Parents of 23 Hospitalized Infants Back Petition Pressing FDA to Test Baby Formula for Botulism
A food-safety attorney, filing on behalf of 23 families, is asking the FDA to require powdered infant formula and its dairy ingredients to be tested for the bacteria that cause botulism, after 52 babies were hospitalized in two outbreaks.
Food-safety attorney Bill Marler is seeking public comments through Oct. 30 on a draft citizen petition that asks the FDA to require manufacturers to test powdered infant formula and the dairy ingredients it is made from for the bacteria that cause infant botulism. He is filing the petition with 23 parents whose babies were hospitalized with botulism after being fed powdered formula, 21 of them from the ByHeart outbreak and two from the Nara Organics outbreak, according to a Food Safety News piece published Monday.
Under current federal rules, 21 C.F.R. section 106.55(e), infant formula makers must test finished product for two organisms: Cronobacter and Salmonella. The FDA added Cronobacter to the list in 2014 after a record of about one reported illness a year; in March 2023, the FDA commissioner wrote to the entire powdered formula industry and named Clostridium botulinum as a hazard to be considered in designing controls. It was never added to the mandatory list.
Two outbreaks, one supply chain
Since that 2023 letter, 52 infants have been hospitalized with botulism in two outbreaks, the petition draft says. 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 Aug. 27, 2026, the 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, and the agency said the evidence points to a common source.
The bacteria may have arrived with the ingredient rather than the plant. ByHeart reported 472 environmental samples from its plants, covering food-contact surfaces, the areas around them and HVAC filters, and every one was negative. The 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. When the FDA sampled 48 powdered milk samples from four suppliers to formula makers in February 2026, two came back positive for a Clostridium carrying a botulinum toxin gene, according to the petition draft.
What the petition asks
The petition lays out seven requests in order of priority: add botulinum neurotoxin-producing clostridia to the finished-product testing table at section 106.55(e); require testing of each lot of whole milk powder, nonfat dry milk, milk protein concentrate, whey and similar ingredients before use; require manufacturers to notify the FDA within one business day of any confirmed positive; finalize the test method within 180 days; require supplier verification and lot-level records that identify the drying facility and each dairy farm; add environmental monitoring as a secondary control; and, in the alternative, grant what can be granted now, with ingredient testing first.
The petition does not ask the FDA to ban any product or brand. Marler notes that the testing list is the FDA’s own and the commissioner can amend it without a new law, and that adding botulism to the list would also pull it under S. 272, a Senate bill that passed unanimously in April and requires one-business-day notice for any organism on that list.
The draft also points to gaps the current setup missed. During the 2025 investigation, the milk supplier gave the 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 the FDA traced the milk to 22 dairies that have never been publicly identified. ByHeart ran about 5,000 C. botulinum tests during its root-cause investigation and now says it tests all dairy ingredients, bulk powder and finished product before release, but nothing requires ByHeart to continue or any other company to begin. At a July 2026 roundtable, the FDA presented an interim testing method that is still pending validation.
“Babies cannot read a label or be warned. The testing has to happen before the can is opened,” Marler wrote. Comments on the draft are due by email to the address in the petition by Friday, Oct. 30, 2026.
Reporting based on coverage by Food Safety News.
