Decomposition, Fecal Bacteria, Adulteration: More Bad News On Seafood Imports

The agency updates and modifies the alerts as needed.

Recent modifications to FDA’s import alerts, as posted by the agency, are listed below.

Click on the links to view the full alerts.

Import Alert | Description | Highlights | URL

IA-16-105 | Detention Without Physical Examination of Seafood and Seafood Products from Specific Manufacturers/Shippers Due to Decomposition and/or Histamines

“The Agency has noted several separate outbreaks of scrombroid poisoning attributed to fresh or frozen tuna. The most recent outbreak occurred in Florida and was traced to frozen tuna packed by a firm in Taiwan.” [Scombroid poisoning typically occurs when people eat certain fish that have been inadequately preserved. Bacteria that grow during improper storage in the dark meat of the fish produce scombroid toxin. Susceptible fish include albacore, amberjack, anchovy, Australian salmon, bluefish, bonito, kahawai, herring, mackerel, mahi-mahi, needlefish, saury, sardine, skipjack, wahoo, and yellowfin tuna. Affected fish may have a metallic or peppery taste. – WebMD]

https://www.accessdata.fda.gov/cms_ia/importalert_19.html

IA-16-125 |Detention Without Physical Examination Of Refrigerated (Not Frozen) Raw Fish And Fishery Products That Are Vacuum Packaged Or Modified Atmosphere Packaged Or Packaged In A Material That Is Not Oxygen- Permeable Due To The Potential For Clostridium Botulinum Toxin Production
“The toxin produced by C. botulinum is considered one of the most poisonous naturally occurring substances known and when ingested can result in paralysis, leading to death from asphyxiation … FDA considers refrigerated raw fish and fishery products in ROP (reduced oxygen packaging) to be adulterated under section 402(a)(4) of the Food, Drug and Cosmetic Act when the C. botulinum toxin hazard is not controlled.” [The notice applies to imported fish from 28 different nations.]https://www.accessdata.fda.gov/cms_ia/importalert_28.html

IA-16-22 | Detention Without Physical Examination of Canned Shrimp from Thailand for Decomposition

“The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to consist in whole or in part of a filthy, putrid, or decomposed substance, or is otherwise unfit for food in that it appears to be decomposed. OASIS charge code – FILTHY”

https://www.accessdata.fda.gov/cms_ia/importalert_39.html

IA-16-39 | Detention Without Physical Examination of Processed Seafood and Analogue Seafood (Surimi) Products for Listeria Monocytogenes

“… shipments of processed seafood and analogue seafood (surimi) products [aka ‘fish paste’] have been found to be contaminated with L. monocytogenes … The article is subject to refusal of admission pursuant to 801(a)(3), in that the article appears to contain Listeria monocytogenes, a poisonous and deleterious substance, which may render it injurious to health.”

https://www.accessdata.fda.gov/cms_ia/importalert_44.html

IA-16-81 | Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella

“Division of Import Operations and Policy has received recommendations from districts for detention without physical examination of seafood products due to Salmonella contamination from specific manufacturers/shippers. This import alert has been developed for seafood products from firms/countries which do not readily fit into previously existing import alerts.” [The notice applies to imported fish from more than 40 different nations.]

https://www.accessdata.fda.gov/cms_ia/importalert_49.html

IA-45-02 | Detention Without Physical Examination and Guidance of Foods Containing Illegal and/or Undeclared Colors

https://www.accessdata.fda.gov/cms_ia/importalert_118.html

IA-53-06 | Detention Without Physical Examination Of Cosmetics That are Adulterated and/or Misbranded Due to Color Additive Violations

https://www.accessdata.fda.gov/cms_ia/importalert_130.html

IA-66-40 | Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs

https://www.accessdata.fda.gov/cms_ia/importalert_189.html

 IA-66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.

http://www.accessdata.fda.gov/cms_ia/importalert_190.html

IA-66-66 | APIs That Appear To Be Misbranded Under 502(f)(1) Because They Do Not Meet The Requirements For The Labeling Exemptions In 21 CFR 201.122

https://www.accessdata.fda.gov/cms_ia/importalert_202.html

IA-68-19 | Detention Without Physical Examination Of Unapproved New Animal Drugs

https://www.accessdata.fda.gov/cms_ia/importalert_1147.html

IA-89-17 | Detention Without Physical Examination of Medical Devices That Appear To Be Adulterated Because Their Quality Falls Below That Which They Purport or Are Represented to Possess

https://www.accessdata.fda.gov/cms_ia/importalert_1156.html

IA-99-08 | Detention Without Physical Examination Of Processed Human and Animal Foods for Pesticides

https://www.accessdata.fda.gov/cms_ia/importalert_259.html

IA-99-19 | Detention Without Physical Examination Of Food Products Due To The Presence Of Salmonella

https://www.accessdata.fda.gov/cms_ia/importalert_263.html

IA-99-21 | Detention Without Physical Examination and Surveillance Of Food Products Containing Sulfites

https://www.accessdata.fda.gov/cms_ia/importalert_265.html