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CFSAN Constituent Update - Final Rule on Infant Formula

 

Center for Food Safety and Applied Nutrition - Constituent Update
http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/default.htm


FDA Issues Final Rule to Add Selenium to List of Required Nutrients for Infant Formula

June 22, 2015

The U. S. Food and Drug Administration today 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.

U.S. manufacturers began adding selenium to infant formula after the Institute of Medicine recognized selenium to be an essential nutrient for infants in 1989, and currently, all infant formulas on the U.S. market contain selenium. By amending regulations to add selenium to the list of required nutrients for infant formula and establish a safe range for this use, the FDA is able to require manufacturers currently marketing infant formula in the U.S. to add selenium within this safe range, and to require any manufacturer newly entering the U.S. market to adopt this practice as well.

Specifically, 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.

Selenium, found in breast milk, is an essential nutrient for infants. Among its benefits, it helps the body defend against oxidative stress and aids in the regulation of thyroid hormones. Because infant formula often serves as a sole source of nutrition for infants, selenium in infant formula is needed to ensure that formula-fed infants are getting this essential nutrient at appropriate levels. Selenium is the 30th nutrient required by law to be in infant formula.

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