RFK Jr.’s Plan to Test Baby Formula Clashes With FDA Staff Cuts

US Health Secretary Robert F. Kennedy Jr.’s initiative to increase oversight of infant formula safety will test the FDA’s resources, as the agency faces downsizing under the Trump administration’s agenda to reshape the federal workforce.

The plan, dubbed “Operation Stork Speed,” will require the Food and Drug Administration to increase testing for heavy metals in infant formula and other children’s food, the Department of Health and Human Services announced March 18. Kennedy has prioritized efforts to review ingredients in the US food supply, directing the FDA to “use all resources and authorities at its disposal” to ensure infant formula products are safe and available.

Studies show the FDA has struggled with food safety oversight amid staffing shortfalls. The agency faced scrutiny over its organization and risk management plans, which critics say led to a nationwide infant formula recall in 2022 and the temporary shutdown of one of the nation’s largest production sites.

It’s unclear what’s at the FDA’s disposal to carry out the operation after President Donald Trump’s onslaught of federal workforce cuts and incoming reductions in force, current and former FDA employees say. The agency lost employees in layoffs, buyouts, and terminated telework arrangements—fueling the understaffing issue that predates Trump.

“The infant formula program at FDA has always been very small,” said Susan Mayne, former director of the FDA’s Center for Food Safety and Applied Nutrition under the first Trump, Obama, and Biden administrations.

“If the administration wants to scale up testing of formula for contaminants beyond what has already been done at the FDA, that will require resources and should reflect risk-based priorities,” said Mayne, who’s now a professor at the Yale School of Public Health.

The FDA regulates infant formula to ensure safety, nutritional adequacy, proper packaging, and labeling of products. The HHS said this assessment of infant formula nutrients would be the first comprehensive review by the FDA since 1998.

“We’re going to test comprehensively now,” Kennedy said March 20 in an interview on Fox News Channel. “Some parents prefer the European formulas,” but he said the agency is going to extend the personal importation ban to them.

A spokesperson for the FDA said the agency is testing approximately 340 samples of infant formulas. The FDA completed testing of 221 samples, which do not indicate that the contaminant levels present in infant formula would trigger a public health concern, the agency said.

‘More Work to Do’

Some FDA employees welcome the initiative, but worry workforce cuts will make it challenging to implement the nutrient review process and increase heavy-metal testing.

The Trump administration in February reportedly fired 89 staffers in the FDA’s Human Foods Program, followed by the resignation of the deputy commissioner for human foods, Jim Jones. The FDA reinstated fired probationary workers and placed them on administrative leave after a federal judge ruled their terminations were unlawful.

“We all want less toxins in infant formula,” said one FDA employee who was granted anonymity to speak freely. “But also, if RFK Jr. is giving the FDA more work to do, then make sure they have the personnel to do it.”

Nonprofit group Consumer Reports launched a petition on March 18 calling on Kennedy to ensure the FDA has the staffing and resources to keep harmful contaminants out of formula. The group that same day released a study that formulas from Abbott Laboratories and Reckitt Benckiser Group PLC‘s Mead Johnson Unit contained concerning levels of heavy metals.

“The teams that work on infant formula ingredients are already spread incredibly thin, so it is unclear where the resources to do this will come from,” said another FDA employee working in the food division. “We will likely need on the order of double the staff we had pre-purging efforts.”

A Bloomberg Law investigation in 2023 found all but one of 33 baby food products purchased in stores and online contained two of three heavy metals.

An HHS watchdog found the FDA during the infant formula recall in 2022 was slow in responding to complaints about the facility and lacked policies and procedures to establish time frames for inspections.

“The reality is that FDA’s infant formula office should have and could have been doing more,” said Frank Yiannas, former FDA deputy commissioner of food policy and response in Trump’s first term and in the Biden administration.

Yiannas testified in 2023 before a House committee that the FDA failed to conduct adequate inspections and wasn’t sufficiently tracking market share by supplier.

The agency has since worked to increase oversight of formula, establishing the Office of Critical Foods under the Human Foods Program.

”The need is to make sure it’s done carefully and it’s done with input from a lot of different sectors,” said Steven Abrams, a professor at the Dell Medical School at the University of Texas at Austin. “A scientific advisory panel would help guide the FDA. There’s a number of different pieces of this that require scientific advice.”

Timelines, Testing

Despite skepticism of resources, some industry watchers say the plan is a step in the right direction.

It builds on the Closer to Zero initiative, which works to reduce childhood exposure to contaminants from foods. The FDA in January established final action levels for lead in processed baby foods. The agency hasn’t set limits for heavy metals in formula.

“If the administration wants to succeed in its goal to ‘Make America Healthy Again,’ infant formula is a smart place to start,” said Jane Houlihan, director of science and health at Healthy Babies Bright Futures. “We also hope the agency retains a strong core of experienced technical staff who can efficiently review the new data and implement meaningful reforms.”

The operation “is clearly a need,” said Tom Neltner, executive director of Unleaded Kids. However, the work shouldn’t just come from the FDA.

“The industry should be testing each and every lot of the product with FDA double-checking the results,” Neltner said. “This is especially important given the staff cuts.”