For Industry

Import Alerts

Overview

This page provides information on what an import alert is and how to interpret it. For information on how to be removed from an import alert, please see the import alert removal page.

Import alerts inform FDA field staff and the public that the agency has enough evidence to allow for Detention Without Physical Examination (DWPE) of products that appear to be in violation of FDA laws and regulations. These violations could be related to the product, manufacturer, shipper and/or other information. Before importing into the United States, importers should know if their products are subject to DWPE. DWPE allows the agency to detain a product without physically examining it at the time of entry.  
 

What is the purpose of an Import Alert?

Import alerts:

  • Prevent potentially violative products from being distributed in the United States;
  • Free-up agency resources to examine other shipments;
  • Provide uniform coverage across the country;
  • Place the responsibility back on the importer to ensure that the products being imported into the United States are in compliance with FDA laws and regulations.

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Where can I find a list of FDA import alerts?

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How do I interpret an import alert?

Each import alert will include the following information:

Import Alert SectionDescription
Import Alert #This is the number issued by the FDA. The first 2 numbers are the industry code of the product. For example, any import alert that starts with a 16 will be related to seafood.
Published DateThis is the last date that there was an update to the alert. This is not the original date the alert was published.
TypeThis describes whether the alert is DWPE or DWPE with surveillance. Import Alerts that are DWPE with surveillance include additional guidance for the field. Such as, IA 12-07 states: Districts should continue to sample and analyze cheese with country of origin of Azores/Portugal, whether imported from Azores/Portugal directly or from Canada for Listeria monocytogenes.
Import Alert NameThis is the name of the alert; it is a brief description of what the alert applies to.
Reason for AlertThis section describes why the alert was issued.
GuidanceThis section describes what actions FDA may take and may provide guidance on how to be removed from the alert. This section can vary based on the type of alert.
Product DescriptionThis section describes what products are subject to DWPE.
ChargeThis section describes the FDA laws and regulations applicable to the import alert.
CountriesThis section is included for country- or area-wide import alerts and includes the countries/areas subject to DWPE.
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)This section lists the firms and/or products that are on the red list of the import alert. If a firm/product is on the red list of an import alert, it means they are subject to DWPE.
List of firms and their products that have met the criteria for exclusion from Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Green List)This section lists the firms and/or products that are on the green list of the import alert. If a firm/product are on the green list of an import alert it means they are not subject to DWPE.

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What are the types of import alerts?

 

Category of Import AlertInstructionsViolation Example
Country- or area-wideFDA may detain without physical examination certain products offered for entry from the specified country or area.EXAMPLE: Import Alert #12-03 “Detention without Physical Examination of Imported Soft Cheese and Soft Ripened Cheese from France.”
Manufacturer/Product SpecificFDA may detain without physical examination certain products from specific manufacturers.

EXAMPLE:  Import Alert #89-16 “Detention Without Physical Examination of Products from Medical Device Firms Refusing FDA Foreign Establishment Inspection.”

EXAMPLE:  Import Alert #99-37 "Detention Without Physical Examination of Low-acid Canned Foods and Acidified Foods Without Filed Scheduled Processes."

ShipperFDA may detain without physical examination certain products from shippers.

EXAMPLE: Import Alert #16-105 "Detention Without Physical Examination of Seafood and Seafood Products from Specific Manufacturers/Shippers Due to Decomposition and/or Histamines."

A specific shipper was found to have caused the violation.

Country/World Wide AlertFDA may detain without physical examination certain products from all countries outside of U.S.

EXAMPLE:  Import Alert #16-20 “"Detention Without Physical Examination of Puffer Fish."

There is a high fatality rate among those who ingest tetrodotoxin, a toxin found in puffer fish. The toxin cannot be destroyed by cooking or freezing. Therefore, the importation of puffer fish products is restricted. There have been several serious illnesses which have occurred due to puffer fish that were illegally imported into the U.S.

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What is a red, green and yellow list?

Type of ListDescriptionExample
Red ListFirms, products and/or countries are subject to Detention without Physical Examination (DWPE) under the Import Alert.

EXAMPLE:  A food that previously was shown to contain deadly bacteria that can cause a food-borne illness.

Green ListFirms, products and/or countries that have met criteria for exemption from Detention without Physical Examination (DWPE) under the Import Alert.

EXAMPLE:  Import Alert 12-03 indicates that all soft cheeses from France are subject to DWPE. However, there are some soft cheeses from firms that received an exemption based on the guidance in the import alert. The firms/ products that are allowed to be imported are on the green list of this import alert.

Yellow ListFirms, products and/or countries subject to intensified surveillance; or firms that may have satisfied GMP issues but where the nature of violations may warrant further field examinations of individual entries and/or additional analyses.

EXAMPLE:  Import Alert 66-38 indicates that Skin Care Products Labeled As Anti-Aging Creams are subject to DWPE. This alert includes a red list and a yellow list.

All entries of skin care products imported by the firms or manufactured/shipped by the firms on the Yellow List will continue to be checked for drug claims until the FDA has confidence the firm's products are in compliance.

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When does FDA decide to create a new import alert?

There are many reasons that FDA may create a new Import Alert. Here are two examples:

  • In March 2007, FDA began investigating pet deaths in the United States associated with the consumption of pet food. FDA found melamine and melamine analogs in the pet food and traced this contamination to products labeled as "wheat gluten" and "rice protein concentrate" imported from China.

    In response to these findings, FDA issued Import Alert #99-29 "Detention without Physical Examination of All Vegetable Protein Products from China for Animal or Human Food Use Due to the Presence of Melamine and/or Melamine Analogs."
  • Due to a large number of detentions for illegal and undeclared food color additives, FDA issued Import Alert 45-02 "Detention Without Physical Examination and Guidance of Foods Containing Illegal and/or Undeclared Colors."

How does FDA decide to add firms or products to the red list or exclude firms or products from the green list of an existing import alert?

Each import alert describes the conditions that may result in the firm being subject to DWPE.  When a product and/or firm is violative and meets the criteria indicated in an import alert, it will be added to the red list or removed from the green list of the alert.
The following are some reasons your product or firm may be subject to DWPE. This list is not all inclusive.

  • FDA has sampled your product and it tested violative for a pathogen
  • FDA has sampled your product and it contains illegal colors or food additives
  • Your product contains pesticides that are not allowed or do not meet tolerance levels
  • The firm has not provided sufficient evidence to support adding them to the green list
  • Your product is an unapproved new drug
  • The foreign firm had a violative inspection by FDA
  • The foreign firm has refused inspection by FDA

Violation information and recommendations for placement on import alert are forwarded to the FDA’s Division of Import Operations  (DIO) and, when applicable, the relevant Center office.  DIO and possibly the Center will determine whether there is sufficient evidence to add the firm/product to an import alert. Import alerts go through an FDA approval process before implementation.

For information on how to be removed from a red list or added to a green list, please see the import alert removal page.

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What do I do if my product is detained without physical examination (DWPE)?
 

If your product is detained without physical examination, you have the right to provide evidence to FDA in an attempt to overcome the appearance of the violation. If you do not provide evidence to FDA, or if the information you provide is not sufficient to overcome the appearance of the violation, your product is subject to refusal into the United States. Visit the Detention and Hearing page for more information on this process.

Contact the compliance officer listed on your FDA Notice of Action if you have questions related to the detention.

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What if I want to submit a private laboratory report as evidence to support release of my product from detention?
 

Depending on the type of issue covered by the import alert, submitting private laboratory reports may be useful as evidence to overcome the appearance of the violation.  Submission of a private laboratory report does not guarantee release of your product.  If you have questions related to the process of submitting a private laboratory report, contact the compliance officer listed on your FDA Notice of Action.

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Page Last Updated: 04/22/2016
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