Published on:

FDA warns product maker that autism supplement is toxic and unapproved

In a letter to Boyd Haley, a retired Kentucky chemist who produced OSR #1, the U.S. Food and Drug Administration (“FDA”) warned that the product promoted to parents of children with autism is not a harmless dietary supplement as claimed. Rather, the FDA states that the product OSR #1 is a toxic unapproved drug that lacks adequate warnings about the product’s potential side effects. The product’s potential dangerous side effects include hair loss and abnormalities of the pancreas. The product liability letter from the FDA details five product violations of the Federal Food, Drug and Cosmetic Act and failing to correct such violations can result in fines, seizure of products, and even criminal prosecution.

In January, The Chicago Tribune reported that OSR #1 had originally been developed to treat mining wastewater and had not undergone rigorous testing to ensure its safety and effectiveness. The website for the product promotes it as a “toxicity free, lipid soluble antioxidant dietary supplement,” which one is able to order through an online pharmacy. The retired chemist reportedly told the Tribune in an interview that the product had been tested on rats and a safety study was conducted on 10 individuals. Contrary to the developer’s contentions, the FDA letter lists side effects recorded during the animal studies, including soiling of the anogenital area, alopecia on the lower trunk, back and legs, a dark substance on the lower truck and anogenital area, and abnormalities of the pancreas.

The Chicago product liability lawyers at Levin & Perconti are worried about the potential harmful effects of this product that has not been rigorously tested. Particularly concerning, the product has been promoted to parents with autistic children, who are anxious for any product that may safely help their children. OSR #1 has been promoted on websites such as Age of Autism, where the managing editor said that she had sprinkled the product on her daughters’ food and saw some nice “wows!”. For your safety, please be sure to check whether any products you use are FDA approved.

Click the link to read the Chicago Tribune OSR #1 product liability article.