What is Import Alert 16-20?

Import Alert 16-20, “Detention without physical examination of puffer fish”, is an FDA import alert; FDA last published the alert on February 21, 2025.

How do firms get off Import Alert 16-20?

A firm asks FDA to remove it by submitting evidence that the cause of the listing has been corrected. The Guidance section of the alert on FDA's website gives the procedure and the contact for 16-20; our guide explains the steps and the evidence FDA usually asks for.

What charge does FDA use under Import Alert 16-20?

The charge section of Import Alert 16-20 names POISONORD (poisonous or deleterious substance (ordinarily injurious)). Each code is a refusal charge in FDA's reference table; the linked pages give FDA's official statement and refusal counts.

Import Alert 16-20: Detention without physical examination of puffer fish

FDA last published February 21, 2025FDA alert page

As of October 26, 2026, FDA Import Alert 16-20 (Puffer Fish) has no foreign food firms listed in SupplierRadar's records; it covers puffer fish, puffer, fugu, tora fugu, Takifugu rubripes, globe fish, swell fish.

Data from FDA public records, last checked October 26, 2026. Request a correction

0
foreign food firms listed: 0
added in the last 90 days: 0
removed in the last 90 days

What changed in the last 90 days

Additions use the date FDA published each listing. Removals are dated by the day SupplierRadar first saw the firm gone; the weekly and daily checks are described on the data sources page.

Removed from Import Alert 16-20

SupplierRadar has recorded no removals from Import Alert 16-20 in the last 90 days, as of October 26, 2026. A removal is shown at the top of this page, and on the firm's own page, the day it is found.

Added to Import Alert 16-20

No firm was added to Import Alert 16-20 in the last 90 days, as of October 26, 2026.

Refusal charges named on this alert

FDA's alert page names these charge codes. The counts are refusal lines FDA recorded under each charge since October 2016, for all firms, not only firms on this alert.

Charge codes named on Import Alert 16-20
Charge code	Meaning	Refusal lines since 2016
POISONORD	Poisonous or deleterious substance (ordinarily injurious)	436

What the alert covers and why FDA issued it

FDA's wording, with FDA's change markers removed.

Official title: Detention Without Physical Examination of Puffer Fish
Product scope: Puffer fish, Puffer, Fugu, Tora fugu, Takifugu rubripes, Globe fish, Swell fish, Balloonfish, Blowfish, Blowies, Bubblefish, Toadfish, Toadies, Honey toads, Sugar toads, Sea squab, Three tooth fish, etc. PROBLEMS: TETROTOXIN (E.G., PUFFERFISH)
Last published: February 21, 2025

Tetrodotoxin (TTX) poisoning results from the ingestion of edible portions of the puffer fish, family Tetraodontidae, of which there are greater than 180 species occurring world-wide. Tetrodotoxin concentration and distribution within the fish varies greatly depending on the species. In several species of puffer fish tetrodotoxin concentrations are sufficient to produce rapid death. Even in commonly consumed species, the edible portions, typically the meat, skin, and male gonad (testes), may also become contaminated from the poisonous excised tissues due to improper processing, or from the transfer of the toxin from poisonous parts as a result of improper freezing and gradual thawing of unprocessed puffer fish.
There is a high fatality rate among those who ingest tetrodotoxin. The toxin cannot be destroyed by cooking or freezing. Therefore, the importation of puffer fish products into the United States is restricted and personal importation is prohibited. See guidance for exceptions and other names for the fish to which this applies. There have also been several serious illnesses which have occurred due to puffer fish that were illegally imported into the US, including species with naturally high concentrations of tetrodotoxin in the meat and/or skin.

FDA Import Alert 16-20, Reason for AlertRead it on FDA

Listing on an import alert is FDA's notice to the firm and a fact an importer must consider in its supplier evaluation under 21 CFR 1.505. What the red, green and yellow lists mean.

Questions about Import Alert 16-20

What is Import Alert 16-20?: Import Alert 16-20, “Detention without physical examination of puffer fish”, is an FDA import alert; FDA last published the alert on February 21, 2025.
How do firms get off Import Alert 16-20?: A firm asks FDA to remove it by submitting evidence that the cause of the listing has been corrected. The Guidance section of the alert on FDA's website gives the procedure and the contact for 16-20; our guide explains the steps and the evidence FDA usually asks for.
What charge does FDA use under Import Alert 16-20?: The charge section of Import Alert 16-20 names POISONORD (poisonous or deleterious substance (ordinarily injurious)). Each code is a refusal charge in FDA's reference table; the linked pages give FDA's official statement and refusal counts.

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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.