Currently browsing posts about: Infant-formula

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?

________________________________________

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.

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]

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.

Nestlé, the world’s largest food company (no relation) has conducted periodic studies of infant feeding practices since 2002, no doubt to encourage sales of its Gerber products.  The surveys—FITS (Feeding Infants and Nutrition) Studies—invariably show that Gerber  baby foods would be better for babies than what they currently are fed.

The latest FITS results, says the Nestlé press release, “are startling.”

• One-third of toddlers and 50% of preschoolers eat fast food at least once a week.
• On-quarter of families eat dinner together four or fewer nights each week.
• Half of 2-year-olds and 60% of 3-year-olds watch more than one hour of television each day.
• 17% of 2-year-olds and 24% of 3-year-olds watch more than two hours of TV each day.
• 25% of older infants, toddlers and preschoolers do not eat even one serving of fruit on a given day, and 30% do not eat a single serving of vegetables.
• French fries are still the most popular vegetable among toddlers and preschoolers.
• 71% of toddlers and 84% of preschoolers consume more sodium than recommended on a given day.

If these trends are real, could food marketing have anything to do with them?  Nestlé/Gerbers does not speculate.

The survey does report some good news:

• “Only” 17% of infants age 6-8 months consumed a dessert or sweetened beverage on a given day compared to 36% in 2002.
• “Only” 14% of infants age 12-14 months drank a sweetened beverage on a given day, down from 29% in 2002.
• 33% of mothers are breastfeeding 9-11 month old children compared to 21% in 2002

The breastfeeding trend, if true, is good news indeed.  Evidently, the word is also getting out on sweetened beverages.  Progress?  Yes, but plenty more to do.

Laurie True, who directs California’s WIC Association ( WIC is the Special Supplemental Nutrition Program for Women, Infants and Children), writes in The Hill about the latest efforts of infant formula company lobbyists to extract more money for their products.

WIC, for the uninitiated, provides formula and foods to low-income mothers of small children.    But unlike Food Stamps, it is not an entitlement.  Eligible families cannot enroll in WIC if the program does not have enough money to pay for the food.

Despite ample research demonstrating the effectiveness of this program in improving the nutritional status of participants, only about half of eligible mothers and children are able to enroll.

Any increase in the cost of infant formula means that even fewer eligible mothers will be able to participate.

At issue is a provision of the Childhood Nutrition Reauthorization Act thrown out when the Senate passed the bill last August.

The dropped provision called for USDA, which manages WIC, to make a scientific decision about whether WIC should offer foods that contain new “functional ingredients” like omega-3s, antioxidants, and probiotics.  These are increasingly being added to infant formula, baby food, and other foods that WIC buys.  They cost more.  But do the ingredients really make kids healthier?

To say the least, the science is highly conflicted and most studies show little evidence of demonstrable benefit.

WIC buys 60% of U.S. infant formula, so formula makers are eager to jack up the price.  USDA’s studies say that functional ingredients cost WIC upwards $90 million annually.  Formula makers are spending a fortune to make sure that these ingredients get no scientific scrutiny.

Call this baby food politics, but it matters.

If the most important risk factor for chronic malnutrition is poverty, natural disaster is surely the most important for acute malnutrition.   Nutrition problems created by natural disasters usually can be alleviated by effective government action and, when necessary, international aid.

But the flood disaster in Pakistan is so huge, and affects so many people over such a large area, that it has become an object lesson in the consequences of international disinterest.  What aid has been forthcoming has been slow to arrive and not much of it comes from the United States.

One result is illustrated in today’s Guardian (UK):

Children at roadside shelter, Northwest Pakistan. Photo: Mohammad Sajjad/AP

The photo was forwarded to me by Patty Rundall, policy coordinator of Baby Milk Action.

It was sent to her by UNICEF, which has produced guidelines on infant feeding and a call for appropriate support for feeding young children in Pakistan.  Bottle feeding in unsterile environments is not healthy for infants.

The Washington Post points out that helping to alleviate this disaster is the right thing to do.  But it is also very much in America’s strategic interest.

If strategic interest is what it takes to get our government and others to move on this, let’s use it.

A reporter sent me this message from Christopher Perille, Mead-Johnson’s Vice President – Corporate Communications & Public Affairs, about the company’s Chocolate and Vanilla sweetened Enfagrow toddler formula, advertised with health claims.  It seems only fair to present the company’s defense of its products.  Here’s what he says:

Enfagrow Premium products contain a balanced blend of protein, fat, carbohydrates and other key nutrients, offered in a form designed to be appealing to even the pickiest eaters. These products were introduced in the U.S. to provide additional nutrition as part of a normal healthy diet for toddlers who have been weaned off breast milk or infant formula. While we recognize that each toddler — and his or her eating habits and nutritional needs — are different, they can often have rather narrow palettes and relatively short lists of acceptable foods. My daughter, for one, had an extended period of time during which hot dogs, chicken fingers and french fries were three of her primary food groups. Happily, her tastes eventually expanded, and she is now a healthy and happy sophomore at Washington University in St. Louis — but there was certainly a time when I was concerned whether or not she was getting all the nutrition she needed.

Enfagrow Premium vanilla has been in the marketplace for nearly a year and has elicited numerous positive comments from grateful parents. They have told us that they consider these products an important option for helping to meet their child’s overall nutritional needs, especially those who are picky or erratic eaters, so as to help provide additional assurance that toddlers achieve their recommended nutrient intake.

As we discussed, you were looking at older packaging. The current labeling for Enfagrow Premium vanilla, indicates 17 grams of total sugar, but even that is overstated due to precautionary rounding — the real figure probably falls closer to 15 (14-16). The majority (approximately three-quarters) of the sugar in our product comes from lactose (that is naturally occurring in milk). So while we do add a small amount of sugar (about 4 grams or 1 teaspoon in a 7 fl. oz. serving) to our Enfamil Premium vanilla product to improve the for finicky eaters, the sugar in our flavoring equates to about 15 calories and is less than 2% of a toddler’s daily allowance of calories.

By comparison, the chocolate-flavored version contained less lactose and required more added sugar to overcome the bitterness of cocoa to make it palatable, so the sugar from lactose accounted for just over half the total sugar.

Even with the added 15 calories of sweetness, Enfagrow Premium vanilla has a superior nutritional profile to many other beverages regularly consumed by toddlers – including apple juice, grape juice and similarly flavored dairy drinks.

Enfagrow products also have beneficial ingredients include iron to help support brain growth and antioxidants and other nutrients to help support the immune system. Additionally these products are also a source of Omega-3 DHA and prebiotics, both of which are lacking in milk. Finally, these products exceed whole milk – serving for serving – for important vitamins such as A, B1, B6, C and E.

Enfagrow Premium products – flavored and unflavored – can be part of a balanced diet, which in combination with routine physical activity and an overall healthy lifestyle, can help avoid obesity. In fact, a peer reviewed article published in April 2008 in the Journal of the American Dietetic Association – based on a study of over 7,500 children and adolescents from ages 2 to 18 – found that consumption of either flavored or plain milk is associated with a positive influence on nutrient intakes by children and adolescents. Additionally, consumption of flavored milk was not associated with adverse effects on Body Mass Index (BMI), a commonly used indicator of obesity.

Convinced?  I’ve said all I have to say about these products in previous posts.  You decide.