ABSTRACT

AlthoughtheFDCActexempts"soap"fromthedefinitionof"cosmetic," itdoesnotdefinetheterm"soap."However,theFDAhasissueda regulationinwhichitinterpretstheterm"soap"verynarrowly.2The FDAviewstheterm"soap"toapplyonlytoarticlesthatmeetthe followingconditions:

(1)Thebulkofthenonvolatilematterintheproductconsistsof analkalisaltoffattyacidsandthedetergentpropertiesofthe articleareduetothealkali-fattyacidcompounds;and (2)Theproductislabeled,sold,andrepresentedonlyassoap. Theagencyconsiderspersonalcleansingproductsthatdonotmeet

thesesoapconditionstobe"cosmetics"andsubjecttoallFDCAct cosmeticrequirements.