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Herbalife International of America, Inc.1800 Century Park East l Century City, CA 90067-150TEL 310.410.9600 x32746 Q FAX [email protected] l www.herbalife.com

August 9,2002

Office of Nutritional ProductsLabeling and Dietary SupplementsFOOD & DRUG ADMINISTRATION200 C Street, S.W.Washington,D.C. 20204Ref: K8 TabletsDear Sir and/or Madam:

John Venardo1 Vice PresideRegulatory & Government Affa

Pursuant o 2 1 CFR 101.93,pleasebe advised hat Herbalife Internationalof America, Inc. has evisedlabeling for ou r K8 dietary supplement ablets o revise cautionarywording appearingon the label asdevelopedby industry in consultationwith the agency. The completeK8 label is attached.K8 tablets are abeledand promotedwith statements rovided or in section403(r)(6) of the FederalFood,Drug and Cosmetic Act:LABEL(Note: Immediately adjacent to the following copy, appears a ruled DSHEA disclaimer box)K8 is a combination of natural herbs, ncluding Kava Kava and ashwagandha, s well as Calcium and sdesigned o help relax the body while contributing to a sense f well-being.Directly beneath he ruled disclaimer box appears he following cautionarywording:CAUTION: THE US FDA ADVISES THAT A POTENTIAL RISK OF RARE, BUT SEVERE, LIVERINJURY MAY BE ASSOCIATED WITH KAVA-CONTAINING DIETARY SUPPLEMENTS. ASK AHEALTH CARE PROFESSIONAL BEFORE USE IF YOU HAVE OR HAVE HAD LIVERPROBLEMS, FREQUENTLY USE ALCOHOLIC BEVERAGES, OR ARE TAKING ANYMEDICATION. STOP USE AND SEE A DOCTOR IF YOU DEVELOP SYMP TOMS THAT MAYSIGNAL LIVER PROBLEMS INCLUDING JAUNDICE (YELLOWING OF THE SKIN OR WHITESOF THE EYES) AND BROWN URINE. OTHER NONSPECIFIC SYMPTOMS CAN I NCLUDENAUSEA, VOMITING, LIGHT-COLORED STOOLS, UNUSAL TIREDNESS, WEAKNESS,STOMACH OR ABDOMINAL PAIN, AND LOSS OF APPETITE. NOT FOR USE BY PREGNANTOR BREASTFEEDING WOMEN. NOT FOR USE WITH ALCOHOLIC BEVERAGES. EXCESSIVEUSE, OR USE WITH PRODUCTS THAT CAUSE DROWSINESS, MAY IMPAIR YOUR ABILITY TOOPERATE A VEHICLE OR HEAVY EQUIPMENT.Product abeling and iterature prominently bears he requiredboxed statement, These statements ave notbeenevaluatedby the Food and Drug Administration. This product s not intended o diagnose, reat, cureor prevent any disease.Herbalife Internationalof America, Inc. certifies that the information in this notice is complete andaccurate,and hat the Companyhas substantiation hat the foregoing statements re ruthful and notmisleading.If you have any questions,pleasedo not hesitate o ask.


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uptoh Supqlement FactsServingize:Tabletherin,~~Iudiagervingser ontainer:0,aswellascdduinIondsdesignedoh& elbx e odyhileIThesetatementsave otbeenevaluatedayheFood ndDrugAdministration,his roductsnotintendedo diagnose,reat, ureorpreventny isease.

Amounfer erving %DV*Totalarbohydrateg 4%Calcium80 g 18%(as icakiumhosphate)DriedavaKavaxnact OOmg t(30%ovokrctones)root)DriedshwagandhaxtractO g

CAUTION:HE S DA DVISESHAT (*5%wBhonoBies)mo+POTENIALlSKF ARE,UTEVERE,VERioQbamRonomiex-53mg TINJURYAA/E SSOCIATEDITHAVA.in, Vimmiab asCodJ$Olmim@,CONTAININGIETARYUPPlEMENTS.SK Plantelluloseazvme.innomonowderHEALTHAREROFEEALTHAREROFESSIONALEFORESEFYOUAVER AVEADIVERROBLEM!OUAVER AVEADlVERROBLEMS,(Lx&)nd ud luckepperxtmaRamF&.JJ~ USELCflHOtlCEVERAGBRRMUENTLYSELCOHOUCEVRAGES,R bopennea)NLT5%perine)fruit).ARETAKlNGNYEIRETAKlNGNYMEDItATlON.TOPSEND Percentailyaluesre edon 2,008SEEDOClORFYOUEVEkOPYMPTOMSTHAT Y SIGNALIVERROBLEMS,INCLUDINGAUNDICEYELLOWINGF HESKINRWHITESF HE!ES)NDROWNURINETHERONSPEClFlfYMPTOh5ANINtLUDEAUSEA,OMlTlNG,GHT-COLOREDTOOLS,NUSUALIREDNESS,WEAKNESS,TOhMHR BDOMINALAIN,ANDOSSF PPETlTE.OTORSEYPERSONSNDER8YEARSF GE,R YPREGNANTR REASTFEEDINGOMEN.OT

I alorieiet.TDoilyalueDV)ot stablished.Otherngredients:iaacrysiullineellulose,Siliconioxide,teariccid,mscaanellasesodium,agnesium&ate,ecithin,exirin,Dexbe,odiumorbaxymetfiykelluktsemSadiumCRmte.

Formulatedxclusivelyor:HEREALIFENTERNATlONALFOR SE ITHlCOHOllEEVERAGES.EKESSIVESE,R SE ITHRODUCfSTHATAUSEROWSINESS,AYMPAIRYOURABlllTVO PERATEVEHICLER EAVYOF MERICA,NC10sngeles,A0080020U.S.A.MADENU.S.A.

EQUIPMENT.STK3057UE3500 I 30-dayoney-backuarantee.0 2002 ERBAUFENTERNATIONAL,NC.,.S.A.IllllllllllllllllllllllllllllllllIlllllTK3051 US-3500

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STK3051US---c$" 7'24'o

Suggestederving:akeneubletpo hreetimesadayasneeded.K8sa combinationfnaturalerbs,ncludingKavuavandhwagandha,swell sCalciumandsdesignedo helpelaxhe ody hilemntrii~ toasensefwellbeing.Thesetatementsave otbeenevaluatedy heFood ndDrugAdministration.his roductsnotintendedo diagnose,reat, ureorpreventny isease.

CAUTION:HE S DA DVISESHATPOTENTIALISKF ARE,UTEVERE,VERINJURYAYE SSOCIATEDITHAVA-CONTAININGlElARYUPPLEMENTS.SKHEALMAREROFESSIONALEFORESEf:YOUAVER AVEADIVERROBLEMS,FRMUENTlYSELCOHOU[EVERAGES,RARETAKINGNYEDICATION.TOPSENDSEEDOC[QRFYOUEVELOPYMPTOM5THAT AY IGNALIVERROBLEMS,INCLUDINGAUNDICEYELLOWINGF HESKINR HITESF HEYES)NDROWNURINE.THERONSPKIFllYMPTOMSANINCLUDEAUSEA,OMRING,IGHT.COLOREDTOOlS,NUSUAlIREDNESS,WEAKNESS,TOMACHR BDOMINALAIN,ANDOSSF PPETITE.OTORSEYPERSONSNDER8YEARSF GE,R YPREGNANTORREASTFEEDINGOMEN.O1FOR SE ITHLCOHOLICEVERAGESEXCESSIVESE,R SE ITHRODUCT!THATAUSEROWSINESS,AYMPAIROURABILITYO PERATEVEHICLER EAYYEQUIPMENT.

Supplement FactsServingize:TabletServingser ontainer:0Amounter ervingTotal &hydrate

%DV*4%

Calcium80mg(as icalciumhosphate)

18%DriedKavaavaExtmctOOmg(30%avalactones)root)Driedshwaqandhaxtract 0mq t

(1.5%itbanolides)root) -fIbabsorptIonomplex-5 3mg tlecithin,itamin as scorhylalmitote),Plant ellulosenzyme,innamonowder(bark)nd riedlackepperxtractfrom8iooetinedP)NLT5%ioerine)fruit).* Percentaily aluesre asedna2,000

calorieiet.DailyalueDV) ot stablished.Otherngredients:iaocrystallineellulose,Siliconioxide,tearicdd,CrostarmelloseSodium,agnesiumteamte,ecihii, exhin,Dexhose,odium~~e~~ellulose ndsodiumtrote.

Formulatedxdusivelyor:HERBALIFENTERNATIONALOF MERICA,NCLos ngeles,A DO804210.SA.MADENUSA3Oday oney-hackuarantee.

STK3057b3EOO 0 2002 ERBAUFENTERNATIONAL,NC., .S.A.IlllllllllllllllllllllllllllllllllllllllllllTK3051 US-3500

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STK3051US-t$" 7'24'o P

hggeskderving:akeneubletpo hreehesodoymeded.K8so~ombinotionfnotorolerbs,ndudiigKovoo andshwogondho,s dl Sokknnndsdesiinedohelpelaxhe odyhiletonirMngo set&3fwelklg.Thesetatementsave otbeenevaluatedy heFood ndDrugAdministration.his roductsnotintendedo diagnose,reclt,ureorpreventny isease.CAUTION:HE S DA DVISESHATPOTENTlAlISKF ARE,UTEVERE,VERINJURYAYE SSOCIATEDITHAVA-CONTAlNlNGIETARYUPPLEMENTS.SKHEALTHAREROFESSIONALEFORESEFYOUAVER AVEADIVERROBLEMS,FREQUENTl!/SElCOHOUCEVERAGES,RARETAKINGNYMEDICATlON.TOPSENDSEEDOCTORFYOUEVELOPYMPTOMSTHAT AY IGNAlVERROBLEMS,INCLUDINGAUNDICEYELLOWINGF HESKINR HlTESF HEYES)NDROWNURINE.THERONSPECIFICYMPTOMSANINCLUDEAUSEA,OMITING,IGHT-COLOREDTOOLS,NUSUALIREDNESS,WEAKNESS,TOMACHR BDOMINALAIN,ANDOSSF PPEHTE.OTORSEYPERSONSNDER8YEARSF GE,R YPREGNANTR REASTFEEDINGOMEN.OTFOR SE ITHL~OHOIICEVERAGES.EXCESSIVESE,R SE ITHRODUCTSTHATAUSEROWSINESS,AYMPAIROURABIUTYO PERATEVEHICLER EAYYEQUIPMENT.STK3057US-35-00 0 2002

Supplement FactsServingize:TabletServingser ontoiner:0Amounter ervino %DV*TotalorbohvdrateB 4%bkium 80 g(OSicolciumhosohotel 18%Driedovoavoxtract 00 g t(30%ovoloctones)root1Driedshwogondhoxtract0mg t(1.5%ithonolides)root)Bionbsorptionomplex-53mg tlecithin,itamin(os scorbylaknitotel,Plantellulosenzyme,innamonowder(bark)nd riedlockepperxtractfromBioperine*)NLT5%iierine)fruit).* Percentoilyaluesre osedn 2,000dorieiet.t DoilyalueOV)ot stablished,Otherngredients:icroqstolliiellulose,Siliconioxide,teoriccid,roscormelloseSodium,agnesiumtearote,ecithin,e&in,~Dextrose,odiumorboxymethykelltrlosend~ odiumie.

Formulatedxdusivelyor:HERBAUFENTERNATlONAlOF MERICA,NC.10sngeles,A 00804210.SA.MADENU.S.A.3Odayoney-buckuarantee.

HEREAUFENTERNATlOMAl+NC.,.S.A.llllllllllllllllllllllllllllllllllllllTK3051 us-35-00

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