FDA Issues Final Rule On Adding Selenium To Infant Formula

On June 22, 2015, FDA announced a final rule to add selenium to the list of required nutrients for infant formula and to establish both minimum and maximum levels of selenium in infant formula. Among other benefits, selenium helps the body defend against oxidative stress and aids the regulation of thyroid hormones. Manufacturers in the United States have been adding selenium to infant formula since 1989, after the Institute of Medicine recognized the nutrient, found in breast milk, as essential for infants. All infant formulas sold today in the United States contain selenium. The final rule requires a selenium range between 2.0 micrograms selenium/100 kilocalories and 7.0 micrograms selenium/100/kilocalories and amends the labeling requirements for infant formula to require the listing of selenium in micrograms per 100 kilocalories on the formula labels. Under the final rule, FDA requires manufacturers to add the nutrient within this range of safety, as well as