New FDA Import Alerts Published This Week

The U.S. Food and Drug Administration (FDA) has published several new FDA Import Alerts this week. Rounding out a busy month for this department.

As of August 26, 2024, 38 Import Alerts have been updated for food and drug products. Of those, 27 were food products. All products were listed under the category of “detain without physical examination.” Meaning that they are held based on the type of product and location they are originating from and/or importer that may have been flagged.

Here’s what we know about the new FDA Import Alerts published this week.

Four New FDA Import Alerts on August 26, 2024

Four new import alerts were published on August 26, 2024. All of these related to food products coming into the United States from other countries. All of these are updates to existing import alerts. Most of them are administrative edits reflecting updated agency contact information.

Import Alert Number 99-19 “Detention Without Physical Examination of Food Products Due to the Presence of Salmonella”

This Alert was updated to include changes to “the reason for the alert, guidance section, agency contacts, and product description.” No major changes or entities appear to be added to this Alert.

Import Alert Number 99-22 “Detention Without Physical Examination Of Foods Containing Undeclared Major Food Allergens or Foods That Fail to Properly Label Major Food Allergens”

This Alert was updated to include ‘sesame’ to the list of allergens. Sesame has recently been added to the major food allergens list and now requires labels to indicate the presence of this allergen.

Import Alert Number 99-08 “Detention Without Physical Examination of Processed Human and Animal Foods for Pesticides”

This alert was updated to include changes in agency contacts. No major changes or entities appear to be added to this Alert.

Import Alert 99-05 “Detention Without Physical Examination Of Raw Agricultural Products for Pesticides”

This alert was updated to include changes in “the reason for alert, guidance section, and agency contact information.” No major changes or entities appear to be added to this Alert.

What Are FDA Import Alerts and Why Are They Important?

FDA Import Alerts are designed to alert customs of potential threats to consumers in the products coming into the country.

Entities are placed on these Import Alerts because they have a history of known violations. Once an entity is placed on the Alert list, future shipments may be detained without having to test or otherwise physically examine it.

This is called “detention without physical exam.” Repeat violators are notified that they are ineligible to ship product into the United States. New importers should be checking these Alerts to determine if their product is eligible for import based on existing criteria.

In some cases, imported products may be detailed until the violation is overcome or by demonstrating that the product does not have the violation listed on the import alert.

There are three lists that an entity may be placed on. Green, yellow, and red.

GREEN LIST

Entities or products appearing on the GREEN LIST are exempt from detaining without physical examination under that alert. While they may still be detained if certain conditions are met, additional examination or testing will take place for action to move forward.

YELLOW or RED LIST

Entities placed on the Yellow or Red List are subject to being detained without physical inspection.

Other Import Alerts for the Month of August

August was a busy month for the FDA Import Program. Beyond last Monday’s update, many other Import Alerts were updated in some way.

Other FDA Alert Updates include:

August 23, 2024

• Import Alert 99-42
  • Detention Without Physical Examination of Foods Due to Heavy Metal (Toxic Element) Contamination

August 21, 2023

• Import Alert 16-25
  • Detention Without Physical Examination of Processed Crabmeat from Thailand
• Import Alert 16-50
  • Detention Without Physical Examination of Molluscan Bivalve Shellfish
• Import Alert 16-120
  • Detention Without Physical Examination of Fish/Fishery Products from Foreign Processors (Mfrs.) Not in Compliance with Seafood HACCP
• Import Alert 99-39
  • Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded

August 20, 2024

• Import Alert 16-137
  • Detention Without Physical Examination of Seafood Due to Viral Contamination
• Import Alert 34-01
  • Detention Without Physical Examination of Cocoa Beans from Brazil, Indonesia, and Malaysia Due to Presence of Live Insects
• Import Alert 23-15
  • Detention Without Physical Examination of Food Products That Are, or That Contain, Areca (Betel) Nuts, Including Finished Dietary Supplements and Bulk Dietary Ingredients
• Import Alert 99-41
  • Detention Without Physical Examination of Human and Animal Foods Imported from Foreign Suppliers by Importers Who Are Not in Compliance with the Requirements of the Foreign Supplier Verification Program (FSVP) Regulation
• Import Alert 16-81
  • Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella
• Import Alert 54-12
  • Detention Without Physical Examination of Foods Labeled As Being Or Containing Siberian Ginseng
• Import Alert 45-02
  • Detention Without Physical Examination and Guidance of Foods Containing Illegal and/or Undeclared Colors

August 15, 2024

• Import Alert 16-105
  • Detention Without Physical Examination of Fish and Fishery Products from Specific Manufacturers/Shippers Due Decomposition and/or Histamine, and/or Indole
• Import Alert 16-124
  • Detention Without Physical Examination Of Aquaculture Seafood Products Due to Unapproved Drugs
• Import Alert 99-43
  • Detention Without Physical Examination Of Ready-To-Eat Human Food Products That Appear to Have Been Prepared, Packaged, Or Held Under Insanitary Conditions
• Import Alert 99-21
  • Detention Without Physical Examination of Food Products Containing Undeclared Added Sulfiting Agents

August 13, 2024

• Import Alert 99-45
  • Detention Without Physical Examination of Food Products That Are or Contain an Unsafe Food Additive
• Import Alert 16-39
  • Detention Without Physical Examination of Ready-to-Eat Seafood for Listeria monocytogenes
• Import Alert 16-129
  • Detention Without Physical Examination of Seafood Products Due to Nitrofurans
• Import Alert 16-127
  • Detention Without Physical Examination of Crustaceans Due to Chloramphenicol
• Import Alert 12-10
  • Detention Without Physical Examination of Cheese Due to Microbiological Contamination

August 9, 2024

• Import Alert 21-17
  • Detention Without Physical Examination of Papaya From Mexico

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By: Heather Van Tassell (contributing writer, non-lawyer)