On August 31, 2026, Abbott announced Similac 360 Total Care Made With Whole Milk, the first and only commercially sterile, ready-to-feed liquid infant formula made with whole milk sold in the United States. Whole milk for a fat blend closer to breast milk, five human milk oligosaccharides, priced near the per-feeding cost of the powder. As launches go, unremarkable.
The frequently asked questions at the bottom are not. Asked what commercial sterility means, Abbott answers that while all formulas, powders included, are made to eliminate potentially harmful microorganisms, commercial sterility means the liquid has gone through an additional, validated heat treatment designed to eliminate spores of potentially harmful microorganisms, particularly Clostridium spores. Asked why liquid is safer for certain babies, Abbott says FDA and CDC advise parents of infants under two months, and of those with weakened immune systems, to consider a commercially sterile liquid when the baby is not receiving breast milk.
I would have skimmed past that. Dr. Jade Cobern’s piece for ABC News pulled the sterility language out of the release and set it beside the two infant botulism outbreaks. Cobern is a board-certified pediatrician and preventive medicine physician with the ABC News Medical Unit. Most of the coverage ran the press release.
The record Abbott is selling against
I have set out both outbreaks in full, the 2023 to 2025 ByHeart outbreak and the 2026 Nara Organics outbreak. ByHeart: 48 infants across 17 states, onsets from December 2023 through November 2025, all hospitalized, declared over February 26, 2026. Nara: four confirmed cases in California, Pennsylvania and Washington, onsets April and May 2026, all hospitalized, declared over August 27, 2026. Fifty-two hospitalized babies. FDA’s closeout reports that one clinical isolate from a Nara infant matches a clinical isolate from a ByHeart infant, a ByHeart base powder sample, and four samples of unopened cans of ByHeart formula. Traceback put the Nara lots on milk supplied by Organic West Milk and spray dried by Dairy Farmers of America, the same suppliers behind ByHeart. FDA still cannot say whether the milk was contaminated before drying or during it.
Where the preparation advice runs out
Abbott’s answer rests on advice about preparing powder carefully for the youngest infants. That advice was written for a different hazard. The joint FAO/WHO expert meeting in June 2026 added botulinum neurotoxin-producing clostridia to the priority hazard list for powdered formula and concluded that current consumer preparation recommendations, designed for Salmonella and Cronobacter, may not be effective against these spores. FDA’s post-outbreak page draws the same line: Cronobacter and Salmonella do not form spores and are killed by pasteurization, while a Clostridium spore survives it. The retort that makes a liquid commercially sterile is the one step here built for a spore.
The wrong test, twice
Nara’s August 27 update closes by reporting that FDA’s tests on sealed cans came back negative for C. botulinum toxin types A and B. Infant botulism does not work that way. The baby swallows spores and the toxin is made in the infant’s intestine, not in the can. A toxin assay on a sealed can is the wrong test.
The screening test fares no better. Nara’s supply chain page reports every batch at or below 10 CFU/g for sulfite-reducing clostridia, the limit of detection. The peer-reviewed analysis of the ByHeart product found C. botulinum in finished formula and in base powder where that same indicator was non-detectable, and concluded that indicator screening would not have prevented the outbreak even had it been in place. The numbers are in the industry’s own report. ByHeart ran roughly 5,000 C. botulinum tests through IEH Laboratories and disclosed nine positives across 4,675 samples, eight of 241 finished-product lots positive by PCR, and one confirmed positive ingredient, organic whole milk powder from Organic West sampled at Dairy Farmers of America. Every one of those positive samples read under 10 cfu/g on the sulfite-reducing clostridia test. Nara’s reassuring number and ByHeart’s positives are the same number.
Nobody assessed the ingredient. FDA named the hazard anyway.
Ask why the screening was so thin and the trail runs back twenty years and stops. A 2004 joint FAO/WHO expert meeting classified C. botulinum as capable of causing illness in infants but did not identify it as a hazard in powdered infant formula. Because of that, the organism is not treated as a hazard in the 2008 Codex Code of Hygienic Practice for powdered formulae. The one real risk assessment was British and ad hoc, done in 2006 after a UK case, and it concluded the risk was low on the strength of production hygiene and a low calculated spore prevalence. In 2014 ICMSF built on the 2004 finding and recommended sulfite-reducing clostridia enumeration as a general indicator instead of routine testing for C. botulinum. That is the document FDA has now asked ICMSF to revisit.
Not one link in that chain examines whole milk powder as an ingredient with its own hazard profile; it is all dairy-based ingredients generally, on a 2004 premise. Meanwhile the ingredient changed. Formula historically used a skim milk protein base with a vegetable oil blend; whole milk powder is a recent premium ingredient sold on being closer to breast milk. No one asked publicly whether that switch changed the spore picture, and FDA did not sample whole milk powder as a category until February 2026. In March 2026 I listed the missing work: prevalence studies on dairy powders including whole milk powder, and the impact of farming practices including spores in silage and bedding. The Nara infants got sick three months later.
None of which excuses anyone, because FDA had already said it in writing. Its Call-to-Action letter of March 8, 2023, sent to every manufacturer, packer, distributor, exporter, importer and retailer of powdered infant formula in the country, told the industry there were other “known or reasonably foreseeable biological hazards” in this product beyond Cronobacter. It reported that the agency had already investigated complaints involving Cronobacter infections, Salmonella infections and infant botulism cases among infants fed powdered formula from a variety of manufacturers. Then it named the organism: historical associations between powdered infant formula and Cronobacter, Salmonella and Clostridium botulinum should be considered when designing and implementing controls. The earliest illness onset in CDC’s final ByHeart case definition came nine months later, on December 24, 2023. I wrote about that letter in June, and it is the document that ends the foreseeability argument.
The customer list
Organic West Milk has never posted a statement. Its only public words are from an owner, Bill Van Ryn, to the Associated Press in January: that nothing had been proven about the milk, and that Organic West sold organic whole milk powder to no infant formula maker besides ByHeart. FDA reports that during the ByHeart investigation Organic West gave the agency an incomplete customer list that did not disclose Nara, and that this year the company told FDA the earlier information should have included the Nara suppliers. Nara’s own page says it bought Organic West milk dried at Dairy Farmers of America from October 2024 to April 2025. Whether the second set of babies had to get sick at all turns on that list.
Dairy Farmers of America told ABC News last month that it is no longer processing milk from or for Organic West Milk. ByHeart’s Action Plan commits to C. botulinum-specific testing of every dairy ingredient and every finished batch before release, an admission that the controls running while 48 babies were hospitalized could not find the hazard. When ByHeart recalled in November 2025, a company Instagram post recommended Nara Organics and offered ByHeart customers a 20 percent discount code, and was later deleted — steering parents fleeing one botulism-linked formula toward another drawing on the same milk.
What is already required, and what is not
FDA’s July 13, 2026 letter to the infant formula industry says the obligations already exist. A supplier of an ingredient that will not receive a lethal treatment at the formula plant is an extension of the manufacturing process. Part 106 requires ingredient specifications, quarantine of nonconforming material and scheduled audits. Part 117 requires a hazard analysis, preventive controls and supplier verification, and a hazard reasonably likely to occur requires a preventive control. What the testing table at 21 C.F.R. § 106.55(e) actually requires anyone to look for is Salmonella and Cronobacter. Nothing else. The international guidance gave the industry a place to stand, FDA knocked it out from under them in 2023, and the agency has now written the industry three letters about this organism without writing a rule.
The industry answered, and paid for the answer
This month the Reagan-Udall Foundation published Applying the Science of Infant Formula Safety, a report on a July 13 roundtable convened with, and funded by, ByHeart and the International Dairy Foods Association. I went through it in detail last week. Twenty-two recommendations, twenty-four contributors, not one of them a parent of the 52 hospitalized infants, and not one recommendation that would require any company to do anything. It is candid in the appendices in a way the recommendations are not: the entry point of the organism into the ingredient has not been established, FDA’s testing workflow is labeled interim pending validation, few laboratories can run the test at all, and the contamination is non-homogeneous and low-level, which means a clean result on any one lot proves very little. Page 15 asks that risk reduction be balanced against supply chain sustainability, because costly controls could cost manufacturers their supply partners.
Which brings this back to Abbott, and to the fact that both halves of this argument live in the same regulation, one paragraph apart. Section 106.55(b) directs a manufacturer of liquid infant formula to comply with Part 113, the rules for thermally processed low-acid foods packaged in hermetically sealed containers — a body of regulation written expressly to keep botulism out of a sealed can. The very next paragraph sends powdered formula to that two-organism table instead. In the decades since, nobody has argued that Part 113 made ready-to-feed unaffordable. A tub of powder gets a letter. Abbott is not inventing anything here. It is charging a premium for a control that liquid has been required to have all along, and that powder has never been required to have at all.
What is left to do
The fix is drafted and sitting in committee. H.R. 7867, the Infant Formula Safety Modernization Act of 2026, introduced March 9 by Rosa DeLauro with nineteen cosponsors, Republican Jeff Van Drew among them, would require standardized pathogen testing of infant formula and of the facilities that make it, and would add C. botulinum to that § 106.55 table. I wrote to the Committee in June supporting it, as have the American Academy of Pediatrics, Consumer Reports, the Center for Science in the Public Interest, STOP Foodborne Illness and the Association of Public Health Laboratories, among others. On April 29 the Senate passed the Protect Infant Formula from Contamination Act, S. 272, which requires testing for Cronobacter or Salmonella and says nothing about this organism. The House Energy and Commerce Health Subcommittee heard H.R. 7867 that same day and has not marked it up since. The Nara babies got sick after that hearing.
Hold the markup. Then hold a hearing with the parents at the witness table, because the members voting on this should hear what a paralyzed two-month-old looks like from the people who sat with one.
And the t-shirts are arriving. Five hundred thirty-five of them, one for every member, each compressed inside a small plastic baby bottle and reading: For Babies’ Sake, Test for Botulism in Infant Formula. Abbott can sell the answer as a premium feature. Congress can make it the floor. If your shirt has not shown up yet, write me. I ordered enough.