In Brief: Miracle Exclusives warning letter
This article was originally published in The Tan Sheet
Executive Summary
Miracle Exclusives warning letter: June 8 letter from FDA's New York district office says that "although [Floradix Herbal Cough Syrup, Salus Honey with Fennel Syrup and Floradix Herbal Rest Liquid Extract Formula] are formulated with botanicals, vitamins and minerals, they are drugs" under the FD&C Act. The cough syrups are in violation of final rules covering OTC antitussive drug products, the letter states, and Herbal Rest is subject to the final monographs for nighttime sleep-aids and daytime sedative drugs...
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