FDA Staff Cuts Leave Baby Formula Safety on a Very Unstable Shelf

Multiple brands of infant formula have been recalled recently due to bacterial contamination, and experts say the Food and Drug Administration is about as prepared for this as a toddler left unsupervised with a jar of pureed peas. The Trump administration’s cuts have left the agency inadequately equipped to handle the health threat.

Last March, the FDA launched Operation Stork Speed, promising to “expand options for safe, reliable, and nutritious infant formula for American families.” Two months later, then-FDA commissioner Martin Makary told Congress that the agency had lost around 3,100 employees due to the administration’s reorganization and cuts. Makary then departed the FDA the same month, presumably to pursue stork-related activities elsewhere.

Tom Brenna, a professor at the Dell School of Medicine with expertise in pediatrics and food science, was brought on to Operation Stork Speed to help design nutrition regulations. “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 emailed the Guardian. The FDA insists the operation is “continuing as planned,” having released one report in April on forever chemicals in infant formula - because nothing says “safe” like a side of PFAS.

“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,” said Sarah Mayne, former director of the FDA’s Center for Food Safety and Applied Nutrition across three presidential administrations, now a Yale public health professor. An FDA spokesperson claimed the administration more than doubled its infant formula staffing and requested Congress mandate more industry accountability, including requiring companies to report positive pathogen testing results. Mayne countered that the boots-on-the-ground workforce for facility inspections has been dramatically reduced, especially lacking “infant formula investigators.” The FDA spokesperson did not answer specific questions about cuts to inspectors.

Several brands have been recalled in the last year, with two cases involving active bacterial outbreaks. In late June, a lawsuit was filed against Nara Organics on behalf of a baby who allegedly contracted botulism from their formula, which the company voluntarily recalled earlier this month. Investigative journalists at Food Safety Magazine found Nara Organics used whole milk powder from Organic West - the same supplier that provided powder to ByHeart, which recalled its formula in November 2025 after an infant botulism outbreak linked to 48 hospitalizations across 17 states.

Infant formula safety has long been “mission critical” to the FDA, which requires annual inspections of all formula manufacturers - though not of ingredient suppliers. States are stepping up, but they don’t always communicate about shared contamination risks, said an anonymous source with FDA operations expertise. States conducted nearly 2,000 recall checks within the first week of the ByHeart response, while the FDA managed only 21, according to April congressional testimony from Steven Mandernach, executive director of the Association of Food and Drug Officials. Mandernach warned that increased reliance on state regulators plus restrictions on interstate communication could slow coordinated safety efforts. The whole milk powder in both contaminated formulas came from Nevada, while ByHeart and Nara Organics formulas are made in Iowa and Germany, respectively.

The Guardian requested FDA comment on June 25, including why Nara Organics’ German facility had no recent inspection data. On June 26, the FDA posted a report noting it had inspected and “found deficiencies” in Nara Organics facilities, adding that manufacturers had submitted “corrective action” under review. A Nara Organics spokesperson said their facility underwent a “routine FDA audit in May 2026” with “three observations” that the agency suggested “be remedied with voluntary corrective actions and did not recommend that formula production be paused or discontinued.” A June advisory from the California Department of Public Health linked three cases of infant botulism from late April and May to Nara Organics’ formula. The FDA report also said insufficient evidence exists to conclude whole milk powder was the contamination source, though the agency is investigating root causes via supply chain assessment and surveillance sampling.

A ByHeart spokesperson said the company is rolling out new safety measures and only learned of the shared milk powder supplier when the FDA posted its June 26 update, adding that “the FDA has shared that the root cause investigation is shifting to now focus on third-party ingredients. This investigation is still ongoing.”

Mayne and the anonymous source say FDA teams responsible for imported food safety are in an especially precarious position. Early this year, the European Union announced a multibrand, precautionary global recall of infant formula tied to concerns about cereulide - another lovely bacterial contaminant. Four months later, the FDA issued a recall alert for a2 Platinum Premium infant formula due to cereulide contamination in a product manufactured in New Zealand and sold only in the US. New Zealand’s food regulation authority, not the FDA, discovered the contamination. The FDA did not respond to questions about cuts to foreign inspection teams.

Mayne notes the FDA is just one component of a multi-agency food safety system “all of which has been damaged by the actions of the Trump administration.” Other forces, like climate change, also add to food risks. “The current administration is embracing policies that will accelerate climate change,” she 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.”