FDA Rules on Selenium Levels in Infant Formula

FDA Rules on Selenium Levels in Infant Formula
FDA Rules on Selenium Levels in Infant Formula

The Food and Drug Administration (FDA) has announced a final rule on the required nutrients for infant formula, along with minimum and maximum levels of the newly required mineral effective immediately.

The final rule requires 2.0µg selenium/100kcal as the minimal level and 7.0µg/100kcal as the maximal level of selenium in infant formula. It also revises the labeling requirements for infant formula to require the listing of selenium in micrograms per 100 kilocalories on the product label.

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Currently, all infant formulas in the United States contain selenium; in 1989, U.S. manufacturers began to add selenium to infant formula after the Institute of Medicine (IOM) recognized selenium as an essential nutrient for infants. The final rule establishes a safe range for this ingredient and requires any manufacturer newly entering the U.S. market to include selenium in infant formula.

For more information call (888) 463-6332 or visit FDA.gov.

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