Currently browsing posts about: Infant-formula

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.

I saw this announcement in Food Navigator: Study: Nutrient dense formula could improve cognition and behaviour in infants.

My immediate question: Who paid for this?

I went right to it.

The study: Schneider N, Hartweg M, O’Regan J, Beauchemin J, Redman L, Hsia DS, Steiner P, Carmichael O, D’Sa V, Deoni S. Impact of a Nutrient Formulation on Longitudinal Myelination, Cognition, and Behavior from Birth to 2 Years: A Randomized Clinical Trial. Nutrients. 2023; 15(20):4439. https://doi.org/10.3390/nu15204439

Conclusions: The results suggest that brain development may be modifiable with brain- and age-relevant nutritional approaches in healthy infants and young children, which may be foundational for later learning outcomes.

Funding: This study received funding from the Société des Produits Nestlé S.A.

Conflicts of Interest: This study received funding from the Société des Produits Nestlé S.A. The funder had the following involvement with the study: study design, study monitoring and oversight, data collection and analysis, decision to publish, and preparation of the manuscript.

Comment: Some of the authors of this study are employed by Nestlé (no relation).  Their disclosure statement is unusually candid: the funder was totally involved in every aspect of the research.  It’s refreshing to see that dislosed.  But the underlying issue still holds: industry-funded reseach all too often produces results favorable to the commercial interests of the funder.

The concern here is that promoting infant formula as better than breast milk is a marketing strategy, as described in reports from the World Health Organization.  And see my previous post on this.

The Department of Health and Human Service’s Inspector General has reported on its investigation of the FDA’s mis-handling of infant formula shortages a couple of years ago: The Food and Drug Administration’s Inspection and Recall Process Should Be Improved To Ensure the Safety of the Infant Formula Supply.

I see this as a direct result of Helena Bottemiller Evich’s reporting in Politico—the power of the press, indeed (she now writes Food Fix, to which I subscribe, and where she discusses this report).

In an earlier report, she detailed the history of FDA’s inspections of the Abbott laboratory and the agency’s surprising delay in getting Abbott to do a “voluntary” recall.

She, justifiably, takes some credit. 

Food safety lawyer Bill Marler also had questions about the quality of production and FDA’s surprising lack of action.

What this is about

Infants who are not breastfed are completely dependent on infant formula. In 2022, contaminated powdered formula from Abbott Labs was associatied with the illness or deaths of several infants,  Despite earlier complaints from whistleblowers about poor sanitation at Abbott plants, the FDA was slow to advise not using this formula.

At the time of the FDA advisory, one infant was ill with Salmonella Newport, and four were ill with Cronobacter sakazakii ); of these, two died—a shocking tragedy.

What the report says

The Inspector General summarizes the findings:

• FDA had inadequate policies and procedures to identify risks to infant formula and respond effectively
• FDA took more than 15 months to address a February 2021 Abbott facility whistleblower complaint. I
• FDA did not escalate an October 2021 whistleblower complaint to senior leadership
• FDA did one inspection 102 days after a whistleblower complaint was received.
• FDA did not initiate an infant formula recall under its FDA-required recall authority.

Why didn’t the FDA act?

One reason was probably because “FDA could not confirm that the Abbott facility’s products caused the infant illnesses or deaths because clinical isolates for the infants were not available or whole genome sequencing was not a match to the Abbott facility Cronobacter investigation findings.”

Another is likely to be inadequate staffing, but a third, I’m guessing, has to do with the culture of the FDA, which increasingly appears captured by the industries it is supposed to be regulating.  The infant formula industry is highly concentrated and Abbott made something like 40% of it—even more reason to make sure the company was taking scrupulous care about safety.

The report instructs the FDA to do better.  Let’s hope.

The Federal Trade Commission (FTC) has issued a report on Market Factors Relevant to Infant Formula Supply Disruptions 2022. 

As the report explains:

Widespread supply disruptions for infant formula began shortly after Abbott Nutrition voluntarily recalled several powdered infant formulas manufactured at its facility in Sturgis, Michigan in response to reports of bacterial contamination on February 17, 2022. The FDA advised consumers that same day not to use the recalled formula. In turn, the USDA provided guidance to WIC State agencies and offered program flexibilities to support WIC participants’ access to infant formula.

The infant formula market in the United States is, to say the least, distorted.

• It is highly concentrated; the top 2  manufacturers control 66% of the market; the top 4 control 97%: Mead Johnson/Reckitt (39%), Abbott (27%), Nestle/Gerber (18%), Perrigo/store brands (13%).
• More than half (56%) of infant formula is sold through the WIC program through state-determined single-supplier contracts awarded to companies who offer the largest rebates (sometimes selling formula to the government below cost).
• Why would they do this?  Suppliers who hold state contracts dominate non-WIC sales in that state (the WIC halo or spillover effect).

Obviously, this system is highly vulnerable to disruptions and price inflation.

So what does the FTC conclude?

This Report was written from the perspective of the FTC, which is an agency tasked with promoting fair, competitive markets that deliver high quality, affordable, reliable supplies of products. Pursuant to this mandate, the FTC analyzes high levels of concentration in the infant formula market and explores whether certain policy changes could promote greater competition and resiliency, thereby rendering the market less susceptible to serious supply disruptions. We recognize that concerns about competition and resiliency must be balanced against other policy priorities, and that any attendant tradeoffs will require thoughtful and careful analysis.

Members of Congress asked for the report.  Did they get what they wanted?

The USDA’s recent annual report on WIC, The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC): Background, Trends, and Economic Issues, 2024 Edition, points out that this system doubles the cost of formula for non-WIC families.  Highly consolidated markets pretty much always lead to higher prices.

WIC is an important program for low-income women and children, demonstrably effective in reducing food insecurity.  Nobody wants to criticize it out of fear that Republicans will cut its budget.

But there has to be a better way to do this.

ProPublica has issued a major and highly importantt investigative report: The U.S. Government Defended the Overseas Business Interests of Baby Formula Makers. Kids Paid the Price.

The report documents how the U.S. has opposed marketing restrictions on infant formula throughout the world.

It refers specifically to what happened in Thailand over attempts to restrict the marketing of toddler formula (an unneccesary product).

In 2017, Thai health experts tried to stop aggressive advertising for all formula — including that made for toddlers. Officials feared company promotions could mislead parents and even persuade mothers to forgo breastfeeding, depriving their children of the vital health benefits that come with it. At the time, Thailand’s breastfeeding rate was already among the lowest in the world.

But the $47 billion formula industry fought back, enlisting the help of a rich and powerful ally: the United States government…U.S. officials delivered a letter to Bangkok asking pointed questions, including whether the legislation was “more trade restrictive than necessary.” They also lodged criticisms in a bilateral trade meeting with Thai authorities and on the floor of the World Trade Organization, where such complaints can lead to costly legal battles…In the end, though, the Thai government backed down. It banned advertising for infant formula but allowed companies to market formula for toddlers like Gustun — one of the industry’s most profitable and dubious products. The final law also slashed penalties for violators.

ProPublica also obtained documents detailing the arguments between trade and health officials over these policies.  See: Documents Show Internal Clash Before U.S. Officials Pushed to Weaken Toddler Formula Rules.

In this case, trade won over health.

The US government role in infant formula marketing goes way back to its opposition to the international code of marketing of breastmilk substitutes.  It is not a nice history and distressing that it continues.

More on infant formula tomorrow…

Dr Katie Pereira-Kotze, a part time Senior Nutritionist at First Steps Nutrition Trust wrote me to ask if I might comment on the conflicts of interest displayed at a conference sponsored by the British Journal of Midwifery (BJM).  This journal accepts sponsorship for its annual conference from breastmilk substitute companies (Nutricia, Kendamil, Nestle).

Groups concerned about the historic role of infant formula compnanies in discouraging breastfeeding in new mothers, have asked the BJM not to permit this funding.

For example, the Baby Feeding Law Group UK wrote a letter to the conference organisers in 2022.

We would also like to share with you our perceptions of the motivations of companies such as Kendamil and Nutricia for sponsoring events such as your conference. It is against the law in many countries including the UK for companies to promote infant formula. By partnering with organisations or sponsoring events, these companies avoid workplace controls on advertising and gain direct access to health care workers, including in the case of the BJM conference, midwives, and in doing so create a valuable link to pregnant and post-partum women.

The British Medical Journal (BMJ) also commented on these conflicted interests: Midwifery conference is criticised over formula milk sponsors.

Three companies that market formula milk (Aptamil, Kendamil, and Nestlé) are sponsoring the conference and have each been given a 40 minute slot during the one day conference programme.

This journal contrasted its own position on infant formula complany sponsorship with that of the midwifery jounral:

In 2019 The BMJ announced that it would no longer carry advertisements for breastmilk substitutes,4 and after pressure from clinicians and campaigners the Royal College of Paediatrics and Child Health also said that it would stop accepting funding from formula milk companies. Robert Boyle, a clinical reader in paediatric allergy at Imperial College London, told The BMJ, “Formula company marketing aims to disrupt breastfeeding, their main competitor, so that the companies can sell more formula.

Comment: The role of the commercial infant formula industry in pushing its products and discouraging breastfeeding has been well documented for decades, most recently in a series of Lancet Commission reports.  Conferences are expensive to run and the  British Journal of Midwifery undoubtedly can use the infant formula company money—but at some cost to its reputation.  The optics do not look good.  Sometimes, the money isn’t worth it.  Infant formula companies have joined cigarette and opioid companies in being viewed as producing products with great capability of doing more harm than good.  The sooner the BJM stops taking their funding, the better.