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2004Q-0098
LET 13
Volumes 15, 16

Letter

Footnotes

Attachment 1 - (Footnote No. 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]

Attachment 2 - (Footnote No. 3) See guidance entitled “Interim Evidence-based Ranking System
for Scientific Data,” July 10, 2003.
[http://www.cfsan.fda.gov/~dms/hclmgui4.html]

Attachment 3 - (Footnote No, 5) 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 are observed or their medical records are reviewed 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]

Attachment 4 - (Footnote No. 10) 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 (see reference list); see also Ioannidis JPA. Contradicted and initially stronger effects in highly cited clinical research. JAMA, 294: 218-228, 2005). Published Material

Attachment 5 - (Footnote No. 11) 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 reference list); 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”)).

Attachment 6 - (Footnote No. 13) National Heart, Lung and Blood Institute (NHLBI), Heart and Blood Vessel Diseases (http://www.nhlbi.nih.gov/health/dci/Diseases/Hbp/HBP_WhatIs.html) and the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation and treatment of high blood pressure, 2003. (http://www.nhlbi.nih.gov/guidelines/hypertension/express.pdf)

Attachment 7 - (Footnote No. 14) National Heart, Lung and Blood Institute (NHLBI), Report of
the Working Group on Research on Hypertension During Pregnancy, 2001. (http://www.nhlbi.nih.gov/resources/hyperten_preg/)

Attachment 8 - (Footnote No. 17) National Heart, Lung and Blood Institute (NHLBI), Diseases and Conditions Index (http://www.nhlbi.nih.gov/health/dci/Diseases/Hbp/HBP_WhoIsAtRisk.html)

Attachment 9 - (Footnote No. 25) See The Keystone National Policy Dialogue on Food, Nutrition, and Health: Final Report, Keystone Press, 1996, p. 37 (“When clinical trials are feasible, health claims need not arise from a multiplicity of accumulated observational data”) Published Material

Attachment 10 - (Footnote No 27) Subjects who are most likely to have a favorable outcome independent of any intervention are not preferentially selected to receive the intervention being studied (“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]

Reference List

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 - Ervin, R.B., C.Y. Wang, J.D. Wright, and J. Kennedy-Stephenson. Dietary intake of selected minerals for the United States population: 1999 - 2000. Advance Data from Vital and Health Statistics; no. 341. Hyattsville, MD: National Center for Health Statistics. 2004.

Reference 3 - Federal Judicial Center, Reference Manual on Scientific Evidence, Second Edition, 2000, p. 93 Published Material

Reference 4 - Hill A.B. The: environment and disease: association or causation? Proc R Soc Med, 1965; 58: 295-300. Published Material

Reference 5 - 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 6 - Institute of Medicine, Dietary Supplements: A Framework for Evaluating Safety. (Washington, D.C.: National Academy Press, 2005a) Chapter 7, “Categories of Scientific Evidence - In Vitro Data.” Published Material

Reference 7 - Institute of Medicine, Dietary Reference Intakes for Water, Potassium, Sodium, Chloride, and Sulfate, (Washington, D.C.: National Academy Press, 2005b, p. 1-20) “Summary” and p 510-511 “Appendix Table D-8.” Published Material

Reference 8 - Lichtenstein, .A.H. and R.M. Russell. Essential Nutrients: Food or Supplements? Journal of American Medical Association. 2005; 294: 351-358. Published Material

Reference 9 - Lee R.D., and D.C. Nieman, Nutritional Assessment, (Madison, Wisconsin: Brown and Benchmark, 1993), p. 234-235. Published Material

Reference 10 - Omenn, G.S., G.E. Goodman, M.D. Thomquist, J. Balmes, M.R. Cullen, A. Glass, J.P. Keogh, F. L. Meyskens, B. Valanis, J.H. Williams, S. Bamhart, 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 11 - 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 12 - 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 13 - Spilker, B. Guide to Clinical Studies. Raven Press, New York, New York, 1991. Published Material

Reference 14 - Torun, B. Protein-energy malnutrition. (2006) In: Modern Nutrition in Health and Disease. Editors: Shils, M.E., Shike, M., Ross, A.C., Caballero, B., Cousin, R.J. (Baltimore: Lippincott Williams and Wilkins), p. 885. Published Material

Reference 15 - Willett, W.C. (1990). Overview of nutritional epidemiology. In Nutritional Epidemiology, (Oxford, United Kingdom: Oxford University Press), pp. 16- 17. Published Material

Reference 16 - 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 17 - Wilson, E.B. (1990). An Introduction to Scientific Research, (Toronto, Canada: General Publishing Company), pp. 46-48. Published Material


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