Proposed framework for evaluating the safety of dietary supplements : for comment /

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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 co...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor Corporativo: Institute of Medicine (U.S.)
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Washington, D.C. : National Academy Press, [2002]
Temas:
Dietary supplements > Evaluation.
Dietary supplements > Toxicology.
Food, Fortified > toxicity
Food Safety > methods
Program Evaluation
Compléments alimentaires > Évaluation.
Compléments alimentaires > Toxicologie.
HEALTH & FITNESS > Nutrition.
HEALTH & FITNESS > Diets.
MEDICAL > Nutrition.
MEDICAL > Nursing > Nutrition.
HEALTH & FITNESS > Food Content Guides.
United States
Livres électroniques.
Acceso en línea:Texto completo
Tabla de Contenidos:
  • 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 forâ€?
  • 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

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