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Selenium Would be Required in Infant Formula Under FDA Proposal

Tuesday, April 16, 2013
By Shawn McCausland
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration 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. A minimum level of 2.0 micrograms/100 kcal and a maximum level of 7.0 micrograms/100 kcal would be established, and the specific level of selenium included would have to be listed on the formula’s label. The FDA notes that selenium is an essential nutrient for infants and would be the 30th mandatory nutrient required in infant formula.

Comments on the proposed minimum and maximum levels of selenium, including whether they provide sufficient flexibility and can be achieved from a practical manufacturing standpoint, are due no later than July 2.

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