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Posted June 24, 2010

FDA Warns Seller of Pills Used to Treat Autism

On June 17, 2010 the U.S. Food and Drug Administration (FDA) sent a Warning Letter of legal violations to CTI Science, Inc., the marketer of OSR#1. The product is marketed as a supplement, but contains an ingredient that is not legally permitted to be sold as a supplement.

According to an article in the Chicago Tribune, OSR#1 is promoted to parents of children with autism. Its main ingredient, N1,N3-bis(2-mercaptoethyl)isophthalamide, is a chelating agent (a compound used to bind and remove metals). The FDA's letter indicates that the CTI Sciences website provides misleading information about the safety of the product as animal studies conducted by CTI "...found various side effects to be associated with OSR#1 use, including, but not limited to, soiling of the anogenital area, alopecia on the lower trunk, back and legs, a dark substance on lower trunk and anogenital area, abnormalities of the pancreas, and lymphoid hyperplasia." Based on these studies and side effects known to be associated with chelating products that have a similar mechanism of action to OSR#1, the FDA believes use of the product has the potential to cause side effects.

CTI Scieneces was given fifteen days to notify the FDA of corrective actions.