FDA News Release
New centralized program and technology upgrades dramatically enhance FDA’s ability to stop dangerous imports at U.S. borders
- For Immediate Release:
The U.S. Food and Drug Administration today 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 just 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.
"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, M.D., M.P.H.
The FDA ImportShield Program, 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. By leveraging time-zone coverage and focused commodity expertise under unified management, the program improves efficiency, consistency, and accountability in import decision-making.
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. This ensures consistent monitoring and enforcement of the FDA laws and regulations, while helping to prevent bad actors from exploiting gaps between regional teams.
“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, Pharm.D., “The FDA ImportShield Program helps the agency tackle this volume increase more efficiently.”
Alongside the FDA ImportShield Program, the agency is also pursuing comprehensive technology modernization, including an advanced review platform system that will for the first time integrate multiple tools and databases. This will enable the FDA’s frontline investigators to access comprehensive information more quickly while maintaining existing connectivity with Customs and Border Protection systems.
These changes represent the FDA's latest commitment to using the best available tools and technology to keep unsafe imported products from reaching American families, while facilitating the flow of safe products to those who need them.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.
