The FDA's June 17 letter to Boyd Haley, a retired Kentucky chemist and hero to the autism recovery movement, details five violations of the Federal Food, Drug and Cosmetic Act related to his product, OSR#1. Failing to correct such violations can result in fines, seizure of products and even criminal prosecution.
Haley did not reply to repeated requests for an interview Wednesday. An FDA spokeswoman said the agency has not received any communication from Haley, who has 15 working days from the date of the letter to respond.
Last year, Haley told the Tribune: "I am not breaking any law. … We are being very, very careful."
The Web site for Haley's company, Lexington, Ky.-based CTI Science, on Wednesday was still promoting OSR#1 as "a toxicity free, lipid soluble antioxidant dietary supplement," and a reporter was able to order 30 100-milligram capsules of OSR#1 for $60 through an online pharmacy.
In the interview last year, Haley called the product "a food" that is "totally without toxicity." Haley said the compound had been tested on rats, and a food safety study was conducted on 10 people. Asked to provide documentation of the research, he stopped communicating with the Tribune.
The FDA letter lists side effects recorded during Haley's animal studies: "soiling of the anogenital area, alopecia (hair loss) on the lower trunk, back and legs, a dark substance on lower trunk and anogenital area, abnormalities of the pancreas" and a rapid increase in normal cells contained in the lymph nodes.
"It would be hard to imagine anything worse," said Ellen Silbergeld, an expert in environmental health who is studying mercury and autism at Johns Hopkins University's Bloomberg School of Public Health. "An industrial chemical known to be toxic — his own incomplete testing indicates it is toxic. It has no record of any therapeutic aspect of it, and it is being marketed for use in children."
OSR#1 has been promoted on autism Web sites including Age of Autism, where Managing Editor Kim Stagliano wrote of sprinkling the white powder on her three daughters' breakfast sandwiches and orange juice. "We've seen some nice 'Wows!' from OSR," she wrote.
In an e-mail, Stagliano wrote that she continues to support Haley, a regular speaker at autism recovery conferences. "Having met Dr. Haley at conferences, including Autism One in Chicago last month, I continue to trust his science," she wrote on Wednesday. "I'm sure CTI Science will address the letter appropriately."
Pharmacologist Dr. Arthur Grollman, director of the Laboratory for Chemical Biology at State University of New York at Stony Brook, said it is clear from the product's chemical structure that it is a "powerful chelator," a compound that binds to heavy metals such as mercury.
The FDA has approved several chelators as drugs to treat heavy-metal poisoning. Some doctors also use the drugs — which carry significant risks — to treat children with autism on the scientifically unfounded idea that their disorder is linked to toxic metals.
The chemical being sold as OSR#1 is part of a family of chelators originally developed for industrial purposes, according to a U.S. patent issued in 2003 and assigned to the University of Kentucky Research Foundation.
The magazine Medical Veritas in 2006 reported that Haley said he was interested in developing better chelators for people. "We've made compounds that ... work tremendously" in a test tube, he was quoted as saying. "However, we've got to show that they're not toxic. That costs a lot of money and it's very difficult to do, you have to have the right facilities. That's where we're hung up right now, the question is, 'How do we get somebody to do these studies?'"
In January 2008, Haley changed the name of his company from Chelator Technologies Inc. to CTI Science Inc., records show. Less than a month later, he notified the FDA he would be introducing the compound as a new dietary ingredient, a designation rejected by the FDA in its recent letter.
"Because OSR#1 does not bear or contain a dietary ingredient as defined (by the food and drug act), this product does not qualify as a dietary supplement," the letter states.
Instead, according to the letter, it is a new drug. Winning FDA approval requires proof of safety and efficacy through clinical trials, a process that can cost hundreds of millions of dollars and take many years.
"Anything might be a cure for anything else, but the odds are it will do nothing and it might very well be toxic," said Richard Mailman, a neuropharmacologist at Penn State University. "That is why drug discovery and development is so expensive."
Silbergeld said the product represents a clear example of endangerment of public health and that the FDA should stop CTI Science from selling it immediately. She drew a comparison to a city's drinking water system: If contamination is found, she said, "they turn off the pumps."
"They don't have to engage in a long discussion with you," Silbergeld said. "It would be hard to imagine a more clear example of immediate endangerment of public health. Turn off the pump."