Blogs | Law Meets Science
FDA Wields Additional Import Power for First Time
Oct 22 2025
Contributors
Reports of radioactive frozen shrimp have recently made headlines. But the bigger story may be how the FDA is responding and what that could mean for the future of imported food.
FDA-regulated food imported into the U.S. must comply with the same FDA laws and regulations that apply to domestic products. Working with the U.S. Customs and Border Patrol (CBP), the FDA monitors imported food shipments for compliance by reviewing paperwork submitted with the shipments and often physically inspecting the food itself.
In this instance, CBP agents found multiple shipments of cloves and frozen shrimp from two Indonesian islands (Java and a providence of Sumatra) were contaminated with Cesium-137, a radioactive isotope known to cause cancer and other health problems.
After confirming the contamination through testing, the FDA issued Import Alert 99-52 on October 3, 2025 for shrimp and all spices (not just cloves) from Java and Sumatra. Import alerts are a tool the FDA frequently uses to alert the public of contamination in imported food. They’re also the mechanism that allows the agency to do what’s called “detention without physical examination”—detaining future shipments of a product without testing it for problems found in previous shipments. Products identified in these alerts will not be allowed into the country unless the importer proves to the FDA that the shipment doesn’t have the problem(s) identified on the import alert. The type of proof the FDA requires can vary, depending on the circumstances.
In Import Alert 99-52, the FDA chose to require “import certification,” a type of proof it had never previously used. Import certification is a statutory tool that allows the FDA to require that specific food-safety measures—such as audits of foreign companies and pre-shipment food testing—be performed and documented as the agency directs. The FDA can require that those measures be taken (or at least overseen) by a foreign government agency of the FDA’s choosing or by an FDA-accredited third party. The FDA can require these measures once it makes a finding they are warranted in light of known risks about the safety of the food at issue. Once it imposes import certification measures, it can continue to do so until affected parties satisfy the agency that the cause of the contamination has been identified and addressed through measures that will prevent future contamination.
Import Alert 99-52, which takes effect this October 31, shows how FDA can use this authority. In the alert, the agency created a “Red List and a “Yellow List.” The Red List names two specific Indonesian companies whose products were found to be radioactive. (More companies can be added if the FDA finds other companies are shipping food with this contaminant). Those companies’ products will be barred from importation until the companies get an approved third party to certify that the root cause of the contamination has been identified, that the company has developed adequate food safety measures to keep this from happening again, and that the company is implementing those measures. The Yellow List covers specific foods: all shrimp and spices from the two Indonesian islands. No shipment of those foods may be imported here without a certification from the designated representative of the Indonesian government that the shipment is not contaminated with Cesium-137. This certification must be done regardless of whether the food came from a company on the Red List.
While only time will tell, these measures appear to be rigorous. At this stage it is unclear how exacting the FDA will be and how much time, effort, and cost will be required to resolve this issue.
The FDA did not make this move quietly: in addition to issuing a press release announcing the new measure, it created a new web page explaining how import certification works. That strongly suggests the agency intends to use import certification going forward and wants regulated industries to be ready for this more robust use of government authority. Businesses that could be affected should familiarize themselves with what the law allows the FDA to do and how to respond when the agency signals that it is considering implementing import certification on a particular product.
