Document rBaRarEM7wOm0q6peDONwOn87

DEPARTMENT OF & HUM AN SERVICES Public Health Service Food and Drug Adm inistration W ashington D C 20204 July 11, 1995 Jill Cashen Cancer Prevention Coalition 520 North Michigan Avenue Suite 410 Chicago, IL 60611 Dear M s . Cashen Re^ Docket No. 94P-0420 This letter is in response to your citizen petition, dated November 17, 1994 and filed on November 23, 1994, which requests that the Food and Drug Administration (FDA) require that all cosmetic talc products bear warning labels stating that talcum powder causes cancer in laboratory animals and that frequent talc application in the female genital area increases the risk of ovarian cancer. The purpose of this response is to advise you, in accordance with 21 CFR 10.30(e)(2), that we have not been able to reach a decision on your petition within the first 180 days of the filing of the petition because of the limited availability of resources and other agency priorities. Sincerely yours AAAjO/y ^ J s- John E. Bailey, Jr., Ph.D. Acting Director Office of Cosmetics and Colors Center for Food Safety and Applied Nutrition HFS-100 200 "C" Street, S.W. Washington, D .C . 20204 1erA