The Chicago Tribune reports that a letter sent on June 17 by the FDA to retired Kentucky chemist Boyd Haley “details five violations of the Federal Food, Drug and Cosmetic Act related to his product, OSR#1.”
According to the agency, the purported autism treatment “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.”
Environmental health expert Ellen Silbergeld believes the product “represents a clear example of endangerment of public health,” especially because it has “no record of any therapeutic aspect” and is being marketed to children.
An FDA spokeswoman confirmed that the agency had yet to receive any communication from Haley since the letter was sent.
Parents who are considering this untested and potentially unsafe therapy should carefully review any potential risks with their child’s physician before using it.