/. KSS1UJES RJEILATHNG TO .El?HEDRA-CONTAllNiNG I DIETARY SUPPLEMENTS HEARINGS BEFORE THE SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS . A}l'D THE SUBCOMMITTEE ON COMMEROE, TRADE, AND CONSUMER PROTECTION I ' .. OF THE ·. COMMITTEE ON ENERGY AND I . COMMERCE . ·. HquSE GJi' REPRESENTATIVES ONE HUNDRED EIGHTH CONGRESS I . FIRST SESSION . ---·- . ·JULY 23 and !!4, 2003 · Printe '' for the use of the Committee on Energy and Commerce · . / A·1;d able vi the World .Wide .Web: http://www.access.gpo.gov/congress/hciuse . U .S. GOVERNMENT PRINTING OFFICE 89-966PDF WASHINGTON : 2003 For Iaale ~y the Superintendent of Documents, U.S. Government Printing Office - ---­ IntcrnJt: bookatore.gpo.gov Phone: toll free (866) 512-1800; DC area (202) 512·-1800 . I:F ax: (202)'512-2250 Maili Stop SSOP, Washington, DC 20402-0001 · COlWMlTTEE Oi.\T ENERGY AND COMMERCE W.J. "BILLY" TAUZIN, Louisiana, Chairman MICHAEL BILIRAKIS, Florida JOHN n. DINGE;LL, Michigan CONTENTS Rankini Member ·. JOE BARTON, Te1cas HENRY A. W/\XMAN, California FRED UPTON, Michiga!l EDWARD MARJ{EY, Massachusetts I CLD.i'F STEARNS, Florida J. Page RALPH M. HALL, Telcas I PAUL E. GILLMOR, Ohio Hearings held: i JAMES C. GREENWOOD, Pennsylvania RICK BOUCHER, Virginia '1 CIUUSTOPHER COX, California EDOLPHUS TOWNS, New York ~4y ~3, 2003!···················"·········································································· ······ FRANK PALLONE, Jr., New Jersey u y 4, 2003, ...................................................... 173 NATHAN DEAL, Georgia '.Pestimony of: .. ············· ..... ······· ·················· · RICHARD BURR, North Carolina SHERROD BROWN, Ohio Be~:d' J. How!lr~, III, Director, Bureau of Consumer Protection, Federal Vice Chairman BART GORDON, Tennessee PETER DEUTSCH, Florida 238 ED WHITFillLD, Kentucky Bechle:. .. CHARLill NORWOOD, Georgia BOBBY L. RUSH, lllinois ~~~~~~~~ ::::::::::::::::::::: : :::::::::::::::::::::::~······· ··· ·· ··· ·· · ······· · ······ ······ · ··· 13 BARBARA CUBIN, Wyoming ANNA G. ESHOO, California Birch, Adolplil.o A., III, Counsel for Labor Rel~ti~~~···N~ti~~~i··F~·~;;b;ll JOHN SHIMKUS,.lllino,is. .. BART STUPAK, Michigan r-·· League ..... }................................................. .......... .. ' 193 HEATHER WILSON, New Me1dco ELIOT L. ENGEL;.New York Boozer, Car?ll Obesity Res~arch Center, St. Luk;'s.. R~~~~~~it'fi~~~it;;i··::::: 103 ALBERT R. WYNN, Maryland Brown, DaVId, former President of Metabolife · JOHN B. SHADEGG, Arizona Chin R b ' ··········································· ···· 92 CHARLES W. "CHIP" PICKERING, ·GENE GREEN, Texas ery, o ~rt, Presid~nt, Cytodyne Technologies ..................................... 106 Mississippi · KAREN McCARTHY, Missouri Co lk er, Carlqn M., Chief Executive Officer and Medical Director Peak VITO FOSSELLA, New York TED STRICKLAND, Ohio DIANA DEGETTE, Colorado . c =e~, J~c c..... d························:······ .. ···· .. ····················: .................. :.. ....... 115 ROY BLUNT, Missouri . 1 113 STEVE BUYER, Indiana LOIS CAPPS, California c~osse, 'Ma~cl~. fcfu:n;:~:;, ':e~tb:'c~~~:p~j;ii~··n:~~ith··~d··s~i~;:;~~ GEORGE RADANOVICH, California J.I4IOHAEL F. DOYLE, Pennsylvania CHARLES F . BASS, New Hampshire CHRISTOPHER JOHN, Louisiana 44 JOSEPH R. PITTS, Pennsylvania TOM ALLEN, Maine cJf!~~~~~~fo=:~~:~~~e~!~e~~rt~~~;; · ~r·Ii~;;ith:·::::::::::::::::::::: 41 MARY BONO, California JIM DAVIS, ·Florida Ellis, Michael, Founder and Director ofMetabolife International .... .......... 92 GREG WALDEN, Oregon JAN SCHAKOWSKY, Illinois Fox, Roseann!, Customer ~eryice Representative, NVE Pharmaceuticals .. 121 LEE TERRY, Nebraska HILPA L. SOLIS, California Garber, D?na:ld P.,.Comrmss10ner, Major League Soccer ............................. 199 ERNill FLETCHER, Kentucky \ Helton, Mike) Pres1~ent, National Association for Stock Car Auto Racing . 196 MIKE FERGUSON, New Jersey Hermann, Hobert, V1ce President, Metabolife International 101 MIKE ROGERS, Michigan Hymsfield, S~even B., ~eputy Director of Obesity Resear~h··c-~;:;t~~ ·· st· DARRELL E. ISSA, California 18 C.L. "BUTCH" OTTER, Idaho M~~:J. R~~~~~lt ~~ss~~~ lri~~~~ti~~ .. vi~~···p;~~ia~~i:··'L~b~~··li~i~ii~~~~ DAN R. BROUILLE'ITE, Staff Director uman Re~ources, Major League Baseball .............................................. 185 JAMES D. BARNE'ITE, Gen~ral Counsel M? C 1e11 an, Hpn. Mark B., Commissioner, Food and Drug Administration·. 228 REID P.F. STUNTZ, Minority Staff Director and Chief Counsel Mitte~, ~atthew J., Associate Dean for Academic Affairs, Marquette Umyersity ILa~ Schoo~ Director, National Sports Law Institute The SUBCOMMITI'EE ON OVERSIGHT AND INVESTIGATIONS N~~o~al ~p~eg~.a~ A~d etic Association ........................................... .'........ 203 JAMES C. GREENWOOD, Pennsylvania, Chairman 0 cc En o, ~ eDrt, es1 ~nt, NVE Pharmaceuticals ............................. :.... 119 MICHAEL BILIRAKIS, Florida PETER DEUTSCH, Florida 0 rza, ugenf . ·•. AssoCiate General Counsel, Major League Baseball CLIFF STEARNS, Florida Ranking Member 189 RICHARD BURR, North Carolina Dl:ANA DEGETTE, Colorado ru;::~k~~.c~!~C: Iiiggb;.~.F"~~d~ti~~·r~;·s-;;b~t~~~·~~p;;~~·s~h.~~i~······· ·· 14 CHARLES F. BASS, New Hampshire .)1M DAVIS, Florida RSohrdrigukezR, Drniel, ~ead Nurse, Metabolife ........................................... :::::::: 92 GREG WALDEN, Oregon JAN SCHAKOWSKY, Illinois c ec , us sell, Chief Executive Officer Metabolife International 99 Vice Chairman HENRY A. WAXMAN, California Vasquez; Michael, Law Offices of Fred G: Cohen ··········· 17 MIKE FERGUSON, New Jersey BOBBY L. RUSH, Illinois WoSo~ley, Ra:0nond, Vice President for Health s~i~·~~~~ ·· Arl~~;:;~··H~~ith MIKE ROGERS, Michigan JOHN D. DINGELL, Michigan, Ciences Center ' 32 W.J. "BILLY" TAUZIN, Louisiana (Ex Officio) Zipes, Do~gl~s P.,··:ni·~ti~~~h~d··:p;~i~~·~~~··~r· ·M:~di~~~···:ph~~~~i~g;; (Ex Officio) .. ... of Cardiology, Kr;nnert SUBCOMMITI'EE ON COMMERCE, AND CONSUMER PROTECTION ~~a;'tll~l~o~':.: ~~.~~~~~· ~.~~si~n In~titute TRADE, Addition~ materj.al submitted for the·;~~~~;i;" ..................................................... 35 CLIFF STEARNS, Florida, Chairman JAN SCHAKOWSKY, Illinois Amfncan Corege of Obstetricians and Gynecologists, prepared statement FRED UPTON, Michigan 170 BARBARA CUBIN, Wyoming Ranking Member B(1e(¥0 •·••••••••••••••••···••••·•••• Mic~ael M., M:n::· · i~i;;~;··'d~t~a··17 .. Jcl:;;··2ooa· ·· ;;;;··li~~··J~~~~ JOHN SHIMKUS, Illinois HILDA L. SOLIS, California EDWARD J. MARKEY, Massachusetts 166 ,TOHN B. SHADEGG, Arizona Met.ab~~:~~~~:o~~~~·;;~··~~~iii~~···~~~ti~~······················: ........................... EDOLPHUS TOWNS, New York . q 8 ............................................. .. 169 Vice Chairman SHERROD BROWN, Ohio GEORGE RADANOVICH, California (III) CHAIU.,ES F. BASS, New Hampshire JIM DAVIS, Florida JOSEPH R. PITTS, Pennsylvania PETER DEUTSCH, Florida BART STUPAK, Michigan MARY BONO, California GENE GREEN, Texas LEE TERRY, Nebraska KAREN McCARTHY, Missouri 'ERNill FLETCHER, Kentucky MIKE FERGUSON, New Jersey TED STRICKLAND, Ohio . DIANA DEGETTE, Colorado DARRELL E. ISSA, California JOHN D. DINGELL, Michigan,· C.L. "BUTCH" OTl'ER, Idaho ........ ,....,.... ' . - . ----·- - .. 64 Mr. VASQUEZ. When I was no longer employed in the company 65 [ inquired about this specific nurse and they said that she was let :ro beca:ttse she was very vocal about the product, whether you ize people probably think that these products are safe because they b:tow,,itw-as doing more harm than good. are no~ prescription drugs or a doctor's order is not required. Do Mr. GREENWOOD. Were you warned or persuaded .bY you_r super­ you think that that's probably true, Mrs. Bechler? · llisor at Metabolife not direct complainants to descnbe their symp­ · Ms. BECHLER. I do. In fact, my son as I hear it from his wife­ toms but instead to just take their name and phone number and Ms. DEGETI'E. Just move that a little closer. That helps. Yes; rive that to your supervisor? . · Ms. BECHLER. As I hear it from his wife, she got it at workout " Mr. VASQUEZ. It would depend on the severity of the call. Some place that she worked out at. And so you-- lf it is minor like abdominal cramps, then you know.you would doc­ Ms. DEGETI'E. So they were giving it out at the gym? llment that. We documented all calls. But if it was moderate to se­ Ms. BECHLER. Yes. In fact, my other son and I worked out at. a trere, you had a proc~dure wh~re 'Ye would take as much informa­ gym .a~d th.ey have it there. So why would not you natural think tion as we can get Without bemg Judgmental and I would fo:ryard that It IS gomg to be as natural and it is herbal, and it is safe. lt to my supervisor Mr. Daniel Rodriguez. And we were basically Ms. DEGETI'E. And, Mr. Riggins, what is your view on that? left in the dark and we would not know what happened to that spe­ Mr. RIG9INS. In .our discuss~ons with kids, and when. I say kids ~ific case. Mr. Rodriguez was the one who was basically the key I am not JUst talking about high school students. We are talking person that would follow up on specific case. · · · about college athletes as well, college students that are looking to Mr. GREENWOOD. Did anyone at Metabolife including your super­ lose weight and with the general public. We have found that when trisor at the Health Information Line, Mr. Rodriguez, monitor your you start bringing the awareness out, when you tell them that the responses to ·customers who were co~plaining of .adverse events or FpA does n?t ~ave-only has minimal control over these compa, o.egative side