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FDA PROPOSALS TO PERMIT THE USE OF DISEASE
SPECIFIC HEALTH CLAIMS ON FOOD LABELS
SUBCOMMITTEE OF THE
DECEMBER 10, 1987
Printed for the use of the Committee on Government Operations
U.S. GOVERNMENT PRINTING OFFICE
WASHINGTON : 1988
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
JON L. KYL, Arizona
CHRISTOPHER SHAYS, Connecticut
WILLIAM M. JONES, General Counsel
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
JACK BROOKS, Texas
FRANK HORTON, New York
DANIEL W. SIGELMAN, Counsel
Barness, Lewis, M.D., representing the American Academy of Pediatrics... 137
ety for Clinical Nutrition .......
York, and chairman, Human Resources and Intergovernmental Rela-
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
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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