FDA says infant formulas are safe – Image for illustrative purposes only (Image credits: Unsplash)
The Food and Drug Administration recently wrapped up an extensive review of the nation’s infant formula, declaring the overall supply safe based on low contaminant levels across hundreds of samples. This effort, dubbed Operation Stork Speed, marked the agency’s most comprehensive examination of such products to date and addressed lingering concerns from a 2022 cronobacter outbreak that disrupted supplies. While levels of heavy metals, pesticides, and chemicals stayed mostly undetectable or minimal, the findings highlighted the absence of federal limits for key contaminants in these products.
Launch of Operation Stork Speed
The FDA initiated Operation Stork Speed in 2025 specifically to bolster oversight of infant formula following the 2022 cronobacter incident, which prompted a major recall by Abbott Nutrition and led to widespread shortages. Agency officials aimed to scrutinize the supply chain’s resilience and verify product quality amid heightened parental anxiety. Testing focused on environmental and chemical contaminants rather than pathogens like Cronobacter, Listeria, or Salmonella.
Health and Human Services Secretary Robert F. Kennedy Jr. emphasized the stakes, stating, “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.” This initiative sought to restore confidence while pushing manufacturers toward even lower contaminant thresholds.
Scope of the Testing Program
Investigators analyzed 312 samples drawn from 16 brands, covering powdered formulas (278 samples), concentrated liquids (11), and ready-to-feed liquids (23). Protein bases included cow’s milk in 258 samples, soy in 44, and amino acid-based options in 10. The lineup targeted arsenic, cadmium, lead, mercury, 30 PFAS compounds, 318 pesticides, 21 phthalates, and one non-phthalate plasticizer.
FDA Commissioner Marty Makary underscored the commitment to availability, noting, “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 program extended briefly to human milk from a single-state donor bank, testing 110 samples for the four metals.
Contaminant Levels Across Categories
Results revealed an overwhelming majority of samples with undetectable or very low contaminants, supporting the FDA’s safety assessment. Heavy metals showed particular restraint: mercury appeared in just 5% of samples, up to 0.3 parts per billion (ppb); cadmium stayed below 1.1 ppb in 95% of cases, with a median of 0.2 ppb; lead hit below 0.5 ppb in 95%, median 0.2 ppb; and arsenic remained under 2.0 ppb in 95%, median 0.5 ppb.
Pesticides proved nearly absent, with 99% of samples showing none; only three carried trace amounts like 0.25 ppb chlorpyrifos. PFAS detections were limited to five compounds, mostly at parts per trillion (ppt) levels, such as PFOS up to 6.0 ppt. Phthalates appeared in about half the samples, though commonly detected ones like DEHP and DINP stayed below 57 ppb and 145 ppb respectively in affected units.
| Contaminant | Not Detected (%) | Max Level | 95th Percentile |
|---|---|---|---|
| Mercury | 95% | 0.3 ppb | N/A |
| Cadmium | 34% | 1.5 ppb | 1.1 ppb |
| Lead | 20% | 1.1 ppb | 0.5 ppb |
| Arsenic | 6% | 4.7 ppb | 2.0 ppb |
Limitations and Ongoing Oversight
Despite the reassuring data, the FDA acknowledged no enforceable limits exist for the tested metals in infant formula, leaving “safe” as a relative term without a fixed benchmark. A few samples exceeded typical lows, prompting further scrutiny and manufacturer discussions to drive levels even lower. Pesticides like glyphosate and glufosinate evaded detection entirely, while phthalates and PFAS warranted continued monitoring given their ubiquity in packaging.
Human milk samples told a starker story: 85% carried at least one metal, with mercury in 61%, cadmium in 57%, arsenic in 33%, and lead in 30%. The FDA report affirmed, “Across the products tested, the majority of infant formula samples had undetectable or very low levels of contaminants,” yet stressed proactive measures ahead.
Implications for Parents and Future Steps
These findings offer reassurance amid past disruptions, confirming the supply’s robustness four years after the crisis. Parents can take comfort in the low exposures, though experts remind that infants’ sensitivity amplifies even trace risks. The operation signals a shift toward stricter supply chain safeguards and potential rulemaking on contaminants.
As the FDA engages producers on reductions, the emphasis remains on vigilance. This testing baseline sets a precedent, ensuring infant nutrition stays a priority in an evolving regulatory landscape.
