Currently browsing posts about: Food-safety

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?]

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

The safety of pet food matters because we have one and only one food supply.  If pet food is unsafe, our safety is at risk.

You don’t believe me?  Try this: Darwin’s raw pet food linked to human case of E. coli O157:H7 in four-year-old child

The US Food and Drug Administration (FDA) is advising the public not to feed certain lots of Darwin’s Natural Pet Products raw food to their pets after a four-year-old child became ill with E. coli O157:H7…The child was hospitalized, and developed a severe case of hemolytic uremic syndrome (HUS), requiring dialysis. He spent a total of six weeks in hospital and is at risk of permanent injury to his kidneys.

The world of people who care about this sort of thing and demand that authorities do something about it is a small one.  I learned about this from Phyllis Entis, author of  TAINTED. From Farm Gate to Dinner Plate, Fifty Years of Food Safety Failures and TOXIC. From Factory to Food Bowl, Pet Food Is a Risky Business.

She learned about it from food safety advocate Bill Marler.  As the food alert explains,

The contamination came to light after food-safety attorney, William Marler, initiated third-party testing of an previously unopened package of BioLogics All-Natural and Grain Free, Beef Recipe for Dogs found E. coli O157:H7 in the raw, frozen product. Whole genome sequencing (WGS) confirmed that the strain found in the pet food was a match for the strain recovered from the child…when Marler reviewed the files once more, he noted that the family had a dog, and…learned that the dog exclusively ate Darwin’s pet food, and had begun vomiting one day before the child fell ill…Marler arranged for an accredited third-party laboratory to test the sealed packages of food that were still in the family’s freezer.

Marler has plenty of work to do.  He now asks: After Listeria, Salmonella and E. coli positive samples, and HUS in a child, why no mandatory recall by the FDA?

In less than one year Darwin’s Natural Pet Products have been found to be contaminated with Listeria, Salmonella (three times) and E. coli O157:H7.  This year Dawin’s pet food has been epidemiologically and genetically linked to kidney failure in a young child in Utah.

Yet, although Darwin’s has refused voluntary recalls in both instances, the question must be asked, why has the FDA not used its mandatory recall authority?

Comment: It’s great that Bill Marler took lthis on but shouldn’t this be the FDA’s responsibility?  Producers are supposed to produce foods safely—by law.  The FDA is responsible for making sure they do.  Its responsibilities apply to pet foods and well as human foods.  Raw pet food is uncooked and potentially risky; it requires vigilant attention to prevention controls.  This line of pet foods is not getting needed attention to food safety.  The FDA should be enforcing food safety rules, vigilantly, and yes for pet foods too.  What happened to this child and his family was entirely preventable.

Note to dog lovers: if you feed your pet raw food, you are taking a risk, and not only to your animal.

Forthcoming November 11, 2025

For Information and Pre-Orders, click here

One of the underfunded and understaffed FDA’s major responsibility is to ensure the safety of the food supply.  Here’ are the actions the Trump Administration’s FDA is announcing lately.

I.  RUF Releases Produce Safety Roadmap: A Call for Action

The Reagan-Udall Foundation (RUF) for the FDA released its Roadmap to Produce Safety: Summary Report of the Produce Safety Dialogue…the report makes two primary recommendations:

• Implement a shared responsibility approach

• Form a structured, stakeholder-led collaboration

In line with the RUF recommendation, the FDA is calling on growers, buyers, sellers, and federal and state regulators to form a sustainably funded stakeholder collaboration that includes academia and consumer advocates and actively improves conditions and practices to reduce contamination and prevent foodborne illness.

Comment: The RUF is an independent group created by Congress to support the FDA.  Produce safety is a huge issue for the FDA, complicated because oversight is split between it and the USDA.  Produce becomes unsafe when it is exposed to pathogenic organisms spread by animal waste.  Yes, everyone involved in the food chain shares responsibility for safety.  By law, everyone who produces food is supposed to do it safely.  In practice, everyone points fingers at everyone else.  Collaboration would be nice.  But calling for enforcement of existing laws makes more sense.

II.  FDA Releases 2025 Human Foods Program Guidance Agenda

The FDA’s Human Foods Program published their proposed 2025 guidance agenda…These topics are a priority for the agency’s Human Foods Program to complete during 2025. New topics include:

• Action Level for Opiate Alkaloids on Poppy Seeds: Draft Guidance for Industry
• Food Colors Derived from Natural Sources: Fruit Juice and Vegetable Juice as Color Additives in Food; Draft Guidance for Industry
• New Dietary Ingredient (NDI) Notifications and Related Issues: Identity and Safety Information About the NDI: Guidance for Industry

Other guidance documents

• Fact Sheet: FDA Good Guidance Practices
• Human Foods Program Regulations Under Development | FDA
• FDA Guidance Documents
• What Does FDA Regulate

Comment:  The list of items under regulatory development is long and involves this one among many others: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food Proposed Rule.  I think preventive controls are extremely important in ensuring food safety.  I looked up this one.  It’s written in FDA-speak:

This proposed rule would remove certain requirements that currently apply when a manufacturer/processor of human food has identified a hazard that requires a preventive control, but does not control that hazard. Although that manufacturer/processor would still be required to provide documentation that the food has not been processed to control the identified hazard, that manufacturer/processor would no longer be required to obtain written assurance from the commercial customer that the identified hazard will be controlled.