Boyd Haley comments on the FDA warning letter.

30 Jun

Below is a communication attributed to Boyd Haley. He is the president of CTI Science which is marketing “OSR#1”. OSR#1 is a chemical which was originally invented to chelate wastewater from mining operations. Mr. Haley’s company markets it, not for its chelating properties, but as a source of “oxidative stress relief” (OSR). The FDA has recently sent him a warning letter noting that it is likely that OSR is (a) not a supplement and (b) is a drug.

Jaquelyn: 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.

It appears to this reader that Mr. Haley’s defense hinges on the part of the law which defines a supplement as “…or combination of any dietary ingredient from the preceding categories”. In particular, he appears to be claiming that his compound, which is apparently in the same form in a food, is a “combination” of other ingredients.

Mr. Haley can point to the various constituents of the molecule he is producing and marketing and state, “that part is from a food”. But, is that a valid argument? Does the law really intend that “combination” means “mixture” as in, say, a multivitamin?

Here is the full section of the law defining a “supplement”

ff) The term “dietary supplement”—

(1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:

(A) a vitamin;

(B) a mineral;

(C) an herb or other botanical;

(D) an amino acid;

(E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or

(F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E);

(2) means a product that—

(A)(i) is intended for ingestion in a form described in section 411(c)(1)(B)(i); or

(ii) complies with section 411(c)(1)(B)(ii);

(B) is not represented for use as a conventional food or as a sole item of a meal or the diet; and

(C) is labeled as a dietary supplement; and

(3) does—

(A) include an article that is approved as a new drug under section 505 or licensed as a biologic under section 351 of the Public Health Service Act (42 U.S.C. 262) and was, prior to such approval, certification, or license, marketed as a dietary supplement or as a food unless the Secretary has issued a regulation, after notice and comment, finding that the article, when used as or in a dietary supplement under the conditions of use and dosages set forth in the labeling for such dietary supplement, is unlawful under section 402(f); and

(B) not include—

(i) an article that is approved as a new drug under section 505, certified as an antibiotic under section 507 7, or licensed as a biologic under section 351 of the Public Health Service Act (42 U.S.C. 262), or

(ii) an article authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, which was not before such approval, certification, licensing, or authorization marketed as a dietary supplement or as a food unless the Secretary, in the Secretary’s discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this Act.

Except for purposes of section 201(g), a dietary supplement shall be deemed to be a food within the meaning of this Act.

I’m trying to find some sort of case-law that would help define the word “combination” here. But I feel that Mr. Haley’s interpretation is not likely to hold.

Mr Haley has in the past described OSR#1 as “totally without toxicity”. Now, “Even then the test animals showed no weight loss or ataxia or other signs of toxicity except diarrhea and a pancreas abnormality. ” Yes, those animals were given massive doses. But, once again, it comes down to definition of words. Is Mr. Haley using the word “totally” appropriately? Is OSR#1 “totally” without toxicity?

8 Responses to “Boyd Haley comments on the FDA warning letter.”

  1. brian June 30, 2010 at 20:00 #

    Haley’s response is quite funny.

    I particularly liked his suggestion that those rubes at FDA can’t understand a pesky chemical formula. (“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.”) I suppose that the chemists that I’ve interacted with at the agency would find this amusing, as well.

    If FDA accepted Haley’s argument to the effect that a compound can be marketed as a dietary supplement if it contains carbon, hydrogen, oxygen, or nitrogen, I might have avoided expending years of effort and many millions of dollars for safety studies and clinical trials to demonstrate to the agency that the drugs that I’ve worked on are, in fact, safe for appropriate use—but apparently those yokels in Silver Spring just don’t get it. Now, of course, some might say that Haley’s argument should not apply to vaccines, which (although they contain natural proteins and nucleic acids composed of the same constituents as everyday foods) should instead be rigorously scrutinized and tested in every possible combination—but sprinkling untested industrial chemicals on a child’s breakfast cereal seems to be OK with the AoA crowd.

  2. Broken Link July 1, 2010 at 14:28 #

    Strangely enough, his argument isn’t very logical (snark)

    He claims his compound contains “two cystamines”. Well, no. BDETH2 (otherwise known as OSR#1) has only two S atoms, not attached to each other. Cystamine has two S atoms connected together. According to Wikipedia:

    Cystamine is an organic disulfide. It is formed when cystine is heated, the result of decarboxylation. Cystamine is an unstable liquid and is generally handled as the dihydrochloride salt, C4H12N2S2·2HCl, which is stable to 203-214 °C at which point it decomposes. Cystamine is toxic if swallowed or inhaled and potentially harmful by contact.

    I think Haley means cysteamine

    Cysteamine is the chemical compound with the formula HSCH2CH2NH2. It is the simplest stable aminothiol and a degradation product of the amino acid cysteine. It is often used as the hydrochloride salt, HSCH2CH2NH3Cl (CAS#[156-57-0])

    cysteamine, otherwise known as 2-aminoethanethiol is “Harmful if swallowed. Skin, eye and respiratory irritant.”

    I don’t think he’s doing himself much good with these arguments – and that’s even leaving aside the fact that it’s nonsensical to state that a new chemical compound is a simple combination of the properties and toxicity of the two or more compounds that were the reactants.

  3. Calli Arcale July 6, 2010 at 21:12 #

    Brian:

    Now, of course, some might say that Haley’s argument should not apply to vaccines, which (although they contain natural proteins and nucleic acids composed of the same constituents as everyday foods) should instead be rigorously scrutinized and tested in every possible combination—but sprinkling untested industrial chemicals on a child’s breakfast cereal seems to be OK with the AoA crowd.

    More directly, his logic could be used to argue that thimerosal is a dietary supplement. After all, it is a form of ethyl mercury, and ethyl groups are frequently found in wholesome plant and animal foods!

  4. brian July 6, 2010 at 21:22 #

    More directly, his logic could be used to argue that thimerosal is a dietary supplement. After all, it is a form of ethyl mercury, and ethyl groups are frequently found in wholesome plant and animal foods!

    Indeed, Calli, and thiol groups like that in thimerosal are present in foods–and mercury is a well-known ingredient in wholesome foods such as tuna.

  5. Moloch July 9, 2010 at 02:43 #

    [quote]…to determine the LD-50 of OSR, that is “what amount of OSR would cause 50% of the test animals to die?”…[quote]

    Thanks, Captain Obvious. Because the FDA really needed help on that.

    Being in chemistry, shouldn’t he know that when you combine two different reactants/groups, you can get something completely different from the properties of both? It does not matter if it is made from things found in other lifeforms, because the combination of them might cause something nothing like what those compounds do. There is a benzoate ring in cocaine too! The man could have picked anything he wanted as an example. Why is he still in a university? I am so ashamed about our public education system…

  6. Broken Link July 9, 2010 at 13:38 #

    Moloch,

    I’m certain that he knows that his stance is nonsense. His purpose is to reassure the parents using this drug – and so he’s written something that sounds “sciencey” and has some “truthiness”. I think he doesn’t really expect to convince the FDA.

    I wouldn’t be surprised if he continues to sell OSR#1 even after he’s ordered to stop doing so. He has had 2 years to promote this freely – his customers are likely to continue to buy it under the table for some time to come. IMO, that’s the group he’s speaking to with this letter.

  7. speciallyforu57 September 24, 2010 at 16:05 #

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