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.
Left Brain Right Brain 
This means only eight more days until Canadian OSR spam begins.
Can anyone find out how much he made off it?
Haley’s not kidding that “achieving formal drug approval is [a] lengthy and costly” process. He’ll never do that. OSR#1 is dead.
brian,
I would be interested in what, exactly, he would do clinical trials on? As in, what is OSR supposed to treat?
The FDA is not going to be interested in data on faux mercury poisoning. Challenge chelation tests and porphyrin profiles are not going to make a clinical trial. It isn’t an autism treatment. What efficacy is Mr. Haley going to show? He has spent the past few years avoiding calling it a chelator. Will he do a 180 now and test it for its function? If so, is there really enough demand for a new chelator?
I’m going to go out on a limb here and suggest that Haley was completely and utterly unable to contest this point, so he had no choice but to give up. Profit loss is no doubt significant.
Joseph,
I would suggest that is not the longest limb you have ever crawled out upon.
“The FDA is not going to be interested in data on faux mercury poisoning…”
I wonder whether FDA may be wary of the reliability of data originating from any investigator who has been involved in this initial attempt to make an end run around the regulations for IND’s. I also wonder whether anyone who’s already tried OSR would now be disqualified from enrolling in a properly run clinical trial, since they’re not drug-naive anymore and have already formulated opinions about the drug that would contribute to reporting bias.
Sullivan, I think Haley’s only option would indeed be to test OSR#1 as a chelating agent, although there are a variety of potential targets and applications–none of which have any apparent connection to ASD.
Haley’s delay in pulling the product off the shelf is an invitation to a “fire sale” at full price.
No kidding. Nothing moves product like impending scarcity. I wonder why Haley didn’t promise to stop selling OSR in mid August, or by 2001? Maybe be knew he could get away with seven days, but no more.
Does anyone think that OSR-1 will still be available after July 29, 2010?
I mean, if people send in money will they just send the money back?
Living Well International in Richmond,VA USA. Still has some OSR for sale if people are looking to buy some. Call and talk to Aaron.
Aaron Payne,
would you be so good as to explain how you justify continuing to sell a product that the FDA requested be pulled from the market?
Kathleen Seidel noted in a comment above:
This is an absolute disinformation site. Leave Haley alone; it’s not working anymore anyways. Too many people are waking up to the cesspool that is the FDA (and government in general.)
Haley was forced to pull his product.
If you want to defend someone selling an industrial chemical as a “supplement”, go ahead. Perhaps you could tell me, why do I need my intake of this chemical supplemented? Since it didn’t exist at all when I was born, I’m a bit curious.
I appreciate you reminding me of this. It was interesting to look up what Prof. Haley is up to now. I’ll have to write about it.