The Food and Drug Administration faces a mounting crisis in infant formula safety just as the agency is operating with dramatically fewer staff members following Trump administration cuts and restructuring. Multiple formula recalls tied to bacterial contamination in recent months have exposed vulnerabilities in a regulatory system that experts say is now stretched dangerously thin.
Last March, the FDA launched Operation Stork Speed, a program designed to expand safe and reliable infant formula options for American families. By May, FDA Commissioner Martin Makary revealed to Congress that the agency had lost approximately 3,100 employees due to administration-directed restructuring. Makary left the FDA that same month.
The timing has proved consequential. Tom Brenna, a professor at the Dell School of Medicine specializing in pediatrics and food science, was brought into Operation Stork Speed to help develop nutrition regulations. "I regret to say there has not been any movement since the summer of 2025, at least none that I know of," Brenna said in an email, though an FDA spokesperson countered that the initiative is "continuing as planned."
Sarah Mayne, former director of the FDA's Center for Food Safety and Applied Nutrition across three administrations and now a Yale public health professor, offered a stark assessment of the agency's position. "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," she said.
The practical impact is evident on the ground. The FDA's workforce of inspectors needed to prevent contamination has been drastically reduced, with infant formula investigators especially hard hit. When ByHeart recalled formula in November following an infant botulism outbreak linked to 48 hospitalizations across 17 states, states conducted nearly 2,000 recall checks within one week. The FDA managed only 21, according to congressional testimony from Steven Mandernach of the Association of Food and Drug Officials.
That outbreak originated from whole milk powder supplied by Organic West. The same supplier later provided powder to Nara Organics, which issued a voluntary recall in June after a California health advisory linked three infant botulism cases to its formula. A lawsuit was filed against Nara Organics on behalf of a baby who allegedly contracted botulism from the product.
The connected contamination cases reveal how gaps in the inspection and communication systems have widened. The whole milk powder was manufactured in Nevada, while ByHeart and Nara Organics produce formula in Iowa and Germany respectively. States do not always communicate with each other about shared contamination risks, and increased reliance on state regulators paired with restrictions on interstate information sharing could slow coordinated safety efforts, according to FDA operations experts.
Foreign-made formula presents a particularly acute challenge. The FDA's teams responsible for imported food safety are in a precarious position with reduced staffing. When the European Union announced a global recall of multiple infant formula brands in early 2026 over concerns about cereulide, a toxin produced by bacterial contamination, the FDA did not discover the problem independently. Four months later, when the FDA issued a recall alert for a2 Platinum Premium infant formula due to cereulide contamination, it was New Zealand's food regulation authority, not the FDA, that had uncovered the contamination in the first place.
The FDA has claimed it more than doubled infant formula staffing and requested congressional action requiring manufacturers to report positive pathogen testing results. An agency spokesperson said it released an April report on forever chemicals in infant formula and posted a June inspection report on Nara Organics noting deficiencies and corrective actions under review. The agency said it continues investigating contamination root causes through supply chain assessment and surveillance sampling.
Mayne emphasized that damage to food safety extends beyond the FDA alone. "The FDA is one component of a multi-agency food safety system, all of which has been damaged by the actions of the Trump administration," she said, adding that other pressures like climate change compound the risks to the food supply.
Author James Rodriguez: "The formula recalls expose a troubling pattern, where reduced federal capacity forces states to scramble independently while international contamination isn't caught until it reaches American babies."
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