
Before I file it, I am asking for comments on a draft citizen petition asking the Food and Drug Administration to require that powdered infant formula, and the dairy ingredients it is made from, be tested for the bacteria that cause infant botulism. The draft, with 31 footnotes to public sources and four appendices, is posted here: https://www.marlerblog.com/files/2026/10/C.-botulinum-Petition-10.15.26-WDM.pdf
I am filing it with twenty-three parents of infants who were hospitalized with botulism after being fed powdered formula – twenty-one from the ByHeart outbreak and two from the Nara Organics outbreak. I represent each of those families in litigation, and the petition says so.
Why it is needed
Federal regulation, 21 C.F.R. § 106.55(e), requires infant formula manufacturers to test finished product for two organisms: Cronobacter and Salmonella. FDA added Cronobacter to that list in 2014 on a record of about one reported illness a year, because it concluded that voluntary industry testing might not be enough for a food that is the sole source of nutrition for infants.
On March 8, 2023, the FDA Commissioner wrote to the entire powdered infant formula industry and named Clostridium botulinum as a hazard to be considered in designing controls.
Since then, 52 infants have been hospitalized with botulism in two outbreaks. ByHeart Whole Nutrition Infant Formula sickened 48 infants in 17 states, with illness onsets from December 2023 through November 2025. Nara Organics Whole Milk Organic Infant Formula sickened four infants in California, Pennsylvania and Washington in April and May 2026. Every one of those babies was hospitalized.
On August 27, 2026, FDA reported that whole genome sequencing linked the two outbreaks. Formula from both brands was made with milk supplied by Organic West Milk and spray dried by Dairy Farmers of America. FDA says the evidence points to a common source.
The organism is still not on the list.
The bacteria came in with the ingredient
ByHeart reported 472 environmental samples from its plants – food-contact surfaces, the areas around them and HVAC filters. Every one was negative. FDA, on the other hand, found the organism in a lot of organic whole milk powder that matched a sick infant by whole genome sequencing. A rule aimed only at the plant environment would have found nothing.
When FDA sampled 48 powdered milk samples from four suppliers to infant formula makers in February 2026, two came back positive for a Clostridium carrying a botulinum toxin gene. During the 2025 investigation, the milk supplier gave FDA an incomplete customer list that left out Nara’s manufacturers, and the first Nara baby got sick 160 days after the ByHeart recall. WJLA reported last week that FDA traced the milk to 22 dairies that have never been publicly identified.
Testing is possible now. ByHeart ran about 5,000 C. botulinum tests during its root-cause investigation, and it now says it tests all dairy ingredients, bulk powder and finished product before release. Nothing requires ByHeart to continue, or any other company to begin. At a July 2026 roundtable, FDA presented an interim testing method, still pending validation.
What I see as the fix
The petition asks FDA to finish what it started in 2023. In order of priority:
1. Add the organism to the testing list. Add botulinum neurotoxin-producing clostridia to the finished-product table at § 106.55(e), with a result of none detected, at not fewer than thirty 200-gram samples per production aggregate or an equivalent plan.
2. Test the dairy ingredients before they are used. Require testing of each lot of whole milk powder, nonfat dry milk, milk protein concentrate, whey and similar ingredients, with a negative result as a condition of use.
3. Notify FDA within one business day of any confirmed positive, whether or not the product has left the plant.
4. Finalize the test method within 180 days, and say that the older direct-plating method is not good enough.
5. Know where the milk came from. Require supplier verification and lot-level records identifying the drying facility and each dairy farm.
6. Environmental monitoring as a secondary control.
7. In the alternative, grant what can be granted now, with priority on ingredient testing and the method.
No new law is needed. The list is FDA’s own, and the Commissioner can amend it. Doing so would also matter to Congress: S. 272, which passed the Senate unanimously in April, requires one-business-day notice for any organism on that list. Add botulism to the list, and that notice requirement reaches it automatically.
The petition does not ask FDA to ban any product or brand.
What comments are being sought?
I want to hear from scientists, laboratories, public health officials, formula manufacturers, dairy processors, pediatricians and parents. In particular:
Is thirty 200-gram samples the right finished-product plan, and is it workable at commercial scale? Is the list of dairy ingredients right, and is the exemption for ingredients that have gone through a validated spore-reduction process drawn correctly? Is farm-level traceability practical, and what would it take? Are the environmental monitoring provisions useful, given that ByHeart’s plant testing found nothing? What data on cost, laboratory capacity or method performance should be in the record? And – because the certification requires it – what information unfavorable to the petition am I missing?
Edits and redlines are welcome. If you would like the Word version to mark up, email me and I will send it.
Comments should be emailed to bmarler@marlerclark.com by Friday, October 30, 2026.
I took the same approach with my raw milk cheese warning label petition and my sprout warning label petition, and the comments made both of them better documents. Babies cannot read a label or be warned. The testing has to happen before the can is opened.







