FDA Proposes Requirements for Selenium in Infant Formula

The Food and Drug Administration (FDA) has issued a proposed rule that would add selenium to the list of nutrients required in infant formula as well as establish minimum and maximum levels for the mineral in this context. Under the proposed rule, which recognizes selenium as an essential nutrient, infant formula labels would also need to list the amount per 100 kilocalories of formula.

According to FDA, the selenium content of soil varies widely by geographic region, leading to either chronic selenium toxicity or dietary deficiencies that can result in diseases such as cardiomyopathy. Recognizing that formula “is intended to be the sole source of nutrition for infants,” FDA has proposed “2.0 µm selenium/100 kcal as the minimum level for selenium in infant formulas and 7.0 µm selenium/100 kcal as the maximum level.” The agency will accept comments on the proposed rule until July 1, 2013. See Federal Register, April 16, 2013.