Proposed Framework for Evaluating the Safety of Dietary Supplements -- For Comment.

FOR COMMENT -- Copyright -- Foreword -- Contents -- Executive Summary -- THE COMMITTEE'S TASK -- BACKGROUND -- FINDINGS -- PROPOSED FRAMEWORK FOR EVALUATING THE SAFETY OF DIETARY SUPPLEMENT INGREDIENTS -- Key Factors Used in the Framework -- Step One: Screening/Flagging -- Step Two: Priority Setting -- Scoring and Sorting the Data -- Sorting the Ingredients by Scores -- Step Three: Critical Safety Evaluation -- Guiding Principles to Follow in Evaluating Data in the Framework -- Attributes of the Proposed Framework -- INGREDIENTS FOR PROTOTYPE MONOGRAPH REVIEWS -- SECOND PHASE OF THIS STUDY -- 1 Introduction and Background -- COMMITTEE CHARGE -- GENERAL BACKGROUND INFORMATION ABOUT DIETARY SUPPLEMENTS -- Consumer Expectations About Dietary Supplement Safety -- History of the Federal Regulation of Dietary Supplements -- Food and Drugs Act of 1906 -- Federal Food, Drug, and Cosmetic Act of 1938 -- Early Attempts to Regulate the Industry -- Food Additives Amendment of 1958 -- 1976 Proxmire Amendments -- The Nutrition Labeling and Education Act and Health Claims -- The Dietary Supplement and Health Education Act -- Food and Drug Administration Actions -- Good Manufacturing Practices -- REFERENCES -- 2 Approaches Used by Others to Consider Dietary Supplement Safety and Other Existing Safety Frameworks -- OTHER APPROACHES FOR CONSIDERING DIETARY SUPPLEMENT SAFETY -- Agency for Healthcare Research and Quality -- U.S. Pharmacopeia-National Formulary -- U.S. Pharmacopeia Dietary Supplement Verification Program -- American Herbal Pharmacopoeia -- American Herbal Products Association -- Natural Medicines Comprehensive Database -- World Health Organization -- Commission E -- Health Canada Natural Health Products Directorate -- European Scientific Cooperative on Phytotherapy.

The Physician's Desk Reference for Herbal Medicines and the Physician's Desk Reference for… -- ANALYSIS OF DIFFERENT APPROACHES TO DIETARY SUPPLEMENT EVALUATION -- ATTRIBUTES OF AN IDEAL FRAMEWORK FOR EVALUATING DIETARY SUPPLEMENTS -- REFERENCES -- 3 Outline of the Overall Process for Evaluation of Dietary Supplement Ingredients -- PROPOSED FRAMEWORK FOR EVALUATION OF DIETARY SUPPLEMENT INGREDIENTS -- Ingredients versus Products -- Initiation of the Process -- Description of the Process -- Information or Factors Used to Identify or Flag Ingredients for Further Evaluation -- Evaluation and Weighting of Available Information -- Monograph Preparation, Internal Review, and In-Depth Safety Evaluation -- Ongoing Review and Reassessment -- REFERENCES -- 4 Factors Considered in Screening, Setting Priorities, and Safety Evaluation -- DESCRIPTION AND USE OF KEY FACTORS -- Key Factor: Data from Humans and Clinical Evidence of Harm -- Clinical Trials -- Observational Epidemiological Research -- Non-Study Information: Spontaneously Reported Adverse Events -- Non-Study Information: Historical Use -- Causation in the Consideration of Adverse Events -- Use of Human Data in the Screening/Flagging and Priority-Setting Steps -- Use of Human Data in the Critical Safety Evaluation Step -- Key Factor: Animal Data -- Importance of Quality Data -- Extrapolations from Animal Studies -- Use of Animal Data in the Screening/Flagging Step -- Use of Animal Data in the Priority-Setting Step -- Use of Animal Data in the Critical Safety Evaluation Step -- Key Factor: Bioactivity of Structurally Related and Taxonomically Related Substances -- Systematically Considering Biological Activity of Structurally Related Substances -- Considering the Chemical Composition of Botanical Ingredients -- Use of Bioactivity of Related Substances in the Screening/Flagging Step.

Use of Bioactivity of Related Substances in the Priority-Setting Step -- Use of Bioactivity of Related Substances in the Critical Safety Evaluation Step -- Key Factor: In Vitro Data -- Use of In Vitro Data in the Screening/Flagging Step -- Use of In Vitro Data in the Priority Setting Process -- Use of In Vitro Data in the Critical Evaluation Step -- MODIFYING FACTORS -- Prevalence of Use in the Population -- Prevalence of Use as a Modifying Factor in the Screening/Flagging Step -- Prevalence of Use as a Modifying Factor in the Priority-Setting Step -- Prevalence of Use as a Modifying Factor in the Critical Evaluation Step -- Use by Vulnerable Subpopulations -- Vulnerable Subpopulation Information as a Modifying Factor in the Screening/Flagging Step -- Vulnerable Subpopulation Information as a Modifying Factor in the Priority-Setting and Critical... -- New Ingredient Status -- Use of New Ingredient Status in the Screening/Flagging Step -- Use of New Ingredient Status in the Priority-Setting and Critical Safety Evaluation Steps -- SUMMARY -- REFERENCES -- 5 Framework Steps One and Two: Screening/Flagging and Priority Setting -- GENERAL APPROACH -- STEP ONE: SCREENING/FLAGGING -- New Ingredient Status -- Human Data -- Other Concerns -- STEP TWO: PRIORITY-SETTING PROCESS -- General Description of How to Score Information -- Which Scores Indicate Higher Priority -- Ranking Ingredients Within the Matrix: Using Scores to Sort Ingredients Into Priority Groups -- Prevalence of Use: A Modifier of Sorting Within Priority Groups -- Specifics on Assigning a Score for Each Factor -- Scoring Human Data -- Scoring Animal Data -- Scoring Data on the Biological Activity of Structurally Related and Taxonomically Related Substances -- Scoring In Vitro Data -- SUMMARY -- REFERENCES -- 6 Framework Step Three: Critical Safety Evaluation of Dietary Supplement Ingredients.

STEP 3A: DRAFT MONOGRAPH PREPARATION AND REVIEW BY THE FOOD AND DRUG ADMINISTRATION -- STEP 3B: CRITICAL EVALUATION BY AN EXTERNAL ADVISORY COMMITTEE -- OVERSIGHT OF MONOGRAPH PREPARATION AND REVIEW -- Preparation of Draft Monographs -- Management of the External Advisory Committee -- SUMMARY -- 7 Attributes and Limitations of the Proposed Framework -- ATTRIBUTES OF THE PROPOSED FRAMEWORK -- LIMITATIONS OF THE PROPOSED FRAMEWORK -- SUMMARY -- 8 Dietary Supplement Ingredients Selected for Prototype Safety Monographs -- CHOICE OF INGREDIENTS FOR PROTOTYPE MONOGRAPH DEVELOPMENT -- NEXT STEP -- REFERENCES -- Appendix A Other Approaches to Considering the Safety of Dietary Supplements -- AGENCY FOR HEALTHCARE RESEARCH AND QUALITY -- U.S. PHARMACOPEIA-NATIONAL FORMULARY -- U.S. PHARMACOPEIA DIETARY SUPPLEMENT VERIFICATION PROGRAM -- AMERICAN HERBAL PHARMACOPOEIA -- AMERICAN HERBAL PRODUCTS ASSOCIATION -- NATURAL MEDICINES COMPREHENSIVE DATABASE -- WORLD HEALTH ORGANIZATION -- COMMISSION E -- HEALTH CANADA NATURAL HEALTH PRODUCTS DIRECTORATE -- EUROPEAN SCIENTIFIC COOPERATIVE ON PHYTOTHERAPY -- REFERENCES -- Appendix B Existing Frameworks or Systems for Evaluating the Safety of Other Substances -- PREMARKET APPROVAL OF FOOD ADDITIVES -- SELECT COMMITTEE ON GRAS SUBSTANCES -- GRAS DETERMINATION FOR FLAVOR INGREDIENTS: FEMA EXPERT PANEL -- COSMETICS INGREDIENT REVIEW -- NEW DRUGS -- OVER-THE-COUNTER DRUGS -- NEW CHEMICALS PROGRAM -- TOLERABLE UPPER INTAKE LEVEL MODEL FOR NUTRIENTS -- REFERENCES -- Appendix C Possible Combinations of Scores -- Appendix D Table of Food and Drug Administration Actions on Dietary Supplements -- Appendix E Presenters at the Open Sessions of the Project on the Framework for Evaluating the... -- Appendix F Biographical Sketches of Committee Members.

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Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2024. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.