by Marion Nestle

Currently browsing posts about: Infant-formula

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 Webb, Health 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).
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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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Aug 4 2022

USDA on the job: feeding kids

I’ve been trying to keep up with USDA press releases, especially those related to food assistance for children.   Here are a few from the last couple of weeks.
I.  USDA Announces Increased Funding for School Meals, Child and Adult Care Meals, Jul 22, 2022  

Effective July 1, 2022, the reimbursement schools receive for each meal served will increase by approximately $0.68 per free/reduced-price lunch and $0.32 per free/reduced price breakfast. Other reimbursement rates, including rates for paid school meals and child care meals, are available online.

With this comes:

II.  USDA Awards over $70 Million in Grants, Increases Access to Local, Healthy Foods for Kids, Jul 25, 2022  

The U.S. Department of Agriculture (USDA) announced it is awarding more than $10 million in Farm to School grants to 123 projects across the country…[these] will serve more than 3 million children at more than 5,000 schools in 44 states and the District of Columbia.

Grants by state are here.    Grant awardees with project descriptions are here.

III.  USDA Extends Flexibility that’s Helping Manufacturers, States get Formula to WIC Families Jul 28, 2022

Under this flexibility – which is now extended through the end of September – USDA is covering the added cost of non-contract formula to make it financially feasible for states to allow WIC participants to purchase alternate sizes, forms, or brands of infant formula.

This has to do with the infant formula shortage.  About half the infant formula in America is purchased by the WIC program, which usually contracts with one formula company to serve participants.  The USDA has relaxed restrictions on brands and imports to help deal with the shortages.  For example, it:

  • Provides a toolkit and guidance to WIC state agencies to assist with distributing imported formula.
  • Calls on states to take advantage of all available WIC flexibilities…Now, nearly all state agencies have applicable waivers in place.
  • Provides guidance to Child and Adult Care Food Program operators to help them navigate the shortage.
  • Provides an Infant Formula Shortage Response webpage

Cheers to USDA for taking action.  Action is what our kids deserve.

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May 17 2022

Infant formula: what’s the shortage really about?

The White House says it is taking steps to alleviate the nationwide shortage of infant formula.

House speaker Nancy Pelosi has written a letter to democrats demanding action.

Nationwide shortage of infant formula?

As CBS News explained,

At retailers across the U.S., 40% of the top-selling baby formula products were out of stock as of the week ending April 24…Prices of baby formula, which three-quarters of babies in the U.S. receive within their first six months, have also spiked…Supply-chain snarls related to COVID-19 are contributing to the shortage of formula around the U.S. They include manufacturers having more difficulty procuring key ingredients, packaging hangups and labor shortages…In addition, a major baby formula recall in January exacerbated shortages.

I wrote about the Abbott recall earlier, on February 22 and March 8.

Politico’s Helena Bottemiller Evich has been following this story closely in Politico.  You can find her articles here.

Her writing is getting action.

For example, Representative Rosa deLauro released a whistleblower report warning about food safety concerns months before infants died and the FDA investigated.

Food safety lawyer Bill Marler posted a link to the redacted  whistleblower report.

He says: Mr. Abbott, you are going to jail for manufacturing tainted infant formula.

The legal jargon aside, if you are a producer of food and knowingly or not manufacturer and sell adulterated food, you can (and should) face fines and jail time.  For Abbott, at least 4 kids were sickened and of those two died, from drinking infant formula.

Here is the most recent inspection report at the plant – APPLIED – FOI II – BR Abbott Nutritions- FEI# 1815692 9-2021 EIR.

In the meantime, Bottemiller Evich keeps the focus on how hard this situation is for parents of infants with special nutritional needs.  She also has a Twitter thread on this “slow-moving train wreck.”  She reproduces this graphic from @erindataviz/@datasembly:

 

The Seattle Times has a particularly useful guide to what to do—and what not to do—if you can’t find the formula you need.

As to what this is really about, see:

The Morning.  This New York Times column attributes this particular shortage to general shortages, monopoly concentration in the formula business, bureaucratic inflexibility, and, most of all, American gerontocracy and overall indifference to the welfare of young children.

A blogger about the politics of monopoly, Matt Stoller, expands on these themes:  baby formula monopoly, FDA collusion, and USDA’s methods for dealing with infant formula in the WIC program (this last alone is reason to read this piece).  In response, the USDA says it is granting states flexibility in apply the WIC rules.

And the Cato Institute has an informative piece on trade restrictions that prevent import of formula from other countries, including the European Union; this pieces also discusses the WIC problem (Government is major buyer; Abbott is major supplier).

Comment: This is a really bad situation that is finally starting to get attention.  Babies are completely dependent on infant formula if they are not being breastfed.  It needs to contain all the right nutrients, but it also needs to be safe.

The FDA says it is taking steps to alleviate the formulat shortage.

Why hasn’t it acted more swiftly?  Perhaps because of what Bottemiller Evich wrote about previously?  See The FDA’s Food Failure.

Basically, we are seeing the results of unregulated monopolies and captured government.  With the most vulnerable members of society—and society’s future—at risk.

Additional links

Additional links that came later

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Mar 8 2022

The Abbott infant formula recall: an update

I posted about this recall on February 22.

A quick review: The FDA is advising consumers not to use certain Abbott’s powdered formula products because they might be contaminated with  Cronobacter sakazakii or Salmonella Newport.

To date, one infant is ill with Salmonella Newport, and four ill with Cronobacter sakazakii with two deaths.

This is a shocking tragedy.  Formula-fed babies are entirely dependent on those products.  They are heavily regulated, or supposed to be.

The three powdered formula brands at issue are Similac, Alimentum, or EleCare.  The FDA says not to use them if:

  • the first two digits of the code are 22 through 37; and
  • the code on the container contains K8, SH or Z2; and
  • the expiration date is 4-1-2022 (APR 2022) or later.

Abbott’s recall announcement has more information about the specific products.

Politico’s Helena Bottemiller Evich is following this case closely.

She interviewed parents of children harmed, sometimes terribly, by consuming contaminated formula.

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.

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

Fortunately, House Appropriations Chair Rosa DeLauro has called on the Department of Health and Human Services’ Inspector General to invesigate whether the FDA “took prompt, appropriate, and effective action” in this situation.

As for Abbott, its statement says:

The company said all of its finished products are tested for the pathogens before they’re released, and samples it retained tested negative for the infections related to the complaints.  “We value the trust parents place in us for high quality and safe nutrition and we’ll do whatever it takes to keep that trust and resolve this situation.”

I have my own question: Why isn’t there far more media attention to the formula recalls?  Babies’ lives are at stake.  Parents, understanably, are frantic.

What should they do?

  • Feed liquid formula.  It, at least, is sterile.
  • Scream for federal action (if enough people do, it might get some).
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Mar 3 2022

Infant formula marketing: an update

As the WHO/UNICEF report I posted yesterday makes clear, the marketing of infant formula—impossible for new mothers to avoid—interferes with breast feeding and, therefore, is a public health concern.

I posted about the Abbott Labs infant formula recall last week.

Here are some additional items I’ve collected on this topic.

I.  What the marketing looks like.

II.  Study finds no benefit of enriched infant formula on later academic performance: Children who are given nutrient or supplement enriched formula milk as babies do not appear to have higher exam scores as adolescents than those fed with standard formula, suggests a study published by The BMJ, leading researchers to argue renewed regulation is needed to better control infant formula promotional claims…. Read more

III.  IBFAN, the International Baby Foods Action Network, writes that it is:

launching a PETITION calling for an immediate halt to a new study  –  funded by the Gates Foundation and led by researchers from the University of California – that is randomly allocating infant formula to breastfeed in low-birth-weight babies in Uganda and Guinea-Bissau on assumption that this might prevent wasting and stunting.

The study, which has been cleared by ethics committees in the USA, Uganda and Guinea -Bissau – uses purchased ready-to-use infant formula made by Abbott, a US pharmaceutical corporation operating in 160 countries.  Abbott is a major violator of the International Code and is currently at the centre of a media storm in the USA because of contamination in its powdered formula. (NB. The formula used in the trial is liquid Ready-to-Feed).

IV.  IBFAN issued an earlier statement: The baby food industry’s destruction of an irreplaceable natural resource.

The International Code of Marketing of Breastmilk Substitutes was adopted forty years ago by the World Health Assembly, the world’s highest health policy setting body…Today 70% of countries have adopted laws based on the Code, however far too many are limited in scope and full of loopholes as a result of industry interference. As a consequence predatory marketing of baby food products continues throughout the world.  and the global Baby Food Drink Market is forecast to rise more than 30% in 5 years (from $68bn in 2020 to $91.5bn by 2026)….Aside from its crucial role in child survival (more than 800,000 children die each year because they are not breastfed and many more do not reach their full potential, ­­ breastfeeding is the most environmentally friendly way to feed an infant, resulting in zero waste, minimal greenhouse gases, and negligible water footprint. As a renewable natural food resource, mother’s milk makes an important contribution to local food and water security.…the baby food industry lost no time in exploiting the fear and confusion during the pandemic: falsely claiming their products build immunity; that their  ‘donations’ are humanitarian; encouraging the needless separation of mothers and babies and pretending that they are essential ‘partners’ who are genuinely working to address the problems.

V.  The Access to Nutrition Initiative (ATNI) assesses nine formula companies’ adherence to WHO recommendations.  Its report is here.

According to its press release,

Despite the World Health Assembly (WHA) adopting ‘The International Code of Marketing of Breast-milk Substitutes’ forty years ago and passing 18 associated resolutions since (collectively referred to as ‘The Code’), the BMS/CF Marketing Index 2021 found that none of the companies it assessed fully abides by The Code’s recommendations and most fall well short.

The summary: 

  • Danone retained first place with a score of 68%, up from its 2018 score of 46%
  • Nestlé, the market leader in sales value, retained its second place with a score of 57% – also a substantial improvement on its score of 45% in 2018
  • KraftHeinz achieved the greatest improvement, ranking third, with a score of 38% compared to in 2018 when it didn’t score at all
  • Reckitt (previously RB) substantially improved its BMS Marketing policies which led to a big jump in its score from 10% in 2018 to 32% in 2021 and climbing one place to fourth in the ranking.

VI.  A study: Conflicts of interest are harming maternal and child health: time for scientific journals to end relationships with manufacturers of breast-milk substitutes.  Pereira-Kotze C, et al.  BMJ Global Health. 2022 Feb;7(2):e008002. doi: 10.1136/bmjgh-2021-008002

The promotion and support of breastfeeding globally is thwarted by the USD $57 billion (and growing) formula industry that engages in overt and covert advertising and promotion as well as extensive political activity to foster policy environments conducive to market growth. This includes health professional financing and engagement through courses, e-learning platforms, sponsorship of conferences and health professional associations and advertising in medical/health journals…journal publishers may consciously, or unconsciously, favour corporations in ways that undermine scientific integrity and editorial independence—even perceived conflicts of interest may tarnish the reputation of scientists, organisations or corporations.  Such conflicts have plagued infant and young child nutrition science for decades.

Comment: As I mentioned yesterday, we now have more than enough evidence to put a stop to this.

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Mar 2 2022

Marketing infant formula: an important report from WHO and UNICEF

WHO and UNICEF have issued a new report: “Examining the impact of formula milk marketing on infant feeding decisions and practices.”

The website summarizes the main message: “More than half of parents and pregnant women [are] exposed to aggressive formula milk marketing.

The report finds that industry marketing techniques include unregulated and invasive online targeting; sponsored advice networks and helplines; promotions and free gifts; and practices to influence training and recommendations among health workers. The messages that parents and health workers receive are often misleading, scientifically unsubstantiated, and violate the International Code of Marketing of Breast-milk Substitutes (the Code) – a landmark public health agreement passed by the World Health Assembly in 1981 to protect mothers from aggressive marketing practices by the baby food industry.

The press release explains:

The largest ever study of its kind, it draws on surveys with over 8 500 pregnant women and mothers of young children (aged 0-18 months) across eight countries, and more than 300 health professionals. The study…conducted in eight countries…exposes the aggressive marketing practices used by the formula milk industry, and highlights impacts on families’ decisions about how to feed their infants and young children.

The report begins with this prose poem:

The report’s main findings:

  1. Formula milk marketing is pervasive, personalized, and powerful.
  2. Formula milk companies use manipulative marketing tactics.
  3. Formula milk companies distort science and medicine.
  4. Industry systematically targets health professionals.
  5. Formula milk marketing undermines parents’ confidence in breastfeeding.
  6. Counter-measures can be effective.

Videos posted on Twitter.

  1.  Images of what you see
  2.  Misleading claims from the formula industry
For Infographics, scroll down on this link.
Comment: This is an important, timely report. Advocates have been complaining about the ways infant formula companies market their products for decades.  It’s way past time to intervene.
More on infant formula marketing tomorrow.
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