U.S. infant formulas are safe, according to the latest report detailing the FDA’s largest and most rigorous evaluation.
| MAY 22, 2026 | 5 MINUTE READ |
Recent headlines about heavy metals in foods, including infant formula, have raised questions from parents. Much of this recent attention stems from the FDA’s Operation Stork Speed, which included the “largest and most rigorous examination” of potential environmental contaminants in U.S. infant formula. And while such efforts to improve transparency and continue advancing food safety are important, the volume and complexity of information make it difficult for parents to separate facts from fear. To help provide clarity and context, we sat down with Dr. Karyn Wulf, one of our pediatric medical experts, to address common questions about environmental contaminants including heavy metals in baby formula.
Heavy metals— such as arsenic, lead, mercury, and cadmium— are naturally existing metals that are heavier or denser than more known metals, like aluminum or iron. They are ubiquitous in the natural environment and therefore, trace amounts are commonly found in foods, such as fruits, vegetables, dairy, meat, and even in human breast milk. Infant formulas are made with ingredients like cow’s milk (for routine formulas) and soybeans (for babies with certain dietary sensitivities), so trace amounts of heavy metals can be present in the final product. While these small amounts are unavoidable and do not make food unsafe, high enough levels over time can be harmful. That’s why infant formula manufacturers have spent more than a decade working to minimize heavy metals as much as possible.
In recent years, concerns around heavy metals in baby foods, and then baby formula, have emerged amidst broader conversations around the safety of the food supply. Building on the Closer to Zero initiative, FDA officials leading Operation Stork Speed recently released environmental contaminant testing results for over 300 infant formula samples.
The FDA report released on April 29th, 2026, affirmed that the U.S. infant formula supply is safe, so parents can feel confident in the safety of the products currently on the market. Most of the infant formula products tested showed undetectable or extremely low levels of environmental contaminants, which affirms product safety.
As noted above, trace amounts of heavy metals are unavoidable in all infant formulas because they contain ingredients that come from the natural environment. Importantly, however, all samples that the FDA tested – including Similac, EleCare, and other specialty products – were well below U.S. Environmental Protection Agency (EPA) drinking water limits for heavy metals. Abbott’s broad portfolio of infant formulas—representing more than one-third of the 312 samples the FDA tested—relies on a variety of ingredients to meet infants’ diverse nutritional needs. The trace amount of heavy metals can vary depending on the ingredient type. For example, plant-based ingredients like soy may naturally contain slightly higher levels than dairy, as they are grown in soil where these elements are present.
PFAS are a group of industrial chemicals known as per-and polyfluoroalkyl substances, which are found in various consumer products and do not break down easily in the environment. Pesticides are compounds used in agriculture to make crops less susceptible to pests in the environment. Recently released FDA testing results determined that 95% of samples had PFAS levels at or below 28 parts per trillion (ppt) and no pesticides were detected in 99% of samples. For context, 28 ppt is equivalent to one drop per 35 Olympic-sized swimming pools.
While the FDA is currently working on establishing federal regulations on environmental contaminants in baby formulas, parents can be assured that Abbott’s U.S. baby formulas meet EPA drinking water limits for heavy metals and other environmental contaminants. They also comply with existing baby formula regulations set by the European Commission and Health Canada, which are among the strictest in the world. At Abbott, we carefully consider the levels of heavy metals and other environmental contaminants when sourcing ingredients. After the initial qualification, we proceed with an ongoing surveillance testing program in which we periodically test samples of ingredients and finished products to ensure that our supplier and ingredient qualification process is working as intended. We do all of this so that parents can feel confident in the nutrition they choose for their babies.
As a pediatrician, medical safety director, and parent, I’m reassured that the FDA’s findings confirm the safety of the current baby formula supply. Baby formulas are already highly-regulated, and it’s encouraging to see continued momentum toward further strengthening the safety of the category. The FDA’s testing represents a critical step toward establishing federally regulated limits grounded in well-established science—an outcome that will ultimately reinforce the U.S. as a leader in best‑in‑class baby formula. When questions come up, I encourage parents to turn to credible, science‑based sources, like the child’s doctor or the FDA, to make informed decisions.
Ensuring a safe, reliable, and resilient baby formula supply is a shared priority for families, healthcare professionals, manufacturers, and regulators alike. Questions about environmental contaminants in baby formula are understandable. The good news is that baby formula remains one of the most highly regulated food products in the U.S., with multiple layers of oversight and continuous improvement informed by the latest science and safe ingredient sourcing. Recently released FDA testing adds transparency and reassurance, showing that U.S. baby formula is safe for parents who choose to feed it to their babies, and lays the groundwork for important federal regulations and limits going forward.
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