KF27 G663 1993a COMMITTEE ON GOVERNMENT OPERATIONS JOHN CONYERS, JR., Michigan, Chairman CARDISS COLLINS, Illinois STEPHEN L. NEAL, North Carolina JOHN M. SPRATT, JR., South Carolina CAROLYN B. MALONEY, New York MARJORIE MARGOLIES-MEZVINSKY, LYNN C. WOOLSEY, California WILLIAM F. CLINGER, JR., Pennsylvania J. DENNIS HASTERT, Illinois CHRISTOPHER SHAYS, Connecticut ILEANA ROS-LEHTINEN, Florida RONALD K. MACHTLEY, Rhode Island WILLIAM H. ZELIFF, JR., New Hampshire JOHN M. MCHUGH, New York BERNARD SANDERS, Vermont (Independent) JOHN CONYERS, JR., Michigan WILLIAM F. CLINGER, JR., Pennsylvania RONALD A. STROMAN, Staff Director (II) 95-17548 CONTENTS Page Block, Gladys, Ph.D., University of California, Berkeley 186 128 172 238 86 Hildwine, Regina, director, Technical Regulatory Affairs, National Food Johnston, Richard, M.D., senior vice president, programs, and medical 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- Shank, Fred R., Ph.D., Director, Center for Food Safety and Applied Silverglade, Bruce, director, legal affairs, Center for Science in the Public 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 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- 210 Hildwine, Regina, director, Technical Regulatory Affairs, National Food 174 Huxtable, Ryan J., Ph.D., University of Arizona: Prepared statement Johnston, Richard, M.D., senior vice president, programs, and medical director, March of Dimes Birth Defects Foundation: Prepared state- 367 McCaleb, Robert S., Herb Research Foundation: Prepared statement Rosenberg, Irwin H., professor of medicine and nutrition, Tufts Univer- 44 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 106 230 162 395 457 FEDERAL DRUG ADMINISTRATION'S REGULATION OF DIETARY SUPPLEMENTS TUESDAY, JULY 20, 1993 HOUSE OF REPRESENTATIVES, HUMAN RESOURCES AND INTERGOVERNMENTAL RELATIONS SUBCOMMITTEE OF THE COMMITTEE ON GOVERNMENT OPERATIONS, Washington, DC. The subcommittee met, pursuant to notice, at 10 a.m., in room 2247, Rayburn House Office Building, Hon. Edolphus Towns (chairman of the subcommittee) presiding. Present: Representatives Edolphus Towns, Thomas M. Barrett, Donald M. Payne, Steven Schiff, Stephen Horn, and Bernard Sand ers. Also present: Ronald A. Stroman, staff director; William M. Layden and Brenda E. Pillors, professional staff members; Martine M. DiCroce, clerk; and Martha B. Morgan, minority professional staff, Committee on Government Operations. OPENING STATEMENT OF CHAIRMAN TOWNS Mr. Towns. The subcommittee will come to order. Today's hearing is on the Food and Drug Administration's regulation of dietary supplements. As required by the Dietary Supplement Act of 1992, on June 15 of this year, FDA proposed regulations governing nutrition labeling and nutrient content, and health claims for all dietary supplements. FDA also asked for comments on how it should regulate dietary supplements. Whether FDA is striking the proper regulatory balance is the focus of this hearing today. Millions of Americans regularly consume vitamins, minerals, herbs, and other dietary supplements to improve their nutrition and health. In recent years, growing scientific research has revealed that certain nutrients, such as vitamin E, may help to prevent heart disease and cancer. At a time when this country is trying to reduce health care costs and improve the health of all Americans, dietary supplements could contribute greatly to the prevention of disease. At the same time, consumers have a right to expect that their dietary supplements are safe and manufactured to the highest standards possible. Consumers also have a right to expect that claims made about the health and nutritional benefits of dietary supplements are truthful and nonmisleading. Consumers are subject to a barrage of conflicting messages in the media about the po (1) tential health benefits and health risks of certain nutrient supplements. We must all work together to avoid the tragedy that occurred in 1989 when a contaminated batch of L-tryptophan was linked to a deadly disease known as EMS. In 1991, this subcommittee, under the leadership of my predecessor, the late Honorable Ted Weiss, Democrat of New York, heard firsthand from some of the innocent persons who were harmed by L-tryptophan. Today we will have an opportunity to follow up on that initial inquiry. It is time to cut through the regulatory fog surrounding dietary supplements and hear from the experts about: (1) FDA's actual and proposed regulations for dietary supplements; (2) the public health risk and benefits of dietary supplements; (3) the scientific data supporting health claims for dietary supplements; and (4) the proper regulatory balance between consumer protection and free trade. I look forward to hearing from our witnesses this morning. Before we hear from our first witness, I would like to yield to Mr. Schiff, the ranking minority member of the subcommittee, for any remarks that he might have at this time. Congressman Schiff. Mr. SCHIFF. Thank you very much, Mr. Chairman. I will certainly be brief. We have a lot of qualified witnesses to hear from. I want to, first of all, thank you for holding this hearing. The subject of dietary supplements, I think, doesn't receive as much media attention as certain other issues we are seeing today. Nevertheless, I can tell you that from the volume of mail I receive from my constituents, there is obviously great public interest in this subject; and I want to thank you personally for holding this hearing. I am an original cosponsor of Congressman Bill Richardson's bill, H.R. 1709, which we believe will strike a balance-the balance that you referred to-between the responsibility of the FDA to look after those substances which we consume and the right of people to select dietary supplements if they choose to do so without interference from the government that goes beyond the government's legitimate interest in protecting public health and safety. I would be interested, from any or all of the witnesses in the course of their testimony, if they happen to be familiar with H.R. 1709, if they would express their support or nonsupport, if that is the case, of that bill. We, the sponsors, believe that we are achieving the correct balance, but I would be interested in other views on that. And with that, I want to, again, say that I think this is a very important hearing; and I look forward to it. And I yield back. Mr. Towns. Thank you very much. Congressman Sanders. Mr. SANDERS. Thank you Mr. Chairman. I will also be brief. This is an extremely important hearing and, as Congressman Schiff has mentioned, has generated a lot of interest in my State of Vermont. I have been a strong supporter for a person's right to seek alternative approaches in medical care. It is clear that western medicine does not have all the answers. I am supportive of a new program which provides grants for alternative health research. In September, we will be holding a conference in Vermont actually on cancer prevention looking at diet and the environmental |