What does hypoallergenic mean with regard to infant formula?
In the United States, the term “hypoallergenic” with respect to infant formulas now refers specifically to those formulas – such as extensively hydrolyzed and amino acid-based formulas – that are used for the treatment of known allergic disorders. In the rest of the world, the term hypoallergenic has a broader meaning, and includes formulas used for prevention.20 According to the American Academy of Pediatrics guidelines, first published in 1990, “hypoallergenic formulas must demonstrate in clinical studies that they do not provoke reactions in 90% of infants or children with confirmed cow’s milk allergy with 95% confidence when given in prospective randomized, double-blind, placebo-controlled trials. Extensively hydrolyzed and free amino acid-based formulas have been subjected to such studies and are considered to be hypoallergenic.