To Safer Infant Formulas and doing away with Botulism, Cronobacter sakazakii, Salmonella and Bacillus cereus

NOTE: This post on Marler Blog was written by food safety attorney, Bill Marler, and is reposted here with the author’s permission.

A bit over a month ago, I was set to testify before the House and Senate Safe Food Caucus in D.C. Instead, the night before I had a heart attack. I am fine. I got great care at Howard University Hospital and have made a complete recovery – although changing a few habits going forward.

I had been asked to share some thoughts on the infant formula industry’s inability to make sure that such a critical food item is safe. As I sit here on this Sunday afternoon I am puzzled how we can spend countless billions on yet another unnecessary war and even more billions on AI and robots to make most of us irrelevant and we cannot make infant food safer? Here is some of what I wanted to discuss. I am sure there are other ideas – I would love to hear them.

Infant formula has until recently been considered low risk for C. botulinum (and, then there are other pathogens – Cronobacter sakazakii, Salmonella and recently, Bacillus cereus of concern).

The recent C. botulinum outbreak and the mixed picture you get from looking at the multitude of WGS sequences on NCBI indicates that infant formula might be riskier. We need a new risk assessment of C. botulinum (and other pathogens) in infant formula and its constituent ingredients and how to control the pathogens in powdered infant formula (PIF). For C. botulinum we need more information about:

How often is infant formula and its constituents contaminated with C. botulinum spores?

Do we detect the pathogen when we need to? We need to assess if the current methods are good enough (sensitive enough)?

How often is a product contaminated with more than one strain of C. botulinum (multiple WGS profiles)? How many isolates (colonies on a plate) from each sample should be sequenced to detect all contaminants?

Should we routinely culture infant formula from cases of infant botulism when the child has been fed such a product? (I highly suspect that infant formula is causing many more cases of infant botulism than we know of at the moment).

How do we best control C. botulinum spores in infant formula. We need studies on methods to control C. botulinum more efficiently in infant formula.

Do we need new regulations and redefined best practices for the production of infant formula and detecting and culturing the organism from product, environment and patients?

Perhaps as a start:

Fund a risk assessment on the prevalence of C. botulinum spores, Cronobacter sakazakii, Salmonella and Bacillus cereus and sulfite reducing clostridia (as indicators) in:

a. raw milk

b. pasteurized milk

c. dairy powders – including whole milk powder, whey powder, whey protein concentrates, whey protein hydrolysates, nonfat dry milk, skim milk powder

A specific risk assessment on the prevalence of C. botulinum spores and sulfite reducing clostridia in Powdered infant formula

Risk assessment on the prevalence of C. botulinum spores in minimally processed (non-retort thermally processed) commercial baby foods fed to children <1 year of age

Risk assessment on the prevalence of C. botulinum spores in low moisture infant first foods (puffs, cereals (rice and oatmeal), peanut butter, etc.)

Processing strategies to minimize spores in PIF – investigate technologies to reduce spores in infant foods while maintaining nutritional standards

Impact of farming practices on the incidence of C. botulinum spores in milk

a. Prevalence of C. botulinum spores in silage, bedding, etc., at the farm

b. Milk collection on organic vs. conventional dairy farms

Improved resources for the tracking and following up of Infant Botulism cases to determine the source of botulism outbreaks

Bottom line for control of spores in powdered infant formula (PIF): either they destroy all the spores or reformulate to lower the incidence of spores in PIF (at least down to where it was prior to the addition of whole milk powder into the formulations of PIF). Because PIF is fed to infants from Day 1 it should be commercially sterile. Leave it up to the companies to determine how to make PIF commercially sterile. At the very least I would suggest that until a study is conducted to show the prevalence of C. botulinum spores in whole milk powder and a risk assessment is conducted, any formulation that contains whole milk powder should not enter into commerce.

Editorial comment from the FoodBugLady

It is inarguable that breastfeeding is the “gold standard” of infant nutrition. Unfortunately, not every woman is capable of providing an adequate supply of breast milk to her newborn.

Infant formula was developed originally as a means of supplementing a woman’s breast milk. Over the decades, it has grown into a Frankenstein’s monster—an ultraprocessed convenience food manufactured on a massive scale and heavily marketed to the medical profession and to individual consumers.

While the ultimate decision of breast- versus bottle-feeding rests with the mother, the responsibility for ensuring that infant formula is both safe and nutritious must sit on the shoulders of the industry and the FDA (and its sister agencies around the world).

The industry and its regulators have abrogated their responsibility for far too long. Bill Marler’s suggestions are sensible and long overdue.

E. coli O157:H7 outbreak linked to raw cheddar cheese from California producer

Company declines to recall implicated products

The FDA and CDC are investigating an outbreak of seven cases of E. coli O157:H7 illnesses in three US states.

Outbreak cases have been reported in California (5), Florida (1), and Texas (1).

Four of the seven victims are three years old or younger, and two people have been hospitalized.

No deaths have been reported, and none of the victims have developed hemolytic uremic syndrome (HUS) as of March 14, 2026.

The first two illnesses associated with this outbreak were recorded in September 2025, and the other five in January and February of 2026.

The CDC warns that the number of outbreak illnesses is likely much higher than reported, as many individuals recover without seeking medical care and are not tested.

Three of the victims have been interviewed so far, and all three reported eating RAW FARM-brand cheddar cheese made from raw (unpasteurized) milk.

Testing of product samples is in progress, but results are not yet available.

The producer, RAW FARM, LLC (previously known as Organic Pastures), has declined the FDA’s recommendation that their raw cheese products be removed from the market.

RAW FARM’s checkered history

This is the second time in two years that RAW FARM-brand raw cheddar cheese has been linked epidemiologically to an outbreak of E. coli O157:H7 illnesses.

On March 26, 2024, the FDA and CDC reported an outbreak of 11 illnesses, including five hospitalizations. Outbreak were reported in California (4), Colorado (3), New Jersey (1), Texas (1), and Utah (2). Two of the outbreak victims developed HUS. There were no deaths.

Seven of the ten victims interviewed as part of the outbreak investigation specifically reported eating RAW FARM brand raw cheddar cheese prior to becoming ill.

The company initially recalled their raw cheddar cheese, but subsequently withdrew their recall after testing of cheese samples failed to find E. coli.

From October 2023 through May 2024, raw milk and cream produced by RAW FARM, LLC was implicated in a Salmonella Typhimurium outbreak that affected 171 individuals in the state of California primarily in the southern counties of the state. Children were affected disproportionately.

In addition to epidemiological evidence pointing to RAW FARM-brand raw milk as the source of the illnesses, the outbreak strain was recovered from three samples of raw milk and one sample of cheese made from the contaminated raw milk.

In October 2023, the company recalled all fluid raw whole milk and raw heavy cream (Best by dates from 10/11/2023 to 11/6/2023.

Even before this major outbreak, the company’s operations had come under scrutiny by the FDA. The federal agency conducted an inspection of Organic Pasture’s (as it was then known) production facility in February 2021, and issued a Form 483 listing several significant infractions, including inadequate sanitary handling procedures, flaws in the company’s hazard analysis for Salmonella and for Listeria monocytogenes, and inadequate record keeping relating to sanitation operations.

The FDA classified the result of the inspection as Official Action Indicated, a failing grade.

What consumers need to know

Although raw milk and other dairy products made with raw (unpasteurized) milk are not permitted to be shipped for retail sale across state lines, they are legal for retail sale within a number of states, including California.

According to the FDA, since 1987 and up to March 2024, there have been 143 recorded outbreaks of illnesses in the United States associated with consumption of raw milk and raw dairy products. These include outbreaks of Listeria monocytogenes, Campylobacter, Salmonella, and shiga toxin-producing E. coli (such as E. coli O157:H7).

If you consumed a RAW FARM, LLC cheese product and you develop symptoms of gastrointestinal upset within the few days following consumption, consider seeking medical treatment, especially if your symptoms include one or more of the following:

Diarrhea and a fever higher than 102°F
Diarrhea for more than 3 days that is not improving
Bloody diarrhea
So much vomiting that you cannot keep liquids down
Signs of dehydration, such as:
- Not peeing much
- Dry mouth and throat
- Feeling dizzy when standing up

TAINTED formats 3 — “Reads like a true crime novel” – Food Safety News

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Chapter 6. Birth of a Pathogen

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Infant botulism outbreak is over — CDC

An outbreak of infant botulism linked to ByHeart powdered infant formula has ended, according to the US Centers for Disease Control and Prevention.

The final tally of victims comprises 28 confirmed cases and 20 probable cases from 17 states. No new cases have been added since December of 2025, and three previously reported suspected cases from 3 different states have been excluded from the totals.

Illnesses in this outbreak first began on December 24, 2023 and continued through November 29, 2025. The 48 victims ranged in age from 16 to 264 days old. All were hospitalized and treated with BabyBIG®. There were no deaths.

Outbreak cases were reported in Arizona (5), California (12), Idaho (2), Illinois (2), Kentucky (1), Massachusetts (2), Michigan (1), Minnesota (3), North Carolina (2), New Jersey (1), Oregon (3), Pennsylvania (1), Rhode Island (1), Texas (8), Virginia (1), Washington (2), and Wisconsin (1).

Epidemiological and laboratory analysis established ByHeart Whole Nutrition infant formula as the source of the illnesses. The company recalled all of its infant formula products on November 11, 2025.

Although the outbreak is officially over, the FDA‘s investigation into the root cause of the contamination continues.