SchaferAutismReport: FDA Warns Maker Of Product Used As Alternative Autism Treatment

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TREATMENTFDA Warns Maker Of Product Used As Alternative Autism Treatment OSR#1 is not a dietary supplement but a toxic, unapproved drug with serious potential side effects, FDA warns By Trine Tsouderos, Tribune xrl.in/5owt

A product promoted to parents of children with autism is not a harmless dietary supplement, as claimed, but a toxic unapproved drug that lacks adequate warnings about potential side effects, including hair loss and abnormalities of the pancreas, the U.S. Food and Drug

Administration has warned in a letter to its maker. 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. The

Tribune in January reported that the compound, sold as OSR#1, had been developed to treat mining wastewater, and that it had not undergone rigorous testing to ensure it is safe and effective. The report was part of an investigation into unproven autism therapies offered by health providers who say they can reverse the disorder. 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

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