 4/20/2021 | KRATOM (HERBAL AND BOTANICAL TEAS II, CONTINUED) 54JYY12 | DIANTRAINDONESIA |
| 5/16/2020 | KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) 54KYT12 | UD. Maju JayaINDONESIA |
| 12/6/2018 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FBY99 | |
| 12/6/2018 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FBY99 | |
| 10/22/2018 | DIETARY CONVENTIONAL FOODS, N.E.C. 41YGT99 | Direct Food IngredientsUNITED KIN |
| 1/12/2018 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YBY99 | CV BAGUS PERDANAINDONESIA |
| 4/19/2017 | KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) 54KBR12 | Arsy CVINDONESIA |
| 4/6/2016 | KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) 54KCS12 | Koperasi Pamane Agro MakmurINDONESIA |
| 4/5/2016 | BANABA (HERBAL & BOTANICALS, NOT TEAS) 54FYY95 | FitriINDONESIA |
| 4/5/2016 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FYY99 | Fadilindo Jasa AntaranINDONESIA |
| 4/4/2016 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FYY99 | Muhammad ArdiansyahINDONESIA |
| 4/4/2016 | OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. 53YY99 | Dani KurniawanINDONESIA |
Frequently Asked Questions
What is FDA violation code 2460?
2460 is an FDA violation code that indicates: "The article appears to be a dietary supplement or contain a dietary ingredient that presents a significant or unreasonable risk of illness or injury under the conditions of use set out in the labeling or, if none are set out in the labeling, under customary conditions of use.". This violation is based on 402(f)(1)(A), 801(a)(3) Adulteration of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 2460?
According to FDA Import Refusal data, there have been 203 import refusals issued for violation code 2460, affecting 101 unique firms.
When was the most recent refusal for violation 2460?
The most recent import refusal for violation 2460 was on December 27, 2024.
What products are commonly refused for violation 2460?
Products commonly refused under violation 2460 include: HERBALS & BOTANICALS (NOT TEAS), N.E.C., VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C., KRATOM (HERBAL AND BOTANICAL TEAS II, CONTINUED), KRATOM (HERBAL AND BOTANICALS, NOT TEAS II). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 2460?
Violation code 2460 is based on 402(f)(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.