Currently browsing posts about: Infant-formula

My days of having small children are long past, but my heart breaks for families trying to decide what to feed infants who cannot be breastfed.

Powdered infant formula is the least expensive option.  Unfortunately—and tragically these days—it is not sterile.

Ordinary bacterial contaminants are not a problem.  Pathogens are.

In recent years, there have been all too many illnesses and deaths among infants unknowingly fed contaminated formula.

What got me started was an article in the Wall Street Journal: “The Baby Formula Probe Produced a Pile of Evidence. Then the DOJ Dropped the Case,”

The Justice Department spent years investigating Abbott Laboratories over how it managed a baby formula facility where potentially deadly bacteria was discovered and suspected of causing infant deaths, worsening a national shortage.

Some prosecutors believed they had evidence to criminally charge the company under a law they have used to pursue other businesses for allegedly selling contaminated foods, according to people familiar with the matter. Some supervisors also thought it was a good case, they said. Top decision makers instead closed the probe, the people said, opting for a lighter-touch option: clawing back money the company earned from selling formula through federally funded nutrition programs. The outcome, which hasn’t been previously reported, illustrates how the Justice Department under President Trump has moved away from strict approaches to corporate enforcement and raised the bar for punishing companies. Trump in an executive order last year called for minimizing the use of criminal sanctions, where civil penalties could be used instead.

And then, KFF Health News and USA Today co-published “A Mom Said Infant Formula Killed Her Baby. The Manufacturer Closed the File.”

When doctors, hospitals, parents, or others alert manufacturers that babies got sick or died while receiving infant formula, what happens next is left largely to manufacturers such as Abbott Laboratories and Mead Johnson Nutrition, giants of the industry…Under federal rules, if a complaint about an infant formula — such as a report of an adverse event — shows a possible health hazard, the company must investigate. But it doesn’t always have to inform the government agency that oversees the safety of infant formula. A company must complete an investigation and notify the Food and Drug Administration within 15 days only if it finds “a reasonable possibility of a causal relationship between the consumption of an infant formula and an infant’s death.” If that happened even once over more than a quarter century, the FDA could find no record of it, according to information obtained through public records requests.

I was curious to know what food safety lawyer Bill Marler, who represents victims of food poisonings, had to say about all this.  Plenty, starting with The Fox Has Been Guarding the Henhouse for Years: Infant Formula Makers Decide for Themselves Whether Baby Deaths Get Reported to the FDA.

The headline finding should stop every parent, pediatrician, and member of Congress in their tracks…Here is what KFF Health News found when it asked the FDA, through the Freedom of Information Act, for every such notification manufacturers had submitted since January 1, 2020: none. The reporters then asked the agency to search all the way back to January 1, 2000. Again: no responsive records.…This is not an academic problem for me. I currently represent families in two infant botulism outbreaks tied to powdered infant formula — the November 2025 ByHeart outbreak that sickened at least 48 infants across 17 states, and the spring 2026 Nara Organics outbreak that so far has sickened three. In those cases, we have dug deeply into the same regulatory framework KFF Health News just exposed…The adverse event reporting system for infant formula is not a system at all. It is an honor code — for an industry that litigation has shown may not deserve it.

On his Publisher’s Platform, Marler writes: Mr. Abbott, You Are Not Going to Jail After All

Four years ago, I wrote two posts with titles I meant: “Mr. Abbott, you are going to face criminal sanctions” and, a few weeks earlier, “Mr. Abbott, you are going to jail for manufacturing tainted infant formula.” I was wrong. Not about the facts — about the willingness of this Justice Department to do anything about them….A DOJ spokeswoman explained that this Justice Department “does not believe in regulation by prosecution”….There are two details in the Journal’s reporting that should make every parent’s stomach turn. First, even if DOJ had wanted to prosecute, the office that does this work — the Consumer Protection Branch — was being disbanded as a cost-cutting measure, the same branch that put away the executives behind the Peanut Corporation of America salmonella outbreak. Second, one of Abbott’s defense lawyers — a former deputy attorney general — reportedly urged the incoming administration to overhaul that very office and strip it of its ability to bring criminal cases at all. Read those two sentences together and ask yourself who is writing the rules now.

Why is this happening?  500,000 Reasons to Drop a Criminal Investigation

Here is why the families I represent — and every parent who lived through the 2022 [Abbott formula] shortage — should be furious.

Abbott gave $500,000 to President Trump’s inaugural fund. Public Citizen has documented that Abbott was one of 58 corporations facing federal investigations or enforcement that together poured some $50 million into the inauguration…And then there is the stock. As Common Dreams reported this week, the President’s own annual financial disclosure…shows that Trump began buying Abbott stock in late September of last year and picked up roughly $500,000 worth of Abbott shares over the course of 2025. The buying happened while his Justice Department was still sitting on a criminal case against the company.

$500,000 into the inauguration. $500,000 in stock in the President’s own portfolio.

As Marler is careful to say, “No court and no investigator has found that the donation or the stock purchases caused this case to be dropped. What is undisputed is the sequence: the money, and then the vanished prosecution. Whether one caused the other is a question no one in a position to answer has been willing to answer.”

I’d say it sures gives the appearance of conflicted interest if not bribery and corruption at the highest levels of government.

Excuse me, but we are talking about helpless newborn and very young infants here, utterly dependent on formula as their sole source of nourishment.

Cases of contaminated formula may be rare, but they have affected commercial, alternative, and organic brands, and their consequences are devastating (take a look at the case studies in Marler’s letter of support for the Infant Formula Safety Modernization Act of 2026).

Congress needs to pass this act, and right away.  And is needs vigorous enforcement.

Legal slaps on wrists will not stop food safety violations.

In the meantime, the safest formula is the liquid form, pasteurized to kill spores as well as living pathogens.   Otherwise, powdered formula is a risk, a small risk, but finite.  You do not want your infant to be one of the unlucky ones.

I know I just wrote about botulism in powdered infant formula but it upsets me so much that I have to do it again.

We now have a second outbreak, first ByHeart now Nara, both linked to contaminated organic whole milk from the same German supplier.

Yes, botulism in infant formula is rare, but not nearly rare enough.  You do not want your infant to be one of the unlucky ones.

I’m trying to understand how this could happen and how it can be stopped.

The clearest explanation comes from food safety lawyer, Bill Marler, who represents families of those unlucky babies.

Let me summarize.

• Botulism comes from bacterial spores (“seeds”) that can germinate in an infant’s intestine, releasing botulinum toxin.
• The spores came from Clostridium botulinum in dirt.  Somehow, the dirt got on the cows and the spores got into their milk.
• Spores resist drying and heat; they survive Pasteurization and the drying that happens when milk is turned into powder.
• Spores can germinate in infants’ digestive tracts and produce botulinum toxin (older children and adults have immunity)
• The fat in whole milk may protect the spores (the ByHeart and Nara formulas are whole milk)
• Pasteurized powdered milk is not sterile; it can contain botulinum spores.

What can parents of bottle-fed infants safely feed them?

The only option is an expensive one: Ready-to-feed formula previously sterilized at temperatures high enough to kill spores.

How about preventing spores in the first place?

This is not easy, according to a study of just this question in the International Dairy Journal: Towards low-spore milk powders: A review on microbiological challenges of dairy powder production with focus on aerobic mesophilic and thermophilic spores (Thanks to Kristin Schill for sending).

Here’s what this study says needs to be done to keep spore levels low:

• Membrane filtration or bactofugation
• Validation of cleaning protocols to avoid recontamination
• Sterilisation of heating equipment
• Development of evaporators that are to be sterilised
• Ensure the plant design is hygienic
• Avoid long production cycles for temperature-sensitive steps, i.e., separation, pasteurisation and evaporation
• In other words, prevention requires a clean farm, clean udders, filtration, a clean plant, and quick processing.

What about testing?  It comes too late in the process and can’t always find rare contaminants.

And formula companies would rather not test for pathogens; if they find some, they have to issue recalls.

They also do not like to take responsibility; they would much rather finger point.

; Nara did not want to reveal the name of its European supplier.

The risk of botulinum spores has been known for a long time, at least since 2013.

Marler, who keeps track of all the problems with powdered infant formula in the past few years, thinks Congress needs to pass the Infant Formula Safety Modernization Act of 2026, which requires much, much higher standards for and oversight of infant formula.

Here is Marler’s letter to Congress summarizing the rationale for and evidence in support of this act.

Congress: Please pass this, and right away.  It will force formula companies to do what they should have been doing all along.

In the way this administration announces things, I saw this on X.

The FDA’s one-page summary says the agency had tested more than 300 samples of infant formulas with these results:

If there is a more detailed report, I can’t find it.

Food Safety News points out

• The FDA did not say which brands it tested
• The FDA has not set standards for contaminants in infant formula
• It did not test for pathogens such as Cronobacter, Listeria, Salmonella, or E. coli

NOTUS points out

• The FDA did not address seed oils or sugars in infant formula

The quality of infant formula is a big issue for the MAHA movement.

Its microbial safety is a bigger issue for me.

The Senate has just passed an infant formula bill to require manufacturers to test for Cronobacter and Salmonella and inform the FDA of positive results.  That’s a good first step.

While all this is going on, I heard this from a reader who works with Rad Moms, a grassroots advocacy group calling on ByHeart, the company that makes infant formula recalled for potentially containing botulism bacteria, to stop running their influencer ads during the recall.

Despite 50+ babies contracting botulism, hundreds of ByHeart ads were still running for MONTHS while cans were still on the shelves (as recently as March 2026). 

The bottom line: Breastfeed if you are able to.  To avoid pathogens, buy pasteurized liquid formula.  I don’t know what to say about the heavy metals and PFAS, except that less is better.

And here is food safety lawyer Bill Marler on what needs to be done to make infant formula safe from pathogens.

Later addition

The Guardian on criticisms of the FDA’s conclusions:  no levels of endocrine disrupting chemicals are safe

I can hardly believe that infant formula, one of the most tightly regulated products on the market, is in the news, but it sure is.  Let’s start with RFK Jr.

Amazing.  I thought infant formula companies were already doing that.  Without question, millions of Americans were raised on the existing infant formulas and have done pretty well on them.

RFK Jr does not like high fructose corn syrup (most formulas don’t use this) or seed oils.  I will be interested to see what his FDA proposes as replacements.

But now we have a new formula company, Little Spoon, putting full-page ads in the New York Times.  “Parents,” it says, “deserve to trust the food that fules their family.”  It says it uses better ingredients and tests for banned chemicals.

And why is this a step forward?  Alas, we have the ByHeart example—a “better-for-you” formula unfortunately—and tragically—contaminated with toxic bacteria.

What’s especially troubling about the ByHeart tragedy is that its products are still on shelves.

• State officials still finding recalled ByHeart infant formula on store shelves
• South Carolina warns Botulism Contaminated Infant Formula Still on Market

Food safety lawyer Bill Marler has plenty to say about this: To Safer Infant Formulas and doing away with Botulism, Cronobacter sakazakii, Salmonella and Bacillus cereus

And then there are Consumer Reports’ investigations of heavy metals in formulas, lead and arsenic, among them.

No wonder parents are concerned.  No wonder there is now a market for better tested formula.

What should parents do while all this is going on?

To avoid pathogens, buy canned and bottled formula that has been Pasteurized.

To avoid toxic metals?  That’s harder to do since most formulas are not tested.

All of this is yet another reason to breastfeed, if at all possible.  And to wean babies off of formula as soon as they are ready.

I’m not sure why we’ve seen so many problems with contaminated infant formula lately, but this must stop—and be stopped.  Infants who are not breast fed are dependent on formula.  Families buying formula for their infants assume it is safe.  If it’s not, it’s a disaster.

The ByHeart formula disaster

This one is about botulism in ByHeart formula.

Oregon baby is still battling infant botulism after ByHeart formula exposure: A Portland, Oregon, baby got sick with infant botulism after drinking contaminated ByHeart formula donated through a program that helps poor and homeless families.  What happens to these babies is devastating.

Ashaan Carter, now 10 months old, was hospitalized twice and remains on a feeding tube after contracting the dangerous infection that has sickened more than 50 babies across the U.S.…Ashaan was hospitalized for nearly two weeks in November and discharged without a feeding tube. His health rapidly declined, including dramatic weight loss, and he was hospitalized again in December…[he] had to have the feeding tube down his throat replaced because his muscles remain weak…He is having to relearn how to crawl and to talk…Since June 2022, nearly 24,000 cans of formula have been distributed to groups that aid homeless and other vulnerable families, the company said.

Food safety lawyer Bill Marler is representing families with children injured by the families.  Here’s what he and Food Safety News have to say about all this:

• The ByHeart Botulism Outbreak is a Moral Disaster
• ByHeart, Safeway, FDA and ADHS – Botulism in a can still on a store shelf?
• I have Questions: Where else did the supplier of whole milk powder implicated by the FDA in the ByHeart Botulism Outbreak send its product? Is that supplier linked to other infant botulism cases?
• FDA – ByHeart is Source of Botulism Outbreak – Tainted Ingredient Likely 
• Unnamed Suppler to ByHeart of Dried Whole Milk tests positive for Botulism
• Question? FDA and CDC has been silent on ByHeart Botulism Outbreak since December 17, 2025 – What’s up?  
• Feds find raw ingredient supplier behind infant formula outbreak: Neither the CDC nor the FDA will name the company.

The Nestlé infant formula disaster

The company, to which I am not related, recalled infant formula products from nearly 60 countries, because cereulide, a toxin that causes nausea and vomiting, was found in an ingredient—ARA oil—used in making it.

ARA stands for arachidonic acid, a long-chain essential omega-6 fatty acid found in breast milk.Like many other nutrient ingredients, it was made in China.  That company is now testing its products.

Here’s what’s happening:

• Nestlé infant formula scandal deepens as sickness cases emerge: British infant hospitalised after consuming recalled Nestlé formula – key questions about the contamination risk remain unanswered… Read more
• Nestlé CEO issues apology following infant formula scandal: Nestlé’s global infant formula recall sparks safety concerns and transparency backlash – can the food giant restore trust?… Read more
• Danone and Lactalis embroiled in global infant formula crisis: Two dairy majors have pulled infant formula products as cereulide fears spread beyond Nestlé… Read more
• Nestlé and Lactalis face lawsuit over infant formula scandal: The CPG majors are facing litigation for their handling of infant formula recalls over possible toxin contamination.
• Nestlé’s infant formula recall: What’s next for the industry?  We look at the supply, safety and quality control implications for infant formula manufacturers and ingredient suppliers… Read more
• First Nestlé, now Danone: The infant formula contamination is spreading:  The detection of cereulide in a batch of Aptamil infant formula pushes Danone deeper into the crisis… Read more

The heavy metals crisis

RFK Jr. says heavy metals in baby formula study coming in April

Kennedy, speaking at a health-themed rally in Harrisburg, Pa., said the studies set to publish in April will focus on the presence of contaminants including cadmium, mercury, and lead in baby formula.  “We’re going to be regulating baby formula companies so they’re giving you something that is as close to mother’s milk as we can get,” Kennedy said.

Officials at HHS and FDA launched “Operation Stork Speed” in March 2025 to improve the safety and supply of infant formula. A Bloomberg Law investigation published in January 2023 found that all but one of 33 baby food products tested by a laboratory contained at least two of three heavy metals: lead, arsenic, and cadmium…As part of the baby formula review, FDA is updating which nutrients manufacturers are required to include in their products. Kennedy said that’s because some of the existing 30 required nutrients were based on “archaic science.”

Comment

What’s going on here?  Why are infant formula supply chains so sloppy?  Isn’t anyone minding the store?

I can’t believe this situation.  What a dilemma it causes for parents who for whatever reason are not breast-feeding their infants.

Maybe it’s time to go back to the do-it-yourself days using evaporated milk, as was done before commercial infant formula was invented? [**But see NOTE below].

* 13 oz. can of evaporated whole milk (reduced fat, skim, and sweetened condensed milk will not provide enough calories or nutrition)

* 18–19 oz. of water

* 2 tablespoons of white granulated sugar or 1 tablespoon of light corn syrup

As of November 19, the FDA says 31 infants have botulism most likely as a result of exposure to ByHeart Whole Nutrition infant formula.  The CDC investigation details are here.

In its most recent letter to customers, ByHeart is finally taking some responsibility for this disaster.

When I wrote about this on November 12, I tried hard to give ByHeart the benefit of the doubt.  I had some sympathy for the difficulty of testing for botulinum spores (seeds) in infant formula.  The tests can only measure the toxin produced by the organisms that develop from the germinated spores (infants consume spores; when the spores germinate, the organisms produce the toxin).

But then I became less sympathetic, for two reasons.

The first is the company’s sloppy production practices.  I had forgotten about my post in November 2023 about the FDA’s warning letter to ByHeart (and other formula companies) for violating basic food safety standards during production.

The New York Times has written about more recent food safety violations: Infant Formula Company Tied to Botulism Outbreak Had Known Problems.

The second is the “it’s not our fault” stance of the company in its “Update for our ByHeart Family” [My comments]

Today, we were made aware by the California Department of Public Health (CDPH) that a single, previously-opened sample from one of the two recalled batches of ByHeart formula tested positive for Clostridium botulinum, the bacteria that causes infant botulism. We are treating the CDPH’s test result very seriously.  [Right.  Of course you are].

However, testing from a previously-opened can lacks scientific basis to establish causation between the product and illness. We know that Clostridium botulinum is a bacteria that exists naturally in the environment—in places like soil, dust, and even vegetables—meaning that an opened can can be contaminated in multiple ways. [Great.  Let’s blame parents for sloppy formula dilution]

Currently global regulatory and scientific authorities do not recommend testing powder infant formula for Clostridium botulinum, and no U.S. or global infant formula company tests for Clostridium botulinum. [Are you really saying that this isn’t your fault, it’s the FDA’s?]

I first learned about this from food safety lawyer Bill Marler: Botulism Alert: ByHeart—brand powdered infant formula linked to 13 illnesses in 10 states.

All 13 cases included in this outbreak are reported to have consumed ByHeart-brand powdered infant formula. Officials in several states have collected leftover infant formula for testing. This testing is underway, and results are not yet available. [Note: Cases are now up to 15].

The FDA announced the out-of-caution recall.

Infant botulism is a rare but potentially fatal illness that presents a serious threat to the health of infants which occurs when Clostridium botulinum spores are ingested and colonize the intestinal tract, producing botulinum neurotoxins in the immature gut of infants. Affected infants can present with some or all of the following signs and symptoms: constipation, poor feeding, ptosis (drooping eyelid), sluggish pupils, low muscle tone, difficulty sucking and swallowing, weak or altered cry, generalized weakness, respiratory difficulty, and possibly respiratory arrest.

• The FDA has an ongoing investigation of infant botulism among babies in the U.S.
• The FDA has not identified a direct link between any infant formula and these cases and there is no historical precedent of infant formula causing infant botulism.
• ByHeart is taking the proactive step to remove any potential risk from the market and ensure the highest level of safety for infants.

But then: Breaking News: Tested sample of ByHeart powdered infant formula linked to illnesses – preliminary tests are positive for Botulism 

CDPH [California Department of Public Health] has tested a can of powdered infant formula that was fed to an infant with infant botulism. Preliminary results suggest the presence of the bacteria that produce botulinum toxin, consistent with the same toxin reported in the confirmed infant cases.

On its website, ByHeart has “an update for our ByHeart Family.”

Today, we were made aware by the California Department of Public Health (CDPH) that a single, previously-opened sample from one of the two recalled batches of ByHeart formula tested positive for Clostridium botulinum, the bacteria that causes infant botulism. We are treating the CDPH’s test result very seriously.

However, testing from a previously-opened can lacks scientific basis to establish causation between the product and illness. We know that Clostridium botulinum is a bacteria that exists naturally in the environment—in places like soil, dust, and even vegetables—meaning that an opened can can be contaminated in multiple ways.

Currently global regulatory and scientific authorities do not recommend testing powder infant formula for Clostridium botulinum, and no U.S. or global infant formula company tests for Clostridium botulinum.

I looked up ByHeart Formula.  It claims to be a healthier alternative to commercial infant formulas:

• Closest-to-breast-milk patented protein blend (alpha-lac, lactoferrin, partially hydrolyzed proteins)
• Made with organic whole milk (not skim)
• Clinically proven benefits (easy digestion, less spitup, softer poops, more efficient weight gain, supports brain & eye development, immune health and gut health).

Clinically proven?  By Heart has a clinical trial to prove it, in which infants were fed By Heart or a commercial formula.

Conclusions: “The SF [study formula] resulted in improved parent-reported gastrointestinal tolerance and more efficient growth with less daily formula and protein intake supporting that this novel formula may potentially reduce the metabolic burden of protein overfeeding associated with infant formula.”

Sources of Funding: “This trial was funded by ByHeart, Inc. No funding was received from National Institutes of Health (NIH), Wellcome Trust, Howard Hughes Medical Institute, or other sources.”

Conflicts of interest: At least five of the authors report honoria for serving on the By Heart Scientfic Advisory Board.

OK, so this is a standard industry-funded study with results interpreted as favoring the sponsor’s interests.

But take a look at the accompanying editorial.  Its authors note that the effects of the By Heart formula are “almost identical” to those of the comparison commercial formula.

“There were no consistent differences in any of the growth parameters measured….no data are presented supporting that this formula achieves outcomes closer to the breastfed reference than did the control formula.”

By law, the contents of infant formula are tightly regulated; formula-fed infants are entirely dependent on formula for their survival.

That’s why this situation is such a tragedy.

Let’s hope ByHeart can figure out a way to make sure this never happens again.

Resources: Bill Marler’s additional links

• FDA Dashboard – ByHeart – you have some issues
• ByHeart Cronobacter Recall 2022 and FDA Warning Letter 2023 predates Botulism Outbreak 2025 
• What is BabyBIG? Treatment of choice for Infant Botulism 
• What you need to know about Botulism during an Outbreak

After two years of work, the Government Accountability Office has just published: WIC Infant Formula:Single-Supplier Competitive Contracts Reduce Program Costs and Modestly Increase Retail Prices.

Here’s its quick summary:

Over half the country’s infant formula is bought through the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). States must contract with the formula manufacturer that offers the lowest price after a rebate to be their sole supplier for WIC.

Two formula manufacturers hold most of the contracts. In 2022, the U.S. had a formula shortage because one of them halted production after a recall.

While sole supplier contracts make states vulnerable to supply disruptions, the rebates saved states about $1.6 billion in FY 2023. These savings offset other WIC food costs, allowing the program to serve more eligible participants.

This is such a weird system—monopoly infant formula in action!—that’s it hard to fathom.  But take a look at this:

Let me just say that all infant formulas have to meet the FDA’s strict nutritional requirements.  This means that they are all the same nutritionally.

But the prices differ by four-fold, as far as I can tell.

So this is all about marketing share.  Take a look at the effects of WIC on this market.