How to Respond to FDA Import Alerts

With today’s increasingly global food system, FDA Import Alerts have become a critical safeguard for public health, enabling the quick and efficient detention of unsafe food and beverage products at the border. Amid supply chain disruption and greater concerns about economically motivated adulteration, there’s been a notable uptick in the number of import alerts issued since the turn of the decade. 

In the first half of 2024, the FDA has already issued over 70 import alerts, compared to the  approximately 40 issued throughout 2023. If your company hasn’t been impacted by this system yet, it’s only a matter of time. Importers need to know exactly what an FDA Import Alert means and how to respond if one of their products or suppliers is implicated. 

What is the FDA Import Alert system? 

The FDA Import Alert system allows the agency to identify and address potential violations in imported products — particularly concerning food safety, accuracy and compliance of labeling and manufacturing practices — and prevent them from entering the U.S. market. These alerts inform both FDA field staff and the general public of potential health and food safety risks. 

Actual violations can be related to individual products or the manufacturers, shippers, or other parties involved in the production, procurement, and distribution of non-compliant products. 

Common reasons for FDA Import Alerts include: 

• The product tested violative for a pathogen. 
• The product contains illegal colors or food additives. 
• The product contains pesticides that are not allowed or do not meet tolerance levels. 
• A company had a violative inspection by the FDA. 
• A foreign company refused inspection by the FDA. 

The import alert grants the agency authority to detain imported products in customs with what’s referred to as Detention Without Physical Examination (DWPE) of products while using the least amount of agency resources possible. This frees up staff to continue examining other shipments and monitoring for food safety issues. 

How to Respond to an FDA Import Alert 

Compliance with FDA laws and regulations ultimately falls on importers. The agency maintains a comprehensive list of import alert notices and regularly updates their site each time an alert is issued. 

The FDA issues each alert as an individual document that contains all the information readers need to understand why the alert was issued and what products and companies are impacted. Each alert contains essential information such as: 

• The import alert number 
• Date published 
• Type of alert (e.g., Detention Without Physical Examination or with surveillance)
• The alert's name and reason 
• Guidance on FDA and other regulatory agency actions 
• Actions to take for potential removal from the alert 
• Description of the products subject to DWPE 
• The specific FDA laws and regulations applicable to the alert 
• Details about countries or areas subject to DWPE  

 In some cases, the alert may list the companies and their products that are subject to DWPE, exempt from detention, or in need of further surveillance. The FDA categorizes these products into three types of color coded lists: 

• Red List: Comprises companies, products, or countries subject to DWPE under an import alert due to compliance issues 
• Green List: Entities that meet criteria for exemption from DWPE 
• Yellow List: Comprises companies, products, or countries under intensified surveillance or with resolved Good Manufacturing Practice (GMP) issues that warrant further scrutiny or analysis 

For items on the Red List, importers usually must provide or obtain evidence that the product is not in violation of FDA regulations. This effort usually involves private laboratory testing showing that products are free of the suspected contaminants that initially triggered the detention. If an importer fails to provide sufficient evidence, it will result in continued detention. 

Navigate FDA Import Alerts With Expert Support 

Sourcing from a supplier that’s impacted by FDA Import Alerts can be incredibly disruptive to your business, but this system is necessary to protect public health. Working with trusted experts to free products from detention — or mitigate supplier risk to begin with — can help keep your organization on track in terms of both food safety and productivity. 

AIB International has helped food and beverage companies navigate the complex landscape of regulatory compliance for over a century. Want to learn more about our services? Assign one of our experts to your case to begin improving your food safety program today.