The Honorable Bill Cassidy, MD, President
The Honorable Bernie Sanders, Ranking Member
Health, Education, Work and Pensions Committee
us senate
428 Senate Dirksen Office Building
Washington DC 20510
Reply: Finish what the Senate started. Botulism in infant formula, shared milk and formula supply behind two outbreaks, hearings and parent testimony
Dear Chairman Cassidy, Ranking Member Sanders, and members of the Committee:
More than 30 years since Jack in the Box in 1993 E. coli Outbreaks — I represented children and families who were poisoned by foods they trusted. I now represent the families of over 25 infants who were paralyzed from botulism in their first months of life due to contaminated formula. Last week, I sent a letter to the House members on this committee supporting HR 7867, the Infant Formula Safety Modernization Act of 2026.(1)I am writing to you now because the Senate has already shown what this agency can do on this issue, and the work is not done.
You have already taken the lead on this, and that was important.
Let’s start with the credit, because you’ve earned it. On April 29, 2026, the committee favorably reported the Protecting Infant Formula from Contamination Act (S. 272) by a vote of 22 to 0, and the full Senate passed it unanimously the same day.(2) A bipartisan bill introduced by Senators Gary Peters and John Hoeven passed the body without a single dissenting voice. That’s no small thing. In Washington, where they agreed on almost nothing, the Senate agreed that parents are entitled to be notified within one business day if the formula in their baby’s bottle tests positive for a deadly pathogen.
These achievements are squarely in line with the food safety agenda the administration has championed under the banner of Making America Healthy Again. The MAHA movement has put the safety and integrity of the food we feed our children at the center of the national conversation. Operation Stork Speed led to a serious review of infant formula for the first time in a generation, and the FDA’s April 2026 contaminant testing was the largest contaminant test this country has ever conducted.(3) I have said it publicly and I will say it to you again. This has been long overdue and I’m glad it’s happening. The passage of S. 272 in the Senate is part of that. You have bridged a real gap and you should be proud of it.
But S. 272 didn’t reach the pathogen that actually paralyzed these babies.
Here’s the hard part, and I say this as someone who supports what you’ve done. S. 272 requires one business day notification only for organisms already on the books. Chronobacter and salmonella. Can’t reach Clostridium botulinumA spore-forming organism that produced a toxin that hospitalized 48 infants across 17 states during the ByHeart outbreak.(4) The Nara Organics outbreak has killed three additional infants in California, Pennsylvania and Washington.(5) All 51 babies were hospitalized. Many people were placed on ventilators. Each patient was treated with BabyBIG antivenom, with a California price of $69,300 per dose.(6) None of them were harmed by the contaminants picked up in the April tests. They were paralyzed by spores, which federal regulations do not require powdered formula to be tested before or after delivery.
The risk was not surprising. On March 8, 2023, two years before the first ByHeart baby got sick, the FDA sent a call to action letter to the entire infant formula industry, signed by the Commissioner of the Food and Drug Administration and the director of the Center for Food Safety and Applied Nutrition. Clostridium botulinum Classify by genus and species and instruct manufacturers to account for this when designing controls.(7) The risks were foreseeable, the government named them in writing, and the rules still do not require testing. HR 7867 — A bill led by Representatives Rosa DeLauro and Jeff Van Drew and endorsed by the American Academy of Pediatrics, Consumer Reports, Consumer Federation of America, Center for Science in the Public Interest, and Stop Food Poisoning. botulism The test list mandates environmental monitoring inside factories and requires foreign manufacturers to comply with U.S. standards.(8) The Senate drafted a narrower bill. Now I have a bigger house in front of me.
My first request is simple. I have asked the House to pass HR 7867. I’m asking the Senate to do the same. Botulinum Adopt companion legislation or your own measure that fills the gaps in S. 272 and finish the work this committee began on April 29.
Why the System Missed It Twice and Why This Committee Should Hold a Hearing
The two outbreaks were not an unrelated coincidence. They shared a supply chain. The FDA’s own backtracking confirmed that the Nara formula fed to the three sick infants was made from milk supplied by Organic West Milk and spray-dried by Dairy Farmers of America. These are the same two vendors involved in the ByHeart outbreak.(9) An upstream source provided milk and powdered milk for both brands. The contamination did not affect the two companies by chance. The system went through one shared stream that it missed the first time and then missed again.
During the 2025 ByHeart investigation, the FDA did exactly what the playbook called for. That means they ran a trace and asked who else supplied Organic West. So I was able to find my next brand before my next baby got sick. According to the FDA’s June 26, 2026 update, the customer list produced by Organic West did not include Nara and was incomplete, and Organic West acknowledged that the list should now include Nara. Tracking occurred during the 2025 outbreak. The country’s babies were hospitalized in April and May 2026. If there had been a complete and accurate list, my country would have been on the radar of the FDA months before a single baby showed symptoms. One mechanism designed to prevent a second outbreak existed and the agency used it, but invalidated it due to incomplete supplier disclosure.
This is the type of congressional oversight failure we are examining. The questions are specific and the answers are on the record under oath.
1. Questions for FDA: When did the agency learn that Organic West and DFA had supplied both ByHeart and Nara? Why has the 2025 Tracking Forward not surfaced the country, what is the backstop when a supplier’s customer list is incomplete, and why do federal regulations still require final powder testing? salmonella and Chronobacter —and nothing Clostridium botulinum(10) — Has it been three years since the agency named an organism in a letter to industry?
2. Questions for American Dairy Farmers: What did you know about the risks of using baby formula in baby formula? What did DFA know about the dried whole milk powder of both brands? What tests were performed for spore-forming organisms? What did I disclose to whom during the ByHeart tracking process?
3. Questions about Organic West Milk: What did you know about the risks of using whole milk in infant formula? Why was my country excluded from the list of customers provided to the FDA in 2025? Who prepared that list, who reviewed it, and when did Organic West first notice that an identical supply of milk had reached a second brand of infant formula?
4. To Nara Organic: What did you know about the risks of using whole milk in infant formula? When did Nara learn that its baby formula was produced through the same Organic West/DFA supply stream involved in the ByHeart outbreak? What did you test? And what did you tell regulators and parents, and when?
The common thread that runs through all four is a single question that this committee is uniquely positioned to ask publicly: Why didn’t we disclose shared milk and formula supplies in 2025, when if we had done so we could have completely prevented a second outbreak?
I’ve watched companies answer those kinds of questions only when forced to do so in court. Discovery and depositions will compel a complete record of the litigation I am handling. But the public policy record – the record that tells you whether the law should be changed – is yours. Hearing parties approach witnesses and ask questions that cannot be asked in a single-plaintiff case.
The second request is to hold a hearing. Bring the FDA, American Dairy Farmers, Organic West Milk and Nara Organics before this committee and put their 2025 disclosure failures on the public record. So the next reform will be based on what actually happened, not on what someone willingly volunteered to do.
Now it is the parents’ turn to testify.
There is one more thing, and for me it is the most important. Throughout this episode, the only people with access to the rooms where decisions are made are companies and agencies. The Minister of Health and Welfare met with top executives of powdered milk companies several times. The FDA convened an industry roundtable. The only group that is not in that room, or any room at all, is the parents.
I represent those families. They followed all the directions on the label and watched their two-month-old baby go limp in their arms. They spent weeks in the pediatric intensive care unit, unsure if the child would ever breathe on his own again. One family was transported by medical ship from Idaho to a children’s hospital in Utah. Some of them have already written statements to Congress. I attached that statement, along with my own words and photos, to a letter I sent to the House Energy and Commerce Committee on June 23, 2026. They want to do more than just write. They are willing to come and testify.
As this committee exposes the human cost of policy failure, no expert or lawyer, including myself, can speak for the parents who have lived through it. These mothers and fathers can tell us better than any of us what “safety” means when systems are tested too little, too late, and too few people are notified when problems arise.
The third question asks parents to testify. Before this committee writes the next chapter of the Infant Formula Safety Act, please give the families of Bayhart and Nara infants and toddlers a seat on the witness stand. They got it the hardest way.
we’ve done this before
The Jack in the Box tragedy led the USDA to declare: E. coli O157:H7 adulterated ground beef in 1994. This single decision kept countless children from hospital beds for decades to come.(11) This committee and this Senate are now keeping the same kind of window open. You have proven that an agreement exists on April 29th. I ask for a further extension as these two outbreaks require. Pass legislation on botulism, hold hearings in 2025 to document public failures, and let parents have their say.
Thank you for your leadership on S. 272 and your consideration of what is needed at this moment.
Truly yours,
William D. Mahler
