FDA's health claim review: whey-protein partially hydrolyzed infant formula and atopic dermatitis.

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.

A single 60-mg iron dose decreases zinc absorption in lactating women.

This study determined whether a single 60-mg dose of ferrous sulfate interferes with fractional zinc absorption (FZA) at 7-9 wk of lactation. In a crossover design, 5 exclusively breast-feeding women were given either a single 60-mg iron supplement or no supplement. FZA was measured by analyzing zinc stable isotope tracers ((70)Zn and (67)Zn) in urine samples collected for 7 d after isotope dosing. A 0.7-micromol intravenous (IV) infusion of (70)Zn as ZnCl(2) in saline was followed by a 0.03-mmol oral dose of (67)Zn as ZnCl(2) given with a standardized meal. After a 7-d wash-out period, the supplement given was reversed and a second FZA measurement was taken. FZA was calculated from isotopic enrichments in urine measured by inductively coupled plasma mass spectrometry. Hemoglobin, plasma ferritin and transferrin receptor, and plasma 5'-nucleotidase, plasma zinc and erythrocyte zinc did not differ before the two measurements of zinc absorption. When women were given a single iron supplement, FZA was significantly lower, 21.7 +/- 1.7% compared with 26.9 +/- 2.6% when no supplement was given (P = 0.032). A single 60-mg iron dose significantly decreases FZA during early lactation.