Dandruff shampoo containing too much coal tar can no longer be sold in California without a warning that it can cause cancer, under a tentative agreement.
The deal would settle a lawsuit brought two years ago against manufacturers of dandruff shampoos by an environmental group, Occupational Knowledge International in San Francisco, and the state attorney general's office.
Coal tar, which is distilled from coal, has been used in dandruff shampoo for decades. But it is now banned in all consumer goods in Europe because of health concerns. California, using its tough anti-toxics law, would be the first state in the country to restrict use of the substance.
Coal tar contains cancer-causing polyaromatic hydrocarbons, including the potent benzo-a-pyrene. Thousands of sites nationwide where coal was converted into gas for lighting left behind toxic coal tar deposits, including Midway Village in Daly City.
Occupational Knowledge, a hazardous materials watchdog group, sued two dozen companies in 1999 under Proposition 65, a 1986 law that prohibits companies from exposing the public to unsafe levels of carcinogens and reproductive toxicants without warnings.
The suit alleged that the levels of coal tar in shampoos, conditioners, ointments and pet shampoos violated the law. At a later date, the attorney general's office filed separate suits.
"There are few chemicals that are this well known to cause cancer that are readily available in every drugstore and grocery store in the country. Furthermore, these products are used directly on the skin, where they are absorbed," said Perry Gottesfeld, executive director of Occupational Knowledge.
In their court filings, the environmental group and the attorney general's office presented studies showing that at the levels allowed by the federal Food and Drug Administration, coal tar created an unacceptable cancer risk.
The FDA permits sales of shampoos with coal tar in the 0.5 to 5 percent range of concentration. According to a risk assessment prepared by NewFields Inc. in Sacramento, that level poses an unacceptable cancer risk to the public.
The state Office of Environmental Health Hazard Assessment also consulted on the scientific arguments for the state.
The environmental group argued that there were safe substitutes. A European study of 60 dandruff sufferers over three months concluded that a shampoo using salicylic acid and other substitutes was more effective than one with coal tar.
Manufacturers countered that the U.S. Food and Drug Administration has reviewed all published scientific information and found the products safe.
The FDA issued a letter in February stating that "at this time there is no evidence that topical treatment of dermatological disorders with over-the- counter coal tar shampoo, soap or ointment drug products increases the risk of skin cancers."
Shampoo makers and drugstores tried to get the case dismissed Dec. 7. They failed, and the case was to go to trial Jan. 7.
The agreement will not be final until it is signed by the attorney general, the parties and the judge.
If a shampoo contains more than a 0.5 percent concentration of coal tar, companies must either remove them from shelves or attach the following label: "Warning: This product contains chemicals known to the state of California to cause cancer."
Neutrogena, a Johnson & Johnson company, would be liable for $240,000 in penalties and attorney fees under the proposed agreement. Company representatives say they will remove products with higher coal tar levels and continue to sell others that would not need a label.
In a statement issued yesterday, Neutrogena representatives said all their products comply with FDA regulations. In September, the company said, the FDA issued a statement that "there is no scientific basis for adding additional carcinogenicity warnings on these products."
The attorney general's office was the principal negotiator of the settlement. Gottesfeld said he wished the allowable level of coal-tar concentration could have been lower, but Susan Fiering, deputy attorney general in chargeof the cases, said she was satisfied that the agreement will protect the public.
In July, American Home Products settled a suit for $400,000, and agreed not to use coal tar in its popular dandruff shampoo, Denorex. Other companies that agreed to warn or reformulate were GenDerm Corp., Medicis Pharmaceutical, J.K. Pharmaceuticals, Galderma Laboratories and Stiefel Laboratories. Several makers of dog shampoos also settled.