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Gottesfeld counters that the government is simply putting business interests ahead of consumer safety. "The FDA doesn't have the backbone to stand up to industry."

How Shampoo Manufacturers Got Into Legal Mess

All of this brouhaha over coal tar shampoos can be traced back to voter passage in 1986 of California's Proposition 65. Many environmentalists consider Proposition 65 to be one of the most important pieces of consumer legislation in the United States, although corporate interests have consistently attacked it. Its passage has helped to force many potentially dangerous consumer products either off the market or caused manufacturers to reformulate their products with safe ingredients.

But when products contain chemicals known to the state of California to cause cancer or reproductive risks, these must be disclosed on the label. Because coal tar is listed by the state of California as a cancer-causing agent, it must be listed on labels of dandruff shampoos—unless it can be convincingly demonstrated that at levels found in shampoos it poses no cancer hazard.

It is against this backdrop where science, public policy and the law interact that the drama over coal tar-based shampoos will eventually be played out.

Safety Questions Persist

Coal tar shampoos have been shown to be clinically beneficial for dandruff sufferers. But coal tar, a black liquid distilled from coal, is not exactly the scalp or skin's best friend.

Coal tar was one of the first cancer-causing agents ever identified and long ago was known to cause cancer among chimney sweeps. The National Institute of Environmental Health Science reports an association with lung cancer among roofers and asphalt workers and skin and scrotum cancer among distillation workers. Today, coal tar and related compounds are used to manufacture dyes, pavements and as active ingredients in pharmaceutical products such as dandruff shampoos. Although companies such as Neutrogena clearly disclose that their products (such as T/Gel Therapeutic Shampoo) contain up to one percent coal tar, they do not discuss its possible toxic properties.

The FDA claims it has never been shown that coal-tar shampoos cause skin cancer. Many of the most noxious chemicals are removed during purification, say manufacturers. What's more, the ingredient, in this case, is being used in rinse-off products wherein skin contact is limited.

However, we believe caution should be exercised. Here's what our review of studies has found:

• In a study from Chester Beatty Laboratories, human skin biopsy samples from psoriasis patients as well as cultured human and mouse tissues were exposed to pharmaceutical-grade coal tar. The application of the coal tar was clearly damaging to the cellular genetic materials. "These results provide direct evidence for the formation of potentially carcinogenic DNA damage in human and mouse tissue by components of these therapeutic tar preparations," note the researchers.
• Meanwhile, scientists at Haddow Laboratories, Institute of Cancer Research, Sutton, Surrey, UK, report, "Treatment of mouse skin with coal tar is known to initiate tumour formation, with the carcinogenic activity associated mainly with polycyclic aromatic hydrocarbons (PAHs)." They go on to note that, "A sample of pharmaceutical coal tar was analyzed by gas chromatography and 19 major PAHs were identified."
• Researchers reporting in 1985 in the Journal of Applied Toxicology note, "The chemical compositions of the coal tar-based therapeutic agents, the industrial coal tar and direct-liquefaction coal liquid were similar." In most cases, "the microbial mutagenicity and tumor-initiating activity in mouse skin for those materials tested were also similar."