Boyd Haley Ordered to Stop Illegal Marketing of OSR#1
Stephen Barrett, M.D.
The FDA has issued a warning letter ordering CTI Science, Inc. and its president, Boyd E. Haley, Ph.D. to stop marketing OSR#1 . Haley, a retired chemist, is a professor at the University of Kentucky. OSR#1 contains an industrial chemical called n,N'-bis(2-mercaptoethyl)isophthalamide. The Neurodiversity Weblog describes its background this way:
Prof. Haley is a vocal proponent of the unproven hypothesis that autism is a consequence of mercury poisoning, and of medical therapies that purport to improve health by the chelation of minerals from the body. You may also be aware that Prof. Haley has offered expert testimony in civil lawsuits alleging harm through "mercury poisoning," although the courts have routinely dismissed his testimony as unreliable. He is also a designated expert witness for petitioners in the Omnibus Autism Proceeding (OAP), which consolidates over 5,000 Vaccine Injury Compensation Program claims. As one of the few scientists who assert that environmental mercury exposure leads to autism, Prof. Haley enjoys a hero's status among parents who suspect that their children's autism was induced by thimerosal-containing vaccines.
In February 2007, Prof. Haley registered the corporation "Chelator Technologies" with the Kentucky Department of State. Subsequently, at conferences attended by parents of autistic children and medical professionals who share his unorthodox convictions regarding autism causation, he revealed that he was developing a new drug for the purpose of mercury detoxification. In his lecture at the May 2007 Autism One conference, "Mercury Toxicity and its Relationship to Neurological Diseases," Prof. Haley described his "New Chelator Concept" and favorably compared the substance he was developing with dimercaptosuccinic acid (DMSA)—an FDA-approved drug for the treatment of lead poisoning — and 2,3-dimercapto-1-propanesulfonic acid (DMPS), an unapproved chelation agent.
In January 2008 Prof. Haley amended the name of his corporation from "Chelator Technologies" to "CTI Science." 
In January 2010, the Chicago Tribune reported that the chemical being sold as OSR#1 is part of a family of chelators developed for industrial purposes. The patent document states that its use is for "binding, rendering insoluble, and precipitating a wide range of heavy metals." The paper also reported that, "A search of medical journals unearthed no papers published about OSR#1, though the compound's industrial uses for toxic cleanup have been explored in publications such as the Journal of Hazardous Materials." .
Literature on the CTI Web site has suggested that the product is effective against thyroid conditions, hypertension, and diabetes. However, Haley's main target market appears to be parents of autistic children. During the past two years, he has promoted OSR#1 at conferences, and autism newsgroups have been abuzz with news of its development. In 2008, a member of the ChelatingKids2 newsgroup posted a statement that she said Haley sends out to parents who ask about OSR. According to this statement:
CTI Science is a beginning company and cannot make enough OSR at this time to supply everyone that wants it. Therefore, we are only supplying OSR to MDs or ODs who are treating autistic children .
Similar messages were posted to at least two autism sites frequented by parents who are interested in "biomedical treatment." The "Find a Doctor" directory on the CTI Web site currently lists 743 providers, about 20% of whom are chiropractors and 10% are dentists.
It is illegal to market products for the prevention or treatment of disease unless they have been recognized by experts as safe and effective. To try get around the law, many sellers sometimes claim that the product is a dietary supplement intended to correct some body function associated with a disease and not the disease itself. In line with this strategy, Haley claims that certain conditions are associated with glutathione deficiency and that OSR#1 could help with these problems by raising the body's glutathione levels. (OSR is an abbreviation for Oxidative Stress Relief) The FDA warning letter noted:
- N,N'-bis(2-mercaptoethyl)isophthalamide cannot be used as a "dietary supplement" because it is not a food component.
- Claims that OSR#1 can alter body structure or function make it subject to regulation as a drug.
- It is illegal to market a new drug without FDA approval as safe and effective for its intended use.
- The FDA is concerned about the risk of adverse reactions.
- Failure to promptly correct these violations can result in legal action, without further notice, including seizure and injunction.
This is not the first time that the FDA has cautioned Haley. Manufacturers who propose to market a new dietary ingredient are required to notify the FDA. In 2008, after he did so, the FDA replied that the information he had submitted did not provide an adequate basis for concluding that N,N'-bis(2-mercaptoethyl)isophthalamide "will reasonably be expected to be safe."  Unlike the warning letter, the FDA notice was merely advisory and did not say the product could not be marketed.
Haley responded to the FDA notice with public statements OSR#1 should not be regulated as a drug because it is a combination of naturally occurring substances—benzoate and cystamines—that are found in cranberries and meat. However, this argument is not valid because the resultant chemical, which is not found in nature, is more than the sum of its parts and has not been proven safe or effective . Two weeks later, however, he announced that he would stop selling OSR#1 on July 29, 2010.
- Thompson TC. Warning letter to Boyd E. Haley, June 17, 2010.
- Seidel K. A fine white powder. Neurodiversity Weblog, Aug 1, 2008.
- Tsouderos T. OSR#1: Industrial chemical or autism treatment? Chicago Tribune, Jan 17, 2010.
- Multientate sulfur-containing ligands. Patent No. 6,585,600, July 1, 2003.
- Wrenn A. Re: OSR Boyd's statement. chelatingkids2 newsgroup, July 29, 2008.
- Pellicore LS. Letter to Boyd E. Haley, June 17, 2008.
- Tsouderos T. Supplement seller says FDA may be 'confused.' Chicago Tribune, July 12, 2010.
This article was revised on July 22, 2010.