by Marion Nestle

Currently browsing posts about: Infant-formula

Nov 4 2016

Weekend reading: Rudd Center report on baby food marketing

The Rudd Center for Food Policy & Obesity at the Univeristy of Connecticut  produces terrific reports.  The latest is Baby Food FACTS: Nutrition and marketing of baby and toddler foods and drinks:

 

Infant formula companies have a marketing problem: breast milk is a better option, all formulas have the same nutrient composition by FDA regulation, and babies only need to use formula for a few months.

Baby food companies also have a marketing problem: babies can eat table foods (suitably ground or cut) and don’t really need the stuff in jars (convenient thought they may be).

The Rudd Center report takes a good hard look at the

  • Contents of food and drink products marketed to parents for their babies and toddlers (up to age 3)
  • The marketing messages used to promote these products
  • Degree to which marketing messages correspond with expert advice on feeding young children

The findings: The nutritional quality is pretty much as advertised but nearly 60 percent of advertising dollars go for products that are not recommended for young children such as sugar-sweetened toddler milk, nutritionally poor snack food, and Pediasure, a high-calorie liquid nutrition supplement.

Here’s the full report 

And here’s a summary

Oct 25 2016

Comments wanted: FDA guidance on structure/function claims for infant formula. Deadline: November 8

The FDA wants to tighten up the rules for labels and advertising of “structure/function” claims on infant formulas.  It has proposed “guidance” and asks for comments on it.

This is a good proposal and needs all the support it can get.

Background

“Structure/function” claims were allowed by the Dietary Supplement Health and Education Act of 1994.  These are pseudo health claims that are really about marketing, not health.  Example: this brand of infant formula “supports digestion.”

All infant formulas must meet FDA nutritional requirements and there is no meaningful difference in any of them.  Structure/function claims market one brand over another.  Worse, they make infant formulas seem better than breast milk and help to discourage women from breastfeeding.

In September, the FDA announced that it was proposing draft guidance for industry, entitled “Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling.”  This says that the infant formula industry must actually produce evidence that the claims do what they say.  Formula makers must substantiate structure/function claims with “competent and reliable evidence,” preferably from clinical research.

Infant formula makers would much rather not bother.

This proposal deserves enthusiastic support.  If you agree with it, please write the FDA and say so.

ChangeLab Solutions has filed a position paper on this topic with the FDA—excellent background reading.

It also has developed a template letter, which you can adapt and send.

But even a shorter statement that you think structure/function claims should not be used to market infant formulas without real science behind them would help.

Here’s the quick one I sent in.  Feel free to copy.  But individual letters carry more weight.

How to do this?

  • Go to the FDA docket website: look for ID: FDA-2016-D-2241.
  • Go to the first of the two FDA documents listed there.
  • Click on “Comment Now!”
  • Fill in the Comment box by saying you are commenting on FDA-2016-D-2241.
  • Upload your letter
  • Following the instructions for the required items (the others are voluntary)

The FDA documents

Jul 1 2016

Reading for the long weekend: Jennifer Grayson’s “Unlatched”

Jennifer Grayson.  Unlatched: The Evolution of Breastfeeding and the Making of a Controversy.  Harper. 2016.

I thought this book had plenty to say and said it well (and has a great cover).  I did a blurb for it:

Unlatched is a deeply engaging, highly personal, well researched, and thoughtfully balanced account of how modern society has denormalized breastfeeding.  Jennifer Grayson does not expect every mother to follow her example and breastfeed babies for three or four years.  Instead, she asks us to consider how formula feeding became the norm and how government policies perpetuate it as the norm (see especially the stunning chapter on the Women, Infants, and Children program).  She argues compellingly that our challenge as a society is to restore breastfeeding as the default for feeding babies, and to provide the support—political as well as emotional–that mothers need to breastfeed successfully.

Dec 27 2011

What’s with the problems with powdered infant formula?

Mead Johnson Nutrition says it has tested additional samples of its Enfamil baby formula and still does not find the bacteria responsible for the death of one newborn infant and the illness of another.

The bacteria at fault are Cronobacter sakazakii, formerly known as Enterobacter sakazakii (bacterial taxonomists proposed this reclassification in 2007).

Last week several retailers pulled Enfamil infant formula from their shelves because of fears that Enfamil was contaminated with this organism.

Walmart was the first to issue a recall.

The retailers actions were unusually cautious.  Neither Mead Johnson nor federal investigators had evidence that the formula caused the illnesses.  Federal agencies had not asked for a recall.

But the retailers must have connected the dots:

  • The most likely source of C. sakazakii is powdered infant formula.
  • The two infants ill with C. sakazakii were fed Enfamil powdered formula (although the second ill infant drank several kinds of formulas).

In the chapter on infant feeding in my book, What to Eat, I noted that the main difference between one kind of infant formula and another is its cost.  Powdered formula is much cheaper than the already reconstituted kinds.  I asked:

Beyond the difference in cost, does it matter which level of convenience you choose?

It might.   Powdered formulas are not sterile.  In this, they differ from concentrate and ready-to-serve formulas, which have been heated to sterilize them.

In 2002, the FDA warned pediatricians that powdered milk formulas could be contaminated with Enterobacter sakazakii, a type of bacteria that causes rare but terrible and sometimes fatal infections in infants, especially those who are premature, weak, or in hospitals.

The FDA says it is not aware of any E. sakazakii infections in healthy full-term infants in home settings.

Reports from other countries, however, suggest that even healthy babies may sometimes acquire such infections [see Kwan Kew Lai, “Enterobacter sakazakii infections among neonates, infants, children, and adults: case reports and a review of the literatur,”(see:  Medicine, Vol. 80, pp. 113-122, March 2001.]

In 2001, the CDC published a case report on this type of infection.  It pointed out that “…in 50-80 % of cases, powdered infant formula is both the vehicle and the source (direct or indirect) of E. sakazakii-induced illness.”

The CDC’s conclusion:

Clinicians should be aware of the potential risk for infection from use of nonsterile enteral formula in the neonatal health-care setting.

The World Health Organization has a Q and A:

3. How does infant formula get contaminated with Enterobacter sakazakii? Can other foods also be contaminated?

Basically there are three routes by which Enterobacter sakazakii can enter infant formula:

a) through the raw material used for producing the formula;

b) through contamination of the formula or other dry ingredients after pasteurization; and

c) through contamination of the formula as it is being reconstituted by the caregiver just prior to

feeding.

Enterobacter sakazakii has been detected in other types of food, but only powdered infant formula has been linked to outbreaks of disease.

So the recalls were precautionary.  It’s hard to argue with that—unless you are a stockholder; Mead Johnson stocks declined by 5% as a result.

At the moment, the source of these particular C. sakazakii infections is unknown.  Let’s give the retailers credit for taking precautions to protect the public.

As for infant feeding in general: Breastfeeding is best, of course.  If you are using formulas to feed your infant, the liquid ones are safer—but much more expensive.

Aug 20 2011

How WIC enriches infant formula companies

The USDA has just analyzed the effect of WIC (the Special Supplemental Program for Women, Infants, and Children) purchases of infant formulas on the companies that produce them. 

WIC provides coupons or vouchers for infant formula for women who are not breastfeeding.  Many people believe that WIC support of infant formulas discourages breastfeeding, but that’s not what this post is about.

WIC buys about half (57 to 68%) of all of the infant formula sold in the United States.   WIC is not an entitlement program.  It only has so much money; once that money is spent, the program has to turn away eligible clients.

The USDA delegates WIC management to states.  As the USDA report explains

To reduce cost to the WIC program, each State awards a sole-source contract to a formula manufacturer to provide its product to WIC participants in the State. As part of the contract, the WIC State agency receives rebates from the manufacturers.

Translation: States grant WIC contracts to the manufacturer who sells infant formula to it at the lowest price.  The winning prices may be as low as 10% of retail cost.

Why would companies want to do this?

In this study, we use 2004-09 Nielsen scanner-based retail sales data from over 7,000 stores in 30 States to examine the effect of winning a WIC sole-source contract on infant formula manufacturers’ market share in supermarkets.

We find that the manufacturer holding the WIC contract brand accounted for the vast majority—84 percent—of all formula sold by the top three manufacturers.

The impact of a switch in the manufacturer that holds the WIC contract was considerable. The market share of the manufacturer of the new WIC contract brand increased by an average 74 percentage points after winning the contract.

Most of this increase was a direct effect of WIC recipients switching to the new WIC contract brand. However, manufacturers also realized a spillover effect from winning the WIC contract whereby sales of formula purchased outside of the program also increased.

Mind-boggling, no?

________________________________________

May 27 2011

Why I think health claims are about marketing, not health? Gerber’s whey claim

Yesterday’s New York Times displayed a full-page advertisement for Gerber baby food (owned by Nestlé, no relation):

Gerber is taking more than baby steps to reduce the risk of certain allergies

.…The FDA concludes that current scientific evidence is appropriate for consideration of a claim regarding the relationship between the consumption of 100% whey-protein partially hydrolyzed infant formula and reduced risk of atopic dermatitis.

….We’re proud to say that Gerber Good Start is the first and only formula brand made from 100% whey-protein partially hydrolyzed.  In contrast, most other routine milk-based formulas are made with intact cow’s milk protein.

Translation: Some infants are allergic to the proteins (whey) in cow’s milk.  Treating the proteins so they are split apart into smaller fragments (partial hydrolysis) apparently destroys some of their ability to elicit allergic immune reactions in the skin.

But here’s where the ad gets totally weird:

The FDA has concluded that the relationship between 100% whey-protein partially hydrolyzed infant formulas and the reduced risk of atopic dermatitis is uncertain, because there is little scientific evidence for the relationship.  Partially hydrolyzed formulas should not be fed to infants who are allergic to milk or to infants with existing milk allergy symptoms.

Huh?

Blame Congress for this one.  It insists that the FDA allow “qualified” health claims” for which scientific evidence is uncertain.

If you want to know why the FDA can’t seem to get anything done, take a look at what it’s staff had to do to respond to the Gerber petition.  Graduate students take note: this is an exhaustive review of scientific studies on the relationship between hydrolyzed whey protein and infant skin allergies.

Here is the FDA’s conclusion, written in FDA-speak, about Gerber’s petition for a health claim:

In light of the above considerations, FDA intends to consider the exercise of its enforcement discretion for the following qualified health claims (my emphasis):

1. “Very little scientific evidence suggests that, for healthy infants who are not exclusively breastfed and who have a family history of allergy, feeding a 100% Whey-Protein Partially Hydrolyzed infant formula from birth up to 4 months of age instead of a formula containing intact cow’s milk proteins may reduce the risk of developing atopic dermatitis throughout the 1st year of life and up to 3 years of age.”

2. “Little scientific evidence suggests that, for healthy infants who are not exclusively breastfed and who have a family history of allergy, feeding a 100% Whey-Protein Partially Hydrolyzed infant formula from birth up to 4 months of age instead of a formula containing intact cow’s milk proteins may reduce the risk of developing atopic dermatitis throughout the 1st year of life.”

3. “For healthy infants who are not exclusively breastfed and who have a family history of allergy, feeding a 100% Whey-Protein Partially Hydrolyzed infant formula from birth up to 4 months of age instead of a formula containing intact cow’s milk proteins may reduce the risk of developing atopic dermatitis throughout the 1st year of life and up to 3 years of age. FDA has concluded that the relationship between 100% Whey-Protein Partially Hydrolyzed infant formulas and the reduced risk of atopic dermatitis is uncertain, because there is very little scientific evidence for the relationship.”

4. “For healthy infants who are not exclusively breastfed and who have a family history of allergy, feeding a 100% Whey-Protein Partially Hydrolyzed infant formula from birth up to 4 months of age instead of a formula containing intact cow’s milk proteins may reduce the risk of developing atopic dermatitis throughout the 1st year of life. FDA has concluded that the relationship between 100% Whey-Protein Partially Hydrolyzed infant formulas and the reduced risk of atopic dermatitis is uncertain, because there is little scientific evidence for the relationship.”

Why would Gerber’s place a hugely expensive full-page ad in national newspapers to celebrate a decision like this?  Because it knows that any health claim, no matter how poorly substantiated by science, gives it a competitive advantage.

This is reason enough to promote breastfeeding.

 

Mar 8 2011

Omega-3s in infant formula: time for a close look

The FDA just announced that it is planning to research health claims on infant formulas such as “supports brain and eye development.’’ The FDA wants to:

assess women’s understanding of and response to various statements on infant formula labels. The study results will be used to help the Agency to understand the role that certain types of statements on infant formula labels have in influencing formula choice….The study will focus on purchase choice, perceived similarity of the formula to breast milk, and perceived likelihood that the formula has certain health benefits.

Translation: the FDA thinks that claims for omega-3 fatty acids—DHA, in this case—on infant formulas mislead mothers into thinking the formulas are better than breast milk.

Despite lack of evidence for benefits, infant formula makers have been so successful in marketing the addition of these omega-3 fatty acids that you can hardly buy a formula without them.

I was in Ecuador a few months ago and saw this sign:

The idea?  Omega-3’s will make your kid smart.

My book, What to Eat, has a chapter on infant formula and baby food. Here are some relevant excerpts:

Infant formulas cause controversy and are endlessly contentious for three important reasons. Formulas are (1) largely unnecessary (most mothers can breast feed their infants), (2) not as perfect as breast milk for feeding babies, and (3) more expensive than breast feeding.

Breast milk is nutritionally superior to formula, but from a marketing standpoint it has one serious disadvantage: it is free. Beyond one-time purchases of breast pumps, storage bottles, or special clothing, nobody makes money from it.

For mothers who cannot, should not, or do not want to breast feed, formula is a socially and nutritionally acceptable substitute. But formula companies do not only promote formulas to mothers who must use formula. In subtle and not-so-subtle ways, they promote the use of formulas to all pregnant women and new mothers.

I go on to explain that because formula is the sole food for infants, its composition is highly regulated. Therefore, all infant formulas have the same composition, and all virtually indistinguishable.

Competition for market share explains why formula companies want to put distinctive nutrients in their formulas–especially nutrients considered “conditional.” A conditional nutrient is one that might have some benefits under some circumstances. Even if the health benefits are minimal or questionable, they can be used in advertising.

That is the principal reason why so many formulas now have fatty acids added—omega 6 arachidonic acid (ARA) and omega-3 docosahexaenoic acid —the same one that is in fish oil. These two fatty acids are normally present in breast milk, and there is some evidence, weak and questionable as it may be, that they support infant brain development and vision.

Formula makers got the FDA to agree that ARA and DHA are normal components of food (which they are) and, therefore, are Generally Recognized As Safe (GRAS). This means that companies could add ARA and DHA to infant formulas without having to prove that either of them really did anything useful or beneficial.

I then explain that the FDA apparently agreed to the GRAS petition with some reluctance, as indicated by its answer to the question, “What is the evidence that addition of DHA and ARA to infant formulas is beneficial?”

The scientific evidence is mixed. Some studies in infants suggest that including these fatty acids in infant formulas may have positive effects on visual function and neural development over the short term. Other studies in infants do not confirm these benefits. There are no currently available published reports from clinical studies that address whether any long-term beneficial effects exist.

My interpretation of the proposed research study is that the FDA thinks the addition of ARA and DHA may discourage mothers from breastfeeding and may unnecessarily cause them to buy more expensive formula.

If you agree, tell the FDA you think the study is a great idea, and the sooner it gets going, the better.

You can file comments at http://www.regulations.gov.  Refer to Docket No. FDA–2011–N–0098]

Jan 16 2011

Furor about new breastfeeding study

A recent commentary in the British Medical Journal (BMJ) is causing a furor among breastfeeding advocates in Great Britain.

Titled Six months of exclusive breast feeding: how good is the evidence?, its authors argue that four months is probably just as good and less likely to cause harm.

The current British recommendation is for six months of exclusive breastfeeding—meaning no added solid foods.  This is based on a systematic analysis of research first published as a Cochrane review in 2002 and updated in 2006.  It compared the health of infants breastfed for six months to those breastfed for three-to-four months, and concluded that the science demonstrated significant advantages to the longer breastfeeding period.

That analysis was the basis of breastfeeding recommendations by United Nations agencies, such as the World Health Organization and UNICEF.  In Great Britain, UNICEF UK has issued its own statement defending the six-months recommendation.

Adding to the furor, the British Guardian titled its article about the new commentary, “Six months of breastmilk alone is too long and could harm babies, scientists now say.”  A second account in the Guardian provided a more cautious interpretation of the science.

I can understand why breastfeeding advocates are so upset about the BMJ paper.  They are worried about promotion of infant formulas as substitutes for breast milk, especially in developing countries.  Infant formulas can be adequate, if not perfect, substitutes for breast milk under conditions where they can be properly diluted and refrigerated.  When those conditions are impossible, as is the case in many low-income areas, formulas can become contaminated with harmful bacteria.  Use of infant formulas has a long history of association with infant illness and death (I wrote about this in Food Politics).

Formula companies did and continue to promote their products as convenient—and preferable—substitutes for breast feeding.

As it turns out, several of the authors of the BMJ commentary consult for formula companies.

Those authors vehemently deny that their ties to formula companies influence their opinions.  That may or may not be so, but such ties strongly correlate with research results and opinions favorable to the corporate ally.

In the United States, pediatricians strongly advocate breastfeeding, but flexibly.  In 1997, the American Academy of Pediatrics (AAP)  policy statement said.

Exclusive breastfeeding is sufficient to support optimal growth and development for approximately the first 6 months of life and provides continuing protection against diarrhea and respiratory tract infection….Complementary foods rich in iron should be introduced gradually beginning around 6 months of age.

But the AAP noted,

Unique needs or feeding behaviors of individual infants may indicate a need for introduction of complementary foods as early as 4 months of age, whereas other infants may not be ready to accept other foods until approximately 8 months of age.

As any parent of more than one child can tell you, babies differ.  Some are happy with exclusive breastfeeding.  Others want solid foods the instant they learn how to swallow.

The new commentary isn’t wrong, exactly, although it says nothing new.

It just isn’t helpful.  And that’s reason enough to be upset about it.

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