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HERBALIF[
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lNTFRNATlONA1.
La Cienega
Blvd.,
Mail in& Address:
(310)
410-9600
OF AMERICA,
Inglewood,
P.O. Box 80210,
●
FAX: (310)
INC.
Vice
CA 90301
I.os Angeles,
CA 90080-021(3
258-7124
IC3HN P. VENARDOS
Prmidcnl,
Regulatory
Affairs
‘Intonational
8025
“00 FM-8
Product
Management
P2:01
)
January 14,2000
EX%IE!UVE
6/’----]
D
Office of Special Nutritional (HFS-450)
Center For Food Safety and Applied Nutrition
FOOD & DRUG ADMINISTRATION
200 C Street, S.W.
Washington, D.C, 20204
Ref.: Thermojetics@
JAN 28
2000
Gold
Dear Sir andior Madam:
Pursuant to 21 CFR 101.93, please be advised that Herbalife
commercializing Thermojetics@ Gold in the United States,
International
of America,
Inc. has
begun
Thermojetics@ Gold is labeled and promoted with statements provided for in section 403(r)(6) of the Federal Food,
Drug, and Cosmetic Act.
I.
LABEL
(Note: On the label, immediately
below the following copy, appears
a ruled DSHEA disclaimer
box.)
Formulated from a select blend of health-enhancing herbs, Thermojctics@ Gold is designed to produce a
more desirable energy balance in the body so excess body fat may be reduced, Helps curb your appetite,
reduce cravings, and provide a natural daytime lift.
2.
HERBALIFE
FACT SHEET
(Note: The asterisks appearing
which is located and asterisked
Thermojetics@
in the copy shown below relate to the ruled DSHEA disclaimer
on the same page of the product literature.)
Gold – the “thermo”
w’
effect
This breakthrough herbal-based supplement is designed to speed
and lowering your desire to eat. Its combination of scientifically
hunger pangs, curb your cravings, diminish your obsession with
day long. Therrnojetics@ Gold is a premium product that offers
you’ve never experienced before.
bo~
up weight loss by raising you~ metabolism
blended ingredients can help reduce
food and provide an exhilarating lift all
weight-loss support in a natural way
Discussion Points
Hunger reliefi Minimizes between-meal hunger pangs and provides increased energy at the same
time.*
●
End the “yo-yo” syndrome: Thermojetics@ Gold makes it easy to stay on your weight-loss program
by providing maximum nutrition while reducing “carbo” urges. *
●
Fast Facts
Thermojetics@ Gold is a unique blend of themogenic herbs that help bum fat and curb appetite in
several ways, *
●
Contains Sida Cordifolia, an Ayurvedic herb from India with appetite-suppressing
alkaloids known to
increase energy and metabolism. *
●
Includes two diuretic herbs (Uva Ursi and Comsilk) to help prc,mote water loss during weight
reduction. *
●
Contains the flavonoid Quercetin, which is extracted from citrus fruits, to provide a calming effect and
help balance the actions of the other herbs. *
●
~ E
T4F47 @
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qb
—
Office of Special Nutritional (HFS-450)
Center For Food Safety and Applied Nutrition
FOOD & DRUG ADMINISTRATION
January [4, 2000
page 2
3.
HERBALIFE
TODAY NEWSLETTER
(Note: The asterisks appearing
in the copy shown below relate
which appears on product literature.)
Thermojetics@
to the ruled DSHEA disclaimer
box
Gold
A state-of-the-art advanced herbal formulation that stops hunger pangs, curbs cravings, energizes your
system and enhances metabolism so you can achieve greater weight loss. *
Thermojetics@ Gold is a great alternative to Thernlojetics@ Green and Beige. Thermojetics@ Gold
contains therm ogenic and Iipolytic herbs (meaning not only calorie consuming, but fat burning.)* If
Original Green is too stimulating, Thermo,jetics@ Gold should not. Yet it still provides powerful api>etitie
control, *
4.
MINI PRODUCT BROCHURES
(Note: The asterisks appearing in the copy shown below relates to the ruled DSHEA disclaimer
which are located on the same pages of the product literature.)
Thermojetics@
Gold – the “thermo”
boxes
effect
Complementing
[he Thermojetics@ IHigh-Protein. Low-Carb Program is a breakthrough
herbal-based
dietary supplement that is designed to speed up ~veight loss by raising your metabolism and lowering your
desire to eat. IIS combination ofscientificaily
blended ingredients can help reduce honger pangs, curb your
cravings, diminish your obsession with food and provide an exllilaratiog lift all da! long, Thermojetics@
Gold is a premium product that offers weight-loss support in a t~a(urally effective \vay you’ve never
experienced before. *
Thcrmojctics@ Gold
Dietary Supplement
d
Tum up the fat-burning flames of your metabolism and energize your system with this breakthrough
herbal-based product. its scientifically advanced formula crcatcs a “thermo effect” in your body tl~at can
help speed up weight loss by targeting stored fat, not lean muscle tissue, And it doesn’t sto~ there.
Thermojetics@ Gold helps reduce hunger pangs, curbs your cravings, diminishes your obsession with food
and provides an exhilarating lift, *
Product labeling and literature prominently bears the required boxed statermeot, “These statements have 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 contained in this notice is complete
accurate, and that the Company has substantiation that the foregoing statements are truthful and not misleading.
Please do not hesitate to adv
and
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Sincerely,
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