As noted here on LeftBrainRightBrain, OSR #1 is currently under scrutiny by the FDA. Our post followed a report by the Chicago Tribune, FDA warns maker of product used as alternative autism treatment.
OSR stands for Oxidative Stress Relief. It is a chemical invented at the University of Kentucky for chelating soil from mining operations. It was originally discussed at autism parent conferences as a chelator, but the focus has changed to “oxidative stress relief” over time. It has not been marketed, to my knowledge, by CTI Science for its chelator properties.
Today, Mr. Boyd Haley, who has been marketing OSR #1 through his company CTI Science, has made a public statement as an Op-Ed piece in his local newspaper, the Lexington Harold-Leader:
Dietary supplement safe for right use
chemical name might be confusing; toxic effects low
First, I note that previous statements have indicated that OSR is “totally” without toxicity. Now the statement is “toxic effects low”.
Mr. Haley starts his piece on the offensive:
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.
He then defends his product:
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.
Mr. Haley is apparently unaware of the potential adverse effects reported on internet forums for his product. Kathleen Seidel of neurodiversity.com has a piece up OSR: A Bevy Of Adverse Events today which may be enlightening.
Mr. Haley notes that his company has made no medical claims about the efficacy of OSR. He then offers a statement about the compound he is marketing:
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.
I don’t think it is the chemical name which has confused the issue. But maybe that is just me. When I read the patent that the University of Kentucky (Mr. Haley’s former institution) has licensed for use as OSR, I read this:
Multidentate sulfur-containing ligands, patent 6,586,600
Which states that (a) the compound is “novel” and (b) it has the function of a chelator.
Novel sulfur-containing ligands for binding of heavy metals are disclosed. The ligands incorporate a central ring structure and pendant alkyl-thiol chains. The ligands are of the general structure: ##STR1##where n is an integer from 1-4, and X is selected from the group consisting of hydrogen, lithium, sodium, potassium, rubidium, cesium, and francium. The ligands of the present invention are suitable for binding any metal in or capable of being placed in a positive oxidation state, such as cadmium, lead, nickel, zinc, mercury, copper, and the like. Additionally, methods for removal of heavy metals from various substances are disclosed, comprising separating selected heavy metals from selected substances by contacting the substances with an effective amount of the novel sulfur-containing chelate ligands for a sufficient time to form stable, irreversible ligand-metal precipitates, and removing such precipitates.
In one of the Chicago Tribune pieces on OSR #1 a pharmacologist was quoted:
The company that makes the supplement, CTI Science, describes it as an antioxidant. But pharmacologist Dr. Arthur Grollman, director of the Laboratory for Chemical Biology at State University of New York at Stony Brook, said it is obvious from the product’s chemical structure that it is also a “powerful chelator,” a compound that binds to heavy metals such as mercury.
I will await the FDA’s review of whether a “novel” compound “might imply a complex chemical with no natural components”. Also, I will await whether under the law one can state that because a chemical has subgroups found in foods, it is a “combination of dietary ingredients”. It strikes this reader as unlikely that the FDA will agree with Mr. Haley’s position, however.
Consider this–take vitamin C powder and Vitamin D powder. Mix them up in whatever ratio you want. Put it in a pill. This is a combination of vitamins C and D. However, the molecules in the mixture exist in original form and can be considered to act in the body in their expected manners. The pill will work as vitamin C and vitamin D.
Now consider OSR #1. Assume that the molecule can be described as segments of various chemicals found in foods. However, the resultant molecule is “novel”, i.e. not found or synthesized previously. The resulting molecule will act in the body in a different manner than the sub-units.
Another way to look at this–if a person were to eat cranberries and meats (which contain the subunits of OSR #1 according to Mr. Haley), would one get the same results in the body? Is OSR “supplementing” the benzoate groups (found in cranberries) and two cystamines one would get from one’s diet?
Is OSR #1 safe or toxic? I don’t think the data are available to answer that question. And that presents a big question here: has sufficient study been performed? Is it appropriate to market this compound as a “supplement”? That will go a long way towards determining whether there is sufficient safety data. The FDA warning letter claimed that OSR #1 is not a supplement but a drug.