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Cancer warnings coming on coal tar products for Psoriasis sufferers
Pending lawsuit settlements means altered choices for consumers reports the NPF

People with psoriasis who use over-the-counter (OTC) coal tar shampoos, ointments or lotions will soon observe a potentially alarming change on those products:

Following settlement of a lawsuit in California that pitted the state against coal tar product manufacturers, most companies that make coal tar products will place the following statement on their products: "Warning: This product contains chemicals known to the state of California to cause cancer."

The lawsuit was filed under California's Proposition 65, a state law passed by voters in 1986 requiring products that contain certain chemicals to include the cancer warning. While the law affects only products in California, most manufacturers are implementing the change nationwide.

Affected companies and their products (in parentheses) are: Alva-Amco (Psoriasin Gel); Baker Cummins (X-Seb T Plus Shampoo and X-Seb T Shampoo); Healthpoint (Ionil T Plus Shampoo and Ionil T Shampoo); Neutrogena (T/Gel Extra Strength Shampoo); Stiefel (Polytar Shampoo and Polytar Soap); Summers (Cutar Bath Oil Liquid Emulsion); and Triton (MG 217 Lotion, Ointment and Soap).

So far, no companies have decided to pull their products from the market nationwide. However, at least one company, Dermik, makers of Zetar (coal tar 1%), has decided to stop selling its products in California. The company must obtain written agreements from its wholesalers not to distribute Zetar in California.

Reedco, the manufacturer of Tegrin shampoo, is currently negotiating a settlement that would require it to reduce the concentration of coal tar in the product from 1.1% to 0.5%. Jose Allen, Reedco's lawyer, said the company is choosing that option rather than placing the warning on the product because the warning is "alarmist

NPF's involvement
As part of the legal proceedings, the NPF and the U.S. Food and Drug Administration (FDA) submitted letters on behalf of the coal tar manufacturers stating there is no scientific evidence that coal tar products cause cancer, and that labels on the products suggesting they are carcinogenic would put them in violation of FDA guidelines. According to the FDA, OTC products with coal tar concentrations between 0.5% and 5% are safe and effective for psoriasis.

"We certainly support the consumer awareness and education that seems to be the intent of Proposition 65, but we believe the outcome of this lawsuit against coal tar manufacturers is very unfortunate," said Gail M. Zimmerman, NPF president and CEO.

"This lawsuit has discouraged some manufacturers of OTC coal tar products from continuing to offer this specialized product. People in every state, but especially Californians with psoriasis, are not going to have the same access to a safe, and effective medical treatment that helps them live with a potentially disabling disease," Ms. Zimmerman continued.

American Home Products-subsidiary Whitehall-Robins, makers of Denorex, was among the first major companies to settle the case in June 2001. According to a company spokesman, Whitehall settled 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 decided to drop coal tar completely from the product and replace it with salicylic acid, a "scale lifter."

In the November 2001 issue of its Psoriasis Resource newsletter, the NPF encouraged members to join a letter-writing campaign stating opposition to the Proposition 65 lawsuit. The campaign got the attention of California Attorney General Bill Lockyer, who responded flatly that, "Proposition 65 does not prohibit the sale of any coal tar products, and my office has not demanded that companies cease selling the products. The issue is simply one of providing the legally required warning

As the case moved forward, the defendants filed a request to have the case thrown out for lack of evidence, based on the FDA's opinion that there is no scientific evidence to suggest that the coal tar in OTC products is carcinogenic.

But the motion to dismiss the case was denied. The judge ruled that FDA guidelines do not pre-empt a law passed by the state's voters.

Case closed?
According to California Deputy Attorney General Sue Fiering, the companies that have agreed to settle the lawsuit will also pay varying penalties. The settlements required warning labels to be placed on lotions and creams by Feb. 20 and on the shampoos by March 31.

At a recent scheduling hearing, a trial was set for May 13. Unless all parties have consented to the terms of the settlements and formally approved them, the case could go to trial. However, the steps that remain are procedural, according to Ms. Fiering.

Background
The NPF has been following the coal tar lawsuit since early 2001. These articles contain additional details

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. We are committed to preserving the availability of all safe and effective psoriasis therapies, and to safeguarding the right of people with psoriasis to make educated choices from among those therapies.

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.

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