/. 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 effects as a result of taking Metabohfe? rues, the maJonty of the people are appalled at that. They just can Mr. VASQUEZ. Like I said earlier, there ~ere 1~ registered nu:r:ses not understand how come a law will allow a company just to run m staff and Mr. Rodriguez and the medical director; _Dr .. Srmth, as one individual put it, helter skelter. · ' b.ad the ability to listen to all the calls that were cormng m. And Ms. DEGE'ITE. But up until they know that information, they just lf they heard something, specifically Dan R?driguez, heard some assume tha:t the product is safe because it is being allowed to just thing. that one of the nurses would say, nght after the call he be sold helter skelter to th.e consumers, would you not agree? would critique, for example, myself and say probably you should Mr. RIGGINS. That is exactly right. Exactly right. b.ave answered that call that way. · Iv.ls. DEGETTE. Thank you. Mr. GREENWOOD. Did you feel under any pressure to conduct Dr. He:ymsfield, I was intrigued by your testimony where you vourself in those phone calls in any way other than you would were talking about ~he product labeling and you were tal,king apout ~ven what you said earlier in your testimony that you wanted to when. you began domg .your research there was no product labeling just do no harm,? . . . as to the dangers, and m fact some of the labels said clinical tested. Mr. VASQUEZ. At times, yes. Because as a nurse It ~eemed hke Is that correct? · , the telemarketer script the kind of answer you woUld give out a~d, Mr. HEYMSFIELD. Well, some of the bottles had statements for vou know, I was trained as a nurse, I went to scho?l, nursmg example, "independently laboratory tested for safety." ' ;;chool. You know, basically you had to really be more Impersonal Ms. DEGETI'E. Have you looked at bottle of Metabolife recently? than you cared. . , · . Mr. HEYMSFIELD. I have not looked at a recent bottle, no. While I was working there there was no nurse/pa~Ient/consumer Ms. DEGETI'E. Okay: I have got one here in my hands. relationship that would, you know, you would be looking out for the Mr. HEYMSFIELD. Yes. . Jest interest of the caller rather than th~ Ms. DEGETI'E. And there this big warning on the side of the label Mr. GREENWOOD. Did you feel that yoti were functioning more as here. Are you familiar with that warning? · 1 marketer of the drug than as an advocate for the patient? Mr. HEYMSFIELD. Yes. Yes. Mr. VASQUEZ. Definitely I wouldn't say marketer, because t~ey Ms. D:EGETI'E. Do you know when they started putting that n.ad a lot of advertisement. So not as a marketer. But. more like, warning on these bottles? · yOU know, less of an advocate from a medical professional, I would Mr. HEYMSFIELD. I am not aware of the date of when that ap- >ay so. · · · peared. . · · Mr. GREENWOOD. Thank you, sir. My time has expired. The gentlelady from Colorado is recognized for 5 minutes. Ms. DEGETI'E. Does anyone else know roughly when this warning Ms. DEGETI'E. Thank you, Mr. Chairman. . started appearing? . Mr. FRANCE. Jim France here, attorney for the B.echlers. I oelieve My first question is for the Bechlers an? for Mr. Rig~s, because It was early 2001. . . ~here are a lot of dietary supplements bemg sold now m the stores md you know, all my middle aged friends and I sit around and Mr. GREENWOOD. Excuse me. I have to quickly. swear you in if ;alk about what we should be taking to make ourselves feel better. you are going to actually speak. !\nd listening to all the testimony.today,. it kind of makes me real- [Witness sworn.] · Mr. GREENWOOD. Okay. You are under oath now. Ms. DEGETI'E. Mr. France, proceed. ·. 66 67 Mr. FRANCE. Yes. n 1999 they were using another label that had 'independently laboratory tested for safety" where that silver decal Mr. WALDEN. There have been reports that I have read in the cS on the front. press that ,said he was terribly overweight. How overweight was he Ms. DEGETI'E. This right here? went he went into camp? Mr. FRANCE. Yes. And then there was a class action lawsuit Ms. BECHLER. Ten pounds. ~ailed Gasperoni v. Metabolife that occurred in the year 2000. And Mr. BECHLER. Ten pounds. :ts a part of that settlement it is my understanding that they could Mr. WALDEN. Ten pounds? 11ot advertise that their product was independently laboratory test Mr. BECHLER. Hi~ body fat. was less than it was a year before. ~d for safety anymore and they put that little decal on the front. Ms. BECHLER. Which the Onoles was impressed about. !\nd then they started selling the product-- Mr. WALDEN. You need to turn on your mike. Ms. DEGETTE. It is a butterfly. Ms. BECHLER.. Which the Orioles were impressed about with just Mr. FRANCE. Yes. It is a silver decal- the 10 pounds, but his body fat had gone down. . Ms. DEGETI'E. It is a butterfly. Mr. WALDEN. Okay. And I guess I want to ask Mr. France this Mr. FRANCE. It is a butterfly. They put the butterfly over the ques~ion, because I was rea«ii.ng the testimony. last night of the safety claim in 2001, ][believe. Pr~s1dent. of Nutr~quest, Inc.,. f~rmer Xenadrine Technologies, Mr. Ms. DEGETI'E. And that is when they put the safety warnings Chinery, IS that nght? And m 1t he says we sold over 20 million on? . . bottles of Xenadrine RFA-1, which is what I think what your son Mr. FRANCE. And they added additionalsafety warning informa took. About 1.2 billion servings. And I understand the comment of tion, but they failed to include the fact that they had received thou our other witness· on that. And received 450 complaints during the sands of AERs. 5 years we s?ld the pro~uct. The great majority .of our complaints Ms. DEGETI'E. Okay. Thank you. were from nuld or transitory effects. Based on all the available sci Going back to Dr. Heymsfield. Thank you for helping us, sir. entific information we did not have any reason to believe that You said that the studies were flawed that were done by the Xenadrine RFA-1 cause!i anything but mild transitory effects. We c:ompanies. ][ am wondering if you can tell me quickly some of the relied upon studies not only on Xenadrine RFA-1 but also on stud reasons why you feel those studies were flawed? i~s o~ other. ephedra dietary supple.ments and on Xenadrine's plin Mr. HEYMSFIELD. Well, this is my opinion, but some of the pub Ciple mgredients, ephedra and caffeme. lished papers, for example, would report ·that effects were statis Studies including the Cantox Report show. that ephedra based tically significant. And that has very specific meaning to a sci products are effective and safe when used properly. · entist. But actually when you investigate the raw data in the ac Mr. France, first of all, are you familiar with any studies that tual statistics, they did not achieve specific significance. That was would confirm that? Would what I have reasoned indicate to the never revealed in the papers. They were misrepresented. And I contrary? · could give you many examples like that of where-- Ms. DEGETTE. And ][ think in addition, Dr. Woosley and others And ·. s~cond, are you aware of any court documents relating to said that the studies were not scientifically controlled because IRB how others have perceived the credibility of these witnesses? would. ever approve that kind of a study? Mr: JfR.AJ:'TCE. yes, I am.. First of :Ul, there was a trial against Mr. HEYMSFIELD. Well, no longer. I mean, at the time the ad Xenadnne m which Mr. Chinery testified about a month and a half verse events were not as clearly recognized. But I today I agree ago. And during that trial several of the alleged clinical studies with them. that took place on Xenadrine RFA-1 were discussed by expert wit Ms. DEGETTE. Okay. Thank you. nesses on both. sides,. And to reiterate what Dr. Hymsfield said, Mr. GREENWOOD. The tinie of the gentlelady has expired. The there was marupulabon of research data found and disclosed dur gentleman from New Hampshire is recognized to inquire for 5 min in.g that trial. The trial judge found there were significant problems utes. With several of the studies that Xenadrine was holding to prove ef- Mr. BASs. Thank you, Mr. Chairman. ][ have one qu.estion. Do ficacy and/or safety. · any of the doctors here see any medicinal value to ephedra? Is And more importantly, the trial judge found in its verdict· a writ there any reason-Okay. That is the only question I have. ten verdict, that Mr. Chinery, Mr. Conklin, who is. here today Dr. ][will yield the rest of my time to my friend Mr. Walden. Colker had no credibility. And the judge sat through alm~st 7 Mr. WALDEN. Thank you very much. weeks-- · ][ would like to address my first question to the Bechlers, and I Mr. WALDEN .. The judge said that? know this is a difficult one, but how did you·feel when the Broward M:r. FRANCE. The judge said that in a written opinion. All I County Coroner concluded that ephedra was "a significant factor" have it here today. . in your son's death? .. Mr. WALDEN. Mr. Chairman, would it be possible to have that M:r. BECHLER. When they told us about it, we knew it had to be written opinion entered into the record? something. It just was not heatstroke because he was in perfect Mr. GREENWOOD. Witho\lt objection, it will be incorporated into condition. I mean, there was nothing wrong with our son. Nothing. the record. [The information referred to follows:] 68
Slip Copy · 69 (CUe as: 2U03 WL 21263814 (Coi.Supcrior)) ,.. Slip Copy (Cite as: 2003 WL 21283814, •2 (Cai.Superior)) Pnge2 Only the Westlow ci~1tion is currently available. forth below· in the discussion of plaintiffs cl.aims linder·Business lind Professions Code sections 17200 South Bay Chevrolet v. General Motors Acceptance 5. Nature oftlte Proof. California Superior Court, County, and 17500 ~t seq. Corp. (1999) 72 Cal.App. 4th 861, 878).
Jlris on A, pARK, on behalf oi himself and nil Phiintill's second "COUSe of action alleges false and 2. Plaintiff Must Prove Public Is "Likely To Be The law in Utis area was summarized in Day ·v. A r & O>rp. ( 1998) .63 Cai.App.4th 325, 331-32: othern Glmilarly Ditunted, misleading advertisements in ~iolotion of Btisiness Deceived." T Sections . 17200 and. 17500 ato conswner l'lolntiiT, IUld Professions Code sections 17200 et ~eq. 'I}'• to v. third eo~e of action alleges fals~ and _nusle~dmg .A plaintiff musi prove that the public is "likely to be protection statutes designed, in part, proll:ct the C'h'TOD'i!NE rnCHNOtOGi:ES, JNC., a New advertisenients in violation of Busmess. and ·deceived" by the statements at issue in. an public by prohibiting false, unfair, misleading or .l'erJey corporndon; nnd Does 1 througb 100, Professions .Code sections 17500 et seq. Pl~intifl's advertisement. deceptive advertising. (Ccmmittee on Chi/dre11's inclusive, Defendants. factual allegations in tltese tWQ .causes o~ acmon are "Likely to deceive" implies mo;e than a mere Television, Inc. v. General Foods Corp. (1983) identicat: Plni,J)tiff does not allege any vaolat10ns of possibility thot the advertisement might 35 Cal.3d 197, 211 [197Cai.Rptr. 783, 673 P.2d ·No. GIC 768364. sections 17200 et seq. other than dte alleged fats~ and conceivably be misunderstood by some few 660] (Committee ).) "To state a cause of action misleading advertising that would also vtolate conswners viewing it iq au unreasonable manner. under Uacse statutes for injunctive relief, it is Mny 30, 2003. sections 17~00 et seq. Further, cases nddreasing fa!se Rather, the phrase indicates that tbe ad .is such necessary only to show that 'members of. the advertisitig clainJS imder both sta\'Jles have applted that it is probable that a significant. portion of the public arc likely to be deceived.' [Citations.]" ( TENTATIVE DECISION d1e snme legal standllrd t9 both. See Day v. AT & T general consuming public or of targeted Ibid.) Actual deception or confusion caused by O>rp. (1998) 63 Cai.App.41h 3_25. For these reasons, consumers, acting reasonably in. the misleading statements is not required. (People v. STYN,J. the ·causes of action under:sections 17200 et seq. and circwnstanccs, could be misled. Dollar Rcmt·A- Car Systems, Inc. (1989) 211 seclio~ 17500 et seq. wt11 be discussed together. Lavie v. Proctor & Gamble 0>. (2003) 105 C;!I.App.3d 119, 129 [259 Cal.Rptr. 191].) An INTRODUCTION Cai.App. 4th 496, 508. "un.fair" practice under section 17200 is one BURDEN OF PROOF "whose harm to the victim outweighs its ''!! Plaintiff·Jasqn A. Parle, on behalf of .hirns~lf ?"d 3. Advertisers Are Not Required to Produce bonefits." (Saunders v. Superior Court (1994) 27 ~ U others simllilrly situated, filed a complaint ngntDSt I. Plaiti~ff Mll5t Prove Statements ·were ·False .or Substantiation for their Advertising C!ninJS. Cai.App. 4th 832, 839 [33 Cai.Rptr.2d 438). ( defendant Cy1odync Technologies, Inc., a New Jersey · Misleading ·and Made Without Reasonable Care. : Saunders ).) In a similar veiti, the term corporation. The complaint · was certified as a class Advertisers arc not n:quired to produce "fraudulent" as used in the section "does not refer action. . Sections 17500 et . seq. prohibit negligent . or substantiation for their advertising cloinJS in actions to ti)e common law tort of fraud but only requires · intentio~al dissemiitation of false or misleading bro~ght by private plaintiffs under Business and • showing members of the .public • 'are likely to Cytodyne mnrlcets and sells Xenadrine RFA~l: .0 advertising. Natinnal. Council Against Health Fraud, Professions Code sections 17200 ct seq. and 17500 et be. deceived." ' [Citation.]" (fbicaffeine. Cytodync argued that private plaintiffs are in the sante position of actual deception, reasonable reliance, and advertises;: Xenadrine RFA-1 · tbrough magazine, Spe~ifi,aily, these statutes pr_os~rihe ~e n:"ldog or as the Attorney Gcneral .lllld that the court should th)lS damage are unoecessary." (Committee, supra, at .)lOS television, and radio advertisements. dissemination before tho pub he tn Califomaa of ·any sb.ift tho burden of production and require advertisers p. 211.) Section 17200 been interpreted sratement concerning the product that lljs. untru~ or to produce evidence substantiating the truth of their broadly to bar all ongoing wrongful business PLAINTIFFS CAUSES qF ACTION misleading, and which is !mown, or which. by the advertising claims. The Court of Appeal rejected that activity,._ including misleading advertising, in exercise of reasonable care should be koifWD, to be argument. The court lteld that private plaititiffs have whatever context it presents itself. (People v. Plaintiffs complaint alleges three causes of action. untrue or misleading." Cal. Bus. & Prof.Code § the burden of producing evidence to prove tbeir Dollar' Rent-A-Car Systems, Inc., supra, 211 Cai.App.3d atp.l29.) · Tile fllSt clnim alleges violations of t~e ~!JS~':' 17500. allegations that challenged advertising is false or Legal Remedies Act ("ci.RA"), ~h~onu~ Ctvtl misleading: •3 Thus, the statutes are meant to protect the Code sections 1750 et seq. Plamtifl's C~ Thus, io maintain ~ claim of false or mistead~g . public from a wide spectrum of itnpropcr conduct allegations couch plaintiffs false . adverttsm.g advertising, a plaintiftmust pro\'e; (I) ~tatements an 4. Statements Must Be Material To Be Actionable. in advertising. They may be invoked where the allegations in the context of a CLRA clallll. There JS the advertising. arc untrue or rruslcadmg, IUld (2) advertising complained of is not actually false, very little relevant case law addr~ing a!leged defendmtS J
SliJl Copy Page3 71 (Cite oo: 2003 WL 21283814, •3 (Cui.Superlor))
upon by n victim who incurs damages. None of the judge to determine, hosed solely upon his or her Slip Copy .Pago4 lhcsc elements ore required to state a cloim for own intuitive renction, whether the ndverti~emcnt is (Cite as: 2003 WL 21283814, *4 (Coi.Supcrior)) injunctive relief under section 17200 or 17500. A deceptive." Rather,, tho Court held that the question perfectly true statement couched in such o manner is: "Wiult docs the person to whom the advertisement Tile court reasoned that the primary evidence in a standard. Uwt it is likely to mislead or deceive the is addressed find to be the message?" According to false advertising case is tho advertising itself. Drockey consumer, such :is by failure to disclose other the Second Circuit, the success of a plaintifl's implied analogized tho *te unlawful advertising claims .to Thcrefore,.thls Court will analyze d1c advertiseme~ts relevant iriforrrllltion, i9 actionable under the9C falsity claim usually toms on the persuasiveness of a federal cases. involving the Federal Trude ~nd opply tbe reasonable consumer. test. If the Cqurt sections. consumer .survey. · ·. C9!1llilission's regUlation of deceptive advertising. finds a claim to be misleading, it means member. of "Tbe United States Supreme Court has rejected a the public arc likely to be.deceivcd, People v. Dollar G. Wb:lt Type of Evidence is Required to Establish *4 In HaslccU v. 1Yme, Inc: (t;:.D.Cal.t997) 965 claim that survey cv i d~nce '>':.IS rcquir~d ... [in) Rent-A-Car Systems. Inc., 211 C.I.App .3d 119, 129 th~ Advertisemenls Are MislcodinJ:. · F.Supp. 1398; the Court held that anecdotal evidence regulation of deceptive advertising." ·citing Fed~ral ( 1989), !hot the claim is material, in that it is likely to ·alone is insufficient to prove that the .public is likely Trade Com. v. . Colgate-Palmolive Co. (1965) 380 influence t11a purchasing decision, Borden It1c. 11. Defendants orgue lluit claims brought under Business to be misled. Relying on Johnson &: Johnson, the U.S. 374, 391-392 [13 L.Ed.2d 904, 918, 8.5 S.CL Krafllnc. (N.J:?.lll1989) 224 U.S.P.Q. 811, 819, ~nd Md Professions Code sectiooo 17200 end 17500 ond Court held lhot to prevail, plairitiff musi demonslnlte 1035) and Resort Cor Re11tal Syslem, Inc. v. Federal the. defendant knew or should have !mown, t;lus. & the CollSUIIlel' Legol Renu:diC!I Act, Civil Code by extrinsic evidence, such os ·consum
Copr. e West 2003 No Claim to Orig. U.S. Govt. Works 72 73 Slip Copy Poge5 (Cite ~s: 2003 WL 21203014, "6 (CnLSuperlor)) Slip Copy Page6 difference according to Dr. Shi. These numbel'$ were intentto treat means that you usc lill of tho subjects in (Cite u: 2003 WL 21283814, •7 (Cai.Supcrior)) reached by compnring the 12 who completed tlte the baseline; i.e., all30 subjects in·tbe Peak Welbtess study in the control group with the 13 who completed test who begnn. This does· not make sense to tile infonnation when· the article was published and even are expected to lose as set forth in some or the the study in the placebo group. Using this ·same group Court. The int e nt-to-~t ·atllllys·is would seem to before when tl1e criticisms of the article · were advertisements. Therefore, both the 17 times and the comporison, Dr. Slii concluded thnt the study group require tlic mearchers to attempt to follow up ori the discussed with Mr. Kalman. Nevertheless, the 38.6 times clnilps are misleading because of the lost 1.93 percent of body fut compared to 0.05 four dropouts ond then use the data from all16 in"dte defendant did not change the representations in the expectaiions raised in the minds of n reasonable percent loss of body fut in the placebo group. original group. This = ·not done and there is no advertisements. conswner that these pcreenlages apply to highet evidence that the Peak Wellness protocol WlL! intent weight losses and fat losses than were dcmonstnited Table II in the Peale Wellness study used 1he to ireat. Since the dalll Was not available from the four Since the TV-ad disclaimers said the average weight iu the Peale Wellness study. .. beginning weight ofnll 30 subjects (including lhe five wb,o dropped out, there is no justification for using all loss was _6.9 poilhds, defendant had octual knowledge dropouts) to show a nine percent weight loss and a 16 16 when comparing to the placebo grilup. Similarly, that the nine percent weight loss claim was a The Peale Wellness study does not justifY any oftl>e percent body fat losa in the ·control group and a body using ail 14 who started in the placebo group is not · distortion of the ~esuits of the Peak Wellness study. perccntase comparison- between-group claims made fot loss of +I percent by all 14 ·or the people·"who justified. Therefore, tlic claim of 1700 percent fai'loss Therefore, the statemepts of the nine percent decrease in the advertisements. Any reasonable consumer began the placebo group. Comparing -16 and +I is difference and the nine percent weight loss diffcn:nce in weight are false and nLislcading and were !mown or reading these percentages would be misled. the basis of the claim of 1700 percent greater fat loss. ore mi s le~ding . should have been known by defendant to be so. .. Dr. SlLi's conclusion of 1.93 percent versus 0.05 TilE EASTERN MICffiGAN UNIVERSITY (EMU) percent is the basis of the claim of 3860 percent ''7 Dr. Shi did not compare the 16 to th~ 14, but Dcfcndal!t's position with respect to the 3860 perce~t STUDY AND XENA DR!NE XTREME MAGAZINE. greater fat loss. rather compared the 12 who fuLished ·to the 13 who or 38.6 times is that in _addition to it being literally finished. He-had data"ori all 30, but did not attempt to accurate, it was blessed by the judge in the Utah case The only reference to the EMU study is on page 31 The fallacy of Ute percentages is cllernplilied by compare them. It nppcors that Mr. Kalman went brought by Bnsic Research. While the judge may of the Xenadrina Xtreme magazine which was mailed comparing -1 6"percent with +1 percent. There is no tlirough and picked ond chose the data which would have indicated that 1he math was accurate, the judge toward the end of the class period. It says the "safety way those percentages can equal n 1700 percent give the mest favorable results. Mr. Kl.!mon adinitted did not say it was appropriate !O make this claim in nnd efficacy" of Xenadrine RFA-1 was examined. difference, no matter what mathematical calculation it would have been more accurate to have compared advertisements, pilrlicularly in the context in which 11Lis is false, as safety was not the purpose of tltc one does. It is impossible to compare plus and minus the 12 to 13, which ·gives a significantly lower defendant used tl1ese nwnbcrs. If anything WltS study. The only specific claim related to the study is and get a multiple: Thin fallacy is illustrated by the reduction in weight for the study group and ·n blessed by Judge Kimball in Utah, it was the intent "the results showed that the subjects ingesting absurdity of theso comp:trisons. Tite -t 6 percent is significantly lower differential between the two to-treat analysis using the subjects including the Xenadrine RFA-1 los t significantly more weight based on o fat loss of approximately 4 percent, or groups. dropouts. The defendant was well aware -ofthe actual (759%) and fat than tl10se using the piaccbo· with.out approximltely 0 pounds. The 3860 percent is based weight loss and actual fat loss -and !mew that 3860 eating fewe r calo~ies or changing tl1cir carb-to-protcin upon a loss of approximately 4 1/4 pounds. Inasmuch The Court con only conclude that the ·money being percent was based on oxtremely low weight and fat ratio. In addition, no negative effects were. found on as the loss of -16 percent of fat was o greater weight paid to Dr. Colleer caused him to influence Mr. losses. TI1ereforc lho defendant knew the misleading resting electrocardiograms or blood lipid profiles." amount, it should not result· in o lower percentage Kalman and to try to cr Copr. 0 West 2003 No Claim to Orig. U.S. Govt. W0rlcs 74 Slip Copy , 75 (Cite os: 2003 WL 21 Z93914, •n(Cai.Superior)) .Slip Copy •9 There wns testimony regarding a press conference Defendant WIIS in possession of Ex!u"bit 222.2, the Page II ond a news releose in which claims were made about "Candidate Progress Chart" for Michael Piacentino. (Cite as: 2003 WL 21283814, ~to (Cai.Superior)) the EMU study. There was no evidence that either the This showed that on hio stoi1ing tho program, ·· he press conference or the news release wns seen or weighed 229 pounds and had 21 percent body fat. Addiction that the weight losses attributable to Karen aware that the claims made .in the early ads were not · heard by California consumers. That would give him a total of 48 pounds ofbody.fat Curtis, Remy Feniello and Maria Korsgaard were not accurate, as Mr, Chinery knew Xcnadrinc RFA-1 had as represented. At week 10, which is the time penod .accurate. There is po evidence that defendant had this not been the subject of the studies, lmew only Therefore notwithstanding the substantial nmount of referred to in the advertisemeJ!t, Mi. Piacentino information. For each of these individuals defendant portions of the ingredients bud been studied. and time nnd ~!fort spent on the ·EMU study during the weighed 195 pounds nnd had 8 percent body fat. That produced an affidavit. atte&ting to accuracy (Ex!)ibits knew of the different dosages. Since Mr. Cbinery wos course of the trial; there is no need to discuss it would give him 15 1/2· pounds of body fat. That 2118, 2120. and 596), There is no evidence that drafting the advertisements, it was his language that further. meant that during this period, he would have lost 32 defendant knew. that the affidavits were innccurate. WllS designed to mislead consumers reading the 112 pounds of body fat, not 46 pounds of body fat as While thcrc is solllC qw;stlon obout the notaHZaqon of odvci1isements by malcing · n .. reader think that THE UTAH CASE represented. Since the . total weight loss was. 34 the affidav:;ts, as they are all noWized by the same Xenadrine RFA-1 had been tested. pounds, he would have lost muscle mosa, no.t gamed notacy, and none of the affidavits .ha1 a date by the The parties hove in!Jo.duccd into evidence opinions it, to make up the difference in the total we1ght Joss notarization, this by itself is not enough to invalidate With respect to tl1e Peak Wellness study, the Court from the bosic rcleurch case in Utah.· The Court has between Uie fat Joss· of 32 1/2 pounds and the. total the affidavits. More importantly, since the before finds Mr, Chinery was well informed of what WllS reviewed those opinions, but neither of these rulings · weight loss of 34 pounds. Even using the week 12 and-after ads are misleading in the context of the going on, and that he understood ·the actual ornounts is binding on this Court. The Court notes tlmt while reduction to 7 percent body fat, would give a total of exaggerateUiggerate the time It took, and the tri.U. .. technology" (Tab 8) are o.ll puffmg. Therefore, these willingness to stretch the truth to make its product therefore, the Court docs not..fmd the claims of weight claims and the mal)y similar claims are not, by appear to be more effective than.it actually was. Both loss by Randy Martin to be misleading. Compare, Cytodyne has consistently failed to produce tlJcmselves, false or misleading. Mr. Chinery and Mr. Conldin used the identical Christjoe Muller "45 pounds in 16 weeks" (Tab 13, documents that could· have. explained things, pushed wording t!iai they were "confused" by the chart of the Exhibit 19) with television 'Clip S, Christine. Muller researchers to make s.tudiea come out favorable to siffiiio.rly, t!Je claim of "pharmaceutical grade" ~r weight loss which showed only c 34-pound weight "45 pounds in 12 weeks" with Clip 6, Christine them and paid money to the key people involved in 11 pha.rmnceutical qunlity" made on the 1abcls m loss end the· affidavit which showed n 46-pound Muller "41 pounds in 12 weeks." providing infonnatio11 to them to ensure U1e puffing. Most of the experts coul.d not even defe~e weight loss. Yet the advertisements cl~im a fat loss of infof11)ation was favorable to them. what this claim me:~nr, and while Dr. Belch, m h1s 46 pounds plus ·a 12-poimd gain of nmscle. CREDIBILITY ~urvey, was able to obtain reactions from consumers, Therefore, the defendant could not be relying on the The discovery responses on the s.Ues in Ollifornia thi~ claim does not appear to be false or misleading. affidavit whiclr sa·ys a weight loss of 46 pounds. lfthe *11 Before discussing the specific advertisements, it seem' to have ·boen designed to mislead the·plaintiff. Further, the testimony of Mel Rich supports thi~ public does not liliow the. difference between fa.t loss Is necessary to discuss the credibility of the The defendant did not have any product complaints claim. and weight .loss 110 argued by the defendnnt, it would defendant's most impommt witnessi·Robcrt Chinery, before 2000. TI1ere were no ccnificatcs of ;malysis. think from the odvertisement that there had been a the president of defendant He worked for Pro Source There were no assays. E- mails were deleted. Peak THE BEFORE-AND-AFTER ADVERTISEMENTS 46-pound weight loss. Sinee the defen":mt knew there and thl'll left and started Cytodyne. He developed Wellness did not have its underlying documents. Mel had only been a 34-poWid lo•s, the defendant !mew Xcnadrinc RF A-1. The Court does not find Mr. Rich did ·not bring documents. Mr. Schiff did not Defendnnt cloims to rely upon the offida~ts of ihe this cloim was flllse. Chinery io be credible. similarly the witnesses on bring docwncnl!:, and some affidavits appeor to be individtiols in the before- and-after tidv¢isements to .defendant's payroll or retainer, e.g., Kelly. Conklin, missing from the before-and-after subjects. support the before-and.:ai\er cloirns. In the cnse of Evidence was introduced in ihe fonn of testimony J:)r. Ziegenfius. and Dr. Colker, were not credible. Mil Copr. C West 2003 No Claim to Orig. U.S. Govt Works 76 77 Slip Copy Page? Slip Copy (CUe ru;: 2003 WL 21283814, ~11 (Coi.Superlor)) (Cile u: 2003 WL 21283814, *13 (Cai.Superlor)) wrong · jo=l as support In one of the thousands of. comploints reg~~rding ephedra prod\u:ts, THE PRINT ADVERTISEMENTS potent thermogenic fat burning effectn ~c !lm lly advertioem::nto. There was o mistake in the weigbt no evideru:e wns introduced of the number ·of increase,.. followed by 0 citation 'to Astrup. nus losn claims. There .won not n patent pending. complaints including strokes and heart attacks that The Court Will now discuss the effectiveness claims refers· to Xcnadrifle RFA-1 's thermogenic octivity, not occur in the general popUlation.nor of the nlllllbor of in individual advertisements. the ingredients in Xenadrine RFA-1 ond siw::e Astrup •12 Defcndanro entire approach to marketing ephedra users. Thus, the l'lltio of complainl!l among tested only generic compounds, this slatement is Xenadrinc RF A-I is epitottdu:d by Dr. Arms1rong nt eplleilra users could not be compared to !he general TAB 1 [FNI] misleading. The next quote is "Xenadrine RFA·I's page 133, line 8 of his deposition when he s:~id that population. Recently, the Rand Report was published. advanced th ennogenic formulo has been shown to whnt he was signing wos "not n lie, per se." While it Was referred to bY so!M of the experts, it Vr.as FNI. Thi: Court l1os admitted the notebook actually spare lean muscle tiisue .... " Tite citntion not allowed into c:videilce and the Court ·did 'not cOrituining the adVertisements with Tabs ogoin io misleading beeliiise it appears that Xenadrine SAFETY consider its conclusions. 1-15 .. Exhibit2393. RFA-'1 was tested. Finliuy, the quote, ''has been shown . to actually prevent regaining of body fat A subst:mtial omounf of the trial was spent with 11 appearo that defendllnt has gone out of its wo.y to The very fll'St ad, Tab I, Exhibit No. 94.3, has normally associated with extreme weight loss," with o eJq)erts on both sides testirY;ng reg~~rding the s:~fet)' of ininirnize the existence of any health risks !hot might several false and.mislcading statcmentsJI'ho nd Gays: citation to Astrup must meoil Xeimdrine RFA-1 'icnadrine RF A- I or the safety of ephedrine and exist. An example' of this i• iri'thc XenadriM Xtrcme "Shown in studies to ·increase the rate of fat loss by because there is no other reference. Tbtw,' the rust ephedrine caffeine productS. Tho issue of Safety is rruigazine. Thc'thermogenics llrticlo by Dr. Ziegenfuss up to 300 percent!" Dr. Krieger; who did the study, advertisement is misleading. relcv:mt to ~•e cxpreso and implied claims of safety. · originally contained language on the last page under testified this claim was false because the study did not the beading, "Take H~me Messages" that measure ·falloss but only weighlloss. Moreover, tho TAB2 Tite Court first notes that while there should be recommended usinc the'ploduct for only four to eight clear implication is that this weight loss relates to the substantial additional investigation into any adverse weeks nnd poinied out that one could expect certain product being advertised, Xenadrine RFA-1, The second print 'advertisement, ·Tab 2, E1chlbit 94.2, event reports and whether odvet'Se reoctioru~ may be si~e effects such <14 trembling, jitters; ·and elevated particularly since·it says, ''New. Available wilhout a "Revolutionary new fat burning technology astounds caused ·by Xenadrine RFA-1 or the other ephedra ·heart l'llte. These health Wlirnings were edited.ounwd prescription" In the comer above this phrase. The the bodybuilding world," has quotes from products on the ·innrket, it is not the role of this Court do not appear in the article that was published irl the amounts of weight loss of the two models ~~re 68 bodybuilders which were not challenged during the to determine whether or n~t this product should· be Xe11adri11e Xtreme mag:tzine, (Exhibit 281 .7, Exhibit poWlcls in IO·wecks and 57 pounds in 9"\Veei Copr. (1) West 2003'No Claim to Orig. U.S. Govt. Works Copr. \C West 2003 No Claim to Orig. U.S. Govl Worl 78 Slip Copy ll'age l2 (Cite as: 2003 WL 21283314, • 16 (Cni.Superior)) Slip Copy. Pag~ 11 (Cite ao: 200.3 WL 21 283614, • 14 (Cai.Superlor)) competitors' claims. Defendant has introduced two tho word, 11 new," there is no way fo r o reasonable magazines for the Court to review to see· the context coilSlUDCr to know that the product did not exist in the burning compound ever developed." It has all of the thermogenic combination has been the subject of in which readers see the Xehadrine RFA·l ads. early '90s when some of the Journal articles were fnlse and misle~ding claims of the flrst·advertisement, nwnerous published clinical studies which offer Exhibit 2376 is Flex Magazine from March 1998 and published. While a skilled grammarian or n skilled but by adding the phrase, "30 poWJds in 30 days," it is .undeniable proof of the extraordinary fat· Exhibit 2377 is Musclemag International for lawyer might find ambiguities in the language to even more misleading. burning/muscle sparing effeclll that are possible. February 2000.lloth magazines consist of articles on show that it does not specifically say that Xelllldrioe In n recent study published in the prestigious bodybuilding and bodybuilding contests with RFA:t waa "testcd, !hot fg not a reasonable conclusion TAB4 International Journal of Obesity, this poll:nt seemingly nn equal amount of advertising, pririlarily for a reasonable coiiswncr. Defendan~s ada· are compound was shown to increase the metabolic for supplements designed to ildd muscle or lose fat writton to leave the render with the impression that it The supplement business appearo be highly was Xe!llldrine RFA -l 'that was tested. As shown in "JS.In Tab 4, EJthibit 97, the trutb·ofthe portion of rqte by over an asto~nding 600%! This same to is the Hydroxycut ads, it is very simple to stnte that it is the advertisement with q~,0,tes from the doctors is journal als~o. published n siudy showing the competitive. Tbe defendant is correct in that unchallenged by the plaintiffs; Other !han safety, the synthetic equivalent of this compound to Increase consumers are bombarded with numerous the ingredients, or ot lens! some of the ingredients, only portion which could be deemed misleading is tho the total rate offat-loss by over 300%1 And in yet advertisements :md many claims of benefit for these that were tested in these studies. [FN2] portion that. laDes about the scientific refereiJCOS. It another groundbrealdng . study, . this potent products. A careful review of the advertisements, SiiYG that .the fonnula "is centercd.around a highly compound was shown t() help prevent regaining however, shows tl~at the advertisements for Xenadrine FN2. Tite Court is not finding the advilnced, tcscarch proven thermogenic of badyfot that is typically associated with RFA-1 make more specific chums than all but o Hydroxycut cdvertisement to be nccurnte. It is only being used to show thnt the compound.... " It then snyil, "Xt;nadrine RFA-l's extrerm: weight los.s. This remarkable feat is couple of the other adycrtisements. revolutionary tl1crmogenic compound has been competitors are giving consumers more actually made possible by way of Xenadrine infonnation nbout the studies. proven effective through a vast series of scientific RFA-t's amazing muscle sparing effects. In other Even those advertisements with specific claims are studies which offer irrefutable proof to the words, preserving lean muscle tissue which is far moro candid than defendant's advertisements. For Contained in Exhibit 2377 is an advertisement for CKtmordinary fat-burning/muscle· sparing effects that more 'metabolically active' than the body is example, Hycfroxycut makes a claim !hot you can r., another Cytodyne product called CytopleJ~" This arc possible. No ot!Jer thermogenic formula is backed lcfi with a permanently increased metabolism bum 613 percent more fat, but in the tex4 it refers to by tllis nwnbcr ofpublishl:d scientific stUdies!" "the highly touted ECA (Ephedrine, caffeine and advertisement says that Cytoplex contains a which in effect burns more calories and prevents revolutionary compound called "Glucostatin-RFS" new fa~ stores from forming. aspirin) stack. This very stack is found in Hydroxycut which is lll!lde up of a. unique blend of substrates The clear implication ofthe se~.ond portion is that •16 Another study published in the Journal of and has been shown in recent clinical study to elicit a J>cnadrine RFA, l has been proven effective in 613 pen:ent greater rate of fat Ieos., .. " (Exhibit 2377, clinically prove11 to stimulate rapid and dramatic Phaflllllcology ond Experimental Therapeutics weight loss tesults, even without dieting." (Emphasis scientific tests because no other thermogenic formula found !hot by adding o specific thermogenic p.3). The advertisement makes it clear that they are is backed by this number ·of tests. Further, since referilng to the ingredients in Hydroxycut and not in original.) It also refers to an article in the synergist, this combina.tion may become over International Journal of Obesity that found Xcnadrinc RFA-1 "is a revolutionary new ~pproach Hydroxycut itsdf. Tlie Hydroxycut ad goes on to .54% mare effective than virtually nny other Glucostatin substmte number one actually increased to weight loss ... based on the latest scientific discuss the other ingredients in Hydroxycut nnd their thennogenic fonuula on the market" (All the rate of weight loss by over 600 pen:ent research," any reasonable. consumer would believe emphasis in original.) added benefits, thus making it clear that Hydroxycut Xenadrine RFA-1 is the subject of the research . was not the subject of the study. Further,. the No other thermogenic combination is backed by Tho Court finds this advertisement significant in two mentioned in the list of scientific references. this number of published clinical studies! advertisement refers to body fat loss· in pounds nnd Therefore, TAB 4 is misleading. shows ·Group I, tl1e control group, lost 1.5 pounds respects. First, it shows that de(endant is capable of Tbe beading "Clinically Proven," followed by writing an advertisement that makes it clear that only references to clinical studies, misleading in thai the whereas Group 2 "ECA stack· as found in Is the ingredients have been tested in scientific journals TABS reader would think !hot it.was Xcnadrine RFA·l !hot Hydroxycut" lost 9.2 pounds. Titus, the reader is able nnd not tho product itself. Second, this appears to be had been clinically .proven, not merely. some to ace the nctual weight loss being claimed. one of the products that Randall Hanson provided to The fifth advertisemen4 Tab 5., Exhibit 98.2 ingrcdicn~ Since none of the studie~ relate to Milce Piacentino and possibly some of the other "Ciinicai studies confumXcnadrine RFA-tic amazing Xenadrine RFA-1, all of !he claims eKcept for the 300 "17 By contras~ the advertisements for Xenadrine before-and· after subjects. Since product is fat-bw:nJni'muscl.e-sparing effects" is a two-page petcent attributed ;o "tl)e synthetic equivalent" arc RFA·l say, "Xenadrine RFA-l's revolutionary this designed to · increase weight loss, it would be advertisement The first page consists of beforc-nnd misleading (and Dr. Kreiger said only weight loss.~ thermogenic compound has been proven effective extremely significant to a before-and-after subject aftcr picturen of Randall Hanson stating !hot. he lost studied.) There is a claim that by adding n specific through a vast series of scientific studies ... ·no other who claims to have lost weight due to Xenadrine "illl ei Copr. 0 West 2003 No Claim 19 Orig. U.S. Oovt. Works 81 80 Slip Copy ll'age14 (Cite c•: 2003 WL 21283014, •t9 (CaJ.Superlor)) Sbp Copy Pugo 13 (Cite 11: 2003 WL ll28J814, *18 (Cai.Superior)) pounds in three weeks), Dave Muller (30 pounds in even more misleading. It is not saved by tim phrase, four weeks), :md Maria Korsga~rd (25 ponnda in "These result!l not typical" because the typical results •18 Since the supplements cam: from Cytodync lo With respect to Tab. 6,- Exhibit 39, the middle page three weeks) refers lo Xcnadrine RFA- 1 having been ore not shown. Mr. Hanson, defcndont cannot claim it did not know appears to be the fu~! print ad to state in bold letters, "clinically proven to increase fat loss by a tlut tbeso supplemeotJ were being provided to the ns a headline, "Clinically proven to increase fat loss phenomenal 17 times more than diet and eliercise Tire oniy time the actual results were Ghown was in before..and-ailer subjects. Defenda nt argues that Mr. by an unprecedented 17.00 percent" This nlonel" nus claim of is followed irmnodintely by, the television commerciills. There was ll statement on Hl115on wa.s do ing be fore- and-oiler studies on ronny advertisement contains both the 1700 percent greater "Whether you neOd. ·to Jose 15 poUnds or 100." nins, the screen tlut the average weight loss was 6.9 ditrcreol prod uc ts Mel, therefore, defendant would not fat-loss cloim and the claim tliat the subjects reduced anyono reading thiS nd would think that the 17-tim es p o~d s in 8 weeks. The Court is W!able to fmd such a know lh.>! subject WM gelling which supplements that their total body weight by a remarkable nine percent loss bears some relation to weight losses of I 5 disclaimer in any of the print ods: The defendant wns defendant provided to Mr, ijanson. Tho defendant Both of these claims arc ·misleading for the reasons pounds to I00 pounds or to the weighi losSes of thee aware of tl1e nctual weight loss and !mew it should be should have known that Mr. . Hanson was pr<~viding discussed in the discussion of the Penlc Wcllness models. Therefore, Tab 11 is misleading. letting people IO]OW the average wciglat loss, yet the Mr. Piacenl ino with additional supplements, sltldy. defendont did not use the actual nverngo weight loss including supplements that were used as meal Tab3 9, 10; 11, 13, and 14 refer to weight/ass in the in any of the print ads where it would be more likely substitute.!l and tl)ercfore were used in losing weight. The 1700-percent andninc-percent claims arc also before-and-oiler pictures and thon make claims nbout to be read than in the teleVision ads. Had defendant done any investigation, such as simply misleading in the context of the advertisement fat loss. Tbio nppenis to be nn inter1tionnl attempt to aslcing Mr. Hanson (who wns being paid by defendant showing Mike Piaccnrino with a 46-pound loss, exagger:>te the claims. Tho weight loss percentage TABI4 as a consultant) who was receiving which which is substantially greater than the weight loss .in differences in · the Peale We lliless test were supplements, it would havo discovered this fact See d1c Peak Wellness study. Further, as previously substantially lower than the fat loss percentage The last advertisement, Tab No. 14, Exlubit 20, People v. Forest E. Olsen (1982) 137 Cai.App.3d discussed, Mr. Piacenrino's weight loss was not 46 differences between groups. The defendant bas "What a difference," suffers from lhe same distortion 137. pounds, nor did he drop 46 poW!ds of fat while argued, and from these advertisements it appe:u. the as the other advertisements with the 3 8.6 times claim "packing on o phenomenal 12 pounds.ofle.an muscle defendant believes, the public confuses fat loss with in the same advertisement witl1 n claim of TAB 6 and TAB 7 mass." Further, any bcforc-and-afler advertisement weight loss. Yet the advertisements usc percentage fat extraordinary weight losses, in this case, Remy with Mr. Piacentino is misleading because it does not loss claims . to make it npp,ear dllit wcighi loss also Feniello's claim of losing 35 pounds in four weeks. Exllibit 40, Tab 6, and Exhibit 237 1, Tab 7, "Take disclose d1c uso of qther s~pplements and, in will be dramatically higher for those using Xenadrine TI1erefore this advertisement is also misleading. Control," feature Nancy Lntarocca losing 57 pounds particular, meal-substitute supplements. . RFA-1 compared to those using diet and cxetcise in nine weci Copr. 0 West2003 No Claim to Orig. U.S. Govt. Works 83 .82 Slip Copy !l'age 16 (Cite Ds: 2003 WL 21283814, • 22 (Cili.Superlor)) Slip Copy .Page IS not carried this burden. commencement of the action and n Firs! Amended (CUe ns: 200:i WL 21283814, *20 (Cai.Superlor)) Complaint was never filed. REMEDY statements that it wus attempting to have vis ible proven effective in scientific studies (Exhibit 1305). A. The Consumer Legal Remedies Act Defendant did not waive the notice re quirem~nt. The disclaimers in the television ads arc disingenuous. and stipulation n«ached at El Copr. Copr. C West 2003 No ClaiJ!t to Orig. U.S. Govt. Works 87 86 Mr. WALDEN. Thank you. Mr. FRANCE. So, if you :want to follow up, m. terms of assessing Slip Copy Puge 19 what Mr. Chinery says, in view of the fact tliat I was at the trial (Cite ns: 2003 WL 21283814, •26 (Cai.Superior)) and I prosecuted that case, and also observed Mr. Chinery, Mr. Xenodrine RFA-1 in California, !hero cannot be any Conklin, Dr. Colker whO·· performed these alleged studies on injunctive relief. This argument is not supported by ATIORNEY'S FEES Xenadrine RFA-1, at least one of them, the Peak Wellness, I ques the atatute, Busi.Qe:~s und l,'rofcs.sions Code section Plaintiffs coWJsel may apply for attomey's.fecs. 17203, which say:;: "llllJI person who engages, has tion highly what Mr. Chinery had to say. ongaged, or proposes to engage in unfair PRODCEDURE Mr. WALDEN. All right. . competition" may 1xl enjoined. (Emphasis Added.) Dr. Woosley, is Xenadrine considered a stimulate? See Stop Youth Addiction, Inc. v. Lucky Stores, Inc. If a Statement of Decision is requested, the Court (1998) 17 Cal.4th 553, 570. will prepare such Statement. This Tentative Decision Mr. WOOSLEY. Yes. shall become the StatetrnOnt of Decision unless within Mr. WALDEN. And what is it and what is its purpose as a dietary Therefore, Cytodyne, its officers, principals, agents, 10 day:; eithci" party specifies contJ:overted issues or supplement for weight loss? servants, employees, succcssoro, ~lgns, nnd all !hose makes proposals not covered by tllis Tentative Mr. WoosLEY. Well, it contains ephedra and ephedrine; which is in active concert or pnrticipalioll. with ~em are ·oc:cision. The Court also requests each side to submit enjoined and restreined . from disseminating or the major stimulant. · causing to be disseminated, lbrough IIDJI proposals on how lhe restitution fund . is to be advcrtiscmeo~ label, commercial . or other disll:ibuted. Mr. WALDEN. Okay. Arid as we understand it, there may be other promotional activity, any advertising claim which ingredients contained in these ephedra caffeine dietary supple includes representations identical or similar to those 2003 WL 21283814 (Cal.Superior) ments.including the one I just referenced, so that is why I am ask claims foWld to be false oi misleading, either directly or by necessary implication, whether material or not. END OF DOCUMENT ing your opinion on this. It is Tyrosine? Mr. WOOSLEY. Tyrosine. Mr. WALDEN. Considered a stimulant? Mr. WoosLEY. No. It's ail amino acid which in high doses might have pharmacologic effect, but not in the doses likely to be used in these products. Mr. WALDEN. Is L-carnatine considered a stimulate? Mr. WoosLEY. Carnatine, no. Mr. WALDEN. Okay. What is its purpose? Mr. WoosLEY. It is argued. People would not agree about its pur pose. It is taken by many people to stimulate muscle growth, but there is no scientific evidence that I am aware of, except in carnatine deficiency. There are inherited disorders where people do not have enough carnatine, but it is very rare. · Mr. WALDEN. What properties does salicine have, that is white oak bark or something? · Mr. WOOSLEY. It is-probably, and I wotild have to say that whether the product that is put in there is exactly what the phar macopeia would say is often not the same. But Salicine is thought to thought to be a salicylic acid base. It is like aspirin. Mr. WALDEN. Can it cause bleeding? Mr. WOOSLEY. Yes in high doses. In the doses that are there, we do not know. Most of these products have never been studied scientifically. Mr. WALDEN. Because some of these say you should not take as- pirin with them. . Mr. WoosLEY. That is theoretically correct. But, again Mr. WALDEN. Is salicine similar to aspirin in that respect, the Copr. @ West 2003 No Claim to Orig. U.S. Govt. Works way it may interact? Mr. WooSLEY. It is chemically similar to aspirin, but frankly we have no idea what those drugs could do in those products because they have never been tested. Mr. WALDEN. No idea? Mr. WoosLEY. No idea. Mr. WALDEN. Thank you, Mr. Chairman. Mr. GREENWOOD. The Chair thanks the gentleman.