PharmaSentry :: FDA 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 [Chicago Tribune]

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FDA warns maker of product used as alternative autism treatment: OSR#1 is n..
From Chicago Tribune (IL) 24-Jun-2010
June 24--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.

Key Concepts
• FDA
• toxicity
• OSR
• autism
• drugs
• dietary supplement
• food
• Tribune
• hair loss
• abnormalities of the pancreas
• chelators
• compounds
• CTI Science
• Silbergeld
• lower trunk

Summary

•	FDA 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 [Chicago Tribune]
•	June 24--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.