Guest guest Posted June 30, 2010 Report Share Posted June 30, 2010 Thanks Heidi. I saw it in another group, good info about the product. Sasmita > > I am not advocating OSR is good or bad, since I have not used it nor looked into it much. But, here is a post I found today that talks about the specific ingredients. > > Love and prayers, > > Heidi N > > > 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. > Quote Link to comment Share on other sites More sharing options...
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