On June 23 and June 29, 2026, I wrote to the House Committee on Energy and Commerce and to the Senate Committee on Health, Education, Labor, and Pensions about Clostridium botulinum in powdered infant formula — 48 hospitalized infants in the ByHeart outbreak, four more in the Nara Organics outbreak, and a federal rule that still requires no one to test infant formula for the organism that paralyzed them. Neither letter drew a reply. On August 27, 2026, the federal government confirmed the central factual claim in both of them, and confirmed it with a laboratory result rather than an inference. On August 28 I wrote to both committees again. All four letters are below.

I asked both committees for the same three things

The June 23 letter went to Chairman Brett Guthrie and Ranking Member Frank Pallone, Jr., in support of H.R. 7867, the Infant Formula Safety Modernization Act of 2026, which Representative Rosa DeLauro introduced in March and which received a Subcommittee on Health legislative hearing on April 29. I asked the Committee to mark the bill up and report it favorably, to hold an oversight hearing, and to put the parents of the injured infants at the witness table. That letter is published here, and the heart of it is not my argument. It is Appendix A — fourteen families describing, in their own words and with their children’s photographs, what infant botulism did to a two-month-old.

The June 29 letter went to Chairman Bill Cassidy and Ranking Member Bernie Sanders, and it began with credit, because the Senate had earned it. On April 29 the HELP Committee reported the Protect Infant Formula from Contamination Act, S. 272, by a vote of 22 to 0, and the full Senate passed it the same day by unanimous consent. In a Washington that agrees on almost nothing, that is not a small thing. My point to that Committee was narrow: S. 272 requires one-business-day notice only for the organisms already on the books — Cronobacter and Salmonella — and does not reach the one that put these babies in intensive care. That letter is published here.

Neither letter was answered, and that is not what this post is about

Congressional committees receive an enormous volume of mail, most of it from people with an interest in the outcome, and I am one of them. A letter from a plaintiffs’ lawyer has no claim on anyone’s reply, and I am not writing to complain about the silence. I am writing again because the record changed. In June I could tell these committees what I believed the evidence would show. In August the government showed it.

On August 27 the government said the two outbreaks were one contamination

The Centers for Disease Control and Prevention declared the Nara Organics outbreak over. The final count is four infants — two in California, one in Pennsylvania, one in Washington — with illness onsets on April 20, May 17, May 20 and May 31, 2026. All four were hospitalized. None died. CDC found that epidemiologic, traceback and laboratory data showed that Nara Organics Whole Milk Organic Infant Formula was contaminated with Clostridium botulinum and made infants sick. Its earlier update had said only that the formula might be contaminated. The agency dropped the qualifier.

Then came the finding that ought to move this from a lawyer’s argument to a committee calendar. Whole genome sequencing linked a patient sample from the Nara outbreak to material collected during the investigation of the 2025 ByHeart outbreak — a patient sample, product samples and an ingredient sample. FDA describes the same result more specifically, reporting a match to a ByHeart clinical sample, a powdered infant formula base sample, and four samples of unopened cans of ByHeart formula. CDC states that FDA’s traceback determined that the formulas sold by both brands were made with milk supplied by Organic West Milk and spray dried by Dairy Farmers of America, and that the matching sequences indicate a common source of contamination for the two outbreaks.

In June I wrote that the contamination did not strike two unrelated companies by chance, and that it traveled through one shared supply stream the system missed twice. The support for that sentence was a traceback and a trade-press report. The support for it now is the government’s own sequencing. The same organism has been found in an infant fed one brand and in the product and the ingredient of the other. A strain does not move between two babies who never consumed the same product by accident. It moves through the thing they shared. I have been making that argument about this ingredient since June, and I would rather have been wrong.

One question the sequencing does not answer, and I would rather say so myself

Neither agency has determined a root cause. FDA says it cannot yet tell whether the milk was contaminated before it was dried or during the drying process. That question decides how responsibility is divided among the brands, the milk supplier and the processor, and it is the question I expect to spend the next two years on. It does not touch whether the formula was contaminated, and it does not touch whether the formula paralyzed babies. CDC decided both of those on August 27.

My June letters undercounted, and the correction runs the wrong way

Both June letters said three Nara infants and fifty-one babies in total. The agencies added a fourth Nara case as the investigation continued, so the correct totals are four and fifty-two. Both follow-up letters state the correction openly rather than quietly restating the number, and I wrote about the fourth case when it was added. Fifty-two infants hospitalized across two outbreaks, many of them on ventilators, each treated with BabyBIG antitoxin that the State of California prices at $69,300 a dose.

The sequencing speaks to four specific provisions of the House bill

H.R. 7867 is not a general expression of concern. It does six concrete things, and the August 27 result speaks directly to four of them. The testing list: federal regulation still requires finished-formula testing only for Salmonella and Cronobacter and says nothing about Clostridium botulinum, so the organism now sequenced across two brands, two outbreaks and fifty-two hospitalized infants is the one organism nobody is required to look for. Environmental monitoring: a single strain persisting through this ingredient stream across two manufacturers, a national recall, a federal investigation and a formal closeout is not an incidental event — it is a resident organism, and Zone 2 and Zone 3 monitoring is how a resident organism gets found. Foreign manufacturers: the Nara formula was made abroad, its milk came from an American supplier, it was dried by an American processor, and the sequencing has now tied it to an American outbreak — the route the bill anticipated is the route the organism actually took. Notice to Congress: consider what this committee would have known in 2025 had that provision been law, and how much of what I am reporting today you would already have had.

The mechanism built to prevent a second outbreak failed on a customer list

During the 2025 ByHeart investigation the FDA did what the playbook calls for. It ran a trace-forward and asked Organic West Milk who else it supplied, so the next brand could be found before the next baby was hurt. The customer list did not include Nara Organics, and Organic West has since told the FDA that it should have. ByHeart recalled all of its product on November 11, 2025. CDC declared that outbreak over on February 26, 2026. The first Nara infant became ill on April 20, 2026 — 160 days after the recall, and 53 days after the government told the country the first outbreak was finished. The one mechanism designed to prevent a second outbreak existed, the agency used it, and an incomplete answer defeated it. We now know at the level of the genome exactly what got through. I have been asking what Nara knew and when it knew it since June, and this is the part of the record that answers a different question — what the government asked, and what it was told.

The three asks are unchanged, and there is now a fourth

First, pass a bill that reaches botulism. The House Committee should mark up H.R. 7867 and report it favorably; the hearing is behind it and the next step is procedural. The Senate should take up a companion measure or write its own. Second, hold the oversight hearing. Bring the FDA, Dairy Farmers of America, Organic West Milk, Nara Organics and ByHeart to the table. The questions are sharper than they were in June because there is now a laboratory result to ask about: how long has this organism been in this ingredient stream, who tested for it, by what method and how often, and who prepared the 2025 customer list, who reviewed it, and when did each company learn that the same milk had reached a second brand. Third, put the parents at the witness table. They are willing to do more than write, and no expert and no lawyer, myself included, can substitute for the parent who lived it.

The fourth is new. Put a written question to the FDA, with a deadline. The agency’s root cause investigation has been open since November 2025, and its own public page on this subject has not been updated since July 13, 2026 — it still says there is not enough evidence to determine whether the shared suppliers are the source of the contamination, language its own sequencing has now overtaken. Ask the Commissioner what the root cause investigation has found, whether the agency intends to require testing or environmental monitoring for Clostridium botulinum by regulation, and if so on what schedule. A date certain would tell Congress whether legislation is necessary or merely useful. The absence of one would tell you something too. I made a version of this point directly to the agency in June, and the answer so far has been letters.

We have done this before

The Jack in the Box tragedy moved USDA to declare E. coli O157:H7 an adulterant in ground beef in 1994 — one decision that has kept countless children out of hospital beds in the decades since. That was a rule. What the powdered infant formula industry has received on botulism is a series of letters, the first of them sent on March 8, 2023, naming the organism by genus and species, three and a half years ago. Letters are not a rule. Fifty-two families already know what the sequencing means, and they would like to know that Congress does too.

My thanks to both committees for their work on infant formula this year, and my standing offer: I will answer any question from either committee or its staff, and I will make the families available to them.

The four letters

https://www.marlerblog.com/files/2026/08/HR_7867_Support_Letter_6_23_26_WDM_FINAL.pdf

Letter to the House Committee on Energy and Commerce, June 23, 2026, with Appendix A — statements and photographs of fourteen families.

https://www.marlerblog.com/files/2026/08/Marler_Senate_HELP_Letter_Letterhead.pdf

Letter to the Senate Committee on Health, Education, Labor, and Pensions, June 29, 2026.

https://www.marlerblog.com/files/2026/08/HR7867_Follow_Up_Letter_8-28-26.pdf

Follow-up letter to the House Committee on Energy and Commerce, August 28, 2026.

https://www.marlerblog.com/files/2026/08/Senate_HELP_Follow-Up_Letter_8_28_26_WDM.pdf

Follow-up letter to the Senate Committee on Health, Education, Labor, and Pensions, August 28, 2026.