At issue | June 26 Chicago Tribune article, "FDA warns Lexington maker of autism pill"
This is just one of several Chicago Tribune articles focusing on criticism of doctors who treat autistic children, raising similar concerns to that of a fringe group called Neurodiversity, which thinks autism should be celebrated instead of treated.
It is critical to be noted that there has been no report of any significant adverse effect for OSR#1. Our legal representation has contacted the Food and Drug Administration and we are working with the agency to resolve its concerns.
CTI Science has never made any medical claim regarding OSR#1; no claims to use OSR#1 to treat autistic children have ever been made. Our Web site was previously approved by legal experts to ensure it was not in violation of FDA regulations.
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What led to the use of OSR#1 by doctors is the fact that autistic children suffer from oxidative stress.
All effective dietary antioxidants could help in this aspect. It appears as if many doctors treating autistic children think OSR#1 is the preferred antioxidant to use in support of their protocols. This is due to OSR#1's outstanding oxygen radical absorbance capacity test scores, which is a measure of effectiveness of antioxidants.
The letter from the FDA might also have been caused by a naming misconception. The chemical name of OSR#1 is N1N3-bis-(2-mercaptoethyl)isophthalamide, which might imply a complex chemical with no natural components.
However, the structure of OSR#1 contains a benzoate group (found in cranberries) and two cystamines (a metabolite of cysteine and found in all meats).
The FDA description of a dietary supplement extracted from their warning letter is: "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."
It is apparent that OSR#1 bears and contains one or more dietary ingredients and is why OSR#1 was submitted over two years ago to the FDA for consideration as a dietary supplement. It might be that the chemical name we placed on the label has confused this issue.
Regarding toxic effects: The diarrhea and pancreatic problems reported occurred during a study to determine what amount of OSR#1 would cause 50 percent of the test animals to die. However, OSR#1-induced death could not be caused at the highest levels given of 5 grams/kg body weight. To reach the highest levels achieved, the OSR#1 (dissolved in corn oil) had to be given daily at three times, and oil is known to induce diarrhea.
When the 28-day toxicity testing was done using a single corn oil dosage to deliver 1 gram OSR#1/kg body weight/day the diarrhea and pancreatic problems did not appear — supporting the concept that the three doses of corn oil might have caused the initial side effects. Even at the highest dosage deliverable, the test animals showed no weight loss or ataxia or other signs of toxicity.
The testers were forcing 1,000 to 5,000 times the recommended level for humans into these animals, trying to kill them — without success. This means that OSR#1 is considerably less toxic than many commonly used supplemental compounds on the market today.
For example, a 220-pound and 110-pound person would have to take 5,000 or 2,500 capsules a day, respectively, to reach the level that may have caused diarrhea.
We recommend 1 capsule a day, which is 5,000 times below the level in this example.
Therefore, any comments implying danger in taking OSR#1 do not reflect a concern I would agree with. We are presenting this in our response to the FDA.