by Marion Nestle

Currently browsing posts about: Infant-formula

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.

What?

  • 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.

Resources

 

Apr 4 2023

The FDA’s ongoing infant formula drama: an update

The FDA is under siege these days.  Two reasons why.

  • Its failure to follow the advice of experts on how to reorganize the agency to give greater prominence and authority to food as opposed to drugs.
  • Its failure to get on top of the safety and supply problems with infant formula.

As usual, Bill Marler gets right to the point.

Two top  food officials at the FDA have retired recently.

Food and Drug Administration Director of the Center for Food Safety and Applied Nutrition (CFSAN) Susan Mayne announced that she will retire on May 31, 2023. Dr. Mayne has served as Director of CFSAN since January 2015. Another retirement among FDA leadership occurred earlier this year when FDA Deputy Commissioner of Food Policy and Response Frank Yiannas retired on February 24, 2023.

Frank Yiannis, formerly deputy commissioner for food policy at the FDA, testified to Congress:

Yiannas said that the FDA’s structure and culture exacerbated delays and that the agency had no data system in place to monitor key food supply chains. While Abbott is responsible for the safety and testing of its own powdered formula, he said, the sickened children and months-long shortage “was all a preventable tragedy” had FDA acted more urgently.

To deal with the uproar about infant formula, the FDA has just released:

But this will not be enough.

Helena Bottemiller Evich’s most recent Politico report is titled “‘Lessons have not been learned’: FDA knew of positive test months before latest infant formula recall.”

And another recall of infant formula occurred more recently.

All of this increases the urgency of the calls on FDA to pay more attention to food issues.

Congress:  Act now!

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Mar 21 2023

The FDA responds

My post last week on the FDA’s lack of action on ensuring the safety of infant formula elicited this response from Taryn WebbHealth Communications Specialist at CFSAN/FDA:

Hi Marion,

In your article below, “Alarming (in)action from the FDA,” you assert that “If FSMA did not require companies to notify the FDA when they found contamination, the FDA should be going to Congress to get that authority to announce its rulemaking to get that authority.” These statements could mislead readers to believe that the agency has not taken action to obtain this authority from Congress. In fact, the FDA is specifically seeking new authority to compel reporting of product positive test results for relevant pathogens (see FY 24 FDA Legislative Proposal titled, “Product Testing Requirements for Foods Marketed for Consumption by Infants and Young Children,” available at: https://www.fda.gov/about-fda/reports/budgets). Furthermore, the statement “FDA should…announce its rulemaking to get that authority,” is factually incorrect as without statutory authority, we are not in the position to undertake rulemaking to require such reporting. To reiterate what appears to be a point of confusion, the FDA cannot create authorities that we do not have through rulemaking. We did notice that you later updated your article at the very bottom to note that FDA did request such authority. However, your initial article and email distribution to readers contained incorrect information.

We are seeing a troubling pattern of articles with erroneous information that then get amplified. In the future, we would appreciate it if you contacted us before publishing articles that are solely about FDA so that we can provide you with the most up-to-date, correct information. You can reach out to our communications staff, which include myself and Jen Dooren (copied here) or by emailing CFSANTradepress@fda.hhs.gov.

As I see it, the “troubling pattern” here is FDA’s responses to advocates like me who want to support this agency’s role in making sure food companies in general—and infant formula companies in particular—do not produce unsafe food.  I want to encourage the FDA  to put public health as its first and immediate priority, as it is supposed to as an agency of the US Public Health Service.

I did not know about the FDA’s request to Congress.  The agency did not publicly announce it was asking for that authority.  I only learned about it from Helena Bottemiller Evich’s Food Fix newsletter, to which I subscribe.  I corrected my post as soon as I could.

Evich has her own issues with the FDA.  In her Food Fix letter last Friday, she said:

I updated last week’s post on FDA asking (not telling) infant formula makers to disclose contamination to clarify that the agency has determined it doesn’t have the authority to require this disclosure.  It’s perfectly normal for an agency to seek a clarification on something, as FDA did here, and I was happy to update the post – no problem. What I did take issue with, however, is FDA Commissioner Robert Califf characterizing the coverage as “misinformation” on Twitter.

…As I reported in Tuesday’s newsletter, FDA asked Congress last week for this test reporting authority in a budget document. This is notable, but it raises another critical question: Why didn’t the agency formally make this request earlier? It wasn’t in the agency’s budget request last year. It’s been more than a year since the massive Abbott Nutrition infant formula recall, and we’ve seen a handful of smaller recalls over Cronobacter concerns in recent months. And infant formula shortages and disruptions continue in many parts of the country.

If she didn’t know that FDA had asked Congress for test-reporting authority, it’s because the FDA wasn’t screaming for it as it should have been doing from the moment the infant formula crisis began.

The lives of infants are at stake.

Here what I wish the FDA had said from the beginning of the infant formula crisis and would still say:

“Marion, we are devastated by what has happened with infant formulas.  We can’t sleep for worrying about how we can protect infants from harm.  We are doing everything in our power to force formula producers to make sure their prevention controls are in place and monitored.  We never want this to happen again and won’t stop pushing them until we are sure infant formula is safe.”

I apologize for my error.  But I stand by my concerns.  FDA: If you want the troubling pattern to go away, fix the problem.

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Mar 14 2023

Alarming (in)action from the FDA

Last week I posted about Bill Marler’s “Take the F out of the FDA” campaign.

Since then, he additionally posted letters from the FDA that make it clear how poorly the agency is doing its job to protect all of us against foodborne illness.

Let’s start with the the agency’s March 8 letter to companies making infant formula.

The agency is asking—not requiring—infant formula companies to:

  • Evaluate their systems for ensuring safety
  • Comply with existing regulations
  • Follow existing rules, and
  • “Voluntarily notify the Agency any time a product sample is found to be positive for Cronobacter spp. or Salmonella, even if the affected lot(s) have not been  distributed.”

What?

The Food Safety Modernization Act (FSMA) of 2011 gave the FDA the authority to ensure safe food by requiring HACCP-like process controls at every stage of production.

Infant formula is the sole source of food for many babies.

The formula crisis of last year, where Abbott Labs produced formula contaminated with Cronobacter and Salmonella, meant that Abbott was not following the law and should have been required to clean up its act instantly.

Companies are supposed to test to make sure their process controls are working.

If FSMA did not require companies to notify the FDA when they found contamination, the FDA should be going to Congress to get that authority to announce its rulemaking to get that authority.

This is not a time for politeness.  Infants’ lives are at stake.

The FDA may argue that it cannot take action because so few companies make infant formula (illustrating why industry consolidation is not good for society).

But it must.  Marler is clear on what the FDA needs to do.

  • Put an inspector in every infant formula plant, 24/7.
  • Require product testing and report results to the CDC (to compare with illness).
  • Lobby to make Cronobacter a reportable infection (to reveal the extent of the problem).

To demonstrate the ineffectiveness of politeness, Marler also posted this 2005 letter from the FDA to lettuce growers (“we strongly encourage your industry to begin or intensify immediately efforts”)….  This was followed a year later by the Dole spinach recalls of 2006 (199 cases, 102 hospitalizations, 3 deaths) and many others, leading up to congressional action in passing FSMA.

It’s the FDA’s job to enforce FSMA.

If the FDA is too captured by industry to do that, let’s get the F out of it and into some place that is serious about doing something about food safety.

FDA Commissioner Califf ‘s tweeted response to Marler’s campaign—a thread of 14 tweets— is not reassuring.

There should be no question in anyone’s mind that the F in FDA is a top priority for me. We’ve accomplished a tremendous amount in the last 10 years to make the American food supply as safe as it’s ever been & improve the nutritional quality of foods. 
Not only does the U.S. have one of the safest food supplies in the world, we’ve also advanced our capabilities to detect pathogens. We’re now detecting more outbreaks & safety issues using modern methods like Whole Genome Sequencing that would have eluded detection in the past….
Creating a new foods agency isn’t in the FDA’s purview and would take years to put in place and distract from the important work that needs to be done today.
Right.  So do it.  Unsafe infant formula is a national scandal, unacceptable by any standard.
Addition: FoodFix reports this morning that the FDA has requested some of this authority in its legislative proposal (see page 4).as part of the Biden administration’s fiscal 2024 budget request that was unveiled Thursday (see page 4).
Feb 17 2023

Weekend reading: Lancet Commission on Breastfeeding vs the Infant Formula Industry

The Lancet has just published its commissioned series on breastfeeding, vs the commercial formula industry: three papers, an editorial, and a comment.

Breastfeeding has proven health benefits for both mothers and babies in high-income and low-income settings alike. Yet, less than 50% of babies worldwide are breastfed according to WHO recommendations. For decades, the commercial milk formula industry has used underhand marketing strategies, designed to prey on parents’ fears and concerns, to turn the feeding of infants and young children into a multibillion-dollar business—generating revenues of about $55 billion each year.

Editorial: Unveiling the predatory tactics of the formula milk industry

For decades, the commercial milk formula (CMF) industry has used underhand marketing strategies, designed to prey on parents’ fears and concerns at a vulnerable time, to turn the feeding of young children into a multibillion-dollar business. The immense economic power accrued by CMF manufacturers is deployed politically to ensure the industry is under-regulated and services supporting breastfeeding are under-resourced.

Breastfeeding: crucially important, but increasingly challenged in a market-driven world. R Pérez-Escamilla,, et al.

In this Series paper, we examine how mother and baby attributes at the individual level interact with breastfeeding determinants at other levels, how these interactions drive breastfeeding outcomes, and what policies and interventions are necessary to achieve optimal breastfeeding.

Marketing of commercial milk formula: a system to capture parents, communities, science, and policy.  N Rollins et al.

We report how CMF sales are driven by multifaceted, well resourced marketing strategies that portray CMF products, with little or no supporting evidence, as solutions to common infant health and developmental challenges in ways that systematically undermine breastfeeding. Digital platforms substantially extend the reach and influence of marketing while circumventing the International Code of Marketing of Breast-milk Substitutes.

The political economy of infant and young child feeding: confronting corporate power, overcoming structural barriers, and accelerating progress.  P Baker, et al.

First, this paper highlights the power of the commercial milk formula (CMF) industry to commodify the feeding of infants and young children; influence policy at both national and international levels in ways that grow and sustain CMF markets; and externalise the social, environmental, and economic costs of CMF. Second, this paper examines how breastfeeding is undermined by economic policies and systems that ignore the value of care work by women, including breastfeeding, and by the inadequacy of maternity rights protection across the world, especially for poorer women. Third, this paper presents three reasons why health systems often do not provide adequate breastfeeding protection, promotion, and support.

Comment: Stemming commercial milk formula marketing: now is the time for radical transformation to build resilience for breastfeeding, by Tanya Doherty et al.

One of the striking messages of the Lancet Breastfeeding Series is that the consumption of commercial milk formula (CMF) by infants and young children has been normalised. More children are consuming CMF than ever before. Only 48% of the world’s infants and young children are breastfed as recommended, despite the huge body of evidence on the lifelong benefits of breastfeeding. This situation reflects the stranglehold the CMF industry has on governments, health professionals, academic institutions, and increasingly on caregivers and families through pervasive social media.

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