OTC ORAL ANTISEPTIC TFM CONTAINS NO CATEGORY I INGREDIENTS
This article was originally published in The Tan Sheet
Executive Summary
OTC ORAL ANTISEPTIC TFM CONTAINS NO CATEGORY I INGREDIENTS but FDA is encouraging interested parties to design studies to upgrade Category II (not safe and effective) or Category III (data insufficient to permit classification) ingredients to Category I (safe and effective). In the over-the-counter oral antiseptics tentative final monograph, published in the Feb. 9 Federal Register, FDA noted that the OTC Oral Cavity Drag Products Review Panel's "proposed in vitro and in vivo testing guidelines and its discussion of clinical studies represent a good starting point for the design of studies to upgrade" Category II and Category III ingredients.