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FDA PROPOSALS TO PERMIT THE USE OF DISEASE

SPECIFIC HEALTH CLAIMS ON FOOD LABELS

HEARING

BEFORE A

SUBCOMMITTEE OF THE

COMMITTEE ON
GOVERNMENT OPERATIONS
HOUSE OF REPRESENTATIVES
ONE HUNDREDTH CONGRESS

FIRST SESSION

DECEMBER 10, 1987

Printed for the use of the Committee on Government Operations

U.S. GOVERNMENT PRINTING OFFICE

WASHINGTON : 1988

83-531

For sale by the Superintendent of Documents, Congressional Sales Office

U.S. Government Printing Office, Washington, DC 20402

COMMITTEE ON GOVERNMENT OPERATIONS

JACK BROOKS, Texas, Chairman JOHN CONYERS, JR., Michigan

FRANK HORTON, New York CARDISS COLLINS, Illinois

ROBERT S. WALKER, Pennsylvania GLENN ENGLISH, Oklahoma

WILLIAM F. CLINGER, JR., Pennsylvania HENRY A. WAXMAN, California

AL MCCANDLESS, California TED WEISS, New York

LARRY E. CRAIG, Idaho MIKE SYNAR, Oklahoma

HOWARD C. NIELSON, Utah STEPHEN L. NEAL, North Carolina

JOSEPH J. DIOGUARDI, New York DOUG BARNARD, JR., Georgia

JIM LIGHTFOOT, Iowa BARNEY FRANK, Massachusetts

BEAU BOULTER, Texas TOM LANTOS, California

DONALD E. "BUZ” LUKENS, Ohio ROBERT E. WISE, JR., West Virginia

AMORY HOUGHTON, JR., New York MAJOR R. OWENS, New York

J. DENNIS HASTERT, Illinois
EDOLPHUS TOWNS, New York

JON L. KYL, Arizona
JOHN M. SPRATT, JR., South Carolina JAMES M. INHOFE, Oklahoma
JOE KOLTER, Pennsylvania

CHRISTOPHER SHAYS, Connecticut
BEN ERDREICH, Alabama
GERALD D. KLECZKA, Wisconsin
ALBERT G. BUSTAMANTE, Texas
MATTHEW G. MARTINEZ, California
THOMAS C. SAWYER, Ohio
LOUISE M. SLAUGHTER, New York
BILL GRANT, Florida
NANCY PELOSI, California

WILLIAM M. JONES, General Counsel
DONALD W. UPSON, Minority Staff Director

HUMAN RESOURCES AND INTERGOVERNMENTAL RELATIONS SUBCOMMITTEE

TED WEISS, New York, Chairman THOMAS C. SAWYER, Ohio

JIM LIGHTFOOT, Iowa JOHN CONYERS, JR., Michigan

JAMES M. INHOFE, Oklahoma HENRY A. WAXMAN, California

CHRISTOPHER SHAYS, Connecticut NANCY PELOSI, California

Ex OFFICIO

JACK BROOKS, Texas

FRANK HORTON, New York
JAMES R. GOTTLIEB, Staff Director

DANIEL W. SIGELMAN, Counsel
GWENDOLYN S. McFADDEN, Secretary
MARY VIHSTADT, Minority Professional Staff

.

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CONTENTS

115

Page

Hearing held on December 10, 1987.

Statement of:

Barness, Lewis, M.D., representing the American Academy of Pediatrics... 137
Shils, Maurice E., M.D., representing the New York Academy of Medicine
Swan, Patricia B., Ph.D., American Institute of Nutrition/American Soci-

ety for Clinical Nutrition .......
Weiss, Hon. Ted, a Representative in Congress from the State of New

York, and chairman, Human Resources and Intergovernmental Rela-
tions Subcommittee: Opening statement ...............

.....

Young, Frank E., M.D., Commissioner, Food and Drug Administration,

accompanied by John M. Taylor, Associate Commissioner for Regula-

tory Affairs; Richard J. Ronk, Acting Director, Center for Food Safety

and Applied Nutrition (CFSAN); Allan L. Forbes, M.D., Director, Office

of Nutrition and Food Sciences, CFSAN; Thomas Scarlett, Associate

General Counsel, Food and Drug Division, Office of the General Coun-

sel; Mary Frances Lowe, Senior Assistant to the Commissioner for

Program Policy, Office of the Commissioner; F. Edward Scarbrough,

Deputy Director, Office of Nutrition and Food Sciences, CFSAN; John

E. Vanderveen, Director, Division of Nutrition, Office of Nutrition and

Food Sciences, CFSAN; Paul J. Sage, Office of Compliance, Center for

Drug Evaluation and Research; and Fred H. Degnan, Food and Drug

Division, Office of the General Counsel .......

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

Barness, Lewis, M.D., representing the American Academy of Pediatrics:

Prepared statement ...........

................................ 139-141

Brown, Virgil, M.D., past chairman, AHA Nutrition Committee, Ameri-

can Heart Association: Prepared statement.....

................. 84-95

Shils, Maurice E., M.D., representing the New York Academy of Medi-

cine: Prepared statement .......

... 118-136

Swan, Patricia B., Ph.D., American Institute of Nutrition/American Soci-

ety for Clinical Nutrition: Prepared statement

.... 100-114

Young, Frank E., M.D., Commissioner, Food and Drug Administration:

Prepared statement....

... 11-33

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FDA PROPOSALS TO PERMIT THE USE OF DIS

EASE-SPECIFIC HEALTH CLAIMS ON FOOD LABELS

THURSDAY, DECEMBER 10, 1987

HOUSE OF REPRESENTATIVES,

HUMAN RESOURCES AND
INTERGOVERNMENTAL RELATIONS SUBCOMMITTEE
OF THE COMMITTEE ON GOVERNMENT OPERATIONS,

Washington, DC. The subcommittee met, pursuant to notice, at 9:35 a.m., in room 2154, Rayburn House Office Building, Hon. Ted Weiss (chairman of the subcommittee) presiding.

Present: Representatives Ted Weiss, Thomas C. Sawyer, Nancy Pelosi, Jim Lightfoot, and Christopher Shays.

Also present: Daniel W. Sigelman, counsel; Gwendolyn S. McFadden, secretary; and Mary Vihstadt, minority professional staff, Committee on Government Operations.

OPENING STATEMENT OF CHAIRMAN WEISS Mr. WEISS. Good morning. The Human Resources and Intergovernmental Relations Subcommittee is now in session. If you will all take seats and make yourselves comfortable, we can proceed.

Today the subcommittee will conduct an oversight hearing on FDA's new proposals to permit disease-specific health claims on food labels.

Over the past half century, Congress has enacted important laws to protect consumers from fraudulent food labeling claims. In particular, the Food, Drug, and Cosmetic Act generally requires all articles, including foods, for which disease-specific health claims are made, to be treated as “new drugs.” Under the law, before a “new drug" may be marketed, "substantial evidence” must be produced to support claims of benefit. The new FDA proposal, however, would authorize, for the first time, the marketing of foods bearing such health benefit claims without a showing of "substantial evidence” or, for that matter, prior FDA approval.

[The proposal referred to is in app. 1, p. 149.]

Mr. WEISS. What could well result is a marketplace inundated with unsupportable, promotionally oriented health claims, in which increasingly competitive market forces unleash ever escalating, and ever less supportable, claims. The victims in such a scenario would be many of the most vulnerable among us—those anxious for any possible respite from sickness and the ravages of the aging process.

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