FDA refusal charge
FDA refusal charge DRUG NAME
DRUG NAME is the FDA import refusal charge for the article appears to be a drug and fails to bear the proprietary or established name and/or name and…; it cites section 502(e)(1) of the FD&C Act (801(a)(3)). FDA recorded it on 5 refused shipment lines from 5 countries between October 2016 and August 30, 2024, most often for dietary supplements from China.
Data from FDA public records, last checked .
- 5
- refused shipment lines carry this charge
- 5
- countries of origin
- 0
- import alerts name this charge
What DRUG NAME means
SupplierRadar has not written a plain-English version of DRUG NAME yet. FDA's own statement is quoted below.
- FD&C Act section
- 502(e)(1)
- Classification
- 801(a)(3)
FDA's official statement
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Countries with the most DRUG NAME refusals
| Country | Lines | Share of DRUG NAME |
|---|---|---|
| China | 1 | 20% |
| India | 1 | 20% |
| Italy | 1 | 20% |
| South Korea | 1 | 20% |
| Nigeria | 1 | 20% |
Product categories with the most DRUG NAME refusals
| Category | Lines | Share of DRUG NAME |
|---|---|---|
| Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties | 4 | 80% |
| Candy without Chocolate, Candy Specialties, and Chewing Gum | 1 | 20% |
Latest DRUG NAME refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Unknown NigeriaUnknown, Nigeria | Aristolochia (fangchi), (herbal & botanicals, not tea) | NOT LISTEDLIST INGREDIRSEXMPT+5 | Source | |
| Hawaban Harde DepotIndore, India | Flavored candy, hard (live savers, etc.), without nuts and fruit (without chocolate) | NOT LISTEDLIST INGREDIRSEXMPT+5 | Source | |
| CNSPHARM KOREA Co., LTD.Eumseong-gun, South Korea | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | LIST INGREDIRSEXMPTUSUAL NAME+4 | Source | |
| Pupa -Micys Co SpaCasatenovo, Italy | Herbals & botanicals (not teas), n.e.c | NOT LISTEDFRNMFGREGDRUG NAME+1 | Source | |
| Synmr Biotechnology (Shanghai) LimitedShanghai, China | L-histadine (protein) | DIRECTIONSFALSEFRNMFGREG+1 | Source |
Questions about DRUG NAME
- What does DRUG NAME mean on an FDA refusal?
- DRUG NAME is the refusal charge “The article appears to be a drug and fails to bear the proprietary or established name and/or name and…”. FDA's official statement for the charge reads: “The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.”
- What law does DRUG NAME cite?
- FDA's refusal charge table cites section 502(e)(1) of the FD&C Act (801(a)(3)) for DRUG NAME, and classifies the charge as 801(a)(3). The table is the Refusal Charges reference file that FDA publishes with its Data Dashboard.
- Which countries have the most DRUG NAME refusals?
- As of October 25, 2026, the countries with the most DRUG NAME refusal lines are China (1), India (1) and Italy (1). The full list with links is in the table on this page.
- Is there an FDA import alert for DRUG NAME?
- SupplierRadar found no food import alert whose charge section names DRUG NAME. An import alert is a list of firms; a charge code is the reason recorded on one refused shipment line.
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SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.