Boyd Haley letter about OSR

[Guest guest]

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]

this so serious,and they re trying enforce h1n1----- Forwarded Message ----From: Sheri Nakken <vaccinedangers@...>Sent: Tue, June 29, 2010 5:08:03 PMSubject: Boyd Haley letter about OSR

Fwd: from Binstock

>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?â€. 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.

..

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