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Remember the fake supplement OSR #1? It’s still being developed

5 Apr

A few years ago a fake supplement was marketed to autism parents for use on their children. The “supplement” was called “OSR #1”, OSR for “oxidative stress releif” or something to that effect. The name was a bit of a dodge, just as packaging it as a supplement rather than a drug was a dodge. It was/is a chelator. The chemical used–a novel synthetic chemical–was developed for use in environmental heavy metal polution.

This is obvious but worth noting: one can not “supplement” one’s intake of a chemical that humans have never been exposed to before.

If you remember OSR #1, you probably remember that the drug was pulled from the market. But you may be surprised to hear that it may be about to resurface.

The FDA found out that this chelator, this drug, was being sold as a supplement (which avoids thorough tests for safety and efficacy). The FDA sent the Boyd Haley, whose company was selling the “supplement” a warning letter that made it very clear:

The claims listed above make clear that OSR#1 is intended to affect the structure or any function of the body of man or other animals. Accordingly, OSR#l is a drug under section 201(g)(1) of the Act, 21 U.S.C. § 321(g)(1). Disclaimers on your website, such as “OSR#l® is not a drug and no claim is made by CTI Science that OSR#1® can diagnose, treat or cure any illness or disease,” do not alter the fact that the above claims cause your product to be a drug.

Moreover, this product is a new drug, as defined by section 201(p) of the Act, 21 U.S.C. § 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. Under sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of OSR#1 without an approved application violates these provisions of the Act.

emphasis added.

Even as a supplement, OSR#1 appeared to be mislabled. Customers were not fully informed of potential side effects, per the FDA letter:

Your website states that” [s]ome reports of temporary diarrhea, constipation, minor headaches have been reported but these are rare and the actual causes are unknown,” as well as “OSR#1 is without detectable toxicity” and “OSR#1® … has not exhibited any detectable toxic effects even at exceptionally high exposure levels.” However, animal studies that you conducted found various side effects to be associated with OSR#1 use, including, but not limited to, soiling of the anogenital area, alopecia on the lower trunk, back and legs, a dark substance on lower trunk and anogenital area, abnormalities of the pancreas, and lymphoid hyperplasia. Based on these animal studies and side effects known to be associated with chelating products that have a similar mechanism of action to OSR#1, we believe the use of your product has the potential to cause side effects, and the before-mentioned website statements falsely assert that the product does not have the potential to cause side effects. Therefore, these statements render your product’s labeling false or misleading. As such, OSR#1 is misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a).

Mr. Haley’s company reportedly sold about $1.5M of OSR#1 as a supplement from his company CTI Science. I saw reports that OSR#1 was selling for about $2/pill so that’s maybe 750,000 pills. That’s a lot for somethiing untested for safety or efficacy. CTI appears to be a shortened version of the original name of the company: Chelator Technologies, Inc.. Chelators are drugs, not supplements.

All this said, CTI Science doesn’t appear to exist any more. If you go to the old website, www.ctiscience.com, you get directed to a non operating website, http://ermesmedical.com/?reqp=1&reqr=.

But obviously I haven’t written all this to say that CTI Science doesn’t exist. It’s not ermesmedical (as their link would suggest), it’s EmeraMed. No idea why they have this confusion over ermesmedical/emeremed. That said, Emeramed describes themselves as:

EmeraMed Limited is a biotechnology firm developing the antidote – heavy metal chelator and antioxidant – Irminix® (Emeramide). The Company is working to obtain marketing authorization in the EU and the US for the treatment of mercury toxicity. Phase 1 and Phase 2a clinical studies have been performed.

They have offices in Ireland, Swedend and the US (Kentucky–home of Boyd Haley). But no mention on the website about who is involved with the company, which I find rather odd. They note that the drug is not yet approved, but that they may be able to supply it to people under an “early access program”. Yes, why wait for actual approval and confirmation of safety and efficacy. This would be for use as a chelator–no mention of work as an autism treatment. There never was a good reason to use this for autism. Boyd Haley was long a proponent that autism is a form of mercury poisoning. Put simply, Boyd Haley was wrong. Very clearly wrong.

Mr. Haley and others may not be named on their website, but on SEC documents, he is named as part of Ermes Medical. If I read this document correctly, they have raised over $3.5M for the company.

As noted in their literature, they have been involved with clinical trials. For mercury poisoning. In Ecuador. No small irony there: many of Mr. Haley’s supporters complain that “big pharma” performs their clinical trials (or experiments, as his supporters would characterize them) in developing countries.

They are still pursuing patents for the treatment neurological disorders. No trial that I have found. Likewise for evidence of efficacy in humans. But a patent application.

A similar patent for treatment of COPD.

Should OSR#1 (under whatever new name) be approved for chelation, we can expect that it will return to the fake autism treatment world. Many still subscribe to the failed idea that autism is caused by mercury poisoning. That idea, pushed by Mr. Haley and others, was based largely on the idea that as mercury exposure from infant vaccines increased, so did the rate of identified autism. Biologically the idea was clearly wrong (autism and mercury poisoning are not similar). Also, even though mercury was removed from infant vaccines, autism rates have not fallen.

All that clear logic said, there still are people who chelate as an “autism treatment” and a new product will almost certainly cause a spike in the numbers trying chelation.

So, yeah, OSR#1 is gone. Except it may return soon under a new name. And likely a higher price tag. And it still won’t be a real treatment for autism.


Matt Carey

Adverse reaction data for alternative therapies for autism?

21 Sep

Edit–Note that ARI has changed their webpage language:

One factor of alternative medicine is that it is impossible to make an informed decision on risks and benefits. Without data on either, all one has is anecdotes. This is especially troublesome, to me at least, when it comes to risks. What are the adverse events associated with a given alternative medicine treatment? This became clear when an industrial chelator was offered as a “supplement” and the proprietor of that business was quoted as telling his clients to report adverse reactions to him, avoiding the FDA.

The Autism Research Institute (ARI) has promoted alternative therapies for autism for some time, even maintaining a list of therapies with survey results claiming high effectiveness. They also maintain a page on adverse reactions. But without any emphasis on informing people about adverse reactions to alternative therapies.

Here is a quote from that page:

Unfortunately, before the drugs are prescribed to their children, parents are not usually informed of the possible dangers related to the drugs. ARI urges all practitioners to inform their clients about the possible adverse effects associated with every treatment or medication that they recommend to their clients.

Many individuals on the spectrum suffer from seizures, and most of the drugs commonly prescribed to these individuals may lower the threshold for having seizures. We have also listed those drugs that are associated with seizures along with a link.

If your son/daughter experiences side effects from receiving prescribed medications, please contact the FDA at: http://www.fda.gov/medwatch or call 1.800.FDA.1088 (1.800.332.1088).

In addition, parents can learn more about possible side effects, as well as benefits, associated with various treatments by reviewing the results from our parent treatment survey. The survey findings are based on over 26,000 responses, and include a large number of biomedical interventions, including drugs, nutritional supplements, and diet.

One is given the information about how to report a reaction from “prescribed medications”, but not for alternative therapies or supplements. Or so they present it. The page they link to isn’t the direct reporting site. Instead, one must follow a link on that page to https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm. There you are informed that you may “Click the BEGIN button to report serious adverse events for human medical products, including potential and actual product use errors and product quality problems associated with the use of:”

FDA-regulated drugs,
biologics (including human cells, tissues, and cellular and tissue-based products)
medical devices (including in vitro diagnostics)
special nutritional products and cosmetics

emphasis added.

So, the same site where ARI sends people to report “side effects from receiving prescribed medications” can be used (and should be used) to report side effects from alternative therapies which are not prescribed. But parents are not encouraged to make such reports. Which, again, limits the public’s ability to estimate the risks involved with these therapies.

On the ARI page are links to adverse reactions (both ARI’s own discussions as well as links to external sites which publish accepted adverse reaction information) for various therapies. Will you learn about the “occasionally severe” skin reactions that occur with the chelator DMSA? No. Deaths from IV chelation? No. Will you hear about the autistic child who was a test case for the Autism Omnibus Proceeding who appeared to have significant adverse reactions to chelation? No. No one in the public would have heard about that were it not for the Omnibus.

ARI makes a major distinction between “Drugs” and “Biomedical/Non-Drug/Supplements” as therapies. Is this a valid distinction? ARI lists “Transfer Factor” as one of their “BIOMEDICAL/NON-DRUG/SUPPLEMENTS”, claiming that autistics “got better” 5.9 times more often than they “got worse”. But no data on what adverse reactions there are. No links. “Transfer Factor” is not a drug to ARI. It is worth noting that it was a drug to Andrew Wakefield. He attempted to patent Transfer Factor as a therapy and as an alternative to the standard measles vaccine.

The question of whether alternative therapies are presented such that one can make an informed decision is an important one. Raising the question is generally guaranteed to garner the reaction: “he’s anti-cure”, or “he’s against treating autism” or the like. But clearly the argument here is simple: are people being given the ability to make an informed decision about alternative medical treatments used for autism? The answer is simple as well: no. They are not.


By Matt Carey

OSR pulled from the market….or is it?

3 Aug

Here on LeftBrainRightBrain we recently discussed a letter from Boyd Haley, Ph.D. announcing his decision to voluntarily remove his product, OSR #1 from the market. The letter from Mr. Haley stated (in part):

The product will not be available for sale after that date until new drug approval has been obtained. Please continue to access our website, http://www.ctiscience.com , for updates on OSR#1® in the future.

The CTI website is down, and has been for a few days. The message I get when try it is:

HTTP Status 404 –

type Status report

message

description The requested resource () is not available.

Two locations I checked are still selling OSR.

The Forrest Health site has the letter from Mr. Haley noting that he has pulled the product from the market. They not only let you buy it, but they require that you purchase 3 or more “Note: you must order at least 3 items”.

Living Well International has OSR on their site as well. In response to my email, they response to my email request, “Do you still have OSR#1 for sale?”, they responded “Yes we do. It is $60 for a box of 30”

I do wonder how long before someone decides to make his or her own batch of OSR. Mr. Haley has been quoted as stating it was not difficult. The published recipe for the chemical indicates a few potential concerns. First, the chemicals are themselves not without hazards.

Triethylamine

Liquid causes first degree burns on short exposure; [CHRIS] Corrosive to skin; [Quick CPC] Short-term exposure at high concentrations may cause pulmonary edema. [ICSC] A lachrymator; [CHEMINFO] Experimental animals exposed repeatedly to 100 ppm show evidence of liver, kidney, lung, and heart damage. [HSDB] A corrosive substance that can cause pulmonary edema; [ICSC]

Chloroform has relatively high LD50 values (the amount where 50% of exposed animals die). But the MSDS lists reproductive toxicity as:

Birth defects have been seen in rats and mice exposed by inhalation of chloroform at concentrations greater than 100 ppm in air. Ingestion of chloroform by pregnant laboratory animals has resulted in fetotoxicity but not birth defects, and only at levels causing severe maternal effects.

Isophthaloyl chloride is only listed as an eye/skin irritant. I won’t go down the list of all the chemicals. I think you get the idea. It is likely that a competent chemist with a reasonable laboratory (including a fume hood and access to nitrogen gas) could produce “bathtub OSR” reasonably safely. I frankly cringe at the thought of someone attempting this at home. I will add, the yield of the published process for producing this chemical is about 72% without optimization. This begs the question to me as to how clean the product is in this form.

OSR to be pulled from the market?

22 Jul

OSR #1, a chemical invented as a chelator and now marketed as a dietary supplement, will be pulled from the market in about 1 week’s time if the message below attributed to Boyd Haley is accurate:

On 18 June 2010, the FDA wrote to CTI Science questioning whether OSR#1® fit within the agency’s definition of a dietary supplement, indicating that instead it appeared to be a drug. Although we believe the product meets the legal definition of a “dietary supplement,” we have decided not to contest this point but to work with the agency. While achieving formal drug approval is lengthy and costly, CTI Science will in the course of it prove to FDA’s satisfaction the safety and efficacy of OSR#1® and ultimately be able to offer OSR#1® to the public with FDA-authorized therapeutic claims.

As a result of this decision, *CTI Science has voluntarily agreed to remove OSR#1® from the market effective Thursday, 29 July 2010*. The product will not be available for sale after that date until new drug approval has been obtained. Please continue to access our website, http://www.ctiscience.com , for updates on OSR#1® in the future.

On a personal note, I have met most of the medical professionals we deal with, and your passion and dedication to excellence are rarely seen these days. It has been an honor to work with you, and I am deeply appreciative of the support you have shown in the past. Please accept my best wishes for your continued success. I look forward to working with you in the future again with OSR#1®.

Boyd E. Haley, PhD

President
CTI Science-Color-EM
CTI Science, Inc.

The Twitter account for CTI science has the following message posted earlier today which would suggest the above message is accurate:

Registered Medical Professionals: Please review your email for an important message about the future availability of OSR#1®. http://www.OSR1.com

I will say that I welcome this move. I agree with the FDA that OSR #1 is not a dietary supplement and, as such, should undergo much more rigorous safety testing before being marketed.

OSR: The Littlest Consumers and other posts from Neurodiversity.com

14 Jul

There has been much discussion here and elsewhere on the net about OSR #1, the chelation chemical sold as “oxidative stress relief” supplement. The latest round of this was sparked by a story in the Chicago Tribune, FDA warns maker of product used as alternative autism treatment.

Much of the early investigation of OSR #1, it’s origins as an industrial chelator and so on, were done by Kathleen Seidel of Neurodiversity.com. Ms. Siedel is probably the most thorough blogger (or writer of any kind) I know of. Her posts are long and detailed and well referenced.

Her recent post, OSR: The Littlest Consumer, takes on the subject of internet reports of OSR being given to small children. The website for OSR (CTI Science) states, OSR#1TM is not recommended for children under 55 pounds or under 4 years of age.”

And, yet, OSR appears to be being given to small children. Also, if the internet reports are accurate, this occurs sometimes under the advice of DAN doctors.

People interested in a thorough discussion of OSR can reference previous articles by Ms. Seidel include:

Haley’s Chelator: For Cats Or For Kids? (April 26, 2008)
A Fine White Powder (August 1, 2008)
The Industrial Treatment (August 8, 2008)
An Inquiry Emerges (August 14, 2008)
FDA To Haley: OSR#1 A Misbranded, Mislabeled, Unsafe Drug (June 24, 2010)
OSR: Fuel For Thought (July 7, 2010)
OSR: A Bevy Of Adverse Events (July 12, 2010)

Boyd Haley discusses OSR #1 in the Lexington Harald-Leader

12 Jul

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.

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?