FDA Warns Maker of Chelation/Antioxidant Pills OSR#1

Antonio Perez, Chicago Tribune

Update:  See this post by Orac on Haley's response to the FDA warning.

I previously wrote a post about a chelating agent marketed as an antioxidant supplement called OSR#1, an unproven product that's been given to children to "treat" autism.  So far it's unclear whether these little pills have any therapeutic effect (seems doubtful) and whether or not they're safe (seems like they're not).

Well the FDA has been paying attention, and recently issued a warning to the maker: CTI Science (previously Chelation Technologies Inc.) run by president and CEO, Boyd Haley.  You can read the full letter from the FDA website.

(No worries - I'll pause here while you read the FDA's letter...)

Journalist Trine Tsouderos of The Chicago Tribune writes...

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.

The Tribune in January reported that the compound, sold as OSR#1, had been developed to treat mining wastewater, and that it had not undergone rigorous testing to ensure it is safe and effective. The report was part of an investigation into unproven autism therapies offered by health providers who say they can reverse the disorder.

Haley did not reply to repeated requests for an interview Wednesday. An FDA spokeswoman said the agency has not received any communication from Haley, who has 15 working days from the date of the letter to respond.
...

In the interview last year, Haley called the product "a food" that is "totally without toxicity." Haley said the compound had been tested on rats, and a food safety study was conducted on 10 people. Asked to provide documentation of the research, he stopped communicating with the Tribune.

The FDA letter lists side effects recorded during Haley's animal studies: "soiling of the anogenital area, alopecia (hair loss) on the lower trunk, back and legs, a dark substance on lower trunk and anogenital area, abnormalities of the pancreas" and a rapid increase in normal cells contained in the lymph nodes.

Continue reading at the Chicago Tribune...

Ouch!

Over at Boyd Haley's OSR1 twitter feed, there hasn't been much action since their last exposure in the Chicago Tribune. Here's the feed as of June 25...

My BS meter tends to go crazy when someone responds to criticism with something like "the truth is at [my website]". Also, that earlier Chicago Tribune article Haley is referring to is this one, also written by Trine Tsouderos.

For more details on Boyd Haley and the autism community, jump over to Respectful Insolence and read Orac's post, Pumping autistic children full  of an industrial chelator (revisited).