OSR: Off The Market · 42 days ago

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)

OSR: The Littlest Consumers · 50 days ago

CTI Science’s online “Recommended Intake” advisory for OSR — a synthetic industrial chelator marketed as a “dietary supplement” since late 2008, subject of numerous articles on this weblog and currently the focus of an FDA investigation and warning letter — features the following recommendations for dosage and administration:

“Recommended dose of OSR#1 for adults is 100 mg once daily… Recommended dose of OSR#1 for children 55-100 pounds is 100 mg once daily. OSR#1 is not recommended for children under 55 pounds or under 4 years of age.“

In a 2009 interview published on Facebook, CTI Science founder Prof. Boyd Haley claimed that OSR was “effective” at binding with mercury and simultaneously altering human metabolism, and that it would be beneficial to autistic children.

“Q: What was your inspiration?”
“A: DMPS and DMSA were invented in 1930’s. We haven’t made a new chelator since then…”
“Q: Is there anything in nature that acts as a chelator?”
“A: …When you get into mercury toxicity, from dental amalgams and vaccines, etc, the body doesn’t have a procedure to protect us, to bind and remove mercury or ethylmercury.”
“Q: How does OSR work in the body?”
“A:OSR goes into lipid/fat stores, mitochondria, etc. It’s not rapidly excreted. Has a long holding time in body and contains two thiol groups. If there is a hydroxy[l] free radical from metal toxicity or any inflammatory process, this thiol group on the OSR will react with it and scavenge it. This scavenging of hydroxyl free radicals salvages glutathione.”
“Q: Besides elevated glutathione, what are other signs that OSR is working?”
“A: Most commonly, bile changes. Feces change, become more normal, less odorous, less sticky/slimy. Intestinal pain decreases. Sleep is better. Eye contact is better. I’m not claiming OSR will cure autism. But it will set us 2 steps ahead…”
“Q: Could OSR help the fish industry?”
“A: Yes, I feel OSR or similar compounds could be used to make fish safer to eat. I’m not advertising this as a chelator though.”

After addressing the matter of dosing, he stated that although OSR’s half-life is unknown, it accumulates in the body.

“Q: What about dosing? Chats are saying different amounts than the bottle.”
“A: The amount we put on the bottle is for compliance with our submission to the FDA. We sell in 50-100-200 mg. That’s an estimate of the amount that is effective…”
“Q: What is the half-life of OSR in the body?”
“A: We don’t know the exact half-life… OSR’s half-life in the body is much longer than DMPS, DMSA and IV given glutathione. It’s a matter of days, not hours.”

He further admitted that no studies had yet validated OSR’s safety for young children, and declared that it should not be administered to them.

“Q: How much do you need to weigh to try OSR?”
“A: We don’t recommend for any child under 40 lbs. While we have no indications of OSR toxicity at any age or size, we also have no studies to infer it’s totally safe under 40 lbs… The safety of OSR should be looked at in a clinical trial. So don’t use OSR for kids under 40 lbs.”

(Prof. Haley did not explain the discrepancy between this 40 lb. minimum weight recommendation and the 55 lb. minimum weight published on the CTI Science website.)

In an apparent attempt to reassure prospective purchasers that he has exercised due caution in marketing OSR for consumption by autistic children, Prof. Boyd Haley includes the following caveats in the OSR product brochure:

“Although OSR#1 is a dietary supplement and not a prescription drug, it is only available through a medical professional or by prescription at this time.”

Doctors, dentists, pharmacists, chiropractors, and others who wish to purchase OSR for resale must acknowledge Prof. Haley’s dosage recommendation in their wholesale agreement:

“I understand that the recommended daily intake of OSR#1 is 100 mg per day for adults and children who are at least 4 years of age and over 55 pounds.”

Prof. Haley’s caveats, disclaimers and legal agreements notwithstanding, since OSR first went on the market in 2008, numerous reports posted to Internet discussion groups suggest that it has been frequently administered to children under 55 pounds and/or under 4 years of age, both by parents acting without a doctor’s supervision, and by recommendation of those authorized by CTI Science to sell OSR to their patients and customers.

[Messages from the ChelatingKids2 list moderator]
“[T]his is just me, forwarding a private message from Boyd Haley to me that he said I could share. He is in the very early stages of working on a new chelator…”
[nine months later]
“Anyone know when Boyd Haley’s chelator is coming out? …I’m hearing late fall…”
[one year later]
“Just trying to check on the dosage of OSR. …I have (from a very reliable source): The recommended dose is 100mg/day for patients over 50 lbs. We measured it and found that 1/16th of a teaspoon (called a minispoon) has about 140mg of OSR. So we have the little kids take half a minispoon or about 70 mg per day.“
ChelatingKids2, December 18, 2006; September 10, 2007; September 3, 2008
“My son has been on OSR for one day now and the only changes we have seen (not that we have expected to see any this quick) have been a prodigious increase in urination and thirst…”
[the next day]
“Second day of OSR. Again, A. is urinating profusely and drinking a lot of juice…”
[two days later]
“3rd and 4th days [on OSR] have brought a reduction in thirst and urination, however, my 20 month old son is still drinking more and urinating more than usual… We are taking 1/16th of a teaspoon (50mg) 2wice daily.”
ChelatingKids2, August 1, 2008
“We just got it from our DAN… [he] could never understand why the dosage was so low of 1/16th or 1/32nd of a teaspoon, he always said that this is low. BTW my son is 43 lbs.“
ChelatingKids2, October 12, 2008
“My son’s Dr. has me give him 1/8th of a teaspoon at night on an empty stomach. My son is 45 lbs. …He has had several poops lately that look like sand is in there what is this caused by??? …My Dr. is Kenneth Stoller in Santa Fe NM.”
ChelatingKids2, October 13, 16, 2008
“My son takes the same dose as yours and he is almost 50 lbs., so I think that’s about right. We use Dr. Stoller too…”
ChelatingKids2, October 12, 2008
“We’re just starting and my guy is only 27 months, so I’m a bit nervous… Our doctor is using it in Asheville.“
AutismWeb, November 20, 2008; October 29, 2008
“My 2-1/2 y.o. son (40 lbs) has been on OSR for 1 month. We give him 2 scoops at midday… Our DAN had us work up to 200mg daily. We started very slowly as directed with just 1/4 scoop to start and then added another 1/4 scoop every couple days… We… drive to Pleasanton each week to see our DAN, Dr. Lynn Mielke. We’re doing IV chelation.”
ChelatingKids2, March 10, 2009; July 23, 2009
“My son seems to be tolerating it just fine. We began with 1/4 scoop and now up to 1 scoop. We’re going to stay there for a while and then slowly increase to 2 scoops, which is the max for my son (5 yr. 50 lb).“
ChelatingKids2, March 9, 2009
“[My son] started on 1/4 of a capsule and is now on one capsule. He started at 48 pounds and is now at 50… We are not chelating with other chelators.”
ChelatingKids2, March 9, 2009
“[My son] was on 50 mg divided into 3 dosage daily in the past… We built up to 100 mg. Now I give him 100 mg at one time 4 days a week. He is about 50 pounds.“
[four weeks later]
“My son has been completely off OSR since mid March, soon after I posted our OSR experience. Having some uncertainty on my part, I decide to take a break from OSR and do another round of tests first and go from there… We had seen improvements in language development when on OSR, but we also experience some complication.”
ChelatingKids2, March 13, 2009; April 8, 2009
“Our DAN wants us to start this for our little peanut. I’m kind of scared though as she is only 36 lbs and it says on Boyd Haley’s site not to us for kids under 55 lbs. He wants us to start out with 25 mg and work our way up to 250 mg a day.”
[ten months later]
“My daughter is 5 yrs. old and we have been on OSR for about 7 months now. She is 42 lbs and we worked up slowly to 100mg… Urine Toxic Metal test showed that she was excreting: Aluminum, Arsenic, Barium, Cadmium, Cesium, Lead, Nickel, Thallium, Tin, and Tungsten… Fecal Metal test showed that she was excreting: Mercury (YAY!!!!), Antimony, Arsenic, Bimuth, Cadmium, Copper, Lead, Nickel, Platinum, Thallium, Tungsten, and Uranium.”
AutismWeb, May 1, 2009; March 12, 2010
“We are using it for my 24 lb almost three year old and 55 and 57 lb 7 and 9 year olds. We have had some trouble with sleep with the youngest…”
AutismWeb, May 1, 2009
“We put 26 month old DS on it in April.”
AutismWeb, June 19, 2009
“My son is 3 1/2 and has PDD-NOS, non-verbal… I read that OSR is only recommended for children over 4 years old and over 55 pounds. Is this absolutely necessary? and why? Our DAN! said I need to figure out what I want to do next, and he’ll help me do it…”
[six weeks later]
“…We’ve been on OSR for two weeks now. I started him on 1/4 of a capsule (Lee Silsby didn’t have the straight powder) and we’re up to 1/3 of a capsule now. He’s 38 lbs 3 1/2 years old. Has anyone ever heard of or experienced a side effect with OSR that might make him itchy? He’s scratching it seems all over. Even his teacher at school wrote me a note about it today.”
ChelatingKids2, May 27, 2009; July 10, 2009
“We’ve started OSR, but only every other day since, at 38lbs, he is below the weight level of 55lbs.“
ChelatingKids2, August 8, 2009
“[What dose of OSR are you on and how fast did you ramp it up?]”
“100 mg a day, he is 40 lbs. We started with maybe 10 mg (eye-balled), and ramped up to 100 mg over 3 weeks because I did not see adverse reactions, except after about 2 weeks I had a sulfur reaction… He got hyper and aggressive.”
ChelatingKids2, August 14, 2009
“We just met with my son’s DAN here in the Chicago suburbs and we’ll be using OSR as a ‘chelating agent,’ although Dr Boyd Haley does not call it that… My son is 3 and a half and has been diagnosed with autism.“
ChelatingKids2, July 23, 2009; August 15, 2009

Needless exposure of children to inadequately tested, potentially hazardous substances is indefensible, regardless of whether the instigator is a multinational corporation, an academic research center, a public residential institution, or a powder-peddling moonshiner working the alternative autism treatment hero circuit. The FDA is to be commended for finally investigating OSR, the target market for which is among the most vulnerable in society. Any action that the agency might take to prevent its further distribution to the public will serve to protect its littlest consumers, and to mitigate the exploitation of these children and of loving parents who long to alleviate their difficulties, by medical cultists and ideological entrepreneurs who recklessly profit from their misplaced trust.


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)

OSR: A Bevy Of Adverse Events · 52 days ago

In his public response to the FDA’s warning letter regarding OSR — a synthetic industrial chelator marketed since 2008 in the guise of a “dietary supplement” — University of Kentucky emeritus Prof. Boyd Haley claims that there have been no undesirable side effects associated with his inadequately tested, unapproved new drug:

“Since CTI Science has been selling OSR (about 2 years) we have not had one severe adverse effect reported to our FDA based adverse effect reporting system.” (June 29, 2010)

Presumably, the “FDA based adverse effect reporting system” to which Prof. Haley refers is a private post-marketing safety surveillance program modeled after but independent of the system established by the FDA to track adverse effects and medication errors associated with approved drugs and biologic products. Adverse event reports submitted to the FDA are made freely available to the public, regardless of the severity of the event. In contrast, adverse event reports submitted to Prof. Haley and his colleagues regarding OSR are closely guarded secrets.

The CTI Science website and OSR’s product information sheet state only that “Allergic or other adverse reactions may occur at any time with any food or dietary supplement as well as OSR#1,” and generally caution those with yeast and fungal conditions, thyroid conditions, hypertension and diabetes from taking OSR without monitoring by a medical professional. A recent statement issued by Haley collaborator Dr. Jerry Kartzinel refers to reports of “temporary diarrhea, constipation, minor headaches,” but minimizes them as “rare,” and contends that “the actual causes are unknown.”

Contrary to Prof. Haley’s suggestion that there have been no “severe” side effects associated with OSR, and contrary to Dr. Kartzinel’s assertion that adverse events have been “rare,” as soon as OSR went on the market, numerous anecdotal reports of side effects began to appear on online discussion groups frequented by parents of autistic children — most notably the 6,465-member ChelatingKids2 Yahoo! group. The volume of these reports slowed after several new restricted-membership groups for discussion of OSR were established in the Spring of 2009, and since ChelatingKids2 was suspended the following August. Notwithstanding the slowing of open public discussion about OSR by its purchasers, the informal reports that have accumulated since its introduction into commerce provide compelling indications of OSR’s potential to significantly, unpredictably alter human fluid balance, disrupt mineral metabolism, and negatively affect gastrointestinal, respiratory and immune function, and should give pause to anyone tempted to trust the safety assurances of those who stand to profit from its continued sale.

Increased Thirst, Urination, Salivation, Mucus Production

“Second day of OSR… A. is urinating profusely and drinking a lot of juice.”
ChelatingKids2, July 31, 2008
“Day 3… He went to the bathroom about 12 times in 2 hours!!! I don’t even think he took in that much liquid today compared to what came out!”
Our OSR Experience, August 25, 2008
“Our initial observations are consistent with what you have seen. Unbelievable thirst and urination, increased appetite, and some improved cognitive ability.”
Autism-Biomedical, September 2, 2008
“We have been doing ALA and DMSA on the weekends. We are on round 16 with mostly negatives at this point. Our plan is to alternate weekends between the OSR and the ALA, DMSA… We were on vacation this week so we did a 4 day round of OSR. He was a little more stimmy and he developed a tremendous thirst.”
Autism-Biomedical, September 1, 2008
“Our DAN! recently increased his dosage and he began hacking up huge amounts of phlegm and saliva from his throat.”
ChelatingKids2, November 10, 2008
“I did report bed wetting to my DAN but I did not purchase the OSR thru him and he does not have any contact w/ Dr Haley…. Is there any way to report this? …My son began bed wetting on OSR when given orally (he is 12 yrs old and had not wet the bed in a good 5 yrs). We stopped the OSR and started it several times and he still wet the bed even when given a small dose in the AM.”
ChelatingKids2, April 8, 2009; June 16, 2009
“I started my son on OSR a month ago and we ramped up to 50 mg a day. The first three weeks I did not see anything, no side-effects, no yeast. Now it’s been a few days that my son has been especially hyper and he is urinating a lot in the afternoon, between around 3:00pm and 8:00pm (we give OSR at 1:00pm).”
ChelatingKids2, June 25, 2009

Constipation, Diarrhea & Gastrointestinal Distress

“Day 3 was yesterday for us with a MASSIVE poop. I guess this stuff is cleansing, huh?”
ChelatingKids2, August 24, 2008
“We saw the same thing. About 1 1/2 feet of poop on day 4 and 5…”
ChelatingKids2, August 24, 2008
“We started on it about 10 days ago and N. has either been constipated or he’s been having BM’s without us knowing. But when we see him go, his stools are kind of mushy and not as voluminous as usual.”
ChelatingKids2, August 29, 2008
“Day 11… [H]e hasn’t had a BM in 3 days. He normally goes once a day, and sometimes skips a day so 2 days in a row didn’t phase me.”
“Day 12… He came home, asked to lay down and for “some juice and water,” threw up, ran 102 temp for about an hour and fell asleep. He slept for an hour, was up for about 2 hours and is now sleeping again. Still no BM despite a glycerine suppository.”
“Day 13… We finally got a poop out of him!!!! Not his norm as far size and amount but a fully formed poop.”
Our OSR Experience, September 2, 3, 4, 2008
“We started at a 1/48 tsp for 2 weeks and went up to 1/32 tsp in divided doses… There were 4 days of smelly very loose stool…”
ChelatingKids2, September 5, 2008
“We have been on OSR for a little over a week now and one of my little guys who usually has a bowel movement every day now only goes every other day…”
ChelatingKids2, September 10, 2008
“After about a week my son, who normally goes 1x a day, stopped going. On day 5 of no BMs I was ready to help things along a bit and he went a little on his own. The next day a little again and finally another day later he went normal. That was 3 days ago and that was the last BM we saw.”
ChelatingKids2, September 9, 2008
“We had some gut problems at first… Things have gotten somewhat back to normal, after about 2-3 weeks, but my son still skips some days on bowel movements where he used to have a bowel movement every day — sometimes more than one.”
ChelatingKids2, September 10, 2008
“We had some constipation/gut issues initially which resolved on their own in a couple of weeks. Also noticed he seems more stimmy.”
ChelatingKids2, October 1, 2008
“We’ve had some constipation too, and some early wakenings…”
ChelatingKids2, October 2, 2008
“My son has been having gritty pooh almost looks like sand is in it… He is taking OSR and other supplements also GFCF SCD and avoiding food sensitives.”
ChelatingKids2, October 16, 2008
“We have been at this for over two months now… We first started and had to back off because after the first week it totally constipated him.”
AutismWeb, November 18, 2008
“We tried and C. kept having stomach aches with it.”
AutismWeb, February 27, 2009
“My girl takes methyl B12 and OSR. I have noticed abdominal bloating lately. I thought she had gained weight since her eating has increased since she no longer takes Ritalin and thought the B 12 shots may have increased her appetite but she woke up this am w/ a flat stomach like she lost 5 lbs over nite.”
ChelatingKids2, June 14, 2009

Upper Respiratory Congestion

“We’ve recently started giving my 7 yr old OSR. He’s had 6 doses so far over 12 days (the study he’s in suggests a dose every 2 days for the first two weeks). For the past week or so he’s been extremely congested, runny nose, cough, etc and hasn’t been able to shake it. He isn’t feverish and has been going to school and other activities as usual. No one else in the house is sick and we haven’t caught any “bug” from him either. It is certainly possible it is a regular cough/cold picked up at school, but I think the OSR might be responsible for this one.”
ChelatingKids2, November 6, 2008
“We are on OSR as well — low dose at approximately 20 mg 3X daily. My son also has been congested, runny nose, cough and has no fevers.”
ChelatingKids2, November 6, 2008
“My son has had a lot of nasty congestion since we started OSR.”
ChelatingKids2, November 17, 2008

Insomnia, Emotional Lability, Agitation, Cognitive & Behavioral Changes

“[We’re giving] 1/32 tsp 1x a day in the morning. We tried it at night and he woke up in the middle of the night and couldn’t go back to bed. I plan to work up to 1/16 tsp over time; however, we started at that dose and he had a lot of frustration and very emotional.”
ChelatingKids2, August 24, 2008
“We’re getting a little more scripting…”
ChelatingKids2, August 24, 2008
“We are on day 17 and for the past 2 days [my son] has had a ton of gas and is visually stimming and his attention is down… these signs are running rapid the last 2 days… We haven’t had yeast issues forever, and we are not even on any yeast supplements, just probiotics and juice plus, SO looks like we might have to add something or stop OSR.”
ChelatingKids2, August 31, 2008
“We will be sending our fecal metals off this week after being on OSR for 20 days. I would have waited longer but we are getting increased eye stimming and attention issues…”
ChelatingKids2, September 3, 2008
“When I started my son on OSR, I used to give it to him in the afternoon (after he got home from school) and he had difficulty going to sleep.”
AutismBiomedical, September 20, 2008
“A. had night awakenings when I gave it at night. This from a child that has slept 12 hours every night since he was 4 months old.”
ChelatingKids2, October 13, 2008
“[W]e have been on it 6 days. [M]y son seems a little spacey…”
ChelatingKids2, October 16, 2008
“We began using it last month… When we first got to a full dose (you work your way up slowly on this), my son began chewing on his shirts… The only side effect we have seen is that he seems a little wired in the early morning hours (3-4am). Not hyper, but wide awake at 3-4 am.”
ChelatingKids2, November 10, 2008
“When we initially introduced OSR, my son went through a period of emotional roller coaster ride and skin rashes on and off for about one month. Both emotional outbursts and skin rashes went away after that.”
ChelatingKids2, March 13, 2009
“Our son just got REALLY different. He seemed depressed and his grades dropped dramatically. He started to forget to hand in his homework. His organizational skills got worse. I just stopped it.”
ChelatingKids2, April 9, 2009
“[OSR] made him [4 year old boy] more hyper and stimmy, we had originally started with an 1/8th capsule and worked up to a full capsule over about two weeks; now we have backed down to a 1/4 capsule and use it daily just as part of his normal regimen.”
AutismWeb, May 20, 2009
“We do have a little more hyperactivity…”
AutismWeb, June 4, 2009
“I only gave it to my son for a short time. I may have seen some positives but I also saw a ton of irritability.”
AutismWeb, June 20, 2009

Headaches & Fatigue

“Our DAN said some known side effects are headaches, irritability and a metal taste in the mouth.”
ChelatingKids2, August 31, 2008
“My son says he gets headaches now and then.”
ChelatingKids2, October 1, 2008
“I tried OSR twice on my son but had to pause since he seemed to weaken.”
ChelatingKids2, March 13, 2009
“My son is on 50mg for past 3 days. He is 11 years old. He says when he move his head the top of it hurts.”
ChelatingKids2, June 18, 2009

Fever

“We have been on 200mg OSR for a few weeks with good results so far. Two days ago I upped the dose to 300mg (three 50mgs scoops at lunch and 3 at dinner time) and now he has come down with a slight fever, even though he really feels hot all over.”
AutismBiomedical, October 5, 2009
“Yes, this happened to my son at about the 3 week mark, and many kids (and some adults) I know experienced the same things… He got sick more, and because he hadn’t done so before, he was getting sick with every little kindergarten bug that came along… Unfortunately, at least for us, although OSR brought loads of good things (cognitive improvement in addition to the above goodies), it proved temporary. After about 4 months he stopped having these improvements. We increased dose, and nothing happened. Being that it’s so expensive, we stopped. We saw no changes when we stopped it.”
AutismBiomedical, October 5, 2009

Rashes, Hives & Bruising

“Oh, he has some weird rash on his torso. Mostly his chest and stomach. You can barely see it, but you can feel it.”
Our OSR Experience, August 26, 2008
“Our 9 year old son, along with myself have been taking OSR for a few weeks now. After 4 days we took a stool test for my son showing little Mercury coming out. I have had no negative reactions thus far but my son is now tapping his right temple with the back of his hand and has developed hives. We plan to take a 4 day break from OSR to see if the hives clear up, then resume at a lower dose.”
AutismBiomedical, September 19, 2008
“This is a product that is supposed to pull heavy metals out of the brain. I waited on this product to come out 2 yrs, but I reacted to it within 2 1/2 wks with horrible hives.”
ProHealth.com, December 4, 2008
“My son started getting bruises on OSR with Phospholipid exchange — followed doc’s dosing instructions. I stopped OSR after ~3days cos new bruises kept showing up each day that he was on it. Bruises eventually disappeared and no new bruises showed up after stopping OSR.”
ChelatingKids2, April 7, 2009
“When I first added the HMD [Heavy Metal Detox, a commercial product] and OSR, she got a lot of rashes on her chest, back, face and arms. Just slight bumps and some pimply bumps, not irritating… The hives she had all over did go away within a week or so of it starting. She has a lot of bumps on her face that don’t seem to be going away.”
AutismWeb, May 1, 2009
“I’ve just had an interesting week trying OSR. I did it for three days. At first I felt great, but then the metals and/or virus die-off began. Ouch. Rashes, incontinence, joint pain, zits, scalp lesions, the works, like overdoing detox. When I’m de-mercing too hard I get fierce sores. So on Day 3 I threw in the towel and really loaded up on magnesium and liquid minerals, and now I feel really good again except I’m having a giant herpes outbreak around my mouth and I DON’T ever get THAT.”
ChelatingKids2, May 14, 2009
“We’ve had a bad break out. I’m really bummed. Not sure if it’s the OSR, but can’t imagine if it isn’t. I love the supplement, but my son came home yesterday full of hives.”
AutismWeb, June 4, 2009
“While on OSR, we have not had bedwetting, but some other symptoms that we had while on TD-DMPS: red ears, spitting, for us these are signs of detox.”
ChelatingKids2, June 16, 2009
“My friend using it on her 12 year old girl has seen blood in her nose after using it – anyone see this?”
AutismWeb, June 17, 2009

Asthma

“My son got this red flush all over his face and ears. The second time I tried it a couple of months later, it triggered an asthma attack that took over 10 days to control. I have not touched it since.”
ChelatingKids 2, April 9, 2009

Seizures

“We had a horrible experience the two times we tried it. We actually saw seizures both times, it took two months to get him back from that.”
AutismWeb, January 21, 2010
“I know 2 children who started with seizures less than a week after starting a low dose of OSR. And I have also spoken to others that have negative reports as well.”
AutismWeb, March 15, 2010

Yeast Infections

“As for the efficacy of OSR, I had my son on it for a month… I stopped because my son developed a yeast problem…”
ChelatingKids2, December 6, 2008
“OSR sucked — gave us horrible yeast.”
ChelatingKids2, April 10, 2009

Increased Menses & Lowered Platelet Counts

“I started my son on OSR last September… We initially saw charcoal-back stools, which got me worry, as black stools can suggest blood in the stools. I spoke with Dr. Klinghardt about this. He said that OSR could thin the blood. For children with inflamed gut, OSR could cause very mild bleeding initially and some inflamed gut mucus could be flushed out. He said not to worry, but if the black stools remained after a few days, I should stop OSR and collect stool sample to test for blood in stool. After 3 or 4 days, my son’s stools returned back to his normal stool color; I never did test him for blood in the stool. Still I was not at all easy with OSR, so I decided to take OSR myself one month after my son had been on it. There was not much information online about it and still isn’t… I was on OSR for two months. And two months in a row my periods for the first time in my life lasted for about two weeks each time, during which my blood gushed down like waterfall each time when I used the restroom. Because of the earlier conversation with Dr. Klinghardt, I started to suspect that OSR might thin the blood and increase blood flow by virtue of lowering blood platelets… I then tested my son’s blood platelet level, for first time in 3 years of periodically testing, my son’s blood platelets dropped below the reference range… I also exchanged a few emails with a mom who posted at another group that her teenage girls’ periods became irregular after the use of OSR…”
ChelatingKids2, March 13, 2009
“OSR does appear to lower platelet levels in my twins. Their platelets were within normal range for years. After a few weeks on OSR their platelets were right near the bottom of the reference range. After 2 weeks off of OSR their platelet levels were about the same, near the bottom of the reference range. After 6 weeks off OSR, their platelets were back to normal for them (middle of the reference range)… We also saw some constipation.”
AutismWeb, June 19, 2009

Incidents requiring hospitalization

“I’m a parent of an ASD kiddo and I ordered the OSR, but chose to try it on myself first since it’s so new. I’m not sure if this is due to the OSR, but the last few days my liver is sensitive to the touch and I’m having some pain. I had a deep tissue massage yesterday which made the liver more sensitive… probably not the smartest thing I’ve done. I’m sure by toxin burden is very high. I’ve been taken it for about 2 weeks. Anyone have any symptoms like this??”
[the next day]
“I’m fairly certain it’s the liver (b/c I’ve had gall bladder pain before and it’s below that), it’s def not the kidneys… Dosage? Not sure. I’ve been using what I consider a very small amount, but I don’t have a way to measure it. What are others using to measure?”
[the day after that]
“I ended up in the emergency room last night with so much pain that I thought I might pass out or die!!! It was terrible. My liver enzymes are fine! I have a blockage almost the size of a baseball in my intestine behind my liver.”
ChelatingKids2, September 13, 14, 15, 2008
“[T]here were a couple of kids and a couple of adults that ended up in the ER with very high temps and viral titers through the roof. Adding OSR at full dosing was the only change and none were “sick” with other symptoms, this happened within 24 hours of starting. We do not necessarily know who will react that way, that is why we advise ramping up dosing slowly to avoid viral reactivation. [Dr.] Julie Buckley will go over what we have seen, the good the bad and the ugly at NAA.”
ChelatingKids2, November 11, 2008

This last poster claims to be an employee of Dr. Jerry Kartzinel and Dr. Julie Buckley; both are Defeat Autism Now! practitioners and members of the Board of Directors of the CTI Science Foundation, which has solicited donations from parents of autistic children to underwrite the purchase of OSR for other potential CTI Science customers, and to fund the sorts of clinical trials that are generally financed by pharmaceutical manufacturers before new drugs are put on the market. In her book, Healing Our Autistic Children, Dr. Buckley praises Prof. Haley as “fiercely ethical,” and describes OSR as a “new supplement [that] is proving to be exceptionally safe.” If Dr. Buckley has ever publicly disclosed the sort of “bad and ugly” incidents associated with OSR that were described by her staff member, it would seem that the information has yet to be conveyed to Prof. Haley, Dr. Kartzinel, and their other colleagues at the CTI Science Foundation.


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)

OSR: Fuel For Thought · 57 days ago

A new paper published in the June 2010 issue of the energy industry journal Fuel — Aqueous mercury precipitation with the synthetic dithiolate, BDTH2 — provides a comprehensive description of the chemical properties and manner of synthesis of the chelator developed for the purpose of toxic waste remediation that has been marketed since 2008 as a “dietary supplement” under the trade name OSR#1.

Co-authors Lisa Y. Blue, Partha Jana and David A. Atwood, are affiliated with the Department of Chemistry of the University of Kentucky; Blue and Atwood are also affiliated with Merloc LLC, a start-up company which has licensed the University of Kentucky’s patents for multidentate sulfur-containing ligands for binding heavy metals for waste management and environmental cleanup applications.

Boyd Haley, Ph.D., University of Kentucky Professor Emeritus, former head of the University’s Department of Chemistry, and a prominent, long-time proponent of the hypothesis that autism is a conseqence of vaccine-mediated mercury poisoning, has licensed the same patents from the University, which in 2007 described the purpose of their license to Haley as “development of water soluble chelators.”

Until early 2008, Prof. Haley made numerous public references to his development of a “new chelator,” and his intention to submit it to the U.S. Food & Drug Administration’s Investigational New Drug approval process. However, in early 2008 he discontinued referring to it as a chelator, and filed a notice of intent “to introduce a new dietary ingredient for use as an antioxidant… into interstate commerce.” He has since dubbed the product “OSR,” has steadfastly referred to it as an “antioxidant,” and has refused to publicly discuss its action as a chelator. In spite of an FDA notice indicating that he had failed to establish the OSR and its components have “any established use as a food for human beings,” and that he had failed to demonstrate that OSR could reasonably be expected to be safe, Prof. Haley has aggressively promoted OSR, focusing largely on the market consisting of parents of autistic children.

OSR#1 is now the subject of a recent warning letter from the FDA, indicating that it is not a “dietary ingredient,” but an inadequately tested, inadequately labeled, unapproved drug, with toxic effects demonstrated in Prof. Haley’s own unpublished studies.

Aqueous mercury precipitation with the synthetic dithiolate, BDTH2 requires a solid grounding in chemistry to be fully understood. The following excerpts nonetheless provide both the lay and professional reader a far more straightforward description of Prof. Haley’s drug than anything provided by Prof. Haley himself, his business associates, or the network of “alternative health care practitioners” who are sharing in the profits from its sale.

Excerpts & Commentary

(All emphasis and subtitles added)

Blue, Lisa Y., Partha Jana, and David A. Atwood
Aqueous mercury precipitation with the synthetic dithiolate, BDTH2
Fuel, Vol. 89, No. 6 (June 2010): 1326-1330.
http://dx.doi.org/10.1016/j.fuel.2009.10.031

Abstract

“BDTH2, 1,3-benzenediamidoethanethiol (common name) and closely related derivatives were specifically designed to become insoluble after the formation of linear, covalent bonds to aqueous mercury. BDTH2 (IUPAC nomenclature, N,N′-bis(2-mercaptoethyl)isophthalamide) emerged as the preeminent reagent for the complete precipitation of mercury from water after several years of studies with a wide range of compounds having one, two, three, and four thiol groups. BDTH2 does not become inactive through oxidation to disulfide and can be applied to mercury-containing water as acidic, basic, and ethanolic solutions. The BDT–Hg precipitate is extremely stable and leaches low-ppm levels of mercury only under extremely acidic and basic conditions. BDTH2 is also effective in the aqueous precipitation of other soft, divalent metals, such as copper, cadmium, lead, and the main group elements, arsenic and selenium. The insolubility of the BDT–M compounds can be attributed to the presence of strong, non-polar, covalent M–S bonding within a water-insoluble organic framework. BDTH2 has no known biological toxicity and is being sold as a nutritional supplement under the trade name OSR-1. This review describes the chemistry, precipitation, and leaching studies of BDTH2 with mercury.”

This is what Prof. Haley’s “dietary supplement” was designed to do:

“BDTH2 represents an inexpensive, very effective means of precipitating soft metals from water and produces solids that will not release the metal after disposal.”
“After discovering that the problems associated with [common commercial metal precipitation] reagents made them relatively ineffective, we began a systematic search for thiol-containing compounds capable of removal [of] soft heavy metals, and in particular, mercury, from water. This entailed the syntheses of new bidentate, tridentate and tetradentate thiols having the following general properties:
(1) stoichiometric precipitation of Hg(II) to low ppb levels,
(2) covalent Hg–S bonding,
(3) insolubility and stability of metal compounds under acidic and basic conditions,
(4) absence of disulfide formation,
(5) thermal stability,
(6) ease of preparation,
(7) low cost,
(8) no biological toxicity.”
“This approach met with some success in the preparation of a wide range of new thiol compounds, including BDTH2 and tetradentate thiols potentially capable of forming tetrahedral mercury compounds. BDTH2 emerged as the ideal reagent for aqueous Hg(II) removal (BDTH2 is the abbreviation derived from the common name 1,3-Benzene Diamido ethane Thiol; the IUPAC nomenclature is N,N0-bis(2-mercaptoethyl)isophthalamide).”
“BDTH2 is effective in precipitating mercury through the formation of covalent Hg–S bonds under a variety of laboratory conditions, from gold mining effluent, from soils and for low ppb field samples from a former chlor-alkali facility. BDTH2 is also effective in precipitating other divalent metals such as Fe, Cu, Cd, and Pb, metal removal from acid mine drainage, for the prevention of metal leaching from coal and sulfide minerals and for the removal of lead from lead-battery recycling effluent.”

This is how Prof. Haley’s “dietary supplement” is synthesized:

“This general procedure can be scaled to prepare smaller or larger amounts of BDTH2. Triethylamine (TEA; 52 mL, 38 g, 375.53 mmol) in chloroform (100 mL) is added slowly to a stirring solution of cysteamine hydrochloride (21.20 g, 186.6 mmol) in chloroform (200 mL) in a 3 L round-bottom flask with a nitrogen stream passed over the mouth of the vessel. The reaction mixture is stirred magnetically with a 1 in. Teflon stir bar. Isophthaloyl dichloride (12.48 g, 61.48 mmol) in chloroform (100 mL) is then added to the solution and allowed to stir for 12 h. At the end of the reaction time, the solution is clear violet in color. The chloroform solution is washed with a 10% HCl solution (500 mL x 2, VWR) in a 2 L separatory funnel. The chloroform layer is transferred to a 1 L Erlenmeyer flask and dried by stirring over sodium sulfate (Na2SO4) for 1 h and filtered. Nitrogen is passed over the solution to evaporate the solvent and induce precipitation of the product. The product is allowed to dry further, open to air, for one day before characterization by melting point, IR, 1H NMR and MS. Yield without optimization: 12.51 g (72%).”

This is what it costs Prof. Haley to manufacture the active ingredient of his “dietary supplement” in small quantities:

“The cost of BDTH2 using laboratory reagents is less than $0.25/g. BDTH2 will be inexpensive when produced in large quantities.”

(According to several retailer websites, 30 100mg capsules of OSR — that is, 3 grams of OSR — cost from $60, or $20/gram, to $105, or $35/gram — a markup of 8,000% to 14,000%. The cost of developing the chelator was largely shouldered by the University of Kentucky. Even factoring in the cost of fillers, capsules, packaging, marketing, business and legal expenses, these figures point to a profit potential that equals or exceeds that enjoyed by mainstream drug manufacturers — all without the fuss and expense involved in conducting proper clinical trials on adult human beings prior to putting the substance on the market for consumption by disabled children. According to Dr. Jerry Kartzinel, over one million capsules of OSR have been sold to date. The profits from the sales of this inadequately tested, unapproved new drug are shared by Prof. Haley, his business associates, and the cadre of doctors, dentists and online retailers who serve as his marketing team.)

This is the extent to which those involved in the promotion and sale of BDTH2/OSR#1 have documented its alleged “non-toxicity”:

“For information regarding the commercial use of BDTH2, now being marketed under the Tradename ‘‘B9”, contact: Inquiries@MerlocLLC.com. Another significant advantage of BDT by comparison to other mercury treatment technologies is that it is non-toxic. This has been demonstrated in animal toxicity (acute oral, subchronic oral, in utero) and mutagenicity studies. Indeed, BDTH2 is currently being sold by CTI Science, Inc. under the Tradename OSR#1 as a nutritional supplement.”

(Both the authors and Prof. Boyd Haley have a powerful economic interest in characterizing their product as “benign,” with no potential for adverse effects if consumed by human beings. However, although the authors cite 46 references in this paper, none are provided to support their assertion that BDTH2/OSR#1 is “non-toxic.” Although it is likely that they have had privileged access to the unpublished animal toxicity and mutagenicity studies commissioned by Prof. Haley — that is, those cited in the FDA’s June 17, 2008 opinion letter and June 17, 2010 warning letter as indicative of toxicity — they do not provide citations for those studies, or for any other studies that might substantiate this claim.)

Due to copyright regulations, I am unable to provide unrestricted access to the full-text article. Readers are welcome to request a copy for their own, non-commercial use via the comments entry form.


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)

FDA To Haley: OSR#1 A Misbranded, Mislabeled, Unsafe Drug · 70 days ago

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)

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