The FDA yesterday quietly put up a new page describing its “post-outbreak response activities” for the Clostridium botulinum illnesses tied to ByHeart powdered infant formula. I have read it more than once. I represent more than twenty of the families behind the numbers on that page, so let me say a few things the agency’s careful prose does not.

Start with the count. Forty-eight infants sickened across seventeen states. Twenty-eight confirmed, twenty probable. Zero deaths — and I am grateful for that every single day, because infant botulism is the kind of illness that takes a healthy baby and, within hours, leaves a parent watching a ventilator breathe for their child. But look at the other line on that ledger: forty-eight hospitalized. Every last one of them. There is no version of “zero deaths” that makes a forty-eight-for-forty-eight hospitalization rate a clean record. These were newborns and infants whose parents fed them a product they had every reason to believe was safe.

The FDA’s page leads with ingredients — incoming powdered milk, a lot of organic whole milk powder, Dairy Farmers of America, Organic West Milk — However, the FDA also tells us the root-cause investigation continues “with a focus on ingredients.” 

Here is what the agency’s own whole genome sequencing showed: C. botulinum type A matching across a clinical isolate, a closed can of ByHeart finished formula, and the ingredient. That is not only an ingredient problem that happened to pass through ByHeart. That is ByHeart’s product, in ByHeart’s can, with ByHeart’s name on it, fed to a baby. Sourcing, verifying, and testing what goes into infant formula is the job.

And spare me the suggestion — built carefully into the bottom of that page — that spore-forming bacteria are simply too resilient, too hard to detect, too slow to culture for anyone to have prevented this. It is all true as a matter of microbiology, and it is also beside the point. The risk of C. botulinum spores in commercial powdered infant formula is not a surprise the science just delivered. Barash, Hsia, and Arnon published soil-dwelling clostridia in commercial powdered infant formulas in the Journal of Pediatrics in 2010. That is sixteen years ago. “It is hard to test for” is an argument for more vigilance from the people selling the product, not a pre-written excuse for the next outbreak.

To the FDA, I will give credit where it is due, and I do not give it often. Unlike the November 2024 romaine outbreak, I have spent the last year prying names out of, the agency named ByHeart, named Dairy Farmers of America, and named Organic West Milk. That is how it is supposed to work. Naming the responsible parties during an outbreak is not punishment; it is the whole point of public reporting. So, I will say to the FDA: good. Now finish the job.

Finishing the job means not letting “we have transitioned to post-outbreak response activities” become the sound of a door closing. A risk assessment from JEMRA and a request to the Codex Committee on Food Hygiene are fine things. They are also years away, and they will not look a single one of my clients’ children in the eye. What those families need is a root cause stated plainly, an accounting of how contaminated formula reached forty-eight babies in seventeen states, and a regulatory posture that treats infant formula as exactly what it is — the only food some of the most vulnerable people in this country eat.