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

CFSAN Constituent Update

April 15, 2013

The U. S. Food and Drug Administration (FDA) today 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. The proposed rule is titled "Infant Formula: The Addition of Minimum and Maximum Levels of Selenium to Infant Formula and Related Labeling Requirements.”

Specifically, 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.

Selenium is an essential nutrient for infants, and formula often serves as a sole source of nutrition for infants. Selenium will be the 30th mandatory nutrient required 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. Currently, all infant formulas contain selenium. 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 U.S. to add selenium within this safe range, and require any manufacturer newly entering the U.S. market to adopt this practice as well.

FDA invites public comment on this proposal starting April 16, 2013 for 75 days. To submit your comments electronically to the docket go to:

  1. Choose “Submit a Comment” from the top task bar
  2. Enter the docket number FDA-2013-N-0067 in the “Keyword” space
  3. Select “Search” 

To submit your comments to the docket by mail, use the following address: 
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane
Room 1061
Rockville, MD 20852

Be sure to include docket number FDA-2013-N-0067 on each page of your written comments.  

For more information:

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