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Dockets Management


Volume 6

Petition Denial

Buckley, D., et al. “Lutein Esters to Reduce the Risk of Age-Related Macular Degeneration and Cataracts.” Oregon Health & Science University, November 15, 2004.

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

Alberts, D.S, M.E. Martinez, D.J. Roe, J.M. Guillen-Rodriguez, J.R. Marshall, J.B. van Leeuwen, M.E. Reid, C., Ritenbaugh, P.A. Vargas, A.B. Bhattacharyya, D.L. Earnest. “Lack of effect of a high-fiber cereal supplement on the recurrence of colorectal adenomas. Phoenix Colon Cancer Prevention Physicians’ Network.” New England Journal of Medicine, 342: 1156-1162, 2000. Published Material

The Alpha-Tocopherol, Beta 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 Engiand Journal of Medicine. 1994; 330: 1029-1035. Published Material

Bonithon-Kopp C., O. Kronborg, A. Giacosa, U. Rath U. and J. Faivre., “Calcium and fibre supplementation in prevention of colarectal adenoma recurrence: A randomized intervention trial.” Lancet, 356: 1300-1306, 2000. Published Material

Cade, J. et al. Development, validation and utilisation of food-frequency questionnaires - a review. Public Health Nutrition 5 (4): 567-587. Published Material

Federal Judicial Center, Reference Manual on Scientific Evidenee, Second Edition, 2000, p. 93. Published Material

Flegal, KM. Evaluating epidemiologic evidence of the effects of food and nutrient exposures. American Journal of Clinical Nutrition. 1999; 69: 1339S-1344S. Published Material

Freudenheim, J.L. Study design and hypothesis testing: isues in the evaluation of evidence from research in nutritional epidemiology. Am J Clin Nutr, 1999; 69(suppl): 1315S-1321S. Published Material

Gruber, M., R. Chappell, A. Millen, T. LaRowe, S.M. Moeller, A. Iannaccone, S.B. Kritchevsky and J. Mares. Correlates of serum lutein+ zeaxanthin: fmdings from the third National Health and Nutrition Examination Survey. Journal of Nutlrition. 2004; 134: 2387-2394. Published Material

Hill A.B. The environment and disease: association or causation? Proc R Soc Med, 1965; 58: 295-300. Published Material

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

Kromhout D., E.B. Bosschieter and C. de Lezenne Coulander “Dietary fiber and 10-year mortality rate from coronary heart disease, cancer, and all causes. The Zutphen study.” Lancet, 2: 518-522, 1982. Published Material

Lanza E., National Cancer Institute Satelite Symposium on Fiber and colon cancer. In Krischevsky D., Bonfield C., Anderson J.W., eds., Dietary Fiber: Chemistry Physiology and Health Effects, New York, Plenom Press., pages 383-387, 1990. Published Material

Lichtenstein, A.H. and R.M..Russell. Essential Nutrients: Food or Supplements? Journal of American Medical Association. 2005; 294: 351-358. Published Material

Omenn, G.S., G.E. Goodman, M.D. Thornquist, J. Balmes, M.R. Cullen, A. Glass, J.P. Keogh, F.L. Meyskens, B. Valsnis, 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

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

Rosenberg, I.H. Science-based micronutrient fortification: which nutrients, how much, and how to know? American Journal of Clinical Nutrition. 2005; 82: 279-280. Published Material

Pfeiffer, C.M. et al. Biochemical indicators of vitamin B status in the US population after folic acid fortification: results from the National Health and Nutrition Examination Survey 1999-2000. American Journal of Clinical Nutrition. 2005; 82: 442-450. Published Material

Schatzkin A., E. Lanza, D. Corle, P. Lance, F. Iber, B. Caan, M. Shike, J. Weissfeld, R. Burt, M.R. Cooper, J.W. Kikendall and J. Cahill. “Lack of effect of a low-fat, high-fiber diet on the recurrence of colorectal adenomas. Polyp Freventiun Trial Study Group.” New England Journal of Medicine, 342: 1149-1155, 2000. Published Material

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

Spilker, B. Guide to Clinical Studies. Raven Press, New York, New York, 1991, pp. 59-64. Published Material

Subar, A.F. et al. Comparative Validation of the Block, Willett, and National Cancer Institute Food Frequency Questionnaires. Am J Epidemiol 2001; 154: 1089-1099. Published Material

Szklo, M. and F.J. Nieto. Epidemilogy: Beyond the Basics. Aspen Publishers, Inc., Gaithersburg, MD, 2000. Published Material

Wilson, E.B. (1990). An Introduction to Scientific Research, (Toronto, Canada: General Publishing Company), pp. 46-48. Published Material

Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements. http://www.cfsan.fda.gov/~dms/ssaguide.html

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