Manufacturers, packers, or distributors whose name appears on the label of a dietary supplement marketed in the United States is required to submit to FDA all serious adverse event reports associated with use of the dietary supplement in the United States.

A "serious adverse event report" is a report that must be submitted to FDA when a manufacturer, packer, or distributor of a dietary supplement receives any report of a serious adverse event associated with the use of the dietary supplement in the United States. MedWatch is the Food and Drug Administration’s reporting system for an adverse event or sentinel event.

A retailer whose name appears on the label of a dietary supplement as its distributor may as well, by agreement, authorize the manufacturer or packer of the dietary supplement to submit the required adverse event reports for a dietary supplement to the FDA as long as the retailer directs to the manufacturer or packer all adverse events associated with such dietary supplement that are reported to the retailer through the address or telephone number on the label of the dietary supplement.

The following must be submitted to FDA no later than 15 business days after the report is received by the “responsible person”:

  • Any serious adverse event report
  • All follow-up reports of new medical information.

Reports of non-serious adverse events associated with a dietary supplement received by the manufacturer, packer, or distributor must be kept along with any related records (e.g., records of your communications with the person(s) who reported the adverse event to you). Records of non-serious adverse events must be kept for six years, just as with records of serious adverse events.

For more information on reporting adverse events and to find out about our Dietary Supplements GMP Consulting Solutions, please contact us. To find out more about marketing a healthcare product in Canada, please request a copy of our white paper.