Background: We sought to determine whether an extensively hydrolyzed formula (EHF) supplemented with two human milk oligosaccharides (HMO) was tolerated by infants with cow’s milk protein allergy (CMPA). Methods: A whey-based EHF (Test formula) containing 2′fucosyl-lactose (2′FL) and lacto-N-neotetraose (LNnT) was assessed for clinical hypoallergenicity and safety. The Control formula was a currently marketed EHF without HMO. Children with CMPA, aged 2 months to 4 years, were assessed by double-blind, placebo-controlled food challenges (DBPCFC) to both formulas, in randomized order. If both DBPCFC were negative, subjects participated in a one-week, open food challenge (OFC) with the Test formula. Symptoms and adverse events were recorded. Hypoallergenicity was accepted if at least 90% (with 95% confidence intervals) of subjects tolerated the Test formula. Results: Of the 82 children with CMPA that were screened, 67 (intention-to-treat [ITT] cohort—mean age 24.5 ± 13.6 months; range 2–57; 45 [67.2%] male) were randomized to receive either the Test or the Control formula during the first DBPCFC. Of these, 64 children completed at least one DBPCFC (modified intention-to-treat [mITT] cohort). Three children were excluded due to protocol deviations (per protocol [PP] cohort; n = 61). There was one allergic reaction to the Test, and one to the Control formula. On the mITT analysis, 63 out of 64 (98.4%; 95% CI lower bound 92.8%), and on the PP analysis 60 out of 61 (98.4%; 95% CI lower bound 92.5%) participants tolerated the Test formula, confirming hypoallergenicity. Conclusion: The whey-based EHF supplemented with 2′FL and LNnT met the clinical hypoallergenicity criteria and can be recommended for the management of CMPA in infants and young children.

Background: Fruits and vegetables are key to a healthy diet, particularly in children; however, parents may be concerned about contaminants found in fruits and vegetables. Making informed food choices for children requires understanding and balancing the risks of contaminant exposure with the importance of providing a healthy diet. The objective of this work is to identify fruits and vegetables commonly consumed by infants and toddlers; identify potential contaminants in fruits and vegetables; and outline considerations in assessing contaminant risks in food categories with a critical role in a healthy diet. Method: Commonly consumed fruits and vegetables were obtained from the Feeding Infants & Toddlers Study (FITS 2016). The US Food and Drug Administration Total Diet Study was reviewed for contaminant occurrence, and multiple experts were consulted on considerations in assessing risk of certain contaminants. Results: FITS data show eight fruits and nine vegetables account for over 80% of consumption in infants and toddlers. Several contaminants have been detected in fruits and vegetables. Questions to be addressed prior to establishing contaminant guidance were identified. Conclusion: Contaminant guidance for fruits and vegetables consumed by infants and toddlers raises several challenges. Expertise from multiple disciplines is required to find an approach that maximizes public health benefit.