Adverse Event Reporting Dietary Supplements

The dietary supplement adverse event reporting rate in the united states was estimated at 2 based on caers data.

Adverse event reporting dietary supplements. To facilitate the reporting of adverse events the labels of dietary supplements marketed in the united states must include a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event with such dietary supplement fdca 403 y. Questions answers regarding adverse event reporting and recordkeeping for dietary supplements as required by the dietary supplement nonprescription drug consumer protection act issued in october 2007 is a helpful guide for compliance with saer requirements. However the system must be easy for the provider to navigate for.

Fda s guidance for industry. The dietary supplement and nonprescription drug consumer protection act signed into law in december 2006 requires manufacturers to report to fda serious adverse events aers associated with dietary supplements whether or not a likely causal connection is established. Although mandatory reporting is limited to serious adverse events the manufacturer is obligated to document and assess every allegation of an adverse event associated with a dietary supplement to determine whether or not it meets the serious criteria for reporting to the fda.

Dietary supplement adverse event report data from the fda center for food safety and applied nutrition adverse event reporting system caers 2004 2013. Members of the dietary supplement industry may now use the reporting form on the safety reporting portal to meet the reporting requirements established in section 761 of the fd c act. Fda data of reported adverse events can be misconstrued says kingston.

The findings show that the. Thus to date there is no adverse event reporting system for dietary supplements in the dod and we know adverse events are rarely reported. This study characterizes caers dietary supplement adverse event data for the 2004 2013 period and estimates a reporting rate of 2 for dietary supplement adverse events based on caers data.