Re: Boyd Haley letter about OSR

[Guest guest]

Andy advises against OSR. It is a chelator without a known or published

half-life, so it can't be dosed properly.

TJ

________________________________

From: Binstock <binstock@...>

Sent: Tue, June 29, 2010 3:24:18 PM

Subject: [ ] Boyd Haley letter about OSR

Fwd:

>From Boyd re OSR#1 to Chicago Tribune

Below is my response to the Chicago Trib article. We have also had our

legal help contact the FDA and explain our position. They have extended

our time to respond in detail until the end of July and implied that

they are willing to work with us on this issue.

The article by the Chicago Tribune and the warning letter from the FDA

are fueled by a misconception. The chemical name of OSR#1 is

N1N3-bis-(2-mercaptoethyl)isophthalamide which makes it sound to many

like an exceptionally complex chemical with no natural components.

However, looking at the structure of OSR it is easily seen that it

contains a benzoate group (found in cranberries) and two cystamines (a

metabolite of cysteine and found in all mammalian cells and on the

terminal end of Coenzyme-A). The coupling of cystamine to benzoate is

through the same type of amide linkage found in connecting amino acids

to produce protein.

The FDA description of a dietary supplement as extracted from their

letter is: To be a dietary supplement, a product must, among other

things, " bear [ ] or contain [ ] one or more...dietary ingredients " as

defined in section 20 I (11)( I) of the Act, 21 U.S.c.§ 321 (ff)( I).

Section 20 1(11)( 1) or the Act defines " dietary ingredient " as a

vitamin, mineral, amino acid, herb or other botanical, or dietary

substance for use by man to supplement the diet by increasing the total

dietary intake. or a concentrate, metabolite, constituent, extract or

combination of any dietary ingredient from the preceding categories.

Using this description it is obvious to a biochemist that OSR#1 bears

and contains two dietary ingredients. It appears as if the chemical

name (which we had to place on the label) has confused this issue.

Hopefully this can be cleared up.

Regarding the toxic effects the FDA and Chicago Tribune comment on. The

diarrhea and pancreas problems reported occurred during an UP/DOWN study

to determine the LD-50 of OSR, that is " what amount of OSR would cause

50% of the test animals to die? " . Problem was that during the

experimentation, even to reach the 5 grams/kg body weight they finally

achieved, the researchers had to give the OSR (dissolved in corn oil) at

three different times during the day. Even then the test animals showed

no weight loss or ataxia or other signs of toxicity except diarrhea and

a pancreas abnormality. They were giving these animals massive doses

(e.g. 1,000 to 5,000 times the recommended level for humans) trying to

kill them. Almost all supplemental materials would cause some problems

at these levels and the LD-50 of OSR (decided to be greater than 5 g/kg)

is considerably above the LD-50 of some commonly used supplemental

compounds used today.

For example, a 220 lb (100 kg) person would have to take 500 grams/day

or 5,000 OSR capsules/day to reach the 5 g/kg body weight level. We

recommend 1 capsule or 0.1 gram/day level usage (i.e. 100mg) which is

5,000 times below the 5 gram/kg level in this example. When the long

term study was done and the maximum amount tested was 1 gram/kg body

weight the diarrhea and pancreas issues disappeared. At 1 gram/kg a 220

lb person would have to take 1,000 capsules/day to reach a level where

no toxic effects were noted. In it's initial letter responding to our

Premarket Notification the FDA did not mention these test animal

toxicity studies as being of any concern. I don't know what changed

their minds to make them go back and review this, but their review and

the comments in this recent letter do not reflect a concern I would

agree with.

Also, OSR has never been promoted by CTI Science as a treatment for any

specific disease and FDA disclaimers are on every package.

I would point out that the FDA warning letter was not based on any

reported adverse effect. Since CTI Science has been selling OSR (about

2 years) we have not had one severe adverse effect reported to our FDA

based adverse effect reporting system. We have had many very positive

responses from physicians and parents regarding the use of OSR.

However, the fact is that I have to obey the FDA directive or risk

damage to my co-workers as well as myself, and/or spend the funds to

legally counter the FDA decision. What to do is under study. But from

the above, you can see why I strongly believe that OSR is a dietary

supplement by FDA criteria and that it is without detectable toxicity at

the levels recommended.

Boyd E. Haley, PhD

Professor Emeritus

University of Kentucky

Chemistry Department

Boyd E. Haley, PhD

President

CTI Science, Inc.

..

[Guest guest]

>

> Andy advises against OSR. It is a chelator without a known or published

half-life, so it can't be dosed properly.

> TJ

And with many other issues.

However, despite some technical disagreements with Dr. Haley I do not wish him

ill and do not wish the FDA to do its usual thing and not let people decide what

to take for themselves.

However, the law is on the FDA's side and they are enforcing it, which is their

job.

>

> Fwd:

>

> >From Boyd re OSR#1 to Chicago Tribune

> The FDA have extended

> our time to respond in detail until the end of July and implied that

> they are willing to work with us on this issue.

Good. I wish him the best of luck.

>looking at the structure of OSR it is easily seen that it

> contains a benzoate group (found in cranberries) and two cystamines (a

> metabolite of cysteine and found in all mammalian cells and on the

> terminal end of Coenzyme-A). The coupling of cystamine to benzoate is

> through the same type of amide linkage found in connecting amino acids

> to produce protein.

>

> The FDA description of a dietary supplement as extracted from their

> letter is: To be a dietary supplement, a product must, among other

> things, " bear [ ] or contain [ ] one or more...dietary ingredients " as

> defined in section 20 I (11)( I) of the Act, 21 U.S.c.§ 321 (ff)( I).

> Section 20 1(11)( 1) or the Act defines " dietary ingredient " as a

> vitamin, mineral, amino acid, herb or other botanical, or dietary

> substance for use by man to supplement the diet by increasing the total

> dietary intake. or a concentrate, metabolite, constituent, extract or

> combination of any dietary ingredient from the preceding categories.

> Using this description it is obvious to a biochemist that OSR#1 bears

> and contains two dietary ingredients.

Ummmmm.....

I will be very surprised if this is legally operative. I would naively think

the law applies to mixtures, not chemical combinations.

However, I am sure the law is well defined and I wish Dr. Haley the best in his

negotiations with the FDA.

Andy

http://www.noamalgam.com/index.html

Amalgam Illness: Diagnosis and Treatment

http://www.noamalgam.com/hairtestbook.html

Hair Test Interpretation: Finding Hidden Toxicities

http://www.noamalgam.com/nourishinghope.html

Nourishing Hope for Autism: Nutrition Intervention for Healing Our Children

http://www.noamalgam.com/biologicaltreatments.html

Biological Treatments for Autism and PDD

[Guest guest]

I don't care much about OSR #1 in particular.

However, I am concerned that FDA is going overdrive on dietary supplements (many

of them are safe) while allowing proven harmful drugs like Avandia. Furthermore,

what can we do if FDA make ALA also a drug?

regards,

Ragha

> >

> > Andy advises against OSR. It is a chelator without a known or published

half-life, so it can't be dosed properly.

> > TJ

>

> And with many other issues.

>

> However, despite some technical disagreements with Dr. Haley I do not wish him

ill and do not wish the FDA to do its usual thing and not let people decide what

to take for themselves.

>

> However, the law is on the FDA's side and they are enforcing it, which is

their job.

>

> >

> > Fwd:

> >

> > >From Boyd re OSR#1 to Chicago Tribune

> > The FDA have extended

> > our time to respond in detail until the end of July and implied that

> > they are willing to work with us on this issue.

>

> Good. I wish him the best of luck.

>

> >looking at the structure of OSR it is easily seen that it

> > contains a benzoate group (found in cranberries) and two cystamines (a

> > metabolite of cysteine and found in all mammalian cells and on the

> > terminal end of Coenzyme-A). The coupling of cystamine to benzoate is

> > through the same type of amide linkage found in connecting amino acids

> > to produce protein.

> >

> > The FDA description of a dietary supplement as extracted from their

> > letter is: To be a dietary supplement, a product must, among other

> > things, " bear [ ] or contain [ ] one or more...dietary ingredients " as

> > defined in section 20 I (11)( I) of the Act, 21 U.S.c.§ 321 (ff)( I).

> > Section 20 1(11)( 1) or the Act defines " dietary ingredient " as a

> > vitamin, mineral, amino acid, herb or other botanical, or dietary

> > substance for use by man to supplement the diet by increasing the total

> > dietary intake. or a concentrate, metabolite, constituent, extract or

> > combination of any dietary ingredient from the preceding categories.

> > Using this description it is obvious to a biochemist that OSR#1 bears

> > and contains two dietary ingredients.

>

>

>

> Ummmmm.....

>

> I will be very surprised if this is legally operative. I would naively think

the law applies to mixtures, not chemical combinations.

>

> However, I am sure the law is well defined and I wish Dr. Haley the best in

his negotiations with the FDA.

>

> Andy

>

> http://www.noamalgam.com/index.html

> Amalgam Illness: Diagnosis and Treatment

>

> http://www.noamalgam.com/hairtestbook.html

> Hair Test Interpretation: Finding Hidden Toxicities

>

> http://www.noamalgam.com/nourishinghope.html

> Nourishing Hope for Autism: Nutrition Intervention for Healing Our Children

>

> http://www.noamalgam.com/biologicaltreatments.html

> Biological Treatments for Autism and PDD

>

[Guest guest]

My sentiments exactly.  Like someone very wise once said, " Why worry about the

speck in your neighbors eye and miss the log in your own? "   Case in point: 

FDA

nancy j

a child is diagnosed with

asd every 20 seconds

From: truthwinsnow <raghavendrapb@...>

Subject: [ ] Re: Boyd Haley letter about OSR

Date: Tuesday, July 6, 2010, 11:41 AM

 

I don't care much about OSR #1 in particular.

However, I am concerned that FDA is going overdrive on dietary supplements (many

of them are safe) while allowing proven harmful drugs like Avandia. Furthermore,

what can we do if FDA make ALA also a drug?

regards,

Ragha

> >

> > Andy advises against OSR. It is a chelator without a known or published

half-life, so it can't be dosed properly.

> > TJ

>

> And with many other issues.

>

> However, despite some technical disagreements with Dr. Haley I do not wish him

ill and do not wish the FDA to do its usual thing and not let people decide what

to take for themselves.

>

> However, the law is on the FDA's side and they are enforcing it, which is

their job.

>

> >

> > Fwd:

> >

> > >From Boyd re OSR#1 to Chicago Tribune

> > The FDA have extended

> > our time to respond in detail until the end of July and implied that

> > they are willing to work with us on this issue.

>

> Good. I wish him the best of luck.

>

> >looking at the structure of OSR it is easily seen that it

> > contains a benzoate group (found in cranberries) and two cystamines (a

> > metabolite of cysteine and found in all mammalian cells and on the

> > terminal end of Coenzyme-A). The coupling of cystamine to benzoate is

> > through the same type of amide linkage found in connecting amino acids

> > to produce protein.

> >

> > The FDA description of a dietary supplement as extracted from their

> > letter is: To be a dietary supplement, a product must, among other

> > things, " bear [ ] or contain [ ] one or more...dietary ingredients " as

> > defined in section 20 I (11)( I) of the Act, 21 U.S.c.§ 321 (ff)( I).

> > Section 20 1(11)( 1) or the Act defines " dietary ingredient " as a

> > vitamin, mineral, amino acid, herb or other botanical, or dietary

> > substance for use by man to supplement the diet by increasing the total

> > dietary intake. or a concentrate, metabolite, constituent, extract or

> > combination of any dietary ingredient from the preceding categories.

> > Using this description it is obvious to a biochemist that OSR#1 bears

> > and contains two dietary ingredients.

>

>

>

> Ummmmm.....

>

> I will be very surprised if this is legally operative. I would naively think

the law applies to mixtures, not chemical combinations.

>

> However, I am sure the law is well defined and I wish Dr. Haley the best in

his negotiations with the FDA.

>

> Andy

>

> http://www.noamalgam.com/index.html

> Amalgam Illness: Diagnosis and Treatment

>

> http://www.noamalgam.com/hairtestbook.html

> Hair Test Interpretation: Finding Hidden Toxicities

>

> http://www.noamalgam.com/nourishinghope.html

> Nourishing Hope for Autism: Nutrition Intervention for Healing Our Children

>

> http://www.noamalgam.com/biologicaltreatments.html

> Biological Treatments for Autism and PDD

>