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FOOD AND DRUG ADMINISTRATION'S
REGULATION OF DIETARY SUPPLEMENTS

HEARING

BEFORE THE

HUMAN RESOURCES AND INTERGOVERNMENTAL
RELATIONS SUBCOMMITTEE

OF THE

COMMITTEE ON

GOVERNMENT OPERATIONS
HOUSE OF REPRESENTATIVES

ONE HUNDRED THIRD CONGRESS

FIRST SESSION

JULY 20, 1993

Printed for the use of the Committee on Government Operations

84-512 CC

U.S. GOVERNMENT PRINTING OFFICE

WASHINGTON: 1994

For sale by the U.S. Government Printing Office

Superintendent of Documents, Congressional Sales Office, Washington, DC 20402

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COMMITTEE ON GOVERNMENT OPERATIONS

JOHN CONYERS, JR., Michigan, Chairman

CARDISS COLLINS, Illinois
GLENN ENGLISH, Oklahoma
HENRY A. WAXMAN, California
MIKE SYNAR, Oklahoma

STEPHEN L. NEAL, North Carolina

TOM LANTOS, California
MAJOR R. OWENS, New York
EDOLPHUS TOWNS, New York

JOHN M. SPRATT, JR., South Carolina
GARY A. CONDIT, California
COLLIN C. PETERSON, Minnesota
KAREN L. THURMAN, Florida
BOBBY L. RUSH, Illinois

CAROLYN B. MALONEY, New York
THOMAS M. BARRETT, Wisconsin
DONALD M. PAYNE, New Jersey
FLOYD H. FLAKE, New York
JAMES A. HAYES, Louisiana
CRAIG A. WASHINGTON, Texas
BARBARA-ROSE COLLINS, Michigan
CORRINE BROWN, Florida

MARJORIE MARGOLIES-MEZVINSKY,
Pennsylvania

LYNN C. WOOLSEY, California

WILLIAM F. CLINGER, JR., Pennsylvania
AL MCCANDLESS, California
J. DENNIS HASTERT, Illinois
JON L. KYL, Arizona

CHRISTOPHER SHAYS, Connecticut
STEVEN SCHIFF, New Mexico
CHRISTOPHER COX, California
CRAIG THOMAS, Wyoming

ILEANA ROS-LEHTINEN, Florida

RONALD K. MACHTLEY, Rhode Island
DICK ZIMMER, New Jersey

WILLIAM H. ZELIFF, JR., New Hampshire
JOHN M. MCHUGH, New York
STEPHEN HORN, California
DEBORAH PRYCE, Ohio
JOHN L. MICA, Florida
ROB PORTMAN, Ohio

BERNARD SANDERS, Vermont (Independent)

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JOHN CONYERS, JR., Michigan

WILLIAM F. CLINGER, JR., Pennsylvania

RONALD A. STROMAN, Staff Director
WILLIAM M. LAYDEN, Professional Staff Member
BRENDA E. PILLORS, Professional Staff Member
MARTINE M. DICROCE, Clerk
MARTHA B. MORGAN, Minority Professional Staff

CONTENTS

Page

Hearing held on July 20, 1993

1

Statement of:

Bailey, Lynn B., Ph.D., nutrition professor, Food Science and Human
Nutrition Department, University of Florida

216

Block, Gladys, Ph.D., University of California, Berkeley
Cordaro, J.B., president, Council for Responsible Nutrition

186

128

172

238

86

Hildwine, Regina, director, Technical Regulatory Affairs, National Food
Processors Association, accompanied by John Bode, legislative counsel ..
Huxtable, Ryan J., Ph.D., University of Arizona

Johnston, Richard, M.D., senior vice president, programs, and medical
director, March of Dimes Birth Defects Foundation
McCaleb, Robert S., Herb Research Foundation

McNamara, Stephen H., Hyman, Phelps & McNamara, P.C., on behalf
of the Utah Natural Products Alliance
Rosenberg, Irwin H., professor of medicine and nutrition, Tufts Univer-
sity

Shank, Fred R., Ph.D., Director, Center for Food Safety and Applied
Nutrition [CFSAN], Food and Drug Administration, accompanied by
Mitchell Zeller, Office of the Deputy Commissioner for Policy; Robert
Lake, Director, Office of Policy, Planning and Strategic Initiatives;
and Lori Love, Ph.D., Director, Clinical Research and Review Staff
Silverglade, Bruce, director, legal affairs, Center for Science in the Public
Interest

Stark, Shirley, assistant attorney general of New York

Sternberg, Esther M., M.D., Chief, Unit on Neuroendocrine Immunology

and Behavior, Clinical Neuroendocrinology Branch, National Institute

of Mental Health, National Institutes of Health

Towns, Hon. Edolphus, a Representative in Congress from the State

of New York, and chairman, Human Resources and Intergovernmental

Relations Subcommittee: Opening statement

Whittekin, Martie, president, National Nutritional Foods Association

Letters, statements, etc., submitted for the record by:

Bailey, Lynn B., Ph.D., nutrition professor, Food Science and Human

Nutrition Department, University of Florida: Prepared statement

Block, Gladys, Ph.D., University of California, Berkeley: Prepared state-

ment

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McCaleb, Robert S., Herb Research Foundation: Prepared statement
McNamara, Stephen H., Hyman, Phelps & McNamara, P.C., on behalf
of the Utah Natural Products Alliance: Prepared statement

Rosenberg, Irwin H., professor of medicine and nutrition, Tufts Univer-

sity: Prepared statement

Silverglade, Bruce, director, legal affairs, Center for Science in the Public
Interest: Prepared statement

66

...........................

Page

Letters, statements, etc., submitted for the record by-Continued

Stark, Shirley, assistant attorney general of New York: Prepared state

ment

Sternberg, Esther M., M.D., Chief, Unit on Neuroendocrine Immunology and Behavior, Clinical Neuroendocrinology Branch, National Institute of Mental Health, National Institutes of Health: Prepared statement Whittekin, Martie, president, National Nutritional Foods Association: Prepared statement

APPENDIXES

Appendix 1.-Answers from the scientists to questions from the Members
Appendix 2.-Additional statements and materials for the record

106

230

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