Scientific American this morning laid out the brutal arithmetic behind the ByHeart and Nara botulism outbreaks, and every member of Congress should sit with it.[1] Clostridium botulinum forms spores that survive pasteurization and spray-drying and hide, dormant, in dried powder — and when they are there, they are there in almost invisible numbers: as low as one spore per three kilograms, about one spore spread across five cans.[2] You cannot even screen the powder for the toxin, because the spores do not make it until they reach a baby’s gut. Nara tested every batch — to a specification ten times stricter than the international guideline, at three separate stages — and still shipped contaminated formula.[3] A study ByHeart commissioned found the same indicator test would not have caught its outbreak either; the lab actually found botulinum in samples where the indicator came back clean.[4]
Here is the lesson I am afraid people will take from that, and it is the wrong one: that if you cannot catch one spore in five cans, mandated testing is pointless. No. The science is the strongest argument I have seen for the part of H.R. 7867 almost nobody talks about — the part that does not stop at the can.[5] The bill requires standardized environmental monitoring inside the plant, on one FDA standard, so contamination is caught in the production zones before it ever reaches a can.[6] You do not bet a baby’s life on finding the single spore at the end of the line. You control the milk and the plant so the spore never gets in. Upstream. That is where this fight is won.
And there is a scandal hiding in that article. The reason almost no one catches this organism is partly biology and partly that almost no one is equipped to look: C. botulinum is a federally classified select agent, and only a handful of labs in the country are cleared to test for it.[7] The New York State lab that finally found the toxin in a sealed ByHeart can did it with a team of seven — five days for a preliminary result and three more weeks to confirm.[8] You cannot mandate a test the country cannot run, inspect plants you have no inspectors for, or prosecute what you were never funded to detect. The Congresswoman who wrote this bill called the agency what it is — a “resource-starved FDA.”[9] A mandate without money is a press release. Fund the labs. Fund the inspectors. Fund the risk assessment the scientists say we still do not have. And fund the science itself: the detection methods here are still primitive — the gold standard injects suspect material into live mice and waits days for an answer — and they will stay primitive until we pay the laboratories that can build something faster and more sensitive. ByHeart’s own post-outbreak investigation has already produced a more sensitive protocol;[10] better testing is exactly what sustained funding buys.
Testing without inspection is a company grading its own homework, and we already know how that ends. A Blendhouse facility in ByHeart’s supply chain was flagged “Official Action Indicated” — FDA’s most serious classification — before a single one of those babies was hurt.[11] Environmental monitoring and real inspection of the plants and the ingredient suppliers are how you find the cracked dryer, the wet floor, and the contaminated milk powder before any of it reaches a bottle.
But testing and inspection still cannot tell you how this happened. The two outbreaks were not bad luck striking twice. FDA’s own traceback shows the milk behind both ByHeart and Nara ran through the same suppliers — Organic West Milk and Dairy Farmers of America.[12] When FDA asked Organic West during the 2025 ByHeart investigation who else it supplied, the list left Nara off it.[13] The one mechanism built to stop the second outbreak existed, the agency used it, and an incomplete disclosure defeated it. I will take those depositions in my own cases. But only Congress can put the answer on the public record, under oath. Bring the CEOs of ByHeart and Nara, and the people who run Organic West and Dairy Farmers of America, to the witness table, and ask them what they knew and when they said it.
And bring the parents. The Secretary of Health and Human Services has met with the formula CEOs more than once; the FDA has held its industry roundtables; the one group never in a room that counts is the families.[14]I represent more than twenty-five of them. Fourteen wrote out what they lived through and let me send it to Congress with their children’s photographs[15] — the mother who watched tears run down a baby who had lost the muscle to cry, the family medevaced from Idaho to a hospital in Utah, the parents who went to the emergency room four times before anyone said the word “botulism.” No expert, me included, can stand in for the parent who lived it.
We have done this before. Jack in the Box, in 1993, is what made USDA declare E. coli O157:H7 an adulterant a year later.[16] The Senate has already passed S. 272 without a single dissenting vote — a good bill that still does not reach the organism that paralyzed these babies.[17] The Scientific American piece is not a reason to give up. It is a blueprint: stop pretending a number on a can is a guarantee, move the controls upstream to the milk and the plant, fund the people who make any mandate real, and put those who caused this — and those who survived it — in the same room, under oath. Pass H.R. 7867. Fund it. Inspect it. And let the parents speak.
We have waited long enough.
[1]Christina Szalinski, Why Botulism Keeps Cropping Up in Infant Formula, Scientific American (June 30, 2026), scientificamerican.com.
[2]Int’l Comm’n on Microbiological Specifications for Foods (ICMSF), Testing of Infant Formula (contamination estimated as low as one spore per three kilograms of powder), icmsf.org (as reported in Scientific American, note 1).
[3]Bailee Henderson, Infant Formula Brands Behind Botulism Outbreaks Used Same Organic Whole Milk Supplier, Food Safety Magazine (June 2026) (Nara screened every batch for sulphite-reducing clostridia at a specification ten times stricter than the ICMSF guideline, at three stages — raw ingredient, in-process powder, and finished product), food-safety.com.
[4]Nadala et al., Detection and Characterization of Clostridium botulinum Isolated from Powdered Infant Formula, Front. Microbiol. 17:1800624 (2026), doi:10.3389/fmicb.2026.1800624 (ByHeart-commissioned; C. botulinum detected in samples where SRC enumeration was negative), frontiersin.org.
[5]Infant Formula Safety Modernization Act of 2026, H.R. 7867, 119th Cong., congress.gov; provisions summarized at DeLauro press release (Marler Blog).
[6]H.R. 7867 (note 5) requires standardized environmental monitoring inside the manufacturing facility on an FDA-set schedule — detecting contamination in the production zones before it reaches the finished product. See DeLauro release.
[7]Szalinski, Scientific American (note 1) (C. botulinum is a federally classified select agent, which limits the number of laboratories cleared to test for it).
[8]Szalinski, Scientific American (note 1) (the New York State Department of Health’s Wadsworth Center used a team of seven; a single positive can took roughly five days for a preliminary result and three more weeks to confirm and sequence).
[9]Rep. Rosa DeLauro, DeLauro Introduces Bipartisan Infant Formula Safety Modernization Act (“a resource-starved FDA has lacked the tools to adequately protect the infant formula supply”), reprinted at Marler Blog, marlerblog.com.
[10]Szalinski, Scientific American (note 1) (ByHeart’s post-outbreak “Advanced C.Bot Safety Protocol,” which the company describes as more sensitive than the industry-standard indicator test).
[11]A Blendhouse facility tied to the ByHeart supply chain carried an “Official Action Indicated” designation — FDA’s most serious inspection classification — before the outbreak. See William D. Marler, Support for H.R. 7867 (June 23, 2026), Marler Blog, marlerblog.com; FDA, FDA’s Actions to Respond to Clostridium botulinum Illnesses, fda.gov.
[12]William D. Marler, FDA Confirms the Shared Suppliers — but Hasn’t Linked them to the Nara Illnesses — Yet (June 26, 2026), Marler Blog, marlerblog.com (FDA traceback: the milk behind both ByHeart and Nara ran through Organic West Milk and Dairy Farmers of America).
[13]Marler, FDA Confirms the Shared Suppliers (note 12) (the customer list Organic West provided during the 2025 ByHeart investigation omitted Nara).
[14]William D. Marler, An Open Letter to Secretary Kennedy: You Met the CEOs — The Parents Are Still Waiting (June 25, 2026), Marler Blog, marlerblog.com.
[15]William D. Marler, Support for H.R. 7867, the Infant Formula Safety Modernization Act of 2026 (June 23, 2026) (Appendix A — statements and photographs of fourteen affected ByHeart and Nara families), Marler Blog, marlerblog.com; see also Letter to the Committee on Health, Education, Labor, and Pensions (June 29, 2026), marlerblog.com.
[16]USDA, Food Safety & Inspection Service (in August 1994 FSIS declared E. coli O157:H7 an adulterant in raw ground beef), fsis.usda.gov.
[17]Protect Infant Formula from Contamination Act, S. 272, 119th Cong., congress.gov (passed the Senate by unanimous consent on April 29, 2026; reaches only Salmonella and Cronobacter).