Executive Summary

FDA should require a warning on infant formulas that contain DHA and ARA from algal and fungal sources to alert parents of the potential for adverse reactions to the formulas, the Cornucopia Institute and the National Alliance for Breastfeeding Advocacy state in Jan. 24 comments to the agency. Labeling should state that the ingredients "have been linked to diarrhea, bloating, vomiting, and other gastrointestinal problems in some infants," the groups say. Additionally, labeling should instruct parents to "discontinue usage and seek medical help if your infant reacts adversely" and if "symptoms do not immediately [resolve] upon switching to [an] alternative formula without DHA/ARA oils," they add. The groups state that 98 adverse reaction reports submitted to FDA's MedWatch program can "reasonably be linked to DHA and ARA oils in infant formula" and say the scientific community disagrees about the benefits of the ingredients in infant formula. Failure to warn parents about these ingredients, they add, violates the Federal Food, Drug and Cosmetics Act...