The FDA Called Infant Formula Safe. It Doesn't Have a Standard for What That Means.
How the FDA declared baby formula safe using a word that has no regulatory definition — and how the press release is designed to keep you from noticing.
The FDA declared safety and admitted it has no safety standard in the same document.
The U.S. has no legal limit for any of these metals in baby formula.
The framing works because it gives newsrooms an easy headline.
Trap two: mistaking volume of testing for adequacy of response.
Trap three: the political framing that buries the regulatory failure.
Formula is essential. That is the argument for standards, not against them.
The FDA declared safety and admitted it has no safety standard in the same document.
The FDA tested 312 formula samples from 16 brands for heavy metals, pesticides, PFAS, and phthalates. Pesticides and mercury came back clean. But arsenic showed up in 94% of samples, lead in 80%, and cadmium in about two-thirds. These are trace levels — from soil and water where ingredients are grown. They are not a reason to panic or stop using formula.
The U.S. has no legal limit for any of these metals in baby formula.
But the U.S. has no legal limit for any of these metals in baby formula. The EU has limits. Canada has them. Australia has them. So when the FDA calls formula “safe,” there is no standard behind that word. The agency admitted as much on the same page — it is still “working to establish action levels.” It declared safety and acknowledged the absence of a safety standard in the same document.
Abbott killed babies. ByHeart hospitalized 51 infants. Formula testing requirements have not changed.
This is happening against the backdrop of two contamination crises. In 2022, Cronobacter bacteria at an Abbott plant in Michigan killed at least two babies and caused a national formula shortage. Last year, at least 51 infants across 19 states were hospitalized with botulism linked to ByHeart formula — a brand that had already received an FDA warning letter for mold, insects, and contamination failures. Formula makers are still only required to test for two germs. The one that caused the ByHeart outbreak is not one of them. Recalled cans were still on store shelves weeks after the recall.
Budget cuts are hitting the people who investigate formula outbreaks.
Meanwhile, the FDA has been losing food safety staff to federal budget cuts. The CDC and state and local health departments have lost the people who actually investigate outbreaks. The people tasked with monitoring for both chemical and microbiological problems are being asked to do more with less.
The framing works because it gives newsrooms an easy headline.
Now here is the part I want you to pay attention to: how this story gets covered is itself a test.
The FDA’s press release is designed to reassure. It leads with quotes from HHS Secretary Kennedy — “protecting our children’s health is nonnegotiable” — and anchors on big numbers: 312 samples, 120,000 data points. The word “safe” appears repeatedly. The framing works because it gives newsrooms a clean headline: FDA’s Largest-Ever Test Confirms Baby Formula Is Safe.
That headline is wrong, but it is easy. And once it circulates, the details become almost impossible to inject into the conversation. This is what information researchers call Brandolini’s asymmetry: it takes far more effort to correct a misleading claim than to produce one.
There are three traps in how this announcement gets covered.
Trap one: repeating "safe" without asking what it means.
The FDA used the word. Reporters will repeat it. But the U.S. has no enforceable standard for what “safe” means in infant formula. The word is a regulatory assertion with nothing behind it. Repeating it without noting that is not reporting.
Trap two: mistaking volume of testing for adequacy of response.
120,000 data points sounds thorough. 312 samples sounds like a lot. But the question that matters is not how much testing was done. It is what action follows. The answer, so far, is none.
Trap three: the political framing that buries the regulatory failure.
Kennedy’s involvement guarantees that coverage will split along political lines. Outlets sympathetic to the administration will cover this as proof that his “Make America Healthy Again” agenda is working. Outlets hostile to it will use the arsenic numbers to scare parents. Neither is accurate. The data are real. The framing is misleading. The regulatory gap is the story, and it predates this administration.
Same data, different ruler, opposite conclusion.
Consumer Reports’ own testing found concerning arsenic levels in over half the formulas it tested, using European standards as a benchmark. That divergence — the FDA calling the same reality “safe” while Consumer Reports flags it as “concerning” — shows how much the framing depends on which ruler you use. The U.S. has chosen not to have a ruler.
Formula is essential. That is the argument for standards, not against them.
Millions of babies and parents depend on infant formula. This is not a reason to stop using it. It is a reason to ask why we are still testing without setting standards, still losing the people who catch problems, and still calling the results reassuring.