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

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Supplement Suggested Serving: Take one tublet up tothree
timesadayasneeded. Serving Size: 1 Tablet K8isa combination ofnatural herbs, including Servings Per Container: 30 Kavu Kava and khwagandha, as well asCalcium Per Serving and isdesigned to help relax thebody whileAmount mntrii~ toasense ofwellbeing. Total G&hydrate

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Facts

%DV* 4%

These statements have notbeen Calcium 18% 180 mg evaluated bytheFood andDrug (as dicalcium phosphate) Administration. This product isnot DriedKava 2OOmg KavaExtmct intended to diagnose, treat, cure (30% kavalactones) (root) orprevent anydisease. Dried Ashwaqandha Extract 50mq t
witbanolides) (root) CAUTION: THE US FDA ADVISES THAT A (1.5% fIbabsorptIon Complex-5 23mg t POTENTIAL RISK OF RARE, BUT SEVERE, UVER lecithin, Vitamin C (as ascorhyl palmitote), INJURY MAY BE ASSOCIATED WITH KAVACellulose Enzyme, Cinnamon Powder CONTAINING DlElARY SUPPLEMENTS. ASK A Plant HEALM (ARE PROFESSIONAL BEFORE USE If: (bark) and Dried Black Pepper Extract (from YOU HAVE OR HAVE HAD LIVER PROBLEMS, (fruit). 8iooetinedP) (NLT 95% oioerine) FRMUENTlY USE ALCOHOU[ BEVERAGES, OR * Percent Daily Values are based ona 2,000 ARETAKING ANY MEDICATION. STOP USE AND SEE ADOC[QR IFYOU DEVELOP SYMPTOM5 calorie diet. THAT MAY SIGNAL LIVER PROBLEMS, Daily Value (DV) not established. INCLUDING JAUNDICE (YELLOWING OF THE Other Ingredients: Miaocrystalline Cellulose, SKIN OR WHITES OF THE EYES) AND BROWN Dioxide, Stearic Add, Crostarmellose URINE. OTHER NONSPKIFll SYMPTOMS [AN Silicon INCLUDE NAUSEA, VOMRING, LIGHT. Dexhin, Sodium, Magnesium Steamte, lecihii, COLORED STOOlS, UNUSUAl TIREDNESS, Dexhose, Sodium ~~~e~~ellulose and WEAKNESS, STOMACH OR ABDOMINAL PAIN, sodium Gtrote. AND lOSS OF APPETITE. NOT FOR USE BY Formulated Exdusively For: PERSONS UNDER 18YEARS OF AGE, OR BY PREGNANTOR BREASTFEEDING WOMEN. NO1 HERBALIFE INTERNATIONAL FOR USE WITH ALCOHOLIC BEVERAGES OF AMERICA, INC EXCESSIVE USE, OR USE WITH PRODUCT! Los Angeles, CA 9DO804210 U.SA. THAT CAUSE DROWSINESS, MAY IMPAIR YOUR MADE INUSA ABILITY TO OPERATE AVEHICLE OR HEAYY 3Oday money-hack guarantee. EQUIPMENT. STK3057b3EOO 0 2002 HERBAUFE INTERNATIONAL, INC., U.S.A.

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

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