Dietary Supplements: FDA May Have Opporunities to Expand Its Use of Reported Health Problems to Oversee Products

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By J. Alfredo Gomez (au)
Year: 2013
Pages: 69
Binding Paperback
ISBN 978-1-4578-4511-6

Product Code: 1457845113

Description

Dietary supplements, such as vitamins and botanical products, are a multibillion dollar industry in the U.S. The Food and Drug Admin. (FDA) regulates dietary supplements and generally relies on postmarket surveillance, such as monitoring adverse event reports (AERs), to identify potential concerns. Since December 2007, firms receiving a serious AER have had to report on it to FDA within 15 days. This report examines the (1) number of AERs FDA has received since 2008, their source, and types of products identified; (2) actions FDA has taken to ensure that firms are complying with AER requirements; (3) extent to which FDA is using AERs to initiate and support its consumer protection efforts; and (4) extent to which FDA has implemented GAOäó»s 2009 recommendations to help FDA identify and act on safety concerns for dietary supplements. Tables and figures. This is a print on demand report.

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