Dockets:

2006P-0243: Qualified Health Claim (QHC) : Corn oil and corn oil containing foods and heart disease
CP 1

Cover Letter

Attachment 3. FDA Implements Enhanced Regulatory Process To Encourage Science-Based Labeling ANd Competition for Healthier Dietary Choices, July 10, 2003

Attachment 4. History of Corn Refining, Corn Refiners Association website Published Material

Attachment 5. American Heart Association, Heart Disease and Stroke Statistics 2006 Update Published Material

Attachment 6. USDA National Nutrient Database for Standard Reference, Release 18 (2005) (http://www.nal.usda.gov/fnic/foodcomp/search/index.html ) (oil, vegetable, corn, industrial and retail, all purpose salad or cooking; 100g and 1 tbsp - 13.6 g)

Attachment 7. National Academy of Sciences, Food Chemicals Codex, Fourth Ed., 100-111 Published Material

Attachment 8. The Food Chemical News Guide, (on-line search: Corn Oil) Published Material

Attachment 9. FDA's October 29, 2004 letter to The North American Olive Oil Association responding to the MUFA from Olive Oil Qualified Health Claim Petition (Docket No. 203Q-0559)

Attachment 10. USDA National Nutrient Database for Standard Reference, Release 18 (2005) (http://www.nal.usda.gov/fnic/foodcomp/search/index.html) (oil, vegetable, corn, industrial and retail, all purpose salad or cooking; 11.2g)

Attachment 11. Food and Drug Administration, Food Advisory Committee, Nutrition Subcommittee, April 27-28, 2004 Briefing Information http://www.fda.gov/ohrms/dockets/ac/04/briefing/0435b1.htm

Attachment 12. Canadian Food Inspection Agency, Guide to Food Labelling and Advertising, ch. 7. Nutrient Content Claims, Section 7.17 Saturated Fatty Acid Claims (http://www.inspection.gc.ca/english/fssa/labeti/guide/ch7ae.shml)

Attachment 13. USDA National Nutrient Database for Standard Reference, Release 18 (2005) (http://www.nal.usda.gov/fnic/foodcomp/search/index.html) (oil, vegetable, corn, industrial and retail, all purpose salad or cooking; 50 g)

Attachment 14. The Final Report of the Keystone National Policy Dialogue on Food, Nutrition and Health, Keystone, CO, and Washington, DC (Excerpts) (March 1996)

Attachment 15. Levy et al. Consumer Impacts of Health Claims: An Experimental Study. Washington, DC: Food and Drug Administration, Center for Food Safety and Applied Nutrition, Division of Market Studies; 1997 (Executive Summary)

Attachment 16. Geiger CJ. Health claims: History, current regulatory status, and consumer research. J. Amer. Diet. Assn. 1998. Vol. 98:11, 1312-1322 Published Material

Part II Summary of Scientific Data / Evidence Analysis

Summary of Scientific Data / Evidence Analysis Appendices

Appendix A1. Pubmed Search Resulta: January 2006

Appendix A2. Citations from the 2005 DIETARY GUIDELINES FOR AMERICANS ADVISORY COMMITTEE REPORT (2004) and the Macro-Nutrient Report (2002)

Appendix B Evidence Analyses Checklists

Appendix B1. Quality Criteria Checklist: Primary Research

Appendix B2. Criteria Checklist: Review Articles

Appendix C. Evidence Table Abbreviations and Footnotes

Appendix D Corn Oil: Effect on Blood Lipids Design Type 1: Randomized, Controlled, Intervention Trials

Appendix D1. Tally Sheet of Quality Ratings

Appendix D2. Evidence Table

Appendix D3. Table: Corn Oil Design Type 1 Studies: Postintervention Blood Lipid Concentrations

Appendix E Corn Oil: Effect on Blood Lipids Design Type 3: Nonrandomized, Intervention Trials with Concurrent or Historical Controls and Case-Control Studies

Appendix E1. Tally Sheet of Quality Ratings

Appendix E2. Evidence Table

Appendix F Corn Oil: Effect on Blood Lipids Design Type 4: Cross-Sectional Studies, Analyses of Secondary Disease Endpoints in Intervention Trieals and Case Series

Appendix F1. Tally Sheet of Quality Ratings

Appendix F2. Evidence Table

Appendix G Corn Oil: Effect on Blood Lipids Meta-Analyses and Systematic Reviews

Appendix G1. Tally Sheet of Quality Ratings

Appendix G2. Evidence Table

Appendix H Corn Oil: Effect on Blood Lipids Animal Studies

Appendix H1. Tally Sheet of Quality Ratings

Appendix H2. Evidence Table

Appendix I Corn Oil: Effect of Phytosterols Design Type 1, Design Type 3 and Analytical Studies

Appendix I1. Tally Sheet of Quality Ratings

Appendix I2. Evidence Table

Appendix J Corn Oil: Effects on Atherogenicity / Oxidative Modification of LDL, Design Type 1 and Design Type 3 Studies

Appendix J1. Tally Sheet of Quality Ratings

Appendix J2. Evidence Table

Appendix K Corn Oil: Postprandial Effects on Blood Lipids, Design Type 1 and Design Type 3 Studies

Appendix K1. Tally Sheet of Quality Ratings

Appendix K2. Evidence Table

Appendix L PUFAs and CHD/CVD Design Type 1: Randomized, Controlled, Intervention Trials

Appendix L1. Tally Sheet of Quality Ratings

Appendix L2. Evidence Table

Appendix M PUFAs and CHD/CVD Design Type 2: Prospective, Observational, Cohort Studies

Appendix M1. Tally Sheet of Quality Ratings

Appendix M2. Evidence Table

Appendix N PUFAs and CHD/CVD Design Type 3: Nonrandomized, Intervention Trials with Concurrent or Historical Controls and Case-Control Studies

Appendix N1. Tally Sheet of Quality Ratings

Appendix N2. Evidence Table

Appendix O PUFAs and CHD/CVD Design Type 4: Cross-Sectional Studies, Analyses of Secondary Disease Endpoints in Intervention Trials and Case Series

Appendix O1. Tally Sheet of Quality Ratings

Appendix O2. Evidence Table

Appendix P PUFAs and CHD/CVD Reviews

Appendix P1. Tally Sheet of Quality Ratings

Appendix P2. Evidence Table

Appendix Q PUFAs and CHD/CVD Animal Studies

Appendix Q1. Tally Sheet of Quality Ratings

Appendix Q2. Evidence Table

Appendix R DV Calculations: Minimum Effective Amount of PUFAs from Corn Oil

Appendix S Nutrient Analyses

Appendix S1 Corn Oil per 14 grams and per 11.2 grams

Appendix S2 Butter per 14 grams and per 11.2 grams

References Published Material