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VALERIAN MONOGRAPH STATUS AS OTC NIGHTTIME SLEEP AID IS SOUGHT

This article was originally published in The Tan Sheet

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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