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MOUTHWASH "KILLS GERMS" CLAIM DOES NOT MAKE PRODUCT A DRUG, WARNER-LAMBERT

This article was originally published in The Tan Sheet

Executive Summary

MOUTHWASH "KILLS GERMS" CLAIM DOES NOT MAKE PRODUCT A DRUG, WARNER-LAMBERT counsel Peter Barton Hurt (Covington & Burling) argued in a Dec. 10 letter to FDA's Plaque Subcommittee members. "Although use of terms such as 'kills germs' or 'fights bacteria' without any qualification may imply a therapeutic effect and therefore be regarded as drug claims," Hutt argued, "the use of these same terms directly tied to an admittedly cosmetic purpose such as deodorancy cannot subject products making such claims to FDA regulation as drugs."

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