by Marion Nestle

Currently browsing posts about: Infant-formula

Jun 18 2024

Inspector General faults FDA for the 2022 infant formula tragedy

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.

Apr 3 2024

The FTC’s wishy-washy report on infant formula disruptions

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.

Apr 2 2024

ProPublica: the U.S. government interferes with international regulation of formula marketing

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…

Mar 8 2024

How the food industry exerts influence V: Professional journals (Infant formula companies)

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.

Nov 28 2023

The hazards of feeding babies and young children: What to do?

I’ve been collecting items on feeding kids.  Here are four.

I.  FDA Warning Letters: The FDA has sent warning letters to ByHeart, Mead Johnson Nutrition (Reckitt), & Perrigo Wisconsin for violating basic food safety standards in manufacture of infant formula.

They [letters] reflect findings from FDA inspections of these facilities over the last several months. At the time of each inspection, the FDA issued inspectional observations and exercised oversight of each firm as they initiated recalls (in December 2022February 2023 and March 2023) to remove product potentially contaminated with Cronobacter sakazakii from the marketplace…The FDA is issuing these letters now as part of its normal regulatory process and to reinforce to these firms the importance of instituting and maintaining appropriate corrective actions when they detect pathogens to ensure compliance with the FDA’s laws and regulations. As part of this, the firms must, among other things, thoroughly conduct root cause investigations and perform subsequent cleaning and sanitation activities. Notably, firms also need to properly evaluate their cleaning and sanitation practices, schedules, and procedures before releasing product. 

Comment: What shocks me is the implication that the companies are not already doing this as part of their normal routines.

II.  Baby food pouches with lead sicken children.   

At least 18 more children have been sickened by the recently recalled applesauce fruit pouches due to dangerous lead contamination, the Food and Drug Administration said, in a recent update.  That brings the total number of affected children to 52. Applesauce pouches recall timeline:From recalls to poisoned kids in multiple states

Comment: Yes, I know self-feeding pouches are convenient, but I sure don’t like them much.  They are usually loaded with sugar and they don’t teach kids about diverse food flavors and textures.  Quality control, apparently, is a big issue.  My vote: avoid.

III. Environmental Working Group study finds 40% of commercial baby foods to contain toxic pesticides.

  • EWG sampled 73 products from three popular brands: 58 non-organic, or conventional, baby foods and 15 organic.
  • At least one pesticide was detected in 22 of the conventional baby foods.
  • No pesticides were detected in any of the 15 organic products.

Comment: Pesticides may be in all foods but they get concentrated in baby foods.  The moral here is clear; if you want baby foods free of harmful pesticides, buy organic.  For more on this, see article in The Guardian.

IV. The marketing of ultra-processed foods especially targets infants and young children.   A study done in the UK provides ample documentation of anything you would want to know about this practice.

Comment: Food companies say they have to market to young children in order to meet sales growth targets.  Ethics is not a consideration here.

Given that situation, what to do?

Understand: commercial infant and baby foods are convenient, but enormously profitable to manufacturers.  Profits induce corporations to cut safety and health cautions.  This tension should make you think twice about using commercial infant and child feeding products.

To the extent you can:

  • Breast feed when possible, for as long as possible
  • If you use infant formula, switch around the brands (they are all the same, nutritionally); buy organic if you can afford it.
  • Make your own baby foods (put whatever healthy foods you are eating or have around in a tiny blender).; buy organic foods if you can afford them.
  • Feed kids real foods as soon as they can grab, chew, and swallow them without choking.

If you eat a generally healthy diet, get your kids eating it as soon as they can.

Oct 25 2023

Who knew? II. The baby formula crisis continues

I saw this notice of Nestlé closing a baby formula factory in Ireland.   I wondered why.

Nestlé cited a significant downward trend in demand for infant nutrition products in the Greater China region as the main driver behind the factory closure, thanks to a sharp decline in the birth rate projected in 2023—9 million down from 18 million in 2016, according to Statista.  The market, which had previously been reliant on imported infant formula products, is also seeing rapid growth in locally-produced products, according to the manufacturer.


  • Nestlé’s factory in Ireland makes formula exclusively for sale in China.?
  • China’s birth rate has dropped by half just since 2016?

The infant formula market is one bizarre entity.  It depends entirely on these factors:

  1. How many mothers breastfeed their infants.
  2. How many babies are born.
  3. How many breastfeeding mothers can be induced to switch to formula.
  4. Ho long caretakers can be induced to continue using formula.

All of this pushes the formula industry to undermine breastfeeding.

Nestlé is moving its factory to China where it must think it can sell even more.

Maybe the Irish factory can make formula for Europe.   Scotland, for example, is worried about the high cost of formula—surely a supply-and-demand problem, at least in part.

Jun 30 2023

Weekend reading: Update on the International Code on infant formula marketing

Earlier this week I wrote about the UNICEF-WHO meeting I went to in Geneva on implementing the 1981 International Code governing marketing of infant formulas.

UNICEF has just issued an update: What I [meaning you] Should Know about the Code

This new publication—a one-stop shopping guide to the issues—summarizes UN resolutions on the Code since 1981 as well as subsequent research on breastfeeding and infant formula marketing, most notably the Lancet Commission reports I wrote about earlier.

Incontrovertible evidence demonstrates how inappropriate marketing of infant formulas undermines breastfeeding and can harm children, especially in places that do not have clean water to dilute formulas.

Every country in the world has committed to the Code—the United States was the last holdout.  We do not seem to pay much attention to the Code’s provisions.

Here is one example.  The Code says:I’m not sure how to interpret the “except” phrase, except that our FDA must think that the health claims on a product like this are entirely acceptable, whereas they would not be allowed in many other countries.  [Reference 23 refers to UN General Assembly Resolution 63.23.]

The Code states that infant formulas should not be labeled in any way that suggests formula might be superior to breast milk.  This and the accompanying statement on the product website, would appear to violate that guideline.

Infant formulas do a good job of substituting for the nutrients in breast milk.  Because the FDA tightly regulates their ingredients, they are all pretty much alike, although they vary in price enormously.

The infant formula industry deserves close scrutiny of its marketing practices and this UNICEF publication is an excellent place to begin.

Jun 27 2023

The UNICEF-WHO Congress on infant formula marketing: a brief report

Last week, I attended and spoke at the UNICEF-WHO Global Congress on Implementation of the International Code of Marketing of Breast-Milk Substitutes at WHO headquarters in Geneva.

The meeting was attended by more than 400 government, health, and advocacy representatives from more than 100 countries.  Representatives of infant formula companies were not invited to participate.

Its purpose was to encourage governments to promote and enforce the International Code, which nearly all U.N. member states ratified and committed to in 1981 (the U.S. was a long-standing holdout).

This meant they would control inappropriate marketing of infant formulas by banning advertising to people who are pregnant or nursing, gifts of formula samples, and doing anything to make formula appear superior to breastfeeding.

The logic of the Congress:

  • Breastfeeding is the superior method for feeding human babies.
  • Successful breastfeeding requires support from families, society, and government.
  • It is quite easy to undermine confidence in the ability to breastfeed.
  • Formula companies do all they can to undermine confidence in breastfeeding.
  • Formula companies’ main goal is to sell more formula.
  • Formula companies promote their products as normal and superior.
  • Breastfeeding is easier when formula marketing is controlled.y

I talked about the food industry “playbook”—strategies and tactics used by industries (tobacco, chemical, drug, alcohol, and food as well as infant formula) to cast doubt on unfavorable research, fund their own research, and lobby against public health recommendations (photo: Arum Gupta).

Many country representatives discussed the effects of the playbook in their areas, and what they are trying to do to stop formula companies from using  the playbook to get around the Code.

The general consensus:  Formula companies should NOT be allowed to:

  • Advertise or market products in violation of the Code.
  • Participate in public health policymaking.
  • Partner with relevant government agencies or non-governmental groups.

Obviously, formula companies are not happy with such recommendations.  If you would like to see an example of the playbook in action, take a look at the response  from the International Special Dietary Foods Industries.

It was exciting to be with so many people who cared so deeply about this issue.