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Consumer OTC Drugs

VALERIAN MONOGRAPH STATUS AS OTC NIGHTTIME SLEEP AID IS SOUGHT

This article was originally published in The Tan Sheet

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Executive Summary

VALERIAN MONOGRAPH STATUS AS OTC NIGHTTIME SLEEP AID IS SOUGHT, based largely on the ingredient's marketing history in Europe, by the European-American Phytomedicines Coalition in a June 8 citizen petition to FDA. "Adequate data are available to establish that valerian is not a new drug," EAPC maintained, "because it is generally recognized as safe and effective and has been marketed for a material time and to a material extent."

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