Autism Blog - OSR to be pulled from the market?

22 Jul 2010

Author: Sullivan
Comments: 14

OSR to be pulled from the market?

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, 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®. 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.

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Comments

14 Responses to “OSR to be pulled from the market?”

ANB
July 23rd, 2010
00:07:58

This means only eight more days until Canadian OSR spam begins.
storkdok
July 23rd, 2010
00:09:59

Can anyone find out how much he made off it?
Tweets that mention Autism Blog - OSR to be pulled from the market? « Left Brain/Right Brain -- Topsy.com
July 23rd, 2010
00:53:32

[...] This post was mentioned on Twitter by Liz Ditz, Liz Ditz. Liz Ditz said: Text of email from Boyd Haley seems to confirm that OSR1 (the #autism "supplement") will be removed from market http://bit.ly/doo3g9 [...]
brian
July 23rd, 2010
01:21:31

Haley’s not kidding that “achieving formal drug approval is [a] lengthy and costly” process. He’ll never do that. OSR#1 is dead.
Sullivan
July 23rd, 2010
01:50:25

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?
Joseph
July 23rd, 2010
02:19:21

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.

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.
Kathleen Seidel
July 23rd, 2010
03:45:20

“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.
brian
July 23rd, 2010
16:29:58

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.
Sullivan
July 23rd, 2010
18:21:31

Joseph,

I would suggest that is not the longest limb you have ever crawled out upon.
FreeSpeaker
July 25th, 2010
04:58:14

Haley’s delay in pulling the product off the shelf is an invitation to a “fire sale” at full price.
ANB
July 25th, 2010
15:31:09

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.
daedalus2u
July 26th, 2010
17:59:28

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?
Aaron Payne
August 5th, 2010
19:13:21

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.
Sullivan
August 5th, 2010
19:32:03

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:

“Under the circumstances, I’ll be interested to see how (or whether) Haley responds to this part of the warning: “Furthermore, please advise this office what actions you will take to address product that you have already distributed.””