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Issues Relating to Ephedra-Containing Dietary Supplements ISSUES RELATING TO EPHEDRA-CONTAINING DIETARY SUPPLEMENTS HEARINGS BEFORE THE SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS AND THE SUBCOMMITTEE ON COMMERCE, TRADE, AND CONSUMER PROTECTION OF THE COMMITTEE ON ENERGY AND COMMERCE HOUSE OF REPRESENTATIVES ONE HUNDRED EIGHTH CONGRESS FIRST SESSION JULY 23 and 24, 2003 Serial No. 108–43 Printed for the use of the Committee on Energy and Commerce ( Available via the World Wide Web: http://www.access.gpo.gov/congress/house U.S. GOVERNMENT PRINTING OFFICE 89–966PDF WASHINGTON : 2003 For sale by the Superintendent of Documents, U.S. Government Printing Office Internet: bookstore.gpo.gov Phone: toll free (866) 512–1800; DC area (202) 512–1800 Fax: (202) 512–2250 Mail: Stop SSOP, Washington, DC 20402–0001 VerDate 11-MAY-2000 09:26 Nov 04, 2003 Jkt 000000 PO 00000 Frm 00001 Fmt 5011 Sfmt 5011 89966.TXT HCOM1 PsN: HCOM1 VerDate 11-MAY-2000 09:26 Nov 04, 2003 Jkt 000000 PO 00000 Frm 00002 Fmt 5011 Sfmt 5011 89966.TXT HCOM1 PsN: HCOM1 COMMITTEE ON ENERGY AND COMMERCE W.J. ‘‘BILLY’’ TAUZIN, Louisiana, Chairman MICHAEL BILIRAKIS, Florida JOHN D. DINGELL, Michigan JOE BARTON, Texas Ranking Member FRED UPTON, Michigan HENRY A. WAXMAN, California CLIFF STEARNS, Florida EDWARD J. MARKEY, Massachusetts PAUL E. GILLMOR, Ohio RALPH M. HALL, Texas JAMES C. GREENWOOD, Pennsylvania RICK BOUCHER, Virginia CHRISTOPHER COX, California EDOLPHUS TOWNS, New York NATHAN DEAL, Georgia FRANK PALLONE, Jr., New Jersey RICHARD BURR, North Carolina SHERROD BROWN, Ohio Vice Chairman BART GORDON, Tennessee ED WHITFIELD, Kentucky PETER DEUTSCH, Florida CHARLIE NORWOOD, Georgia BOBBY L. RUSH, Illinois BARBARA CUBIN, Wyoming ANNA G. ESHOO, California JOHN SHIMKUS, Illinois BART STUPAK, Michigan HEATHER WILSON, New Mexico ELIOT L. ENGEL, New York JOHN B. SHADEGG, Arizona ALBERT R. WYNN, Maryland CHARLES W. ‘‘CHIP’’ PICKERING, GENE GREEN, Texas Mississippi KAREN MCCARTHY, Missouri VITO FOSSELLA, New York TED STRICKLAND, Ohio ROY BLUNT, Missouri DIANA DEGETTE, Colorado STEVE BUYER, Indiana LOIS CAPPS, California GEORGE RADANOVICH, California MICHAEL F. DOYLE, Pennsylvania CHARLES F. BASS, New Hampshire CHRISTOPHER JOHN, Louisiana JOSEPH R. PITTS, Pennsylvania TOM ALLEN, Maine MARY BONO, California JIM DAVIS, Florida GREG WALDEN, Oregon JAN SCHAKOWSKY, Illinois LEE TERRY, Nebraska HILDA L. SOLIS, California ERNIE FLETCHER, Kentucky MIKE FERGUSON, New Jersey MIKE ROGERS, Michigan DARRELL E. ISSA, California C.L. ‘‘BUTCH’’ OTTER, Idaho DAN R. BROUILLETTE, Staff Director JAMES D. BARNETTE, General Counsel REID P.F. STUNTZ, Minority Staff Director and Chief Counsel SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS JAMES C. GREENWOOD, Pennsylvania, Chairman MICHAEL BILIRAKIS, Florida PETER DEUTSCH, Florida CLIFF STEARNS, Florida Ranking Member RICHARD BURR, North Carolina DIANA DEGETTE, Colorado CHARLES F. BASS, New Hampshire JIM DAVIS, Florida GREG WALDEN, Oregon JAN SCHAKOWSKY, Illinois Vice Chairman HENRY A. WAXMAN, California MIKE FERGUSON, New Jersey BOBBY L. RUSH, Illinois MIKE ROGERS, Michigan JOHN D. DINGELL, Michigan, W.J. ‘‘BILLY’’ TAUZIN, Louisiana (Ex Officio) (Ex Officio) SUBCOMMITTEE ON COMMERCE, TRADE, AND CONSUMER PROTECTION CLIFF STEARNS, Florida, Chairman FRED UPTON, Michigan JAN SCHAKOWSKY, Illinois BARBARA CUBIN, Wyoming Ranking Member JOHN SHIMKUS, Illinois HILDA L. SOLIS, California JOHN B. SHADEGG, Arizona EDWARD J. MARKEY, Massachusetts Vice Chairman EDOLPHUS TOWNS, New York GEORGE RADANOVICH, California SHERROD BROWN, Ohio CHARLES F. BASS, New Hampshire JIM DAVIS, Florida JOSEPH R. PITTS, Pennsylvania PETER DEUTSCH, Florida MARY BONO, California BART STUPAK, Michigan LEE TERRY, Nebraska GENE GREEN, Texas ERNIE FLETCHER, Kentucky KAREN MCCARTHY, Missouri MIKE FERGUSON, New Jersey TED STRICKLAND, Ohio DARRELL E. ISSA, California DIANA DEGETTE, Colorado C.L. ‘‘BUTCH’’ OTTER, Idaho JOHN D. DINGELL, Michigan, W.J. ‘‘BILLY’’ TAUZIN, Louisiana (Ex Officio) (Ex Officio) (II) VerDate 11-MAY-2000 09:26 Nov 04, 2003 Jkt 000000 PO 00000 Frm 00003 Fmt 6011 Sfmt 0486 89966.TXT HCOM1 PsN: HCOM1 C O N T E N T S Page Hearings held: July 23, 2003 ..................................................................................................... 1 July 24, 2003 ..................................................................................................... 173 Testimony of: Beales, J. Howard, III, Director, Bureau of Consumer Protection, Federal Trade Commission ........................................................................................ 238 Bechler, Pat ....................................................................................................... 13 Birch, Adolpho A., III, Counsel for Labor Relations, National Football League ............................................................................................................ 193 Boozer, Carol, Obesity Research Center, St. Luke’s Roosevelt Hospital ..... 103 Brown, David, former President of Metabolife ............................................... 92 Chinery, Robert, President, Cytodyne Technologies ...................................... 106 Colker, Carlon M., Chief Executive Officer and Medical Director, Peak Wellness, Inc ................................................................................................. 115 Conklin, Kelly, Cytodyne Technologies ........................................................... 113 Crosse, Marcia, Acting Director, Health Care-Public Health and Science Issues, U.S. General Accounting Office ....................................................... 44 Culmo, Cynthia, former official, Texas Department of Health ..................... 41 Ellis, Michael, Founder and Director of Metabolife International ............... 92 Fox, Roseann, Customer Service Representative, NVE Pharmaceuticals ... 121 Garber, Donald P., Commissioner, Major League Soccer .............................. 199 Helton, Mike, President, National Association for Stock Car Auto Racing . 196 Hermann, Robert, Vice President, Metabolife International ........................ 101 Hymsfield, Steven B., Deputy Director of Obesity Research Center, St. Luke’s Roosevelt Hospital ............................................................................ 18 Manfred, Robert D., Jr., Executive Vice President, Labor Relations/ Human Resources, Major League Baseball ................................................ 185 McClellan, Hon. Mark B., Commissioner, Food and Drug Administration . 228 Mitten, Matthew J., Associate Dean for Academic Affairs, Marquette University Law School, Director, National Sports Law Institute, The National Collegiate Athletic Association ..................................................... 203 Occhifinto, Robert, President, NVE Pharmaceuticals ................................... 119 Orza, Eugene D., Associate General Counsel, Major League Baseball Players Association ....................................................................................... 189 Riggins, Kevin, Sean Riggins Foundation for Substance-Free Schools ........ 14 Rodriguez, Daniel, Head Nurse, Metabolife ................................................... 92 Schreck, Russell, Chief Executive Officer, Metabolife International ........... 99 Vasquez, Michael, Law Offices of Fred G. Cohen .......................................... 17 Woosley, Raymond, Vice President for Health Sciences, Arizona Health Sciences Center ............................................................................................. 32 Zipes, Douglas P., Distinguished Professor of Medicine, Pharmacology and Toxicology, Director, Division of Cardiology, Krannert Institute of Cardiology .................................................................................................. 35 Additional material submitted for the record: American College of Obstetricians and Gynecologists, prepared statement of ..................................................................................................................... 170 Baden, Michael M., M.D., letter dated 17 July 2003, to Hon James C. Greenwood ................................................................................................ 166 Metabolife, responses to committee questions ............................................... 169 (III) VerDate 11-MAY-2000 09:26 Nov 04, 2003 Jkt 000000 PO 00000 Frm 00004 Fmt 0486 Sfmt 0486 89966.TXT HCOM1 PsN: HCOM1 ISSUES RELATING TO EPHEDRA-CONTAINING DIETARY SUPPLEMENTS WEDNESDAY, JULY 23, 2003 HOUSE OF REPRESENTATIVES, COMMITTEE ON ENERGY AND COMMERCE, SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS, Washington, DC. The subcommittee met, pursuant to notice, at 10 a.m., in room 2123, Rayburn House Office Building, James C. Greenwood (chair- man) presiding. Members present: Representatives Greenwood, Stearns, Burr, Bass, Walden, Tauzin (ex officio), Deutsch, DeGette, Davis, Schakowsky, Waxman, Rush, and Dingell (ex officio). Also present: Representatives Barton and Susan Davis. Staff present: Alan Slobodin, majority counsel; Mark Paoletta, majority counsel; Casey Hemard, majority counsel; Kelli Andrews, majority counsel; Tom Dilenge, majority counsel; William Carty, legislative clerk; David Nelson, minority investigator and econo- mist; Nicole Kenner, minority research assistant; and Jessica McNiece, minority staff assistant. Mr. GREENWOOD. Meeting will come to order. I ask the guests please take seats. We welcome everyone this morning, particularly our witnesses. I want to warn you all that we are probably going to be begin votes in something like 15 to 20 minutes, and so we
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