Infant Formula: Selenium in the List of Required Nutrients


Posted By: Selerant RSA

 

In June 23, 2015, the U.S. Food and Drug Administration announced a final rule on nutrient specifications and labeling for infant formula to:

  • add the mineral selenium to the list of required nutrients,
  • establish minimum and maximum levels of selenium in infant formula.

Background

Section 412(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C.350a(i)) establishes requirements for the nutrient content of infant formulas (including minimum and, in some cases, maximum levels for nutrients).

In the Federal Register of April 16, 2013 (78 FR 22442), FDA proposed to amend the nutrient specifications for infant formula to include selenium as a required nutrient in § 107.100(a). FDA also proposed to establish minimum and maximum levels for selenium in infant formulas because evidence exists for both deficiency and toxicity of selenium.

Since scientific evidence for both deficiency and toxicity of selenium supported the FDA proposed levels, the new levels are as follows:

  • 2.0 μg selenium per 100 kilocalories (/100 kcal) as the minimum level of selenium in infant formulas,
  • 7.0 μg/100 kcal as the maximum level of selenium in infant formulas.

 

 

The final rule also requires adding selenium to the statement of the amounts of nutrients required for infant formula labeling in § 107.10(a)(2).

The final rule amends § 107.100 and the legal authority for the amendment to § 107.100 comes from section 412(i)(2) of the FD&C Act. It is effective from June 22, 2016. Submit either electronic or written objections and requests for a hearing by July 23, 2015.

 

For more information: Federal Register Final Rule on Infant Formula