As FDA continues to work under Operation Stork Speed and Closer to Zero, the question remains whether the data will translate into binding standards – or remain a category snapshot.
FDA released results last week from what it says is the largest infant formula contaminant testing the agency has conducted, examining more than 300 infant formula samples sold in the US, including domestically produced and imported products.
Some critics point out that while FDA’s expanded testing is a step in the right direction, more work needs to be done to ensure accountability, safety and transparency at the manufacturing level.
According to the agency, the samples were representative of the infant formula market based on 2023 retail sales data. FDA purchased products directly from retail locations, including grocery stores and online retailers, to capture what it described as a snapshot of what was on store shelves at a particular point in time and what caretakers are buying most often.
The testing is part of FDA’s ongoing oversight of infant formula under Operation Stork Speed and as the agency works to establish action levels for contaminants (e.g. lead, arsenic, cadmium and mercury) through its Closer to Zero initiative, which aims to reduce contaminants in foods for infants and children.
Across the samples tested for contaminants such as lead, arsenic and per- and polyfluoroalkyl substances (PFAS), FDA said most revealed “very low or undetectable” concentrations. The agency summarized the findings based on contaminant levels in formula, allowing results to be compared across products.
FDA did not provide numeric ranges or publicly rank contaminants by priority. The agency also said the testing did not trigger regulatory or enforcement actions. Market basket surveys are intended to provide a “snapshot of products” sold at retail and to help identify contamination levels that can inform future testing, according to the agency.
“If safety concerns with specific products are identified, FDA will take appropriate follow-up action,” the agency said, adding testing will continue as part of its ongoing monitoring efforts. All infant formula sold in the US, regardless of whether it is produced domestically or overseas, must meet US requirements and is subject to FDA oversight.
‘Testing without standards is just data’
Some stakeholders welcomed the testing as progress while also pointing out its limitations.
Little Spoon Co‑founder and CEO Ben Lewis described the testing as a positive step in the right direction but said it mainly shows where the category stands today – not whether products were tested for contaminants before they reached store shelves.
“We welcome any increase in scrutiny, and the FDA’s testing initiative is a positive step in the right direction. That said, a one-time market basket survey is a starting point, not a safety system. The distinction matters: These results tell us where the category stands today. They don’t tell parents that the specific can on the shelf was tested before it shipped. We believe the needs pre-market batch testing with published results,” Lewis said.
Contaminant testing is critical for infant formula brands like Little Spoon, which launched its launched its Organic Grass-fed Whole Milk Infant Formula earlier this year.
The brand operates under its internal “Always Tested” standard, which independently tests each infant formula batch across six categories prior to shipment, including “heavy metals, pathogens, toxin-producing and spore-forming bacteria, hygiene indicators, pesticides, glyphosate and plasticizers,” Lewis said.
These categories are tested against Little Spoon’s voluntary standards based on European and global benchmarks rather than FDA limits. Testing results are published publicly and if a batch is contaminated, it will not be shipped, according to the company.
“We’ve publicly defined the safety thresholds we hold ourselves to, test every batch against them before it ships, and publish the results – no lot code required. Not once. Every time. Testing without standards is just data,” Lewis said.
From Little Spoon’s perspective, FDA testing without enforceable standards still leaves major gaps. Lewis emphasized that federal regulation needs to “catch up,” including the establishment of “enforceable federal limits for heavy metals, mandatory batch‑level testing before products reach shelves and transparent published results.
‘What is needed is a fundamental shift in regulatory posture’
From a human health standpoint, FDA’s testing highlights deeper structural problems in how infant formulas are regulated and manufactured Elena Medo, co‑founder of Leonie Health and a human milk researcher with more than 40 years of experience said.
Medo pointed to contamination events in infant formula facilities like ByHeart and Abbott Nutrition as evidence of failures at both the agency and company levels, arguing that a clean safety record is achievable with sufficient oversight and accountability. She said the issue is not access to capital or investors but how companies manage their facilities and how consistently and efficiently regulators show up for inspections.
“Stronger written standards alone will not fix this. The standards already on the books, if actually enforced, would have prevented both outbreaks. What is needed is a fundamental shift in regulatory posture, from reactive documentation to genuine, measurable prevention, combined with industry standards and leadership cultures that reflect the clinical reality of who is consuming these products,” she emphasized.
Additionally, FDA’s structural changes, including leadership turnover and layoffs, impact the efficiency of the agency at a time when regulatory demands are increasing, Medo said. She emphasized the need for mandatory, independently verified root‑cause investigations at manufacturing facilities, with regulators present and accountable during those processes.
Regulatory bar should be higher for novel ingredients used in infant formula
Medo also raised concerns about how novel ingredients are introduced into infant formula, particularly through the “generally recognized as safe,” or GRAS, self‑affirmation pathway. Lab‑grown and precision‑fermentation ingredients increasingly are used, but more information is needed on manufacturing processes, ingredient stability and how those ingredients behave in infants’ bodies, she said.
“The GRAS pathway was not designed with the preterm infant in mind, and applying it to biologically complex fermented or lab-grown proteins intended for the most fragile patients in any NICU is a regulatory mismatch with potentially serious consequences,” she argued.
Rather, the regulatory standard should be significantly higher for novel ingredients used in infant formula, which is often the sole source of nutrition for infants, including those born prematurely.
“They should be subjected to the same regulatory rigor as investigational new drugs: robust preclinical safety data, staged clinical evaluation with appropriate endpoints, independent review and post-market surveillance,” she added.
