LET 9599 Herbalife International of America Inc Vol - Food and Drug

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LET 9599 Herbalife International of America Inc Vol - Food and Drug Powered By Docstoc
					     HERBALIFE INTERNATIONAL OF AMERICA, INC.                                                               JOHN VENARDOS
     1800 Century Park East                                                                  Vice President, Regulatory Affairs
     Century City, CA 90067-1501                                                           international Product Management
     (310)203-7746    - FAX (310)   557-3916
     Email: johnv@herbalife.com


February25,2002



O ffice of Nutritional Products
Labeling and Dietary Supplements
FOOD & DRUG ADMINISTRATION
5 100 Paint Branch Parkway
College Park, Maryland 20740-3835

Ref: Thermojetics@ Green Ephedra Free and Thermojetics@ Beige Sampler

Dear Sir and/or Madam:

Pursuantto 2 1 CFRlO 1.93, pleasebe advisedthat Herbalife Internationalof America, Inc. has begun
commercializing Thermojetics@  GreenEphedraFree and Thermojetics@      Beige Sampler.

                                                                                    provided
Thermojetics@GreenEphedraFree and Beige Samplerare labeledand promotedwith statements
for in section 403(r)(6) of the federalFood, Drug and CosmeticAct.

1.      LABEL

        Take one Thermojetics@GreenEphedraFreeTablet with one Thermojetics@   Beige Tablet twice a day
        at midmorning and midafternoon. Theseherbalproductscontain no preservativesand no animal
        products.

2.      PRODUCT FOCUS
                                                         s
        Green Ephedra Free - key to keeping your New Year’ resolution

        Burn fat faster
        Are you tired of making the sameresolution to lose weight eachNew Year only to fall off the wagon
        by January2 ? Break that patternonce and for all with Thermojetics@ Green EphedraFree. This
        herbal dietary supplement,taken twice daily, is designedto reducehungerpangs,boost your
        metabolismand increaseyour energy,while helping you achievethat goal to slim down and shapeup.*

        Helps speed up weight loss
        Utilizing a carefully selectedblend of herbsand botanicals,Thermojetics@  Green EphedraFree helps
        increasethe rate at which your body bums fat and helps to curb your appetite.* In the end, it allows
        you to overcomeobstaclesto weight loss and achieveresults quickly, easily and safely.*

        Turn up your metabolism
        Thermojetics@   Green EphedraFreehas no ephedra-containing       herbs. Instead,it contains a unique
        blend of five complex herbal extractsthat can help support weight loss, including citrus aurantium
        (bitter orangeextracts of fruit and peel), greentea, yerba mate, cocoaand Bioperinea (black pepper
        extract).* Theseplant factors work synergistically to adjust metabolismat the cellular level so your
        body is able to burn stored fat more efficiently.*

        Publishedstudieshave found that Advantra ZTM- also known as citrus aurantium- is effective at
        stimulating the burning of fat. Not only will you lose weight faster,but you will also have more
        energy and feel better.*
        ,Office if Nutritional Products
         4.,abelingand Dietary Supplements
        FQOD & DRUG ADMINISTRATION
.       February 252002
        Page 2 of 2

             An added health boost
             In addition to promoting fat burning and curbing your appetite, ThermojeticsB Green Ephedra Free
             also provides numerous other health benfits .* The herbal supplement is enhancedwith black pepper
                                                    s
             extract, which helps improve the body’ ability to absorb nutrients from the digestive tract, and it also
             includes cocoa, which is a powerful antioxidant,*

                                                                                                   s
             ThermojeticsB Green Ephedra Free will be most effective when combined with Herbalife’ nutrition
             programs. You can use Green EphedraFree with either the ThermojeticsB Green Program or our
             ThermojeticsB Gold High-Protein, Low-Carb Program for safe and effective weight loss. These
             programs come in QuickStart, Advanced and Ultimate versions depending on your budget and how
             quickly you want to reach your goal weight.

             Start your New Year off on the right foot. ThermojeticsQ Green Ephedra Free will help you reach
                                               t
             your weight-loss goal so you won’ be making the sameresolution when the next New Year rolls
             around. *


         The Product Focus prominently bears the required boxed statementlinked by an asterisk (*) to the
         structure/function statementsin the preceding copy: “These statementshave not been evaluated by the
         Food and Drug Administration. This product is not intended to 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 substantiation that the foregoing statementsare truthful and not
         misleading.

         If you have any questions,please do not hesitate to ask.

         Sincerely,


                   by&
         J   :gf

    f
     .


prqduct
 L                      focus

         Green Ephedra Free-
         key to keeping your
                   s
         New Year’ resolution
         Burn     fat   faster
         Are you tired of making the same resolution
         to lose weight each New Year only to fall off
         the wagon by January 2? Break that pattern once
         and for all with Thermojetics@ Green Ephedra Free.
         This herbal dietary supplement, taken twice daily, is
         designed to reduce hunger pangs, boost your
         metabolism and increase your energy, while helping
         you achieve that goal to slim down and shape up.*

         Helps     speed         up weight    loss
         Utilizing a carefully selected blend of herbs and
         botanical% Thermojetics* Green Ephedra Free
         helps increase the rate at which your body burns
         fat and helps to curb your appetite.* In the end, it
         allows you to overcome obstacles to weight loss
         and achieve results quickly, easily and safely.*

         Turn    up your         metabolism
         Thermojetics@ Green Ephedra Free has no
         ephedra-containing herbs. Instead, it contains a
         unique blend of five complex herbal extracts that
         can help support weight loss, including citrus
         aurantium (bitter orange extracts of fruit and peel),
         green tea, yerba mate, cocoa and Bioperinea                      Thermojetics@ Green Ephedra Free will be most
         (black pepper extract).* These plant factors work                                                       s
                                                                          effective when combined with Herbalife’ nutrition
         synergistically to adjust metabolism at the cellular level       programs. You can use Green Ephedra Free with either
         so your body is able to burn stored fat more efficiently.’       the Thermojetics@ Green Program or our Thermojetics@
                                                                          Gold High-Protein, Low-Carb Program for safe and
         Published studies have found that Advantra ZTM-                  effective weight loss. These programs come in
         also known as citrus aurantium-is effective at                   QuickStart, Advanced and Ultimate versions depending
         stimulating the burning of fat. Not only will you                on your budget and how quickly you want to reach your
         lose weight faster, but you will also have more energy           goal weight.
         and feel better.*
                                                                          Start your New Year off on the right foot. Thermojetics@
         An     added      health     boost                               Green Ephedra Free will help you reach your weight-
         In addition to promoting fat burning and curbing your                                t
                                                                          loss goal so you won’ be making the same resolution
         appetite, ThermojeticS Green Ephedra Free also                   when the next New Year rolls around.*
         provides numerous other health benefits.* The herbal             Thermojeticsm      Green      Ephedra      Free
         supplement is enhanced with black pepper extract,                #0070 $21 .oo
                                         s
         which helps improve the body’ ability to absorb
                                                                          Complete-Thermojeticsm             Green     Ephedra   Free
         nutrients from the digestive tract, and it also includes         and ThermojeticsQD         Beige
         cocoa, which is a powerful antioxidant.*                         #0071   $29.95

                                                                           statements notbeen
                                                                      *These       have            bythe and Administration.This isnot
                                                                                            evaluated Food Drug            product            3
                                                                             todiagnose, cure prevent disease.
                                                                       intended      treat, or     any                                        k   I
                                                                      I                                                                  Id       I
                                                                                                          .           .
                                                                                                                          ,

product           focus                                                                                         a >

   1 Outer Nutrition Training
     Tools support your business
     and healthy living
                                     Herbalife has              n   Outer Nutrition Opportunity Video is a four-part
                                     developed a set of             training video that will show you 1) how to add
                                     Outer Nutrition training       on to your nutrition/weight-loss business with
                                     tools that provide             Personal Care; 2) how to conduct an Action
                                     information on our             Group; 3) how to conduct a Product
                                     entire line: skin care,        Demonstration and 4) techniques on how:0
                                     hair care, co/our and          use the Spa Bag.
                                     body care.
                                     These tools help           n   Steps to Success Video has
                                     Distributors sell,             been updated to reflect the
                                     recruit and                    new products and packaging
                                     build a stronger               changes, giving your
                                     personal-care business.        customers a quick reference
                                                                    to all of our wonderful Outer
      Outer    Nutrition   Training      Tools   include:           Nutrition products.
      n   Outer Nutrition Flipchart is designed with
          high impact visuals to guide you through              Promote good health from
          each step of a personal-care demonstration.           the inside out with these
          It provides information on skin care, co/our,         Outer Nutrition training tools.
          Outer Nutrition and hair care, along with the
          Herbalife business opportunity. The Flipchart         Flipchart                                       Outer Nutrition
          also includes step-by-step instructions on            #6265 $5.50                                      Video-English
          how to conduct a personal-care
          demonstration.                                        Action       Group      Workbook
                                                                English #6218 $19.95 (set of 5)
      n   Action Group Workbook is a go-page guide              Spanish #6219 $19.95 (set of 5)
          packed with in-depth information for
          trainers. This workbook contains the tools            Outer       Nutrition         Video
          necessary to conduct a one-day training               English #9159 $2.00 each
          providing you with 1) product features and
                                                                Steps       to   Success         Video
          benefits; 2) a step-by-step product
          demonstration guide; and 3) great selling             English #8963 $2.00 each
          and recruiting tips.                                  Spanish #8964 $2.00 each

                                                                Outer   Nutrition             Product
                                                                Catalog                                       Steps            to Success
                                                                                                                              Video
                                                                English #5946 $7.75 (set of 10)
                                                                Spanish #5947 $7.75 (set of 10)

                                                                Additional          Support       Tools
                                                                Spa Bag
                                                                #0900 $370.85
                            Action      Group    Workbook       Colour       Case
                                                                #2928 $115.00
        l


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                THERMOJETlCSc
                HERBAL TABLETS
            TABLETAS HIkRBAS FINAS
                   DE

				
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