FDA vs. Dietary Supplement, affects Children with Autism

 

Photo by A. Belani/Flickr

The United States Food and Drug Administration (FDA) has spoken out against OSR #1: a supposedly dietary supplement that is produced by Boyd Haley and sold through his company, CTI Science.  The product is promoted to be used as a treatment for children with autism.  The FDA says that contrary to what OSR #1 is promoted as, it is actually toxic and does not have their approval for consumption.  Additionally, the FDA is arguing that the OSR #1 product does not thoroughly convey what side effects can occur.

The FDA wrote to Haley on June 17th, informing him of his current five violations of the Federal Food, Drug, and Cosmetic Act.  If Haley chooses to ignore the violations, then he is looking at the possibility of his product being taken off shelves, fines, or being prosecuted over the affairHaley has 15 business days to respond to the FDA’s letter before they take action against him.

As of June 24th, he has not yet responded and OSR #1 is still being sold through CTI Science’s website.

Ellen Silbergeld, a student at Johns Hopkins University’s Bloomberg School of Public Health says: “It would be hard to imagine anything worse.  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.”

In their letter to Haley, the FDA stated that OSR #1 contains no dietary ingredient that is defined in the Federal Food, Drug, and Cosmetic Act.  Therefore, it is considered in the FDA’s eyes to be a new drug, and must go through proper safety testing before it can be seen as legal to them.

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One Comment

  1. Posted September 11, 2010 at 6:52 pm | Permalink

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