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OTC Coal Tar Skin Cancer Causation Data Lacking - FDA

This article was originally published in The Tan Sheet

Executive Summary

The future of California Proposition 65 litigation against manufacturers, distributors and retailers of coal tar-containing dandruff shampoos, soaps and ointments could become clearer at a March 16 status conference in San Francisco state court.

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Presence of cancer warnings on some dandruff, psoriasis OTCs "may render the products misbranded," and FDA is "evaluating the complex issues raised" by such warnings, 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 Tan Sheet" March 5, p. 4). Prop 65 lawsuit against Alva-Amco, other coal tar product makers slated for trial in January...

Coal tar

Presence of cancer warnings on some dandruff, psoriasis OTCs "may render the products misbranded," and FDA is "evaluating the complex issues raised" by such warnings, 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 Tan Sheet" March 5, p. 4). Prop 65 lawsuit against Alva-Amco, other coal tar product makers slated for trial in January...

Coal tar

Presence of cancer warnings on some dandruff, psoriasis OTCs "may render the products misbranded," and FDA is "evaluating the complex issues raised" by such warnings, 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 Tan Sheet" March 5, p. 4). Prop 65 lawsuit against Alva-Amco, other coal tar product makers slated for trial in January...

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