Import Alert 16-20

Import Alert # 16-20

Published Date: 04/22/2022

Type: DWPE

"Detention Without Physical Examination of Puffer Fish"

NOTE: The revision of this Import Alert dated 04/22/2022 updates the guidance section and the product codes section. Changes are noted and bracketed by asterisks "***".

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.

Divisions may detain, without physical examination, all shipments of 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, or other members of the Tetraodontidae family. Divisions may also detain any food that is found to list these in the ingredient statement or anywhere on the product label. Because of the potential presence of toxin, puffer fish can be considered adulterated under 402(a)(1) of the Federal Food, Drug and Cosmetics Act.

This import alert applies to entries from all countries, including Japan, with the only exception being outlined through the "Exchange of Letters" between the Japanese Ministry of Health and Welfare and the US FDA.

Note: The Japanese Ministry of Health and Welfare and the US FDA reached an agreement regarding the importation of a single species of puffer fish, Takifugu rubripes, also known as "Tora Fugu" for "special occasions" only.

*** Please note that the agreement was at no time established to permit the unrestricted importation of puffer fish into the United States. The intention of the agreement is to allow for puffer fish to be imported on the basis of special occasions only.

The decision to allow the restricted importation of puffer fish were predicated on the Japanese Ministry of Health and Welfare officials' development and implementation of an export protocol for puffer fish, which provides assurance that FDA's concerns are adequately addressed. Shipments of puffer fish or products containing puffer fish being offered for import outside this agreement are not permitted.

As a result of the potential public health hazard associated with the consumption of puffer fish, imported puffer fish remains restricted and subject to Detention Without Physical Examination in any and all forms. ***

The agreement is outlined in an "Exchange of Letters" between the two governments and can be found at: https://www.fda.gov/international-programs/cooperative-arrangements/fda-japan-exchange-letters-regarding-puffer-fish

The agreement expends resources for both government agencies to ensure the safety of a limited amount of product entering the US. The agreement was never established to permit the unrestricted importation of Japanese puffer fish into the US.

When encountering shipments of Japanese puffer fish being offered for import under the agreement and on the basis of a "special occasion," prior to rendering an admissibility decision, Divisions should verify that following actions were taken:

I. Each entry is to be inspected by the appropriate official of the Japanese government and certified as safe.

II. Develop and implement the necessary conditions (Proposed Requisite Matters) for export of Japanese puffer fish into the United States.

(a) SPECIFIC CRITERIA

1. Species and Regions (edible parts)

2. Processing (Hygienic Practices)

3. Packing

4. Labeling

5. Transportation

6. Certification
(Please see the exchange letters link above for details)

(b) OTHER MATTERS

1. There is to be a recognized export organization
(Please see the exchange letters link above for details)

2. There is to be a recognized import organization
(Please see the exchange letters link above for details)

*** Please see the "Exchange of Letters Between Japan and the U.S. Food and Drug Administration Regarding Puffer Fish" when encountering imported shipments under this agreement. (The link is provided above with the details) ***

Questions or issues involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov

Questions or issues on policy, sample collection recommendations, or any other additional questions, should be addressed to CFSAN/Division of Enforcement's Food Adulteration Assessment Branch at (240) 402-1750 or CFSANEnforcement@fda.hhs.gov

                                                                                                                                                                       

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)

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a poisonous or deleterious substance which would ordinarily render the article injurious to health. Contains: "

OASIS CHARGE CODE - POISONORD