FDA refusal charge HISTAMINE: histamine

← All charge codes Histamine Dashboard

The HISTAMINE charge appeared in 150 FDA import refusals between 2020 and 2026 — 0.8% of the 19,123 refusals that identify a hazard. The origins cited most often are Senegal, Indonesia, Vietnam. The most-affected product category is Fishery/Seafood Products. Volume in 2025 was up 157% on 2024.

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What FDA's charge says

HISTAMINE is the code FDA prints on a refusal; below is the charge language FDA publishes for it, quoted from its charge table, with the sections of the FD&C Act it cites.

The article appears to bear or contain histamine, a poisonous and deleterious substance in such quantity as ordinarily renders it injurious to health.

Sections 402(a)(1), 801(a)(3); Adulteration

HISTAMINE refusals by year

YearRefusalsYoY
202012—
202124+100.0%
202215-37.5%
202313-13.3%
202421+61.5%
202554+157.1%
202611—YTD
Total150

Origins most often refused under HISTAMINE

#Origin countryRefusals
1Senegal63
2Indonesia29
3Vietnam15
4Ecuador11
5Mozambique8
6Thailand4
7Costa Rica3
8Brazil2
9China2
10Malaysia2
11Panama2
12Philippines2
13Yemen2
14Guyana1
15Morocco1
16Sri Lanka1
17Suriname1
18United Arab Emirates1

Product categories refused under HISTAMINE

#Product categoryRefusals
1Fishery/Seafood Products150

Latest refusals citing HISTAMINE

About HISTAMINE

What does the FDA import refusal charge HISTAMINE mean?

FDA uses HISTAMINE for: histamine. Its published charge language reads: “The article appears to bear or contain histamine, a poisonous and deleterious substance in such quantity as ordinarily renders it injurious to health.”

Is HISTAMINE a food safety finding?

Yes. This site counts HISTAMINE as a hazard finding, so a refusal citing it is on the hazard side of the hazard and paperwork split, whatever else the refusal cites.

What happens to a shipment refused under HISTAMINE?

Under section 801(a) of the FD&C Act a refused entry has to be exported or destroyed, normally within 90 days of the notice of refusal. Bringing a product into compliance, for instance by relabelling, is something the importer asks FDA for before the decision is final. The notice itself and FDA's guidance govern a particular case; this page describes the published data and is not legal advice.