FDA Reports Increased Efficiency in Imported Product Reviews with New ImportShield Program

The U.S. Food and Drug Administration (FDA) announced its initial review of the effectiveness of the FDA ImportShield Program (FISP), which launched in August 2025 to modernize how the FDA reviews imported products.

In four months, FISP increased processing speed by 66%, boosted monthly volume capacity by 33%, and reduced staff hours by 20%, saving approximately 3,388 hours each month, according to the agency.

FISP, formerly known as the Nationalized Entry Review Program, streamlines the FDA’s import review process by combining five separate regional teams into one centralized operation. This new, unified team provides consistent oversight across all U.S. ports of entry, said the FDA. By leveraging time-zone coverage and focused commodity expertise under unified management, the program aims to improve efficiency, consistency and accountability in import decision-making.  

"Whether it's detecting counterfeit medications or identifying contaminated food products, the FDA ImportShield Program and other modernization efforts add a powerful new layer of protection for American families," said FDA Commissioner Marty Makary.

This coordinated approach creates real-time protection through nationwide alerts. When the FDA discovers high-risk products like tainted infant formula or counterfeit medications at one port, all other ports are notified so they can prevent similar dangerous products from reaching consumers, said the agency. This ensures consistent monitoring and enforcement of FDA laws and regulations while helping to prevent bad actors from exploiting gaps between regional teams, said FDA.

“The FDA's import review workload has grown substantially, with admissibility decisions increasing from 58 million lines in 2024 to 75 million lines in 2025,” said Associate Commissioner for Inspections and Investigations Elizabeth Miller. “The FDA ImportShield Program helps the agency tackle this volume increase more efficiently.”

Alongside the FDA ImportShield Program, the agency is pursuing technology modernization, including an advanced review platform system that will for the first time integrate multiple tools and databases, said FDA. This will enable the FDA’s frontline investigators to access comprehensive information more quickly while maintaining existing connectivity with Customs and Border Protection systems, said the agency.