附註:Title from PDF title page.
Includes bibliographical references.
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 REVIEWSSECOND 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 ActFood 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 OrganizationCommission 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 ProductsInitiation 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
摘要:This report outlines a three-step framework for considering the safety of dietary supplement ingredients. The first two steps in the process, "screening/flagging" and "priority setting," are designed to categorize dietary supplement ingredients based on theoretical or possible concern, and therefore the immediacy of the need for in-depth evaluation of safety, the third step of the process.
