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FDA Releases Results from Largest-Ever Testing of Infant Formula in the U.S.

Agency to Continue Rigorous Oversight and Additional Testing

The U.S. Food and Drug Administration today announced results from the largest and most rigorous examination ever conducted focused on chemical contaminants in infant formula available on the U.S. market. While breast milk is widely considered the gold standard and optimal source of nutrition for infants whenever possible, millions of parents depend on formula.

“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.”

“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,” said FDA Commissioner Marty Makary, M.D., M.P.H. “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.” 

Across the products tested, an overwhelming majority of samples had undetectable or very low levels of contaminants, affirming that the U.S. infant formula supply is safe. The FDA tested more than 300 infant formula samples representative of products sold at retail across the U.S.—generating more than 120,000 data points—for lead, mercury, cadmium, arsenic, pesticides (including glyphosate and glufosinate), per- and polyfluoroalkyl substances (PFAS), and phthalates. The samples, which included powders, ready-to-feed liquids, and concentrated liquids, were rigorously tested and analyzed in FDA laboratories.

While overall levels of contaminants in the infant formula samples tested were low, the FDA is following up with additional testing as part of the agency’s ongoing robust monitoring and oversight efforts and will take additional action where appropriate. This includes conducting further testing, including for additional contaminants, continuing to engage with manufacturers on measures to reduce the levels of contaminants to as low as possible, and working to establish action levels for contaminants in infant formula.

“As a father, I understand how important it is for parents to trust the safety of the food they give their children. At the FDA, ensuring the health of America's next generation is vital,” said Kyle Diamantas, J.D., Deputy Commissioner for 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.”

Small amounts of contaminants may be present in foods—including infant formula and breast milk—because they occur naturally or enter the environment through human activities in the areas where ingredients are grown or produced.  

This testing was conducted as part of Operation Stork Speed, the FDA’s Closer to Zero initiative, and the FDA’s routine food surveillance work to help ensure safe, reliable, and nutritious infant formula for families across the U.S.

The FDA will continue to test infant formula as part of Operation Stork Speed and ongoing surveillance of foods, including testing infant formula products that have entered the U.S. market since this initial survey began and conducting additional compliance sampling. Consistent with FDA’s commitment to transparency, the agency will share results from follow-up surveys.

Secretary Kennedy will 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 includes aspects of nutrition, chemical, and microbiological food safety.

Grok Assessment

The FDA's April 29, 2026 announcement reports reassuring results from the largest-ever U.S. testing of infant formula for chemical contaminants.

The agency tested over 300 samples (mostly powdered, plus liquids) from 16 brands, purchased at retail between 2023–2025, generating >120,000 data points. Contaminants screened included heavy metals (lead, mercury, cadmium, arsenic), pesticides (including glyphosate/glufosinate), PFAS ("forever chemicals"), and phthalates.

Key FDA Findings (as prepared for feeding)

  • Heavy metals: Overwhelmingly low/undetectable and below EPA drinking water limits.
    • Lead: Not detected in 20% of samples; range ND–1.1 ppb; 95th percentile <0.5 ppb; median 0.2 ppb.
    • Mercury: Not detected in 95%; range ND–0.3 ppb.
    • Cadmium: Not detected in 34%; range ND–1.5 ppb; 95th percentile <1.1 ppb; median 0.2 ppb.
    • Arsenic: Not detected in 6%; range ND–4.7 ppb; 95th percentile <2.0 ppb; median 0.5 ppb (mostly inorganic when detected).
  • Pesticides: None detected in 99% of samples; glyphosate/glufosinate not detected at all (only 3 samples had trace other pesticides at very low levels).
  • PFAS: 25 of 30 compounds not detected; most common (PFOS) in ~50% at 0.51–6.0 ppt; 95% of samples <2.9 ppt for PFOS; overall low.
  • Phthalates: Not detected in 54%; some detected at low levels (e.g., DEHP up to 57 ppb, DINP up to 145 ppb in a minority).

Overall assessment: The FDA states the U.S. supply is safe, with most samples showing undetectable or very low levels. They note small exposures still matter for infants and plan follow-up testing, manufacturer engagement to reduce levels further, and action levels. Contaminants can enter via environment/soil/water/ingredients (also present in breast milk).

Independent experts reviewing the data generally viewed heavy metals/pesticides as good news, though some raised questions about detectable (even low) PFAS/phthalates.

Independent Testing (Consumer Reports, 2025–2026)

Consumer Reports (CR) tested dozens of formulas (powdered in 2025; additional liquids/specialty in 2026) for heavy metals, PFAS, BPA, acrylamide, etc.

  • About half showed potentially concerning levels of at least one contaminant (e.g., inorganic arsenic at/above CR's level of concern in many; lead in a few; PFAS in >25%).
  • The other half had low/no detections, highlighting safer options (including major brands).
  • CR's thresholds are more precautionary than some regulatory benchmarks; results prompted FDA action like "Operation Stork Speed."

CR findings align directionally with FDA data (low overall but some detections), though CR highlighted more products exceeding their internal concern levels. Heavy metals are ubiquitous in the environment and also appear in breast milk.

Bacterial Contamination (e.g., Cronobacter)

Chemical testing is separate from microbiological risks. Powdered infant formula is not sterile and can harbor Cronobacter sakazakii, which poses serious risks (meningitis, sepsis) to newborns/preterm/low-birth-weight infants.

  • Major 2022 outbreak linked to Abbott's Sturgis plant (environmental contamination, recalls, illnesses/deaths).
  • Additional incidents/recalls since (e.g., ByHeart in 2025; other facilities). Contamination can occur at manufacturing, reconstitution, or home use.
  • FDA/CDC advise proper preparation/hygiene; liquid formulas are sterile until opened.

 

Overall Concerns and Context

  • Low risk for most: FDA's large-scale testing supports safety for chemical contaminants under current standards. Breast milk remains ideal when possible, but formula is a safe, necessary option for many.
  • Ongoing vigilance needed: Trace contaminants are hard to eliminate entirely due to environmental sources. Vulnerable infants face higher risks from bacteria or cumulative exposure. Recent CR tests and past outbreaks show room for better ingredient sourcing, manufacturing controls, and transparency.
  • Practical advice: Follow FDA/CDC preparation guidelines (e.g., use safe water, proper hygiene). Parents can check CR ratings for lower-contaminant options or consult pediatricians. The FDA continues monitoring and aims to drive levels "as low as possible."

Sources

Consumer Reports (Independent Testing)

Other Context (Cronobacter/Bacterial Risks)

These align with the data summarized (low overall chemical contaminants per FDA, some concerns per CR, and bacterial risks).

Additional links from independent conservative-leaning sources on the topic: