- Consumer Reports testing found lead in about half of baby formulas.
- Manufacturers assert compliance with rigorous EU regulatory standards against contaminants.
- The FDA pledged a year ago to carefully review baby formula to ensure it meets standards.
A year ago, U.S. Health and Human Services Secretary Robert F. Kennedy Jr. and the U.S. Food and Drug Administration vowed to beef up quality assurance testing for the nation’s infant formula supply. The pledge came after Consumer Reports found through lab testing that about half of the powder formulas it tested contained heavy metals at possibly concerning levels, including lead, which can cause developmental delays and other problems.
The FDA’s effort was nicknamed Operation Stork Speed.
What’s happened in the year since?
Consumer Reports did a new round of testing, looking into 49 baby formulas to see if there were concerning levels of lead and arsenic, which were among the contaminants found in the initial round. It was also looking for bisphenol A and acrylamide.
The new tests also included liquid formulas and “alternative-protein formulas” such as soy milk and goat milk formulas, along with some hypoallergenic formulas.
The results were a mixed bag, with a number of formulas with little or no detected contaminant levels, according to Consumer Reports. But they still found “contaminants at potentially concerning levels” in 26 of 49 formulas tested.
Per the article on the results, “Aside from our own test results, other alarming recent developments like the 2025 ByHeart recall for botulism have laid bare the shortcomings of some formula manufacturers’ safety processes. Quiet cuts to staffing and budgets at the Food and Drug Administration have the potential to weaken oversight even more."
What contaminants can do
Here’s what Consumer Reports said it found:
Arsenic is a heavy metal that can increase risk of some cancers. The Environmental Protection Agency says only 10 parts per billion of arsenic is allowed in city drinking water supplies, but the FDA has no specific standard for arsenic in baby formula. Consumer Reports said it can get into the food supply by way of groundwater and soil that foods grow in. Twenty-six of the formulas had concerning levels of inorganic arsenic.
While there is no safe level of lead for a baby, it’s more complicated because lead is a naturally-occurring heavy metal that is found in nature. Per Consumer Reports, “The FDA’s oversight plan to reduce lead exposure in early childhood is called Closer to Zero because it is so difficult to ensure that food or water is entirely lead-free. Its guidance to manufacturers of baby and toddler food is to keep lead at or below 10 or 20 parts per billion, depending on the ingredients, but that guidance doesn’t apply to formula.”
Consumer Reports used California’s maximum daily limit as a guide and found three powdered formulas had too much lead and a few others had between half that level and just below it. The article said the limit they chose was very conservative because babies can have other common lead exposures, such as “household dust, soil and the tap water used to mix powdered formula.”
It’s important to note that contaminants, including lead, are so common that traces are sometimes even found in breast milk.
Per- and polyfluoroalkyl substances — so-called forever chemicals — can accumulate and perhaps cause harm. They are manmade, not naturally occurring, and were detected in several formulas. The company said more research is needed to determine what health risks might be triggered and at what levels they pose danger if babies consume them.
They found little or no other chemicals that worried them, per Consumer Reports.
And they also concluded that the ready-to-feed formulas in the tests were all safe for babies to consume.
A complete list of the results is online here.
Companies push back
CBS News reported that two of the biggest formula manufacturers, Abbott and Mead Johnson, “challenged Consumer Reports’ findings, saying that trace levels of heavy metals occur naturally in the environment and throughout the food supply.”
Abbott told CBS News that all of its formulas, including those sold in the U.S., comply with the European Commission’s heavy metals regulations, “which are the most stringent in the world.” They also meet FDA rules.
And Mead Johnson told CBS news that its infant formulas ”have consistently met or outperformed U.S. and global regulatory standards, including the rigorous EU regulatory limits for heavy metals."
What the FDA pledged
In its announcement in 2025, the FDA promised to “start the first comprehensive update” of baby formula in nearly 30 years, with a focus on nutrients.
The regulatory agency also said it would bolster its testing for heavy metals and other contaminants not just in formula, but also in other foods babies consume.
Other priorities it announced relating to formula safety included working with the industry to improve transparency and nutrition labeling, and working with the National Institutes of Health on research that would fill in gaps in what’s known about long-term and short-term health outcomes over the course of not just infancy but across the lifespan.
The CBS News article quoted the Infant Nutrition Council of America, which said in a written statement that “INCA looks forward to the FDA setting science-based limits that help guide parents and healthcare providers in their infant feeding decisions and uphold the highest standards of infant nutrition.”