Céline Gounder just laid it out more clearly than any regulator has: two infant botulism outbreaks in a single year, ByHeart and now Nara Organics, and the same organic whole milk moving through the same drying plant into both cans. Organic West Milk supplied it. Dairy Farmers of America dried it into powder. FDA has confirmed the shared pipeline. Two premium brands sold to parents as the clean, careful choice, drawing from one upstream source.

Infant formula is the most regulated food in this country. Every plant inspected every year (clearly, not often enough), every batch tested for Cronobacter and Salmonella before it ships. And it still put babies in the ICU twice in twelve months, because inspection plus the current rules don’t require anyone to look for the thing that actually sickened these children. 

I represent more than two dozen of these families. I’ve read the medical records — the constipation, the weak suck, the floppy head, the intubation. I’ve filed the complaints. And I can tell you the fix isn’t a mystery. Test the ingredients upstream, where the spores enter. Monitor the plant and milking environment. And make a company pick up the phone the moment it finds a positive — not after the batch ships, not never. Right now, a manufacturer can test its own product, find a deadly pathogen, and sit on the result as long as the lot hasn’t left the warehouse. That is legal. It should not be.

Rosa DeLauro’s Infant Formula Safety Modernization Act (H.R. 7867) does all three — C. botulinum testing, environmental monitoring, mandatory disclosure of positive results. It’s had bipartisan support since March. It has sat in committee since March. And in the time, it sat, a second outbreak arrived and Nara stayed on Target shelves until June. I support this bill without reservation, and I support the FDA’s own request for the authority to require reporting of a positive test even when the tainted formula never leaves the building.

And I haven’t waited on Congress. I wrote directly to the two men who could move this tomorrow without a single vote — an open letter to Health Secretary Robert F. Kennedy Jr., who toured a formula plant and praised whole milk the same day his own agency knew whole-milk powder was the vehicle in both outbreaks; he’s met the CEOs, he hasn’t met the parents, and I asked him to fix that. And a letter to Acting FDA Commissioner Kyle Diamantas, counselor to counselor, because he spent years defending an infant-formula maker against failure-to-warn claims before he held the pen at the FDA, so of all people he knows what foreseeability means. Next I’m taking it to all 535 of them the way I have before — handing out t-shirts on the Hill, because a slogan on a chest gets read when a letter on a desk does not.

But a bill in committee doesn’t hold anyone accountable, and a markup isn’t the same as a hearing. Congress should hold one — and it should invite the parents. Not the trade association, not the consultants. The mothers and fathers who watched a baby go limp after a feeding they were told was the safe choice. Let them sit at the witness table and describe what “voluntary reporting” and a 40% inspector vacancy rate feel like from a pediatric ICU. I’ll help any family who wants to be there get there.

I’ve been doing this since 1993. The details change — the pathogen, the brand, the supplier — but the pattern doesn’t: a gap everyone knew about, a warning nobody was required to act on, and children who paid for it. Gounder’s reporting closes the information gap. Congress can close the legal one. Pass the bill and hold the hearing.