How do I interpret an import alert?
Each import alert will include the following information:
|Import Alert Section||Description|
|Import Alert #||This is a number issued by the FDA. The first 2 digits refer to the industry code of the product. For example, any import alert number beginning with 16 is related to seafood products.|
|Published Date||This is the last date that there was an update to the alert. This is not the original date the alert was published.|
|Type||This 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 Name||This is the name of the alert; it is a brief description of what the alert applies to.|
|Reason for Alert||This section describes why the alert was issued.|
|Guidance||This 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 Description||This section describes what products are subject to DWPE.|
|Charge||This section describes the FDA laws and regulations applicable to the import alert.|
|Countries||This 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.|
What are the types of import alerts?
|Category of Import Alert||Instructions||Violation Example|
|Country- or area-wide||FDA 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 Specific||FDA 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.”
|Shipper||FDA 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 Alert||FDA 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.
What is a red, green and yellow list?
|Type of List||Description||Example|
|Red List||Firms, 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 List||Firms, 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 List||Firms, 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.
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.