FDA warns maker of OSR #1, dietary supplement for autistic children is a “toxic” “drug”

24 Jun

“OSR#1 is not a dietary supplement but a toxic, unapproved drug with serious potential side effects, FDA warns”. So starts a recent article in the Chicago Tribune, FDA warns maker of product used as alternative autism treatment.

The article is by Trine Tsuderos who has previously reported on the the industrial chelator turned dietary supplement in Industrial chemical OSR#1 used as autism treatment.

According to the website for the product, “OSR#1® is a toxicity free, lipid soluble antioxidant dietary supplement that helps maintain a healthy glutathione level”. According to the story in the Tribune, the claim of “toxicity free” may not be accurate. According to the Tribune story:

The FDA letter lists side effects recorded during Haley’s animal studies: “soiling of the anogenital area, alopecia (hair loss) on the lower trunk, back and legs, a dark substance on lower trunk and anogenital area, abnormalities of the pancreas” and a rapid increase in normal cells contained in the lymph nodes.

Here is that section of the letter in full:

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.

Mr. Haley is not unused to criticism of his so-called supplement. After the previous story by the Tribune, Boyd Haley tweeted multiple times “Contrary to the Chicago Tribune implication, OSR1 has undergone extensive safety testing. The truth is at http://www.OSR1.com. Please retweet!” When I checked the OSR website, I could find no mention of these test results–the results Boyd Haley himself submitted to the FDA. Is that the “truth”?

The Tribune quotes Ellen Silbergeld, a John’s Hopkins researcher:

“It would be hard to imagine anything worse,” said Ellen Silbergeld, an expert in environmental health who is studying mercury and autism at Johns Hopkins University’s Bloomberg School of Public Health. “An industrial chemical known to be toxic — his own incomplete testing indicates it is toxic. It has no record of any therapeutic aspect of it, and it is being marketed for use in children.”

and

Silbergeld said the product represents a clear example of endangerment of public health and that the FDA should stop CTI Science from selling it immediately. She drew a comparison to a city’s drinking water system: If contamination is found, she said, “they turn off the pumps.”

“They don’t have to engage in a long discussion with you,” Silbergeld said. “It would be hard to imagine a more clear example of immediate endangerment of public health. Turn off the pump.”

Kim Stagliano, Managing Editor of the Age of Autism blog, has touted OSR #1 in the past. She was quoted in the Tribune article:

In an e-mail, Stagliano wrote that she continues to support Haley, a regular speaker at autism recovery conferences. “Having met Dr. Haley at conferences, including Autism One in Chicago last month, I continue to trust his science,” she wrote on Wednesday. “I’m sure CTI Science will address the letter appropriately.”

There doesn’t seem to be any mention of the fact that Prof. Haley appears to have withheld safety information from the autism community. She “trusts his science”, yet makes no mention of the fact that it is precisely “his science” that indicates that this chemical is toxic.

The warning letter from the FDA is quoted below:

WARNING LETTER CIN-10-107927-14

Boyd E. Haley, President
CTI Science, Inc.
2430 Palumbo Drive, Suite 140
Lexington, Kentucky 40509

Dear Mr. Haley:

This letter concerns your firm’s marketing of the product OSR#1 on your website, http://www.ctiscience.com.This product is marketed in violation of provisions of the Federal Food, Drug, and Cosmetic Act (the Act) as described below.

Your firm markets OSR#l as a dietary supplement; however, this product does not meet the definition of a dietary supplement in section 201(ff) of the Act, 21 U.S.C. § 321(ff). To be a dietary supplement, a product must, among other things, “bear[ ] or contain[ ] one or more … dietary ingredients” as defined in section 201(ff)(1) of the Act, 21 U.S.C.§ 321(ff)(1). Section 201 (ff)(1) of 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. The only substance listed as a dietary ingredient on the labeling of OSR#1 is N1,N3-bis(2-mercaptoethyl)isophthalamide. N1,N3-bis(2mercaptoethyl) isophthalamide is not 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. Further, N1,N3-bis(2-mercaptoethyl)isophthalamide is not a concentrate, metabolite, constituent, extract or combination of any such dietary ingredient. Thus, because OSR#1 does not bear or contain a dietary ingredient as defined in section 201(ff)(1) of the Act, this product does not qualify as a dietary supplement under section 201(ff) of the Act.
Your website includes claims such as the following:

• “OSR#1® … helps maintain a healthy glutathione level.”

• “Both OSR#1® and glutathione scavenge free radicals, allowing the body to maintain its own natural detoxifying capacity.”

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.

Your website includes the following statements: “Thyroid conditions, hypertension, and diabetes: Because thyroid conditions, hypertension, and diabetes have been associated with low glutathione levels …” and “OSR#1® … helps maintain a healthy glutathione level.” These statements suggest that OSR#1 is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Because thyroid conditions, hypertension, and diabetes are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use it safely for its intended uses. Thus, OSR#1’s labeling fails to bear adequate directions for its intended uses, causing it to be misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1). OSR#1 is not exempt under 21 C.F.R. §§ 201.100(c)(2) and 201.115 from the requirement that its labeling bear adequate directions for use because OSR#1 lacks an approved application.

Additionally, under section 502(a) of the Act, 21 U.S.C. § 352(a), a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the Act, 21 U.S.C. § 321(n), provides that, “in determining whether a drug’s labeling or advertising is misleading, there shall be taken into account (among other things) not only representations made or suggested … but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations ….” 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).

Because the labeling does not warn consumers of the above-mentioned potential for side effects, the product OSR#1 is also misbranded under section 502(f)(2) of the Act, 21 U.S.C. § 352(f)(2), in that the labeling lacks adequate warnings for the protection of users. The introduction or delivery for introduction into interstate commerce of this misbranded drug violates section 301(a) of the Act, 21 U.S.C. §§ 331(a).

The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your product. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations. In this regard, please note that products are misbranded under section 502(j) of the Act, 21 U.S.C. § 352(j) if they are dangerous to health when used in the dosage or manner; or with the frequency or duration prescribed, recommended, or suggested in the products’ labeling.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action, without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Furthermore, please advise this office what actions you will take to address product that you have already distributed. Additionally, if another firm manufactures the product identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the product is not the manufacturer, please include the name of your supplier in addition to the manufacturer. Address your reply to the Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237, Attention: Stephen J. Rabe, Compliance Officer.

A description of the new drug approval process can be found on FDA’s internet website at
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/default.htm. Any questions you may have regarding this process should be directed to the Food and Drug Administration, Division of Drug Information, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993.

Sincerely,

/s/

Teresa C. Thompson
Cincinnati District

This story is being discussed at Countering Age of Autism as FDA Steps Up to the Plate on OSR#1.

Addenda:

CTI solicited charitable donations to help get started through the CTI Science Foundation, which includes “Katie Wright, Julie Obradovic, Dr. Jerry Kartzinel, Dr. Julie Buckley, Scott Barli and Kathryn Wachsman”

Kim Stagliano discussed previous Tribune stories and the question of toxicity of OSR in another piece

I was contacted by Ms. Tsouderos for an interview about her forthcoming article on a supplement called OSR from CTI Science. CTI’s Science’s FAQ page says OSR is less toxic than aspirin and Vitamin E. If the Tribune has its own toxicity testing, I’m sure readers will be interested in seeing the data. In light of the skewing of parental interviews in the past, I chose not to respond to her requests for an interview. Others, like the founder of CTI Science, Dr. Boyd Haley, graciously allowed the interview process to continue until such time as it became clear that the writer’s goal precluded gaining meaningful insight.

It appears to this reader that perhaps it was CTI Science and Boyd Haley who may have kept the readers from obtaining “meaningful insight”. If a reporter asks about toxicity and you have data showing hair loss, discolorations, and “abnormalities of the pancreas, and lymphoid hyperplasia” shouldn’t you produce that data?

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16 Responses to “FDA warns maker of OSR #1, dietary supplement for autistic children is a “toxic” “drug””

  1. Edgar June 24, 2010 at 09:31 #

    They won’t vaccinate their kids because they say vaccines are toxic, despite all the evidence.

    …And they give their kids drugs which are demonstrably toxic.

    These people say they want to “cure” autism. Do they plan to do so by killing all autistic people? Because that’s what it looks like to me.

  2. Kwombles June 24, 2010 at 13:25 #

    Excellent write up, Sullivan. Having the whole FDA letter is helpful. I wonder if AoA will link to the FDA letter?

  3. Sullivan June 24, 2010 at 13:57 #

    Kwombles,

    they haven’t in their first piece. They downplay the letter, as you can imagine.

  4. Joseph June 24, 2010 at 14:02 #

    The claim that OSR is “toxicity free” (based on no testing) is clearly fraudulent – plain and simple.

  5. Squillo June 25, 2010 at 03:49 #

    Kim Stagliano “continue[s] to trust [Haley's] science” based on having met him “at several conferences”?

    Speaks volumes.

  6. Vicki July 30, 2010 at 01:00 #

    I have twins with autism and I find these replies offensive. I am a Registered Nurse and did my research before starting or stopping anything with my children. My twins were on OSR for 2 years and improved greatly! We saw NO side effects at all. My non-verbal son began talking. Those of you just responding and actually have no idea what you are talking about…just want to sit back and condemn us parents and Boyd Haley need to shut up…you don’t have a clue about what you are talking about. If my twins had not been pumped full of FDA approved vaccines filled with mercury we wouldn’t need OSR to begin with!!!!

  7. Kwombles July 30, 2010 at 01:12 #

    Vicki,

    Interesting comment; so, you’re acknowledging that OSR being adverstised as a powerful antioxidant is subterfuge. After all, you think your kids were “pumped full” of mercury and OSR fixed that. How on earth, though, could you have done your “research” when Haley didn’t do his. You assert no side effects, but there’s no research out there to conclude that OSR could cure your children’s autism.

    Instead, this screams of defensive posturing; admitting you used untested, potentially dangerous mining chelators on your children for TWO years would be mighty hard to do.

  8. Chris July 30, 2010 at 01:14 #

    So, as a nurse, you are offended by the FDA requesting information, and then making a decision?

    What evidence do you have that vaccines had enough mercury to cause issues? Did your children show symptoms of Pink’s Disease?

    Unless you can come up with an answer that includes actual scientific evidence, I am very offended that you are denigrating competent nurses everywhere.

  9. Dawn July 30, 2010 at 12:51 #

    @Chris and Kim: as a RN, I’m really embarrassed to be in the same listing as someone like Vicki. Someone who has to lie about her kids being “pumped full of FDA approved vaccines filled with mercury”. ANY nurse worth her salt, who did research, would know that thimerosol has been out of vaccines for nearly 10 years, AND that that thimerosol is processed by the body and out within a week. Obviously, Vicki flunked her pharmacology and toxicology classes.

    Sometimes, when nurses post these things, I want to find a mask or paper bag, like Orac wants to do when MDs post stupid things.

  10. William January 20, 2011 at 05:08 #

    If the FDA had their way, every natural, herbal, or alternative treatment plan and or supplement would be off the market. How can we trust a government organization who’s policies and regulations are ‘for sale’? If the sale of any ‘non-pharmaceutical’ supplement cuts into the bottom line of drug manufacturers, you better believe they will do whatever they have to do insure that product is pulled off the market.

    As someone who has taken OSR and seen the benefits that it can bring, I am disgusted to live in a country where my tax dollars fund hypocritical organizations such as the FDA. Read the following mission statement of the FDA and then explain to me how they can approve drugs such as Mepron, which as any nurse will tell you, is extremely toxic to the body and in particular, the liver. Explain to me why the FDA now recommends ALL segments of the general population now get their annual flu vaccinations? It seems as though injecting toxic vaccination preservatives is OK in the eyes of teh FDA. Please explain to me EXACTLY the process that Mercury and Aluminum are “processed” by the body within 10 days of vaccination? Perhaps in nursing school you did not learn that Mercury in ANY amount is TOXIC? Why would you EVER consent to someone intentionally doing so? I would rather have the flu! In case you did not know, the FDA does NOT regulate nearly ALL of the chemicals that go into your cosmetic products. Research Triclosan if you are interested. This is the active antibacterial pesticide used in many antibacterial soaps and cosmetic products we use. It has been shown to cause hormone disruption among other things, yet the FDA permits its use in our products! How are they protecting us? Unfortunately MANY healthcare providers AND nurses are trained in a system which revolves around pharmacological drugs as a means of treatment often without cure or resolution of symptoms for the patient. If a product is truly a danger to the public, ban it! HOWEVER, your evidence must be replicable, reliable, and appropriate with specific regard to the exact product, substance, or supplement in question.

    “FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.”

    http://www.fda.gov/aboutfda/whatwedo/default.htm

    Bottom line, DO your research. Be informed. Don’t believe everything the FDA tells you!

  11. sharon January 20, 2011 at 05:20 #

    Not just the FDA William, anyone who has done their research, as you suggest, would like to see the abolition of the memory water market.

  12. Chemmomo January 20, 2011 at 09:07 #

    William,
    “If the FDA had their way, every natural, herbal, or alternative treatment plan and or supplement would be off the market. ”

    OK, so I agree that OSR#1 is alternative. But can you explain to me what’s “natural” or “herbal” about it? It was designed and synthesized in order to chelate heavy metals from contaminated soil. In what herb or what part of nature was it found before the chemists at the U of Kentucky put it together?

    • Dale June 21, 2013 at 12:52 #

      The FDA is the enemy. They have approved thousands of lethal drugs while banning thousands of safe products that save lives by harassing and threatening the manufacturers and distributors of these products. There is a lot more money to be made in continued treatment than there is in healing.
      The committee to investigate the Food and Drug Administration (FDA) has completed a lengthy investigation into the illegal activities of the FDA and found a mountain of evidence of illegal actions.

      You might be interested in knowing that the investigators have discovered that more than 150 of the highest ranking officials of the FDA owned stock in the drug companies they were supposed to be regulating. The FDA is the enforcement agency and participant in a conspiracy to keep beneficial products off the market while promoting poison and habit forming drugs to their own financial interest.

      The researchers found many all-natural cures for such ailments as arthritis, cancer, heart condition, etc. Those products have been tested, proven effective, and are safe. They have no side effects, but are kept off the market by the FDA. The FDA says that the makers of these products may sell them if they don’t tell you what the products can do for you; or they can tell you what the products can do for you if they don’t sell the products. You and I know that doesn’t make sense; but the FDA officials know that it makes money (for them).

Trackbacks/Pingbacks

  1. Tweets that mention Autism Blog - FDA warns maker of OSR #1, dietary supplement for autistic children is a “toxic” “drug” « Left Brain/Right Brain -- Topsy.com - June 24, 2010

    [...] This post was mentioned on Twitter by Kev, shannonrosa. shannonrosa said: RT @kevleitch: FDA warns maker of OSR#1: “OSR#1 is not a dietary supplement but a toxic, unapproved drug… http://bit.ly/9T73f9 #autism [...]

  2. FDA Steps Up to the Plate on OSR#1 « Countering… - June 30, 2010

    [...] such violations can result in fines, seizure of products and even criminal prosecution.” **Sullivan from LBRB links to the FDA [...]

  3. AoA: Come On, He’s A Nice Guy! The FDA is Mean and So Are You! « Countering… - June 30, 2010

    [...] LBRB, first article covering Tsouderos’s article. [...]

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