MOUTHWASH "KILLS GERMS" CLAIM DOES NOT MAKE PRODUCT A DRUG, WARNER-LAMBERT
This article was originally published in The Rose Sheet
Executive Summary
MOUTHWASH "KILLS GERMS" CLAIM DOES NOT MAKE PRODUCT A DRUG, WARNER-LAMBERT counsel Peter Barton Hutt (Covington & Burling) argued in a Dec. 10 submission 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 tie to an admittedly cosmetic purpose such as deodorancy cannot subject products making such claims to FDA regulation as drugs."