On June 2 you toured a formula plant in Eau Claire and, the same day, stood on a dairy farm and praised whole milk. I represent the families whose babies were hospitalized by what was in that milk — in powdered form. They have not been in the room.
Dear Secretary Kennedy:
You know I have spent more than thirty years representing the families of people poisoned by what they ate — and this year, twice, those families have been the parents of newborns poisoned by their infant formula. I paid close attention when you toured the Perrigo plant in Eau Claire, Wisconsin on June 2 — one of the largest formula facilities in the country — and spoke about giving every baby “the healthiest possible start in life.” Let me begin by giving you credit, because you have earned some. Operation Stork Speed has forced the first real look at infant formula nutrition since 1998. You have pushed on seed oils, on added sugars, on heavy metals, and in April your FDA ran the largest contaminant testing of formula this country has ever done. That work is long overdue, and I am glad it is happening. I mean that.
But I have to tell you what was missing from Eau Claire, because it is the thing that matters most to young parents, and it was nowhere on your agenda.
Nutrition is not what put these babies in the hospital
In the last seven months, this country has had two outbreaks of infant botulism traced to powdered whole milk infant formula. The first, tied to ByHeart, sickened 48 babies across 17 states — every one of them hospitalized. The second, tied to Nara Organics, has hospitalized three more infants, in California, Pennsylvania, and Washington, all of them between two and five months old.
Not one of those babies was harmed by a seed oil. Not one was hurt by a gram of added sugar or a microgram of lead. They were paralyzed by a spore — Clostridium botulinum — that produces one of the most dangerous toxins known to medicine. They went limp. They stopped feeding. They lost the ability to swallow and to hold up their heads, and some of them stopped breathing. That is what infant botulism does, and that is what was never mentioned on your visit.
I do not say this to diminish the nutrition work. I say it because a parent standing in a store does not need help choosing between a slightly better and slightly worse fat profile nearly as much as she needs to know the powder in the can will not put her child on a ventilator.
You praised whole milk the same day — and whole milk powder is the vehicle
Here is what troubles me most about that day in Wisconsin. Before you toured the formula plant, you stood at the Gilbertson family dairy farm and praised the nutritional benefits of whole milk.
I have nothing against whole milk. But you should know — and your FDA already knows — that the vehicle in both of these botulism outbreaks was whole milk powder. In the ByHeart investigation, the FDA’s own whole genome sequencing matched the Clostridium botulinum found in closed, finished cans of formula, and in a sick infant, to organic whole milk powder dried at a Dairy Farmers of America facility — the processor for ByHeart’s supplier. And reporting now confirms that Nara Organics, for a stretch, drew its whole milk powder from that very same supply chain. Two outbreaks. One ingredient. The same possible upstream source.
On the same day, in the same trip, your department celebrated whole milk as wholesome nutrition and toured a formula plant — and said nothing about the fact that this ingredient, in its dried powdered form, is exactly what carried botulinum toxin into these infants. The fluid milk on a Wisconsin farm and the spore-contaminated dried powder that reached these babies are not the same thing, and I am not pretending they are. But you cannot hold up one as a symbol of health while ignoring that the other has now put more than fifty babies in hospital beds. The irony is not rhetorical.
You met the CEOs – You have not met the parents
This is the part I most need you to hear.
When you launched Operation Stork Speed, you convened the chief executives of the largest formula companies — Abbott, Reckitt, Bobbie, Perrigo — around a table. This spring your department announced another CEO roundtable to modernize formula oversight. On June 2 you toured a manufacturer’s plant and stood beside its executives for the cameras. The industry has had your table, your podium, and your time.
I represent the other people in this story. The parents who followed every instruction on the label and watched their two-month-old go limp in their arms. The families who spent weeks in pediatric intensive care not knowing if their child would breathe on his own again. They are the ones who paid for the gap in this system. And as far as the public record shows, not one of them has been in the room with you.
You said your goal is to give parents honest data they can trust, and that protecting our children’s health is nonnegotiable. I believe you mean it. I am asking you to prove it in the most basic way there is: sit down with these families. Not the CEOs — the parents. Look at the people who trusted the label and were failed by it and let them tell you what “safe” turned out to mean.
What I am asking you to do
Earlier today I sent an open letter to your Acting FDA Commissioner, Kyle Diamantas — who until last month was your Deputy Commissioner for Food — a lawyer who, before he joined your agency, spent years defending an infant formula maker in court. I wrote to him about the regulation, because he can change it. I am writing to you about something that sits even above the Acting Commissioner: priorities. He can rewrite a testing rule. Only you, the Secretary, can decide whether this department’s attention belongs on the formula’s recipe or on what is getting into it. Here is what I am asking of you.
Meet the parents of the babies hospitalized by ByHeart and by Nara Organics. Before your next roundtable with industry, give the families one.
Then act on what the record already shows. We have been here before. In March 2023, your own agency told this entire industry, in writing and naming Clostridium botulinum, that powdered formula had a documented history of botulism and that manufacturers had to control for it. The hazard was foreseeable. It was named. And our federal regulations still require finished-powder testing only for Salmonella and Cronobacter — there is no botulinum testing standard for powdered formula at all. Close that gap. Test and inspect the whole chain — the dairy, the dryer, the blender — not just the recipe in the finished can. And fund the inspectors to do it, rather than cutting the very people who catch these outbreaks and trace them home.
You have spent a year talking about what goes into the formula. I am asking you to spend the next one on what is getting into it — and to start by facing the families who already know the difference.
Come sit with these parents, Mr. Secretary. Then tell me the nutrition label was the most urgent thing in the room.
Respectfully,
Sources
- Secretary Robert F. Kennedy, Jr. (@SecKennedy), post on the Eau Claire, Wisconsin Perrigo infant formula plant tour with Rep. Van Orden (June 2, 2026) — x.com/SecKennedy/status/2070166373469175974
- HHS, Secretary Kennedy Highlights Dairy Farmers, Infant Formula Safety, and Addiction Recovery as ‘Take Back Your Health’ Tour Stops in Wisconsin (June 2, 2026) (Gilbertson Farm whole-milk remarks; Perrigo tour) — hhs.gov
- FDA, FDA Releases Results from Largest-Ever Testing of Infant Formula in the U.S. (Apr. 29, 2026) (chemical-contaminant testing; announces May CEO roundtable on modernizing oversight) — fda.gov; HHS version — hhs.gov
- STAT, FDA Commissioner Marty Makary resigns, replaced by Kyle Diamantas (May 12, 2026) (Diamantas named Acting FDA Commissioner) — statnews.com
- FDA, Outbreak Investigation of Infant Botulism: Infant Formula (November 2025) (ByHeart; 48 infants, 17 states; WGS link from finished formula to organic whole milk powder dried at Dairy Farmers of America) — fda.gov
- FDA, Outbreak Investigation of Infant Botulism: Powdered Infant Formula (June 2026) (Nara Organics; three infants in California, Pennsylvania, and Washington, ages 2–5 months) — fda.gov
- Food Safety Magazine, Infant Formula Brands Behind Botulism Outbreaks Used Same Organic Whole Milk Supplier (June 2026) (Nara and ByHeart shared Organic West Milk dried by Dairy Farmers of America) — food-safety.com
- STAT, RFK Jr. presses infant formula makers on seed oils, supply chain, and contaminants (Mar. 18, 2025) (CEO roundtable with Abbott, Reckitt Benckiser, Bobbie, and Perrigo) — statnews.com
- FDA, FDA’s Actions to Respond to Clostridium botulinum Illnesses Associated with Consumption of Powdered Infant Formula (discusses the March 8, 2023 Call-to-Action letter naming Clostridium botulinum) — fda.gov
- 21 C.F.R. § 106.55 (powdered-formula microbiological testing limited to Salmonella and Cronobacter) — ecfr.gov