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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.

The GAO estimates that adverse events may be under-reported by consumers, especially in cases where consumers do not make the connection between the symptoms they are experiencing and the supplement they are taking, or when a supplement label does not provide the manufacturer’s contact information (which is required by federal regulations). Still other adverse events may be reported to poison control centers rather than to the FDA; poison control centers received over 1,000 more AERs associated with dietary supplements than the FDA did during the same time period. However, there is currently no system in place that integrates reports to poison control centers with those received by the FDA, allowing for gaps in data and potentially delaying the ability of the agency to spot trends in adverse events for specific products or ingredients.

In addition, the GAO suggested that the FDA improve its use of the information provided by AERs. For example, these reports can be used to demonstrate health risks associated with violations found during FDA inspections, and they have been used to inform and support some consumer protection actions. However, since the agency “does not track the relationship between AERs and its other data management systems” it cannot identify “the extent to which AERs were used in this capacity.”

Although it is unclear what specific steps the FDA will take in order to improve their ability to receive and utilize AERs, the GAO made several recommendations with which the FDA has stated it “generally agrees.” These include continuing efforts to “explore all possible options to obtain poison center data,” keeping records of when and how AERs are used to support and inform consumer protection actions, allowing dietary supplement companies to report adverse events electronically rather than requiring reports be sent in hard copy by mail, and determining how to make information about AERs more accessible to the public. The GAO also urged the FDA to establish a time frame for issuing a final guidance clarifying when liquid and non-liquid products should be marketed as dietary supplements or convention foods, proposing that such a distinction may help companies to better develop and organize their policies and reporting procedures for adverse events.

Adverse events associated with dietary supplements can be reported to the FDA’s MedWatch Adverse Event Reporting Program.

If you believe that a dietary supplement or other nutritional product has caused an unexpected, adverse reaction please let us know on ConsumerLab.com’s new Dietary Supplement or Nutritional Product Problem Report page.

To read the GAO’s complete report, use the link below.