The FDA lost roughly 3,100 employees under Trump administration cuts and reorganization, former Commissioner Martin Makary told Congress in May 2025, the same month he departed the agency. Food safety experts and former agency officials say that staffing reduction has left the agency struggling to oversee infant formula safety at a time when recalls are piling up.

Sarah Mayne, who served as director of the FDA’s Center for Food Safety and Applied Nutrition across three administrations and is now a professor of public health at Yale, said the agency’s capacity to inspect facilities has been dramatically reduced. “When it came to resources and personnel at the FDA, I frequently said we can always do more with more. Well, now, the FDA is of course doing less with less,” Mayne said. She added that the agency’s field inspection workforce is “especially lacking infant formula investigators.”

The FDA launched Operation Stork Speed in March 2025, a planned initiative described as intended to “expand options for safe, reliable, and nutritious infant formula for American families.” The agency told the Guardian that the initiative is “continuing as planned” and has released one related report, on so-called forever chemicals in formula. But Tom Brenna, a professor at the Dell School of Medicine with expertise in pediatrics and food science who was brought on to the project, said he has seen no progress. “I regret to say there has not been any movement [on Operation Stork Speed] since the summer of 2025, at least none that I know of,” Brenna said in an email.

The FDA said it has more than doubled its infant formula staffing and asked Congress to require companies to report positive pathogen test results. The agency’s spokesperson did not respond to the Guardian’s specific questions about cuts to field inspectors.

Two separate infant formula recalls in recent months have each been tied to active bacterial outbreaks. Nara Organics voluntarily recalled its powdered infant formula in June after the California Department of Public Health linked three infant botulism cases to its products. A lawsuit was filed in late June against Nara on behalf of a baby who allegedly contracted botulism from the formula.

Investigative reporting by Food Safety Magazine found that Nara Organics used whole milk powder from Organic West, the same Nevada supplier that provided milk powder to ByHeart. ByHeart recalled its formula in November 2025 following an infant botulism outbreak that led to 48 hospitalizations across 17 states, according to the Guardian’s reporting. A ByHeart spokesperson said the company learned of the shared supplier only after the FDA posted an inspection update on June 26, and that “the FDA has shared that the root cause investigation is shifting to now focus on third-party ingredients.”

Nara Organics said its facility underwent a routine FDA audit in May 2026 and that the agency found three observations it suggested “be remedied with voluntary corrective actions and did not recommend that formula production be paused or discontinued.” The FDA later posted an online report noting it had inspected the Nara facilities and found deficiencies, and that manufacturers had submitted corrective action for review. The agency said there is insufficient evidence to conclude whole milk powder was the contamination source and that its investigation continues.

Food safety oversight has increasingly fallen to state regulators. Steven Mandernach, executive director of the Association of Food and Drug Officials, testified in Congress in April that states conducted nearly 2,000 recall checks within the first week of the ByHeart response, while the FDA conducted only 21. Mandernach warned that heavier reliance on states, combined with restrictions on interstate communication, could slow coordinated safety responses. A source with expertise in FDA operations who requested anonymity said states do not always share information about shared contamination risks.

The FDA also faces challenges with imported formula. Earlier this year, the European Union announced a global, multibrand recall tied to cereulide contamination. Four months later, the FDA issued a recall alert for a2 Platinum Premium infant formula due to cereulide in a product manufactured in New Zealand and sold only in the U.S. The contamination was discovered by New Zealand’s food regulator, not the FDA.

Mayne said the FDA is just one part of a food safety system that has been eroded by administration actions. Climate change, she noted, introduces additional risks. “The current administration is embracing policies that will accelerate climate change,” Mayne said. “So, there is really a multipronged attack on our food safety system, the full impact of which will be revealed in the months and years to come.”