Rule establishes both minimum and maximum levels of selenium in formula.
The U. S. FDA has announced a final rule to add selenium to the list of required nutrients for infant formula, and to establish both minimum and maximum levels of selenium 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, and currently, all infant formulas on the U.S. market contain selenium. By amending regulations to add selenium to the list of required nutrients for infant formula and establish a safe range for this use, the FDA is able to require manufacturers currently marketing infant formula in the U.S. to add selenium within this safe range, and to require any manufacturer newly entering the U.S. market to adopt this practice as well.
Specifically, the rule requires 2.0 micrograms (μg) selenium/100 kilocalories as the minimum level and 7.0 μg/100 kilocalories as the maximum level of selenium in infant formula. It also amends the labeling requirements for infant formula to require the listing of selenium in micrograms per 100 kilocalories on infant formula labels. Selenium, found in breast milk, is an essential nutrient for infants. Among its benefits, it helps the body defend against oxidative stress and aids in the regulation of thyroid hormones. Because infant formula often serves as a sole source of nutrition for infants, selenium in infant formula is needed to ensure that formula-fed infants are getting this essential nutrient at appropriate levels. Selenium is the 30th nutrient required by law to be in infant formula.
For more information:
- Federal Register Notice Infant Formula Guidance Documents & Regulatory Information
- June 24, 2013 – Youngevity Urges FDA to Require Selenium in Infant Formula
- April 22, 2013 – Dr. Joel Wallach’s Selenium Research Continues to Benefit Many
- April 15, 2013 – FDA Issues Proposed Rule to Add Selenium to List of Required Nutrients for Infant Formula
The human body needs trace amounts of selenium to perform a variety of functions including synthesizing antioxidants shown to protect against cell-damaging free radicals. Since selenium can’t be manufactured by the human body it has to be obtained from diet or supplements. Ultimate™ Selenium provides selenium vitamins and other trace minerals and nutrients to support good health.