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OTC dental products

Executive Summary

Representatives for Vipont (Viadent), Pfizer (Plax) and Warner-Lambert (Listerine) met with FDA Chief Counsel Margaret Porter and other agency officials on April 20 to discuss whether "products intended for the treatment of plaque and similar conditions" are drugs or cosmetics, according to a memorandum of the meeting. The three companies have received reg and/or warning letters from FDA concerning plaque/gingivitis claims deemed by the agency to be drug claims. Drug Labeling Compliance Div. Director Richard Chastonay told a recent FDLI-sponsored meeting that FDA and industry may have reached an "impasse" on the OTC dental claims issue and that the agency may initiate legal actions.
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