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DHHS/FDA-The Safety Reporting Portal

As of January 13, 2014, the U.S. Food and Drug Administration is accepting voluntary and mandatory reports of dietary supplement adverse events online.

The secure reporting portal was implemented to simplify and allow for easy reporting of these events by manufacturers, distributers and the public. The FDA will also continue to accept paper 3500A and 3500 reporting forms.

The Dietary Supplement and Nonprescription Drug Consumer Protection Act requires the manufacturer, packer, or distributor of a dietary supplement marketed in the United States to report to the FDA any serious adverse events received when their product is used in the United States. The FDA also strongly encourages physicians to file voluntary reports of adverse events experienced by their patients after using dietary supplements.

The new online reporting capability is now available through the Department of Health and Human Services’ Safety Reporting Portal. To submit a dietary supplement adverse event report, please visit www.safetyreporting.hhs.gov.

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