Document kmMnGGV0Qq1vVn62bEgKEdKp0

April 1, 1996 M s . Jill Cashen Cancer Prevention Coalition 520 North M ichigan Avenue Suite 410 Chicago, IL 60611 is r_>-' Re: Docket No. 94P-0420 D ear M s. Cashn: T his letter is in response to your citizen petition referenced above. In this petition you request that th Commissioner o f the Food and Drug Adm inistration require all cosm etic talc products to bear labels with warning statem ents such as "Talcum powder causes cancer in laboratory anim als. Frequent talc application in the female genital area increases the risk o f ovarian cancer." In the petition, you cite published literature in support o f your request. Under the Code o f Federal Regulations (CFR), 21 CFR 10.20(c): Information referred to or relied upon in a submission is to be included in full. We, therefore, ask that you subm it copies o f all articles referenced in the petition to fulfill the requirements for a petition. W e are enclosing copies o f the relevant regulations requiring this subm ission: 21 CFR 10.30(b), 10.20(c)(1) and (c)(6), and 510.95. Please send all articles referenced in your petition to: Lark A Lambert Food and Drug Administration (H FS-106) 200 C St. S.W . W ashington, D .C. 20204 9 L/P'oyz Page - 2 - Cashen W e, in turn, will forward these materials to the FDA Dockets M anagem ent Branch. Sincerely yours, Lark A Lambert Office o f Cosm etics and Colors Center for Food Safety and Applied N utrition Enclosures cc: HFA-305 (Docket N o. 94P-0420/CP 1) H FS-100 (Bailey) H FS-105 (Decker) H FS-106 (Lambert, Fe) H FS-125 (Dennis) H FS-127 (Havery) H FS-128 (Bronaugh) R/D :H FS-106:LALam bert:3/29/96:202-205-4095 Revised: H FS-125:D A D ennis:4/l/96 c:\w pdocM etters\cashen.tlc Finalized:M G raves:205-4494:04/01/96