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2004Q-0102
PDN 1
Volumes 7, 8

Petition Denial

Footnotes

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]

Footnote 2 - See guidance entitled “Interim Evidence-based Ranking System for Scientific Data,” July 10, 2003. [http://www.cfsan.fda.gov/~dms/hclmgui4.html]

Footnote 3 - In an intervention study, subjects similar to each other are randomly assigned to either receive the intervention or not to receive the intervention, whereas in an observational study, the subjects (or their medical records) are observed for a certain outcome (i.e., disease). Intervention studies provide the strongest evidence for an effect. See Guidance entitled “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]

Footnote 4 - Replication of scientific findings is important for evaluating the strength of scientific evidence (An Introduction to Scientific Research, E. Bright Wilson Jr., pages 46-48, Dover Publications, 1990) and Ioannidis JPA. Contradicted and initially stronger effects in highly cited clinical research. JAMA, 294: 218-228, 2005. Published Material

Footnote 5 - Consistency of findings among similar and different study designs is important for evaluating causation and the strength of scientific evidence (Hill A.B. The environment and disease: association or causation? Proc R Soc Med 1965; 58: 295-300);
See also Systems to rate the scientific evidence, Agency for Healthcare Research and Quality
http://www.ahrq.gov/clinic/epcsums/strengthsum.htm#Contents, defining “consistency” as “the extent to which similar findings are reported using similar and different study designs.” Published Material

Footnote 6 - Kidney Stones in Adults, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health, U.S. Department of Health and Human Services
http://kidney.niddk.nih.gov/kudiseases/pubs/stonesadults/index.htm

References

Reference 1 - 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 England Journal of Medicine. 1994; 330: 1029-1035. Published Material

Reference 2 - Asplin, J.R., F.L. Coe, and M.J. Favus. Nephrolithiasis. In Harrison’s Principles of Internal Medicine, A.S. Fauci, E. Braunwald, K.J. Isselbacher, J.D. Wilson, J.B. Martin, D.L. Kasper, S.L. Hauser, and D.I. Longo, eds. (New York: McGraw-Hill Health Professions Division), 1998, pp. 1569-1575. Published Material

Reference 3 - Bihl, G. and A. Meyers. Recurrent renal stone disease-advances in pathogenesis and clinical management. Lancet 2001; 358: 651-656. Published Material

Reference 4 - Curhan, G.C., W.C. Willett, E.L. Knight, and M.J. Stampfer. Dietary factors and the risk of incident kidney stones in younger women: Nurses’ Health Study II. Archives of Internal Medicine. 2004; 164: 885-891. Published Material

Reference 5 - Dawson-Hughes, B., D.T. Stern, C.C. Shipp, and H.M. Rasmussen. Effect of lowering dietary calcium intake on fractional whole body calcium retention. Journal of Clinical Endocrinology and Metabolism. 1988; 67: 62-68. Published Material

Reference 6 - Dorland’s Illustrated Medical Dictionary. (2002). (Philadelphia, Pennsylvania: W.B. Saunders and Company). p. 273. Published Material

Reference 7 - Federal Judicial Center. Reference Manual on Scientific Evidence, Second Edition. p. 93. 2000. Published Material

Reference 8 - Heller, H.J., M.F. Doemer, L.J. Brinkley, B. Adams-Huet, and C.Y. Pak. Effect of dietary calcium on stone forming propensity. Journal of Urology. 2003; 169: 470-474. Published Material

Reference 9 - Institute of Medicine, Dietary Reference Intakes for Calcium, Phosphorus, Magnesium, Vitamin D and Fluoride, (Washington, D.C.: National Academy Press, 1997), p. 1-20 “Summary,” p 71-145 “Calcium,” and p 314 - 324 “Uses of Dietary Reference Intakes.” Published Material

Reference 10 - Institute of Medicine, Dietary Supplements: A Framework for Evaluating Safety. (Washington, D.C.: National Academy Press, 2005), Chapter 7, “Categories of Scientific Evidence - In Vitro Data”. Published Material

Reference 11 - Lichtenstein, A.H. and R.M. Russell. Essential Nutrients: Food or Supplements? Journal of American Medical Association. 2005; 294: 351-358. Published Material

Reference 12 - 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

Reference 13 - 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

Reference 14 - Sakhaee, K., S. Baker, J. Zerwekh, J. Poindexter, P.A. Garcia-Hernandez, and C.Y. Pak. Limited risk of kidney stone formation during long-term calcium citrate supplementation in nonstone forming subjects. Journal of Urology. 1994; 152: 324-327. Published Material

Reference 15 - 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

Reference 16 - Spilker, B. (1991). Guide to Clinical Studies. (New York, New York: Raven Press). Published Material

Reference 17 - Szklo, M. and F. J. Nieto. (2000). Epidemiology. Beyond the Basics. (Gaithersburg, Maryland; Aspen Publishers). Published Material

Reference 18 - Taylor, E.N. and G.C. Curhan. Role of nutrition in the formation of calcium-containing kidney stones. Nephron Physiology. 2004; 98: 55-63. Published Material

Reference 19 - Taylor, E.N., M.J. Stampfer, and G.C. Curhan. Dietary factors and the risk of incident kidney stones in men: new insights after 14 years of follow-up. Journal of the American Society of Nephrology. 2004; 15: 3225-3232. Published Material

Reference 20 - Willett,W.C. (1990). Overview of nutritional epidemiology. In Nutritional Epidemiology, (Oxford, United Kingdom: Oxford University Press), pp. 16- 17. Published Material

Reference 21 - 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

Reference 22 - Zerwekh, J.E., T.I. Hwang, J. Poindexter, K. Hill, G. Wendell, and C.Y. Pak. Modulation by calcium of the inhibitor activity of naturally occurring urinary inhibitors. Kidney International. 1988; 33: 1005-1008. Published Material


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