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Posted April 12, 2013

Adverse Event Reports Associated With Dietary Supplements Increase, But Remain Underreported And Underutilized

On March 18, 2013, the U.S. Government Accountability Office (GAO) announced the number of adverse events reports (AERs) for dietary supplements submitted annually to the FDA has doubled in recent years, increasing from 1,119 in 2008 to 2,480 in 2011. The majority of these reports - 71% - were from dietary supplement companies, which have been required by law since 2007 to inform the FDA within 15 days of receiving a report of a serious adverse event from a consumer or healthcare provider. Because the FDA does not have the authority to test or approve dietary supplements for safety and effectiveness before they sold, the agency relies on these reports, along with its inspections of manufacturer facilities, to help monitor the safety of dietary supplements. Yet despite the increase in AERs, FDA officials said that their greatest challenge in identifying safety concerns for dietary supplements remains the relatively small number of reports they receive.

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