Document M0XyKJ8NGOQ4wz28aqd7VNLL

i IT # September 26, 1995 Cancer Prevention Coalition Fighting for o safer environment at home, in the community and at work 5 2 0 N. MICHIGAN AVENUE SUITE 410 CHICAGO, IL 60611 312-467-0600 FAX 312-467-0599 INTERNET: cpc@igc.apc.org BOARD O F DIRECTORS Iro Ariook Judith Brody Irwin Bross, PhD Jay Feldm an Jodi Geiger, AAD Gillian Goodm an William Lijinsky, PhD Thomas Mancuso, MD Gary Null, PhD Sandra Steingrober, PhD David Steinmon . Ernest Stemglass, PhD Quentin Young, M D Samuel Epstein, MD Chairm an STAFF Keith Ashdow n Jill Cashen Benjamin Lilliston ADVISO RY BOARD U.5. Rep. John Conyers Edwofd Goldsmith Hon. Gaylord Nelson Studs Terkel Nobel Laureate G eorge Wald Sep l ** Commissioner David Kessler (By fax and mail) Food and Drug Administration 5600 Fischer Lane E^C u Rockville, MD 20857 i ii ob t D ear Commissioner Kessler, kaOy O In a September 21 press conference in W ashington D C., the Cancer Preve^SJon^ Coalition (CPC) along with Ralph N ader, released a "Dirty Dozen" list o f ^ consumer products; cosmetics and toiletries; foods and beverages; and also ^ ^ Tfv, '--pi o household products. The list detailed information on a w ide range o f undisclosed toxic and r*2-Ep-m cft ^ zrn- ' carcinogenic ingredients and contam inants in foods and summarized undisclosed Ti information on their hazards, and also on the hazards o f cosmetics. Responding to the "Dirty Dozep" list, FD A spokeswoman Betsy Adams is quoted in a 9/21 R euters news story as saying, "The Food and D rug Administration believes that all these products are generally safe under conditions for normal use." In further clarification o f FDA's position, I w ould appreciate your confirmation that there is no FDA requirem ent for any pre-m arket safety testing o f cosmetics. Could you also confirm that there is no requirem ent for labelling cosmetics and food for any known risks relating to their content o f toxic and carcinogenic ingredients and contaminants (w ith the exception o f saccharin in diet foods). W ould you also comment on the fact that FDA has still taken no action to require disclosure o f the contam ination o f cosm etics w ith carcinogenic nitrosamines, nor o f any warning o f their cancer risks in spite o f the following considerations: In 1979 (FR April 10, 1979), FD A published a notice calling for the cosmetic industry to rem ove triethanolam ine (TEA) and diethanolamine (DEA), which interact w ith nitrite preservatives or contaminants to form carcinogenic nitrosamines. Following pressure by the German Federal Health Office in 1987, the German cosm etic industry phased out their use o f DEA and TEA, and thereby reduced cancer risks o f these products. o y o  In 1988, FDA issued a `'Progress Report" w arning o f the presence o f nitrosamines in 37 percent o f cosmetics tested. I enclose the following Citizen Petitions: with regard to risks o f ovarian cancer following the use o f talcum pow der (filed 11/17/94); and with regard to risks o f childhood cancer following the consumption o f nitrite-hot dogs (filed 4/27/95). In these petitions, CPC details the scientific basis o f these concerns. Apart from formal acknowledgement, w e have not yet received any response to these petitions. W ould you also kindly explain what are the "conditions o f normal use" which would ensure the safety o f cosmetic talc and nitrite-hot dogs. I await a reply at your early convenience. Sincerely, Samuel S. Epstein, MD Chairman, Cancer Prevention Coalition cc. Ralph N ader 2 Citizen Petition Seeking Labeling of Nitrite-Preserved Hot Dogs For Childhood Cancer Risk. April 25, 1995 David A. Kessler, M .D. C om m issioner Food and D rug Administration, Room 1-23 12420 Parklawn Drive Rockville, MD 20857 The undersigned submits on behalf o f the Cancer Prevention Coalition, Inc. (CPC), Samuel S. E pstein, M .D ., Chair, and on behalf o f the Center for C onstitutional Rights, Michael Deutsch, Esq., Legal D irector. This citizen petition is based on accum ulating scientific information on excess risks o f childhood brain tum ors and leukemia from the consum ption o f hot dogs containing nitrite preservatives. The undersigned submits this petition under 21 U .S.C. 321 (n), 361, 362, and 371 (a); and 21 CFR 740.1,740.2 o f 21 CFR 10.30 o f the Federal Food, D rug, and Cosm etic A ct to request the Commissioner o f the Food and Drug Administration (FDA) to label hot dogs that contain nitrites with a cancer risk warning. A. Agency Action R equested This petition requests th at FD A take the following action: . (1) Immediately require nitrite-containing hot dogs to be labelled w ith warnings such as "hot dogs containing nitrites have been shown to pose risks o f childhood cancer." (2) Pursuant to 21 CFR 10.30 (h) (2), a hearing at which tim e w e can present our scientific evidence. B. Statem ent o f G rounds N itrites are w idely used as preservatives in hot dogs, besides other m eat products. Nitrites combine with amines naturally present in meat to form carcinogenic N -nitroso compounds. UA4 Nnitrosodimethylamine has been identified in nitrite-preserved m eat products.** There is overwhelming evidence on the carcinogenicity o f N-nitrosodimethylamine in animal experim ents.7 Furthermore, epidemiologic evidence has associated N -nitroso carcinogens w ith cancer o f the oral cavity, urinary bladder, esophagus, stom ach and brain.*'9,10 There is substantial evidence on the risks o f childhood cancer from the consum ption o f meats containing nitrites.11,12'13 In 1982, Preston-M artin, e ta i found that "consumption during pregnancy o f meats cured with sodium nitrite has been associated w ith development o f brain tumors in the offspring."14 Recent case-control studies have confirmed the risks o f cancer from consumption o f hot dogs. Eating many hot dogs by children, as well as maternal hot dog consumption during pregnancy, has been shown to be associated with brain cancer and leukemia in children. 1516117 Bunin, etal. studied children who were diagnosed w ith brain cancer before age six, between 1986 and 1989. O f 53 foods and beverages and three alcoholic beverages consumed by mothers during pregnancy, only hot dogs were associated with an excess risk o f childhood b ra n tum ors.1* Sarusua and Savitz studied 234 childhood cancer cases in Denver and found a strong association between the consumption o f hot dogs and brain cancer. Children bom to mothers who consumed hot dogs one or more times per week during pregnancy had approximately double the risk o f developing brain tumors. Children who ate hot dogs one or more times per week w ere also at higher risk o f brain cancer. In addition, children who ate hot dogs and took no vitamins, which retard the formation o fN-nitroso carcinogens, w ere m ore strongly associated with both acute lymphocytic leukemia (ALL) and brain cancer.19 Sarusua and Savitz concluded: T h e results linking hot dogs and brain tum ors (replicating an earlier study) and the apparent synergism betw een no vitamins and meat consum ption suggest a possible adverse effect o f dietary nitrites and nitrosam ines."20 Peters, et aL studied the relationship between the intake o f certain foods and the risk o f leukemia in children from birth to age 10 in Los Angeles County between 1980 and 1987. The researchers found thrd children who ate 12 o r more hot dogs per month had approximately nine times the normal risk for developing childhood leukemia. A strong risk for childhood leukemia also existed for those children w hose fathers' intake o f hot dogs w as 12 o r more per month.21 Peters, et aL concluded: "Our results provide evidence for an association between consumption o f hot dogs and risk o f childhood leukemia. Adjustments for all factors thought to be potential confounders did not affect these associations. Independent risks w ere associated with both children's and fathers' consumption. . .The findings, if correct, suggest that reduced consumption o f hot dogs could reduce leukemia risks, especially in those consuming the m o st.n22 These findings are o f particular significance considering a 38 percent increase in the incidence o f brain and nervous system cancers in children from 1973-1991.23Brain tum ors account for about one in five childhood cancers.24 2 C. Claim for Categorical Exclusion A claim for categorical exclusion is asserted pursuant to 21 CFR 25.24 (a) (11). D. Certification The undersigned certifies, that, to the best know ledge and belief o f the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitioner w hich are unfavorable to the petition. This petition is submitted by: Benjamin S. Lilliston Samuel S. Epstein, M .D. Cancer Prevention Coalition 520 N orth M ichigan Avenue, Suite 410 Chicago, Illinois 60611 312-467-0600 - phone 312 -4 6 7 -0 5 9 9 - f e x Signature o f petitioner4321* D ate Signature o f petitioner D ate Council to the Cancer Prevention Coalition: M ichael E Deutsch, Esq. Legal D irector C enter for Constitutional Rights 666 Broadway N ew York, N Y 10012 212-614-6427 * E n d n o tes 1. Lijinsky W , Epstein, S. "Nitrosamines as environm ental carcinogens," Nature 225 (5 2 2 7 ):2 1 -1 2 ,1970. 2. Anonym ous. "Nitrates and nitrites in food," M edicalL etter on D ru gs < Therapeutics. 16(18): 7 5 -6 ,1 9 7 4 3 . Issenberg P. "Nitrite, nitrosam ines, and cancer," Federation Proceedings 35(6): 1 3 2 2 -1 3 2 6 ,1 9 7 6 . 4 . IARC, "Monograph on the evaluation o f die carcinogenic ride o f chem icals to humans: som e N-m troso compounds," 17:36-38,136-144,1978. 3 # 5 . Ibid. 6 . Issenberg P, "Nitrite, nitrosamines, and cancer," Federation Proceedings 35 (6): 1322-1326,1976. 7. IARC, "Monograph on the evaluation of the carcinogenic risk of chemicals to humans: some N-nitroso compounds." 8. Fraser P et al "Nitrate and human cancer: A review of the evidence." ni. J. Epidemiol, 9: 3-11, 1980. 9 . Reed PI. "The role of nitrosamines in cancer formation." Biblthca. Ntur. Dieta 37: 130-8, 1986. 10. Craddock VM, "Nitrosamines, food and cancer: assessment in Lyon," FdChem . Toxic. 2 8 (l):6 3 -6 5 ,1990. 1 1 . Preston-M artin S et al. "N-nitroso com pounds and childhood brain tumors. A case-control study." Cancer Res. 1982; 42: 5240-5 12. Bunin GR, et al. "Relation between maternal diet and subsequent prim itive neuroectodermal brain tumors in young children." H EnglJ M ed 3 2 9 :5 3 6-41,1993. 13. Buiun G R ,etal. "Maternal diet and risk o f astrocytic gliom a in children: a report from the children's cancer group (United States and Canada)," Cancer Causes & Control 5: 1 7 7 -8 7 ,1 9 9 4 . 14. Preston-Martin S. et a t "N-nitroso com pounds and childhood brain tumors: A case control study." 1 5 . B u n in G R ,e/o /, "Maternal diet and risk o f astrocytic gliom a in children." 1 6 . Sarasua S , Savitz D . "Cured and broiled m eat consum ption in relation to childhood cancer: D enver, Colorado (United States)," Cancer Causes & Control 5 :1 4 1 -8 ,1 9 9 4 . 1 7 . P e to s J, et a l "Processed m eats and risk o f d ild h o o d leukem ia (California, U SA )" Cancer Causes & Control 5: 1 9 5 -2 0 2 ,1 9 9 4 . 18. Bunin GR, e/aZ, "Maternaldiet andrisk of astrocytic glioma in children." 1 9 . Sarasua S , Savitz D . "Cured and broiled m eat consum ption in relation to childhood cancer." 20. Ibid 2 1 . Peters J, Preston-M artin S , London S , et al. "Processed m eats and risk o f childhood leukem ia (California, USA)" 22. Ibid. 2 3 . R eis L e ta l, (ed s), SEER CancerStatistics Review, 1973-199J: Tables and Graphs, National Cancer Institute. NIH Pub. N o. 9 4 -2789, Bethesda, M D, 1994, p. 428. 2 4 . Bunin, GR, et a /, "Maternal diet and risk o f astrocytic gliom a in children," 177-87. 4 Citizen Petition Seeking Carcinogenic Labeling on all Cosmetic Talc Products. 17 November 1994 David A. Kessler, M.D. Commissioner Food and Drug Administration, Room 1-23 12420 Parklawn Drive Rockville, MD 20857 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) , 361, 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 talc products bear labels with a warning such as "Talcum powder causes cancer in laboratory animals. Frequent talc application- in the female genital area increases the risk of ovarian cancer." AGENCY ACTION REQUESTED This petition requests that FDA take the following action; (1) Immediately require cosmetic talcum powder products to bear labels with a warning such as "Talcum powder causes cancer in laboratory animals. Frequent talc application in the female genital area increases the risk of ovarian cancer."2* (2) Pursuant to 21 CFR 10.30 (h) (2), a hearing at which time we can present our scientific evidence. B. S t a t e m e n t . . o f G ro u n d s Ovarian cancer is the fourth deadliest women's cancer in the U.S., striking approximately 23,000 and killing approximately 14,000 women this year. Ovarian cancer is very difficult to detect at the early stages of the disease, making the survival rate very low. Only three percent of ovarian cancer cases can.be attributed to family history.1 One of the avoidable risk factors for ovarian cancer is the daily use of talcum powder in the genital area.2 Research done as early as 1961 has shown that particles, similar to talc and asbestos particles, can translocate from the exterior genital area to the ovaries in women.3,4,5 These findings provide support to the unexpected high rate of mortality from ovarian cancer in female asbestos workers.5,7,8 Minute particles such as talc are able to translocate through the female reproductive tract and cause foreign body ^reactions in the ovary. There is a large body of scientific evidence, dating back thirty years, on the toxicity and mineralogy of cosmetic talc products. As early as 1968, Cralley et al. concluded: All of the 22 talcum products analyzed have a...fiber content...averaging 19%. The fibrous material was predominantly talc but probably contained minor amour ts of tremolite, anthophyllite, and chrysotile [asbestos-like fibers] as these are often present in fibrous talc mineral deposits...Unknown significant amounts of such materials in products that may be used without precautions may create an 1SBR Cancer SttCitti, 1973*1990. 2Harlow Bb. C t M M OH, Bell on, Helen HR. -perineal exposure to le and ovarian cascar risk.* Otoacet Gvnecol. 10: 1 9 . 2fi, 1392. 3 Egli GB, newton K,. -Th* transport o f cartoon partici* in the human eoa!* reproductive trace. ffereiliey bearli lev. 12: lSl-ISS, 1961. 4Venter FF. Iturralde M. "Migration of particulate radioactive tracer from the vagina to the peritoneal cayicy and ovari**.- S African Wad J . 33: 917-919. 197. 58enderson WJ. Hamilton TC, Baylia MS, Piarrepoint CG. Griffiths K. -The demonstration of migration of talc from the vagina and poaterior uterus to the ovary in the rat.- environ Research. 40: 247*230, 19S6.*75 5Hawhouse ML, Barry G, Wagner JC. Turok HE. -A study of the mortality of femai* asbestos workers.- Brit 3 Indust Med. 29: 134-141, 1972. 7Hignsll BK. Fox AJ. -Mortality of female gas mask assemblers.- Brit J Industrial Med. 39: 34-36, 1962. a Acheson SO, Gardner MJ, Pippard 8, Grim* LP. -Mortality of two groups of women who manufactured gaa masks from chrysotile end crocidolit asbestos: a 4Q-year follow-up." Brit J Ind Med. 39: 344-346, 1962. 2 unsuspected problem.9 As a follow-up to previous findings, Rohl, et al., examined 21 samples of consumer talcums and powders, including baby powders, body powders, facial powders and pharmaceutical powders between 1971-1975. (See "Appendix I) The study concluded: "...cosmetic grade talc was not used exclusively. The presence in these products of asbestiform anthophyllite and tremolite, chrysotile, and quartz indicates the need for a regulatory standard for cosmetic talc...We also recommend that evaluation be made to determine the possible health hazards associated with the use of these products."910 Talc is a carcinogen, with or without the presence of asbestos-like fibers. In 1993, the National Toxicology Program published a study on the toxicity of non-asbestiform talc and found clear e v i d e n c e o f c a r c i n o g e n i c activity.11 Recent cancer research in the United States has found conclusively that frequent talcum powder application in the genital area increases a woman's risk of developing ovarian cancer.12'13'14'15*17 Cramer, et al., suggested- that talc application directly to the genital area around the time of ovulation might lead to talc particles becoming deeply imbedded in the substance of the ovary and perhaps causing foreign body reaction (granulomas) capable of causing growth of epithelial ovarian tissue.1617 Harlow, et al., found that frequent talc use directly on the 9Crai1y UT, K*y m . Groth OH, Laiahare WS, Lise StM. *FIbrou* ad e Inaral eaacene o eosnecic calcue produce*.* q In d erial a w iM Anace J . 39: 350 -3 3 4 . 1 9 . 10Rohl A, U n g e r AH, SelifofE U , Tardisi A. Kllswncidis R, tcws OR, SkinaarOL. `Coadunar tilcuma and pondera: minarmi od chic*l characcariiacion. * J Taxi col Rnviron Health. 2 : 233-284, 1175. 11llciool Tcxlcology Program. --Toxicoiogy an dcarcingu*sia studia OC cole (CAS N* 14407-94-4) in F344/W rats od BSC3F, mie* (Inhalacin scudi*).* Rooorc Series 421. spcmbr 1993 12H*rcg* P, Hoovor R, L*sb*r IP. HcGowaa U. T a l e ad ovaran cancar.* leccar, JTf-A. 230: 1844, 1983. 13R a**abiatc SA, Sxfclo M, 2osa*tM a SS. *H iarm t C ibar xpoaura ad eh* dvlop **ic o ovaran c * a c r . * gvw acol Q ncel. 45: 20- 25. 1992- 14Whiecmora AS. Wu KL, pmffanbargar RS. Sari* DL, Rampare JB, Crossar S, Jng DL.. Ballon s , HndricJc*on m . -Personal ad oviroaoeaeal cbarrc*ri*cie* relatad co piciMlial varia anear- II. Sxpo*un* co calcue pewder. cobacco. alcohol, ad off.* Affi J Boldemiol. 1128: 1228-1240. 1988. . 1SHarlcw, 1992. 16B s i d . 17Cramr OW, wlch WR, Scully RS, wojciechovaki CA. -Ovaran anear and cale: a casa enrol study.* 37, 1982. * SO: 372. 3 genital area during ovulation increased a woman's risk threefold. That study also found: "The most frequent method of talc exposure was use as a dusting powder directly to the perineum [genitals] ...Brand or generic "baby powder" was used most frequently and was the category associated with a statistically significant risk for ovarian cancer." In Harlow's report, arguably the most comprehensive study of talc use and ovarian cancer to date, 235 ovarian cancer cases were identified and compared to 239 controls, women with no sign of ovarian cancer or related health problems. Through personal interviews, Harlow, et al., found that 16.7% of the control group reported frequent talc application to the perineum.18 This percentage is useful in estimating the number of women in the general population exposed to cosmetic talc in the genital area on a regular basis. Harlow, et a l ., concludes: .. .given the poor prognosis for ovarian cancer, any potentially harmful exposures should be avoided, particularly those with limited benefits. For this reason, we discourage the use of talc in genital hygiene, particularly as a daily habit." Clearly, jarge numbers ol women - an estimated 17% - are using cosmetic talc in the genital area and may not be adequately warned of the risk of ovarian cancer from daily use. C. C la im f o r C a t e g o r i c a l . E x c l u s i o n A claim for categorical exclusion is asserted pursuant to 21 CFR 25.24 (a) (11) . D r ,-Certification The undersigned /certifies, that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it Includes representative data and information known to the petitioner which are unfavorable to he petition 18 Barlow, 1592. f 4 This petition is submitted by: Jill A. Cashed Samuel S . Epstein, M.D. Cancer Prevention Coalition Michael E . Deutsch, Legal Director 6 6 6 Broadway New York, NY 10012 212-614-6427 5 DATE; OCT 02,1995 FDA CONTROL NUMBER: 958994 T R A C E R #: O S#: DATE OF CORRESPONDENCE: 0 9 /2 6 /9 5 DATE INTO FDA: 0 9 /2 9 /9 5 TO: D A V ID A KESSLER H F 4 FROM ; SA M U E L S EPSTEIN , CPC, C A NC ER PR EV EN TIO N CO ALITIO N SYNO PSIS: R EQ U E STS CLARIFICATION O F R E G U L A T IO N O F COSM ETICS A N D FO LLO W U P O N TW O C ITIZ EN PETITIO NS LEAD OFFICE: H FS-1 HOM E OFFICE: H F-40 C O N T A C T /P H O N E #: N A N C Y L T IL L E R 301-443-3428 COPIES: G E N E R A L D ISTR IBU TIO N H FA -305 C O O R D IN A T IO N : SIGNATURE REQUIRED: REFERRALS FRO M H F-40 ASSIG NED TO A C T IO N DUE DATE H FS-1 PR EPA RE D IR EC T REPLY REM ARKS: PLEASE SEN D COPY O F R ESPO N SE T O N A N C Y TILLER W ITH F D A C O N TR O L N U M BE R IN D IC ATED 1 0 /3 0 /9 5