The Food and Drug Administration reports that the FDA ImportShield Program, which launched in August 2025 to modernize how the agency reviews imported products, has already yielded some significant results.
According to an FDA press release, FISP (formerly known as the Nationalized Entry Review Program) streamlines the agency’s import review process by combining five separate regional teams into one centralized operation that provides consistent oversight across all U.S. ports of entry. Under this program, when the FDA discovers high-risk products 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 FDA laws and regulations while helping to prevent bad actors from exploiting gaps between regional teams.
The FDA states that in just a few months the FISP has increased processing speed by 66 percent, boosted monthly volume capacity by 33 capacity, and reduced staff hours by 20 percent. These advancements come as 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.
The press release notes that the FDA 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 U.S. Customs and Border Protection systems.
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