Ins and Outs of Import Alerts

An AFI Staff Report

FDA reviews entries to ensure the products comply with U.S. regulations. The review may include a request for more information or an examination or sampling of the product. It’s important to note that during the review period, product shouldn’t be distributed.

FDA may refuse an entry if its review determines it violates or appears to violate any U.S. regulation. Once a product is found to be violative, future shipments of that product from that manufacturer – and perhaps the importer – are also subject to refusal. These products are detained without physical examination by FDA and listed on an import alert.

Import alerts inform FDA’s 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’s 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’s laws and regulations.

Where can I find a list of the FDA’s import alerts?

Go to www.fda.gov and search for import alerts. It will take you to a page where you can search alerts by country/area, industry, number or date.

How do I interpret an import alert?

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 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 20-05 states: Surveillance of heavy metal levels in fruit juices and fruit juice concentrates from all countries is warranted.

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 the 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’s 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.

What are the types of import alerts?

Country- or area-wide

The FDA may detain without physical examination certain products offered for entry from the specified country or area.

Manufacturer/Product Specific

The FDA may detain without physical examination certain products from specific manufacturers.

Shipper

The FDA may detain without physical examination certain products from shippers.

Country/World Wide Alert

The FDA may detain without physical examination certain products from all countries outside of U.S.

What is a red, green and yellow list?

Red List

Firms, products and/or countries are subject to Detention without Physical Examination (DWPE) under an import alert.

Green List

Firms, products and/or countries that have met criteria for exemption from Detention without Physical Examination (DWPE) under an 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.

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.

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.

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

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.