FDA announced Monday it issued a final rule to add selenium to the list of required nutrients for infant formula and establish both minimum and maximum levels of the element allowed in the products.
According to FDA, US manufacturers began adding selenium to infant formula after the Institute of Medicine recognized selenium to be an essential nutrient for infants in 1989. Currently all infant formulas in the US contain selenium.
By adding selenium to the list and establishing a safe range of use, FDA can require all new and current manufacturers marketing infant formula in the US to add selenium.
The rule requires 2.0 micrograms (μg) selenium/100 kilocalories as the minimum level and 7.0 μg/100 kilocalories as the maximum level of selenium in infant formula. It also amends the labeling requirements for infant formula to require the listing of selenium in micrograms per 100 kilocalories on infant formula labels.