Since 2011, Gerber Products Co., who has also done business as Nestlé Nutrition, has been claiming that its Good Start Gentleinfant formula can prevent or reduce the risk that baby will develop allergies. The Good Start formula uses partially hydrolyzed whey proteins, which the company claims are easier to digest than regular cow’s milk proteins.
Since one or more of the protein fractions in whey protein, one of the two proteins in milk, are typically responsible for milk protein allergies, it is possible breaking down these fractions could prevent allergic reactions in those sensitive to these particular proteins. One way to do this would be to use hydrolyzed whey protein made to specific standards. I am not aware of the particulars of Gerber’s whey protein, and whether their claims are based this, but you can think of “hydrolyzed whey protein” as something like “partially predigested whey protein.” Hydrolyzed whey protein is often claimed to be easier to digest.
The company said that using this formula, instead of formulas made with “intact cow’s milk proteins” will protect against allergies. Since there is no scientific basis for these claims, the FTC has charged Gerber for deceptive advertising. As if these false claims weren’t enough, says the FTC, the company also included a gold seal stating that the product was the first and only one to meet an FDA qualified health claim.
Ads for the product stated such things as “You want him to have your smile, not your allergies,” and “I love Mommy’s eyes, not her allergies.” These claims specifically are stating that the Good Start Gentle Formula will prevent your child from developing your particular allergies.
Some other ads stated: “”If you have allergies in your family, breastfeeding your baby can help reduce their risk. And if you decide to introduce formula, research shows the formula you first provide your baby may make a difference. In the case of Gerber Good Start Gentle Formula, it’s the Comfort Proteins Advantage that is easy to digest and may also deliver protective benefits.”
These ads seem to imply that using a specific formula will protect children from any and all allergies, not just food allergies. After all, when we think of allergies, most of us think of hay fever and specific food allergies, not just, for example, dairy allergies.
Gerber, in 2005, had petitioned the FDA for approval to make a health claim that stated the relationship between whey-based formula and the reduced risks of later food allergies in kids. The FDA decided that there was no credible evidence to support such a claim. Gerber persisted, asking in 2009 for permission to say that “emerging clinical research” shows whey-based formula may reduce the risk of atopic dermatitis, or eczema.
The claims that Gerber wanted to make concerning atopic dermatitis had to do with purported evidence showing a positive association between breastfeeding and eczema. For example, in two British cohort studies done in 1958 and 1970, results indicated that the longer the child was breastfed, the more likely they would not be reported as having eczema later on. However, and earlier 1946 studied show no such relationship.
More recent studies have shown no effect of breastfeeding, or even an increased risk with prolonged breastfeeding. it is true that among children with atopic dermatitis, there is an increase in sensitivity to cow’s milk, eggs, nuts, and wheat. These children with food allergies may tend to manifest their allergies as atopic dermatitis early in life. Theoretically, introducing certain foods into a child’s diet after weaning from breastfeeding may increase their risk of developing food allergies and so atopic dermatitis (eczema).
There is little evidence that specifically shows the role of early childhood nutrition and later development of eczema, however. The Gerber claims conflate the limited evidence from breastfeeding and the connection between food allergies to cow’s milk and dermatitis, and a possibility that introduction to cow’s milk early in life may trigger eczema in those children who are susceptible. Since Gerber’s formula does not use “intact milk proteins,” they are basically saying that this is preventing dermatitis.
Furthermore, ads specifically compared the formula to breastfeeding. Since all of the evidence is scanty, and since avoiding cow’s milk early on can in now way be said to completely abolish the risk of childhood atopic dermatitis, or later development of the condition, Gerber had no real scientific basis on which to rest these claims.
The ad below shows this comparison between breastfeeding and the Gerber Good Start formula. It states that breastfeeding helps reduce the risk of eczema, a claim that itself is far from credible. Then, it says that “now there is a formula that can help too, especially for those babies with a family history of allergies.” Notice that no mention of specific allergies are made. Also notice the small print, which says that Gerber Good Start should not be fed to infants who are allergic to milk or infants with existing milk allergy symptoms.
The FDA refused this petition as well, but told Gerber that it let a very narrow statement slide. This type of more narrow statement is sometimes called a “qualified health claim.” It basically means that the claim is ‘qualified’ with a statement explaining that there is little evidence. In this case, the FDA was saying that Gerber could make a claim about a relationship between whey-based formula and less risk for atopic dermatitis, if they also said, clearly, that “there is little scientific evidence” for this relationship. In other words, you can say it, as long as you then say you don’t have much basis for saying it.
Gerber took this ball and forgot to dribble, turning FDA’s approval of a ‘qualified health claim’ in to a Gold Badge, shown above, proclaiming the formula to be the one and only such formula to meet a qualified health claim. This was deceptive language, according to the FTC (I agree), since using the words “qualified health claim” would make it seem to most consumers that the product had been ‘qualified by the FDA to make the claim.’ In other words, the language makes it appear as if Good Start Gentle met FDA’s approval for a health claim. The Gold Badge on labels did not even state anything about atopic dermatitis, let alone a lack of scientific evidence. Other advertisements also made similar claim about an FDA qualified health claim, such as the banner below.
Based on deceptive advertising claims and the claims concerning the FDA, the Federal Trade Commission filed suit against Gerber, on Octover 29, 2014, in the U.S. District Court for the District of New Jersey. You can read the FTC’s press release on this case here.