What is an Import Alert?

An Import Alert is FDA’s way of telling the world that the Agency thinks your products present safety problems. As a result of an Import Alert, FDA will automatically detain your products at the border, costing your customers a lot of money. More technically, FDA Import Alerts are issued whenever FDA determines that it already has sufficient evidence to conclude that your products appear to be adulterated, misbranded, or unapproved, and that therefore they may be refused admission. Many products listed on import alert can still be imported into the USA. However, the import process will be more expensive for the importer, which will reduce the amount of money the importer is willing to pay for the product. Also, if FDA refuses the shipment because the importer decides not to bother trying to reverse an FDA automatic detention, or because the importer or private lab or customs broker fails to meet a simple deadline, the refused shipment will have to be exported or destroyed. In severe cases, FDA might ask Customs to seize the imported products.

What are the Different Types of Import Alerts?
There are many types of Import Alerts, both in terms of scope and impact, but also in terms of affected countries, regions, companies and product industries.  The largest and most active Import Alerts affect seafood, cosmetics, fruits and vegetables, color additives, dietary supplements, pesticide residues in foods, bakery items, active pharmaceutical ingredients (drugs), latex gloves and condoms (medical devices). Very few Import Alerts apply to only a single company. There is even an Import Alert specifically for companies that refuse an FDA facility inspection (new authority given to FDA under the Food Safety Modernization Act (FSMA)).

How is a Firm Added to an Import Alert?
First, FDA finds a problem with an imported product or a foreign manufacturer. Then, the FDA district office that found the problem prepares a recommendation to include the company and product on an Import Alert list, resulting in FDA Detention Without Physical Examination (DWPE – or “Automatic Detention”) for all future shipments of that product or from that company. The recommendation is sent to FDA’s Division of Import Operations (DIO, formerly DIOP (for “Policy”)) in headquarters (near Washington, DC).  Although most Import Alert recommendations come from the FDA compliance officer who found the problem originally, they can come from many more sources, including FDA inspectors, federal, state or local agencies, foreign or other government authorities, press releases, and industry complaints.  DIO reviews the recommendation, the supporting evidence, and current and past national detention data to determine whether Automatic Detention or DWPE is appropriate.  DIO sometimes refers the recommendation to one of FDA’s six Product Centers (Foods, Drugs, Devices, Biologics, Vet Medicine, or Tobacco). If FDA concludes that the recommendation is appropriate, DIO will either add the manufacturer, importer, or product to an existing Import Alert, or create a new one.  The company and product will then appear on the Import Alert’s “Red List.”