A message from PharmaOmega for CHERAB members

[Guest guest]

FIRST, the Speak™ Focus Group is NOT A RESEARCH TRIAL. It is a

Consumer Focus Group, intended to share product with consumers and

gather feedback about the product. We wanted to give product to

families for free and we will ask general questions, such as How the

product was consumed, What flavors you might like to see in the

future, etc. It is NOT a Research Project in any way. It is not

science (if it were science, there would be several preliminary

steps).

SECOND, Dr. , MD, is NOT involved with the Focus Group

or with Marketing with PharmaOmega. She is NOT a consultant to the

company. Dr. developed the formula and PharmaOmega produced

it.

THIRD, on the product website (www.SpeechNutrients.com) there is

ready access for you to contact us by phone 1-800-471-0358 or email:

info@.... We invite you to contact us directly.

There is also product information, including Frequently Asked

Questions, on the website. If you don't find an answer to your

question, please send your questions to us.

Gretchen Vannice, MS, RD

Scientific Affairs

NourishLife, LLC

[Guest guest]

Thank you for this clarification, it is indeed a focus group which is

very different from a clinical trial. I have participated in many

other focus groups locally involving consumer products and that

usually involves the consumers discussing among us our experiences. I

think I expected something of that nature with your company, which is

why I posted why we weren't discussing on a daily/weekly basis with

the company our experiences. Given that, I've turned to this group to

discuss my experiences as a group member in order to gain

understanding of how other members' children are reacting to the

SPEAK supplements.

I have several concerns. The first one is that the box indicates

giving 2 capsules 2 to 3 times a day. Most children do not need this

much supplement to start. From what I understand, members here have

gradually introduced one capsule and monitored how much of a surge

their child had before giving anotheer capsule (or a proepa) if their

child plateaued. In addition, upon closer inspection of the box, in

very tiny print, I discovered that the amount of vitamin E was 5,000%

of the recommened daily value for children less than 4 years of age

and 1,665% of the recommneded daily value for children 4 or more

years of age. (for those of you who don't know, DV. A term used on a

food or dietary supplement product label to describe the recommended

levels of intake of a nutrient. The percent Daily Value (% DV)

represents how much of a nutrient is provided in one serving of the

food or dietary supplement. For example, the DV for calcium is 1,000

mg (milligrams); a food that has 200 mg of calcium per serving would

state on the label that the % DV for calcium is 20%).

In addition, vitamin K was listed as +, meaning daily value not

established for children under age 4, and at 2,875% of the

reoommneded daily value for children age 4 or older. At

http://www.iom.edu/Object.File/Master/7/296/0.pdf, the National

Institute of Health has a chart of dietary reference intake for all

ages including children. It is listed in micrograms for vitamin K. If

you look at page 7, at the bottom, it states that " Due to lack of

suitable data, ULs could not be established for vitamin K, thiamin,

riboflavin, vitamin B12, pantothenic acid, biotin, or carotenoids. In

the absence of ULs,

extra caution may be warranted in consuming levels above recommended

intakes. " For children and adults, upper limites were " ND = Not

determinable due to lack of data of adverse effects in this age group

and concern with regard to lack of ability to handle excess amounts.

Source of intake should be from food only to prevent high levels of

intake. "

Upon further research at

http://ods.od.nih.gov/FACTSHEETS/VITAMINE.ASP, and at

http://www.webmd.com/diet/vitamins-supplements-8/supplement-guide-

vitamin-e, I discoverd that the recommened dietary allowance for

children ages 1-3 is 9 i.u. and 10.5 i.u. for ages 4-8. In addition,

NIH list the tolerable upper level limits of vitamin E in children

ages 1-3 as 300 I.U. and 450 I.U. in ages 4-8. Two capsules of SPEAK

contains 500 i.u. and for those giving 6 capsules a day, thats 1,500

i.u. a day!

I also looked up information about vitamin K at

http://www.webmd.com/diet/vitamins-supplements-8/supplement-guide-

vitamin-k

For ages 1-3, 15 MCG (microgram), which is the equalivent of 0.015 MG

(milligram)

and ages 4-6, 20 mcg, the equivalent of 0.02 mg

2 SPEAK capsules has the equivalent of 2.3 MG which is 2300 MCG.

Recommendation for my daughter is 15 MCG and 2 capsules contains 2300

MCG.

As a precaution, please review

http://www.nlm.nih.gov/MEDLINEPLUS/ency/article/002596.htm for an in

depth list of reactions to multiple vitamin overdose. Something you

dismissed as a virus in your child may in fact be a symptom.

My second concern addresses your statement in number 2 and 3.

Your website is designed to lead parents to believe that Dr.

has personally endorsed this product. Dr. may not be

involved in the direct marketing of your product, but you are using

her to market your product. Many parents here trust Dr. and

her expertise and this portrayal on your website is clearly in

conflict of your statement that she is not involved in your company

and its products. The research you listed at

http://www.speechtrial.com/research_publications.aspx list

specifically Dr. , Dr. Agin and

[Guest guest]

Supplements are unregulated in this country, which is both a blessing

and a curse. Mostly a blessing if you ask me considering what the

government has done in the name of safety in the past. Antimony comes

to mind among other things.

Your questions to Pharmomega are great but the bottomline is they can

say whatever they want on the label.

In time it may be found that this supplement can help all our kids

but at different levels depending on whether or not fat malabsorption

or other issues exist.

Anyone who is a member of this board had the benefit of the numerous

posts by Dr. about vitamin E, how RDA is determined for

healthy kids, whether it even applies to our kids, etc.

If you are reading negative info. about vitamin E just make sure it

is the same form of E in the supplement.

Another thing to consider is what diet, accompanying conditions, and

other supplements are being taken by those doing well and those

having issues with this supplement.

>

> Thank you for this clarification, it is indeed a focus group which is

> very different from a clinical trial. I have participated in many

> other focus groups locally involving consumer products and that

> usually involves the consumers discussing among us our experiences. I

> think I expected something of that nature with your company, which is

> why I posted why we weren't discussing on a daily/weekly basis with

> the company our experiences. Given that, I've turned to this group to

> discuss my experiences as a group member in order to gain

> understanding of how other members' children are reacting to the

> SPEAK supplements.

>

> I have several concerns. The first one is that the box indicates

> giving 2 capsules 2 to 3 times a day. Most children do not need this

> much supplement to start. From what I understand, members here have

> gradually introduced one capsule and monitored how much of a surge

> their child had before giving anotheer capsule (or a proepa) if their

> child plateaued. In addition, upon closer inspection of the box, in

> very tiny print, I discovered that the amount of vitamin E was 5,000%

> of the recommened daily value for children less than 4 years of age

> and 1,665% of the recommneded daily value for children 4 or more

> years of age. (for those of you who don't know, DV. A term used on a

> food or dietary supplement product label to describe the recommended

> levels of intake of a nutrient. The percent Daily Value (% DV)

> represents how much of a nutrient is provided in one serving of the

> food or dietary supplement. For example, the DV for calcium is 1,000

> mg (milligrams); a food that has 200 mg of calcium per serving would

> state on the label that the % DV for calcium is 20%).

>

> In addition, vitamin K was listed as +, meaning daily value not

> established for children under age 4, and at 2,875% of the

> reoommneded daily value for children age 4 or older. At

> http://www.iom.edu/Object.File/Master/7/296/0.pdf, the National

> Institute of Health has a chart of dietary reference intake for all

> ages including children. It is listed in micrograms for vitamin K. If

> you look at page 7, at the bottom, it states that " Due to lack of

> suitable data, ULs could not be established for vitamin K, thiamin,

> riboflavin, vitamin B12, pantothenic acid, biotin, or carotenoids. In

> the absence of ULs,

> extra caution may be warranted in consuming levels above recommended

> intakes. " For children and adults, upper limites were " ND = Not

> determinable due to lack of data of adverse effects in this age group

> and concern with regard to lack of ability to handle excess amounts.

> Source of intake should be from food only to prevent high levels of

> intake. "

>

>

> Upon further research at

> http://ods.od.nih.gov/FACTSHEETS/VITAMINE.ASP, and at

> http://www.webmd.com/diet/vitamins-supplements-8/supplement-guide-vitamin-e,

I discoverd that the recommened dietary allowance for

> children ages 1-3 is 9 i.u. and 10.5 i.u. for ages 4-8. In addition,

> NIH list the tolerable upper level limits of vitamin E in children

> ages 1-3 as 300 I.U. and 450 I.U. in ages 4-8. Two capsules of SPEAK

> contains 500 i.u. and for those giving 6 capsules a day, thats 1,500

> i.u. a day!

>

> I also looked up information about vitamin K at

> http://www.webmd.com/diet/vitamins-supplements-8/supplement-guide-vitamin-k

> For ages 1-3, 15 MCG (microgram), which is the equalivent of 0.015 MG

> (milligram)

> and ages 4-6, 20 mcg, the equivalent of 0.02 mg

> 2 SPEAK capsules has the equivalent of 2.3 MG which is 2300 MCG.

> Recommendation for my daughter is 15 MCG and 2 capsules contains 2300

> MCG.

>

> As a precaution, please review

> http://www.nlm.nih.gov/MEDLINEPLUS/ency/article/002596.htm for an in

> depth list of reactions to multiple vitamin overdose. Something you

> dismissed as a virus in your child may in fact be a symptom.

>

>

> My second concern addresses your statement in number 2 and 3.

>

> Your website is designed to lead parents to believe that Dr.

> has personally endorsed this product. Dr. may not be

> involved in the direct marketing of your product, but you are using

> her to market your product. Many parents here trust Dr. and

> her expertise and this portrayal on your website is clearly in

> conflict of your statement that she is not involved in your company

> and its products. The research you listed at

> http://www.speechtrial.com/research_publications.aspx list

> specifically Dr. , Dr. Agin and