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.

FDA regulatory proceedings could be critical to, or dispositive of, plaintiffs' claims that manufacturers, distributors and retailers have failed to warn consumers, pursuant to Proposition 65, that use of coal-tar-containing hair and skin care products expose users to cancer-causing chemicals, Bergen says.

"FDA should be allowed to decide, based upon scientific considerations, whether coal tar USP poses risks substantial enough to warrant inclusion in the Proposition 65 scheme, and what should be the proper regulatory action level for coal tar USP," Bergen and co-defendant Reedco state in the Aug. 9 motion.

In the alternative, Bergen and Reedco seek summary judgment, asserting the 1997 amendments to the FD&C Act preempt California state law civil penalty provisions.

A consolidated trial in separate lawsuits brought by the State of California and Occupational Knowledge International Exec Director Perry Gottesfeld under Prop 65 is scheduled for Oct. 10. The stay motion will be heard in San Francisco Superior Court Sept. 22.

Bergen and Reedco are attempting to use Gottesfeld's recent citizen petition requesting FDA conduct a "formal review" of coal tar use in shampoo, soap and ointments as a way of delaying trial in the state litigation. Gottesfeld urged the agency March 6 to "restrict the sales and distribution of these products to prescription sales" (¹ (Also see "Coal tar safety" - HBW Insight, 3 Apr, 2000.)).

Bergen and Reedco are among the more than 20 original defendants named in the litigation. Reedco is a subsidiary of Block Drug, which manufactures Tegrin dandruff shampoos.

Johnson & Johnson's Neutrogena division also is a named defendant in the suit. About half the defendants reportedly have reached settlements in the state attorney general's lawsuit, including Denorex shampoo marketer Whitehall-Robins Healthcare. Whitehall, however, said it has not settled the lawsuit.

Coal tar and its constituents are "known human carcinogens," Gottesfeld charges in the citizen petition, adding "current labeling requirements are insufficient and require additional warning language to protect public health." FDA is reviewing and analyzing data provided by Gottesfeld.

In Aug. 8 comments to FDA, Bergen declined a settlement offer from the California AG office limited to two dandruff shampoos marketed under Bergen's Brite-Life and Good Neighbor Pharmacy brands, which are formulated and labeled by a contract manufacturer.

"The proffered terms of settlement require Bergen Brunswig to pay a small penalty and either stop selling Bright-Life and Good Neighbor Pharmacy shampoos or to place a Proposition 65 warning on the label," the company says.

The text of the state-mandated warning - "This product contains coal tar, a chemical known to the state of California to cause cancer" - would "misbrand the shampoos and does not comply with the labeling forms of the monograph," Bergen tells the agency.

The final monograph covering external OTC products for the control of dandruff, seborrheic dermatitis and psoriasis allows use of coal tar as an active ingredient in concentrations ranging from .5% to 5%. The reg requires warnings against internal use, eye contact and the potential for increased sunburn.

The proffered settlement did not cover distribution of products under other defendants' trademarks, and the California AG advised the company to either stop distributing coal-tar containing products in the state or label them with the Prop 65 warning to avoid additional liability, according to Bergen.

The company was willing to withdraw Brite-Life and Good Neighbor Pharmacy shampoos from the market in California, where sales total less than 1,000 units, Bergen says. However, the requirement to withdraw or label its vendors' products "raised significant legal and contractual issues," according to the distributor.

Bergen asks FDA to consider whether coal tar USP is chemically identical to crude coal tar, the substance upon which Bergen asserts the plaintiffs are basing their Prop 65 challenges. Bergen questions whether the agency considers the Prop 65 coal tar warning to constitute "misbranding" under the FD&C Act.

"If not, does FDA approve of the addition to the monograph of the [Prop 65] safe-harbor warning for inclusion on OTC pharmaceuticals containing coal tar USP," Bergen asks. If FDA concludes coal tar in OTCs poses a cancer risk when used as directed, "what cautionary test or instruction would FDA recommend to be used to inform consumers?"