Violation Code: 3900
FDA Violation
Charge Code: NDIDIETSP
Violation Details
- Violation Code (ASC ID)
- 3900
- Charge Code
- NDIDIETSP
- Description
- The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be a food that is a dietary supplement or that contains a dietary ingredient that is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
- Legal Section
- 402(f)(1)(B), 801(a)(3) Adulteration
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | DYNAMIC GROUP | Laval, CANADA | 5 |
| 2 | Suzhou Win Health International Co.,Ltd. | Dongtai City, CHINA | 4 |
| 3 | JX NUTRITIONAL CHEMICAL CO.,LIMITED | Shanghai, CHINA | 3 |
| 4 | JUPITER FULLFILMENT CENTER | Denver, UNITED STA | 2 |
| 5 | EGI ASTRIA | Jakarta Selatan, INDONESIA | 1 |
| 6 | FARIZ ADHA | Bekasi, INDONESIA | 1 |
| 7 | DINAND | Bekasi, INDONESIA | 1 |
| 8 | PT ANAK MAKMUR BA | Bekasi, INDIA | 1 |
| 9 | CV. SETIA COCONUT INDONESIA | Kota Singkawang Kalim, INDONESIA | 1 |
| 10 | CV MELDA FAMILY | Pontianak, INDONESIA | 1 |
| 11 | IDEAL LIFE TECHNOLOGY CO.,LTD | Mongkok, HONG KONG | 1 |
| 12 | PUTRA EDI | Jakarta, INDONESIA | 1 |
| 13 | CV KING PREMIER FAMILY | Jakarta Timur, INDONESIA | 1 |
| 14 | CV RAZQA ANUGERAH | Kalimanta Barat, INDONESIA | 1 |
| 15 | YPJ INFINTY HERB CO LTD | Chonburi, THAILAND | 1 |
| 16 | Pt. Sentosa Herbal Indonesia | Pontianak, INDONESIA | 1 |
| 17 | SCELETIUM SOURCE AFRICA | Wilderness, SOUTH AFRI | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 5/27/2025 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | DYNAMIC GROUPCANADA |
| 5/27/2025 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | DYNAMIC GROUPCANADA |
| 5/27/2025 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | DYNAMIC GROUPCANADA |
| 5/27/2025 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | DYNAMIC GROUPCANADA |
| 5/19/2025 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | DYNAMIC GROUPCANADA |
| 2/26/2025 | KRATOM (HERBAL AND BOTANICAL TEAS II, CONTINUED) 54JFY12 | YPJ INFINTY HERB CO LTDTHAILAND |
| 1/10/2025 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FAY99 | |
| 1/10/2025 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FBY99 | |
| 11/8/2024 | KRATOM (HERBAL AND BOTANICAL TEAS II, CONTINUED) 54JBY12 | CV RAZQA ANUGERAHINDONESIA |
| 4/24/2024 | MORINGA OLEIFERA (HERBAL AND BOTANICAL TEAS II, (CONTINUED) 54JBR10 | CV KING PREMIER FAMILYINDONESIA |
| 11/19/2023 | KRATOM (HERBAL AND BOTANICAL TEAS II, CONTINUED) 54JBR12 | PUTRA EDIINDONESIA |
| 10/4/2023 | CANNABIDIOL (ANTI-CONVULSANT) 61MDB49 | JUPITER FULLFILMENT CENTERUNITED STA |
| 10/4/2023 | CANNABIDIOL (ANTI-CONVULSANT) 61MDB49 | JUPITER FULLFILMENT CENTERUNITED STA |
| 5/9/2022 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | IDEAL LIFE TECHNOLOGY CO.,LTDHONG KONG |
| 3/21/2022 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FYY99 | CV. SETIA COCONUT INDONESIAINDONESIA |
Frequently Asked Questions
What is FDA violation code 3900?
3900 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 a food that is a dietary supplement or that contains a dietary ingredient that is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.". This violation is based on 402(f)(1)(B), 801(a)(3) Adulteration of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3900?
According to FDA Import Refusal data, there have been 27 import refusals issued for violation code 3900, affecting 17 unique firms.
When was the most recent refusal for violation 3900?
The most recent import refusal for violation 3900 was on May 27, 2025.
What products are commonly refused for violation 3900?
Products commonly refused under violation 3900 include: VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3900?
Violation code 3900 is based on 402(f)(1)(B), 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.