The U.S. Food and Drug Administration (FDA) has instituted an import certification requirement for shrimp and spices originating from a specific region of Indonesia. This action follows the detection of elevated levels of Cesium-137 (Cs-137), a radioactive element, in products from that area. Notably, this marks the first time that FDA has exercised this authority, which it received more than 14 years ago through the Food Safety Modernization Act (FSMA) (FDCA, Section 801(q)).

Under this new requirement, any import shipment subject must be accompanied by certification that the food complies with FDA standards and is free from Cs-137 contamination (FDA, FAQ about FDA’s Response). This certificate must be issued by the Government of Indonesia and if the required certification is not provided, FDA will refuse the import (FDCA, Section 801(a)).

The certification requirement is outlined in Import Alert 99-52, which creates a two-tier system: red list and yellow list. A firm on the “red list” is essentially barred from exporting to the United States until they provide FDA with adequate assurances. Everyone else is on the “yellow list”—which is this certification requirement.

This new requirement will affect import timelines and necessitate increased coordination among stakeholders. The appropriate certificate must be obtained from the designated Indonesian authority. These import certifications must be submitted directly to FDA from the Indonesian authority using a system that only works after the U.S. Customs broker has filed the import filing. As such, strong communication between the importer, exporter/manufacturer and the certifying entity is essential to ensure timely and accurate submission of documentation to FDA and to avoid import refusals.

If a shipment lacks the required certification or originates from a manufacturer on the red list, FDA will deny the importation. This requirement takes effect on October 31, 2025. As this is the first time FDA is implementing this authority, some initial challenges are expected. It remains to be seen whether this is a one-time action or the beginning of a broader FDA regulatory strategy for imported food products. 

By Senior Counsel John F. Johnson III