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.
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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.
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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.Â
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 below the LD-50 of some commonly used supplemental
compounds used today.Â
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.
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Also, OSR has never been promoted by CTI Science as a treatment for any specific
disease and FDA disclaimers are on every package.
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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. Â 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.Â
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.
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Boyd E. Haley, PhD
