FDA now accepting Dietary Supplement “adverse events” reports online

FDA Initiates New Online Reporting Method for Dietary Supplement Adverse Events to Facilitate Reporting


The U.S. Food and Drug Administration (FDA) is now accepting online submission of voluntary and mandatory dietary supplement adverse event reports.

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.

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