In the last seven months this country has had two outbreaks of infant botulism, both traced to powdered whole-milk infant formula. The first, tied to ByHeart, sickened 48 babies across 17 states — every one of them hospitalized. I represent more than twenty-five of those families. The second, tied to Nara Organics, hospitalized three more infants in California, Pennsylvania, and Washington, all between two and five months old, all treated with BabyBIG. I represent two of those families.
Two outbreaks. One ingredient. And, as reporting now confirms, and likely the same upstream supply stream behind both. The contamination did not strike two unrelated companies by chance. It traveled through a chain the system missed the first time and missed again.
Here is what eats at me. None of this was a surprise. On March 8, 2023 — two years before the first ByHeart baby got sick — the FDA sent a Call-to-Action letter to the entire powdered formula industry, signed by the Commissioner and the head of the food-safety center, naming Clostridium botulinum by genus and species and telling manufacturers to control for it across the whole chain. Two years later, under Operation Stork Speed, the agency went further — saying it would test formula and its ingredients for spore-formers, C. botulinum among them, and opening a sampling assignment for the very dairy ingredients at issue — and still no rule required anyone to test whole-milk-powder formula for botulinum before it shipped. The hazard was foreseeable. It was named, in writing, by the regulator, twice. And our federal rules still require finished-powder testing for only two organisms — Salmonella and Cronobacter. There is no botulinum standard for powdered formula at all. A sealed can of liquid formula gets the full low-acid-canned-food botulism regime. A tub of powder gets nothing. That is the hole these babies fell through.
Over the past several days I did what I know how to do. I wrote.
I wrote an open letter to Secretary Kennedy, because on June 2 he toured a formula plant and praised whole milk on the same day — and the vehicle in both outbreaks was whole milk powder. He has met the CEOs. He has not met the parents. I asked him to fix that.
I wrote a letter to Acting Commissioner Kyle Diamantas, counselor to counselor, because before he held the pen at the FDA he spent years defending an infant-formula maker against failure-to-warn claims. He, of all people, knows what a warning is and what foreseeability means. I asked him to write the standard of care into the rule — test and inspect the whole chain, not just the last can on the line.
And I wrote in support of H.R. 7867, the Infant Formula Safety Modernization Act, with an appendix of the families’ own words, because the bill closes the exact gaps that let these babies get hurt — and because a second outbreak arrived while the bill was already pending.
I believe in those letters. But I have been doing this for thirty-three years, and I am going to be honest with you about what I have learned in that time: a letter appeals to someone’s discretion, and discretion can be ignored at no cost. Reform in this country has almost never arrived because one lawyer wrote a persuasive letter. It arrived when Jack in the Box put enough sick children in the news that USDA had to declare E. coli O157:H7 an adulterant. It arrived when enough people pushed, in enough places, at the same time, that doing nothing became the harder choice.
Which brings me to why I am writing this one to you.
There are something like 55,000 of you who read Food Safety News — and you are not a casual crowd. You are former regulators and current ones, public-health laboratorians, epidemiologists, plaintiff and defense lawyers, industry quality people who have walked these plants, journalists, academics, and parents who have lived the worst of it. Collectively you know more about how to actually move this system than any single person, including me.
I am asking you a real question, not a rhetorical one: what is the next move?
Here is where my own head is, to prime the pump — and I want you to tell me what I have wrong and what I am missing:
• A formal citizen petition under 21 C.F.R. § 10.30 to add C. botulinum and Bacillus cereus to § 106.55 and require upstream sampling of dairy ingredients — a filing the agency is legally obligated to answer, in a docket the public can join.
• A congressional hearing with the parents at the witness table, not just the bill — testimony under oath that takes “meet the families” out of anyone’s discretion.
• Following the supply chain all the way up, in the litigation and in the public record, so the shared-supplier story is a documented fact and the whole chain — not just the brand on the can — understands the cost of leaving the gap open.
• An unlikely coalition asking for the same fix: the American Academy of Pediatrics, the public-health labs, the responsible manufacturers who already test for spore-formers voluntarily, and a state attorney general or two.
• A GAO or HHS Inspector General review of the testing gap and the inspection-resource cuts, so there is an institutional finding that outlives any one administration.
That is my list. I am sure it is incomplete. Maybe the best idea is one I have not thought of and one of you has lived. Maybe it is a state-level testing requirement. Maybe it is something inside industry I am not seeing from the outside.
Tell me. Email me at bmarler@marlerclark.com with the subject line “Next Move.” I will read every one of them, and in a follow-up Publisher’s Platform I will print the best of what you send — with credit, or anonymously if you would rather — and then I am going to act on it. Also, feel free to comment here.
The hazard was named in 2023. We have buried no babies yet, thank God, but we have filled too many hospital beds, twice, with a danger the government wrote down years before it arrived. I have written the letters. Now help me figure out how we make someone answer them.
