AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND RELATED AGENCIES APPROPRIATIONS FOR 1994 Y 4.AP 6/1: AG 8/8 Agriculture! Rural Developneab Foo. RINGS BEFORE A SUBCOMMITTEE OF THE COMMITTEE ON APPROPRIATIONS HOUSE OF REPRESENTATIVES ONE HUNDRED THIRD CONGRESS FIRST SESSION SUBCOMMITTEE ON AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND RELATED AGENCIES RICHARD J. DURBIN, Illinois Chairman JAMIE L. WHITTEN, Mississippi JOE SKEEN, New Mexico MARCY KAPTUR, Ohio JOHN T. MYERS, Indiana RAY THORNTON, Arkansas BARBARA F. VUCANOVICH, Nevada ROSA L. DeLAURO, Connecticut JAMES T. WALSH, New York DOUGLAS "PETE" PETERSON, Florida ED PASTOR, Arizona NEAL SMITH, Iowa Robert B. Foster, Timothy K. Sanders, and Carol Murphy, Staff Assistants DIETARY SUPPLEMENTS DEC 2 3 1933 -aSRSBHsSHS. Printed for the use of the Committee on Appropriations AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND RELATED AGENCIES APPROPRIATIONS FOR 1994 HEARINGS BEFORE A SUBCOMMITTEE OF THE COMMITTEE ON APPROPRIATIONS HOUSE OF REPRESENTATIVES ONE HUNDRED THIRD CONGRESS FIRST SESSION SUBCOMMITTEE ON AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND RELATED AGENCIES RICHARD J. DURBLN, Illinois Chairman JAMIE L. WHITTEN, Mississippi JOE SKEEN, New Mexico MARCY KAPTUR, Ohio JOHN T. MYERS, Indiana RAY THORNTON, Arkansas BARBARA F. VUCANOVICH, Nevada ROSA L. DeLAURO, Connecticut JAMES T. WALSH, New York DOUGLAS "PETE" PETERSON, Florida ED PASTOR, Arizona NEAL SMITH, Iowa Robert B. Foster, Timothy K. Sanders, and Carol Murphy, Staff Assistants DIETARY SUPPLEMENTS Printed for the use of the Committee on Appropriations U.S. GOVERNMENT PRINTING OFFICE 73-485 O WASHINGTON : 1993 For sale by the U.S. Government Printing Office Superintendent of Documents, Congressional Sales Office, Washington. DC 20402 ISBN 0-16-041758-9 COMMITTEE ON APPROPRIATIONS WILLIAM H. NATCHER, Kentucky, Chairman JAMIE L. WH1TTEN, Mississippi, JOSEPH M. McDADE, Pennsylvania Vice Chairman JOHN T. MYERS, Indiana NEAL SMITH, Iowa C. W. BILL YOUNG, Florida SIDNEY R. YATES, Illinois RALPH REGULA, Ohio DAVID R. OBEY, Wisconsin BOB LIVINGSTON, Louisiana LOUIS STOKES, Ohio JERRY LEWIS, California TOM BEVILL, Alabama JOHN EDWARD PORTER, Illinois JOHN P. MURTHA, Pennsylvania HAROLD ROGERS, Kentucky CHARLES WILSON, Texas JOE SKEEN, New Mexico NORMAN D. DICKS, Washington FRANK R. WOLF, Virginia MARTIN OLAV SABO, Minnesota TOM DELAY, Texas JULIAN C. DKON, California JIM KOLBE, Arizona VIC FAZIO, California DEAN A. GALLO, New Jersey W. G. (BILL) HEFNER, North Carolina BARBARA F. VUCANOVICH, Nevada STENY H. HOYER, Maryland JIM LIGHTFOOT, Iowa BOB CARR, Michigan RON PACKARD, California RICHARD J. DURBIN, Illinois SONNY CALLAHAN, Alabama RONALD D. COLEMAN, Texas HELEN DELICH BENTLEY, Maryland ALAN B. MOLLOHAN, West Virginia JAMES T. WALSH, New York JIM CHAPMAN, Texas CHARLES H. TAYLOR, North Carolina MARCY KAPTUR, Ohio DAVID L. HOBSON, Ohio DAVID E. SKAGGS, Colorado ERNEST J. ISTOOK, Jr., Oklahoma DAVID E. PRICE, North Carolina HENRY BONILLA, Texas NANCY PELOSI, California PETER J. VISCLOSKY, Indiana THOMAS M. FOGLIETTA, Pennsylvania ESTEBAN EDWARD TORRES, California GEORGE (BUDDY) DARDEN, Georgia NITA M. LOWEY, New York RAY THORNTON, Arkansas JOSE E. SERRANO, New York ROSA L. DeLAURO, Connecticut JAMES P. MORAN, Virginia DOUGLAS "PETE" PETERSON, Florida JOHN W. OLVER, Massachusetts ED PASTOR, Arizona CARRIE P. MEEK, Florida Frederick G. Mohrman, Clerk and Staff Director 01) AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND RELAT- ED AGENCIES APPROPRIATIONS FOR 1994 Monday, October 18, 1993. DIETARY SUPPLEMENTS WITNESSES HON. BILL RICHARDSON, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW MEXICO HON. ORRIN G. HATCH, A UNITED STATES SENATOR FROM THE STATE OF UTAH HON. ELTON GALLEGLY, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA Mr. Durbin. Today we are convening the Subcommittee on Agri- culture, Rural Development, Food and Drug Administration and Related Agencies for a hearing on dietary supplements. The pur- pose of this hearing is to discuss balance, striking a balance be- tween ensuring the safety and accurate labeling of dietary supple- ments while protecting the American consumer's freedom to choose. The vitamin and dietary supplement industry is big business with sales in excess of $4 billion annually. Many of the products sold are on the cutting edge of modern thinking about our health and the quality of our life, but there are also dietary supplements for sale in America which are worthless and dangerous. Innocent people en- dangered their lives because some unscrupulous companies have sold lethal doses of so-called health foods. The role of government and the FDA is the central issue of this hearing. There have been excesses by this agency and there have certainly been excesses by the dietary supplement industry as they have lobbied Capitol Hill. Today we are looking for balance, not a consensus but a balance of viewpoints on this emotional issue. A balance between govern- ment and the dietary supplement industry so that Americans can enjoy even better health in the years ahead. I will now recognize my colleague from New Mexico, Mr. Skeen. Mr. Skeen. I agree that the key word in this whole discussion is going to be balance. I think we in the United States are probably more interested in safeguarding the public and the things that are being consumed. The things that we have to consider at these hearings is how much regulation is necessary, what are the problems that have caused us to become concerned about regulation. Also, how much cost is involved in doing an adequate job of regulating the public health and safety. So I agree with you, this is a timely hearing. (l) We have had a lot of the discussions prior to our regular hearing process during the appropriations cycle. I want to welcome espe- cially my colleague from New Mexico, Bill Richardson, and Mr. Gallegly. Senator Hatch, glad to have you here. Let's get on with the business of seeing what we can do about this problem. Mr. Durbin. Unless my colleagues have an opening statement, we will start with the first panel. The first panel of witnesses in- cludes our colleague from New Mexico, the Honorable Bill Richard- son; the Senator from Utah, Orrin Hatch; Congressman Elton Gallegly from the State of California. I will start with Mr. Richardson. Mr. Richardson. Mr. Chairman, thank you very much for hold- ing this hearing, honoring our request to deal with this issue and for your very balanced statement. I also would like to thank my good friend and colleague, Senator Hatch, the pioneer on this issue; and my friend, Elton Gallegly, who has labored very hard on this issue. My colleagues have done a very good job of spreading the im- portance of ensuring access to dietary supplements for people who want them. Mr. Chairman, at a time when our President has released a com- prehensive plan to reform this Nation's health care system, we should be doing all that we can to secure the freedom of consumers to choose safe dietary supplements and to help them prevent ill- nesses and disease. This is what this issue is about; the safe use of dietary supplements could save the Nation billions of dollars in health care costs, but people are not as informed as they could be because manufacturers aren't allowed to provide the information consumers need. The issue is also about the appropriate level of government regu- lation and the proper use of scarce government resources. Mr. Chairman, I also want to call note to the tremendous public outpouring of support for the legislation that all of us here have in- troduced, close to 60 Members of the United States Senate and over 150—hopefully, soon to be 200—Members of the House. Mr. Chairman, we are also concerned about the FDA's role on this issue. Federal courts have found recently that the FDA's at- tempt to regulate supplements as food additives, in the words of 1st Circuit Court's opinion is "nonsensical and hence incorrect," and in the words of the 7th District Court's opinion, "defies logic and common sense." The 7th District Court went so far as to say that FDA's efforts represented "an Alice in Wonderland approach to regulation." As a legislator, I resent FDA's using its and our limited resources to litigate cases by reasoning which is clearly contrary to legislative intent. There are adequate precautions for safety in the legislation that we have introduced. I am by no means saying that we must cast all caution to the wind and not be concerned about potential risks of fraud and injury to consumers of supplements, and I detest any effort to try to portray H.R. 1709, the Dietary Supplement Health and Education Act, as a bill that in unconcerned about fraud and safety. H.R. 1709 requires that all supplement manufacturers employ good manufacturing practices as well as notify the FDA prior to any significant changes in their manufacturing. My legislation would also require manufacturers to notify the FDA 30 days prior to marketing products with health claims. These health claims must be truthful, nonmisleading, and based upon the totality of sci- entific evidence. H.R. 1709 does not take anything away from the enforcement powers of FDA to prosecute misleading and false claims. If any- thing, H.R. 1709 strengthens those powers. Mr. Chairman, the bottom line is that manufacturers of supple- ments must be allowed to make truthful and nonmisleading health claims when there is known scientific evidence backing those claims. To prohibit such claims is to block the constitutional right to free speech. Any regulatory process that forces health claims for supplements to be preapproved by the FDA without procedural safeguards, such as prompt agency action and judicial review, can easily be construed as prior restraint of constitutionally protected speech. In fact, Mr.