Scientific American The cruel math behind the ByHeart and Nara botulism outbreaks was revealed this morning, and every member of Congress must agree.(1) Clostridium botulinum It survives pasteurization and spray drying and forms spores that hide in a dormant, dried powder form. If they do exist, they exist in almost invisible numbers. Approximately 1 spore per 3 kg spreads across 5 cans.(2) Since spores are not produced until they reach the baby’s intestines, the powder cannot be screened for toxins. Nara tested every batch over three stages and to specifications 10 times more stringent than international guidelines, but still shipped contaminated formula.(3) Even the same indicator tests would not have caught the outbreak, according to a study commissioned by ByHeart. In fact, laboratories have found botulinum in samples that came back clean.(4)
I am afraid of what people will learn from this. This is wrong. In other words, mandatory testing is pointless if you can’t catch even one spore in five cans. no. Science is the strongest argument I’ve seen for the part of HR 7867 that almost no one talks about: the part that doesn’t stop at the can.(5) The bill would require standardized environmental monitoring inside factories to one FDA standard, so contamination is caught in the production area before it reaches the can.(6) You can’t risk your baby’s life looking for a single spore at the end of the line. Manage milk and plants to prevent spores from entering. Upstream. This is where this fight is won.
And there is a scandal hidden in that article. The reason so few people catch these organisms is partly because of their biology and partly because so little equipment is available to anyone to see them. C. botulinum is a selective agent classified by the federal government, and only a very few laboratories in the United States are authorized to test for it.(7) The New York State laboratory that finally discovered the toxin in the sealed ByHeart had a team of seven people to do it. That means it takes five days to get preliminary results and three more weeks to confirm.(8) The state cannot order tests it cannot run, inspect plants that do not have inspectors, or prosecute detections that are not funded. The House member who authored the bill called the agency an “under-resourced FDA.”(9) An order without money is just a press release. Fund the lab. Fund inspectors. Funding for the risk assessment, scientists say, has not yet been secured. And fund the science itself. Detection methods here are still primitive. The gold standard is to inject a suspect substance into a live rat and wait several days for a response. And it will remain primitive until we can pay for labs that can create something faster and more sensitive. ByHeart’s own post-outbreak investigation has already resulted in more sensitive protocols.(10) A better test is ongoing funding.
Testing without inspection is like a company grading its own homework, and we already know how it ends. Blendhouse facilities in the ByHeart supply chain were labeled with an “Official Action Label,” the FDA’s most serious classification, before a single baby was harmed.(11) Through environmental monitoring and physical inspections of plant and ingredient suppliers, there are ways to find broken dryers, wet floors, and contaminated formula before it reaches your bottles.
But tests and inspections cannot tell us how this happened. The two outbreaks were not a double stroke of bad luck. According to the FDA’s own backtracking, ByHeart and Nara’s milk operated through the same suppliers, Organic West Milk and Dairy Farmers of America.(12) When the FDA asked Organic West who else it supplied to Organic West during its 2025 investigation of ByHeart, the list excluded Nara.(13) One mechanism built to prevent a second outbreak existed, and the agency used it and invalidated it due to incomplete disclosure. I will accept that testimony in my case. But only Congress can place answers under oath on the public record. Bring the CEOs of ByHeart and Nara and the people who run Organic West and Dairy Farmers of America to the witness stand and ask them what they knew and when they said it.
And bring your parents. The Secretary of Health and Human Services has met with official CEOs more than once. The FDA hosted an industry roundtable. One group that is never less important in a room is the family.(14) I represent more than 25 of them. Fourteen people wrote down their experiences and sent them to parliament, along with photos of their children (15). A mother watched her baby cry as she lost the strength to cry, a family was rushed from Idaho to a hospital in Utah, and a parent went to the emergency room four times before anyone said the word “botulism.” No expert, including me, can replace the parents who lived that life.
We’ve done this before. In 1993, Jack in the Box was declared by the USDA. E. coli O157:H7 is adultery after one year.(16) The Senate has already passed S. 272 without a single dissenting vote. This is a good measure that has not yet been reached for the organism that paralyzed these babies (17). Scientific American Pieces are not a reason to give up. It’s a blueprint. It’s a guarantee to stop pretending there are numbers on the can. Move control upstream of the milk and mills, fund the people who make certain orders a reality, and get the people who made this happen and those who survived into the same room and make them swear an oath. Pass and fund HR 7867. Please check it. And let parents talk.
We’ve waited long enough.
(1)Christina Szalinski, Why botulism in infant formula continues to increaseScientific American (June 30, 2026); scientificamerican.com.
(2) International Standard on Microbiological Specifications for Food (ICMSF), Infant formula testing (The level of contamination is estimated to be as low as 1 spore per 3 kg of powder.) icmsf.org (As reported in Scientific American, Reference 1).
(3)Bailey Henderson, The baby formula brand behind the botulism outbreak used the same organic whole milk supplier.Food Safety Magazine (June 2026) (Nara tested all batches for sulfite-reduced clostridium across three stages: raw material, in-process powder, and finished product, to specifications 10 times more stringent than ICMSF guidelines); food-safety.com.
(4) Nadala et al.; Detection and characterization of Clostridium botulinum isolated from powdered milkFront. microorganism. 17:1800624 (2026), doi:10.3389/fmicb.2026.1800624 (commissioned by ByHeart; C. botulinum detected in samples with negative SRC enumeration) frontiersin.org.
(5) Infant Formula Safety Modernization Act of 2026, HR 7867, 119th Cong.; congress.gov; The provisions are summarized below: DeLauro Press Release (Marler Blog).
(6)HR 7867 (Note 5) requires standardized environmental monitoring within manufacturing facilities according to a schedule established by FDA. This means that contamination from production areas is detected before it reaches the finished product. see DeLauro launched.
(7)Szalinski, Scientific American (Note 1) (C. botulinum It is a federally classified screening agent, limiting the number of laboratories approved for testing.
(8)Szalinski, Scientific American (Note 1) (The New York State Department of Health’s Wadsworth Center used a team of seven people. A single positive test took roughly five days to obtain preliminary results and another three weeks to confirm and sequence.)
(9) Representative. Rosa Delauro, DeLauro Introduces Bipartisan Infant Formula Safety Modernization Act (“The under-resourced FDA lacked the tools to adequately protect the infant formula supply.”), reprinted from the Marler blog; marlerblog.com.
(10)Szalinski, Scientific American (Note 1) (ByHeart’s post-outbreak “advanced C.Bot safety protocols,” which the company describes as more sensitive than industry-standard indicator tests).
(11)Blendhouse facilities connected to the ByHeart supply chain received an “Official Action Indication” designation, the FDA’s most severe inspection classification, prior to the outbreak. William D. Marler; Support for HR 7867 (June 23, 2026), Mahler Blog; marlerblog.com; FDA, FDA’s Actions to Combat Clostridium Botulinum Disease, fda.gov.
(12)William D. Mahler, The FDA has identified the shared supplier but has not yet linked it to Naarabyeong. (June 26, 2026), Mahler Blog; marlerblog.com (FDA Traceback: ByHeart and Nara’s milk was distributed through Organic West Milk and Dairy Farmers of America.)
(13) Mahler, FDA Verifies Shared Suppliers (Reference 12) (Nara omitted from Organic West customer list provided during 2025 ByHeart survey).
(14)William D. Mahler, An Open Letter to Secretary Kennedy: I Met the CEO, but My Parents Are Still Waiting (June 25, 2026), Mahler Blog; marlerblog.com.
(15)William D. Mahler, Supports HR 7867, the Infant Formula Safety Modernization Act of 2026 (June 23, 2026) (Appendix A – Statements and photos of 14 affected ByHeart and Nara families), Marler Blog; marlerblog.com; See also Letter to the Health, Education, Work and Pensions Committee (June 29, 2026), marlerblog.com.
(16)USDA, Food Safety and Inspection Service (FSIS declaration, August 1994) E. coli O157:H7 adulterant of raw ground beef), fsis.usda.gov.
(17) Act Protecting Infant Formula from Contamination, S. 272, 119th Cong.; congress.gov (Passed unanimously in the Senate on April 29, 2026. salmonella and Chronobacter).
