American Vitamin Products
This article was originally published in The Tan Sheet
Executive Summary
Receives FDA warning letter telling the firm that its Nite Nite caplets (valerian root, passionflower, skullcap, hops and chamomile), which are labeled for use prior to bedtime, do not fall under the OTC nighttime sleep-aid monograph, under which only diphenhydramine is considered safe and effective. Labeling that warns consumers not to take the product while driving or operating machinery also deems it an OTC daytime sedative, an indication for which there are no safe and effective ingredients, FDA said