Full Breakdown
FDA’s Operation Stork Speed Testing Finds Low Levels of Contaminants in U.S. Infant Formula
5/1/2026, 12:16:53 AM
Core Findings of the Nationwide Test
Between 2023 and 2025 the Food and Drug Administration purchased and analyzed more than 300 infant-formula samples from 16 brands sold across the United States. The agency screened for lead, arsenic, cadmium, mercury, glyphosate, glufosinate, 30 PFAS compounds, and phthalates. Across the dataset, the majority of samples showed undetectable or very low contaminant levels, leading officials to describe the domestic supply as “safe.”
Background & Context
Operation Stork Speed was launched in March 2025 by the Trump administration to review infant-formula safety for the first time in decades. The effort followed a 2025 Consumer Reports investigation that flagged “worrisome” heavy-metal levels and a 2024 botulism outbreak linked to ByHeart formula, prompting heightened public scrutiny.
Key Figures & Groups
- Robert F. Kennedy Jr., HHS Secretary – announced the results.
- Kyle Diamantas, Deputy Commissioner for Food, FDA – oversaw testing.
- Marty Makary, FDA Commissioner – highlighted the “Closer to Zero” initiative.
- Steven Abrams, pediatric professor, University of Texas at Austin – independent reviewer.
- Sheela Sathyanarayana, pediatric professor, University of Washington – external expert.
- Brian Ronholm, head of food policy, Consumer Reports.
- Abbott Nutrition, Bobbie, Mead Johnson (Enfamil) – major manufacturers represented in the sample set.
Data & Statistics
- 312 samples tested (over 120,000 data points).
- 99 % of samples had no detectable pesticides; 95 % of PFAS levels <= 28 ppt; 95 % of phthalates <= 116 ppb.
- Lead was undetectable in 20 % of samples; mercury undetectable in 95 %.
- All heavy-metal concentrations fell below EPA drinking-water limits.
- 25 of 30 PFAS compounds were not detected at all.
Why It Matters
Heavy-metal exposure can impair brain development, learning, and behavior. Even trace exposures to PFAS and phthalates have been linked to endocrine disruption. The FDA frames formula safety as a matter of national security because millions of families rely on it for infant nutrition.
Official Statements & Responses
Kennedy emphasized that “even small exposures matter for newborns” and pledged transparent data and manufacturer accountability. Makary called the study a “vital step” toward a resilient supply chain. Diamantas said the agency will “drive contaminants to as low as possible through rigorous oversight.” Abbott affirmed its products meet EPA, EU, and Health Canada limits.
Criticism & Opposition
Sheela Sathyanarayana warned that any detection of PFAS or phthalates is “problematic” and demands continued monitoring. Consumer Reports’ Brian Ronholm urged the FDA to establish public-health-based limits, noting that “non-detect levels are feasible.” Sana Mujahid of Consumer Reports called for formal contaminant standards, citing methodological differences between the FDA and its own testing.
Conflicting Reports & Gaps
The United States lacks enforceable contaminant limits for infant formula, unlike the EU, Canada, and Australia. The FDA applied EPA drinking-water thresholds, while Consumer Reports used stricter internal benchmarks, preventing direct comparison. This round of testing did not assess microbiological hazards such as botulism spores, a gap highlighted by the agency’s later sampling efforts.
Verbatim Quotes
- “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.” — Robert F. Kennedy Jr., HHS Secretary
- “There’s no reason not to use any available formula” — Steven Abrams, professor of pediatrics, University of Texas at Austin
- “Any detection of PFAS or phthalates is problematic" and deserves scrutiny, especially in products that babies consume, Dr.” — Sheela Sathyanarayana, professor of pediatrics, University of Washington
- “It would be disappointing if the FDA doesn’t proceed with any meaningful regulatory action, such as establishing public health-based limits for contaminants,” — Brian Ronholm, head of food policy, Consumer Reports
- “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.” — Kyle Diamantas, Deputy Commissioner for Food, FDA
What’s Next
The FDA will expand surveillance, conduct follow-up testing of newer market entries, and develop formal “action levels” for contaminants. Secretary Kennedy will convene a May roundtable with chief executives of leading formula manufacturers to discuss modernizing oversight, nutrition standards, and microbiological safety under Operation Stork Speed.
