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Rights & Permissions Free PDF Access Free Resources Sign in to download PDF book and chapters PDF EXECUTIVE SUMMARY Display this book on your site! Related Titles Dietary Supplements: A Framework for Evaluating Safety Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients) Other Related Titles Proposed Framework for Evaluating the Safety of Dietary Supplements -- For Comment (2002) Food and Nutrition Board (FNB) Institute of Medicine (IOM) Board on Life Sciences (BLS) Web Search Builder Use this book's key terms to search within this book, across our collection, or across the Web. Skim This Chapter Skim this chapter and use this chapter's key terms to search within this book. Reference Finder Paste in your own text to find books that relate to your topic. Page 124   E-mail  Facebook  Digg  Stumble  Twitter More The following HTML text is provided to enhance online readability. Many aspects of typography translate only awkwardly to HTML. Please use the page image as the authoritative form to ensure accuracy. Appendix C Possible Combinations of Scores There are 625 possible combinations of scores that fall under Priority Groups I through V. These are all listed below, in the priority order that would be indicated by the proposed framework. As described in Chapter 5, high prevalence of use would shift supplements to the highest priority within each Priority Group. NAD=no appropriate data. Priority Group Human Data Animal Data Structure Data In Vitro Data I 3 3 3 3   3 3 3 2   3 3 3 NAD   3 3 3 1   3 3 3 0   3 3 2 3   3 3 NAD 3   3 3 1 3   3 3 0 3   3 3 2 2   3 3 2 NAD   3 3 2 1   3 3 2 0   3 3 NAD 2   3 3 NAD NAD   3 3 NAD 1   3 3 NAD 0   3 3 1 2   3 3 1 NAD   3 3 1 1   3 3 1 0   3 3 0 2   3 3 0 NAD   3 3 0 1   3 3 0 0 Page 124 Front Matter (R1-R12) Executive Summary (1-12) 1 Introduction and Background (13-28) 2 Approaches Used by Others to Consider Dietary Supplement Safety and Other Existing Safety Frameworks (29-38) 3 Outline of the Overall Process for Evaluation of Dietary Supplement Ingredients (39-46) 4 Factors Considered in Screening, Setting Priorities, and Safety Evaluation (47-76) 5 Framework Steps One and Two: Screening/Flagging and Priority Setting (77-90) 6 Framework Step 3: Critical Safety Evaluation of Dietary Supplement Ingredients (91-98) 7 Attributes and Limitations of the Proposed Framework (99-102) 8 Dietary Supplement Ingredients Selected for Prototype Safety Monographs (103-105) Appendix A Other Approaches to Considering the Safety of Dietary Supplements (106-115) Appendix B Existing Frameworks of Systems for Evaluating the Safety of Other Substances (116-123) Appendix C Possible Combinations of Scores (124-137) Appendix D Table of Food and Drug Administration Actions on Dietary Supplements (138-139) Appendix E Presenters at the Open Sessions of the Project on the Framework for Evaluating the Safety of Dietary Supplements (140-140) Appendix F Biographical Sketches of Committee Members (141-144)

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OCR for page 124
For Comment: Proposed Framework for Evaluating the Safety of Dietary Supplements Appendix C Possible Combinations of Scores There are 625 possible combinations of scores that fall under Priority Groups I through V. These are all listed below, in the priority order that would be indicated by the proposed framework. As described in Chapter 5, high prevalence of use would shift supplements to the highest priority within each Priority Group. NAD=no appropriate data. Priority Group Human Data Animal Data Structure Data In Vitro Data I 3 3 3 3   3 3 3 2   3 3 3 NAD   3 3 3 1   3 3 3 0   3 3 2 3   3 3 NAD 3   3 3 1 3   3 3 0 3   3 3 2 2   3 3 2 NAD   3 3 2 1   3 3 2 0   3 3 NAD 2   3 3 NAD NAD   3 3 NAD 1   3 3 NAD 0   3 3 1 2   3 3 1 NAD   3 3 1 1   3 3 1 0   3 3 0 2   3 3 0 NAD   3 3 0 1   3 3 0 0

OCR for page 125
For Comment: Proposed Framework for Evaluating the Safety of Dietary Supplements Priority Group Human Data Animal Data Structure Data In Vitro Data II 3 2 3 3   3 NAD 3 3   3 1 3 3   3 0 3 3   3 2 3 2   3 2 3 NAD   3 2 3 1   3 2 3 0   3 2 2 3   3 2 NAD 3   3 2 1 3   3 2 0 3   3 NAD 3 2   3 NAD 3 NAD   3 NAD 3 1   3 NAD 3 0   3 NAD 2 3   3 NAD NAD 3   3 NAD 1 3   3 NAD 0 3   3 1 3 2   3 1 3 NAD   3 1 3 1   3 1 3 0   3 1 2 3   3 1 NAD 3   3 1 1 3   3 1 0 3   3 0 3 2   3 0 3 NAD   3 0 3 1   3 0 3 0   3 0 2 3   3 0 NAD 3   3 0 1 3   3 0 0 3   3 2 2 2   3 2 2 NAD   3 2 2 1   3 2 2 0   3 2 NAD 2   3 2 NAD NAD   3 2 NAD 1   3 2 NAD 0   3 2 1 2   3 2 1 NAD   3 2 1 1   3 2 1 0

OCR for page 126
For Comment: Proposed Framework for Evaluating the Safety of Dietary Supplements Priority Group Human Data Animal Data Structure Data In Vitro Data II 3 2 0 2   3 2 0 NAD   3 2 0 1   3 2 0 0   3 NAD 2 2   3 NAD 2 NAD   3 NAD 2 1   3 NAD 2 0   3 NAD NAD 2   3 NAD NAD NAD   3 NAD NAD 1   3 NAD NAD 0   3 NAD 1 2   3 NAD 1 NAD   3 NAD 1 1   3 NAD 1 0   3 NAD 0 2   3 NAD 0 NAD   3 NAD 0 1   3 NAD 0 0   3 1 2 2   3 1 2 NAD   3 1 2 1   3 1 2 0   3 1 NAD 2   3 1 NAD NAD   3 1 NAD 1   3 1 NAD 0   3 1 1 2   3 1 1 NAD   3 1 1 1   3 1 1 0   3 1 0 2   3 1 0 NAD   3 1 0 1   3 1 0 0   3 0 2 2   3 0 2 NAD   3 0 2 1   3 0 2 0   3 0 NAD 2   3 0 NAD NAD   3 0 NAD 1   3 0 NAD 0   3 0 1 2   3 0 1 NAD   3 0 1 1   3 0 1 0

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For Comment: Proposed Framework for Evaluating the Safety of Dietary Supplements Priority Group Human Data Animal Data Structure Data In Vitro Data II 3 0 0 2   3 0 0 NAD   3 0 0 1   3 0 0 0 III NAD 3 3 3   2 3 3 3   1 3 3 3   0 3 3 3   NAD 3 3 2   NAD 3 3 NAD   NAD 3 3 1   NAD 3 3 0   NAD 3 2 3   NAD 3 NAD 3   NAD 3 1 3   NAD 3 0 3   2 3 3 2   2 3 3 NAD   2 3 3 1   2 3 3 0   2 3 2 3   2 3 NAD 3   2 3 1 3   2 3 0 3   1 3 3 2   1 3 3 NAD   1 3 3 1   1 3 3 0   1 3 2 3   1 3 NAD 3   1 3 1 3   1 3 0 3   0 3 3 2   0 3 3 NAD   0 3 3 1   0 3 3 0   0 3 2 3   0 3 NAD 3   0 3 1 3   0 3 0 3   NAD 3 2 2   NAD 3 2 NAD   NAD 3 2 1   NAD 3 2 0   NAD 3 NAD 2   NAD 3 NAD NAD   NAD 3 NAD 1   NAD 3 NAD 0

OCR for page 128
For Comment: Proposed Framework for Evaluating the Safety of Dietary Supplements Priority Group Human Data Animal Data Structure Data In Vitro Data III NAD 3 1 2   NAD 3 1 NAD   NAD 3 1 1   NAD 3 1 0   NAD 3 0 2   NAD 3 0 NAD   NAD 3 0 1   NAD 3 0 0   2 3 2 2   2 3 2 NAD   2 3 2 1   2 3 2 0   2 3 NAD 2   2 3 NAD NAD   2 3 NAD 1   2 3 NAD 0   2 3 1 2   2 3 1 NAD   2 3 1 1   2 3 1 0   2 3 0 2   2 3 0 NAD   2 3 0 1   2 3 0 0   1 3 2 2   1 3 2 NAD   1 3 2 1   1 3 2 0   1 3 NAD 2   1 3 NAD NAD   1 3 NAD 1   1 3 NAD 0   1 3 1 2   1 3 1 NAD   1 3 1 1   1 3 1 0   1 3 0 2   1 3 0 NAD   1 3 0 1   1 3 0 0   0 3 2 2   0 3 2 NAD   0 3 2 1   0 3 2 0   0 3 NAD 2   0 3 NAD NAD   0 3 NAD 1   0 3 NAD 0

OCR for page 129
For Comment: Proposed Framework for Evaluating the Safety of Dietary Supplements Priority Group Human Data Animal Data Structure Data In Vitro Data III 0 3 1 2   0 3 1 NAD   0 3 1 1   0 3 1 0   0 3 0 2   0 3 0 NAD   0 3 0 1   0 3 0 0 IV NAD 2 3 3   NAD NAD 3 3   NAD 1 3 3   NAD 0 3 3   2 2 3 3   2 NAD 3 3   2 1 3 3   2 0 3 3   1 2 3 3   1 NAD 3 3   1 1 3 3   1 0 3 3   0 2 3 3   0 NAD 3 3   0 1 3 3   0 0 3 3   NAD 2 3 2   NAD 2 3 NAD   NAD 2 3 1   NAD 2 3 0   NAD NAD 3 2   NAD NAD 3 NAD   NAD NAD 3 1   NAD NAD 3 0   NAD 1 3 2   NAD 1 3 NAD   NAD 1 3 1   NAD 1 3 0   NAD 0 3 2   NAD 0 3 NAD   NAD 0 3 1   NAD 0 3 0   2 2 3 2   2 2 3 NAD   2 2 3 1   2 2 3 0   2 2 2 3   2 2 NAD 3   2 2 1 3   2 2 0 3

OCR for page 130
For Comment: Proposed Framework for Evaluating the Safety of Dietary Supplements Priority Group Human Data Animal Data Structure Data In Vitro Data IV 2 NAD 3 2   2 NAD 3 NAD   2 NAD 3 1   2 NAD 3 0   2 NAD 2 3   2 NAD NAD 3   2 NAD 1 3   2 NAD 0 3   2 1 3 2   2 1 3 NAD   2 1 3 1   2 1 3 0   2 1 2 3   2 1 NAD 3   2 1 1 3   2 1 0 3   2 0 3 2   2 0 3 NAD   2 0 3 1   2 0 3 0   2 0 2 3   2 0 NAD 3   2 0 1 3   2 0 0 3   NAD 2 2 3   NAD 2 NAD 3   NAD 2 1 3   NAD 2 0 3   NAD NAD 2 3   NAD NAD NAD 3   NAD NAD 1 3   NAD NAD 0 3   NAD 1 2 3   NAD 1 NAD 3   NAD 1 1 3   NAD 1 0 3   NAD 0 2 3   NAD 0 NAD 3   NAD 0 1 3   NAD 0 0 3   1 2 3 2   1 2 3 NAD   1 2 3 1   1 2 3 0   1 2 2 3   1 2 NAD 3   1 2 1 3   1 2 0 3

OCR for page 131
For Comment: Proposed Framework for Evaluating the Safety of Dietary Supplements Priority Group Human Data Animal Data Structure Data In Vitro Data IV 1 NAD 3 2   1 NAD 3 NAD   1 NAD 3 1   1 NAD 3 0   1 NAD 2 3   1 NAD NAD 3   1 NAD 1 3   1 NAD 0 3   1 1 3 2   1 1 3 NAD   1 1 3 1   1 1 3 0   1 1 2 3   1 1 NAD 3   1 1 1 3   1 1 0 3   1 0 3 2   1 0 3 NAD   1 0 3 1   1 0 3 0   1 0 2 3   1 0 NAD 3   1 0 1 3   1 0 0 3   0 2 3 2   0 2 3 NAD   0 2 3 1   0 2 3 0   0 2 2 3   0 2 NAD 3   0 2 1 3   0 2 0 3   0 NAD 3 2   0 NAD 3 NAD   0 NAD 3 1   0 NAD 3 0   0 NAD 2 3   0 NAD NAD 3   0 NAD 1 3   0 NAD 0 3   0 1 3 2   0 1 3 NAD   0 1 3 1   0 1 3 0   0 1 2 3   0 1 NAD 3   0 1 1 3   0 1 0 3

OCR for page 132
For Comment: Proposed Framework for Evaluating the Safety of Dietary Supplements Priority Group Human Data Animal Data Structure Data In Vitro Data IV 0 0 3 2   0 0 3 NAD   0 0 3 1   0 0 3 0   0 0 2 3   0 0 NAD 3   0 0 1 3   0 0 0 3 V 2 2 2 2   2 2 2 NAD   2 2 2 1   2 2 2 0   2 2 NAD 2   2 2 NAD NAD   2 2 NAD 1   2 2 NAD 0   2 2 1 2   2 2 1 NAD   2 2 1 1   2 2 1 0   2 2 0 2   2 2 0 NAD   2 2 0 1   2 2 0 0   2 NAD 2 2   2 NAD 2 NAD   2 NAD 2 1   2 NAD 2 0   2 NAD NAD 2   2 NAD NAD NAD   2 NAD NAD 1   2 NAD NAD 0   2 NAD 1 2   2 NAD 1 NAD   2 NAD 1 1   2 NAD 1 0   2 NAD 0 2   2 NAD 0 NAD   2 NAD 0 1   2 NAD 0 0   2 1 2 2   2 1 2 NAD   2 1 2 1   2 1 2 0   2 1 NAD 2   2 1 NAD NAD   2 1 NAD 1   2 1 NAD 0

OCR for page 133
For Comment: Proposed Framework for Evaluating the Safety of Dietary Supplements Priority Group Human Data Animal Data Structure Data In Vitro Data V 2 1 1 2   2 1 1 NAD   2 1 1 1   2 1 1 0   2 1 0 2   2 1 0 NAD   2 1 0 1   2 1 0 0   2 0 2 2   2 0 2 NAD   2 0 2 1   2 0 2 0   2 0 NAD 2   2 0 NAD NAD   2 0 NAD 1   2 0 NAD 0   2 0 1 2   2 0 1 NAD   2 0 1 1   2 0 1 0   2 0 0 2   2 0 0 NAD   2 0 0 1   NAD 2 2 2   NAD 2 2 NAD   NAD 2 2 1   NAD 2 2 0   NAD 2 NAD 2   NAD 2 NAD NAD   NAD 2 NAD 1   NAD 2 NAD 0   NAD 2 1 2   NAD 2 1 NAD   NAD 2 1 1   NAD 2 1 0   NAD 2 0 2   NAD 2 0 NAD   NAD 2 0 1   NAD 2 0 0   NAD NAD 2 2   NAD NAD 2 NAD   NAD NAD 2 1   NAD NAD 2 0   NAD NAD NAD 2   NAD NAD NAD NAD   NAD NAD NAD 1   NAD NAD NAD 0   NAD NAD 1 2

OCR for page 134
For Comment: Proposed Framework for Evaluating the Safety of Dietary Supplements Priority Group Human Data Animal Data Structure Data In Vitro Data V NAD NAD 1 NAD   NAD NAD 1 1   NAD NAD 1 0   NAD NAD 0 2   NAD NAD 0 NAD   NAD NAD 0 1   NAD NAD 0 0   NAD 1 2 2   NAD 1 2 NAD   NAD 1 2 1   NAD 1 2 0   NAD 1 NAD 2   NAD 1 NAD NAD   NAD 1 NAD 1   NAD 1 NAD 0   NAD 1 1 2   NAD 1 1 NAD   NAD 1 1 1   NAD 1 1 0   NAD 1 0 2   NAD 1 0 NAD   NAD 1 0 1   NAD 1 0 0   NAD 0 2 2   NAD 0 2 NAD   NAD 0 2 1   NAD 0 2 0   NAD 0 NAD 2   NAD 0 NAD NAD   NAD 0 NAD 1   NAD 0 NAD 0   NAD 0 1 2   NAD 0 1 NAD   NAD 0 1 1   NAD 0 1 0   NAD 0 0 2   NAD 0 0 NAD   NAD 0 0 1   NAD 0 0 0   1 2 2 2   1 2 2 NAD   1 2 2 1   1 2 2 0   1 2 NAD 2   1 2 NAD NAD   1 2 NAD 1   1 2 NAD 0   1 2 1 2

OCR for page 135
For Comment: Proposed Framework for Evaluating the Safety of Dietary Supplements Priority Group Human Data Animal Data Structure Data In Vitro Data V 1 2 1 NAD   1 2 1 1   1 2 1 0   1 2 0 2   1 2 0 NAD   1 2 0 1   1 2 0 0   1 NAD 2 2   1 NAD 2 NAD   1 NAD 2 1   1 NAD 2 0   1 NAD NAD 2   1 NAD NAD NAD   1 NAD NAD 1   1 NAD NAD 0   1 NAD 1 2   1 NAD 1 NAD   1 NAD 1 1   1 NAD 1 0   1 NAD 0 2   1 NAD 0 NAD   1 NAD 0 1   1 NAD 0 0   1 1 2 2   1 1 2 NAD   1 1 2 1   1 1 2 0   1 1 NAD 2   1 1 NAD NAD   1 1 NAD 1   1 1 NAD 0   1 1 1 2   1 1 1 NAD   1 1 1 1   1 1 1 0   1 1 0 2   1 1 0 NAD   1 1 0 1   1 1 0 0   1 0 2 2   1 0 2 NAD   1 0 2 1   1 0 2 0   1 0 NAD 2   1 0 NAD NAD   1 0 NAD 1   1 0 NAD 0   1 0 1 2

OCR for page 136
For Comment: Proposed Framework for Evaluating the Safety of Dietary Supplements Priority Group Human Data Animal Data Structure Data In Vitro Data V 1 0 1 NAD   1 0 1 1   1 0 1 0   1 0 0 2   1 0 0 NAD   1 0 0 1   1 0 0 0   1 0 0 0   0 2 2 2   0 2 2 NAD   0 2 2 1   0 2 2 0   0 2 NAD 2   0 2 NAD NAD   0 2 NAD 1   0 2 NAD 0   0 2 1 2   0 2 1 NAD   0 2 1 1   0 2 1 0   0 2 0 2   0 2 0 NAD   0 2 0 1   0 2 0 0   0 NAD 2 2   0 NAD 2 NAD   0 NAD 2 1   0 NAD 2 0   0 NAD NAD 2   0 NAD NAD NAD   0 NAD NAD 1   0 NAD NAD 0   0 NAD 1 2   0 NAD 1 NAD   0 NAD 1 1   0 NAD 1 0   0 NAD 0 2   0 NAD 0 NAD   0 NAD 0 1   0 NAD 0 0   0 1 2 2   0 1 2 NAD   0 1 2 1   0 1 2 0   0 1 NAD 2   0 1 NAD NAD   0 1 NAD 1   0 1 NAD 0

OCR for page 137
For Comment: Proposed Framework for Evaluating the Safety of Dietary Supplements Priority Group Human Data Animal Data Structure Data In Vitro Data V 0 1 1 2   0 1 1 NAD   0 1 1 1   0 1 1 0   0 1 0 2   0 1 0 NAD   0 1 0 1   0 1 0 0   0 0 2 2   0 0 2 NAD   0 0 2 1   0 0 2 0   0 0 NAD 2   0 0 NAD NAD   0 0 NAD 1   0 0 NAD 0   0 0 1 2   0 0 1 NAD   0 0 1 1   0 0 1 0   0 0 0 2   0 0 0 NAD   0 0 0 1   0 0 0 0

Representative terms from entire chapter:

data structure