FDA adds selenium to nutrients required in infant formula.

  • In 2013, FDA proposed to amend the infant formula regulations at 21 C.F.R. 107.100 to add selenium to the list of required nutrients.  78 Fed. Reg. 22442 (April 16, 2013). Although selenium was not recognized as an essential nutrient for infants when FDA established its regulations, in 1989, the Food and Nutrition Board of the National Research Council established a Recommended Dietary Allowance (RDA) for selenium for infants 0 to 6 months of age of 10.0 micrograms per day (μg/day).  Although not currently required in infant formula, all U.S. manufacturers add selenium to their infant formulas.
  • On June 22, 2015, FDA finalized the proposed rule; as of June 22, 2016, manufacturers will be required to add at least 2.0 micrograms of selenium per 100 kilocalories and no more than 7.0 micrograms per 100 kilocalories.  80 Fed. Reg. 35834 (June 23, 2015).  Additionally, infant formula labels will be required to list selenium in micrograms per 100 kilocalories.
  • Selenium becomes the thirtieth mandatory nutrient required in infant formula.  By amending the regulations, FDA is able to require manufacturers to add selenium within a specified range; FDA set both a minimum and maximum level because, although dietary intake of this trace mineral is essential, chronic, and more rarely, acute selenium toxicity have been reported.