Dietary Supplementation in Children and Adolescents

Abstract

The drug approval process of the US Food and Drug Administration (FDA) has evolved into the world’s gold standard for ensuring that drugs introduced to the public are safe and effective for their intended use. One important and often overlooked part of the FDA’s approval process by health care professionals is that of manufacturing. The FDA ensures, through premarket approval standards, that drugs contain the labeled amount of active pharmaceutical ingredient, even if the product is generic. Unfortunately, the same cannot be said about products that do not undergo premarket review, such as dietary supplements. Dietary supplements are regulated separately from drugs under the regulatory framework created by the Dietary Supplement Health and Education Act of 1994. The Dietary Supplement Health and Education Act of 1994 allows dietary supplements to forgo premarket review by the FDA, instead initially relying on dietary supplement manufacturers’ compliance with FDA regulation and guidance. Given the lack of premarket review, dietary supplement manufacturers should follow dietary supplement current good