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FDA evaluation of coal tar warnings

This article was originally published in The Rose Sheet

Executive Summary

Presence of cancer warnings on some dandruff, psoriasis OTCs "may render the products misbranded," and FDA is "evaluating the complex issues raised" by such cautions, agency says in recent letter to Alva-Amco counsel Bell, Boyd & Lloyd (Chicago). Law firm had requested FDA determine whether Prop 65 cancer warnings found on some OTC coal tar medications - including Alva-Amco's Psoriasin Gel, GlaxoSmithKline/Block Drug's Tegrin, Medtech's Oxipor - constitute misbranding. Agency's February decision that additional warnings are not required on such products did not address whether inclusion of Prop 65 statement would misbrand them (1"The Rose Sheet" March 5, p. 8). Prop 65 lawsuit against Alva-Amco, other coal tar product makers is set for trial in January...

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