Coal Tar Lawsuit #5
This is a reprint of the fifth of eight documents originally published by the National Psoriasis Foundation (NPF) regarding the 2000-2002 lawsuit in California over coal-tar products and Prop 65.
Denorex products first casualty of California coal tar lawsuit
Whitehall-Robins will remove coal tar completely from Denorex products by mid-December and replace it with salicylic acid, as part of the settlement of a lawsuit in California that accused the company of exposing consumers to cancer-causing agents (coal tar) in Denorex.
According to company representative Fran Sullivan, Whitehall settled the lawsuit to avoid prolonged and costly litigation. Initially, the company agreed to pay $400,000 in penalties and reformulate Denorex so it contained a lower concentration of coal tar. Facing stiff costs to reformulate, however, the company has decided to drop coal tar completely from the product and replace it with salicylic acid.
The lawsuit in question was filed under Proposition 65, an initiative passed by California voters in 1986 that requires cancer warnings on products that contain chemicals “known to the state” to be carcinogens or reproductive toxicants. In July 2001, a California Superior Court judge ruled the lawsuit could proceed against Whitehall and approximately 15 other manufacturers of coal tar products in that state. A trial for the case is set for Jan. 7, 2002.
Whitehall will pay half of the cash settlement to the state and half to a private citizen who filed the lawsuit under California’s Proposition 65.
Salicylic acid softens and lifts psoriasis scales, while coal tar slows the overly rapid rate of skin cell growth that causes lesions to form. Coal tar contains up to 10,000 compounds, only about 5 percent of which have been identified. Studies show some of the chemicals in coal tar may cause cancer, but only in very high concentrations, such as are found in the types of coal tar used in industrial paving.
The U.S. Food and Drug Administration (FDA) permits the sale of over-the-counter (OTC) products for the treatment of psoriasis with concentrations of coal tar between 0.5 percent and 5 percent.
Early FDA involvement
The trial was originally scheduled to go to court on Sept. 11, 2000. However, San Francisco Superior Court Judge David Garcia granted a stay on the case at the request of the companies being sued. The companies asked for the stay to await the outcome of a safety review of OTC coal tar products by the FDA.
On Feb. 22, 2001, the FDA formally concluded: “There is no evidence that topical treatment of dermatological disorders with OTC coal tar shampoo, soap or ointment drug products increases the risk of skin cancers.”
The FDA was petitioned to review the products by the same private citizen, Perry Gottesfeld, who filed the lawsuit in California. Gottesfeld maintains that coal tar shampoos such as Denorex are unsafe because they contain coal tar.
It remains unclear whether the FDA’s decision will have any bearing on the case in California. The NPF and its Medical Advisory Board recognize that OTC coal tar shampoos and skin care products are a valuable and relatively inexpensive therapeutic option for people who have psoriasis, especially those who have mild to moderate involvement.
The NPF wrote a letter to the California attorney general outlining its opposition to the lawsuit, and a response was sent to the NPF explaining the attorney general’s position.
For more details about the lawsuit, see the NPF’s original article on the case. The NPF will continue to monitor this situation and publish updates on the Web, as well as in our member publications, the Bulletin and Psoriasis Resource.
Article reviewed Oct. 5, 2001
First posted and last updated Oct. 5, 2001
This document was reprinted with the permission of the National Psoriasis Foundation. The original can still be found in the Internet Archive.