Document 155060

NOTIFICATION PURSUANT TO
SECTION 6 OF DSHEA
AND 21 CFR 0 101.93
This notification is being filed on behalf of Basic Research, L.L.C. dba
Silver Sage that is the Distributor of the product(s) which bear the statements
identified in this notification. Its business address is: 402 West 5050 North,
Provo, Utah 84604. This notification is being made pursuant to Section 6 of
DSHEA and Rule 21 C.F.R. § 101.93. The dietary supplement product on whose
label or labeling the statements appear is Permanent Weight Loss Systemm 45 ct.
The text of each structure-function
being given is:
(Statement
(Statement
1):
2):
(Statement
3):
(Statement 4):
(Statement
5):
(Statement
6):
(Statement 7):
(Statement
8):
(Statement
9):
(Statement
10):
(Statement
11):
(Statement
12):
(Statement
13):
statement for which notification
is now
“Permanent Weight Loss Easy 3-Step System”
“ThermoGenics [email protected] Original” - The primary
Weight Control Compound
“ThermoGenics [email protected] OriginaIm - Long-term weight
loss and weight maintenance”
“Step 2 and Step 3: Two adjunct support formulations
that make diet failure virtually impossible”
“LipoLytics [email protected] - Insures proper support for the
elimination of deep excess stored fat”
“MetaBolics [email protected] - Insures proper support for the
production of lean, fat-free muscle mass”
“Tired of YO-YO Dieting: It’s ThermoGenics [email protected]
“Original” long-term weight loss &weight maintenance
formula”
“Tired of YO-YO Dieting: For clinically proven,
permanent, long-term weight loss there is no
alternative”
“Thermogenics [email protected] Original - clinically proven fat
burner”
“Tired of YO-YO Dieting: At last, there’s a patentprotected, weight-loss compound clinically proven to
take off excess body fat and keep it off for more than
2 full years”
“Tired of YO-YO Dieting: It’s ThermoGenics [email protected]
“Original” long-term weight loss & weight maintenance
formula”
“ThermoGenics [email protected] Original Step 1: The primary
weight control compound
“ThermoGenics [email protected] Original Formulated to: Break
through the dreaded “Diet Plateau”
97s 0162
LET
k70&74
(Statement
14):
(Statement
15):
(Statement
16):
(Statement
(Statement
17):
18):
(Statement
19):
(Statement
(Statement
20):
2 1):
(Statement
22):
(Statement 23):
“ThermoGenics [email protected] Original Formulated to:
Continue loss of stubborn excess body fat and
maintain high energy levels while dieting”
“ThermoGenics [email protected] Original Formulated to:
Defend against the yo-yo diet syndrome”
“Step 2 and Step 3: An adjunct weight control
compound
“Lipolytic Synergist”
“LipoLytics [email protected] Formulated to: Optimize elimination
of deep excess stored fat”
“Lipolytics [email protected] Formulated to: Overcome the dropoff in fat reduction that occurs as a result of
insufficient Lipolytic nutrients”
“Metabolic Optimizer”
“MetaBolics [email protected] Formulated to: Maximize caloric
usage”
“MetaBolics [email protected] Formulated to: Optimize
production of lean muscle mass”
“MetaBolics [email protected] Formulated to: Minimize fatigue”
The following summary identifies the dietary ingredient(s)
supplement(s) for which a statement has been made:
Statement
Number
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
Identity of
that is the
Permanent
Permanent
Permanent
Permanent
Permanent
Permanent
Permanent
Permanent
Permanent
Permanent
Permanent
Permanent
Permanent
Permanent
Permanent
Permanent
Permanent
Permanent
Permanent
Permanent
Permanent
Dietary
Subiect
Weight
Weight
Weight
Weight
Weight
Weight
Weight
Weight
Weight
Weight
Weight
Weight
Weight
Weight
Weight
Weight
Weight
Weight
Weight
Weight
Weight
or
Ingredient(s)
or Supplement(s)
of the Statement:
Loss Systemm- 45 ct. Box
Loss SystemTM- 45 ct. Box
Loss SystemTM- 45 ct. Box
Loss System”- 45 ct. Box
Loss System”- 45 ct. Box
Loss SystemTM- 45 ct. Box
Loss SystemTM- 45 ct. Box
Loss SystemTM- 45 ct. Box
Loss SystemTM- 45 ct. Box
Loss SystemTM- 45 ct. Box
Loss SystemTM- 45 ct. Box
Loss SystemTM- 45 ct. Box
Loss SystemTM- 45 ct. Box
Loss SystemTM- 45 ct. Box
Loss System”45 ct. Box
Loss Systemm- 45 ct. Box
Loss SystemTM- 45 ct. Box
Loss SystemTM- 45 ct. Box
Loss SystemTM- 45 ct. Box
Loss SystemTM- 45 ct. Box
Loss SystemTM- 45 ct. Box
22
23
Permanent Weight Loss System”- 45 ct. Box
Permanent Weight Loss SystemTM- 45 ct. Box
The following identifies the brand name of each supplement for which a
statement is made:
Statement
Number
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
Brand Name
Basic Research,
dba Silver Sage
Basic Research,
dba Silver Sage
Basic Research,
dba Silver Sage
Basic Research,
dba Silver Sage
Basic Research,
dba Silver Sage
Basic Research,
dba Silver Sage
Basic Research,
dba Silver Sage
Basic Research,
dba Silver Sage
Basic Research,
dba Silver Sage
Basic Research,
dba Silver Sage
Basic Research,
dba Silver Sage
Basic Research,
dba Silver Sage
Basic Research,
dba Silver Sage
Basic Research,
dba Silver Sage
Basic Research,
dba Silver Sage
Basic Research,
dba Silver Sage
Basic Research,
dba Silver Sage
Basic Research,
dba Silver Sage
Basic Research,
dba Silver Sage
L.L.C.,
Label or Labelinrr?
both
L.L.C.,
both
L.L.C.,
both
L. L. C.,
both
L. L. C.,
both
L. L.C.,
both
L.L.C.,
both
L. L.C.,
both
L.L.C.,
both
L.L.C.,
both
L.L.C.,
both
L. L.C.,
both
1.1. C.,
both
L. L. C.,
both
L. L.C.,
both
L. L.C.,
both
L.L.C.,
both
L.L.C.,
both
L.L.C.,
both
20
21
22
23
Basic Research,
dba Silver Sage
Basic Research,
dba Silver Sage
Basic Research,
dba Silver Sage
Basic Research,
dba Silver Sage
L.L.C.,
both
L.L.C.,
both
L.L.C.,
both
L.L.C.,
both
I, Daniel B. Mowrey, Ph.D., am authorized to certify this Notification on
behalf of Basic Research, L.L.C. dba Silver Sage. I certify that the information
presented and contained in this Notification is complete and accurate, and that
Basic Research, L.L.C. dba Silver Sage has substantiation that each structurefunction statement is truthful and not misleading.
Dated this vrday
of My
,2002.
Consultant to Basic Research, L.L.C.
dba Silver Sage
-,.w~~~-~““-~
----
-
-x
_.
..“.
_
.-
Thermoknic s
PATWNo.
N *Ms.ass
T
[email protected]
OR/G//VA L
Fomwlated To:
BreakThrough the
Dreaded ‘Diet Plateau”
y&y
LoFa;;;;bborr
l
w
CA
Wd
l
Maintam
~~ . Igh.EnFrgy
LevelsW hlie Dletlng
* Defend aaainst the YO-YO
Diet Syndrome*
4cUveIngredients:Ephedra,Caffeine,AMylsalieylicAd
Suuulement Facts
Sefvin~SEe:2
Supplement Facts
Serving Size: 2 capsules
Servings Per Container: 45
Tiesner: 45
SetvingsPer Conis
knauntper %odlY
ServinQ value’
Anwntf’er % Dailv
Lone&m /chelated)
Selenium
(chelatedl
Manaanese
Ichelated)
Molvbdenum
(chelatedI
Potassium
(chelatedI
EholineBiite
illOSitOi
pet&n~
(Fumaratel
Fizz%?
DandeiiihNn
Irwtl
Tunetic 8ubetl
MilkThistie(seedI
c inm bark’
berian(jlnsenalmot)
9’
GoblKoia6ea8
fil-li bti
‘Tavell~Peooer
mui’
i?O lO ll(chehtedl
Vanadium
l&Meal
[email protected]*
~m~~dp&asod
tw
-.
. .
l
16.6ma 4%
66.7mca 95%
3.2ma 166%
16.7mca 22%
33ma >1%
47.3ma t
33.3ma t
22.2ma t
22.2ma t
22.2ma t
33.3ma t
16.7ma t
16.7ma
t
16.7ma t
16.7ma t
16.7ma t
ll.lma
ll.lma
5a
66?nZa
16:7mca
66.7mg
t
t
t
t
t
t
ServingSize: 2 capsules
ServingsPerContainer.45
=w’,
E2
Vimin 86 (F$&k&KY.)
VitaminB12(Cyanocobaiamin)
155.6mQ
Lkorice(motl
89mg
Siiiei”sens (rootI
89mg
44.4mg
Panax
G inseng
8ooU
44.4mg
[email protected]
schizandra
/fruii
g
Y&g
Chioreiia
(wholep!antI
44.4m9
22.2ma
AmHicimGim~luou
89mca
Chmmium
Fdynikothwte
ho
Z4mg
4414mg
22.2mg
PA8A
44.4mg
DMAE
t
t
t
t
t
t
t
t
t
t
t
t
t
t
t
* PercentDaiiyYalussabasedma2,[email protected]
tDaiiyVaiuemte&abtiN
ona 2,6X1calorie
diet
02001 SihwSage
SilverSage Cares About Our Envhnment
a
n
fi
Printed on Recyc/ed Pepehomd
TIRED OF
YO-YO DIETING?
At last, there’s a patent-protected,weight-loss compound
Takethe PermanentWeightloss System’”Test!
Areyou a victimof r0-r0dieting?
Didyour last dietproductstop workingbeforeyou reachedyour goal?
q Lookingfor long-term,visibleresufts?
0 Readyfor yearsof successful,documented,sustainedweightloss and increasedenergy?
ffyou answered“ves”to any oneof thesequestkms,thenthe PermanentWeightLoss
1 SystemTMmay be theperfectweightcontrolfomula for you!*
0
0
clinically proven to take off excessbodyfat and keep It off for
morethan 2 full years It’s ThermoGenics
PlusQ“Original”LongTerm WeightLoss & WeightMaintenanceFormula.* No other
dietary supplementweight control product can make this
claim. For clinically proven,permanent,long-termweight loss
there Is no alternative.* Plus,it’s guaranteedto work for you or
it costsyou absolutelynothing!
PATENTED
After threelongyearsof initial research,
the active [email protected]
ingredients were finallv oranted United
,_ St&s Lettersof Patent’N< !&&&,n
% October8,1991 as a “MethodFor Produclno
-“Or MaintainingWeightLossIn Humans.” -
-
--..- -_-._..
”
..
I).,
Notice PertelnlngTo [email protected](the white capsules):The recommended
servingis two
capsulesthreetimesa day,whichIs the exactservingusedIn the clinicaltrials.However,manypeople
whoaresensitiveto stimulantshavereducedthe servingas low as onecapsuletwicea dayandhavestill
seenresults.As with manyingestiblecompounds,
eachindividualreactsdifferentlyto ThennoGenics
[email protected]
OriginalFormula.The effectiveservingdependsupona person’sbodyweight,metabolism,and overall
health.Youmay want to start with oneThermoGenics
[email protected] OriginalFormulacapsuletwice a day and
graduallyincreasethe serving(upto the recommended
level)untilyoufindwhatworksbestfor yourbody. !
Before
starting
thisoranyweighl
cc&mlprogram,
check
withyourhealth
careprovider
tomakesureyouarein
overall
goodhealth,
if yourhealth
careprovider
hasanyquesbns
please
havehimorhercall1-BWBgB-5153
THERMOGEIVICS [email protected]
ORIGINAL
CLINICALLY PROVEN
FAT BURNER*
with
ADRENAL SUPPORT
The PRIMARY Weight B
Control Compound* -
ThermoGenics
[email protected]
TIRED OF
YO-YO D/ET/NG?
At last,there’sa patent-protected,
weight-loss
Weiaht Loss and Weiaht Maintenance*
.
I
compoundclinically provento takeoff excess
bodyfat and keep it eff for morethan 2 full
years.* It’s [email protected]“Original”
Long-TenWeightLoss& WeightMaintenance
Formula.’No other dietarysupplement
weight
control pmduct can make thls claim. For
clinicallyproven,permanent,long-termweight
loss there is no alternative. Plus, It’s
guaranteedto work for you or It costs you
absolutely
nothing!
Distributed
by
Two ADJUNCT Support Formulations
That Make Diet Failure Virtually impossible *
Uporytics
[email protected] MetaBolics P/[email protected]
insures ProperSupport
for the Elimination of
Deea. Excess Stored Fat *
Diotarv
insuresProperSupport
for the Productionof lean,
Fat-Free Muscle Mass *
Suaalement
AC Easv-to-Use
w
Mb&al& Wrapped
S~LVERSAGE
Prwo,[email protected] 9 www.stvamgs.com
0201
ManufacturedhtheUSA