On June 19, 2013, Emord & Associates, on behalf of Youngevity, Inc., filed a Comment to FDA’s proposed rule, “Infant Formula: The Addition of Minimum and Maximum Levels of Selenium to Infant Formula and Related Labeling Requirements.” If adopted, the Rule would require inclusion of selenium as an essential nutrient in infant formula.
FDA concluded that selenium is “an essential trace element for humans,” referencing selenium’s proven ability to defend against “oxidative stress, regulation of thyroid hormone action, and regulation of the oxidation/reduction status of vitamin C and other molecules.” Given the possibility of selenium deficiencies in infants from reduced maternal intake, selenium supplementation ensures that infants and young children receive ample amounts of this essential nutritive component.
Youngevity markets selenium-containing dietary supplements and has provided innovative health enhancing products, including dietary supplements, to customers worldwide since 1991. It is the only company of its kind to have obtained a qualified health claim for selenium following submission of a health claim petition in 2002 and again in 2008. In support of its Comment to the FDA, Youngevity included an evaluation by noted researcher, chemist, and scholar, Dr. G.N. Schrauzer, Ph.D. In reliance on Dr. Schrauzer’s expert opinion, Youngevity recommended to the agency that it require the use of an organic form of selenium, selenomethionine, which provides greater health benefits to humans than does the mineral’s inorganic form, sodium selenate.
The FDA will continue to accept comments on its proposed rule until July 1, 2013. A copy of the Comment and exhibits are available here. For any questions about the Proposed Rule or Youngevity’s Comment, contact Jonathan Emord (firstname.lastname@example.org).