FDA To Haley: OSR#1 A Misbranded, Mislabeled, Unsafe Drug · 2010-06-24 08:00

Today’s Chicago Tribune reports that the U.S. Food and Drug Administration has issued a warning letter to Boyd Haley, Ph.D., Professor Emeritus, University of Kentucky, advising him that OSR#1 — a powerful industrial chelator which he describes as an “antioxidant dietary supplement,” and sells to parents persuaded to believe that their children were made autistic by “mercury poisoning” — is, in fact, an illegally marketed drug.

The warning letter validates observations made in the articles A Fine White Powder, The Industrial Treatment, and An Inquiry Emerges, published on Neurodiversity Weblog in August 2008, shortly after Prof. Haley first offered OSR#1 for sale to the public.

FDA has determined that:

• The active ingredient in OSR#1 — N1,N3-bis(2-mercaptoethyl)isophthalamide — is not a dietary ingredient or a derivative of a dietary ingredient.

• OSR#1 is intended to alter the structure and function of the body and therefore meets the legal definition of a drug.

• Prof. Haley’s assertions that “OSR#1 is not a drug” and that it is not intended to “diagnose, treat or cure any illness or disease,” are false, and do not alter the reality that OSR#1 is a drug.

• OSR#1 “is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling.”

• Prof. Haley and his colleagues are violating the provisions of the U.S. Food & Drug Act by marketing OSR#1 without having filed an Investigational New Drug application with the FDA.

• OSR#1’s labeling fails to bear adequate directions for its intended uses, thereby rendering the product misbranded.

• OSR#1’s labeling is false and misleading. Although Prof. Haley has claimed that his chelator is “toxicity free,” the FDA letter reveals that his own animal testing, not heretofore publicly disclosed, demonstrated numerous signs of toxicity — “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.“

• OSR#1’s labeling “lacks adequate warnings for the protection of users” because it fails to mention the potential for side effects.

Prof. Haley has had two years to promote and profit from the sale of OSR#1 to parents wrongly led to believe that his product is safe and may potentially benefit their autistic children. Now, he has until July 2, 2010, to respond to the FDA.


June 17, 2010

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, 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#1 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#1® 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©(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


All articles about OSR on Neurodiversity Weblog:

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)
OSR: The Littlest Consumers (July 14, 2010)

Articles about OSR in The Chicago Tribune:

OSR#1: Industrial chemical or autism treatment? (January 17, 2010)
FDA warns maker of product used as alternative autism treatment (June 23, 2010)
Supplement seller says FDA may be ‘confused’ (July 12, 2010)

Comments


  1. Well, that took awhile. I remember when you blogged about Haley’s FDA submission he had redacted the testing info as a trade secret so there was no way for the public to see the adverse information discussed in the warning letter. Are people going to pay attention to this? Internet commentary indicates that Boyd Haley may be seated with Andrew Wakefield in the holy martyr section.

    — Anne    2010-06-24 11:20    #

  2. “OSR#1’s labeling is false and misleading. Although Prof. Haley has claimed that his chelator is “toxicity free,” the FDA letter reveals that his own animal testing, not heretofore publicly disclosed, demonstrated numerous signs of toxicity — “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.“”

    If that’s true, Haley’s claims that OSR is “toxicity free” are not just incorrect. They are outright criminal.

    — Joseph    2010-06-24 11:27    #

  3. Very glad to see this. Let’s hope it puts him out of business, and destroys whatever reputation he has left. Let this be a warning to all snake-oil salemen!

    — Clay    2010-06-24 11:33    #

  4. CTI Science has posted a FAQ page on its site about the FDA letter, where CTI denies that OSR#1 is a drug and that it has safety problems.

    There is a carefully worded comment about whether OSR#1 is a chelator:

    “There is an internet rumor that OSR#1® is an Industrial Chelator. Is this true?

    No. OSR#1® as produced by CTI Science is not now and has never been marketed or tested as an environmental or industrial chelator. Nor has OSR#1® been tested in humans as a chelator by CTI Science, and no claims of chelation treatment use are made by CTI Science.”

    I don’t know whether this helps or hurts CTI Science’s position with the FDA, which already stated in the warning letter that OSR#1 is a chelator. Indeed, there was a lot of internet nudging and winking when Boyd Haley decided to market his new chelator as a dietary supplement. I don’t see how it helps to say that it has never been tested in humans as a chelator.

    — Anne    2010-06-27 15:35    #

  5. OSR#1 is not a chelator! Huh? CTI Science is a name change; used to be Chelator Technologies, Inc., that is CTI, and was changed to CTI Science on 01/14/08 re http://apps.sos.ky.gov/business/obdb/(S(tdy35l45d5eukw55b1ahhg45))/showentity.aspx?id=0656716&ct=09&cs=9999

    One wonders why…SBD III

    — Sebastian B. Dangerfield III    2010-07-14 17:42    #

  6. Wow…it amazes me how people believe anything they read. If the FDA said it then it must be true. Give me a break. Had a vaccine approved by the FDA not been given to my twins we would have never needed the OSR. Can u not see they are pissed cause they are not making money on Boyd’s antioxidant?? My twins took the OSR for almost 2 years with GREAT results. This is a witch hunt and anyone that can’t see that is blind and needs to do their research. Believe me I did. My non-verbal son started talking after using the OSR and my daughter stopped eating her own feces. For anyone to take this away from my children is what is criminal. Labeled wrong! Or u kidding me??? Funny how the FDA gave Boyd Haley grant money to research autism and when he said his hypothesis was it may be the mercury in the vaccines they pulled every dime from him. They are crooks and it is all about the money …not the kids that OSR has helped!!!!!

    — Vicki    2010-08-05 14:12    #

  7. Vicki, what evidence do you have that the vaccine is the problem?

    Or that OSR helped?

    Also, when did Boyd Haley get grant money from the FDA, do you have documentation? From what I remember Haley had been cashing in on the mercury mania for over a decade. He used to have a company that “diagnosed” and “treated” problems from dental fillings.

    — Chris    2010-08-09 12:34    #

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