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