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.

Bill Marler forwarded his post about how some pet cats got bird flu from drinking raw milk or eating raw pet food.

He learned about this from a Los Angeles County Animal Health Alert: H5 bird flu confirmed in four domestic cats that consumed recalled raw milk, and in one cat that consumed commercially produced raw pet food.

The Guardian explains how transmission works.

Pet Food Industry writes, Raw pet food linked to H5N1 infection, cat euthanizations: Officials found the cats all consumed the same brand of raw pet food before becoming ill.  Read more

Mother Jones asks: A Raw Milk Magnate Has Spent Years Fighting Public Health Agencies. Will RFK Jr. Take His Side?  (The article is about Mark McAfee, founder and CEO of Raw Farm, which sells the raw milk allegedly implicated in the death of cats.

Marler lists lawsuits over previous outbreaks—among humans—attributed to tRaw Farm milk.

Marler published a Parents’ guide to the safe use of raw milk.  His conclusion:

There is a movement in the U.S. to consume organic, locally grown, unprocessed, more nutrient-dense foods.

Some believe raw milk is more nutritious and provides the body “good bacteria.”

There are many other foods that contain “good bacteria” and are less risky than raw milk. Many stores carry pasteurized yogurt and kefir with probiotics that are very safe to feed children.

There are also high quality nutritional supplements that can be used to add probiotic bacteria into one’s diet.

For more information visit www.realrawmilkfacts.com.

Other resources

Phyllis Entis (aka FoodBugLady), who writes a newsletter about food safety, efoodalert.com, discusses bird flu in cats and includes a useful handout from the Washington State Department of Agriculture on the topic.

The FDA has issued its boringly titled Southwest Agricultural Region Environmental Microbiology Study (2019 – 2024).

The report seems designed to be boring.  Its subject, however, is anything but.

Let me do some translating (in Italics).

• “The study was designed to improve understanding of the environmental factors that may impact the presence of foodborne pathogens in the Southwest agricultural region.”  [Leafy greens contaminated with pathogenic bacteria make lots of people really sick, undoubtedly because they come in contact with CAFOs, confined animal feeding operations].
• “Samples were collected from irrigation waters, soil, sediments, air/dust, animal fecal material, wildlife scat, and other sources across approximately a 54 mile (7,000 acres) area of the southwest growing region.” [It’s about time the FDA did this].
• “Special attention was given to the geography of the study region and the types and locations of agricultural and other adjacent and nearby land use activities relative to produce production areas.  For example, there is a Concentrated Animal Feeding Operation (CAFO) with more than 80,000 head of cattle and an associated compost operation in proximity to some of the produce production areas studied. [Oh.  What a surprise].

The investigation’s findings

• “STEC [Shiga toxin-producing E. coli] can survive in the air and that dust can act as a transfer mechanism for both pathogens and indicator organisms (e.g. generic E. coli) from adjacent and nearby land to water, soil, and plant tissue “[toxic bacteria spread from CAFOs by air and dust].
• “The research team repeatedly observed that generic E. coli concentrations and STEC prevalence and isolation frequency increased as irrigation canal water flowed past an adjacent livestock and compost operation” [toxic bacteria spread from CAFOs by water].
• “…birds and other wildlife do not appear to be significant sources of STEC or E. coli O157:H7 ” [blaming wild birds for contaminating leafy greens is not going to work].
• “STEC strains detected in water, sediment, and plant tissue harvested from our research plots genetically matched strains isolated in air samples providing evidence that bacteria in air can transfer to other locations and surfaces.”  [Toxic bacteria get around easily].

The conclusions

Having proven that CAFOs contaminate air, soil, and water with toxic bacteria, the report concludes:

The preliminary results of this study stress the interconnectedness between people, animals and the environment and serve as an important model for how to foster productive dialogue among diverse stakeholders to improve food safety.

Comment

Foster dialogue?  They have to be kidding.  CAFOs need to be held responsible for the waste produced by their animals.  Human wastes are not allowed to be released untreated into the environment; neither should animal wastes.

Here is food safety lawyer Bill Marler’s comment.

I’m having a hard time with this one.

Once again, the FDA is warning all of us : “Do not eat, sell, or serve recalled cantaloupes or recalled products containing pre-cut cantaloupe.”

The warning lists the products implicated and all the ones that have been recalled.

The CDC says much the same:

CDC is concerned about this outbreak because the illnesses are severe and people in long-term care facilities and childcare centers have gotten sick. Do not eat pre-cut cantaloupes if you don’t know whether Malichita or Rudy brand cantaloupes were used.

As of November 30, the toll is:

Total Illnesses: 117
Hospitalizations: 61
Deaths: 2

But that’s only in the U.S.  Canada reports illnesses too: 63 sick, 17 hospitalized and 1 death.

This, mind you, is from eating cantaloupe.

It’s not that nobody knew cantaloupe poses special safety problems.  It’s grown on the ground and is hard to wash.  If it is grown anywhere near animal wastes, it has a high risk of getting Salmonella on its rind.  Cutting through the rind can move harmful bacteria on the rind into the interior.

Food safety lawyer Bill Marler, who tracks such things, reminds us of previous lawsuits over cantaloupe food poisonings.

He also has some useful things to say about Salmonella during a Cantaloupe Outbreak – Symptoms and Treatment

Cantaloupes, he points out, might still be in season, but Salmonella should not be.

He quotes Perdue (sic Purdue) Extension on how to make cantaloupe safer: scrub and wash in very hot water.

But Marler has been quoted as saying he does not eat cut fruit (implying you should not either).

What’s infuriating about all this is that Congress passed the Food Safety Modernization Act to give the FDA the power to require safety plans from producers of every food under its jurisdiction.  This means cantaloupe growers are supposed to take steps—and test—to make sure the fruit is not contaminated with pathogenic bacteria.

Clearly, the system isn’t working.

The FDA needs to find out why not.

The FDA is chronically and infamously underfunded for what it is supposed to do.

Congress needs to pay attention to this issue.

Nobody should get this sick from eating cut fruit.

And if you haven’t seen the film featuring Marler (I’m in it too, briefly), take a look at Poisoned on Netflix.  It talks about cantaloupe, among other things worth knowing.

Every now and then I run across a report about something I know absolutely nothing about but wish I did, and this is one of them—an analysis from the University of California on Sample Costs to Produce and Harvest Romaine Hearts Lettuce.

I’m particularly interested in Romaine because it is one of those foods that turns up frequently in food poisoning incidents.  Why?  Because in California and Arizona it is often grown in close proximity to Confined Animal Feeding Operations (CAFOs), as shown in the Netflix film, Poisoned, in which I appear briefly.

Bill Marler, the lawyer featured in the film, does not eat bagged Romaine.  Neither do I.

The cost analysis, which concludes that it takes about $17,000 an acre to produce Romaine, does not factor in fmeasures to assure safety.

But what it does consider is impressive.  Here is just the first part of a Table that continues well into another page.

I would not have guessed.

I grow Romaine lettuce in pots on my Manhattan terrace.  All I pay for is seeds.  I’ve never gotten sick from eating it.

Apparently, industrial lettuce is an entirely different matter.

Enjoy the weekend!

Poisoned, the food safety film featuring the lawyer, Bill Marler,  is now available to watch on Netflix.

I wrote about earlier when I saw it at the Tribeca Film Festival.

It’s totally worth watching, and not only because I have a cameo in it.

Bill Marler explains why.  I reproduce his post with permission.

After Netflix Poisoned – What would I do with a Food Safety Magic Wand?

By Bill Marler on August 4, 2023

Over two months ago, while watching the premiere of the documentary, “Poisoned,” at the Tribeca Film Festival in NYC, I got thinking again about how little in the past 30 years I feel I have moved the needle on food safety – pathogens and certainly, human nutrition.  Now that “Poisoned” is up on the Netflix platform, it has become the most watched documentary in the world – at least for the last few days.

The real issues to me is how do we engage the food industry, policy makers, academics and most importantly consumers, to focus on driving the numbers down on the pathogens that kill us quickly and the products that kill us over time?

I will focus on pathogens as I have for the last 30 plus years. I will leave it to some very smart people who are rightly concerned about the millions of us who become sick and die due to inadequate nutrition – especially the millions of illnesses and deaths due to heart disease, diabetes and obesity caused by ultra-processed foods, salt, sugar, and fat.

There is so much to do, and the list is long. So, what would I do with a Food Safety Magic Wand on day one?

1. Vaccinate. The first thing I would do is mandate that all food service workers be vaccinated against hepatitis A.  Perhaps to some, not the most pressing food safety issue, but it is forefront of my mind.  In the past few months, I finished up litigation around a hepatitis A outbreak involving one ill food service work who infected nearly 50 people, hospitalizing most, killing four and causing two liver transplants.  With regret, I forced a family-owned restaurant chain to file for bankruptcy.  All of this could have been prevented by a safe vaccine that has been around for decades.  It is time for the restaurant industry and the CDC to step up.

• Investigate. Invest in public health surveillance over human pathogens, like, Listeria, E. coli and Salmonella, etc.  A dirty truth is that most culture-confirmed illnesses are never attributable to a food source, so people never know what sickened or killed them. Not because the source was not food, but because we fail to invest adequate resources in the epidemiologists that investigate illnesses and track those illnesses to the cause. Tracking illnesses to the cause gets tainted product off the market and helps us all understand what products and producers to avoid.  We need to continue to invest in the science of whole genome sequencing, so we know with certainty which pathogens are causing which illnesses. Foodborne illness epidemiology helps us understand the root cause of an outbreak and helps prevent the next one from happening at all.

• Relegate. Allow public health officials access, especially during an outbreak investigation, to all areas around farms that grow fruits and vegetables.  It is long past time to allow investigators access to neighboring cattle, dairy, chicken, or hog operations that spill billions of deadly pathogens into the environment, via air or water.  We need to think of our growing regions as an integrated system and that all sectors responsible need to play a role.  Access allows investigators to understand the likely cause of an outbreak, and again, what can be done to prevent the next one.

• Advocate. Make all pathogens that can sicken or kill us adulterants.  In 1994 Mike Taylor making E. coliO157:H7 and adulterant has saved countless lives and has saved the beef industry from my lawsuits. We can do the same for all food producers, especially chicken, turkey, and pork.  Remember, in the 1990’s nearly all the lawsuits I filed were E. coli cases linked to ground beef.  Today that is zero.  Think about it.

• Educate. Give everyone a thermometer and provide better education to middle and high school teachers and students around food safety and human nutrition policy, not in a dry, technical way, but by sharing engaging history, microbiology, patient stories, and case studies. We need to teach how and why our food can be unsafe and what consumers can do about it.

• Consolidate. Finally, make a single federal agency out of USDA/FSIS, FDA, and the food safety parts of CDC, NOAA, and EPA, to oversee food safety and human nutrition. Making food safety and human nutrition its own agency would help increase governmental accountability,  close regulatory loopholes, facilitate the collection and sharing of information and facilitate critical change.  I might have a suggestion for someone to run it.

With the CDC estimating 48,000,000 are sickened each year, 125,000 hospitalized, and 3,000 die from food, preventing pathogenic foodborne illness is no simple matter.  And, if you consider the millions that are impacted by the lack of adequate and safe nutrition, we have a lot to do.  However, it can be done, and the six ideas above are a small start.

“Doing anything is better than doing nothing,” my Marine drill sergeant father used to say.  He used to require my brother and I to make our beds every morning and bounce quarters on them.  For the longest time I thought this was punishment.  But it was not punishment, it was accomplishment, that you could build on for the rest of the day.  Doing “little” things, like the six things above, are accomplishments. Doing them starts a process that will continue to make all our lives just a little bit safer.

Once again I am indebted to Bill Marler for keeping me informed about items related to food safety: Publisher’s Platform: The House Appropriations Committee Directs the FDA to Restructure – will it be Ignored? 

He points to this item on page 79 of the House Agriculture Appropriations bill.

I’ve written about problems with the FDA’s oversight of food and food safety previously (see this for example).

Food has always been a stepchild at the FDA, getting much less attention than drugs or medical devices.  When I was on the FDA’s Food Advisory Committee in the early 1990s, the FDA seemed to be trying to do better but that committee did not last long.  In any case, we were not advising the FDA on what it was proposing to do; we were giving the FDA a notion of the response to decisions it had already made.

What’s needed now is to unite the three units of FDA that deal with food: the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine’s food oversight programs, and the office that overseed food regulations.

And bring back the Foods Advisory Committee and listen to its advice.

The FDA commissioned a report on what it should do (see Reagan-Udall Foundation report and my comments on it).

What will happen now?  As Bill Marler puts it, “Grab the popcorn.”

Here’s what the FDA says it’s doing (thanks to Jerry Hagstrom’s Hagstrom Report for the links)

• FDA — Proposed Human Foods Program Organization Chart 
• Updates to FDA Proposal to Unify Human Foods Program / Create New ORA Model
• Proposed Office of Regulatory Affairs Organization Chart

This does some of what’s needed but the organization charts still look complicated, and the more complicated an organization chart, the least likely it is to work.

Will this work?  Bill Marler says it might.  Grab the popcorn indeed.