Document 2NKr8BBKGK329xjxbnJmZ19ba

FILE NAME: Talc (TALC) DATE: 1994 Nov 17 DOC#: TALC094 DOCUMENT DESCRIPTION: Cancer Prevention Coalition Press Release - Dusting with Cancer CANCER PREVENTION COALITION 520 NORTH MICHIGAN AVENUE SUITE 410 CHICAGO, IL 60611 312-467-0600 FAX 312-467-0599 BOARD OF DIRECTORS Ire Arlcok Judith Brody Irvm Brass, Ph.D Samuel Eastern. M.D Clamai Jcy fe'Cmcn Jc o Geiger M D GiiliCh Geocmen Viikcm LijinsKy Ph.D Thomes Mcncusc, M.D Pete' Orns. m D Ernest Sterngloss. Ph.D. STAFF Keith Ashaown Cammumccocns Jill Cesnen Research, Jon Krclcvec Director PRESS RELEASE Embargoed for Release Novem ber 17, 1994 Contact: Keith Ashdown 312-467-0600 DUSTING WITH CANCER COALITION URGES CH ICA G O DRUG STORES TO LABEL TALC Chicago - According to the Cancer Prevention Coalition the regular use of talc increases the risk of ovarian cancer. The Cancer Prevention Coalition (CPC) w ill announce its plans for a talcum powder labeling initiative here in Chicago at a Thursday, November 17, 1994 press briefing. Speakers at the press briefing will include CPC Chair Dr. Samuel Epstein, CPC board members Dr. Quentin Young and Dr. Peter Orris, and an ovarian cancer survivor. The speakers w ill explain why a labeling initiative is important to residents of Chicago, and will also answer questions from the press. Recently, CPC sent letters to the Chicago corporate offices of Osco and Walgreen drug stores uroin that they provide customers with information on the dangers associated with the use 0ftalc. Additionally, CPC is filing a petition with the FD A requesting that talc products be explicitly labeled.* The use of talc poses a serious risk of ovarian cancer. Estimates are that up to 17 o of Am erican women regularly use talc in the genital area. Women have been compelled, through advertisements of the cosmetic industry, to dust themselves to mask odors. Talcum powder has historically been a symbol of freshness, cleanliness and punty.Talc is even more commonly used on infants. Ovarian cancer is a silent killer. It causes 38 deaths daily among American women - totalling 14,000 deaths annually. It is the fourth highest w om en's cancer death rate in the U.S. Over 60% of ovarian cancer victims die within five years of diagnosis. (more) Cancer prevention through reduction cr carcinogens m o r water, food, consumer products and the worlsplac "Studies seem to indicate that talc poses an increased risk factor for Ovarian Cancer, thus I would support a warning label to alert women to this possible risk," stated Diane Farrell, a Chicago resident who has been fighting ovarian cancer for the last two years. According to Dr. Samuel Epstein, of the Cancer Prevention Coalition, "A wide range of scientific studies over the last three decades have clearly linked regular talc use by women and ovarian cancer." The talc labeling project is the first phase of a "Consumer Labeling Initiative" that will inform citizens of the presence of undisclosed carcinogenic ingredients and contaminants in cosmetics, other consumer products, and food and how to avoid them. W H EN : Thursday, November 17, 1994 at 10:30 a.m. W H A T: Press briefing to announce the talc labeling initiative W HERE: Cancer Prevention Coalition, 520 North Michigan, Suite 410 PHO TO O P P O R TU N IT Y : CPC Board members, ovarian cancer survivor, products that contain talc, and a poster size version of a proposed label. # # # , The Cancer Prevention Coalition is a Chicago-based national organization of leading , independent experts on cancer prevention and public health together with citizen activists, organized labor, public interest and women's cancer groups.* *The New York-based Center for Constitutional Rights, one of the nation's leading public interest legal organizations in the country, will be acting as CPC's legal counsel. Citizen Petition Seeking Carcinogenic Labeling on all Cosmetic Talc Products. 17 November 1994 David A. Kessler, M.D. Commissioner Food and Drug Administration, 12420 Parklawn Drive Rockville, MD 20857 Room 1-23 The undersigned submits on behalf of the Cancer Prevention Coalition, Inc. (CPC), Samuel S. Epstein, M.D., Chair and National Advisor of the Ovarian Cancer Early Detection and Prevention Foundation (OCEDPF), Nancy Nehls Nelson, member of the Ovarian Cancer Early Detection and Prevention Foundation, Peter Orris, M.D. and Quentin Young, M.D. This citizen petition, is based on scientific papers dating back to the 1960s which warn of increased cancer rates resulting from frequent exposure to cosmetic grade talc . The undersigned submits this petition under 21 U.S.C. 321 (n) , 36i 362, and 371 (a); and 21 CFR 740.1, 740.2 of 21 CFR 10.30 of the Federal Food, Drug, and Cosmetic Act to request the Commissioner of Food and Drugs to require that all cosmetic ta c products bear labels with a warning such as "Talcum powder causes cancer in laboratory animals. Frequent talc application m the female genital area increases the risk of ovarian cancer. A. AGENCY ACTION REQUESTED. This petition requests that FDA take the following action: (l) Immediately require cosmetic talcum powder products to bear labels with a warning such as "Talcum powder causes c a n c e r in laboratory .animals. Frequent talc application in the female genital area increases the risk of ovarian cancer. (2) Pursuant to 21 CFR 10.30 (h)(2), a hearing at which time we can present our scientific evidence. o ci-atc n-r11' of Grounds Ovarian cancer is Che fourth approximately U.S., scribing approximately 22' is , difficult to detect 14, women this year. making the survival rate very at the early stages of the d ^ cases can be attributed low. only three percent avoiaable risk factors for ovarian ranees " ly us": ol S c u m powder in the genital area, lv l96i Research done as ear y , similar to talc and asbestos part exterior genital area to the w a n has shown that particles, can translocate from the , women.s...S These findings o morCality from provide - P P " \ t V h:ir aS ^ * r , `- Minute P i o l e s ovarian cancer in female bo translocate through the female such as talc are able foreign body reactions in the ovary, reproductive tract and cause foreign * evidence, dating back p There is a large body of o cosmeCio calc -- - - - - - " " > r; , r v . r : r t s " r ; "s a....fxher co predominantly talc but fibrous material am0unts of tremolite, probably contame m tile [asbestos-like r r ^ f i ^ t h e s e ^ a r e ofytenC present in fibrous fibers] deDOSits...Unknown significant talc mineral dePoslC ln products that may amounts of such without precauciono creata an j h z n Cancer Statistics, l - 9 cancer riI* - gh,r.f, SYngSgl- - 2 d r DW Bell 0 *. welch TO. -Perineal exposure to t.lc a 2Harlow BL, Cramer ow, B e n u*. 15,3 3 igu newton M, -- ' , in ch. human tsmal. productive tract.- r T 'I l H erlliK. transport of carbon particle, in the huma T M. -Migration of p.rtioul.t. radioactive trat.r from the vegina to the peritoneal cavity - Jan'.- dMlon/cr.cion of migration of talc from cn. SH.nd.rson, Hamilton TC. ayli. MS, ^ j a a a S . 0 ; 3 4 7 -1 S0 . l.M- vagina and posterior uterus to the ovary i -i Mir mx scudy of che mottiut/ 6*Nvhouee mMLl . BBeerrrryy 0 m . . Weg*ner JC, Turo* MB. * scuoy asbesto, worker,.- 29: 134-141. W l - . n;.. . Til1,||ffrrial Mjd. 39' 34-1, , vi -Mortslity of female gas "sk assemblers^ Tlr." T T"'1"" --" 7wignaU at. POX AJ. Mortslity o , ^ ,to ^ , , curl 9 !rot unsuspected problem.* As a follow-up to samples of c o , a n d * ' pharmaceutical powders between i^I-lP97WS I s e e A ^ p e n d L I) The study conduced: rale was r.ot used ...cosmetic grade these products i ,,.iv Th presence m these pr ^ : r b e o - h o p h y l l i c e - d - emditeo . a regu a also recommend determine the associated with taic.. that evaluation be made to th^ health hazards P thse products."10 the use of these p.o with or without the presence of Talc is a carcinogen, National Toxicology Program ssbestos-lika t U . ; of non-asbastiform talc and found published a study on the clear evidence of carcinogenic act.vx y _i_ted states has found t- rancr research it. the C r-0iication in the genital conclRu_sive\ly thau ffv-oerquueetnt. talcum powdledrci^;n-'c- ovarian 12,13.1*^ cancer. increases a woman's risx or Vication directly to the et a1 -, suggested tnat ta_ -- ; might lead to talc T - t V -4 a around the time or ovul~ s substance of the ovary gen_'-- & . deec^Y imbedded in t.u n .r^ r i e s becoming deep_y (granulomas) capable of and "perhaps u e .lS1, causing growth or epiune.ia. calc use directly on the Harlow, et aI., found that frequent -------------- --------- " ----------------------- . ,, ravMM, GroC3OK. L*l.--w.--^-. Un.ugcOo AIM. . ' ___ T 29: 150-15. 13iJ- 19<>- and m u - .- ' c o n s .n e efi c o sm .c lo s .l c u p ro d u c e s.* 40 * r ia r o u s nd m-- - - to . _____ _ Qowd.rs: ^ ^ iaa.e-Bt. -cansum --leu. -- .... - -- -M.cicn.1 e^c o l o g y ^ tsssss asear sue. (Inalcuon scudissl. T I1 1 " t fALe A , . > . K o o v r A. U ..K .C o p . M = c - n 0 . T 1 sssts^~ ~ ....... ., _ . . e.,r. .TAMA. ISO: I l9*3- o vacian eaaeo- of * .U . -- * - , ^ 11 32JAaaos.nns3al*ce-.- r*,*. sS i-liad * o . N. dSooa*. .nn*n. n*.4i nA . - U-- . .435:: 2Z30--ZIS5., 11999911.. H i r a . - M S acio * Ob. p o s u r. nd - - . . . . . uHoainiddrrilecxxsjoonnMH.. * P .c s o n * l . j J u n g 3 t . B a i l o flQ* d e t o b a c c o . <=" * * - t x p o i u r o o co e a le u * O***- 1 4 w r ,i- - - - .n v r . AS. U ML. .5 * \ ' l , J . ; i a Cd s o . p i = h . U l o v a r i a n S n c . . . and nvj.rono.nsAl snrc-. ^ . 2...:.,:. n n illi-U*0. `9aa- alconol. nd cot:.-* 22 T *-L- 15 iarlow, 199Z* 15 a i d . . c c ^-lo: i -L-u.w* CV. *0vc*aA sc*f 1 7 ^ , 0,, . ,, . l e a w . S c u l l y . H o j c t .c h o v s i c . CA. J 7 . 19SI. . 3 . c s. concrol scudy* C * W* , n increased a woman's risk threefold, genital area during ovulation inoreased That study also found: th d of talc exposure was "ThS mOSCafra S t i n g powder directly to the UpeSrei-naeSum '[rgJeintitaall.s]! ...-Brand orcl genaenrdicuas"btahbey powder" was used most qu ^ sCaCistically ^ i S a n r S l o r ovarian cancer." ` in Harlows report, calc use and ovarian oancer: to identified and compared to 23 9 ^ women with no sign of oblems. Through personal ovarian cancer or relate P the control group interviews, Harlow, <:*. l i c a t i o n t o the perineum.- This reported frequent talc number of women in the percentage is useful in calc in the genital area on general population exposed " " " eludes: a regular basis. Harlow, et a l ., cone cho ooor prognosis for ovarian ...given the poor P 9 harTtlful exposures =" "= h " av o w e d pirticularly those with should be avoided, p th^s reason, we limited be" flutsse of talc in genital hygiene, particularly as a daily habit." deariy, mTy n o ^ ^ t h e ' r i s k of ovarian cancer from daily use. We^telT-^ r rTajm for C II -`-rnn'nl 10H i i asserted pursuant to 21 A Claim for categorical exclusion is asse P CFR 25.24 (a) (H) p, certification . ,. that: to the best knowledge and ,, ,, . r v r "' t sr, are unfavorable to the petition -- -- - -- 18Harlow, H U - 4 This petition is submitted, by. _ Jill A. Cashen Samuel S. Epstein, M.D. Cancer Prevention Coalition 520 North Michigan Avenue, Suite 410 Chicago, Illinois 60611 312.467.0600 - phone 312.467.0599 - fax Council to the Cancer Prevention Coalition: Center for Constitutional Rights Michael E. Deutsch, Legal Director 666 Broadway New York, NY 212-614-6427 10012 5 APPENDIX I : informal survey of talc products in Chicago Results from an drug stores. Rahv Powders Johnson 4 Johnson Baby Powder (Johnson 4 Johnson, Skillman, NJ> Contains: TALC, fragrance Oaco Brand Baby Powder (Osco Drug, Oak Brook, IL) Contains: TALC, fragrance Rndv powders ; Jean Hate Perfumed Talc (Revlon, New York, NY) fraoranoe Contains: TALC, kaolin, magnesium carbonate, fragrance. qhnwer to Shower (Johnson & Johnson, Skillman, NJ) Contains: TALC, cornstarch, sodium bicarbonate, polysaccarides. fragranc polysaccarides. Ammens Medicated Powder (Bristol-Myers Squibb New York, Contains: Zinc oxide, cornstarch, fragrance, isostean acid, PPG-20, methyl glucose ether, TALC. Cashmere Bouquet Perfumed Powder (Colgate, N e w ^ Contains: TALC, magnesium carbonate, zinc stearat , fragrance. s : t r s r r i ) s n i. methyl salicylate, salicylic acid, TALC, thymol, z stearate. Fminin** product Si. Vagisil Feminine Ppwder (COMBE, Inc.,White Plains, NY^ 9 contains: Cornstarch, aloe mineral oil magnesium stearete, silica, benzthonium chloride, fragrance. V a g i n Fminin. Powder (Schmid Laboratories,Sarasoea, FL) Contains- Zinc oxide, cornstarch, fragrance, _ hydroxquinoline, 8-hydroxquinoline sulfate, isostearic PPG-20, methyl glucose ether, TALC. acid, Summer's Eve Feminine Powder <CB Fleet Co. .Lynchburg, VA) Contains: Cornstarch, tricalcium phosphate, oxoxynol-9, benzthonium chloride, fragraence. FDS Feminine Deodorant Spray (Alberto Culver, Melrose Park, IL) Contains: isobutane, isopropyl myristate, cornstarch, mineral oil, fragrance, lanolin alcohol, hydrated silica, magnesium stearate, benzyl alcohol.