FDA Infant Formula Safety Study Finds Low Contaminant Levels Amid Mounting Recall Concerns
核心洞察
The FDA's largest-ever infant formula contaminant study tested 312 samples across 16 brands and found overwhelmingly undetectable or very low levels of heavy metals, pesticides, and PFAS (搜索).
All formula samples tested well below EPA and EU limits for heavy metals, and all but three samples were free of the 318 pesticides tested, though some phthalates (搜索) and PFAS (搜索) were detected at very low levels.
Outside experts cautioned that any detection of PFAS (搜索) or phthalates (搜索) in infant products warrants scrutiny, highlighting the need for continued monitoring and reduction efforts.
The U.S. Food and Drug Administration has released results from the largest and most rigorous examination of chemical contaminants in infant formula ever conducted, analyzing 312 powdered and liquid formulas from 16 brands purchased at stores and online retailers across the northeastern United States. The findings, announced Wednesday, show that an overwhelming majority of samples had undetectable or very low levels of contaminants, affirming that the U.S. infant formula supply is safe.
"We tested more infant formula than ever before, and the results are clear: most products meet a high safety standard—but even small exposures matter for newborns," said Health and Human Services Secretary Robert F. Kennedy Jr. "We will hold manufacturers accountable, and give parents honest, transparent data they can trust. Protecting our children's health is nonnegotiable."
The agency tested for heavy metals including lead (搜索), mercury (搜索), cadmium (搜索), and arsenic (搜索); pesticides such as glyphosate and glufosinate; and polyfluoroalkyl substances (PFAS (搜索)), commonly referred to as "forever chemicals." According to the results, all formula samples tested well below EPA and EU limits for heavy metals, and all but three of the samples were free of the 318 pesticides tested. The FDA detected some phthalates (搜索) and PFAS in the formula samples, though the agency characterized the levels as being very low.
Experts note that these contaminants are ubiquitous in the environment, making it difficult to remove them entirely from the food supply, including infant formulas.
Operation Stork Speed and Ongoing Oversight
The study was conducted as part of Operation Stork Speed, an initiative launched last year by the FDA to improve the safety and quality of U.S. infant formulas through increased testing for heavy metals, pesticides, and other contaminants. "The FDA will use all resources and authorities at its disposal to make sure infant formula products are safe and wholesome for the families and children who rely on them," Kennedy said at the program's launch.
FDA Commissioner Marty Makary emphasized the broader mission: "You can judge a society by how it treats its most vulnerable members. That's why we're doing everything in our power to make sure our babies and infants have safe, high quality formula options that are backed by a resilient supply chain. The results of this study are encouraging. We will continue to advance formula innovation and safety for the millions of families who depend on it."
The FDA said it is following up with additional testing as part of ongoing monitoring and oversight efforts, including testing for additional contaminants and continuing to engage with manufacturers on measures to reduce contaminant levels to as low as possible.
Outside Experts Raise Concerns
While federal health officials describe the results as reassuring, some outside experts noted that certain phthalate and PFAS (搜索) levels were concerning. "Any detection of PFAS or phthalates (搜索) is problematic" and deserves scrutiny, especially in products that babies consume, Dr. Sheela Sathyanarayana, a professor of pediatrics at the University of Washington, told The New York Times.
Dr. Sathyanarayana added that the findings highlight the need for continued monitoring and work to reduce levels of these contaminants in formula.
Vulnerability of Infants to Contaminants
Infants and children exposed to metals such as lead (搜索), mercury (搜索), cadmium (搜索), and arsenic (搜索) can experience impaired development, learning, and attention, and face an increased risk of lifelong health problems including cancer and respiratory and cardiovascular conditions, according to the Children's Environmental Health Collaborative. Children are particularly vulnerable because their brains and bodies are still developing, and they eat, drink, and breathe more than adults relative to their body size, meaning they absorb higher amounts of toxic metals when exposed and are less able to detoxify them.
Staffing Cuts and Recall Challenges
The release of the contaminant study comes against a backdrop of significant staffing reductions at the FDA. According to reporting from The Guardian, Martin Makary, who was FDA commissioner at the time, told Congress that the FDA had lost around 3,100 employees due to Trump administration reorganization and cuts. Makary departed the FDA in May.
Sarah Mayne, former director of the FDA's center for food safety and applied nutrition across three presidential administrations and now a professor of public health at Yale, said: "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."
Tom Brenna, a professor at the Dell School of Medicine with expertise in pediatrics and food science who was brought on to Operation Stork Speed, told The Guardian: "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." An FDA spokesperson maintained that Operation Stork Speed is "continuing as planned."
Several brands of infant formula have been recalled in the U.S. in the last year, including two cases involving active bacterial outbreaks. In late June, a lawsuit was filed against Nara Organics (搜索) on behalf of a baby who allegedly contracted botulism (搜索) from the company's infant formula. A ByHeart (搜索) formula recall in November of last year was linked to an infant botulism outbreak associated with 48 hospitalizations across 17 states.
Mayne noted that the FDA's workforce of inspectors to examine facilities and prevent contamination has been dramatically reduced and is "especially lacking infant formula investigators." She also warned that the FDA teams responsible for imported food safety are in an especially precarious position, noting that infant formula imported from abroad carries particular safety concerns.
Next Steps
Secretary Kennedy plans to host chief executives from leading infant formula companies in May for a roundtable discussion focused on modernizing FDA's infant formula oversight and continued implementation of Operation Stork Speed, which encompasses nutrition, chemical, and microbiological food safety.
"As a father, I understand how important it is for parents to trust the safety of the food they give their children," said Kyle Diamantas, the FDA's Deputy Commissioner for Food. "Through Operation Stork Speed and our Closer to Zero initiative, this testing—the first of its kind—reinforces that infant formula in the U.S. is a safe option for parents and caregivers who rely on it. We will continue working to drive contaminants to as low as possible through rigorous oversight."