FDA Infant Formula Safety Study Drives Enforceable Limits Push

Pressure is mounting on the Food and Drug Administration to set enforceable limits regulating the level of contaminants allowed in infant formula as lawmakers, manufacturers, doctors, and consumer advocates urge the agency to translate its research into binding safety standards.

FDA officials vowed last week they would continue working to establish action levels for infant formula contaminants when they released a study that found few instances of heavy metals or chemicals in formula products. Action levels set a threshold that, if crossed, enable the agency to pursue enforcement actions, including mandatory recalls.

Yet the agency’s limited resources, staff cuts, and the Trump administration’s deregulatory efforts could affect how quickly, if it all, FDA can achieve that goal. The agency’s next steps come as Health and Human Services Secretary Robert F. Kennedy Jr. drives increased oversight of the infant formula industry through a plan dubbed “Operation Stork Speed,” which is focused on increasing the safety and nutritional quality of products that substitute for breast milk.

“Without a legal obligation there’s always a risk that they skimp on the testing if it’s something that someone can get a competitive advantage out of,” said Thomas Gremillion, the director of food policy at the Consumer Federation of America, an association of pro-consumer organizations.

Even though infant formula companies say they already test their products and comply with limits set by other countries, clear rules are still needed to account for stragglers, Gremillion said.

Regulators in the European Union, Canada, Australia, and New Zealand have already set infant formula limits for heavy metals, including lead and arsenic.

“When you don’t set the action levels, you are in this weird gray zone” that makes it harder for industry, the regulatory community, and consumers to know what level of contamination warrants action, said Steven Mandernach, the executive director of the Association of Food and Drug Officials.

“We urge the FDA to set scientifically established standards to help consumers further trust the safety of U.S. infant formulas,” John Koval, a spokesperson for Abbott, said in an email. Abbott is one of the largest infant formula manufacturers.

Setting action levels are a priority for the FDA, and it continues to dedicate resources “to advance this effort,” HHS spokesperson Andrew Nixon said in an emailed statement.

The agency has requested additional authorities from Congress to set those action levels “by administrative order” in recognition of “the need for improved efficiency,” Nixon said.

Hurdles Ahead

Action levels take time to develop. The FDA typically issues draft guidelines first so the public and industry can provide feedback, and the limits don’t become enforceable until they’re finalized.

The agency must pursue a “science-based process that evaluates toxicity, exposure levels, and how commonly the contaminant occurs in the product,” Nixon said.

Tom Brenna, a pediatrics professor at the the University of Texas’ Dell Medical School, said the agency will need to consider the costs of setting limits or not.

“The administration’s policy to remove, I think the number is 10 regulations for every new one that gets put in, might be an impediment to actually moving forward,” Brenna said.

President Donald Trump established that policy by executive order shortly after returning to the White House in January 2025.

Resources could be another hurdle.

The FDA’s Human Foods Program, which houses the Office of Critical Foods responsible for overseeing infant formula safety, operates with significantly less funding than the side of the agency responsible for regulating drugmakers.

The Food and Drug Administration lost 3,870 employees in 2025 and 647 so far in 2026, according to the Office of Personnel Management.

“This is not possible to do with existing resources,” Mandernach said.

Lawmakers sitting on the House Energy and Commerce Committee acknowledged as much during an April 29 hearing deliberating a range of food safety topics, including infant formula.

Attrition at the FDA included 89 people in the Human Foods Program who specialized in infant formula and food safety, Rep. Frank Pallone (D-N.J.) said at the hearing.

“These cuts showed the Trump administration has no interest in protecting our families from harmful chemicals and showed complete disregard for the fragile infant formula market that parents rely on,” Pallone said.

At least two bills (H.R. 8429, H.R. 2472) introduced since March and backed largely by Democrats would make the FDA set limits on arsenic, lead, cadmium, and mercury in infant formula.

FDA regulators in January established action levels for lead in baby foods, which took roughly four years to develop. It was the agency’s latest step to advance its Closer to Zero Initiative, which was launched months after a 2021 congressional report found high levels of toxic heavy metals—including arsenic, lead, cadmium, and mercury—in baby foods. The initiative seeks to to minimize the presence of those contaminants.

“When we make products, when we store products, that ends up adding to some of this contamination that we’re actually seeing,” said Valeria Cohran, a doctor at Children’s Hospital of Chicago and pediatrics professor at Northwestern University’s Feinberg School of Medicine.

An investigation Bloomberg Law published in 2023 found at least two heavy metals in all but one of 33 baby food products available to consumers.

Eye on Pathogens

Despite the FDA’s focus on reducing heavy metal and chemical levels in infant formula, a different culprit was responsible for the country’s two most recent formula-related public health crises: bacteria. Lawmakers are pushing for more action there, too.

On April 29, the Senate unanimously passed an infant formula bill (S. 272) that would expand the FDA’s infant formula testing authorities and require companies notify the agency when it discovers products contaminated with pathogens.

House lawmakers introduced several similar bills following two pathogen outbreaks that hospitalized dozens of babies since 2022.

Some think the agency could accelerate its long-term strategy to make formula safer without new legislation.

“They could be requiring a lot more under the existing law with respect to microbiological contaminants,” Gremillion said.