Adverse Event Reporting With Dietary Supplements

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

Adverse event reporting with dietary supplements. Fda s guidance for industry. 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.

Dietary supplement adverse event report data from the fda center for food safety and applied nutrition adverse event reporting system caers 2004 2013.