Coal tar safety
This article was originally published in The Rose Sheet
Executive Summary
FDA asked to conduct "formal review" of coal tar use in shampoo, soap and ointments by Occupational Knowledge International in a March 6 petition. The agency should "restrict the sales and distribution of these products to prescription sales," the group states. As a "known carcinogen," coal tar "labeling requirements are insufficient and require additional warning to protect public health." Coal tar use in OTC drug products was banned in Germany in 1995 and in the European Union in 1997, the comments point out. Occupational Knowledge International is involved in ongoing litigation with Cal-EPA regarding coal tar safety
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Animal data on carcinogenic risk of dandruff shampoo ingredient are insufficient to support a change in OTC monograph status or new labeling warnings, J&J subsidiary Neutrogena asserts in Oct. 24 comments to FDA. Stressing its opposition to restrictions on coal tar-containing OTCs requested by Occupational Knowledge International in a March petition, the T/Gel marketer also notes the research cited by the petitioners examined "coal tar oil, not coal tar" (1"The Rose Sheet" April 3, In Brief). Neutrogena is one of several defendants in the ongoing Prop 65 lawsuit over coal tar in OTCs brought by Occupational Knowledge International and California Attorney General Bill Lockyer
Coal tar
Animal data on carcinogenic risk of dandruff shampoo ingredient are insufficient to support a change in OTC monograph status or new labeling warnings, J&J subsidiary Neutrogena asserts in Oct. 24 comments to FDA. Stressing its opposition to restrictions on coal tar-containing OTCs requested by Occupational Knowledge International in a March petition, the T/Gel marketer also notes the research cited by the petitioners examined "coal tar oil, not coal tar" (1"The Rose Sheet" April 3, In Brief). Neutrogena is one of several defendants in the ongoing Prop 65 lawsuit over coal tar in OTCs brought by Occupational Knowledge International and California Attorney General Bill Lockyer
California Coal Tar Litigation Stay Sought Pending FDA Petition Review
California litigation over the use of coal tar in dandruff shampoos and other OTC drugs should be suspended pending FDA review of the ingredient's safety, drug distributor Bergen Brunswig tells a San Francisco judge.