FDA’s ImportShield Program Delivers Significant Gains in Safety and Efficiency
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The U.S. Food and Drug Administration (FDA) is reporting substantial improvements in its ability to safeguard American consumers through its new FDA ImportShield Program (FISP). Launched in August 2025, the program has already yielded a 66% increase in processing speed, a 33% boost in monthly volume capacity, and a 20% reduction in staff hours – 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,” stated FDA Commissioner Marty Makary, M.D., M.P.H.
The FISP, previously known as the Nationalized Entry Review Program, represents a fundamental shift in how the agency handles the review of imported goods. By consolidating five separate regional teams into a single, centralized operation, the FDA has established consistent oversight across all U.S. ports of entry. This unified structure leverages time-zone coverage and specialized commodity expertise, leading to improved efficiency, consistency, and accountability in import decision-making.
Real-Time Protection Through Nationwide Alerts
A key feature of the ImportShield Program is its ability to disseminate real-time alerts nationwide. When the FDA identifies high-risk products – such as tainted infant formula or counterfeit medications – at one port, all other ports are immediately notified. This proactive approach prevents similar dangerous products from reaching consumers and ensures consistent enforcement of FDA laws and regulations, effectively closing loopholes previously exploited by bad actors.
“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,” explained Associate Commissioner for Inspections and Investigations Elizabeth Miller, Pharm.D. “The FDA ImportShield Program helps the agency tackle this volume increase more efficiently.”
Investing in Future Capabilities
Beyond the ImportShield Program, the FDA is actively pursuing comprehensive technology modernization. This includes the development of an advanced review platform system designed to integrate multiple tools and databases for the first time. This platform will empower frontline investigators to access comprehensive information more quickly, while maintaining seamless connectivity with Customs and Border Protection systems. .
These changes underscore the FDA’s ongoing commitment to utilizing the best available tools and technology to protect American families from unsafe imported products, while simultaneously facilitating the flow of safe and necessary goods.
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.
Content current as of: January 21, 2026.
