The U. S. Food and Drug Administration (FDA) has announced a proposed rule to add selenium to the list of required nutrients for infant formulas, and to establish both minimum and maximum levels of selenium in infant formulas. Specifically, the FDA proposes 2.0 μg (micrograms) selenium/100 kcal as the minimum level and 7.0 μg/100 kcal as the maximum level of selenium in infant formulas. The proposed rule will also amend the labeling requirements for infant formula to require the listing of selenium per 100 kilocalories.
According to the FDA proposal, “Infant Formula: The Addition of Minimum and Maximum Levels of Selenium to Infant Formula and Related Labeling Requirements,” at the time FDA established nutrient specifications for infant formula, selenium was not recognized as an essential nutrient and was not one of the nutrients required by statute in infant formula. As explained in detail in this document, selenium has subsequently been recognized as an essential nutrient. Selenium, the proposal explains, is an essential trace element for humans that functions largely through an association with proteins known as selenoproteins. The known biological functions of selenium include defense against oxidative stress, regulation of thyroid hormone action, and regulation of the oxidation/reduction status of vitamin C and other molecules. Keshan disease, a cardiomyopathy that occurs almost exclusively in children, has been linked to selenium deficiency.
What is Selenium?
Typically, the FDA indicates, plant foods are the major dietary sources of selenium although selenium is also found in some meats, seafood, and nuts. The selenium content of a food depends on the selenium content of the soil where the plant was grown or where the animal was raised. In the United States, food distribution patterns across the country help prevent people living in geographic areas with low-selenium levels in the soil from having low dietary selenium intakes. And, in the U.S., selenium in not typically added to foods. However, as infant formula is intended to be the sole source of nutrition for infants, all essential nutrients must be provided; selenium, the FDA indicates with this new proposal, should be one of those nutrients required in infant formula, and should contain minimum and maximum levels as indicated. Currently, according to labeling of products, infant formulas now available contain 1.8 μg to 3.0 μg selenium per 100 kilocalorie (kcal) of formula.
Selenium will be the 30th mandatory nutrient required in infant formula.
Submit a Comment
The FDA is currently accepting public comments on this proposal. To submit your comments electronically to the docket go to: www.regulations.gov. Then, follow the following steps provided by the FDA:
- Choose “Submit a Comment” from the top task bar
- Enter the docket number FDA-2013-N-0067 in the “Keyword” space
- Select “Search”
To read the full proposal, visit the Federal Register online.
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