FDA Initiates New Online Reporting Method for Dietary Supplement Adverse Events to Facilitate Reporting
CFSAN Constituent Update
January 13, 2014
The U.S. Food and Drug Administration (FDA) is now accepting online submission of voluntary and mandatory dietary supplement adverse event reports.
The FDA has implemented a secure capability in the interest of efficiency and as a convenience to dietary supplement manufacturers, packers and distributors, as well as the public at large. Both mandatory and voluntary dietary supplement adverse event reports (currently the 3500A and 3500 forms, respectively) may now be submitted online.
Under the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Public Law 109-462), the manufacturer, packer, or distributor of a dietary supplement whose name appears on the label of a dietary supplement marketed in the United States is required to report to the FDA any serious adverse events received regarding their dietary supplement products when used in the United States.
Reporting of dietary supplement adverse events is critically important in protecting consumers’ health and safety. The FDA routinely monitors the marketplace. However, with more than 85,000 dietary supplements on the market and no product specific registration requirement, adverse event reporting is invaluable in identifying harmful products.
The FDA today sent a letter to manufacturers, packers and distributors of dietary supplements, encouraging them to use the new capability and detailing its benefits. Those who submit reports may use either the system’s non-registered (“Guest”) or “Registered” accounts. The use of registered accounts provides for the convenience of saving partially completed reports, certain information pre-populated into new reports, and the ability to review one’s reporting history online.
For mandatory reporters, there is a new electronic alternative to the MedWatch 3500A paper form, but this announcement signifies no changes to the existing reporting requirements. The FDA will continue to accept paper 3500A and 3500 forms.
Anyone can submit a voluntary dietary supplement adverse event report (3500 form). The FDA encourages physicians, in particular, to file voluntary reports when their patients have experienced adverse events associated with dietary supplements.
The new submission capability is available through the Department of Health and Human Services’ Safety Reporting Portal. To submit a dietary supplement adverse event report, visit http://www.safetyreporting.hhs.gov.