Today the FDA called on the infant formula industry to do a better job guarding against contaminants that come in through their supply chains. Read that again. Called on. Not required. Not ordered. After babies stopped breathing, the agency’s move is to send a letter asking manufacturers to please keep a closer eye on where their ingredients come from.
I have spent the last year representing more than two dozen families whose infants were poisoned by powdered formula, and I know exactly what that letter is worth to them.
Start with ByHeart. Forty-eight infants were hospitalized and treated with human botulism immune globulin after being fed ByHeart Whole Nutrition formula, and when investigators went back through the records, the illnesses reached all the way to December 2023. FDA and CDC cultured Clostridium botulinum from an opened can fed to a sick baby — and then from cans that were never opened at all. That single fact should end every conversation about whether a parent did something wrong. The poison was sealed inside the product before it ever reached a kitchen counter, which is why no amount of looking or smelling would have warned a single parent.
Then came Nara Organics, a second and separate infant botulism outbreak, its formula manufactured in Europe and recalled in June. Two different brands, one pattern — and, as my clients’ cases lay out, one supply chain. The organic whole milk powder that tested positive for C. botulinum in the ByHeart outbreak was made from milk supplied by Organic West Milk and spray-dried at a Dairy Farmers of America plant in Fallon, Nevada. FDA’s own testing matched that contaminated powder to a finished can of ByHeart formula and to a sample taken from a sick baby. The very “supplier oversight” the agency is now politely requesting is the exact link in the chain that failed — and it failed long before ByHeart or Nara ever printed their names on a can.
And this is not only an American problem. Between late 2025 and early 2026, cereulide — a heat-stable toxin made by Bacillus cereus — was traced to contaminated arachidonic acid oil, an ingredient added to formula to mimic the fatty acids in breast milk. The World Health Organization counted 144 suspected and confirmed cases across ten countries. Cereulide shrugs off the heat of ordinary processing, so pasteurizing and drying the formula does not kill it. Same lesson, written in a different toxin: what goes into the can decides whether the baby is safe, and by the time it reaches the can, it is already too late.
What does the FDA actually ask for? That manufacturers understand where their ingredients originate, how they are made, what risks they carry, and whether those risks are controlled — and that they treat recalls, outbreak investigations, and import alerts as warnings instead of somebody else’s problem. All of which is true. All of which they should already be doing. And all of which the agency now admits it cannot even tell them how to accomplish, conceding there is no single validated method for controlling spore-formers in these ingredients and promising to keep talking with Codex and the international specification bodies. Talking. The response to poisoned babies is advisory, with no new testing requirement, and the verification methods are left to the discretion of the very companies whose products did the poisoning.
A letter is not a recall. A letter is not a rule. A letter does not test a drum of milk powder before it is scooped into a can that is fed to a baby. If the FDA wants to stop these outbreaks, it can require that formula ingredients be tested for these organisms before they reach the manufacturing line, and it can make that testing enforceable. Until it does, families will keep learning about supply-chain oversight the way my clients did — in a pediatric ICU, holding an infant who cannot breathe, staring at a sealed can that told them nothing was wrong.