Frequently Asked Questions

Health Claim

Exactly what is a health claim (HC) and what is a Qualified Health Claim (QHC)?

Health claims (HC) are part of an FDA initiative to provide Americans with information to help them make healthier dietary choices. A HC “characterize[s] a relationship between a substance and its role in reducing the risk of a disease or health-related condition.” Usually, a HC is visible to consumers as a benefit statement on the product label. A QHC is one which such a benefit statement must include qualifying language indicating any limitations on the degree to which the science supports the claim.

Why did Nestlé petition the FDA for a Qualified Health Claim (QHC)?

Nestlé Infant Nutrition filed a petition with the FDA for a QHC in order to be able to communicate to consumers the science supporting the relationship between 100% whey protein partially hydrolyzed infant formula (PHF-W) and risk reduction of atopic dermatitis (AD).

How does the FDA evaluate a Qualified Health Claim (QHC)?

In a Qualified Health Claim (QHC) petition the FDA qualifies the level of strength and the certainty of the relationship between a substance (100% whey-protein partially hydrolyzed infant formula) and a disease (atopic dermatitis). 

Then the FDA determines the ranking that reflects the agency’s level of comfort with the science regarding the relationship of the substance and disease. Examples of these rankings for previously granted food / disease related QHCs include “Highly unlikely evidence”, “very limited and not conclusive evidence”, “Very limited and preliminary”, “Limited but not conclusive”. Based on the totality of the scientific evidence, FDA determines whether such evidence is credible to support the substance / disease relationship.

What does the Qualified Health Claim (QHC) authorized for use with 100% whey protein partially hydrolyzed infant formula (PHF-W) say?

The QHC authorized for use for PHF-W by the FDA is as follows: 

“Breastfeeding is the best way to nourish infants. 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

Partially hydrolyzed formulas should not be fed to infants who are allergic to milk or to infants with existing milk allergy symptoms. If you suspect your baby is already allergic to milk, or if your baby is on a special formula for the treatment of allergy, your baby’s care and feeding choices should be under a doctor’s supervision.”

Did the FDA provide more than one option for language of the Qualified Health Claim (QHC)?

Yes. The FDA provided 4 different claim options in response to Nestlé’s petition that are authorized for use. The language is captured below, and the FDA intends to consider the exercise of its enforcement discretion for the following Qualified Health Claims:
  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.
Inclusion of the following language with any of the above Qualified Health Claims is required (including bolding the noted words): 

Partially hydrolyzed formulas should not be fed to infants who are allergic to milk or to infants with existing milk allergy symptoms. If you suspect your baby is already allergic to milk, or if your baby is on a special formula for the treatment of allergy, your baby's care and feeding choices should be under a doctor's supervision." 

Additionally the FDA does not object to the placement of the phrase “Breastfeeding is the best way to nourish infants” at the start of the claim, but it is not part of the Qualified Health Claim.

What is the scientific evidence that Nestlé submitted as support for a Qualified Health Claim (QHC)?

Nestlé submitted 18 publications of 12 cohorts to support its petition for a QHC. The FDA concluded that the current scientific evidence is appropriate for consideration of a Qualified Health Claim regarding the relationship between the consumption of 100% whey protein, partially hydrolyzed infant formula and a reduced risk of atopic dermatitis.

Is there any other evidence that looks at 100% whey protein partially hydrolyzed infant formula (PHF-W) compared to intact protein cow’s milk formula (CMF), and a reduced risk of atopic dermatitis (AD)?

The role of PHF-W in reducing the risk of developing AD in formula-fed infants is backed by a number randomized controlled clinical trials, including the German Infant Nutritional Intervention (GINI) studies (von Berg 2003, 2007, 2008), two meta-analyses done in 2010 (Alexander and Cabana 2010, Szajewska 2010), and two reviews (Hays 2005 and Alexander 2010). Additionally, leading allergy and pediatric organizations, including the American Academy of Allergy Asthma and Immunology (AAAAI), the National Institute of Allergy and Infectious Diseases (NIAID) and the American Academy of Pediatrics (AAP) have affirmed the potential role of certain hydrolyzed protein infant formulas in helping reduce the risk of developing AD, particularly in infants with a family history of allergy. This body of scientific evidence and expert opinion indicate that it is possible to reduce the risk of developing the most common allergic disease in infancy, AD, by feeding either PHF-W or extensively hydrolyzed casein (EHF-C) instead of formulas made with intact cow’s milk protein when used as a supplement or substitute for breastmilk.

What scientific evidence supported the FDA’s decision to authorize the use of this Qualified Health Claim (QHC)?

In evaluating the specific language of the QHC petitioned by Nestlé, FDA considered a number of clinical studies but relied on findings from two studies (von Berg 2003, 2007; Chan 2002) in issuing the QHC decision.

Was this scientific work funded by Nestlé?

Although some of the studies supporting the petition were funded by Nestlé, others – most notably the German Infant Nutritional Intervention (GINI) study (von Berg 2003, 2007, 2008) – were not. The GINI study was funded by the German government and is the largest independent study ever conducted with a focus on reducing the risk of allergy manifestations, including atopic dermatitis.

Didn’t Nestlé submit a petition for this same health claim in 2005 and wasn’t it rejected by the FDA?

The petition that Nestlé submitted in 2005 was different than the petition submitted in 2009. The FDA rejected the 2005 petition because they interpreted the language used in the submission as a claim to reduce the risk of “food allergy”, which is different than intended. The disease in question is atopic dermatitis, not “food allergy”.

What is atopic dermatitis (AD) and how prevalent is it in infancy?

Atopic dermatitis, a form of eczema, is a persistent, itchy, red skin rash that is the most common allergic disease in infants. In the U.S., nearly one in five infants will develop atopic dermatitis.

Will the Qualified Health Claim (QHC) authorized by the FDA for 100% whey protein partially hydrolyzed infant formula (PHF-W) be applicable to your entire Gerber® Good Start® line of infant formula?

The claim applies to routine, starter milk-based formulas, Gerber® Ggood Start®Gentle and Gerber® Good Start® Gentle for Supplementing, which are made with PHF-W. These formulas are the only PHF-W available for routine use, and are the only infant formulas that meet the criteria of a QHC. This is the first time a routine infant formula has been able to make a QHC.

Is Gerber® Good Start® the only formula that can make a Qualified Health Claim (QHC)?

Yes. In fact, Gerber® Good Start® is the first and only routine infant formula that meets the criteria for a Qualified Health Claim.

Can other infant formula products use this Qualified Health Claim (QHC) authorized for use with 100% whey protein partially hydrolyzed infant formula (PHF-W)?

No. Gerber® Good Start® milk-based formulas are the first and only routine infant formulas that meet the criteria to make this QHC. The FDA has authorized the use of this QHC for PHF-W. GERBER® GOOD START® milk based-formulas are the only infant formulas that are PHF-W.

How is Gerber® Good Start® different from hypoallergenic formulas?

Gerber® Good Start® infant formula is not for the treatment of infants with a known allergy. Only extensively hydrolyzed or amino acid formulas – which are classified in the U.S. as “hypoallergenic” -- should be recommended for the treatment of known allergic disorders.

How are Gerber® Good Start® Gentle for Supplementing and Gerber® Good Start® Gentle different from other partially hydrolyzed infant formulas?

Gerber® Good Start® Gentle for Supplementing and Gerber® Good Start® Gentle are the first and only 100% whey protein, partially hydrolyzed formulas available in the United States. Other partially hydrolyzed infant formulas, currently available in the U.S. have a whey/casein blend, partially hydrolyzed formula. Gerber’s 100% whey protein partially hydrolyzed formulas are the only routine infant formulas that meet the criteria for the for the Qualified Health Claim authorized by the FDA for use in infant formula.

Is atopic dermatitis a disease?

Yes, it is the most common disease of infancy.

Can Gerber® Good Start® milk-based formulas prevent a child from developing atopic dermatitis?

No. Risk for atopic dermatitis is affected by several factors, including family history of allergy. There are steps you can take to help reduce the risk, such as breastfeeding. Or, if not exclusively breastfeeding, initiating formula feeding with a 100% whey protein partially hydrolyzed infant formula may also provide a benefit as provided for in the FDA Qualified Health Claim.

If a baby suffers from atopic dermatitis, will Gerber® Good Start® milk-based formulas cure this condition?

No. Gerber® Good Start® milk-based formulas should not be used for treatment or for feeding infants with allergies. They will not cure or prevent atopic dermatitis.

Will introducing a Gerber® Good Start® routine milk-based formula, after exclusively breastfeeding, have less of an effect on the development of atopic dermatitis than if another formula had been chosen?

Exclusive breastfeeding is the best way to minimize the risk of allergies because the proteins in a mother’s milk are generally not allergenic to her own infant. For infants who are not exclusively breastfed, Gerber® Good Start® milk-based formulas are the only 100% whey protein partially hydrolyzed formulas in the U.S.

What formula should be used if a baby already has allergies?

If you suspect your baby has an allergy or has been diagnosed with an allergy, parents should work with baby’s doctor to determine the best course of treatment. Gerber® Good Start® milk-based formulas should not be fed to infants who are allergic to milk or infants with existing milk allergy symptoms.
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