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2004Q-0097
PDN 1
Volumes 24, 25

Petition Denial

Tab 1 - American Cancer Society, Cancer Facts and Figures, 2004. Published Material

Tab 2 - Baron JA., Beach M., Wallace, K., Grau MV., Sandler, RS., Mandel, JS., Heber D., Greenberg, EA. "Risk of prostate cancer in a randomized clinical trial of calcium supplementation." Cancer Epidemiology, Biomarkers and Prevention, 14: 586-589, 2005. Published Material

Tab 3 - Baron JA., Beach M., Mandel JS., Van Stolk RU., Haile RW., Sandler RS., Tothstein R., Summers RW., Snover DC., Beck GJ., Bond JH., Greenberg ER. "Calcium supplements for the prevention of colorectal adenomas.: New England Journal of Medicine, 340: 101-107, 1999. Published Material

Tab 4 - Benito E., Stiggelbout A., Bosch FX., Obrado A., Kaldor J., Mulet M., Munoz N. "Nutritional factors in colorectal cancer risk: a case-control study in Majorca. International Journal of Cancer, 49: 161-167, 1991. Published Material

Tab 5 - Berndt SI., Carter HB., Landis PK., Tucker KL., Hsieh LJ., Metter EJ., Platz EA. "Calcium intake and prostate cancer risk in a long term aging study: The Baltimore longitudinal study of aging. Urology, 60: 1118-1123, 2002. Published Material

Tab 6 - Bonithon-Kopp C., Kronberg O., Giacosa A., Rath U., Faivre J. "Calcium and fibre supplementation in preventation of colorectal adenoma recurrence: A randomized intervention trial." Lancet, 356: 1300-1306, 2000. Published Material

Tab 7 - Boutron MC., Faivre J., Marteu P., Couillault C., Sensesse P., Quipourt V. "Calcium, phosphorus, vitamin D. dairy products and colorectal carcinogenesis: a French case-control study." British Journal of Cancer, 74: 145-151, 1996. Published Material

Tab 8 - Boyapati SM., Shu XO., Jin F., Dai Q., Ruan Z., Gao YT., Zheng W. "Dietary calcium intake and breast cancer risk among Chinese women in Shanghai." Nutrition and Cancer, 46: 38-43, 2003. Published Material

Tab 9 - Chan JM., Giovannucci E., Anderson SO., Yuen J., Adami HO., Wolk A. "Dairy products, calcium, phosphorus, vitamin D and risk of prostate cancer." Cancer Causes Control, 9: 559-566, 1998. Published Material

Tab 10 - Chan JM., Peitenen P., Virtanen M., Malila N., Tangrea J., Albanes D., Virtamo J. "Diet and prostate cancer risk in a cohort of smokers, with a specific on calcium and phosphorus (Finland)." Cancer Causes Control, 11: 859-867, 2000. Published Material

Tab 11 - Chan JM., Stampfer MJ., Ma., Gann PH., Gaziano JM., Giovannucci EL. "Dairy products, calcium, and prostate cancer risk in the physicians' health study." American Journal of Clinical Nutrition, 74: 549-554, 2001. Published Material

Tab 12 - Duris I., Hruby D., Pekarkova B., Huorka M., Cernakova E., Bezavova T., Ondrejka P. "Calcium chemoprevention in colorectal cancer" Hepatogastroenterology, 43: 152-154, 1996. Published Material

Tab 13 - Ervin RB., Wang CY., Wright JD., and Kennedy-Stephenson, J., 2004. Dietary intake of selected minerals for the United States population: 1999-2000. Advance data from vital and health statistics; no. 341. Hyattsville, Maryland: National Center for Health Statistics. 2004.

Tab 14 - Federal Judicial Center. Reference Manual on Scientific Evidence, Second Edition, p. 93, 2000. Published Material

Tab 15 - Flood A., Peters U., Chatterjee N., Lacey JV., Schairer C., Schatzkin A. "Calcium from diet and supplements is associated with reduced risk of colorectal cancer in a prosective cohort of women." Cancer Epidemiology, Biomarkers and Prevention, 14: 126-132, 2005. Published Material

Tab 16 - Giovannucci E., Rimm EB., Wolk A., Ascherio A., Stampfer MJ., Coldizt GA., Willett WC. "Calcium and fructose intake in relation to risk of prostate cancer." Cancer Research, 58: 442-447, 1998. Published Material

Tab 17 - Graham S., Hellmann R., Marshall J., Freudenheim J., Vena J., Swanson M., Zielezny M., Nemoto T., Stubbe N., Raimondo T. "Nutritional epidemiology of postmenopausal breast cancer in western New York." American Journal of Epidemiology, 134: 552-566, 1991. Published Material

Tab 18 - Hayes RB., Ziegler RG., Gridley G., Swanson C., Greenberg RS., Swanson GM., Schoenberg JB., Silverman DT., Brown LM., Pottern LM., Liff J., Schwartz AG., Fraumeni JF. Jr., Hoover RN. "Dietary factors and risks for prostate cancer among blacks and whites in the United States." Cancer Epidemiology, Biomarkers and Prevention, 8: 25-34, 1999. Published Material

Tab 19 - Hill AB. "The environment and disease: association or causation?" Proc R Soc Med, 58: 295-300, 1965. Published Material

Tab 20 - Hyman J., Baron JA., Dain BJ., Sandler RS., Haile RW., Mandel JS., Mott LA., Greenberg ER. "Dietary and supplemental calcium and the recurrence of colorectal adenomas." Cancer Epidemiology, Biomarkers and Prevention, 7: 291-295, 1998. Published Material

Tab 21 - Ioannidis, JPA. "Contradicted and initially stronger effects in highly cited clinical research." Journal of the American Medical Association, 294: 218-228, 2005. Published Material

Tab 22 - Institute of Medicine, National Academy of Sciences. Dietary Supplements: A Framework for Evaluating Safety. Chapter 7, Categories of Scientific Evidence - In Vitro Data. National Academy Press. Washington, D.C. 2005. Published Material

Tab 23 - Institute of Medicine, National Academy of Sciences. Dietary Reference Intakes for Calcium, Phosphorus, Magnesium, Vitamin D, and Fluoride. National Academy Press. Washington D.C., 1997. Published Material

Tab 24 - Katschinski B., Nemes K., Marr A., Rump B., Leiendecker B., Breuer N., Goebell H. "Colorectal adenomas and diet: a case-control study." Digestive Disease Science, 46: 86-95, 2001. Published Material

Tab 25 - Katsouyanni K., Willett W., Trichopoulos D., Boyle P., Tricholoulow A., Vasilaros S., Papadiamantis J., MacMahon B. "Risk of breast cancer among Greek women in relation to nutrient intake." Cancer, 61: 181-185, 1988. Published Material

Tab 26 - Kneckt P., Jarvinen R., Seppanen R., Pukkala E., Aromaa A. "Intake of dairy products and the risk of breast cancer." British Journal of Cancer, 73: 687-691, 1996. Published Material

Tab 27 - Kristal AR., Standford JL., Cohen JH., Wicklund K., Patterson RE. "Vitamin and ineral supplement use is associated with reduced risk of prostate cancer." Cancer Epidemiology, Biomarkers and Prevention, 8: 887-892, 1999. Published Material

Tab 28 - Kristal AR., Cohen JH., Qu P., Stanford JL. "Vitamin and mineral supplement use is associated with reduced risk of prostate cancer." Cancer Epidemiology, Biomarkers and Prevention, 11: 719-725, 2002. Published Material

Tab 29 - Levine AJ., Harper JM., Ervin CM., Chen YH., Harmon E., Wue S., Lee ER., Frankel HD., Haile RW. "Serum 25-hydroxyvitamin D, dietary calcium intake and distal colorectal adenoma risk." Nutrition and Cancer, 39: 35-41, 2001. Published Material

Tab 30 - Lichenstein, AH. and RM. Russell. Essential Nutients: Food or Supplements? Journal of American Medical Association. 2005; 294: 351-358. Published Material

Tab 31 - Macquart-Moulin G., Riboli E., Cornee J., Charnay B., Berthezene P., Day N. "Case-control study on colorcetal cancer and diet in Marseilles." International Journal of Cancer, 38: 183-191, 1987. Published Material

Tab 32 - Marcus PM., Newcomb PA. "The association of calcium and vitamin D, and colon and rectal cancer in Wisconsin women." International Journal of Epidemiology, 27: 788-793, 1998. Published Material

Tab 33 - Martinez ME., McPherson RS., Annegers JF., Levin B. "Association of diet and colorectal adenomatous polyps: dietary fiber, calcium and total fat." Epidemiology, 7: 264-268, 1996. Published Material

Tab 34 - Martinez ME, McPherson RS., Levin B., Glober GA. "A case-control study of dietary intake and other lifestyle factors for hyperplastic polyps." Gastroenterology, 113: 42-429, 1997. Published Material

Tab 35 - Martinez ME., Marshall JR., Sampliner R., Wilkinson J., Alberts D. "Calcium, vitamin D, and risk of adenoma recurrence (United States)." Cancer Causes and Control, 13: 213-220, 2002. Published Material

Tab 36 - McCullough ML., Robertson AS., Rodriguez C., Jacobs EJ., Chao A., Carolyn J., Calle EE., Willett WC., Thun MJ. "Calcium, vitamin D, dairy products and risk of colorectal cancer in the cancer prevention study II nutrition cohort." Cancer Causes and Control, 14: 1-12, 2003. Published Material

Tab 37 - Morimoto LM., Mewcomb PA., Ulrech CM., Bostick RM., Lais CJ., Potter JD. "Risk factors for hyperplastic and adenomatous polyps: Evidence for malignant potential?" Cancer Epidemiology, Biomarkers and Prevention, 11: 1012-1018, 2002. Published Material

Tab 38 - Negri E., La Vecchia C., Franceschi S., D'Avanzo B., Talamini R., Parpinel M., Ferraroni M., Filiberti R., Montella M., Falcini F., Conti E., DeCarlo A. "Intake of selected micronutients and the risk of breast cancer." International Journal of Cancer, 65: 140-144, 1996. Published Material

Tab 39 - Neugut AI., Horvath K., Whelan RL., Terry MB., garbowski GC., Bertram A., Forde KA., Treat MR., Waye J. "The effect of calcium and vitamin supplements on the incidence and recurrence of colorectal adenomatous polyps." Cancer, 78: 723-728, 1996. Published Material

Tab 40 - Ohno Y., Yoshida O., Oishi K., Okada K., Yamabe H., Schroeder FD. Dietary beta-carotene and cancer of the prostate: a case-control study in Kyoto Japan." Cancer Research, 48: 1331-1336, 1988. Published Material

Tab 41 - Omenn G.S., G.E. Goodman, M.D. Thornquist, J. Balmes, M.R. Cullen, A. Glass, J.P. Keogh, F.L. Meyskens, B. Valanis, J.H. Williams, S. Barnhart, and S. Hammer. Effects of a combination of beta carotene and vitamin A on lung cancer and cardiovascular disease. New England Journal of Medicine. 1996; 334: 1150-1155. Published Material

Tab 42 - Peleg II., Lubin MF., Cotsonis GA., Clark WS., Wilcox CM. "Long-term use of nonsteroidal anti-inflammatory drugs and other chemopreventors and risk of subsequent colorectal neoplasia." Digestive Disease Science, 41: 1319-1326, 1996. Published Material

Tab 43 - Peto, R., R. Doll, J.D. Buckley, M.B. Sporn. Can dietary beta-carotene materially reduce human cancer rates? Nature. 1981; 290: 201-208. Published Material

Tab 44 - Schatzkin A., Freedman LS., Dawsey SM., Lanza E. "Interpreting precursor studies: what polyp trials tell us about large bowel cancer." Journal of the National Cancer Institute, 86: 1053-1057, 1994. Published Material

Tab 45 - Schuurman AG., van der Brandt PA., Dorant E., Goldbohm RA. "Animal products, calcium, and protein and prostate cancer risk in the Netherlands cohort study." British Journal of Cancer, 80: 1107-1113, 1999. Published Material

Tab 46 - Sellers TA., Bazyk AE., Bostick RM., Kushi LH., Olson JE., Anderson KE., Lazovich D., Folsom AR. "Diet and risk of colon cancer in a large prospective study of older women: an analysis stratified by family history." Cancer Causes and Control, 9: 357-367, 1998. Published Material

Tab 47 - Sempos, C.T., K. Liu, and N.D. Ernst. Food and nutrient exposures: what to consider when evaluating epidemiologic evidence. American Journal of Clinical Nutrition. 1999; 69: 1330S-1338S. Published Material

Tab 48 - Shin MH., Holmes MD., Hankinson SE., Wu K., Colditz GA., Willett WC. "Intake of dairy products, calcium, and vitamin D and risk of breast cancer." Journal of the National Cancer Institute, 94: 1301-1311, 2002. Published Material

Tab 49 - Silker, B. Guide to Clinical Studies. Raven Press, New York, New York, 1991. Published Material

Tab 50 - Szklo M. and Nietro FJ. Epidemiology Beyond the Basics, Aspen Publishing, 2000. Published Material

Tab 51 - The Alpha-Tocopherol; Beto Carotene Cancer Prevention Study Group. The effect of vitamin E and beta carotene on the incidence of lung cancer and other cancers in male smokers. New England Journal of Medicine. 1994; 330: 1029-1035. Published Material

Tab 52 - Tavani A., Gallus S., Franceschi S., La Vecchia C. "Calcium, dairy products, and the risk of prostate cancer." Prostate, 48: 118-121, 2001. Published Material

Tab 53 - Tseng M., Murray SC., Kupper LL., Sandler RS. "Micronutrients and the risk of colorectal adenomas." American Journal of Epidemiology, 144: 1005-1014, 1996. Published Material

Tab 54 - Tzonou A., Signorello LB., Lagiou P., Wuu J., Trichopoulou A. "Diet and cancer of hte prostate: a case-control study in Greece.: International Journal of Cancer, 80: 704-708, 1999. Published Material

Tab 55 - Vlajiniac HD., Marinkovic JM., Ilic MD., Kocev NI. "Diet and prostate cancer: a case-control study." European Journal of Cancer, 33: 101-107, 1997. Published Material

Tab 56 - Van 't veer P., van Leer EM., Riedijk A., Kok FJ., Schouten EG., Hermus RJ., Sturmans F. "Combination of dietary factors in relation to breast cancer ocurrence.: International Journal of Cancer, 47: 649-653, 1991. Published Material

Tab 57 - Whelan RL., Horvath KD., Gleason NR., Forde KA., Treat MD., Teitelbaum SL., Bertram A., Neugut AI. "Vitamin and calcium supplement use is associated with decreased adenoma recurrence in patients with a previous history of neoplasia." Diseases of the Colon and Rectum, 42: 212-217, 1999. Published Material

Tab 58 - White E., Shannon JS., Patterson RE. "Relationship between vitamin and calcium supplement use and colon cancer." Cancer Epidemiology, Biomarkers and Prevention, 6: 769-774, 1997. Published Material

Tab 59 - Willett, W.C. (1990). Overview of nutritional epidemiology. In Nutritional Epidemiology, (Oxford, United Kingdom: Oxford University Press), pp.16-17. Published Material

Tab 60 - Willett, W.C. (1998). Issues in analysis and presentation of dietary data. In Nutritional Epidemiology, Second Edition, (Oxford, United Kingdom: Oxford University Press), pp.339-340. Published Material

Tab 61 - Wilson, E.B. An Introduction to Scientific Research, pagse 46-48, Dover Publishing, 1990. Published Material

Tab 62 - Wu AH., Paganini-Hill A., Ross RK., Henderson BE. "Alcohol, physical activity and other risk factors for colorectal cancer." British Journal of Cancer, 55: 687-694, 1987. Published Material

Tab 63 - Wu K., Willett WC., Fuchs CS., Colditz GA., Giovannucci EL. "Calcium intake and risk of colon cancer in women and men." Journal of the National Cancer Institute, 94: 437-446, 2002. Published Material

Tab 64 - Yang CY., Chiu HF., Chiu JF., Tsai SS., Cheng MF. "Calcium and magnesium in drinking water and risk of death from colon cancer." Japanese Journal of Cancer Research, 88: 928-933, 1997. Published Material

Tab 65 - Yang CY., Chiu HF. "Calcium and magnesium in drinking water and risk of death from rectal cancer." International Journal of Cancer, 77: 528-532, 1998. Published Material

Tab 66 - Zaridze D., Lifanova Y., Maximovitch D., Day NE., Dufffy SW. "Diet, alcohol consumption and reproductive factors in a case-control study of breast cancer in Moscow." International Journal of Cancer, 48: 493-501, 1991. Published Material

Tab 67 - Zhang Y., Kiel DP., Ellison RC., Schatzkin A., Dorgan JF., Kreger BE., Cupples LM., Felson DT. "Bone mass and the risk of prostate cancer." American Journal of Medicine, 113: 734-739, 2002. Published Material

Footnotes

Tab 1 - (Footnote 1) Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements, July 10, 2003. http://www.cfsan.fda.gov/~dms/nuttf-e.html

Tab 2 - (Footnote 3) Interim Evidence-based Ranking System for Scientific Data, July 10, 2003. http://www.cfsan.fda.gov/~dms/hclmgui4.html

Tab 3 - (Footnote 5) Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements, December 22, 1999.http://www.cfsan.fda.gov/~dms/ssaguide.html

Tab 4 - (Footnote 11) Agency for Healthcare Research and Quality, Systems to Rate the Strength of Scientific Evidence, Evidence Report/Technology Assessment No. 47, March 2002. http://www.ahrq.gov/clinic/epcsums/strengthsum.htm#Contents

Tab 5 - (Footnote 13) www.nci.nih.gov/cancertopics/commoncancers, National Cancer Institute, Common Cancers, Sections on Breast Cancer, Colon and Rectal Cancers, and Prostate Cancer.


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