Herbalife

International
l

of America, Inc.

John Venardos
Vice President Regulatory & Government Affairs

Century City, CA 90067-150 1 TEL 310.410.9600 x32746 Q FAX 310.557.3916 johnv@herbalife.com l www.herbalife.com

1800 Century Park East

August 9,2002 Office of Nutritional Products Labeling and Dietary Supplements FOOD & DRUG ADMINISTRATION 200 C Street, S.W. Washington, D.C. 20204 Ref: K8 Tablets Dear Sir and/or Madam: Pursuantto 2 1 CFR 101.93, pleasebe advisedthat Herbalife Internationalof America, Inc. has revised labeling for our K8 dietary supplementtabletsto revise cautionarywording appearingon the label as developedby industry in consultationwith the agency. The completeK8 label is attached. K8 tablets are labeled and promotedwith statements provided for in section 403(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, including Kava Kava and ashwagandha, well as Calcium and is as designedto help relax the body while contributing to a senseof well-being. Directly beneaththe ruled disclaimer box appears following cautionarywording: the CAUTION: THE US FDA ADVISES THAT A POTENTIAL RISK OF RARE, BUT SEVERE, LIVER INJURY MAY BE ASSOCIATED WITH KAVA-CONTAINING DIETARY SUPPLEMENTS. ASK A HEALTH CARE PROFESSIONAL BEFORE USE IF YOU HAVE OR HAVE HAD LIVER PROBLEMS, FREQUENTLY USE ALCOHOLIC BEVERAGES, OR ARE TAKING ANY MEDICATION. STOP USE AND SEE A DOCTOR IF YOU DEVELOP SYMPTOMS THAT MAY SIGNAL LIVER PROBLEMS INCLUDING JAUNDICE (YELLOWING OF THE SKIN OR WHITES OF THE EYES) AND BROWN URINE. OTHER NONSPECIFIC SYMPTOMS CAN INCLUDE NAUSEA, VOMITING, LIGHT-COLORED STOOLS, UNUSAL TIREDNESS, WEAKNESS, STOMACH OR ABDOMINAL PAIN, AND LOSS OF APPETITE. NOT FOR USE BY PREGNANT OR BREASTFEEDING WOMEN. NOT FOR USE WITH ALCOHOLIC BEVERAGES. EXCESSIVE USE, OR USE WITH PRODUCTS THAT CAUSE DROWSINESS, MAY IMPAIR YOUR ABILITY TO OPERATE A VEHICLE OR HEAVY EQUIPMENT. Product labeling and literature prominently bearsthe requiredboxed statement,These statementshave not been evaluatedby the Food and Drug Administration. This product is not intendedto diagnose,treat, cure or prevent any disease. Herbalife International of America, Inc. certifies that the information in this notice is complete and accurate,and that the Company has substantiationthat the foregoing statementsare truthful and not misleading. If you have any questions,pleasedo not hesitateto ask.

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Serving 1Tablet Size: herin, i~~Iudiag Per Servings Container: 30 ,aswellascdduin _I %DV* Per Serving ond designed relbx body Amounf is toh& me while I Total 4% Carbohydrate 1g These statements notbeen Calciummg have 18% 180 evaluated Food Drug (as phosphate) lay the and dicakium Administration, This productnot Dried Exnact2OOmg t is KavaKava intended diagnose, cure (30% to treat, kovokrctones) (root) orprevent disease. any Dried Ashwagandha mg Extract SO mo+ CAUTION: FDA THE US ADVISES ( THAT *5%wBhonoBies) A POTENIALRARE, RlSK BUT UVER OF SEVERE, 8ioQbamRon 23mg T Comiex-5 INJURYBE /AA ASSOCIATED tin, Vimmia asCodJ$ / WITH RAVA. cb pOlmim@, CONTAINING DIETARY SUPPlEMENTS. Cellulose Cinnomon ASK Plant Eazvme. Powder A HEALTH CARE PROFE BEFORE (Lx&) Dud Pepper (Ram PROFESSIONAL USE IF and Bluck Extma HAD PROBLEMS, (NLT Nperine) LIVER YOU OR HAD PROBLEM! HAVEHAVE 1lVER bopennea) 95% (fruit). F&.JJ~ USE ALCflHOtlC OR I FRMUENTLY EEVERAGB USE ALCOHOUC OR BEV ERAGES, ANYMEDItATlON. * PercentValues ona 2,008 USE AND Daily are bed ARETAKlNG ANY MEI STOP SEE ADOClOR DEVEkOP calorie IFYOU SYMPTOMSdiet. THAT SIGNAL PROBLEMS, IDV) established. MY LIVER TDoily Value not INCLUDING (YELLOWING JAUNDICE OF THE Other Miaacrysiulline Cellulose, SKINWHITES E!ES) BROWN Ingredients: OR OF THE AND Silicon Stearic Cmscaanellase Dioxide, Acid, URINE NONSPEClFlf CAN OTHER SYMPTOh5 INtLUDE NAUSEA, VOMlTlNG, sodium, S&ate, Dexirin, UGHT- MagnesiumLecithin, COLORED UNUSUAL Dexbe, Corbaxymetfiykelluktse STOOLS, TIREDNESS, Sodium am WEAKNESS, ABDOMINAL STOhMH OR PAIN, SadiumCRmte. AND OF 1OSSAPPETlTE. USE NOT FOR BY Formulated For: Exclusively PERSONS YEARS OR UNDER OF 18 AGE,BY PREGNANT OR BREASTFEEDING HEREALIFE WOMEN. NOT INTERNATlONAL FOR WITH USE AlCOHOllE BEVERAGES. OF AMERICA, INC EKESSIVE USE PRODUCfS Angeles, 10 USE, WITH OR 10s CA 9008002 U.S.A. THAT DROWSINESS, CAUSE MAY IMPAIRYOUR MADE IN U.S.A. ABlllTVOPERATE OR TO AVEHICLE HEAVY I 30-day money-back guarantee. EQUIPMENT. HERBAUFE INTERNATIONAL, INC., U.S.A. STK3057UE3500 0 2002

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Supplement Suggested Take tublettothree Serving: one up
timesadayasneeded. Serving 1 Tablet Size: K8isa combination herbs, ofnatural including Servings Container: Per 30 Kavu and Kava khwagandha, asCalcium as well Per and designed relax body Amount Serving is to help the while mntrii~ toasense ofwellbeing. Total G&hydrate

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These statements notbeen Calcium mg have 18% 180 evaluated theFood Drug (as by and dicalcium phosphate) Administration. This productnot DriedKava is 2OOmg KavaExtmct intended diagnose, cure (30% to treat, kavalactones) (root) orprevent disease. any Dried Ashwaqandha 50mq t Extract
witbanolides) (root) CAUTION: FDA THE US ADVISES (1.5% THAT A Complex-5 mg t 23 POTENTIAL BUT UVER RISKRARE, OF SEVERE,fIbabsorptIon lecithin, C(as Vitamin ascorhyl palmitote), INJURYBE MAY ASSOCIATED WITH KAVAEnzyme, Powder CONTAINING DlElARY SUPPLEMENTS. Cellulose Cinnamon ASK Plant A HEALM PROFESSIONAL (bark) Dried Pepper (from (ARE BEFORE USE If: and Black Extract YOU OR HAD PROBLEMS, (NLT oioerine) HAVEHAVE LIVER (fruit). 8iooetinedP) 95% FRMUENTlY BEVERAGES, USE ALCOHOU[ OR Daily are on ARETAKING ANY MEDICATION. * Percent Values based a 2,000 STOP USE AND SEE ADOC[QR DEVELOP calorie IFYOU SYMPTOM5diet. THAT SIGNAL PROBLEMS, (DV) established. MAY LIVER Daily Value not INCLUDING (YELLOWING JAUNDICE OF THE Other Miaocrystalline Cellulose, SKINWHITES EYES)BROWN Ingredients: OR OF THE AND URINE. NONSPKIFll [AN Silicon Stearic Crostarmellose OTHER SYMPTOMS Dioxide, Add, INCLUDE VOMRING, Sodium, NAUSEA, LIGHT. Magnesium lecihii, Steamte, Dexhin, COLORED UNUSUAl STOOlS, TIREDNESS, Sodium Dexhose, ~~~e~~ellulose and WEAKNESS, ABDOMINAL Gtrote. STOMACH OR PAIN, sodium AND OF lOSS APPETITE. USE NOT FOR BY Formulated For: Exdusively PERSONS YEARS OR UNDER OF 18 AGE, BY PREGNANTOR WOMEN. BREASTFEEDING HERBALIFE NO1 INTERNATIONAL FOR WITH USE ALCOHOLIC BEVERAGES OF AMERICA, INC EXCESSIVE WITH USE, USE PRODUCT! Angeles, OR Los CA 9DO804210 U.SA. THAT DROWSINESS, CAUSE MAY YOUR IMPAIR MADEUSA IN ABILITY TO OPERATE OR AVEHICLE HEAYY 3Oday money-hack guarantee. EQUIPMENT. STK3057b3EOO 0 2002 HERBAUFE INTERNATIONAL, INC., U.S.A.

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Facts hggeskd Take tublet three Serving: one up to Supplement Serving 1Tablet Size: hesodoymeded. K8 o~ombinotionherbs, Servings is ofnotorol indudiig Per Contoiner: 30 Kovo and ho bshwogondho, os OS wdl Cokkn Per Servino %DV* nnddesiined relax body Amount is tohelp the while tonirMng ofwelklg. to0set&3 Total Corbohvdrate 4% 1B These statements notbeen bkium mg have 180 18% evaluatedtheFood Drug (OS ohosohotel by and dicolcium Administration. This productnot Dried Kavo is Kovo Extract mg t 200 intended diagnose, cure (30% to treclt, kovoloctones) (root1 orprevent disease. any Dried Ashwogondho mg t Extract 50 withonolides) (root) CAUTION: FDA THE US ADVISES (1.5% THAT A Bionbsorption 23mg t Complex-5 POTENTlAl BUT UVER RISKRARE, OF SEVERE, Vitamin oscorbyl INJURYBE MAY ASSOCIATED lecithin, ( (os paknitotel, WITH KAVACONTAlNlNG DIETARY SUPPLEMENTS. Cellulose Cinnamon ASK Plant Enzyme, Powder A HEALTH CARE PROFESSIONAL (bark) Dried Pepper (from BEFORE USE IF ond Block Extract YOU OR HAD PROBLEMS, (NLT piierine) HAVE HAVE LIVER Bioperine*) 95% {fruit). FREQUENTl!/ BEVERAGES, USE AlCOHOUC OR Doily ore bosed o ARETAKING STOP * PercentValues on 2,000 ANYMEDICATlON. USE AND SEE ADOCTORDEVELOP dorie IFYOU SYMPTOMSdiet. THAT SIGNAl PROBLEMS, (OV) established, MAY UVER t Doily Value not INCLUDING (YELLOWING JAUNDICE OF THE Other Microqstollii Cellulose, SKINWHlTES EYES)BROWN Ingredients: OR OF THE AND Silicon Steoric Croscormellose Dioxide, Acid, URINE. NONSPECIFIC OTHER SYMPTOMS CAN INCLUDE VOMITING, Sodium, Stearote, De&in, NAUSEA, LIGHT- Magnesiumlecithin, COLORED UNUSUAL ~ STOOLS, TIREDNESS,Sodium Dextrose, Corboxymethykelltrlose and WEAKNESS, ABDOMINAL Cie. STOMACH OR PAIN, ~ Sodium AND OF LOSS APPEHTE. USE NOT FOR BY Formulated For: Exdusively PERSONS YEARS OR UNDER OF 18 AGE,BY PREGNANT OR BREASTFEEDING HERBAUFE WOMEN. NOT INTERNATlONAl FOR WITH USE AL~OHOIIC BEVERAGES. OF AMERICA, INC. EXCESSIVE WITH USE, USE PRODUCTSAngeles, OR 10s (A900804210 U.SA. THAT DROWSINESS, CAUSE MAY YOUR IMPAIR MADE IN U.S.A. ABIUTY TO OPERATE OR AVEHICLE HEAYY 3Oday money-buck guarantee. EQUIPMENT. HEREAUFE iNTERNATlOMAl+ INC., U.S.A. STK3057US-35-00 0 2002

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