New lab tests show what's really in infant formula as FDA promises to clean up industry
WASHINGTON (SOA) — The new FDA leadership says it is prioritizing clean and safe infant formula, targeting an embattled industry many say has failed American families. Now, we have new testing data that shows while dangerous toxins still invade food for newborns, a new generation of manufacturers is changing the landscape. We asked the FDA's new commissioner what he's going to do about it.
Dr. Marty Makary, Commissioner of the FDA, is clear: cleaning up infant formula is a top priority for his agency.
"Gandhi once said that the best measure of a society is how it treats its most vulnerable members," Makary told us. "That is, it's elderly and its children, and no one is more helpless in society than a newborn baby."
But America watched a crisis play out in recent years, including tragic deaths from bacterial contamination, a shortage of critical products, and toxins in infant formula.
Three years later, Makary is making no excuses for the agency he inherited.
"Infant formula has had very little innovation in the last 30 years, and in part that's because of the FDA," he said. "It was a regulatory failure. There was a sort of recipe list. It was very rigid, and if you wanted to innovate infant formula, you couldn't deviate from that recipe list."
He said outdated FDA guidelines prevented industry expansion and innovation. In fact, historically, only four companies controlled nearly the entire US infant formula market and were left to their own devices.
But that's changing.
We obtained exclusive new infant formula test results from the Clean Label Project, a non-profit that tests and certifies consumer products.
It found that heavy metals "dropped significantly" since 2021, but they aren't gone.
Arsenic was detected at levels unsafe even for apple juice, according to the FDA's limit. Cadmium, known to damage kidneys and other organs, exceeded safety limits proposed by lawmakers for baby food.
We asked Makary about the persistence of those toxic metals in food for our most vulnerable citizens.
"We're asking the companies to reduce the number of heavy metals because it's too high," he said. "In many instances, the right number of heavy metals in baby formula is zero. Now, it's not technically feasibly possible to get to an absolute zero level with certain foods by the nature of heavy metals being in the ground, but we need to do much better."
Newer, smaller companies generally outperformed established brands with fewer heavy metals in their formulas. Critically, some brands showed zero heavy metals are achievable, highlighting the failure of others to do the same.
In fact, we proved it was possible back in 2021, when we visited the Ohio manufacturing facility of a baby formula company known as Nature's One, now owned by Bobbie. That brand consistently had zero concentrations of heavy metals in products, with its then-CEO telling us it was thanks to careful sourcing and meticulous testing that could be done by all manufacturers.
This year, three Republican senators introduced a bill to ban all heavy metals in infant formula once and for all. It hasn't come to a vote.
Still, as heavy metals overall decrease, other concerns arise.
This summer, Makary brought together formula makers and experts to lay it all on the table. Contaminants were an important part of the conversation.
A former EPA biologist, Thomas Knudsen, widened the discussion from heavy metals.
"Not only the heavy metals, but things such as phthalates from the plasticizers, perfluorinated compounds and one of the big emergent areas, microplastics and nanoplastics. I think all of these things need to be part of the safety considerations," he said.
The test results we obtained provide the first definitive evidence of the chemical DEHP in infant formula, which can leach into food from packaging.
DEHP was detected in nearly 95% of legacy brand formulas, with the highest levels in those brands almost 6 times higher than newer brands.
Studies have linked DEHP exposure to cancer, developmental delays and neurological effects.
The threat is so significant, Congress banned it from children's toys in 2008.
Molly Hamilton, Executive Director of the Clean Label Project, said their test results show that this is a sector of the market that cannot be ignored.
"It underscores that there is still a lot of work to be done. When it comes to DEHP, if it isn't safe to be in toys, it certainly shouldn't be in infant formula. We cannot continue to settle for anything less, effectively allowing our kids to be guinea pigs while we slow-walk evaluating and addressing what toxins we will tolerate in their diet."
But broader protections that would examine all contaminants in food products don't exist. We asked the FDA Commissioner if he'd like to see a larger regulatory framework that broadly encompasses baby foods and infant formulas as finished products, rather than how industry traditionally operates: focusing on a singular contaminant, often only after it's identified by a crisis, advocacy group or news report.
"Yes," Dr. Makary said. "We're going to go from a standard of basically innocent until proven guilty to the opposite. And that is you have to prove to us that it's safe for kids."
It's a mindset already adopted in Europe, but represents a seismic shift from an FDA that has historically allowed an industry to self-certify as safe, and permit companies to include ingredients that may or may not be harmful.
Commissioner Makary told us the "regulatory failure" is an old rule called GRAS, or Generally Recognized as Safe, which allowed companies to insert ingredients and chemicals into food just by declaring it as safe.
He's taking steps to change the GRAS rule as part of his pledge to remove industry influence from the FDA.
"We have got to start talking about food as medicine, the microbiome, environmental exposures, the root causes of our problems, and there should be no sacred cows," he said. "There are no corporate or lobbying interests that we're tiptoeing around, but there's a lot of work that needs to be done."
We'll continue to monitor that work as it happens.
Despite concerns, the American Academy of Pediatrics cautions parents against making homemade baby formula with store-bought ingredients. Doctors say babies need a precise combination of ingredients that are safe for an infant, and too much or too little can have dangerous consequences.
