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The Office of the Inspector General (OIG) of the Department of Health and Human Servies has investigated the oversight of the Food and Drug Administration (FDA) of dietary supplements. Unlike new prescription and over-the-counter drugs, dietary supplements do not undergo FDA premarket approval for safety and efficacy. Therefore, FDA must rely on its adverse event reporting system to identify safety problems. This inspection found that the adverse event reporting system is inherently limited as a tool to safeguard consumers. As is true of most adverse event reporting systems, FDA's system detects relatively few adverse events. For those that are reported, FDA often lacks important information, such as medical information, product and manufacturer information, and clinical information. With limited information, FDA rarely reaches the point of knowing when to take a safety action. The OIG made several recommendations to FDA to address this shortcoming