What is an FDA Import Alert?

Importers of food and dietary supplements into the U.S. must pay close attention to import alerts issued by the U.S. Food and Drug Administration (FDA). Failure to do so could cause your product to be detained at the port and ultimately refused entry.

What is an FDA import alert?  

An import alert is issued by the FDA to inform its field workers and the U.S. Customs and Border Patrol that a product appears to be in violation of the United States law. Food products subject to an import alert will also be subject to a Detention Without Physical Examination (DWPE). Products subject to a DWPE will be detained until the importer can show that the product is safe and meets U.S. standards. If an importer cannot demonstrate this, then product will be refused entry.   

Import alerts can be based on a number of key identifiers, such as: (1) the country or area of the product’s origin; (2) the name of the manufacturer; (3) the type of product being imported; (4) the name of the shipper; and/or (5) a worldwide alert relating to shipments of certain products or ingredients.

For example, in 2007, after tracing melamine in pet food to imported “wheat gluten” and “rice protein concentrate” from China, the FDA issued an import alert titled "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." As a result, absent an applicable exclusion, any vegetable protein products imported from China will be detained at the border. 

Import alerts can also relate to individual companies, including both manufacturers and shippers.  

• The FDA’s Red List lists all companies and their products that are subject to a DWPE due to an import alert.  
• The FDA’s Green List lists the companies and products that have met the criteria for exclusion from a DWPE based on an import alert.
• The FDA’s Yellow List lists companies, products and/or countries that are subject to intensified surveillance, or where the nature of past violations may warrant further field examinations or additional analyses.

How can my company avoid being subject to an import alert?

Each import alert describes the conditions that may result in the company or product being subject to DWPE. When a product and/or company 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. Import alerts can be found here: Search for Import Alerts | FDA. 

The following are some reasons your product or firm may be subject to DWPE: 

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

Recommendations for placement on an import list, and import violations, are sent to the FDA’s Division of Import Operations  (DIO).  The DIO will determine whether there is sufficient evidence to add the company and/or product to an import alert.  

What if my product is detained?

If your product is detained due to an import alert, you will receive a Notice of Action from the FDA. You will then have the right to provide evidence to the FDA to overcome the appearance of a violation. The FDA will likely require additional information, corrective action, and/or evidence of other non-violative shipments before approving a DWPE removal. If you do not overcome the appearance of a violation, your product will be refused entry into the U.S.  

Needless to say, it is important to make sure your product will not be subject to an import alert before shipment and to have a plan in place in the unfortunate event that your product is DWPE.  

For more information on how to ensure your product is not subject to an import alert or what to do if your product is detained, please visit the U.S. Imports website.