Document 44jDpx4baEQa5Yq120abZoKXa

# April 1995 David A. Kessler, M.D. Commissioner Food and Drug Administration, 12420 Parklawn Drive Rockville, MD 20857 Room 1-23 95APR 12 PH 12: 52 Dear Dr. Kessler: This letter is in support of the petition submitted by the Cancer Prevention Coalition, Inc. (CPC); docket number 94P-0420/CP 1, filed on 11/17/94. This petition requests that the Commissioner of Food and Drugs require that all cosmetic talc products bear labels with a warning such as "Talcum powder causes cancer in laboratory animals. Frequent talc application in the female genitalia area increases the risk of ovarian cancer." There is a very large amount of literature on the research that has been done this topic. Current research indicates a strong association between the use of talcum powder in the female genitalia area and ovarian cancer, despite the lack of a conclusive, direct link, as "proven" by research. With such a vast literature on the subject, I am astounded that talc is still being used in products, such as feminine deodorant sprays and powders, as well as many brands of condoms. While talc is still being used in these types of products, despite existing literature, that repeatedly links genital talc use and ovarian cancer, I find it absolutely negligible that these products carry no warnings as to the danger of talc. It is the right of women to be warned of the possible association, and I hope that you will strongly consider this citizen's petition. 3 4 3 0 n . b'lame Place #11 Chicago, IL 60657 ccs Samuel M. Epstein, M.D. Cancer Prevention Coalition 520 N. Michigan Avenue Chicago, IL 60610 5 April 1995 Marion Merrill Dow Clomid Marketing Department 9300 Ward Parkway P.0. Box 9627 Kansas City, MO 64134-0627 To Whom it May Concern: This letter is regarding my request for any consumer and medical information on the product known as Clomid. from your organization. I am a graduate student at the School of Public Health, University of Illinois at Chicago, and I am looking into the association between clomiphene citrate, and ovarian cancer. I called your organization, with my requests, at the end of March, and upon explaining my intentions, I was directed to the employees who could provide me the information I was seeking. I was treated with courtesy and respect, and was assured that the relevant information would be sent to me. I want to commend your polite and professional staff, and thank you for your cooperation. Please consider this letter a formal request for any information you can provide, on your product, Clomid. that might assist me in my research on this very important topic. Your diligent attention and cooperation are greatly appreciated. .Qi n fo rel \r 3430 N. Elaine Place #11 Chicago, IL 60657 cc: Samuel M. Epstein, M.D. Cancer Prevention Coalition David A. Kessler, M.D. Commissioner, Food and Drug Administration 5 April 1995 Robert Lederer Vice President, Marketing Serono Laboratories 100 Longwater Circle Norwell, MA 02061 Dear M r . Lederer: This letter is regarding my attempts to attain some consumer and medical information on the product known as Serophene. from your organization. I am a graduate student at the School of Public Health, University of Illinois at Chicago, and I am looking into the association between clomiphene citrate, and ovarian cancer. I started my inquiries, by phone, during the middle of March, 1995. Upon explaining my intentions, and requesting any available information, and/or further reference resources, I was transferred to several different people, one of which was Mr. Steve Eby. Mr. Eby was to have directed my inquiries to an employee who could provide the information I was requesting, however, I have not heard from any Serono employee since my last conversation with Mr. Eby in March. Please consider this letter a formal request for any information you can provide, on your product, Serophene. that might assist me in my research on this very important topic. Your diligent attention and cooperation are greatly appreciated. w xv j j x rim k fjr 3430 N. Elaine Place #11 Chicago, IL 60657 ccs Samuel M. Epstein, M.D. Cancer Prevention Coalition David A. Kessler, M.D. Commissioner, Food and Drug Administration jC3y4HL3KI0E^.GRO,EELILEA.INTE6E0MP6IB5AY7CE #11 DOAOVMICDIISAS.IGNKEESRSLER, M.D. FOOD ND DRUG ADMINISTRATION, ROOM 1-23 12420 PARKLAWN DRIVE ROCKVILLE, MD 20857