FDA’s Health Claim Review: Whey-protein Partially Hydrolyzed Infant Formula and Atopic Dermatitis

Abstract

In this review, we explain how the US Food and Drug Administration (FDA) used its evidence-based review system to evaluate the scientific evidence for a qualified health claim for 100% whey-protein partially hydrolyzed infant formula (W-PHF) and reduced risk of atopic dermatitis (AD). The labeling of health claims, including qualified health claims, on conventional foods and dietary supplements require premarket approval by the FDA. Health claims characterize the relationship between a substance (food or food component) and disease (eg, cancer or cardiovascular disease) or health-related condition (eg, hypertension). To determine whether sufficient evidence exists to support the qualified health claim, the FDA evaluated human intervention studies that evaluated the role of W-PHF in reducing the risk of AD. The FDA concluded there is little to very little evidence, respectively, to support a qualified health claim concerning the relationship between intake of W-PHF and a reduced risk of AD in partially breastfed and exclusively formula-fed infants throughout the first year after birth and up to 3 years of age. In addition, the FDA required a warning statement be displayed along with the health claim to indicate to consumers that partially hydrolyzed infant formulas are not hypoallergenic and should not be fed to infants who are allergic to milk or to infants with existing milk allergy symptoms.