Dietary Supplements Adverse Event Reporting

This guidance provides recommendations to industry regarding postmarketing adverse event reporting for drugs biologics medical devices combination products and dietary supplements during a.

Dietary supplements adverse event reporting. 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. 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. 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.

The electronic submission of dietary supplement adverse event information to us via the fda safety reporting portal has been approved under omb control no.