FDA says infant formulas are safe – Image for illustrative purposes only (Image credits: Unsplash)
Parents and caregivers have sought reassurance about infant formula since a Cronobacter outbreak in 2022 disrupted supplies and raised health concerns. The Food and Drug Administration addressed those worries through its most comprehensive testing to date. Officials examined 312 samples across 16 brands and reported that the vast majority showed undetectable or very low contaminant levels.
Launch of Operation Stork Speed
The FDA initiated Operation Stork Speed in 2025 to bolster oversight of infant formula following the 2022 recall by Abbott Nutrition. That event severely strained national supplies and highlighted vulnerabilities in production and distribution. The operation aimed to verify product quality and strengthen the supply chain for this critical food source.
FDA Commissioner Marty Makary emphasized the agency’s commitment during the review. “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,” he stated. This effort marked a proactive step to restore confidence among families reliant on these products.
Details of the Testing Program
Agency scientists analyzed samples for heavy metals, pesticides, PFAS chemicals, and phthalates, excluding pathogens like Cronobacter or Salmonella. They focused on powdered formulas with 278 samples, alongside 11 concentrated liquids and 23 ready-to-feed options. Protein bases included cow’s milk in 258 samples, soy in 44, and amino acid-based in 10.
Health and Human Services Secretary Robert F. Kennedy Jr. highlighted the scale of the undertaking. “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,” he said. The program built on prior monitoring but expanded to unprecedented levels of scrutiny.
Contaminant Levels Across Categories
Results revealed broad compliance with safety expectations, though the U.S. lacks specific legal limits for metals in infant formulas. An overwhelming majority of samples registered undetectable or minimal traces. Officials noted that some elevated readings prompted further manufacturer consultations and additional tests.
| Contaminant | Not Detected (%) | Range (ppb unless noted) | 95th Percentile (ppb) | Median (ppb) |
|---|---|---|---|---|
| Mercury | 95% | ND – 0.3 | N/A | N/A |
| Cadmium | 34% | ND – 1.5 | <1.1 | 0.2 |
| Lead | 20% | ND – 1.1 | <0.5 | 0.2 |
| Arsenic | 6% | ND – 4.7 | <2.0 | 0.5 |
Pesticides appeared in just three samples at trace amounts below 0.3 ppb, with none showing glyphosate or glufosinate. PFAS detections involved five compounds, primarily PFOS at levels up to 6 ppt in half the samples. Phthalates like DEHP and DINP surfaced in under 20% of cases, peaking at 145 ppb but mostly absent.
What matters now: While levels stayed low, the FDA continues targeted follow-ups to drive contaminants even lower. Parents can reference these findings for informed choices amid ongoing supply improvements.
Broader Insights and Next Steps
The review also examined 110 human milk samples from one state’s donor bank. Eighty-five percent contained at least one metal, with mercury most prevalent at 61% detection. Such data underscores environmental contaminant presence but does not alter formula safety conclusions.
Without binding standards for metals, the FDA’s assessment relies on comparative benchmarks and risk evaluations. The agency plans sustained engagement with producers to minimize residues. This positions Operation Stork Speed as an evolving safeguard for infant nutrition in the U.S.
These results offer tangible evidence of a robust formula supply, even as vigilance persists. Families benefit from transparent data that prioritizes the unique vulnerabilities of newborns.
