Jun 12 2010

Mead-Johnson defends Vanilla Enfagrow

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.

Jul 29 2010

Breastfeeding in the news

The Berkeley Media Studies Group has just released a “Framing Brief” with “how-to” advice for breastfeeding advocates.  The Brief argues that babies’ health is not a sufficient reason to get moms to breastfeed.

Instead, advocates need to help create environments that support breastfeeding.

This  and a previous report on breastfeeding issues, “Talking about Breastfeeding,” were commissioned by the California WIC Association with support from The California Endowment.

That these reports come none too soon is evident from a recent commentary that the International Code of Marketing of Breastmilk Substitutes (“the Code”) has become ineffectual.

The Code is an international agreement about what infant formula companies can and cannot ethically do to promote their products, based on substantial research that infant formula marketing undermines breastfeeding.

According to the study in the Archives of Diseases of Children, the Code has become

mired by a series of alleged violations and boycotts, which are counter productive to the code’s goal….[These include an] unrelenting series of disputes, predominantly relating to alleged violations of the code, which have provoked high profile acrimonious exchanges, boycotts and legal proceedings…[leading] to an atmosphere of mistrust that has now become embedded between key agencies.

The author focuses on disputes between the non-governmental group Baby Milk Action and infant formula manufacturer Nestlé (no relation).  He recommends that an  “ombudsman” or some other independent body be given authority “to arbitrate and ensure that actions taken by respective parties are in keeping with the spirit of the code.”

This is not a bad idea—if the body is truly independent. Take a look at the Baby Milk Action website and judge for yourself whether you think the group makes a compelling case for Code violations.  Some of them seem pretty obvious to me.

As I recount in Food Politics, infant formula companies have a long pre-Code history of putting sales before infant health.  Almost everyone I know thinks the situation has improved post-Code, but not nearly enough.

As I explain in What to Eat, formula companies have a business-model problem: there are only so many infants born each year and they only use formula for a limited time.

The companies only have two choices for growth: recruit more babies onto formula or extend the period of formula feeding.  The first strategy was well documented pre-Code and continues to be documented.  The second is illustrated by the now withdrawn product, chocolate toddler formula Enfagrow (see previous posts).

Breastfeeding advocates: read the new reports and get busy!

Update, July 31: Patty Rundall of Baby Milk Action has written a rebuttal to the commentary.  Other ideas?  You can forward them to her at prundall@babymilkaction.org.

Jun 11 2010

Health claims: Should the First Amendment protect bad science?

I keep complaining about the health claims on Enfagrow toddler formula, a sugary product aimed at children from ages one to three:

These claims, for the uninitiated, are a special kind called structure-function.  Congress authorized such claims when it passed the Dietary Supplement Health and Education Act (DSHEA) in 1994.

Structure-function claims do not say that the product can prevent or treat disease. They merely suggest that the product can help in some unspecified way with some structure or function of the body.

When Congress passed DSHEA, it meant the claims to apply to dietary supplements, not foods. Enfagrow is marketed as a food, not a supplement.  It displays a Nutrition Facts label, not a Supplement Facts label.

Over the years, the FDA has issued cease-and-desist warnings about foods that bear structure-function claims.  In recent years, it has simply stated that manufacturers are responsible for ensuring that the claims are “truthful and not misleading.”

One reason for the shift is what the Courts have ruled.  The Courts say that structure-function claims are protected by First Amendment guarantees of free speech.  The most recent case is Alliance for Natural Health USA v. Sebelius. As described in Food Chemical News (June 7), a D.C. District Court judge ruled that the FDA cannot deny health claims that link selenium supplements to reduced risk of several diseases, or require those claims to be qualified, just because the claims lack adequate scientific substantiation.

In other words, supplement makers can say anything they want to about the benefits of their products—on the grounds of free commercial speech—whether or not science backs up the claim.

Recently, the FDA issued a warning letter to Nestlé, the maker of a Juicy Juice product aimed at toddlers, which displays a claim that its content of added omega-3 DHA improves brain development.  The FDA did not take on the claim, even though research seems unlikely to find that such drinks have any special benefits for brain development.  Instead, the FDA focused on a technicality:

The product makes claims such as “no sugar added,” which are not allowed on products intended for children under 2 yrs of age because appropriate dietary levels have not been established for children in this age range.

I’m guessing—this is speculation—that the FDA is reluctant to take on Enfagrow’s brain or immunity claims because Mead-Johnson has deep pockets and might well be willing to fight this one in court as a First Amendment case.

I am not a lawyer but I thought that intent mattered in legal cases.  Surely, the intent of the founding fathers in creating the First Amendment was to protect the right of individual citizens to speak freely about their political and religious beliefs.  Surely, their intent had nothing to do with protecting the rights of supplement, food, and drug corporations to claim benefits for unproven remedies, or to promote sales of sugary foods to babies.

I think it is time to give these First Amendment issues some serious thought.  How about:

  • FDA: Fire those lawyers and hire some who will protect the FDA’s ability to use science in its decisions.
  • FTC: Take a look a the immunity claim on the Enfagrow Vanilla toddler formula, now that the Chocolate is off the market.
  • Legal scholars: Surely there are ways to protect real First Amendment rights while restricting unsubstantiated health claims?

Other ideas are most welcome.  Your thoughts?

Jun 10 2010

Mead-Johnson withdraws Chocolate toddler formula: Meaningful or just PR?

Mead Johnson announced yesterday that it was withdrawing its Enfagrow Chocolate Toddler Formula–just the Chocolate version–from the market:

Like all our Enfagrow Premium products, the recently introduced chocolate-flavored version has a superior nutritional profile to many other beverages typically consumed by toddlers — including apple juice, grape juice, and similarly flavored dairy drinks. Unfortunately, there has been some misunderstanding and mischaracterization regarding the intended consumer for this product and the proper role it can play in a child’s balanced diet. The resulting debate has distracted attention from the overall benefits of the brand, so we have decided to discontinue production of Enfagrow Premium chocolate toddler drink and phase it out over the coming weeks.

I can’t resist quoting the Chicago Tribune’s explanation of the origin of the debate caused by “misunderstanding and mischaracterization:”

Introduced in February, the chocolate-flavored formula was widely criticized in the blogosphere after Marion Nestle, professor of nutrition, food studies and public health at New York University, wrote that the drink would lead children to crave sugary beverages on her influential blog, www.foodpolitics.com.

Influential?  Maybe, but it seems that my comments on this formula did not go nearly far enough.  Mead-Johnson may be withdrawing the Chocolate version, but it is keeping the Vanilla (as explained by Susan James on ABCNews.com, which also quotes me).

What’s the difference?  The Vanilla has exactly one gram less sugar than the Chocolate, 18 grams per 6-ounce serving, rather than 19 grams.  In contrast, the milk in my refrigerator has 9 grams of sugar (natural, not added) in 6 ounces.

Clearly, Mead-Johnson doesn’t get that it’s the sugars, stupid.

Why do I think this is a PR stunt?  Three reasons:

  • The Vanilla doubles the sugars in regular milk.
  • The Vanilla has the same health claims as the Chocolate: growth, brain development, and immunity.
  • Mead-Johnson’s stock went up after the announcement.

One more time: Where are the FDA and FTC on this product?  This Immunity claim is no different from the one on Kellogg’s Krispies cereals that the FTC went after a couple of days ago.

Tomorrow: Some speculation on why the FDA is reluctant to take on things like this.

Addition, June 11: Here is Melanie Warner’s take on this on her BNet Food Industry blog site (she quotes my post).

May 12 2010

IOM wants just as rigorous science for food claims as for drugs

Buried in an Institute of Medicine report released today on, of all things, “biomarkers and surrogate endpoints in chronic disease” are some truly astonishing recommendations:

Rec. 3: The FDA should use the same degree of scientific rigor for evaluation of biomarkers across regulatory areas, whether they’re proposed for use in the arenas of drugs, medical devices, biologics, or foods and dietary supplements.

Rec. 4: The FDA should take into account a nutrient’s or food’s source as well as any modifying effects of the food or supplement that serves as the delivery vehicle and the dietary patterns associated with consumption of the nutrient or food when reviewing health-related label claims and the safety of food and supplements.

Translation: The FDA should require the same level of scientific substantiation for health claims as for pharmaceutical drugs, and not assume that a supplement has the same health effect as a food or diet.

As the press release states:

The FDA should apply the same rigor to evaluating the science behind claims of foods’ and nutritional supplements’ health benefits as it devotes to assessing medication and medical technology approvals…There are no scientific grounds for using different standards of evidence when evaluating the health benefits of food ingredients and drugs given that both can have significant impacts on people’s well-being.

The committee set out to recommend scientific criteria for evaluating the types of scientific data that companies use to convince the FDA to allow health and safety claims.  Food claims got tossed into the mix. 

The impact of these recommendations could be considerable.  The IOM is saying that health claims need to have rigorous science to back them up, not least because the kinds of claims now used to market foods do not come close to meeting those criteria.

Here’s what the Wall Street Journal has to say about this report (it quotes me).

How right they are, as witnessed by the health claims on chocolate-flavored, sugar-sweetened Enfagrow.

Apr 26 2010

Chocolate toddler formula?

Mead-Johnson, the company that prides itself on its “decades-long patterning of infant formulas after breast milk,” now goes one better.  It sells chocolate- and vanilla-flavored formulas for toddlers, fortified with nutrients, omega-3s, and antioxidants.

The company’s philosophy: Your toddler won’t drink milk?  Try chocolate milk!

The unflavored version of this product, Enfagrow, has been around for a while.  In 2005, nutritionists complained about this formula because it so evidently competed with milk as a weaning food.  Mead-Johnson representatives explained that Enfagrow is not meant as an infant formula.  It is meant as a dietary supplement for toddlers aged 12 to 36 months.

Really?  Then how come it is labeled “Toddler Formula”?

And how come it has a Nutrition Facts label, not a Supplement Facts label?

Here’s the list of ingredients for everything present at a level of 2% or more:

  • Whole milk
  • Nonfat milk
  • Sugar
  • Cocoa
  • Galactooligosaccharides (prebiotic fiber)
  • High oleic sunflower oil
  • Maltodextrin

I bought this product at Babies-R-Us in Manhattan.  It’s not cheap: $18.99 for 29 ounces.  The can is supposed to make 22 servings (one-quarter cup of powder mixed with 6 ounces water).  At that price, you pay 86 cents for only six ounces of unnecessarily fortified milk plus unnecessary sugar and chocolate.

No wonder Jamie Oliver encountered so much grief about trying to get sweetened, flavored milks out of schools.

But really, aren’t you worried that your baby might be suffering from a chocolate deficit problem?  Don’t you love the idea of year-old infants drinking sugar-sweetened chocolate milk?  And laced with “omega-3s for brain development, 25 nutrients for healthy growth, and prebiotics to support the immune system”?

Next: let’s genetically modify moms to produce chocolate breast milk!

FDA: this package has front-of-package health claims clearly aimed at babies under the age of two.  Uh oh.  Shouldn’t you be sending out one of those package label warning letters to Mead-Johnson on this one?

Addition, May 1: in response to interest in what other products are made by Mead-Johnson, or its parent, the drug company Bristol-Myers Squibb, I’ve linked their names to product pages.

Addition, May 6: Julie Wernau of the Chicago Tribune did a front page (business section) story on this and is following up on it in her blog.