OSR: Off The Market · 2010-07-22 19:45

The following message attributed to Boyd Haley, addressed to wholesale distributors of OSR, and posted to several autism discussion lists, reveals that Prof. Haley has elected not to challenge FDA’s June 17, 2010 determination that OSR is a drug subject to the same regulations for premarket approval as any other drug sold in the United States, and that CTI Science, Inc. has “voluntarily agreed” to withdraw it from the market.

From: Boyd Haley
Date: Thu, Jul 22, 2010 at 4:52 PM
Subject: OSR#1 Market Withdrawal
To: Registration
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, 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, Inc.

Although the message ostensibly reassures distributors that OSR will be available for another week, any of the “passionate and dedicated medical professionals” who have simultaneously rushed to recommend this latest autism treatment fad to their patients and profited from its sale, and who continue to peddle this inadequately tested brew until the door to Prof. Haley’s still slams shut, risk liability under the same statutes invoked by the FDA that have compelled its manufacturer to suspend his operations.



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. Is there enough of a market for a new chelator to warrant the expense of a clinical trial?

    Will this be repackaged as a veterinary drug, as some were implying early on (for cats or kids?)? That would seem a very unwise move. I doubt the FDA would be taken by that now.

    Sullivan    2010-07-22 20:50    #

  2. Me, too, though you can bet that there are at least a few frustrated consumers out there now who are fantasizing about exactly such a scenario.

    Kathleen Seidel    2010-07-22 21:23    #

  3. There is virtually no chance Haley will get this compound approved as a drug. That would require years of clinical trials, in addition to extensive initial toxicity studies. This would cost at the very least $500M.

    — Rob    2010-07-23 09:01    #

  4. I have been working in the medical device industry for the last 20 years and the few times the FDA has barked at the companies I have worked for the device in question was instantly suspended for sale. Isn’t he in violation in continuing to sell with out answering the FDA letter?

    — Robert Estrada    2010-07-23 13:23    #

  5. That’s great news, almost as good as hearing Wakers had his license yanked!

    “Mad cow Haley shut down!”

    Now can we do the same for the Geiers?

    Clay    2010-07-23 15:01    #

  6. “Isn’t he in violation in continuing to sell with out answering the FDA letter?”

    I would think so. The warning letter was pretty clear that FDA regards OSR as an unapproved drug, and therefore illegal for Haley (or anyone else, for that matter) to sell. I don’t see how saying that you'll stop selling it by a certain date would make it legal to keep selling it until then.

    Keep in mind that the above memo was sent to OSR distributors; it’s not CTI Science’s official response to the FDA. That has yet to be made public.

    Kathleen Seidel    2010-07-23 20:01    #

  7. Keep in mind that the above memo was sent to OSR distributors; it’s not CTI Science’s official response to the FDA. That has yet to be made public.

    Oh-ho! Has anyone forwarded Haley’s letter to the FDA? Things will get… interesting for Haley if he told his distributors one thing and the FDA another.

    — Matthew Cline    2010-07-24 20:48    #

  8. Off the market…except that retailers are still selling it. I checked two retailers today and found it was still for sale. One has taken the step of requiring people to buy 3 lots at a time (at $60 per lot).

    Sullivan    2010-08-02 20:44    #

  9. People more faith in a bureaucratic, profit-centered system than they ought to. I hope people have to eat their words for speaking on something they don’t have any idea about!

    — Shannon    2010-08-05 15:45    #

  10. Well Boyd Haley did make lots more profit by ignoring the rules to make sure the OSR was safe and effective!

    — Chris    2010-08-07 13:43    #

  11. It’s amazing that this is still being sold despite the evidence.

    — Ksmith    2010-08-18 04:49    #

  12. If the FDA wants to shut them down it must be something REALLY good. I am going to buy as much as I can as fast as I can before it’s all gone! If you trust the FDA, you must have your head in the sand!

    Nick    2010-10-06 09:19    #