USFDA starts accepting online reporting of adverse events in dietary supplements


The US Food and Drug Administration (US-FDA) has announced that it is now accepting online submissions of voluntary and mandatory dietary supplement adverse event reports (AERs). 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 AERs may now be submitted online.

In US, 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 U.S.

FDA recently 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.

According to FDA, anyone can submit a voluntary dietary supplement adverse event report. The FDA encourages physicians, in particular, to file voluntary reports when their patients have experienced adverse events associated with dietary supplements.

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