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.

I don’t usually host guest posts here, but I read food safety lawyer Bill Marler’s blog and obtained his permission to reprint it.  It should be obvious why I thought you should read it.

The people who find foodborne outbreaks are being fired, defunded, and disbanded — and the bugs do not care.

For more than thirty years I have represented the families on the other end of a foodborne outbreak — the parents of children on dialysis with hemolytic uremic syndrome, the survivors of a contaminated hamburger or a bag of spinach, the people left planning funerals. I built a career holding companies accountable when the food safety system failed. I never imagined the federal government itself would become one of the things that fails. Over the past year and a half, it has.

The cuts this administration has made to the FDA, the CDC, and the USDA’s Food Safety and Inspection Service are not abstract budget lines. They are going to get people sick, and some of them are going to die. The cruelest part is that it is all being done under a banner that reads “Make America Healthy Again.”

Consider the FDA, which polices roughly 80 percent of our food. It lost nearly 3,900 employees in 2025 alone, part of an HHS purge of some 20,000 jobs. It began in February with what the agency’s own deputy commissioner for human foods called the “indiscriminate” firing of 89 people from the food program — after which he resigned, saying it was “fruitless” to continue. The administration fired so blindly that it had to scramble to rehire the official in charge of infant formula safety.

By March, HHS planned to cut a fifth of the FDA’s workforce, including more than 170 people from inspections and investigations. Understand what that means. In 2024 the FDA had all of 443 inspectors to cover more than 36,000 food facilities at home and abroad — against the roughly 1,500 it says it actually needs. We were already running on fumes. ProPublica found that foreign food inspections fell by nearly half in early 2025. We are importing more food than ever and looking at less of it.

Then there is the surveillance — the quiet, unglamorous detective work that is the entire ballgame in my world. By the time a family calls me, public health investigators have usually already connected a sick child in Ohio to a sick adult in Oregon and traced both to a single contaminated lot. On July 1, the CDC gutted that capacity, scaling its FoodNet surveillance network back from eight pathogens to two. It stopped actively tracking Campylobacter, Listeria, and four others. Listeria — the same pathogen that, in the Boar’s Head outbreak just last year, caused the deadliest listeriosis outbreak in over a decade. We are turning off the smoke detectors and telling ourselves the house won’t burn.

The USDA has done its part. Its inspection service shed hundreds of positions while line speeds at some slaughterhouses climb and inspectors step back — fewer people asked to catch more contamination moving faster. And in a move that should alarm anyone who believes in evidence, the department disbanded the two scientific advisory committees that had guided federal food safety policy for decades, one of them since 1971. Their combined cost was about $300,000 a year. One was, at the moment it was dissolved, reviewing how to keep Listeria out of deli meat. That work simply stopped. For good measure, FSIS withdrew its proposed rule to limit Salmonella in raw poultry — a pathogen that sickens more than a million Americans a year — after years of work.

I want to be fair. No one in Washington woke up wanting to poison a child, and the food safety system was underfunded long before this administration; I have said so under presidents of both parties. But you cannot fire the inspectors, blind the surveillance, suspend the lab testing, dismiss the scientists, and abandon the rule making all at once and still claim that food safety is a priority. Actions are what count, and these all point one direction.

Here is what three decades have taught me. Outbreaks do not announce themselves. They are found by people — inspectors who walk the plants, epidemiologists who connect the dots, technicians who confirm the strain. Take those people away and the outbreaks still come. We just find them later, after more children are on dialysis and more families are planning funerals instead of birthday parties. The bacteria do not care about budget cuts. They never have.

I have spent my life suing companies that put profit ahead of safety. If these cuts stand, I expect to be busier than ever. That is the worst thing I could possibly tell you.

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 thought this post on X was well worth a follow up.  I went right to the site: Human Foods Program 2026 Priority Deliverables.

Its vision: “to ensure that food serves as a vehicle for wellness.”

Its mission: “to protect and promote the health and wellness of the American public through science-based approaches to prevent foodborne illness, reduce diet-related chronic disease, and ensure chemicals in food are safe.”

Its 2026 Priority Deliverables: these are listed in three categories: food chemical safety, nutrition, and microbiological food safety.

I.  Food Chemical Safety (my selection and summary)

• Reform GRAS; regulate
• Review safety of food chemcials
• Conduct research on microplastics
• Establish action levels for cadmium and inorganic arsenic in baby foods
• Research consumer exposure to PFAS and other chemicals
• Regulate new dietary ingredients
• Modernize oversight of supplements
• Collect opinions on allergens; develop regulations

II.  Reducing chronic disease through better nutrition

• Research ultra-processed foods; develop definition
• Research infant formula nutrient requirements
• Recruit experts to develop a UPF policy agenda
• Work toward issuing a front-of-package label to encourage healthier consumer choice and reformulation
• Implement the “healthy” front-of-package label
• Develop strategy to reduce added sugars
• Evaluate phase I targets for sodium reduction
• Issue guidance on food labeling for online shopping

III.  Microbiological food safety

• Get states to take action
• Increase oversight of imported food
• Increase oversight of imported shrimp
• Train growers to prevent produce contamination
• Improve recall communication

Comment

I haven’t listed everything but this should give you the idea.  Lots of this involves “research,” “develop,” and “evaluate.”  Hardly any involves real regulation (except for chemical food additives).  Still, this is, or could be, an impressive list.

The most pressing area is microbial food safety, because we are still seeing so many people made ill by contaminated food, especially infant formula.

The big question: Where is the FDA going to get the resources needed to carry out this agenda?  The FDA, already working for decades on an increasingly bare-bones budget for all it is required to do, eliminated a fifth of its workforce last year.

And this administration prefers personal responsibility as the primary approach to dietary health.

It would be great if the FDA could do all this in 2026.  We are already in February.  It has best get busy.

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

The FDA is cutting down its safety inspections of foreign food imports, even though nearly all seafood, about 60% of fresh fruit and about 40% of vegetables are imported, and we increasingly rely on food imports.

As ProPublica explains, Foreign Food Safety Inspections Hit Historic Low After Trump Cuts.

These crucial foreign inspections are neither easy nor cheap. They typically last longer than domestic ones and cost nearly $40,000 a visit, and they can require months of logistical planning, special visas and diplomatic approval from the host country…Then Congress passed the Food Safety Modernization Act of 2011, which set firm targets for the agency: It needed to conduct more than 19,000 foreign food inspections annually by 2016 and increase the number of food field staff to no fewer than 5,000 workers.

The FDA has never fulfilled this congressional mandate…ProPublica’s Annie Waldman and Brandon Roberts crunched the numbers and found that the U.S. is on track to have the fewest foreign food inspections since 2011 (excluding pandemic years).

This does not bode well for food safety.

It’s not as if we don’t already have plenty of food safety problems.

• The FDA’s list of current recalls and warnings
• The USDA’s list of current recalls and warnings

To review the status of food safety regulation:

• We have plenty of laws requiring all food producers to follow rigorous procedures to greatly reduce the risk of pathogenic contaminants.
• But these laws work much, much better when they are enforced through inspection.
• It’s not that food producers want to make customers sick; it’s that it’s all too easy to cut corners on safety.
• No food producer wants to test for pathogens; if they find any, they have to recall products.
• The system only works with firm oversight.

Fewer inspections gives producers license to be sloppier.

Not a good idea.

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?]