Controversial supplement to come off shelves

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http://www.chicagotribune.com/health/ct-met-autism-treatment-pulled-20100726,0,6\

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Controversial supplement to come off shelves

Product FDA called 'unapproved drug' is popular in autism cases

By Trine Tsouderos, Tribune reporter

5:11 p.m. CDT, July 26, 2010

Pharmacies are halting sales of OSR#1, a compound marketed as a dietary

supplement to parents of children with autism, six weeks after the U.S. Food and

Drug Administration called the product an unapproved new drug.

Several pharmacists told the Tribune they received an e-mail last week from Boyd

Haley, president of the company that makes the product, informing them that

OSR#1 would not be available after Thursday.

One online pharmacy, Forrest Health, posted this message: " CTI Science has

voluntarily agreed to remove OSR#1® from the market effective Thursday, 29 July

2010. "

The product, sold as a toxicity-free antioxidant supplement, was featured on

autism Web sites such as Age of Autism, whose managing editor described

sprinkling it in her children's juice and breakfast sandwiches.

The Tribune reported in January that the compound had been developed as an

industrial chemical used to treat mining wastewater, an issue apparently first

raised by blogger Kathleen Seidel of neurodiversity.com.

On June 17, the FDA sent Haley a warning letter calling the product an

unapproved new drug with false or misleading labeling regarding side effects.

Failing to correct such violations can result in fines, seizure of products and

even criminal prosecution.

Haley did not respond to requests for an interview Monday. An FDA spokeswoman

said the agency had not heard from Haley or CTI Science.

Ellen Silbergeld, an expert in environmental health who is studying mercury and

autism at s Hopkins University's Bloomberg School of Public Health, urged

the FDA to monitor the company to ensure it does not continue selling the

product.

" It is welcome news, but in these conditions, without government action, the

situation remains unsettled, " Silbergeld said.

A number of pharmacies listed on the CTI Science Web site as sellers of the

product reported they were no longer selling OSR#1.

" We sold out last week, " said pharmacist Kurt Moyer of Dr. Aziz Pharmacy in

Indianapolis, which last week posted a message on the company Facebook page:

" OSR#1 will no longer be available after July 29, 2010 and there is no

anticipated release date, so once we sell out we will not be able to order

additional stock. "

Forrest Health urged customers to stock up while they still could. On Monday,

online customers wanting to purchase OSR#1 were required to buy a minimum of

three 30-capsule boxes at $60 each.

" OSR is going off the market, " the site declared Friday. " We are stocking up as

much as we can but supplies are going fast. We suggest you purchase large

quantities if you want to assure availability. "

Calls to Forrest Health were not returned.

The FDA's warning letter was enough to prompt Koutsaris, president of

Spectrum Supplements in Olean, N.Y., to stop selling OSR#1. " Obviously, the No.

1 concern for us is the health of the customer, " Koutsaris said.

According to Koutsaris, Haley indicated in his e-mail that he would be seeking

approval for OSR#1 as a new drug from the FDA. That process can cost hundreds of

millions of dollars and take many years with no guarantee of success.