The Reagan-Udall Foundation for the FDA has published Applying the Science of Infant Formula Safety, a 44-page report on a July 13, 2026 roundtable about Clostridium botulinum in powdered infant formula. Two lines on the cover tell you how to read it. The first says the meeting was convened in collaboration with ByHeart and the International Dairy Foods Association. The second says ByHeart and IDFA paid for it. The company that recalled the formula that put 48 babies in the hospital, and the trade association for the dairy ingredient that carried the organism, funded the report on their own outbreak.
Twenty-four contributors are listed. They represent the formula industry, academia, one consumer advocacy organization and FDA. Not one is a parent of the 52 infants hospitalized across the ByHeart and Nara Organics outbreaks. Each contributor signed a disclaimer that inclusion does not mean endorsement, and the Foundation says it alone is responsible for the content. The report also says the roundtable focused primarily on formula manufacturers and lists a session with the dairy industry as a future step, even though the contamination came from the dairy side.
What the report recommends to prevent the next outbreak.
Appendix A collects 22 recommendations under four themes. Stripped of the connective tissue, they come to this:
- conduct a baseline study of spore prevalence on farms, in the supply chain and in finished goods;
- develop screening methods that are specific and sensitive; look for other indicators of spore presence;
- monitor environmental and supply changes; increase research funding;
- engage a trusted third party to house and anonymize industry testing data;
- write governance and confidentiality rules for that data;
- validate preventive technologies such as bacterial-removal separators and ultrafiltration;
- ask FDA to issue guidance on fit-for-purpose tests and thresholds;
- coordinate with CDC and USDA;
- hold a similar roundtable with the dairy industry;
- work toward accreditation of a validated test;
- and gather lessons from outside the United States.
Read them a second time and notice the verbs. Conduct, develop, investigate, explore, establish, nurture, educate, work toward. None of the 22 would require any company to do anything. The word “rule” does not appear. The closest it comes is recommendation 17, which asks FDA for guidance on fit-for-purpose tests and for standardized testing methods and requirements, without saying by what authority or on what schedule. Affordability and supply continuity appear as a theme on nearly every page, and recommendation 16 is simply to maintain them. Page 15 says it plainly: increasingly complex and costly control requirements could cause manufacturers to lose critical supply partners, so risk reduction must be balanced against supply chain sustainability. That is the industry position on regulation, stated in a document the industry paid for, and it is the reason the report asks for studies where a rule is needed.
What the report concedes, and it is more than the recommendations admit.
The appendices are more candid than the body. ByHeart reports roughly 5,000 C. botulinum tests run by IEH Laboratories: nine positives in 4,675 samples, eight of 241 finished-product lots PCR-positive, and one confirmed positive ingredient, organic whole milk powder from Organic West Milk sampled at Dairy Farmers of America. Every sample that tested positive for C. botulinum read under 10 cfu/g on the sulfite-reducing clostridia test, the indicator the industry has relied on for decades.
The report’s own conclusion is that trace amounts of spores can be present at levels too low for that method to detect, but enough to make infants sick. That finding is now published and it applies to every plant using the method, not just one.
ByHeart’s own open-questions slide states that the entry point of the organism into the ingredient has not been established. FDA’s testing workflow is labeled interim, pending validation. The report says only a limited number of laboratories can run the test at all, and that contamination is non-homogeneous and low-level, which means a negative on any single lot proves little. The opening pages set up the defense ICMSF gave the industry: before November 2025 this organism was not considered a hazard in formula. However, FDA named C. botulinum in a letter to the entire industry on March 8, 2023.
What the report leaves out, because it stopped at July 13.
The report is dated September 2026, and its factual record ends with FDA’s July 13 letter. It does not mention what has happened since. On August 27, CDC and FDA reported that whole genome sequencing links a Nara Organics infant to a ByHeart clinical sample, a ByHeart base-powder sample and four unopened cans of ByHeart formula, and that both brands’ formula was made from Organic West milk dried by Dairy Farmers of America. FDA calls that a common source of contamination. The report refers to recent outbreaks in the plural without ever naming Nara. It does not mention that FDA’s own closeout file, released under FOIA, sorted 37 isolates into 17 strains, recorded a death complaint the final count never resolves, found no root cause, and blacks out the names of six companies that received the contaminated milk powder lots. It does not mention that ByHeart says FDA has no further questions on a root cause submission the public has not seen. And it does not mention that Nara Organics has announced it will sell formula again on the strength of sealed-can tests that look for toxin rather than spores.
A report on C. botulinum in infant formula that omits the government’s finding that two outbreaks were one contamination is out of date on its own subject.
Their list next to mine.
The report and I agree on more than the funding line suggests. Testing alone will not protect formula; the controls have to reach upstream to the dryer and the farm; bactofugation and microfiltration deserve validation; the dairy suppliers belong at the table – along with 52 sets of parents and their babies. Where we part is on whether any of it should be mandatory.
- They recommend a prevalence study. I have asked Congress to add C. botulinum to the testing table at 21 C.F.R. § 106.55, which today names Salmonella and Cronobacter and nothing else. That is H.R. 7867, which had its hearing on April 29 and has not moved since.
- They recommend that FDA issue guidance on tests and thresholds. I have asked FDA to write a rule, because it has now written the industry three letters about this organism and a company that ignores a letter has broken nothing.
- They recommend a trusted third party to collect industry data and anonymize it before anyone sees it. I have asked FDA to release the six company names it redacted, to publish the results of its milk-powder surveillance sampling with the firms identified, and asked ByHeart to release its root cause submission and FDA’s letter accepting it. Anonymized data is what the public has now. It did not stop the second outbreak.
- They recommend a second roundtable with the dairy industry. I have asked for an oversight hearing with FDA, Dairy Farmers of America, Organic West Milk, ByHeart and Nara Organics at the table, where the questions are asked by members of Congress and the answers are on the record.
- They recommend that any new control be balanced against affordability. I would note that liquid formula already gets the full low-acid canned food regime built to keep botulism out of a sealed can, and nobody argues that made it unaffordable. A tub of powder gets a letter.
They did not invite the parents. I have asked both committees to put them at the witness table, and I have asked every official who touches this to spend one hour with one of these families before deciding what is operationally feasible.
What a report like this is for.
The Foundation is an independent nonprofit chartered by Congress, and convening the industry around a real problem is useful work. A roundtable where the recalled company presents its own investigation, the funders set the agenda, the families are absent and the output is a request for more research is not the same thing as a plan to prevent the next outbreak. The plan exists. It is a bill with a hearing behind it and a rule FDA could write tomorrow. Congress returns this month. The four offices that decide whether H.R. 7867 moves are the same four they were last week, and the report gives every one of them a reason to move: the industry has now put in writing that the test it relies on cannot find this organism. The second week of September, 535 t-shirts arrive on Capitol Hill, one for every member, each rolled inside a plastic baby bottle, and each carrying the same argument in six words: For Babies’ Sake, Test for Botulism in Infant Formula. The report just supplied the footnote.