**GAO-09-250**                      Published: Jan 29, 2009. Publicly Released: Mar 02, 2009.                  

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## Highlights

Dietary supplements and foods with added dietary ingredients, such as vitamins and herbs, constitute multibillion dollar industries. Past reports on the Food and Drug Administration's (FDA) regulation of these products raised concerns about product safety and the availability of reliable information. Since then, FDA published draft guidance on requirements for reporting adverse events--which are harmful effects or illnesses--and Current Good Manufacturing Practice regulations for dietary supplements. GAO was asked to examine FDA's (1) actions to respond to the new serious adverse event reporting requirements, (2) ability to identify and act on concerns about the safety of dietary supplements, (3) ability to identify and act on concerns about the safety of foods with added dietary ingredients, and (4) actions to ensure that consumers have useful information about the safety and efficacy of supplements.

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## Topics

Agriculture and Food

Commercial productsConsumer protectionContaminated foodsData centersData integrityFederal agenciesFederal regulationsFood additivesFood and drug legislationFood industryFood inspectionFood safetyFood supplyLabeling lawProduct evaluationProduct recallsProduct safetyPublic healthReporting requirementsRisk managementSafety regulationSafety standardsSurveysUnderreporting