What is an FDA import alert?

What FDA says an import alert does

FDA's import alerts page describes them as a way to inform the public and the import community about products and firms that appear to violate FDA regulations. It says FDA can place a product on an import alert after finding a violation and then detain future shipments without having to test or otherwise physically examine them.

Detention without physical examination (DWPE) is the mechanism. A shipment on the alert is detained, and release depends on the importer showing evidence that the shipment does not have the violation FDA cited.

Example: the GLP-1 ingredient alert

On Sept. 5, 2025, FDA announced a green list, an import alert for GLP-1 active pharmaceutical ingredients. FDA said ingredients from facilities it had inspected and found compliant would be listed, and that ingredients from other sources would face detention without physical examination.

The alert is Import Alert 66-80, titled as a detention without physical examination of GLP-1 receptor agonist bulk drug substances. Its charge is current good manufacturing practice violations. As FDA explains it, after inspecting and assessing 48 GLP-1 ingredient manufacturers it found about 21 percent noncompliant. The alert page references a March 2026 revision. We did not settle the exact revision history, so we give FDA's announcement date, not the page's own date.

What an import alert does not tell you

• It concerns shipments offered for entry into the U.S. It does not by itself say anything about a domestic company or its products.
• Being on an alert is FDA's position that a product or firm appears to violate requirements. It is not a court finding.
• An alert about one ingredient class, such as GLP-1 ingredients, says nothing about other peptides.
• Alerts are revised. Check the alert page for its current text.