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Coal Tar Shampoo Litigation
A February 22, 2001 letter from the Food and Drug Administration rejected a citizen's petition filed by Perry Gottesfeld, seeking to have coal tar containing dandruff shampoos restricted to prescription status, and carry cancer warnings. The petition, filed on March 14, 2000, had argued that, based on an unpublished study, a Prop 65 NSRL of 0.2 micrograms/day justified FDA's action. Based on this citizen's petition, the defendants in People v. Alva-Amco, et al., had convinced the trial court to stay further proceedings.
The FDA noted that its original review of the literature found coal tar to be "safe and effective." Upon reviewing the data submitted by Gottesfeld, the agency determined:
"that a quantitative risk assessment cannot be reasonably conducted using data from this study because of the presence of skin lesions, which likely changed the exposure to target sites and would confound extrapolation to humans. . . . In addition, it is not clear how the type of coal tar used in this study relates chemically to the types used in OTC drug products, which must meet the monograph and compendia1 (United States Pharmacopeia) standards. Therefore, we find that the Fraunhofer dermal study in mice adds nothing to what is already known about carcinogenic liability of coal tar under conditions of OTC use and should not be used to estimate an NSRL."
FDA concluded that:
"While there are animal and human occupational exposure data to show that coal tar is carcinogenic, the data does not support that therapeutic use of coal tar in concentrations and formulations used in OTC drug products poses a risk of carcinogenicity. Upon reviewing the published studies, the agency does not find that there is evidence to implicate the use of OTC coal tar-containing drug products as an independent risk factor for the development of skin cancer. Therefore, we conclude that, at this time, 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."
As an article in the Washington Post recently pointed out, "Until the case is resolved, you can go back to the old reliable beer and egg shampoo -- provided the eggs don't have salmonella, and the beer isn't past its expiration date. . . ." Gee, Your Hair Smells Carcinogenic! Why California Wants to Expose the Coal Tar in Dandruff Shampoos -- And Why the Industry Is Resisting, March 27, 2001.
Whitehall-Robins Healthcare Settles
In a June 13, 2001 consent judgment, Whitehall settled with both Gottesfeld and the Attorney General, covering Denorex products. The consent judgment contained a limitation on the concentrations of both coal tar solution and benzo(a)pyrene; if reformulation were unsuccessful, the products would bear Prop 65 warnings. Setlement payments included a $200,000 civil penalty and $200,000 in attorney's fees, split equally between the AG and Gottesfeld.
This page last updated January 14, 2002.
