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FDA Finalizes Rule on the Selenium Used for Infant Formula

July 27, 2015

The US Food and Drug Administration (FDA) has issued a final rule for the selenium used for infant formula, adding selenium to the list of required nutrients for infant formula and establishing minimum and maximum levels for the nutrient. Selenium is an essential nutrient found in breast milk. The said nutrient for infants helps the body to defend against oxidative stress and aids in the regulation of thyroid hormones.

The final rule requires current manufacturers of infant formula to add selenium into their product given the limits of 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. The final rule also requires listing of selenium in micrograms per 100 kilocalories on infant formula labels.

The rule is effective June 22, 2016.

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