First-ever Qualified Health Claim for infant formula

The FDA acknowledges a potential link between infant nutrition choices and atopic dermatitis

Atopic dermatitis (AD) is one of the most common chronic skin diseases in children. Nearly 1 in 5 infants develops AD by 6 months of age, and prevalence has increased 2- to 3-fold over the past 30 years. 

Based on the evidence that 100% whey protein partially hydrolyzed infant formula (100% PHF-W) may reduce the risk of AD in some infants, Nestlé petitioned the US Food and Drug Administration (FDA) to allow a Qualified Health Claim (QHC). 

On May 24, 2011, the FDA concluded that the current scientific evidence was sufficient to consider a QHC. The claim is worded as follows:

“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 first year of life. 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. 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.” 

Frequently asked questions about the Qualified Health Claim

Read the press release from Gerber about the Qualified Health Claim

More about allergy and the Qualified Health Claim

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See how our unique hydrolysis process may help reduce allergy risk.

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Key studies on which the FDA based its conclusions.

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Learn more about infant feeding and allergy.

Feeding choices matter

Gerber recommends breastfeeding as the ideal nutrition for babies

  • Gerber recommends breastfeeding as the best start for babies. The Gerber® Start Healthy, Stay Healthy™ Nutrition System starts with breastfeeding education and is followed by developmentally and nutritionally appropriate, stage-based feeding choices

When considering breastfeeding alternatives, recommend GERBER® GOOD START® milk-based, term-infant formulas:

  • Made with 100% whey proteins partially broken down with our unique hydrolysis process
  • Meets the criteria for a Qualified Health Claim
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