03.03.14
FDA is accepting online submission of voluntary and mandatory dietary supplement adverse event reports. The agency 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 U.S. is required to report to FDA any serious adverse events received regarding their dietary supplement products when used in the U.S.
FDA sent a letter to manufacturers, packers and distributors of dietary supplements encouraging them to use the new capability and detailing the new system’s 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. FDA will continue to accept paper 3500A and 3500 forms.
Anyone can submit a voluntary dietary supplement adverse event report (3500 form). 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 www.safetyreporting.hhs.gov.
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 U.S. is required to report to FDA any serious adverse events received regarding their dietary supplement products when used in the U.S.
FDA sent a letter to manufacturers, packers and distributors of dietary supplements encouraging them to use the new capability and detailing the new system’s 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. FDA will continue to accept paper 3500A and 3500 forms.
Anyone can submit a voluntary dietary supplement adverse event report (3500 form). 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 www.safetyreporting.hhs.gov.