FDA: Autism 'Therapy' Illegal - LA Times 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. "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."