Complaint Exhibits GM

25 Pages·2015·3.89 MB·English

by  Federal Trade Commission

Case: 1:15-cv-00093 Document #: 1-2 Filed: 01/07/15 Page 1 of 25 PageID #:62

EXHIBIT G
014000003
Case: 1:15-cv-00093 Document #: 1-2 Filed: 01/07/15 Page 2 of 25 PageID #:63
nourish life
speak
Speech
Nutrients~
TM
~ourishlife
·
Speech
Nutrients~
speak,.
Formulated by a pediatrician to
support normal and healthy speech
development and maintenance.
Speech Nutrients speak rM is a
patented nutritional formula
developed by a pediatrician
to support healthy speech
development and coordination.
Join the 4,000+ speak families
who have experienced targeted
benefits including:
• Nutritional support of verbal
and motor skills
• Reduction in oxidative stress
• Promotion of a
healthy inflammatory
response
Case: 1:15-cv-00093 Document #: 1-2 Filed: 01/07/15 Page 3 of 25 PageID #:64

EXHIBIT H
The making of
What is SpeechNutrients speak"'?
SpeechNutrients speak'M ~ourish
life- SpeechNutrients speak'• is a patented C
Tspene+a ky'e" aisrs t hine trhees umlta okfin rega, lS lipfee eecxhpNeruietrniecnetss -:i_; . SpeechN utrients ~ formulation that provides a precise dose & ratio as
from families who took action based on ground ..., ..1'\. ~ ,. . speak'" of the important nutrients needed for normal and e:
healthy speech and coordination development.
breaking research regarding the role of essential 1
:
fatty acids and antioxidants for child development. Jl SpeechNutrients speak'" combines 7 all natural 15
After the exact formula was specified, the L nutrients in pre-measured, ultra-purified, -c
omega-3 experts at SpeechNutrients partnered hypo-allergenic doses. v
with the world's leading producers to find the SpeechNutrients speak .. contains the purest Formulated by a pediatrician to -0
pharmaceutical grade ingredients in the most The nutrients in SpeechNutrients 0
purest ingredients in their appropriate support normal and healthy speech 0
biochemical form for optimal absorption and cidoenacl eranttiroast eadn, dt hfoer mingsr. eUdliternat-sp uinri fsiepde aakn'd" ahrieg hthlyir d development and maintenance. t isnpceluakd<iMn pgr obvuitd neo tat rligmeitteedd btoe:nt efits, 93
utilization. The result is SpeechNutrients speak
party tested and exceed all US and European D
standards for purity. • Nutritional support of verbal and motor skills o
,.\tl••~,t.,IV\. tUtttArlli- c
The formula has been concentrated to prescription • Reduction in oxidative stress u
m
AT hseturadpyi epsu binli sHheeadlt hin aAnltde rMneadtivicein e' strength by a certified GMP f;~~cility specifically for • Promotion of a healthy inflammatory response e
Nourishlife, LLC. SpeechNutrients speak'" has n
reported data on 187 children been ultra-refined and distilled for purity. t
supplementing with an omega-3 #
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and oxidative stress.' retillfers, and:-.JPOO!lers of omega-3. Dorianne n Califomla 0
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To read the study in its entirety, go to /
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the couch or me but she never Bl/a'1 had the concept ITt r-·..._~ 91•' r'JtJtH·· neA v~ -~ P
of that before. Her horse trainer says she is amazingly OC·J-47i -0358 PI l.,. atlD,:.hP~"',U1HTJr:.(J ~ a
shteror onwgenr naolswo. a" nd able to control her horse mostly on WININ.SpeecrNutrients.c .)(!' l,.lPtTItIWU1" fri~(C)tCll-," n'' .(..l .Prw 11·"~".00•. 1n"r r :.:.::' ; ge
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Why is this particular Patented by Renowned Children's
Choose the form of
formulation effective? Research Facility C
The unique speak formulation contains a blend speak™t hat is best Nourishlife's speak product is produced under a
s
of concentrated and purified omega-3s from fish exclusive license to a formulation patKent dev eloped e
oil (EPA and DHA), natural vitamin E (d-alpha and for your child. by Children's Hospital & Research Center Otak land :
1
gamma tocopherols), Vitamin K {K1 and K2), (CHRCO). Children's :1
borage oil (GLA) and natural orange flavor. Hospital & Research 't ~ - A- 5
Research has speak'M Capsules Center Oakland is the -c
oldest pediatric CHILDREN'S HOSPITAL v
shown that these speak Capsules for those medical center between & RESEARCH CENTER 0-'l<LAND -0
nutrients play children who prefer to 0
an important role swallow a capsule Los Angeles and Seattle and has provided 0
exceptional medical care of children in the region 9
in speech and 3
coordination We take the guesswork out ianndde pbeenydoenndt f cohr ialdlmreons'st h1o0 s0p yiteaal rins .N Boeritnhge rtnh e only D
development, speak'MT wist-offs o
of supplementation Galifomia, Children's Hospital Oakland is able to c
and thousands u
of children have SpeechNutrients speak'" provides ultra-purified speak Twist-offs for those focus all of its attention on caring for children. m
experienced positive outcomes while taking and concentrated nutrients combined in who prefer an oil that e
these nutrients. Due to potential issues with a convenient serving (either 2 capsules or can be squeezed ~ n
malabsorption, some children may be deficient 1-tablespoon) resulting in greater ease of use out on a spoon or ~ (_ ) t #
in vitamin E and at the same time may not absorb for parents and children and a lower cost than mixed into foods or ~· - :
it well. In fact, many of the symptoms associated purchasing individual ingredients. beverages -· 1-20~~
with speech issues mirror vitamin E deficiency. The seven nutrients in speak'" are combined in F00
Antioxidants (specifically vitamin E) have the simple, easy-to-use, capsules or in our delicious speak'M Smooth ile000 0
potential to be depleted during oxidative stress speak smooth liquid. d"'
and inflammation of the Gl tract. If there's not SpeechNutrients speak'" is a hypo-allergenic speak Smooth for those who :
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enough vitamin E available, the environment formula and does not contain milk, egg, tree nuts, prefer an orange-vanilla liquid 1
within the cell membrane becomes antagonistic wheat, peanuts, yeast, gluten, casein. pork, sugar. with absolutely no fish taste /0
to omega-3 rendering it useless. The nutrients starch, artificial flavors, colors or preservatives. or smell 7
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contained in speak are needed to counteract Individuals with fish and seafood allergies may 1
5
malabsorption and oxidation. wish to consult with a specialist.
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'We have seen significant benefits in his speech including •J ohn has been taking 3 :L'6<.1k capsules a day for a few weeks "' have a 3 year old daughter and after a year and a half e
increase in vocaliZations, babbling and abiHty to imitate and we are just uppng him to four capsules a day. Not only is with slow and little progress, we were feeling hopeless, 5
speech sounds more readily. We have been on other fish he speaking more, there is less of him repeaUng what he hears/ discouraged and defeated. We had read about the benents
oU supplements in the past and there Is no comparison to sees. I was overjoyed Saturday when John came to me in the of fish oils end vitamin E and we started using '"v>ak in of
the differences that we see with ---~ . We stU/ have a kitchen and did the sign for "cheese". Before I could give him hopes of giving our daughter more supplementation with the 2
long way to go, but thank you so much for making this the option between cheddar and the white string cheese, he ease of using 1 piH vs. 5 or 6 pills. Wtth/n 2 days, we started 5
product possible. • said and signed "orange "I My hands were shaking as I handed to see progress. As we proceeded with '>O"alc , we noticed
him the cheddar. His face broke Into a huge smile as I gave It to huge improvements in her skill set, and her health. Thank P
Usa, VA him and he went off munching on his cheese. TH.tWK YOU for you so much for giving us a healthier child wrth more hope a
recommending Deo r to me!" for the future." g
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Agnesl., CA Pattie L. I
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Case: 1:15-cv-00093 Document #: 1-2 Filed: 01/07/15 Page 6 of 25 PageID #:67

EXHIBIT I
nourish life ...
spea
Speech Nutrients kTM
Dosage Information
8
6Dosage Recommendations:
:
#Suggested dosage plan for getting started with speak. Continue with established dosing at 12 weeks and beyond:

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e• Begin with one speak'" capsule daily (given with food) and increase slowly.
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a• Toddlers and smaller children may see the most benefits with 2 to 4 capsules per day.
P• Older and larger children may see the most benefits with 4 to 6 capsules per day.

5• Consider increasing dosage until no additional benefits are noted, at that point revert back to the
1
/ prior weeks' dosage. Increased benefits are often noted at higher dosages.
7
0• Administering speak lor a minimum of 4 months may be required to determine potential benefits.
/
1
0Why is speakTMu nique?

:
dOmega-3 is found in many forms and combinations including high EFA,
e
Filhigh EPA, and omego-3,6,9. While these may be beneficial for the general
population, they do not contain the additional nutrients in doses and ratios
2
-necessary for the unique population of children concerned with speech and
1
: coordination. The higher amounts of the two forms of vitamin E contained
#
in speok'M ore critical components working synergistically with omego-3 to reduce oxidation and support a healthy
t
ninflammatory response. In addition, K 1 and K2 (natural blood coagulants) ore included in the formulation for nutrient
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mbalance due to the theoretical blood thinning effects of omego-3 and vitamin E.
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cDeveloped by a pediatrician and noted researcher, the unique omego-3 + vitamin E formulation 1t t At A-
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Dcontained in speokTM is produced under exclusive license to a formulation potent developed by the
3 Children's Hospital & Research Center Oakland (CHRCO) CH, IL. ~DA."Rt":E·~N· '~S~H HOIO OS•·P~IlTAIA'.LiO
9
0
0These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure ar prevent any disease. ©20 12 Nourishlife LLC
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nourish
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speak™
SpeechNutrients
Nutrient Information
W9hat are the nutrients in speak'M ?
6
:
# The patented speak'" formulation

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includes 7 nutrients in closes ancl Supplement Facts
I
e ratios cleterminecllo be most
g coNTAINING· .... .. ~ 200 mg gamma tocopherol Serving Size: 2 softgel capsules
a eHective. This precise combination
P Servings per container: 30
of pharmaceutical grade
5 2 softgels %DV %DV
2 CONTAINING·· · · · · ~ 500 IU d-alpha tocopherol ingredients is conveniently offered for Cl1tldren for Adults
of 3 - omega-3 7e;o2o5sa pmoogtoe EnoPicaA< :ld ainn sdo tfwtgiestl ocaffp csauplessu lteos bweh sicwha lallolowwed yuenaadrgese ro 4f ayne4da o rCsr hmoiflo darregee n
e 8 CONTAINING········~ and 275 mg OHA the oil to be squirted directly into a
g child's mouth or easily mixed with
a
P CONTAINING· . ~ 60 mg GL A gamma Hnolanic acid foods or liquids .

5
1 1- vitamin K 1 Are there any sicle eHects?
7/ CONTAINING· .. 2 mg phytonadione Possible side effects are typically
0
1/ 1- vitamin K 2 associated with omega-3 and
0 vitamin E supplements (not unique to
CONTAINING · · · ~ 300 meg menaquinone
d: speak™). Moodiness, irritability, and
e emotional outbursts are sometimes
Fil reported in children during the first
W hat about purity?
2 few days/weeks of omega-3
W1-e partner with the world's most esteemed producers of omega-3 fish oil for supplementation; however, this

t:he speak formulation. The oil used is cold extracted, highly refined,
# usually comes with increased
unt ltra-purified and molecularly distilled. Lab results are confirmed by third party babbling, imitation of sounds, and
teests. The omega-3 used meets or exceeds all U.S. and European standards for eventually words to sentences. Some
m
purity, complies with California Prop 65, and meets and exceeds the GOED children may experience loose stools
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(cGlobal Organization for EPA and DHA) monograph. This partnership ensures when they begin supplementation
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tDhat SpeechNutrients speak'M contains the purest pharmaceutical grade oils with oil-based capsules; this usually
w3 ith the ideal ratio of active EPA and DHA. resolves quickly.
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Case: 1:15-cv-00093 Document #: 1-2 Filed: 01/07/15 Page 9 of 25 PageID #:70

EXHIBIT J
Case: 1:15-cv-00093 Document #: 1-2 Filed: 01/07/15 Page 10 of 25 PageID #:71
nourish life"'
SpeechN utrients ..
Nourish Life Speak Dosage Information I Questions
1. How should I begin supplementing with speak?
2. What is the correct dosage of speak for my child's height, weight, and age?
3. How often and at what times should I administer speak to my child?
4. How should I give speak to my child?
5. When should I begin to notice beneficial changes in my child?
6. Is speak effective for older children and does it take longer to start to work?
7. My child seems more emotional, weepy, agitated. Is this normal?
8. What are the possible side-effects of omega-3 and vitamin E supplementation?
1. How should I begin supplementing with speak?
If your child is not currently taking omega-3 fish oil or vitamin E supplements:
Start with 1 capsule of speak daily. After 2 weeks increase the dosage to 2 capsules
daily until reaching a dosage of 4 capsules per day over 8 weeks. If you believe that your
child will benefit from additional supplementation beyond 4 capsules, regardless of
previous omega-3 supplementation, check with your healthcare practitioner (e.g.:
Medical Doctor, Registered Dietitian, Certified Clinical Nutritionist, Naturopathic Doctor,
Doctor of Osteopathy).
s . E
uggest e d d osa ge plan f or t h ose no current tak m" g f IS h 01" I or v1tam1n supplements:
Week Week Week Week Week Week Week Week
1 2 3 4 5 6 7 8
#of Speak 1 1 2 2 3 3 4 4
capsules:
If your child is already taking individual omega-3 fish oil and vitamin E
supplements:
• First determine the current dosage amount of the active omega-3 (EPA and
DHA) and vitamin E (if any) that your child is receiving with the existing
supplement* (usually listed clearly on the "Supplement Facts" panel. Be sure to
determine the amount per serving or per capsule). This will provide you a
baseline from which to start for an equivalent dosage. Some families administer
both "High EFA" and "High EPA" supplements. Shown below is a chart illustrating
the amounts of each ingredient and how 2 capsules of speak provide the
essential equivalent to two capsules of the other supplements plus additional
nutrients in speak provide added benefits and nutrient balance, not found in other
omega-3 supplements.
*Feel free to contact SpeechNutrients at 1-847-471-0358 if you have any
questions.
Nourtshltfe llC, 272 East Deerpath Road, Suite 244, lake Forest, ll 60045 USA t 847 234 2334 • f 847.234 5545 • www SpeechNutnents com