Background: Zinc plays an important role in antioxidant defense and the maintenance of cellular DNA integrity. However, no experimental human studies have been performed to examine the role of zinc status on DNA damage. Objective: We evaluated the effects of dietary zinc depletion and repletion on DNA strand breaks, oxidative stress, and antioxidant defenses in healthy men. Design: Nine healthy men with reported mean daily zinc intakes .11 mg/d were recruited. Subjects completed 3 consecutive dietary periods: baseline (days 1 to 13; 11 mg Zn/d), zinc depletion (days 14 to 55; 0.6 mg Zn/d for 1 wk and 4 mg Zn/d for 5 wk), and zinc repletion (days 56 to 83; 11 mg Zn/d for 4 wk with 20 mg supplemental Zn for first 7 d). Blood samples were collected on days 1, 13, 35, 55, and 83. DNA damage in peripheral blood cells, plasma oxidative stress, and antioxidant defense biomarkers were assessed. Results: Dietary zinc depletion (6 wk) was associated with increased DNA strand breaks in peripheral blood cells (day 13 compared with day 55; P , 0.05), changes that were ameliorated by zinc repletion (day 55 compared with day 83; P , 0.05). Plasma zinc concentrations were negatively correlated with DNA strand breaks (r = 20.60, P = 0.006) during the zinc-depletion period. Plasma a-and c-tocopherol concentrations, plasma total antioxidant capacity, and erythrocyte superoxide dismutase activity did not change significantly, and plasma F 2 -isoprostanes were unaffected by dietary period. Conclusions: Changes in dietary zinc intake affected DNA singlestrand breaks. Zinc appears to be a critical factor for maintaining DNA integrity in humans.

FZA was inversely related to current zinc intake, but there was no detectable effect of longer-term dietary zinc. If longer- term zinc intake does modify FZA, such changes are smaller than those caused by current zinc intake, or they occur only after more severe zinc depletion.

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.