WASHINGTON (dpa-AFX) - The U.S. Food and Drug Administration has announced that its ImportShield Program has delivered impressive results in strengthening FDA oversight at U.S. ports of entry.
FDA announced its initial review of the effectiveness of the FDA ImportShield Program, which launched in August to modernize how the FDA reviews imported products.
The review found that the centralized program and technology upgrades dramatically enhanced FDA's ability to stop dangerous imports at U.S. borders.
In just four months, FISP increased processing speed by 66 percent, boosted monthly volume capacity by 33 percent, and reduced staff hours by 20 percent, 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.
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.
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