Agentic AI deployment will enable FDA staff to further advance the use of AI to assist with more complex tasks, such as meeting management, pre-market reviews, review validation, post-market surveillance, inspections and compliance and administrative functions.
Inspections began to decline in early 2025, after 65% of the staff in the FDA divisions responsible for coordinating travel and budgets left or were fired in the name of government efficiency. Because of staff reductions, investigators suddenly had to book their own flights and hotels, obtain diplomatic passports and visas, and coordinate with foreign authorities. While the rate of foreign inspections had significantly decreased, domestic inspections have continued almost uninterrupted.
As of November 19, 2025, a total of 31 infants with suspected or confirmed infant botulism and confirmed exposure to ByHeart Whole Nutrition infant formula (various lots) have been reported from 15 states. Laboratory confirmation for some cases is ongoing. For 27 cases with illness onset information available, illnesses started on dates ranging from August 9 to November 13, 2025. All 31 infants were hospitalized. No deaths have been reported to date.
As of November 10, 2025, a total of 15 infants with suspected or confirmed infant botulism and confirmed exposure to Byheart Whole Nutrition infant formula. All 15 infants were hospitalized. No deaths have been reported to date. FDA’s Commissioner, Dr. Marty Makary, interviewed on CBS News on Nov.12, stated that the FDA did find one positive case of the bacteria that produce botulinum toxin in a can of ByHeart infant formula. Update: The New York Times reported that a Pennsylvania plant run by the company, ByHeart, was shut down this year after inspectors found mold, a leaking roof and more than 2,500 dead insects in a food production area.
“Government departments and agencies serve all citizens – republicans and democrats. This type of partisan rhetoric undermines trust in government and may violate the law.” Sandy Eskin, former Deputy Under Secretary for Food Safety at USDA
A total of 27 people infected with the outbreak strain of Listeria have been reported from 18 states. Of the 26 people with information available, 25 have been hospitalized and 6 deaths have been reported. One pregnancy-associated illness resulted in a fetal loss.
The agency will require import certification for shrimp and spices from certain regions of Indonesia, based on the risk of potential contamination of the food with Cesium-137
Due to the absence of either a fiscal year 2026 appropriation or a Continuing Resolution, only certain government activities will continue. While FDA will continue to conduct foodborne outbreak surveillance and response activities, the CORE Investigation Table will not be updated weekly during this time.
One Day Conference hosted by Institute for Food Safety and Nutrition Security (IFSAN), October 9, 2025 in Washington DC
From food safety and quality to food defense, integrity, and physical and digital security, the system continues to operate in silos. More than ever, there is the need for a unified, risk-based U.S. food protection system.
