Earlier this week, the FDA published its proposed rule, Infant Formula: The Addition of Minimum and Maximum Levels of Selenium to Infant Formula and Related Labeling Requirements, in the US Federal Register.
According to the proposed rule, which is open for comment until 1 July 2013, selenium is an essential nutrient for infants.
It can help to provide defense against oxidative stress, regulate thyroid hormone activity, and regulate the oxidation and reduction status of vitamin C, according to the FDA.
“Establish minimum and maximum levels”
“The Food and Drug Administration (FDA) is proposing to amend the regulations on nutrient specifications and labeling for infant formula to add the mineral selenium to the list of required nutrients and to establish minimum and maximum levels of selenium in infant formula,” said the proposed rule.
“Selenium is an essential nutrient for infants, and formula often serves as a sole source of nutrition for infants,” said the proposed rule.
The Federal Register-filed document details proposed minimum level and maximum levels for selenium in infant formula - 2μg (micrograms) per 100 kilocalories (kcal) minimum, and 7μg per 100 kcal maximum.
Approval of the proposed rule would also result in the amendment of current labelling requirements to include the listing of selenium per 100 kcal.
US infant formula market entry requirement
According to the FDA, selenium has been added to US-made infant formula products since 1989, when it was recognised by the Institute of Medicine as an essential nutrient for infants.
“Currently, all infant formulas contain selenium,” the FDA document said.
By adding selenium to the list of required nutrients for infant formula, the FDA believes it can ensure that all infant formula products entering the country meet domestic standards.
“By amending regulations to add and establish a safe range of selenium in infant formula, FDA is able to require manufacturers currently marketing infant formula in the US to add selenium within this safe range, and require any manufacturer newly entering the US market to adopt this practice as well,” said the filed document.
If approved, selenium will become the thirtieth mandatory nutrient required in infant formula products by the FDA.