FDA refusal charge
FDA refusal charge HISTAMINE
HISTAMINE is the FDA import refusal charge for histamine; it cites sections 402(a)(1) and 801(a)(3) of the FD&C Act (adulteration). FDA recorded it on 465 refused shipment lines between October 2016 and September 23, 2026, most often for seafood from Senegal.
Data from FDA public records, last checked .
- 465
- refused shipment lines carry this charge
- 22
- countries of origin
- 0
- import alerts name this charge
What HISTAMINE means
The product appeared to contain histamine in a quantity that ordinarily makes it injurious to health.
This restates FDA's statement. It says what the charge means, never why a particular shipment was refused.
- FD&C Act section
- 402(a)(1)801(a)(3)
- Classification
- adulteration
FDA's official statement
The article appears to bear or contain histamine, a poisonous and deleterious substance in such quantity as ordinarily renders it injurious to health.
Countries with the most HISTAMINE refusals
| Country | Lines | Share of HISTAMINE |
|---|---|---|
| Senegal | 111 | 24% |
| Vietnam | 108 | 23% |
| Indonesia | 106 | 23% |
| Ecuador | 31 | 7% |
| Mozambique | 21 | 5% |
| Philippines | 18 | 4% |
| Thailand | 18 | 4% |
| United Arab Emirates | 13 | 3% |
| Taiwan | 8 | 2% |
| Guyana | 4 | 1% |
Product categories with the most HISTAMINE refusals
| Category | Lines | Share of HISTAMINE |
|---|---|---|
| Fishery/Seafood Products | 465 | 100% |
Latest HISTAMINE refusals
Questions about HISTAMINE
- What does HISTAMINE mean on an FDA refusal?
- HISTAMINE is the refusal charge “Histamine”. The product appeared to contain histamine in a quantity that ordinarily makes it injurious to health.
- What law does HISTAMINE cite?
- FDA's refusal charge table cites sections 402(a)(1) and 801(a)(3) of the FD&C Act (adulteration) for HISTAMINE, and classifies the charge as adulteration. The table is the Refusal Charges reference file that FDA publishes with its Data Dashboard.
- Which countries have the most HISTAMINE refusals?
- As of October 26, 2026, the countries with the most HISTAMINE refusal lines are Senegal (111), Vietnam (108) and Indonesia (106). The full list with links is in the table on this page.
- Is there an FDA import alert for HISTAMINE?
- SupplierRadar found no food import alert whose charge section names HISTAMINE. 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.