Proposed framework for evaluating the safety of dietary supplements / Committee on the Framework for Evaluating the Safety of Dietary Supplements, Food and Nutrition Board, Board on Life Sciences, Institute of Medicine, National Reasearch Council.

Format:

Book

Author/Creator:

Committee on the Framework for Evaluating the Safety of Dietary Supplements.

Contributor:

National Research Council (U.S.). Food and Nutrition Board.

National Research Council (U.S.). Board on Life Sciences.

Institute of Medicine (U.S.)

Language:

English

Subjects (All):

Dietary supplements--Evaluation.

Dietary supplements.

Dietary supplements--Toxicology.

Physical Description:

1 online resource (156 p.)

Edition:

1st ed.

Place of Publication:

Washington, DC : National Academy Press, c2002.

Language Note:

English

Contents:

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

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

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

5 Framework Steps One and Two: Screening/Flagging and Priority Setting

GENERAL APPROACH

STEP ONE: SCREENING/FLAGGING

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

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

7 Attributes and Limitations of the Proposed Framework

ATTRIBUTES OF THE PROPOSED FRAMEWORK

LIMITATIONS OF THE PROPOSED FRAMEWORK

8 Dietary Supplement Ingredients Selected for Prototype Safety Monographs

CHOICE OF INGREDIENTS FOR PROTOTYPE MONOGRAPH DEVELOPMENT

NEXT STEP

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

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

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.

Notes:

At head of title: For comment.

Includes bibliographical references.

OCLC:

58651468