The phrase “Never let a serious crisis go to waste” is usually attributed to Rahm Emanuel and usually said with a wink — a crisis grabs the public’s attention and opens room for things that, in calmer times, never make it out of committee. I am going to say it without the wink.
For more than thirty years — since the 1993 Jack in the Box E. coli outbreak — I have represented families poisoned by food they trusted and told anyone who would listen that my goal is to put myself out of business by making food safe. The cruel arithmetic of my work is that reform rarely arrives until enough people are hurt to force it. We have done exactly this before: the Jack in the Box outbreak is what pushed USDA’s Food Safety and Inspection Service to declare E. coliO157:H7 an adulterant in ground beef in 1994 — a single decision that made hamburger dramatically safer and has kept countless children out of hospital beds in the decades since. That was a crisis put to use, not wasted. We have a window open like that right now, and when Congresswoman Rosa DeLauro introduced the bipartisan Infant Formula Safety Modernization Act of 2026, I read every line. It is sober, specific, and it closes the exact gaps that let babies get hurt — on my watch and on the government’s. I support it without reservation, and the outbreaks are the argument.
We knew about Cronobacter for twenty years. In 2001, a Cronobacter (then called Enterobacter sakazakii) outbreak in a Tennessee NICU killed a newborn, traced to a contaminated lot of powdered formula; in April 2002 FDA warned hospitals against using powdered formula in NICUs because it is not sterile. And still, in 2022, four infants were infected with Cronobacter sakazakii from formula made at Abbott’s Sturgis, Michigan plant, and two died. The plant — roughly forty percent of the domestic supply — shut down, triggering a months-long national shortage. The lesson we failed to learn: our formula supply is dangerously concentrated, and our testing regime was built only for the pathogens we already knew about.
Then botulism — twice. The ByHeart outbreak of November 2025 was the first documented outbreak of botulism in the United States ever attributed to contaminated infant formula: at least 48 infants across 17 states, every one hospitalized. I represent some of those families. FDA’s whole-genome sequencing traced the C. botulinum to a routine ingredient — organic whole milk powder, sampled at Dairy Farmers of America, the processor for ByHeart’s supplier — and one ByHeart-affiliated Blendhouse facility in Reading, Pennsylvania had already been flagged “Official Action Indicated,” FDA’s most serious inspection finding, years earlier.
Seven months later, it happened again. Three more infants — in California, Pennsylvania, and Washington, all two to five months old, all hospitalized and treated with BabyBIG, all fed Nara Organics Whole Milk Organic Infant Formula bought at Target. The detail that stitches this together: Nara’s formula is manufactured in Europe. To be fair about the science, no Nara lot has yet tested positive for C. botulinum and confirmatory testing is still pending — but that cuts both ways: detection is notoriously hard, a negative does not clear a product, and three infants do not land in the hospital on the same brand by coincidence. A second botulism outbreak in the same year was not a freak event. It was foreseeable — we had just lived through the first — and the system did nothing in between.
And this is neither new nor only ours. In Europe this past winter, a multi-country recall of infant nutrition followed the detection of cereulide — a toxin produced by Bacillus cereus in arachidonic acid oil from a single Chinese supplier; the European Food Safety Authority was left scrambling to set a basic infant safety threshold after the recalls began, while Nestlé and Danone faced scrutiny over “silent” withdrawals made before any public recall. Go back to 2013, when New Zealand’s Fonterra warned that batches of whey protein concentrate — a powdered formula ingredient — might carry Clostridium botulinum, triggering a global infant-formula recall before testing identified the harmless cousin Clostridium sporogenes. A false alarm, yes — but more than a decade ago a botulism threat in powdered formula was plausible enough to clear shelves worldwide, so no one got to act surprised when the real thing surfaced in 2025.
The record runs deeper still. In 2017, Salmonella Agona in infant formula made at the Lactalis plant in Craon, Francesickened dozens of babies and forced a recall of more than 7,000 tons across some eighty countries — the same strain that had contaminated the same plant in 2005, with Lactalis accused of knowing months early, botching the recall, and later criminally charged with “aggravated deceit.” And in 2008, melamine added to watered-down milk in China sickened an estimated 300,000 infants and young children and killed at least six, after the producer sat on complaints for the better part of a year. A plant that poisons babies twice with the same bug; a company that knows and waits; testing you can game. Sound familiar?
These are not isolated tragedies. Cronobacter since 2001, melamine in 2008, a botulism scare in 2013, Salmonella in 2017, botulinum twice in 2025 and 2026, cereulide across Europe this winter. The thread is not bad luck. It is a system that tests for too little, too late, and tells too few people when something goes wrong.
DeLauro’s bill amends the Federal Food, Drug, and Cosmetic Act and does six concrete things, each mapped to a failure above.
Expand required pathogen testing. Current law effectively requires testing finished formula only for Cronobacter and Salmonella. Clostridium botulinum was not on the list — which is precisely why two botulism outbreaks slipped through. The bill directs FDA to build a real list and names C. botulinum on it.
Mandate environmental testing inside the plant. Standardized monitoring of Zones 2 and 3 catches contamination in the production environment before it reaches a can on a Target shelf. Standard practice elsewhere; astonishingly, not required by law for the food we feed newborns.
Set consistent standards. FDA sets the testing frequency, so “we tested” means the same thing at every facility instead of each company grading its own work.
Require early FDA notification — within one business day of a positive test, even before product leaves the building. This is the one that haunts me. Today a company can get a positive and sit on it: Lactalis allegedly did for months; recalled ByHeart product lingered on shelves for weeks; Europe saw “silent” withdrawals. Mandatory early notice shrinks the gap between when the company knows and when parents do — and in botulism, that gap is measured in hospitalized babies.
Hold foreign manufacturers to the same standards. This used to read like housekeeping. Not anymore: ByHeart’s botulinum rode in on an imported ingredient, the European cereulide on a Chinese supplier’s oil, and Nara’s formula — behind the second outbreak — is made in Europe. If it is sold to an American baby, it should meet American testing requirements, whether it was made in Iowa or shipped in on a pallet.
Strengthen Congressional oversight. The bill requires notice to Congress of any confirmed positive in finished formula and any “Official Action Indicated” finding. Remember Reading, Pennsylvania: that finding existed and went nowhere. Sunlight is how “we knew” stops being something we learn in a deposition years later.
The bill also gives FDA 90 days to finalize the rules. Good. We have waited long enough.
I make my living, in part, because companies cut corners and regulators are under-resourced. I would rather not. The families I represent never wanted a lawsuit; they wanted a healthy baby and a safe can of formula. Every provision here is something that, had it been law a year ago, might have meant fewer of those families ever needing to call me.
This is bipartisan legislation — DeLauro, a Democrat, leads it as H.R. 7867, joined by Republican Jeff Van Drew of New Jersey — which tells you protecting infants from poisoned formula is not a left-or-right question. It is a question of whether we act on what these outbreaks have already taught us, or wait for the next three babies, or the next forty-eight.
Pass it. We turned the Jack in the Box tragedy into a rule that made hamburger safer for a generation of children; we can do the same for the formula we feed newborns. Then let’s make it so the next time someone like me goes looking for an infant formula case, there isn’t one to find. That has always been the goal — to put myself out of business by making food safe.
The full text of the Infant Formula Safety Modernization Act of 2026 is available here.
