The FDA's Final Guidance on SAER Labeling Released

The U.S. Food and Drug Administration (FDA) has announced its final guidance discussing “Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.”

Under the act, a dietary supplement label is required to have a domestic phone number and/or domestic address to report adverse events to companies. The phone number must include an area code, but can also be a toll-free number. The listed address must include a street address or P.O. Box number with the city, state and zip code. Labels may also include website addresses where reports can be made, so long as a phone number or address is also included on the labeling.

The ruling also recommends that “the label also bear a clear, prominent statement informing consumers that they may report serious adverse events to the domestic address or domestic phone number on the label.”

To see AHPA’s release commenting on the document on NPIcenter, click here.

To view the original document on the FDA’s website, click here.

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